2012/0278(COD)

Proposal for a regulation
Recital -1a (new)

(-1a) The Union has put in place an ‘EU Biodiversity Strategy to 2020’, which commits it to step up its contribution to averting global biodiversity loss by 2020;

Amendment 2 #

Proposal for a regulation
Recital 3a (new)

(3a) It is important to recall that according to the European Patent Convention plant and animal varieties (Article 53(a)) as well as biological processes for the production of plants and animals (Article 53(b)) are not patentable. When inventions are based on genetic resources or on components of genetic resources, applications for patents covering inter alia genetic resources, products, including derivates, and processes derived from the use of biotechnology, or traditional knowledge associated with the genetic resource, the resources should be indicated and their origin should be provided to the relevant authorities and transmitted to the competent authority. The same obligation should apply to new plant variety rights.

Amendment 3 #

Proposal for a regulation
Recital 6

(6) The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity (the Nagoya Protocol) is an international treaty adopted on 29 October 2010 by the Parties to the Convention. The Nagoya Protocol significantly expands the general rules of the Convention on access and benefit- sharing for the usetilisation and subsequent commercialisation of genetic resources and traditional knowledge associated with genetic resources.

Amendment 4 #

Proposal for a regulation
Recital 9

(9) In order to ensure legal certainty, it is important that the rules implementing the Nagoya Protocol should only apply to genetic resources and traditional knowledge associated with genetic resources that are accessed or utilised after the entry into force of the Nagoya Protocol for the Union.

Amendment 5 #

Proposal for a regulation
Recital 14

(14) With a view to ensuring an effective implementation of the Nagoya Protocol, all users of genetic resources and traditional knowledge associated with such resources should have to exercise due diligence to ascertain that the genetic resources and associated traditional knowledge used were accessed in accordance with applicable legal requirements and to ensure that, where relevant, benefits are shared. Users However, given the diversity of users within the Union it is not appropriate to oblige all users to take the same measures for exercising due diligence. Therefore, only minimum features of due diligence measures should be set out. The specific choices taken by users on the tools and measures applied for exercising due diligence should be supported through the recognition of best practices as well as complementary measures in support of sectoral codes of conduct, model contractual clauses, and guidelines with a view to increasing legal certainty and reducing costs. The obligation on users to keep information relevant for access and benefit-sharing, in particular documented proof that benefit-sharing obligations have been fully and legally carried out, should be limited in time, consistent with the time-span for an eventual innovation.

Amendment 6 #

Proposal for a regulation
Recital 14a (new)

(14a) The successful implementation of the Nagoya Protocol depends on users and providers of genetic resources or of traditional knowledge associated with genetic resources negotiating mutually agreed terms that not only lead to fair benefit-sharing, but also contribute to the Protocol's wider objective of contributing to the conservation of biological diversity.

Amendment 7 #

Proposal for a regulation
Recital 16

(16) Best practices developed by users should play an important role in identifying due diligence measures that are particularly suitable for achieving compliance with the system of implementation of the Nagoya Protocol with high legal certainty and at low costs. Users should be enabled to build on existing access and benefit-sharing codes of conduct developed for the academic sector and different industries. Associations of users should be able to request that the Commission determines whether a specific combination of goals, activities, procedures, tools or mechanisms overseen by an association may be recognised as best practice. Competent authorities of the Member States should consider that the implementation of a recognised best practice by a user reduces that user's risk of non-compliance and justifies a reduction in compliance checks. The same should apply to best practices adopted by the collective of the Parties to the Nagoya Protocol.

Amendment 8 #

Proposal for a regulation
Recital 19

(19) Collections are ~~major~~the most accessible suppliers of genetic resources and traditional knowledge associated with genetic resources utilised in the Union. A system of Union trusted collections should be set in place. It would ensure that collections included in the register of Union trusted collections effectively apply measures to only supply samples of genetic resources to third persons with documentation providing evidence of legal acquisition and the establishment of mutually agreed terms, where required. A system of Union trusted collections should substantially lower the risk that illegally acquired genetic resources are utilised in the Union. Competent authorities of Member States would verify if a collection meets the requirements for recognition as Union trusted collection, including demonstrating the capacity to respect the broad objectives of the Nagoya Protocol in terms of achieving a fair and equitable sharing of the benefits arising from the utilisation of genetic resources and contributing to the conservation of biodiversity. Users that acquire a genetic resource from a collection listed in the Union register should be considered to have exercised due diligence as regards the seeking of all necessary information. This should prove particularly beneficial for academic researchers as well as small and medium sized enterprises.

Amendment 9 #

Proposal for a regulation
Recital 25a (new)

(25a) The Union and Member States, for the purposes of fully implementing the Nagoya Protocol over coming years, should consider taking complementary measures under their respective research and development (R&D), agricultural and development policies to intensify cooperation with developing countries aimed at reinforcing their capacities for the conservation of biological diversity.

Amendment 10 #

Proposal for a regulation
Article 1 – paragraph -1 (new)

(-1) The objective of this Regulation is the fair and equitable sharing of the benefits arising from the utilisation of genetic resources thereby contributing to the conservation of biological diversity and the sustainable use of its components, in accordance with the objectives of the Convention on Biological Diversity.

Amendment 11 #

Proposal for a regulation
Article 2 – paragraph 1

This Regulation applies to genetic resources over which states exercise sovereign rights and to traditional knowledge associated with genetic resources that are accessed or utilised after the entry into force of the Nagoya Protocol for the Union. It also applies to the benefits arising from the use of such genetic resources and to traditional knowledge associated with genetic resources.

Amendment 12 #

Proposal for a regulation
Article 3 – paragraph 3

(3) "genetic resources" means genetic material of actual or potential value, or derivatives thereof;

Amendment 13 #

Proposal for a regulation
Article 3 – paragraph 4a (new)

(4a) “derivative” means a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity;

Amendment 14 #

Proposal for a regulation
Article 3 – paragraph 5

(5) "user" means a natural or legal person utilising genetic resources or traditional knowledge associated with genetic resources or subsequently commercialising genetic resources or products based on genetic resources, or traditional knowledge associated with genetic resources;

Amendment 15 #

Proposal for a regulation
Article 3 – paragraph 6

(6) "usetilisation of genetic resources" means to conduct research and development on the genetic or biochemical composition of genetic resources including through the application of biotechnology;

Amendment 16 #

Proposal for a regulation
Article 3 – paragraph 8

(8) "traditional knowledge associated with genetic resources" means traditional knowledge held by an indigenous or local community that is relevant for the use of genetic ~~resources and that is as such described in the mutually agreed terms applying to the use of genetic~~ resources;

Amendment 17 #

Proposal for a regulation
Article 3 – paragraph 8 a (new)

(8a)"biopiracy" means utilisation, or subsequent commercialisation of illegally acquired genetic resources or products derived from such resources, or associated traditional knowledge;

Amendment 18 #

Proposal for a regulation
Article 4 – paragraph -1 (new)

(-1) Biopiracy shall be prohibited in the Union.

Amendment 19 #

Proposal for a regulation
Article 4 – paragraph 1

1. Users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources used were accessed ~~in accordance with~~with prior informed consent and based on mutually agreed terms as defined by applicable access and benefit-sharing legislation or regulatory requirements and that~~, where relevant,~~ benefits are fairly and equitably shared upon mutually agreed terms. Users shall seek, keep, and transfer to subsequent users all information and documents relevant for access and benefit- sharing and compliance with the provisions of this Regulation, in particular all documented proof that benefit-sharing obligations have been fully and legally carried out.

Amendment 20 #

Proposal for a regulation
Article 4 – paragraph 1a (new)

1a. Genetic resources and associated traditional knowledge shall only be transferred to other users if in accordance with prior informed consent and mutually agreed terms. Subsequent users may only utilise the material received in accordance with the original terms. If there is no prior informed consent and mutually agreed terms or subsequent users anticipate to utilise the genetic resources or traditional knowledge under conditions that are not included in the original terms, they are required to seek new prior informed consent from the country of origin and new mutually agreed terms preceding commencement of new utilisation.

Amendment 21 #

Proposal for a regulation
Article 4 – paragraph 4a (new)

4a. Users, when negotiating mutually agreed terms with providers of genetic resources or of traditional knowledge associated with genetic resources, shall seek to ensure that such terms contribute to the conservation of biological diversity and the sustainable use of its components and to technology transfer to developing countries.

Amendment 22 #

Proposal for a regulation
Article 5 – paragraph 1

1. In order to ensure that only genetic resources acquired in accordance with applicable requirements are supplied, a voluntary system of Union trusted collections is hereby established. The Commission shall establish and maintain a Union register of trusted collections. That register shall be open format, internet- based, easily accessible to users, and shall include the collections of genetic resources identified as meeting the criteria of Union trusted collection.

Amendment 23 #

Proposal for a regulation
Article 5 – paragraph 3– point -a (new)

(-a) respect the broad objectives of the Nagoya Protocol, working towards a fair and equitable sharing of the benefits arising from the utilization of genetic resources whilst simultaneously contributing to the conservation of biodiversity;

Amendment 24 #

Proposal for a regulation
Article 6 – paragraph 3a (new)

3a. The competent authorities and the focal point on access and benefit-sharing shall provide advice to the public and potential users seeking information on the implementation of this regulation and the relevant provisions of the Convention and the Nagoya Protocol in the Union.

Amendment 25 #

Proposal for a regulation
Article 7 – paragraph 1

1. Member States and the Commission shall request all recipients of public research funding involving uses of genetic resources and traditional knowledge associated with genetic resources to declare that they will exercise due diligence in accordance with Article 4.Deleted

Amendment 26 #

Proposal for a regulation
Article 7 – paragraph 2

2. Users shall declare to the competent authorities established under Article 6(1) that they ~~exercised due diligence in accordance with Article 4 on the occasion of~~have complied with the provisions of Article 4 and shall submit the related information on the occasion of: (a) establishing prior informed consent and mutually agreed terms; (b) receiving research funding involving utilisation of genetic resources and traditional knowledge associated with genetic resources; (c) applying for patents or for new plant variety rights at relevant national, regional or international institutions covering inter alia the accessed genetic resources, products, including derivates, and processes derived from the use of biotechnology, or traditional knowledge associated with the genetic resource; (d) requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources, or (e) at the time of commercialisation where a market approval is not required.

Amendment 27 #

Proposal for a regulation
Article 7 – paragraph 3

3. Competent authorities shall verify the information provided under points (b) to (e) and transmit to the Commission ~~every two year~~within three months the information received ~~on the basis of paragraphs 1 and 2~~pursuant to this article. The Commission shall within three months summarise the information received and make ~~it available to the Access and Benefit-sharing Clearing House~~the information required for the internationally recognised certificate available to the Access and Benefit-sharing Clearing House as well as to the public in an easily accessible open format.

Amendment 28 #

Proposal for a regulation
Article 8 – paragraph 1

1. Any association of users or organisation with interest and expertise in the utilisation of genetic resources and access and benefit sharing may submit an application to the Commission for recognising as best practice a combination of goals, activities, procedures, tools or mechanisms developed and overseen by it. The application shall be supported by evidence and information. In considering applications for recognition of best practice, the Commission shall give priority to goals, activities, procedures, tools or mechanisms that contribute to: - the conservation of biological diversity and the sustainable use of its components; - technology transfer; - poverty eradication in developing countries.

Amendment 29 #

Proposal for a regulation
Article 8 – paragraph 2

2. The Commission shall assess each application, taking into account information and evidence from the applicant, relevant providers, users, authorities, institutions, inter- governmental and non-governmental organisations, as well as representatives of indigenous and local communities and other actors, as appropriate. Where, on the basis of information and evidence supplied to it by an association of users , the Commission determines that the specific combination of goals, activities, procedures, tools or mechanisms, when effectively implemented by a user, enables the user to comply with its obligations set out in Articles 4 and 7, it shall grant recognition as best practice.

Amendment 30 #

Proposal for a regulation
Article 10 – paragraph 2

2. The information referred to in paragraph 1 shall be made available in accordance with Directive 2003/4/EC in an easily accessible open format.

Amendment 31 #

Proposal for a regulation
Article 11 – paragraph 2 – point b

(b) immediate suspension of specific use activities, including withdrawal of market approval or of the right of commercialision of products or suspension of research and development activities;

Amendment 32 #

Proposal for a regulation
Article 12 – paragraph 2 a (new)

2a. The Commission shall seek arrangements with the European Patent Office and with the World Intellectual Property Organization to ensure that references to genetic resources and their origin are included in patent registrations.

Amendment 33 #

Proposal for a regulation
Article 14 – point d a (new)

(da) take measures to support users that contribute to the conservation of biological diversity and cultural diversity with limited means to become trusted collections;

Amendment 34 #

Proposal for a regulation
Article 14 – point d b (new)

(db) support, under their respective research and development (R&D) agricultural and development policies: - capacity-building activities in developing countries aimed at reinforcing their administrative and legal structures for the purposes of successfully implementing the Nagoya Protocol; - technology transfer aimed at increasing developing countries' capacities for the conservation of biological diversity and the sustainable use of its components;

source: PE-507.964

2013/03/28 DEVE 80 amendments...

Amendment 1 #

Proposal for a regulation
Citation -1 (new)

Having regard to the Convention on Biological Diversity and to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization,

Amendment 2 #

Proposal for a regulation
Recital (2)

(2) Genetic resources represent the gene pool in both natural and cultivated or domesticated stocks and play a significant and growing role in many economic sectors including food production, forestry, ~~development~~biotechnology, development and production of medicines, cosmetics or development of bio-based sources of renewable energy.

Amendment 3 #

Proposal for a regulation
Recital (3)

(3) Traditional knowledge that is held by indigenous and local communities may provide important lead information for the scientific discovery of ~~interesting genetic~~potentially valuable genetic or biochemical properties of genetic resources, including knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use orf bio~~chemical properties of genetic resource~~logical diversity. Rights of such communities laid down in Convention No 169 of the International Labour Organisation on Indigenous and Tribal Peoples and also set out in the UN Declaration on the Rights of Indigenous Peoples adopted by the UN General Assembly in 2007 should be respected and EU implementing measures should facilitate this.

Amendment 4 #

Proposal for a regulation
Recital (3a) (new)

(3a) It is important to recall that according to the European Patent Convention plant and animal varieties (Article 53(a)) as well a biological processes for the production of plants and animals (Article 53(b)) are not patentable. When inventions are based on genetic resources or on components of genetic resources, applications for patent covering inter alia genetic resources, products, including derivates, and processes derived from the use of biotechnology, or traditional knowledge associated with the genetic resource, the resources should be indicated and their origin should be provided to the relevant authorities and transmitted to the competent authority. The same obligation should apply to new plant variety rights.

Amendment 5 #

Proposal for a regulation
Recital (4a) (new)

(4a) Genetic resources should be preserved "in situ" and used in sustainable ways and the benefits arising out of their utilisation should be fairly and equitably shared. As parties to the Convention on Biological Diversity, the EU and its Member States have committed themselves to these principles. The EU and its Member States have also signed the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation. Capacity to effectively implement this Protocol should be built up.

Amendment 6 #

Proposal for a regulation
Recital (4b) (new)

(4b) Benefit-sharing should be seen in a context where biodiversity-rich developing countries dominate the provision of genetic resources, while users are mainly found in developed countries. In addition to having the potential to contribute to conservation and sustainable use of biodiversity, access and benefit-sharing can contribute to poverty eradication and environmental sustainability and thereby to the progress towards the Millennium Development Goals, as acknowledged in the preamble of the Nagoya Protocol. The implementation of the Nagoya Protocol should also aim at realising these potentials.

Amendment 7 #

Proposal for a regulation
Recital (4c) (new)

(4c) The right to food, laid down in Article 25 of the Universal Declaration of Human Rights and Article 11 of the International Covenant on Economic, Social and Cultural Rights, as well as the right to the enjoyment of the highest attainable standard of health recognised in Article 12 of the International Covenant on Economic, Social and Cultural Rights, are of superior importance and must always be protected.

Amendment 8 #

Proposal for a regulation
Recital (4d) (new)

(4d) Like the genetic resources, traditional knowledge associated with such resources is largely concentrated in developing countries, in particular in indigenous and local communities. Rights of such communities laid down in Convention No 169 of the International Labour Organisation on Indigenous and Tribal Peoples and also set out in the UN Declaration on the Rights of Indigenous Peoples adopted by the UN General Assembly in 2007 should be respected and EU implementing measures should facilitate this.

Amendment 9 #

Proposal for a regulation
Recital (5)

(5) The Convention recognises that states have sovereign rights over natural resources found within their jurisdiction and the authority to determine access to their genetic resources. The Convention imposes an obligation on all Parties to facilitate access to genetic resources, for environmentally sound uses by other Parties, over which they hold sovereign rights. It also makes it mandatory for all Parties to take measures to share in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Party providing these resources. Such sharing shall be upon the prior informed consent requirement of the country of origin of this resource and the benefits shall be based on mutually agreed terms. The Convention also addresses access and benefit-sharing in relation to the knowledge, innovations and practices of indigenous and local communities relevant for the conservation and sustainable use of biological diversity.

Amendment 10 #

Proposal for a regulation
Recital (6)

(6) The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity (the Nagoya Protocol) is an international treaty adopted on 29 October 2010 by the Parties to the Convention12. The Nagoya Protocol significantly expands the general rules of the Convention on access and benefit- sharing for the usetilisation and subsequent commercialisation of genetic resources and traditional knowledge associated with genetic resources.

Amendment 11 #

Proposal for a regulation
Recital (8)

(8) It is important to set out a clear and sound framework for implementing the Nagoya Protocol that should ~~enhance opportunities av~~support its main objective, notably the conservation of biological diversity and sustailnable ~~for nature-based research and development activities in the Union. It is also essential to~~use of its components and the fair and equitable sharing of the benefits arising from the utilization of genetic resources. This includes preventing the use of illegally acquired genetic resources or traditional knowledge associated with ~~genetic~~such resources in the Union and to support the effective implementation of benefit-sharing commitments set out in mutually agreed terms between providers 1 Annex I to Document UNEP/CBD/COP/DEC/X/1 of 29 October 2010.. 2 Annex I to Document UNEP/CBD/COP/DEC/X/1 of 29 October 2010.. and users. It is also essential to enhance opportunities available for nature-based research and development activities in the Union, in particular by improving the conditions for legal certainty in connection with the use of genetic resources and traditional knowledge.

Amendment 12 #

Proposal for a regulation
Recital (8a)

(8a) Biopiracy consisting of either unauthorised extraction of genetic resources, or unauthorised utilisation or subsequent commercialisation of products based on such resources or associated traditional knowledge, should be prohibited and subject to criminal sanctions in accordance with Directive 2008/99/EC.

Amendment 13 #

Proposal for a regulation
Recital (8b)

(8b) The framework created by this regulation is needed also to maintain and increase trust between Parties, indigenous and local communities as well as stakeholder groups involved in access and benefit sharing of genetic resources.

Amendment 14 #

Proposal for a regulation
Recital (9)

(9) In order to ensure legal certainty, it is important that the rules implementing the Nagoya Protocol should only apply to new acquisition and new utilisation of genetic resources and traditional knowledge associated with genetic resources that ~~are access~~has commenced after the entry into force of the Nagoya Protocol for the Union.

Amendment 15 #

Proposal for a regulation
Recital (10)

(10) Council Decision 2004/869/EC of 24 February 2004 concerning the conclusion, on behalf of the European Ccommunity, of the International Treaty on Plant Genetic Resources for Food and Agriculture ~~International Treaty on Plant Genetic Resources for Food and Agriculture1~~ approved that Treaty on behalf of the Union. That Treaty constitutes a separate, specialized international access and benefit-sharing instrument ~~that should not be affected by the rules implementing the Nagoya Protocol. 1~~ with its own implementing arrangements. Or. en OJ L 378, 23.12.2004, p. 1.

Amendment 16 #

Proposal for a regulation
Recital (11)

(11) It is important to define, in accordance with the Nagoya Protocol, that usetilization of genetic resources refers to research and development on the genetic or biochemical composition of samples of genetic material, which includes research and development on isolated compounds extracted from genetic material that was accessed in a Party to the Nagoya Protocol.

Amendment 17 #

Proposal for a regulation
Recital (14)

(14). With a view to ensuring an effective implementation of the Nagoya Protocol, all users of genetic resources and traditional knowledge associated with such resources should have to exercise due diligence to ascertain that the genetic resources and associated traditional knowledge used were accessed in accordance with applicable legal requirements and to ensure that~~, where relevant, benefits are shared~~ fair and equitable benefit-sharing occurs whenever this should be the case. However, given the diversity of users within the Union it is not appropriate to oblige all users to take the same measures for exercising due diligence. T~~herefore, only minimum f~~ools and meatsures ~~of due diligence measures should be set out. The specific choices taken by users on the tools and measures applied for exercising due diligence~~applied for facilitating the exercise of due diligence which have been shown to be reliable and efficient should be supported through the recognition of best practices ~~as well as complementary measures in support of s~~. Sectoral codes of conduct, model contractual clauses, and guidelines should also be supported with a view to increasing legal certainty and reducing costs. The obligation on users to keep information relevant for access and benefit- sharing should be limited in time, consistent with the time-span for an eventual innovation.

Amendment 18 #

Proposal for a regulation
Recital (16)

(16) Best practices developed by users ~~should play an important role in identifying~~or organisation with interest and expertise in the utilisation of genetic resources and access and benefit sharing should be evaluated. When found useful and consistent with the Nagoya Protocol and this Regulation, they should be drawn upon in the identification of due diligence measures that are particularly suitable for achieving compliance with the system of implementation of the Nagoya Protocol with high legal certainty and at low costs. Users should be enabled to build on existing access and benefit-sharing codes of conduct developed for the academic sector and different industries provided that they facilitate users' compliance with their obligations, which will include fair and equitable benefit-sharing. Associations of users should be able to request that the Commission determines whether a specific combination of procedures, tools or mechanisms overseen by an association may be recognised as best practice for facilitating compliance with user obligations. Competent authorities of the Member States should consider that the implementation of a recognised best practice by a user reduces that user's risk of non-compliance and justifies a reduction in compliance checks. The same should apply to best practices adopted by the collective of the Parties to the Nagoya Protocol.

Amendment 19 #

Proposal for a regulation
Recital (17)

(17) Users should declare at identified points in the chain of activities that ~~constitute use that~~ they have exercised due diligence, and provide evidence to that effect. Suitable points for such declarations are the ~~receiving of public research fund~~establishment of prior informed consent and mutually agreed terms, the receiving of research funds, when applying for intellectual property rights at relevant national, regional or international institutions, when a market approval for a product developed on the basis of genetic resources is requested or at the time of commercialisation where a market approval is not required. Notably, the declaration made upon occasion of applying for intellectual property rights or requesting market approval would not constitute part of the approval procedure as such and would be directed to competent authorities established under this Regulation.

Amendment 20 #

Proposal for a regulation
Recital (18)

(18) Collecting of genetic resources in the wild is mostly undertaken for non- commercial purposes by university-based researchers or collectors. In the vast majority of cases and in almost all sectors, access to newly collected genetic resources is gained through intermediaries, collections, or agents that acquire genetic resources in third countries. This Regulation should ensure that the provisions of mutually agreed terms for the initial access relevant for third party transfer are followed by all parties involved. In many cases subsequent utilisation or commercialisation might require new prior informed consent and mutually agreed terms.

Amendment 21 #

Proposal for a regulation
Recital (19)

(19) CMost collections are ~~major~~the most accessible suppliers of genetic resources and traditional knowledge associated with genetic resources utilised in the Union. As suppliers they can play an important role in helping other users in the chain of custody to comply with their obligations. In order to do so a system of Union trusted collections should be set in place. It would ensure that collections included in the register of Union trusted collections effectively apply measures to only supply samples of genetic resources to third persons with documentation providing evidence of legal acquisition and the establishment of mutually agreed terms, where required. A system of Union trusted collections should substantially lower the risk that illegally acquired genetic resources are used in the Union. Competent authorities of Member States would verify if a collection meets the requirements for recognition as Union trusted collection. Users that acquire a genetic resource from a collection listed in the Union register should be considered to have exercised due diligence as regards the seeking of all necessary information. This should prove particularly beneficial for academic researchers as well as small and medium sized enterprises.

Amendment 22 #

Proposal for a regulation
Recital (19 a) (new)

(19a) Union trusted collections should adhere to the objective of the Nagoya Protocol. They should contribute to awareness raising and capacity-building, in line with that Protocol's Articles 21 and 22, to the extent that the resources at their disposal so permit. Competent authorities may consider providing funding to collections for such activities. Every Union trused collection should seek to contribute to efforts to document traditional knowledge associated with genetic resources, in cooperation with indigenous and local communities, authorities, anthropologists and other actors, as appropriate. Such knowledge must be handled with full respect for relevant rights. Information on such knowledge should be publicised when this serves and does not in any way contravene or hamper the protection of relevant rights.

Amendment 23 #

Proposal for a regulation
Recital (21 (a) (new)

(21a). The Nagoya Protocol's Article 18 prescribes that each Party shall ensure that an opportunity to seek recourse is available under their legal systems, consistent with applicable jurisdictional requirements, in cases of disputes arising from mutually agreed terms. The agreements on the terms will be private law agreements. As parties to the Nagoya Protocol, Member States of the EU must put in place recourse mechanisms. These mechanisms should be as similar as possible.

Amendment 24 #

Proposal for a regulation
Recital (22 (a) (new)

(22a) The European Union should act in a proactive manner to ensure that the objectives of Nagoya Protocol regarding global multilateral benefit-sharing mechanims are achieved in order to increase resources to support of conservation of biological diversity and the sustainable use of its component globally.

Amendment 25 #

Proposal for a regulation
Recital (22 (b) (new)

(22b) The principle of benefit sharing as enshrined in Article 10 of the Nagoya Protocol should be implemented on the Union side awaiting the establishment of a global multilateral mechanism as envisaged in the Protocol. Until the multilateral mechanism is in place, a Union Benefit Sharing Fund should be established to collect benefit-sharing contributions and channel them to the conservation of biological diversity globally. To that end, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of detailed criteria and rules for benefit sharing in situations where genetic resources originate from areas beyond the jurisdiction of the Member States, or the country of origin of such resources cannot be established, or it is not possible to grant or obtain prior informed consent. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

Amendment 26 #

Proposal for a regulation
Recital (23)

(23) A Union platform on access and fair and equitable benefit-sharing should enable discussions on and contribute to the streamlining of access conditions in Member States, the design and performances of access and benefit- sharing regimes, simplified access and benefit-sharing for non-commercial research, access and benefit-sharing practices of collections in the Union, access and benefit-sharing of Union stakeholders in third countries and the sharing of best practices.

Amendment 27 #

Proposal for a regulation
Article 1 – subparagraph -1 (new)

The objective of this Regulation is the fair and equitable sharing of the benefits arising from the utilisation of genetic resources thereby contributing to the conservation of biological diversity and the sustainable use of its components, in accordance with the objectives of the Convention on Biological Diversity.

Amendment 28 #

Proposal for a regulation
Article 1 – subparagraph 1

This Regulation establishes rules governing access and fair and equitable benefit-sharing for genetic resources and traditional knowledge associated with genetic resources, in accordance with, and support of the provisions of the Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation to the Convention on Biological Diversity (the Nagoya Protocol).

Amendment 29 #

Proposal for a regulation
Article 1 – subparagraph 2 (new)

This regulation lays down obligations for users of genetic resources and traditional knowledge associated with genetic resources. The system for implementing the Nagoya Protocol established by this regulation also includes arrangements for facilitating user compliance with their obligations and a framework for monitoring and control arrangements to be elaborated and put in place by the Member States of the Union. This regulation also includes provisions encouraging activities by relevant actors to raise awareness of the importance of genetic resources and traditional knowledge associated with genetic resources and related access and benefit- sharing issues, as well as activities contributing to capacity-building in developing countries, in line with the Nagoya Protocol's provisions.

Amendment 30 #

Proposal for a regulation
Article 2 – subparagraph 1

This Regulation applies to genetic resources ~~over which states exercise sovereign rights~~ and to traditional knowledge associated with genetic resources that are accessed or utilised after the entry into force of the Nagoya Protocol for the Union. It also applies to the benefits arising from the usetilisation of such genetic resources and to traditional knowledge associated with genetic resources as well as subsequent applications and commercialisation.

Amendment 31 #

Proposal for a regulation
Article 3 – subparagraph 3

(3) "genetic resources" means genetic material of actual or potential value, or derivatives thereof;

Amendment 32 #

Proposal for a regulation
Article 3 – subparagraph 3(a) (new)

(3a)“derivative” means a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity;

Amendment 33 #

Proposal for a regulation
Article 3 – subparagraph 4

(4) "access" means the acquisition of genetic resources or of traditional knowledge associated with genetic resources in ~~a Party to the Nagoya Protocol in~~ accordance with the applicable domestic access and benefit-sharing legislation or regulatory requirements of th~~at Party~~e country of origin.

Amendment 34 #

Proposal for a regulation
Article 3 – subparagraph 5

Amendment 35 #

Proposal for a regulation
Article 3 – subparagraph 6

(6) "usetilisation of genetic resources" means to conduct research and development on the genetic or biochemical composition of genetic resources including through the application of biotechnology;

Amendment 36 #

Proposal for a regulation
Article 3 – subparagraph 10 (a) (new)

(10a) "illegally acquired genetic resources" means genetic resources and traditional knowledge associated with genetic resources accessed in contravention to the applicable international and national legislation or regulatory requirements on access and benefit sharing in the country of origin;

Amendment 37 #

Proposal for a regulation
Article 3 – subparagraph 10 (b) (new)

(10b) "biopiracy" means utilisation, or subsequent commercialisation of illegally acquired genetic resources or products derived from such resources, or associated traditional knowledge;

Amendment 38 #

Proposal for a regulation
Article 4 – subparagraph -1 (new)

(-1) The utilisation and commercialisation of illegally acquired genetic resources shall be prohibited in the EU.

Amendment 39 #

Proposal for a regulation
Article 4 – paragraph -1

1. Users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources used were accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements, a~~nd that, where relevant, benefit~~fter obtainment of prior informed consent when so required and with full respect of existing duties aregarding fairly and equitablye benefit- shareding upon mutually agreed terms. Users shall seek, keep, and transfer to subsequent users information relevant for access and benefit- sharing and compliance with the provisions of this Regulation.

Amendment 40 #

Proposal for a regulation
Article 4 – paragraph -1 (a) (new)

1a. Genetic resources and associated traditional knowledge shall only be transferred to other users if in accordance with prior informed consent and mutually agreed terms. Subsequent users may only utilise the material received in accordance with the original terms. If there is no prior informed consent and mutually agreed terms or subsequent users anticipate to utilise the genetic resources or traditional knowledge under conditions that are not included in the original terms, they are required to seek prior informed consent from the country of origin and mutually agreed terms preceding commencement of new utilisation.

Amendment 41 #

Proposal for a regulation
Article 4 – paragraph -1 (b) (new)

1b. As regards genetic resources originating from areas beyond national jurisdiction, or where country of origin can not be established, or where it is not possible to grant or obtain prior informed consent, new users shall provide benefit sharing to a Union Benefit Sharing Fund dedicated to the conservation of biological diversity globally, until a Global Multilateral Benefit-sharing Mechanism is established pursuant to Nagoya Protocol Article 10.

Amendment 42 #

Proposal for a regulation
Article 4 – paragraph 2 – subparagraph (a) (5)

(5) access decisions and mutually agreed terms, including benefit-sharing arrangements, where applicable;

Amendment 43 #

Proposal for a regulation
Article 4 – paragraph 4

4. Users ~~acquiring~~that have accessed a genetic resource or traditional knowledge associated with a genetic resource from a collection listed in the Union register of trusted collections referred to in Article 5(1) and produce the documentation they have obtained from this collection together with the genetic resources or traditional knowledge shall be considered to have exercised due diligence as regards the seeking of information relevant to access and benefit- sharing for genetic resources and traditional knowledge associated with genetic resources.

Amendment 44 #

Proposal for a regulation
Article 4 – paragraph 4 (a) (new)

4a. The Commission shall be enpowered to adopt delegated acts in order to establish the rules for benefit-sharing in accordance with paragraph 1c by [six months after the entry into force of this Regulation]. Those rules shall require benefit-sharing at least at the level of best practice in the sector concerned and establish conditions for sharing of non- monetary benefits.

Amendment 45 #

Proposal for a regulation
Article 5 – paragraph 3 (a)

(a) apply standardised procedures for exchanging samples of genetic resources and ~~related~~ information on traditional knowledge associated with genetic resources with other collections, and for supplying samples of genetic resources and ~~related~~ information on such knowledge to third persons for their use;

Amendment 46 #

Proposal for a regulation
Article 5 – paragraph 3 (b)

(b) have samples of genetic resources and related information supplied to third persons for their usetilisation only with documentation providing evidence that the resources and the information were accessed in accordance with applicable ~~legal requirements and, where relevant,~~access and benefits sharing legislation or regulatory requirements and mutually agreed terms for the fair and equitable sharing of benefits;

Amendment 47 #

Proposal for a regulation
Article 5 – paragraph 3 (f) (new)

(f) make efforts, in cooperation with indigenous and local communities, other collections, authorities, organisations or institutions, as appropriate, to document traditional knowledge associated with genetic resources or to make information on such knowledge available for the purpose of helping to protect relevant rights and facilitate utilisation of such knowledge in full respect of relevant rights;

Amendment 48 #

Proposal for a regulation
Article 5 – paragraph 3 (g) (new)

(g) contribute to awareness-raising on the importance of genetic resources and traditional knowledge associated with genetic resources, and related access and benefit-sharing issues, in line with Article 21 of the Nagoya Protocol;

Amendment 49 #

Proposal for a regulation
Article 5 – paragraph 3 (h) (new)

(h) contribute to capacity-building in developing countries, in line with Article 22 of the Nagoya Protocol;

Amendment 50 #

Proposal for a regulation
Article 7 – paragraph 1

Amendment 51 #

Proposal for a regulation
Article 7 – paragraph 2

2. Users shall declare to the competent authorities established under Article 6(1) that they ~~exercised due diligence in accordance with Article 4 on the occa~~have complied with provisions of ~~requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources, or at the time of commercialis~~Article 4 and shall submit the related information wthe~~re a market approval is not required.~~ occasion of::

Amendment 52 #

Proposal for a regulation
Article 7 – paragraph 2 – subparagraph (a) (new)

(a) etablishing prior informed consent and mutually agreed terms;

Amendment 53 #

Proposal for a regulation
Article 7 – paragraph 2 – subparagraph (b) (new)

(b) receiving research funding involving utilisation of genetic resources and traditional knowledge associated with genetic resources;

Amendment 54 #

Proposal for a regulation
Article 7 – paragraph 2 – subparagraph (c) (new)

(c) applying for patents or for new plant variety rights at relevant national, regional or international institutions covering inter alia the accessed genetic resources, products, including derivates, and processes derived from the use of biotechnology, or traditional knowledge associated with the genetic resource;

Amendment 55 #

Proposal for a regulation
Article 7 – paragraph 2 – subparagraph (d) (new)

(d) requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources, or Or. en (Text is from end of Article 7, paragraph 2)

Amendment 56 #

Proposal for a regulation
Article 7 – paragraph 3

3. Competent authorities shall verify the information provided under points (b) to (e) and transmit to the Commission ~~every two year~~within three months the information received ~~on the basis of paragraphs 1 and 2~~pursuant to this article. The Commission shall within three months summarise the information received and make ~~it available to the Access and Benefit-sharing Clearing House~~the information required for internationnally recognised certificate available to the Access and Benefit-sharing Clearing House as well as to the public in an easily accessible open format.

Amendment 57 #

Proposal for a regulation
Article 8 – paragraph 1

Amendment 58 #

Proposal for a regulation
Article 8 – paragraph 2

2. WThe~~re on the basis of information and evidence supplied to it by an association of users~~ Commission shall assess each application, taking into account information and evidence from the applicant, relevant providers, users, authorities, institutions, inter- governmental organisations, as well as representatives of indigenous and local communities, non-governmental organisations and other actors, as appropriate. On the basis of this information and evidence, the Commission shall determine~~s that~~ whether the specific combination of procedures, tools or mechanisms, when effectively implemented by a user, enables the user to comply with its obligations set out in Articles 4 and 7, i~~t shall grant recognition as best practice~~ncluding those relating to the obtainment of prior informed consent and to fair and equitable benefit- sharing upon mutual agreed terms, where applicable. The Commission shall grant recognition as best practice to the combination of procedures, tools or mechanisms for which an application has been filed if this combination enables users to comply with their obligations and does so in a more reliable and efficient way than other existing or emerging combinations.

Amendment 59 #

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2(a) (new)

Where use of genetic resources or traditional knowledge associated with genetic resources has the potential to lead to the development of medicinal products of interest to the provider and importance to the human right of the enjoyment of the highest attainable standard of health, affordable access to these products may be an important aspect of fair and equitable benefit-sharing and best practices in relevant areas shall take account of this.

Amendment 60 #

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 (b) (new)

Where use of genetic resources or traditional knowledge associated with genetic resources may influence food security, e.g. by leading to restrictions on farmers' possibilities to reseed or exchange seeds, avoiding negative such influences may be an important aspect of fair and equitable benefit-sharing and best practices in relevant areas shall take account of this.

Amendment 61 #

Proposal for a regulation
Article 11 – paragraph 2 – subparagraph (a)

(a) fines proportional to the value of the use of genetic resources concerned;

Amendment 62 #

Proposal for a regulation
Article 11 – paragraph 2 – subparagraph (b)

(b) immediate suspension of specific use activities including commercialisation of products based on genetic resources and associated traditional knowledge;

Amendment 63 #

Proposal for a regulation
Article 12 – paragraph 1

1. The competent authorities shall cooperate with each other, with the administrative authorities of third countries and with the Commission sin order to reinforce effective coordination and ensure compliance of users with this Regulation. Cooperation shall also be conducted with other relevant actors, including collections, non-governmental organisations and representatives of indigenous and local communities when important for the correct implementation of the Nagoya Protocol and this Regulation.

Amendment 64 #

Proposal for a regulation
Article 12 – paragraph 2

2. The competent authorities shall receive information from relevant actors and exchange information between themselves on serious shortcomings detected through checks referred to in Article 9(1) and on the types of penalties imposed in accordance with Article 11 with the competent authorities of other Member States and with the Commission.

Amendment 65 #

Proposal for a regulation
Article 12 – paragraph 2 (a) (new)

Amendment 66 #

Proposal for a regulation
Article 13 – title

Union platform on access and benefit- sharing

Amendment 67 #

Proposal for a regulation
Article 13 – paragraph 1

1. A Union platform on access to genetic resources and traditional knowledge associated with genetic resources and on fair and equitable benefit-sharing is hereby established.

Amendment 68 #

Proposal for a regulation
Article 13 – paragraph 2

2. The Union platform shall contribute to the streamlining of access conditions at Union level by discussing related issues, including the design and performances of access regimes established in Member States, ~~simplified access for non- commercial research, access practices of collections in the Union, access of Union stakeholders in third countries and the sharing of best practices~~the promotion of research which contributes to the conservation and sustainable use of biological diversity, particularly in developing countries, including simplified access for non- commercial research, access practices of collections in the Union, access of Union stakeholders in third countries on mutually agreed terms after the obtainment of prior informed consent, benefit-sharing practices, the implementation and further development of best practices and the functioning of dispute settlement arrangements..

Amendment 69 #

Proposal for a regulation
Article 13 – paragraph 4

4. Each Member State and the Commission may nominate one regular member for the Union platform. Stakeholders, representatives of relevant inter- governmental and non-governmental organisations and other experts in matters addressed by this Regulation ~~may~~shall be invited as appropriate.

Amendment 70 #

Proposal for a regulation
Article 14 – subparagraph (e) (new)

(e) ensure that, in situations where genetic resources and associated traditional knowledge are utilised illegally, or not in compliance with prior informed consent or mutually agreed terms, those competent to grant access to genetic resources and sign mutually agreed terms are entitled to bring an action to prevent or stop such utilisation, including through injunctions, and to seek compensation for any damages resulting therefrom, as well as, where appropriate, for the seizure of the genetic resources concerned.

Amendment 71 #

Proposal for a regulation
Article 14 – subparagraph (f) (new)

(f) encourage users and providers to direct benefits arising from the utilisation of genetic resources towards the conservation of biological diversity and the sustainable use of its components.

Amendment 72 #

Proposal for a regulation
Article 14 – subparagraph (g) (new)

(g) support regional cooperation on benefit-sharing regarding transboundary genetic resources and associated traditional knowledge.

Amendment 73 #

Proposal for a regulation
Article 14 (a) Title (new)

Union Benefit Sharing Fund

Amendment 74 #

Proposal for a regulation
Article 14 (a) – paragraph 1 (new)

1. A Union Benefit Sharing Fund is hereby established.

Amendment 75 #

Proposal for a regulation
Article 14 (a) – paragraph 2 (new)

2. The Fund shall receive revenues from the implementation of Article 4 (1c).

Amendment 76 #

Proposal for a regulation
Article 14 (a) – paragraph 3 (new)

3. The Commission shall be empowered to adopt delegated acts to establish the procedures for implementing and operating the Union Benefit Sharing Fund to finance the conservation of biodiversity globally.

Amendment 77 #

Proposal for a regulation
Article 15 (a) – Title (new)

Consultation Forum

Amendment 78 #

Proposal for a regulation
Article 15 (a) – paragraph 1 (new)

The Commission shall ensure that, in the implementation of the Regulation a balanced participation of Member States’ representatives and relevant provider organisations, user associations, inter- governmental, non-governmental organisations as well as representatives of indigenous and local communities is ensured. These parties shall contribute, in particular, to defining and reviewing delegated acts pursuant to Article 4(5), 9(8), and 14a(3), and to the implementation of Articles 5, 7 and 8, and eventual guidelines for establishing mutually agreed terms. These parties shall meet in a Consultation Forum. The rules of procedure of the Forum shall be established by the Commission.

Amendment 79 #

Proposal for a regulation
Article 16a (new)

Directive 2008/99/EC1
Article 3 – paragraph ia (new)

16a. The following point shall be added to Article 3 of Directive 2008/99/EC, with effect from …*: '(ia) biopiracy.' *OJ: one year after the date of entry into force of this Regulation.

Amendment 80 #

Proposal for a regulation
Article 16b (new)

Directive 2008/99/EC2
Annex A – indent (new)

1 Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law, OJ L 328, 6.12.2008, p. 28. 2 Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law, OJ L 328, 6.12.2008, p. 28. effect from …*: '– Regulation (EU) No …/2013 of the European Parliament and of the Council of ... on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union.' *OJ: one year after the date of entry into force of this Regulation.16b. The following indent shall be added to Annex A of Directive 2008/99/EC, with

source: PE-507.953

2013/04/03 PECH 3 amendments...

Amendment 1 #

Ian HUDGHTON

Proposal for a regulation
Recital 7 a (new)

(7a) The Nagoya Protocol applies to genetic resources falling within the scope of Article 15 of the Convention as opposed to the wider scope of Article 4 of the Convention. This implies that the Protocol does not extend to the full jurisdictional scope of Article 4, such as to activities taking place in marine areas beyond national jurisdiction. Nonetheless, nothing in the Protocol prevents Parties to it from extending its principles to activities taking place in such marine areas.

Amendment 2 #

Ian HUDGHTON

Proposal for a regulation
Recital 23

(23) A Union platform on access should enable discussions on and contribute to the streamlining of access conditions in Member States, the design and performances of access regimes, simplified access for non-commercial research, access practices of collections in the Union, access of Union stakeholders in third countries and the sharing of best practices. The Union platform should fully respect Member State competences and aim to ensure, as appropriate, the involvement of indigenous and local communities in accordance with the Nagoya Protocol.

Amendment 3 #

Ian HUDGHTON

Proposal for a regulation
Article 13 – paragraph 3

3. The Union platform may provide non- binding advice, guidance or opinions on issues under its mandate. Any such advice, guidance or opinions provided shall have due regard for the requirement to involve the relevant indigenous and local communities concerned.

source: PE-504.318

2013/04/29 AGRI 28 amendments...

Amendment 35 #

Proposal for a regulation
Recital 1

(1) A broad range of ~~play~~users and suppliers in the Union, including academic researchers and companies from different sectors of industry, use genetic resources for research, development and commercialisation purposes; some also use traditional knowledge associated with genetic resources. Research and development activities imply not only the study and analysis of the genetic or biochemical composition of genetic resources but also measures to generate innovation and practical applications. The successful implementation of the Nagoya Protocol also depends on the way in which users and suppliers of genetic resources or traditional knowledge associated with genetic resources are able to negotiate agreed conditions for the promotion of biodiversity conservation in accordance with the ‘EU biodiversity strategy to 2020’.

Amendment 36 #

Proposal for a regulation
Recital 2

(2) Genetic resources represent the gene pool in both natural and cultivated or domesticated stocks and play a significant and growing role in many economic sectors including food production, forestry, development of medicines, or development of bio-based sources of renewable energy. Genetic resources play a significant role in the implementation of strategies designed to restore damaged ecosystems and safeguard endangered species.

Amendment 37 #

Herbert DORFMANN, Elisabeth JEGGLE, Albert DESS, Britta REIMERS, Elisabeth KÖSTINGER

Proposal for a regulation
Recital 2 a (new)

(2a) Access to genetic resources and the fair and equitable distribution of benefits resulting from their use should provide an answer to the problem of supplying enough food to meet the needs of an expanding world populace.

Amendment 38 #

Proposal for a regulation
Recital 6

(6) The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity (the Nagoya Protocol) is an international treaty adopted on 29 October 2010 by the Parties to the Convention. The Nagoya Protocol ~~significantly expand~~further details the general rules of the Convention on access and benefit- sharing for the use of genetic resources and traditional knowledge associated with genetic resources.

Amendment 39 #

Herbert DORFMANN, Albert DESS, Elisabeth JEGGLE, Britta REIMERS, Sergio Paolo Francesco SILVESTRIS, Elisabeth KÖSTINGER

Proposal for a regulation
Recital 11

(11) It is important to define, in accordance with the Nagoya Protocol, that the use of genetic resources refers to research and development on the genetic or biochemical composition of ~~samples of genetic material, which includes research and development on isolated compounds extracted from genetic material that was accessed in a Party to the Nagoya Protocol~~genetic resources.

Amendment 40 #

Elisabeth JEGGLE, Herbert DORFMANN

Proposal for a regulation
Recital 11 a (new)

(11a) In accordance with the Nagoya Protocol, it must be stipulated that Member States shall not be restricted in their interpretation at national level of Directive 98/44/EG on the legal protection of biotechnical inventions (bio patent directive). In particular, the use of biological materials for the purpose of breeding, discovery and developing other plant varieties and the use by farmers of crops for propagation or multiplication by them on their own holdings must be guaranteed.

Amendment 41 #

Herbert DORFMANN, Elisabeth JEGGLE, Albert DESS, Britta REIMERS, Elisabeth KÖSTINGER, Sergio Paolo Francesco SILVESTRIS

Proposal for a regulation
Recital 14

(14) With a view to ensuring an effective implementation of the Nagoya Protocol, all users of genetic resources and traditional knowledge associated with such resources should have to exercise due diligence to ascertain that the genetic resources and associated traditional knowledge used were accessed in accordance with applicable legal requirements and to ensure that, where relevant, benefits are shared. However, given the diversity of users within the Union ~~it is not appropriate to oblige all users~~not all users must be obliged to take the same measures for exercising due diligence. Therefore, only minimum features of due diligence measures should be set out. The specific choices taken by users on the tools and measures applied for exercising due diligence should be ~~supported through~~based on the recognition of best practices as well as complementary measures in support of sectoral codes of conduct, model contractual clauses, and guidelines with a view to increasing legal certainty and reducing costs. The obligation on users to keep information relevant for access and benefit-sharing should be limited in time, consistent with the time-span for an eventual innovation.

Amendment 42 #

Herbert DORFMANN

Proposal for a regulation
Recital 14

~~(14)~~ With a view to ensuring an effective implementation of the Nagoya Protocol, all users of genetic resources and traditional knowledge associated with such resources should have to exercise due diligence to ascertain that the genetic resources and associated traditional knowledge used were accessed in accordance with applicable legal requirements and to ensure that, where relevant, benefits are shared. However, given the diversity of users within the Union it is not appropriate to oblige all the users to take the same measures for exercising due diligence. Therefore, only minimum features of due diligence measures should be set out. The specific choices taken by users on the tools and measures applied for exercising due diligence should be supported through the recognition of best practices as well as complementary measures in support of sectoral codes of conduct, model contractual clauses, and guidelines with a view to increasing legal certainty and reducing costs. The obligation on users to keep information relevant for access and benefit-sharing should be limited in time, consistent with the time-span for an eventual innovation.

Amendment 43 #

Proposal for a regulation
Recital 14

(14) With a view to ensuring an effective implementation of the Nagoya Protocol, all users of genetic resources and traditional knowledge associated with such resources should have to exercise due diligence to ascertain that the genetic resources and associated traditional knowledge used were accessed in accordance with applicable legal requirements and to ensure that, where relevant, benefits are shared. However, given the diversity of users within the Union it is not appropriate to oblige all users to take the same measures for exercising due diligence. Therefore, only minimum features of due diligence measures should be set out. The specific choices taken by users on the tools and measures applied for exercising due diligence should be supported through the recognition of best practiis is the case in particular for subsequent users where the due diligence obligation should only apply in the case such users access a~~s well as complementary meas~~nd use genetic resources in ~~support of sectoral codes of conduct, model contractual clauses, and guidelines with a view to increasing legal certainty and reducing costs~~the form as originally accessed by the initial user. The obligation on users to keep information relevant for access and benefit-sharing should be limited in time, consistent with the time-span for an eventual innovation.

Amendment 44 #

Proposal for a regulation
Recital 16

~~(16)~~ Best practices developed by users ~~should~~ play an important role in identifying due diligence measures that are particularly suitable for achieving compliance with the system of implementation of the Nagoya Protocol with high legal certainty and at low costs. Users should be enabled to build on existing access and benefit-sharing codes of conduct developed for the academic sector and different industries. Associations of users ~~should be able to~~can request that the Commission determines whether a specific combination of procedures, tools or mechanisms overseen by an association may be recognised as best practice. Competent authorities of the Member States should consider that the implementation of a recognised best practice by a user reduces that user's risk of non-compliance and justifies a reduction in compliance checks. The same should apply to best practices adopted by the collective of the Parties to the Nagoya Protocol.

Amendment 45 #

Proposal for a regulation
Recital 19

(19) Collections are major suppliers of genetic resources and traditional knowledge associated with genetic resources used in the Union. A system of Union trusted collections should be set in place. It ~~would~~ ensures that collections included in the register of Union trusted collections effectively apply measures to only supply samples of genetic resources to third persons with documentation providing evidence of legal acquisition and the establishment of mutually agreed terms, where required. A system of Union trusted collections should substantially lower the risk that illegally acquired genetic resources are used in the Union. Competent authorities of Member States would verify if a collection meets the requirements for recognition as Union trusted collection. Users that acquire a genetic resource from a collection listed in the Union register should be considered to have exercised due diligence as regards the seeking of all necessary information. This should prove particularly beneficial for academic researchers as well as small and medium sized enterprises.

Amendment 46 #

Herbert DORFMANN, Albert DESS, Elisabeth JEGGLE, Britta REIMERS, Sergio Paolo Francesco SILVESTRIS, Elisabeth KÖSTINGER

Proposal for a regulation
Recital 28

(28) The objectives of this Regulation are to minimise the risk that illegally genetic resources or traditional knowledge associated with genetic resources are used in the Union, and to support the fair and equitable sharing of benefits resulting from the use of genetic resources or traditional knowledge associated with genetic resources upon mutually agreed terms. These cannot be achieved by the Member States individually, and can therefore, by reasons of their scale and to ensure functioning of the internal market, be better achieved at Union level. The Union may therefore adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve its objectives. At the same time, one objective of this regulation is the fair and equitable distribution of the benefits resulting from the use of genetic resources, thereby helping to conserve biodiversity in accordance with the ‘EU biodiversity strategy to 2020’ guidelines.

Amendment 47 #

Proposal for a regulation
Article 1 – paragraph 1

This Regulation establishes rules governing compliance with access and benefit-sharing for genetic resources and traditional knowledge associated with genetic resources, in accordance with the provisions of the Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation to the Convention on Biological Diversity (the Nagoya Protocol).

Amendment 48 #

Elisabeth JEGGLE, Herbert DORFMANN

Proposal for a regulation
Article 2 – paragraph 2 a (new)

This Regulation shall not restrict the Member States in their interpretation of Directive 98/44/EG on the legal protection of biotechnical inventions (bio patent directive). In particular, the use of biological materials for the purpose of breeding, discovery and developing other plant varieties and the use by farmers of crops for propagation or multiplication by them on their own holdings shall be guaranteed.

Amendment 49 #

Herbert DORFMANN, Elisabeth JEGGLE, Albert DESS, Britta REIMERS, Sergio Paolo Francesco SILVESTRIS, Elisabeth KÖSTINGER

Proposal for a regulation
Article 3 – paragraph 5

(5) „"user" means a natural or legal person using genetic resources or traditional knowledge associated with genetic resources, as well as a natural or legal person subsequently marketing these genetic resources, products based on them or traditional knowledge associated with them;

Amendment 50 #

Proposal for a regulation
Article 4 – paragraph 2 – point a – subpoint 3

(3) the source from which the resources or the knowledge were directly obtained ~~as well as subsequent users of genetic resources or traditional knowledge associated with such resources~~;

Amendment 51 #

Herbert DORFMANN, Elisabeth JEGGLE, Albert DESS, Britta REIMERS, Elisabeth KÖSTINGER

Proposal for a regulation
Article 4 – paragraph 2 – point a – subpoint 5

(5) access ~~decision~~permits and mutually agreed terms, where applicable;

Amendment 52 #

Herbert DORFMANN, Elisabeth JEGGLE, Albert DESS, Britta REIMERS, Elisabeth KÖSTINGER

Proposal for a regulation
Article 4 – paragraph 2 – point c

(c) obtain a proper access permit, and establish mutually agreed terms~~, or discontinue the use~~ where it appears that access was not in accordance with applicable access and benefit-sharing legislation or regulatory requirements.

Amendment 53 #

Herbert DORFMANN, Elisabeth JEGGLE, Albert DESS, Britta REIMERS, Sergio Paolo Francesco SILVESTRIS, Elisabeth KÖSTINGER

Proposal for a regulation
Article 5 – paragraph 3 – point a

(a) apply standardised procedures for exchanging samples of genetic resources and related information with other collections, and for supplying samples of genetic resources and related information to third persons for their use; seek and apply improved support mechanisms for the creation, use and distribution of knowledge and access to the necessary funding;

Amendment 54 #

Proposal for a regulation
Article 5 – paragraph 3 – point e a (new)

(e a) The obligation referred to in paragraphs (1) to (3) of this Article shall only apply to subsequent users in case such users access and use genetic resources in the form as originally accessed by the initial user.

Amendment 55 #

Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 1

Member States shall regularly verify that each collection under their jurisdiction included in the Union register of trusted collections effectively applies the measures set out in paragraph 3; at the same time, the provisions adopted must not lead to increased bureaucracy or additional costs.

Amendment 56 #

Herbert DORFMANN, Elisabeth JEGGLE, Albert DESS, Britta REIMERS, Elisabeth KÖSTINGER

Proposal for a regulation
Article 7 – paragraph 2

2. Users shall declare to the competent authorities established under Article 6(1) that they ~~exercised due diligence in accordance with Article 4 on the occasion of~~have complied with the provisions of Article 4 and shall submit the related information on the occasion of: (a) establishing prior informed consent and mutually agreed terms ; (b) receiving research funding involving the utilisation of genetic resources and traditional knowledge associated with genetic resources ; (c) applying for patents, bearing in mind that, according to the European Patent Convention, plant and animal varieties (Article 53(a)) as well as biological processes for the production of plants and animals (Article 53(b)) are not patentable,. or for new plant variety rights at relevant national, regional or international institutions covering inter alia the genetic resources, products, including derivates, and processes derived from the use of biotechnology, or traditional knowledge associated with genetic resources, (d) requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources, or (e) at the time of commercialisation where a market approval is not required.

Amendment 57 #

Proposal for a regulation
Article 9 – paragraph 2

2. The checks referred to in paragraph 1 of this Article shall be conducted in accordance with a periodically reviewed plan following a risk-based approach~~. When developing this risk-based approach, Member States shall consider~~, of which the key principles shall be laid down by the Commission in accordance with the procedure referred to in Article 15(2). Such an approach shall take into account that the implementation by a user of a best practice recognised under Article 8(2) of this Regulation or under Article 20(2) of the Nagoya Protocol reduces that user's risk of non-compliance.

Amendment 58 #

Herbert DORFMANN, Elisabeth JEGGLE, Albert DESS, Britta REIMERS, Elisabeth KÖSTINGER

Proposal for a regulation
Article 9 – paragraph 4 – introductory part

4. The checks referred to in paragraph 1 shall include ~~at least~~:

Amendment 59 #

Herbert DORFMANN, Elisabeth JEGGLE, Albert DESS, Britta REIMERS, Sergio Paolo Francesco SILVESTRIS, Elisabeth KÖSTINGER

Proposal for a regulation
Article 12 – paragraph 2

2. The competent authorities shall exchange information on the organization of their checking system for monitoring user compliance with this Regulation and on serious shortcomings detected through checks referred to in Article 9(1) and on the types of penalties imposed in accordance with Article 11 with the competent authorities of other Member States and with the Commission.

Amendment 60 #

Herbert DORFMANN, Elisabeth JEGGLE, Albert DESS, Britta REIMERS, Sergio Paolo Francesco SILVESTRIS, Elisabeth KÖSTINGER

Proposal for a regulation
Article 13 – paragraph 1

1. A Union platform on access to genetic resources and traditional knowledge associated with genetic resources is hereby established. Member States which envisage adopting access rules as regards their genetic resources shall first conduct an impact assessment of these rules and submit the result of this assessment to the Union platform for consideration pursuant to the procedure laid down in paragraph 5 of this Article.

Amendment 61 #

Herbert DORFMANN, Elisabeth JEGGLE, Albert DESS, Britta REIMERS, Elisabeth KÖSTINGER

Proposal for a regulation
Article 13 – paragraph 2

Amendment 62 #

Herbert DORFMANN, Elisabeth JEGGLE, Albert DESS, Britta REIMERS, Elisabeth KÖSTINGER

Proposal for a regulation
Article 16 – paragraph 3

3. Every ten years after its first report the Commission shall, on the basis of reporting on and experience with the application of this Regulation, review the functioning and effectiveness of this Regulation. In its reporting the Commission shall in particular consider the administrative consequences for specific sectors, public research institutions, small or medium- sized enterprises and micro-enterprises. It shall also consider the need for further Union action on access to genetic resources and traditional knowledge associated with genetic resources.

source: PE-507.965

2013/04/30 PECH 3 amendments...

Amendment 4 #

Proposal for a regulation
Recital 2a (new)

(2a) Research on genetic resources is gradually being extended into new areas, especially the oceans, which are still the planet's least explored and least well- known environments. The deep ocean in particular represents the last great frontier on the planet and is attracting growing interest in terms of research, prospecting and resource exploration. In this context, a study of the immense biodiversity to be found in deep marine ecosystems is an emerging and highly promising area of research with a view to the discovery of genetic resources offering potential applications for a wide range of purposes.

Amendment 5 #

Alain CADEC

Proposal for a regulation
Recital 15

(15) The due diligence obligation should apply to all users irrespective of their size, including to micro-enterprises and small and medium-sized companies. Excluding these actors from the system would entirely undermine its effectiveness. It would also run against the international obligations of the Union under the Nagoya Protocol. However, the Regulation should offer a range of measures and tools to enable micro-enterprises and small and medium- sized companies to comply with their obligations at low cost, without this affecting their competitiveness, and with high legal certainty.

Amendment 6 #

Alain CADEC

Proposal for a regulation
Article 6 – paragraph 2

2. The Commission shall make public, including on the internet, a list of the competent authorities. The Commission shall keep the list up to date; particular attention shall be paid to the outermost regions, bearing in mind the significance and fragility of the genetic resources found on their territories, and with a view to preventing any abusive exploitation.

source: PE-510.628

2013/05/06 DEVE 84 amendments...

Amendment 1 #

Proposal for a regulation
Recital 2

Amendment 2 #

Proposal for a regulation
Recital 3

(3) Traditional knowledge that is held by indigenous and local communities may provide important lead information for the scientific discovery of ~~interesting genetic~~potentially valuable genetic or biochemical properties of genetic resources, including knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use orf bio~~chemical properties of genetic reso~~logical diversity. The rights of such communities, as laid down in Convention No. 169 of the International Labour Organisation on Indigenous and Tribal Peoples and also set out in the UN Declaration on the Rights of Indigenous Peoples adopted by the UN General Assembly in 2007 should be respected and Union implementing measurces should facilitate that aim.

Amendment 3 #

Proposal for a regulation
Recital 3 a (new)

(3a) It is important to recall that according to the European Patent Convention plant and animal varieties as well as biological processes for the production of plants and animals are not patentable. When inventions are based on genetic resources or on components of genetic resources, applications for a patent covering, inter alia, those resources, products, including derivates, and processes derived from the use of biotechnology, or traditional knowledge associated with the genetic resources, should indicate the resources and their origin should be provided to the relevant authorities and transmitted to the competent authority. The same obligation should apply to new plant variety rights.

Amendment 4 #

Proposal for a regulation
Recital 4 a (new)

(4a) Genetic resources should be preserved in situ and used in sustainable ways and the benefits arising from their utilisation should be shared fairly and equitably. This would contribute to poverty eradication and, thereby, to achieving the United Nations Millennium Development Goals, as acknowledged in the preamble of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity ("the Nagoya Protocol"), adopted on 29 October 2010 by the Parties to the Convention. As parties to the Convention, the Union and most of its Member States have signed the Nagoya Protocol. Capacity to effectively implement that Protocol should be supported.

Amendment 5 #

Proposal for a regulation
Recital 5

(5) The Convention recognises that states have sovereign rights over natural resources found within their jurisdiction and the authority to determine access to their genetic resources. The Convention imposes an obligation on all Parties to facilitate access to genetic resources, for environmentally sound uses by other Parties, over which they hold sovereign rights. It also makes it mandatory for all Parties to take measures to share in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Party providing these resources. Such sharing shall be upon mutually agreed terms. The Convention also addresses access and benefit-sharing in relation to the knowledge, innovations and practices of indigenous and local communities relevant for the conservation and sustainable use of biological diversity.

Amendment 6 #

Proposal for a regulation
Recital 6

Amendment 7 #

Proposal for a regulation
Recital 8

(8) It is important to set out a clear and sound framework for implementing the Nagoya Protocol and the relevant provisions of the Convention that should enhance opportunities available for nature- based research and development activities in the Union. It is also essential to prevent the use of illegally acquired genetic resources or traditional knowledge associated with genetic resources in the Union and to support the effective implementation of benefit-sharing commitments set out in mutually agreed terms between providers and users.

Amendment 8 #

Proposal for a regulation
Recital 8 a (new)

(8a) Biopiracy consisting of either unauthorised acquisition of genetic resources, or unauthorised utilisation or subsequent commercialisation of products based on such resources or associated traditional knowledge, should be prohibited and made subject to criminal sanctions in accordance with Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law1. _______________ 1 OJ L 328, 6.12.2008, p. 28

Amendment 9 #

Proposal for a regulation
Recital 8 b (new)

(8b) The framework created by this Regulation is needed also to maintain and increase trust between Parties, indigenous and local communities as well as stakeholder groups involved in access and benefit-sharing of genetic resources.

Amendment 10 #

Proposal for a regulation
Recital 9

(9) In order to ensure legal certainty, it is important that the rules implementing the Nagoya Protocol should only apply to new acquisition or new utilisation of genetic resources and traditional knowledge associated with genetic resources that ~~are accessed~~take place or commence after the entry into force of the Nagoya Protocol for the Union.

Amendment 11 #

Proposal for a regulation
Recital 11

(11) It is important to define, in accordance with the Nagoya Protocol, that usetilisation of genetic resources refers to research and development on the genetic or biochemical composition of samples of genetic material, which includes research and development on isolated compounds extracted from genetic ~~material~~resources that was accessed in a Party to the Nagoya Protocol. Research and development should be understood to mean the investigation and study of the genetic or biochemical composition of genetic resources in order to establish facts and reach conclusions, including the creation of innovations and practical applications.

Amendment 12 #

Proposal for a regulation
Recital 13

(13) There is currently no internationally agreed definition on "traditional knowledge associated with genetic resources" or on "holding" such knowledge by an indigenous and local community. International definitions of those terms and concepts are being negotiated in the Intergovernmental Committee of the World Intellectual Property Organization. Therefore, in order to ensure flexibility and legal certainty for providers and users, this Regulation should make reference to traditional knowledge associated with genetic resources as described in benefit-sharing agreements.

Amendment 13 #

Proposal for a regulation
Recital 14

(14) With a view to ensuring an effective implementation of the Nagoya Protocol, all users of genetic resources and traditional knowledge associated with such resources should have to exercise due diligence to ascertain that the genetic resources and associated traditional knowledge used were accessed in accordance with applicable legal requirements and to ensure that, ~~where relevant,~~ benefits are shared. However, given the diversity of users within the Union it is not appropriate to oblige all users to take the same measures for exercising due diligence. ~~Therefore, only minimum features of due diligence measures should be set out.~~ The specific choices taken by users on the tools and measures applied for exercising due diligence should be supported through the recognition of best practices as well as ~~complementary measures in support of~~ sectoral codes of conduct, model contractual clauses, and guidelines with a view to increasing legal certainty and reducing costs. The obligation on users to keep information relevant for access and benefit-sharing should be limited in time, consistent with the time-span for an eventual innovation.

Amendment 14 #

Proposal for a regulation
Recital 16

(16) Best practices, developed by users or organisations with an interest, and expertise, in the utilisation of genetic resources and access and benefit-sharing, should play an important role in identifying due diligence measures that are particularly suitable for achieving compliance with the system of implementation of the Nagoya Protocol with high legal certainty and at low costs. Users should be enabled to build on existing access and benefit-sharing codes of conduct developed for the academic sector and different industries as long as they are consistent with the Nagoya Protocol and this Regulation. Associations of users should be able to request that the Commission determines whether a specific combination of procedures, tools or mechanisms overseen by an association may be recognised as best practice. Competent authorities of the Member States should consider that the implementation of a recognised best practice by a user reduces that user’s risk of non-compliance and justifies a reduction in compliance checks. The same should apply to best practices adopted by the collective of the Parties to the Nagoya Protocol.

Amendment 15 #

Proposal for a regulation
Recital 17

(17) Users should declare at identified points in the chain of activities that ~~constitute use that~~ they have exercised due diligence, and provide evidence to that effect. Suitable points for such declarations are the ~~receiving of public~~establishment of prior informed consent and mutually agreed terms, the receipt of research fundsing, when applying for intellectual property rights at relevant national, regional or international institutions, where a market approval for a product developed on the basis of genetic resources is requested or at the time of commercialisation where a market approval is not required. Notably, the declaration made upon occasion of applying for intellectual property rights or requesting market approval would not constitute part of the approval procedure as such and would be directed to competent authorities established under this Regulation.

Amendment 16 #

Proposal for a regulation
Recital 18

(18) Collecting of genetic resources in the wild is mostly undertaken for non- commercial purposes by university-based researchers or collectors. In the vast majority of cases and in almost all sectors, access to newly collected genetic resources is gained through intermediaries, collections, or agents that acquire genetic resources in third countries. This Regulation should ensure that the provisions of mutually agreed terms for the initial access relevant for third party transfer are followed by all parties involved. In many cases subsequent utilisation or commercialisation could require new prior informed consent and mutually agreed terms.

Amendment 17 #

Proposal for a regulation
Recital 19

(19) Collections are ~~major~~the most accessible suppliers of genetic resources and traditional knowledge associated with genetic resources utilised in the Union. As suppliers they can play an important role in helping other users to comply with their obligations. In order to do so a system of Union trusted collections should be set in place. It would ensure that collections included in the register of Union trusted collections effectively apply measures to only supply samples of genetic resources to third persons with documentation providing evidence of legal acquisition and the establishment of mutually agreed terms, where required. A system of Union trusted collections should substantially lower the risk that illegally acquired genetic resources are utilised in the Union. Competent authorities of Member States would verify if a collection meets the requirements for recognition as Union trusted collection. Users that acquire a genetic resource from a collection listed in the Union register should be considered to have exercised due diligence as regards the seeking of all necessary information. This should prove particularly beneficial for academic researchers as well as small and medium sized enterprises.

Amendment 18 #

Proposal for a regulation
Recital 22 a (new)

(22a) The Union should act in a proactive manner to ensure the objectives of the Nagoya Protocol regarding global multilateral benefit-sharing mechanisms are achieved in order to increase resources to support conservation of biological diversity and the sustainable use of its components globally.

Amendment 19 #

Proposal for a regulation
Recital 22 b (new)

(22b) The principle of benefit-sharing as enshrined in Article 10 of the Nagoya Protocol should be implemented by the Union pending the establishment of a global multilateral mechanism as envisaged in the Protocol. Until the multilateral mechanism is in place, a Union benefit-sharing fund should be established to collect benefit-sharing contributions and channel them to the conservation of biological diversity globally. To that end, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of detailed criteria and rules for benefit-sharing in situations where genetic resources originate from areas beyond the jurisdiction of the Member States, or the country of origin of such resources cannot be established, or it is not possible to grant or obtain prior informed consent. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

Amendment 20 #

Proposal for a regulation
Article – 1 a (new)

The objective of this Regulation is the fair and equitable sharing of the benefits arising from the utilisation of genetic resources, thereby contributing to the conservation of biological diversity and the sustainable use of its components, in accordance with the objectives of the Convention on Biological Diversity ("the Convention").

Amendment 21 #

Proposal for a regulation
Article 2 – paragraph 1

This Regulation applies to genetic resources ~~over which states exercise sovereign rights~~ and to traditional knowledge associated with genetic resources that are accessed or utilised after the entry into force of the Nagoya Protocol for the Union. It also applies to the benefits arising from the usetilisation of such genetic resources and to traditional knowledge associated with genetic resources, as well as subsequent applications and commercialisation.

Amendment 22 #

Proposal for a regulation
Article 3 – paragraph 1 – point 3

(3) "genetic resources" means genetic material of actual or potential value, or derivatives thereof;

Amendment 23 #

Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)

(3a) “derivative” means a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity;

Amendment 24 #

Proposal for a regulation
Article 3 – paragraph 1 – point 4

Amendment 25 #

Proposal for a regulation
Article 3 – paragraph 1 – point 5

(5) "user" means a natural or legal person u~~sing~~tilising genetic resources or traditional knowledge associated with genetic resources or who subsequently commercialises genetic resources or products based on genetic resources or traditional knowledge associated with genetic resources;

Amendment 26 #

Proposal for a regulation
Article 3 – paragraph 1 – point 6

(6) "usetilisation of genetic resources" means to conduct research and development on the genetic or biochemical composition of genetic resources including through the application of biotechnology;

Amendment 27 #

Proposal for a regulation
Article 3 – paragraph 1 – point 6 a (new)

(6a) "biotechnology” means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use;

Amendment 28 #

Proposal for a regulation
Article 3 – paragraph 1 – point 6 b (new)

(6b) "research and development" means the investigation and study of the genetic or biochemical composition of genetic resources in order to establish facts and reach conclusions, including the creation of innovations and practical applications;

Amendment 29 #

Proposal for a regulation
Article 3 – paragraph 1 – point 8

Amendment 30 #

Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)

(12) "illegally acquired genetic resources" means genetic resources and traditional knowledge associated with genetic resources acquired in contravention of the applicable international and national legislation or regulatory requirements on access and benefit-sharing in the country of origin;

Amendment 31 #

Proposal for a regulation
Article 3 – paragraph 1 – point 8 b (new)

(13) "biopiracy" means utilisation, or subsequent commercialisation, of illegally acquired genetic resources or products derived from such resources or traditional knowledge associated with genetic resources.

Amendment 32 #

Proposal for a regulation
Article 3 – paragraph 1 – point 11

(11) "internationally recognised certificate of compliance" means an access permit or its equivalent issued by a competent national authority in accordance with Article 6(3)(e) of the Nagoya Protocol, that is made available to the Access and Benefit- sharing Clearing-House;

Amendment 33 #

Proposal for a regulation
Article 3 – paragraph 1 – point 12

(12) "Access and Benefit-sharing Clearing- House" means the global information- sharing portal established under Article 14(1) of the Nagoya Protocol.

Amendment 34 #

Proposal for a regulation
Article 4 – paragraph -1 (new)

-1. Biopiracy shall be prohibited in the Union.

Amendment 35 #

Proposal for a regulation
Article 4 – paragraph 1

1. Users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources used were accessed ~~in accordance with~~with prior informed consent and based on mutually agreed terms as defined by applicable access and benefit-sharing legislation or regulatory requirements and that, ~~where relevant,~~ benefits are fairly and equitably shared upon ~~mutually~~those agreed terms. Users shall seek, keep, and transfer to subsequent users all information and documents relevant for access and benefit- sharing and compliance with the provisions of this Regulation.

Amendment 36 #

Proposal for a regulation
Article 4 – paragraph 1 a (new)

1a. Genetic resources and associated traditional knowledge shall only be transferred to other users if in accordance with prior informed consent and mutually agreed terms. Subsequent users may only utilise the material received in accordance with the original agreed terms. In the absence of prior informed consent and mutually agreed terms or if subsequent users envisage utilising such genetic resources or traditional knowledge under conditions that are not included in the original terms, those users shall be required to seek prior informed consent from the country of origin and mutually agreed terms, before any new utilisation.

Amendment 37 #

Proposal for a regulation
Article 4 – paragraph 1 b (new)

1b. In the case of genetic resources originating from areas outside of national jurisdictions, or where the country of origin cannot be established, or where it is not possible to grant or obtain prior informed consent, new users shall provide benefit-sharing to a Union benefit- sharing fund dedicated to the conservation of biological diversity globally, until a global multilateral benefit-sharing mechanism is established pursuant to Article 10 of the Nagoya Protocol.

Amendment 38 #

Proposal for a regulation
Article 4 – paragraph 2 – point a – point 5

(5) access decisions and mutually agreed terms, including benefit-sharing arrangements, where applicable;

Amendment 39 #

Proposal for a regulation
Article 4 – paragraph 3

3. Users shall keep the information relevant for access and benefit-sharing for twenty years after the end of the period of usetilisation or subsequent commercialisation.

Amendment 40 #

Proposal for a regulation
Article 4 – paragraph 4

4. Users acquiring a genetic resource from a collection listed in the Union register of trusted collections referred to in Article 5(1) shall be considered to have exercised due diligence as regards the seeking of information relevant to access and benefit- sharing for genetic resources and traditional knowledge associated with genetic resources without prejudice to paragraphs 1, 1a and 1b of this Article.

Amendment 41 #

Proposal for a regulation
Article 4 – paragraph 4 a (new)

4a. The Commission shall be empowered to adopt delegated acts in accordance with Article 14b in order to establish the rules for benefit-sharing in accordance with paragraph 1 b by …*. Those rules shall require benefit-sharing at least at the level of best practice in the sector concerned and establish conditions for sharing of non-monetary benefits. ____________ * OJ: six months after the entry into force of this Regulation.

Amendment 42 #

Proposal for a regulation
Article 5 – paragraph 1

1. In order to contribute to the objective that only genetic resources acquired in accordance with applicable requirements are supplied, a voluntary system of Union trusted collections is hereby established. The Commission shall establish and maintain a Union register of trusted collections. That register shall be open format, internet- based, easily accessible to users, and shall include the collections of genetic resources identified as meeting the criteria of Union trusted collection.

Amendment 43 #

Proposal for a regulation
Article 5 – paragraph 3 – point b

(b) have samples of genetic resources and related information supplied to third persons for their usetilisation only with documentation providing evidence that the resources and the information were accessed in accordance with applicable ~~legal requirements and, where relevant,~~access and benefit-sharing legislation or regulatory requirements, and mutually agreed terms for the fair and equitable sharing of benefits;

Amendment 44 #

Proposal for a regulation
Article 5 – paragraph 3 – point c

(c) keep records of all samples of genetic resources and related information supplied to third persons for their usetilisation;

Amendment 45 #

Proposal for a regulation
Article 6 – paragraph 3 a (new)

3a. The competent authorities and the focal point on access and benefit-sharing shall provide advice to the public and potential users seeking information on the implementation of this Regulation and of the relevant provisions of the Convention and the Nagoya Protocol in the Union.

Amendment 46 #

Proposal for a regulation
Article 7 – paragraph 1

Amendment 47 #

Proposal for a regulation
Article 7 – paragraph 2

2. Users shall declare to the competent authorities established under Article 6(1) that they ~~exercised due diligence in accordance with Article 4 on the occasion of~~have complied with Article 4 and shall submit the related information on the occasion of: (a) establishing prior informed consent and mutually agreed terms; (b) receiving research funding involving utilisation of genetic resources and traditional knowledge associated with genetic resources; (c) applying for patents or for new plant variety rights at relevant national, regional or international institutions covering, inter alia, the accessed genetic resources, products, including derivates, and processes derived from the use of biotechnology, or traditional knowledge associated with the genetic resources; (d) requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources, or (e) at the time of commercialisation where a market approval is not required.

Amendment 48 #

Proposal for a regulation
Article 7 – paragraph 3

3. Competent authorities shall verify the information provided under points (b) to (e) and transmit to the Commission ~~every two year~~within three months the information received ~~on the basis of paragraphs 1 and 2~~pursuant to this Article. The Commission shall within three months summarise the information received and make ~~it available to the Access and Benefit-sharing Clearing House~~the information required for the internationally recognised certificate available to the Access and Benefit-sharing Clearing House as well as to the public in an easily accessible open, internet-based, format.

Amendment 49 #

Proposal for a regulation
Article 8 – paragraph 1

1. Any association of users or organisations with an interest, and expertise, in the utilisation of genetic resources and access and benefit-sharing may submit an application to the Commission for recognising as best practice a combination of procedures, tools or mechanisms developed and overseen by it. The application shall be supported by evidence and information.

Amendment 50 #

Proposal for a regulation
Article 8 – paragraph 2

2. The Commission shall assess each application, taking into account information and evidence from the applicant, relevant providers, users, authorities, institutions, inter- governmental and non-governmental organisations, as well as representatives of indigenous and local community organisations and other actors, as appropriate. Where, on the basis of information and evidence supplied to it by an association of users , the Commission determines that the specific combination of procedures, tools or mechanisms, when effectively implemented by a user, enables the user to comply with its obligations set out in Articles 4 and 7, it shall grant recognition as best practice.

Amendment 51 #

Proposal for a regulation
Article 8 – paragraph 4

4. If evidence from competent authorities of the Member States or other sources indicates ~~repeated~~ cases where users implementing a best practice fail to comply with their obligations under this Regulation, the Commission shall examine in dialogue with the relevant association of users whether the ~~repeated~~ cases of non- compliance indicate possible deficiencies in the best practice.

Amendment 52 #

Proposal for a regulation
Article 8 – paragraph 5

5. The Commission shall withdraw the recognition of a best practice, when it has determined that changes to the best practice compromise a user’s ability to meet the conditions set out in Articles 4 and 7, or when ~~repeated~~ cases of non- compliance by users relate to deficiencies in the practice.

Amendment 53 #

Proposal for a regulation
Article 9 – paragraph 1

1. The competent authorities shall carry out checks to verify if users comply with the requirements set out in Articles 4 and 7 and, where applicable, that they effectively implement declared best practices.

Amendment 54 #

Proposal for a regulation
Article 9 – paragraph 2

2. The checks referred to in paragraph 1 of this Article shall be conducted in accordance with a periodically reviewed plan following a risk-based approach. When developing this risk-based approach, Member States ~~shall~~may consider that the implementation by a user of a best practice recognised under Article 8(2) of this Regulation or under Article 20(2) of the Nagoya Protocol reduces that user’s risk of non-compliance.

Amendment 55 #

Proposal for a regulation
Article 9 – paragraph 3

3. CAdditional checks ~~may~~shall be conducted when a competent authority is in possession of relevant information, including on the basis of substantiated concerns provided by third parties, concerning non-compliance of a user with this Regulation.

Amendment 56 #

Proposal for a regulation
Article 9 – paragraph 4 – point a

(a) examination of the measures taken by a user to ~~exercise due diligence in accordance~~comply with Article 4;

Amendment 57 #

Proposal for a regulation
Article 9 – paragraph 4 – point b

(b) examination of documentation and records that demonstrate ~~the exercise of due diligence in accord~~compliance with Article 4 in relation to specific use activities;

Amendment 58 #

Proposal for a regulation
Article 9 – paragraph 7 – subparagraph 1

7. Without prejudice to Article 11, where, following the checks referred to in paragraph 1 and 3 of this Article, or following verification under Article 7(2), shortcomings have been detected, the competent authority shall issue a notice of remedial actions to be taken by the user.

Amendment 59 #

Proposal for a regulation
Article 9 – paragraph 7 – subparagraph 2

~~Additionally,~~If no positive or satisfactory response is given by the user, and depending on the nature of the shortcomings detected, Member States may take immediate interim measures, including inter alia seizure of illegally acquired genetic resources and suspension of specific use activities including commercialisation of products based on genetic resources and associated traditional knowledge.

Amendment 60 #

Proposal for a regulation
Article 9 – paragraph 8

8. The Commission shall be empowered to adopt ~~implement~~delegated acts ing actscordance with Article 14b to establish the procedures for implementing paragraphs 1 to 7 of this Article. ~~The implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2).~~

Amendment 61 #

Proposal for a regulation
Article 10 – paragraph 2

2. The information referred to in paragraph 1 shall be made available in accordance with Directive 2003/4/EC in an easily accessible open, internet-based, format.

Amendment 62 #

Proposal for a regulation
Article 11 – paragraph 2 – point a

(a) fines proportional to the value of the use activities related to genetic resources concerned and at least effectively depriving those responsible of the economic benefits derived from the infringement, increasing for repeated infringements;

Amendment 63 #

Proposal for a regulation
Article 11 – paragraph 2 – point b

(b) immediate suspension of specific use activities including commercialisation of products based on genetic resources and associated traditional knowledge;

Amendment 64 #

Proposal for a regulation
Article 12 – paragraph 1

1. The competent authorities shall cooperate with each other, with the administrative authorities of third countries and with the Commission in order to reinforce coordination and to ensure compliance of users with this Regulation.

Amendment 65 #

Proposal for a regulation
Article 12 – paragraph 2a (new)

2a. The Commission shall seek to make arrangements with the European Patent Office and with the World Intellectual Property Organization to ensure that references to genetic resources and their origin are included in patent registrations.

Amendment 66 #

Proposal for a regulation
Article 13 – paragraph 2

2. The Union platform shall contribute to the streamlining of access conditions at Union level by discussing related issues, including the design and performances of access regimes established in Member States, the promotion of research which contributes to the conservation and sustainable use of biological diversity, particularly in developing countries, including simplified access for non- commercial research, access practices of collections in the Union, access of Union stakeholders in third countries and the sharing of best practices.

Amendment 67 #

Proposal for a regulation
Article 14 – point d a (new)

(da) take measures to support users who contribute to the conservation of biological diversity and cultural diversity but who have insufficient means to become trusted collections;

Amendment 68 #

Proposal for a regulation
Article 14 – point d b (new)

(db) ensure that, in situations where genetic resources and associated traditional knowledge are utilised illegally, or not in compliance with prior informed consent or mutually agreed terms, providers who are competent to grant access to genetic resources and sign mutually agreed terms are entitled to bring an action to prevent or stop such utilisation, including through injunctions, and to seek compensation for any damages resulting therefrom, as well as, where appropriate, for the seizure of the genetic resources concerned.

Amendment 69 #

Proposal for a regulation
Article 14 – point d c (new)

(dc) encourage users and providers to direct benefits arising from the utilisation or subsequent commercialisation of genetic resources towards the conservation of biological diversity and the sustainable use of its components.

Amendment 70 #

Proposal for a regulation
Article 14 – point d d (new)

(dd) support, upon request, regional cooperation on benefit-sharing regarding transboundary genetic resources and associated traditional knowledge.

Amendment 71 #

Proposal for a regulation
Article 14 a (new)

Union benefit-sharing fund 1. A Union benefit-sharing fund ("the fund") is hereby established. 2. The fund shall receive revenues from the implementation of Article 4 (1 b). 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 14b to establish the procedures for implementing and operating the fund to finance the conservation of biodiversity globally.

Amendment 72 #

Proposal for a regulation
Article 14 b (new)

Article 14b Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 4(4a), 9(8) and 14a (3) shall be conferred on the Commission for a period of five years from ...The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 4(4a), 9(8) and 14a (3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 4(4a), 9(8) or 14a (3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. * OJ please insert date: the date referred to in Article 17(1)

Amendment 73 #

Proposal for a regulation
Article 15 a (new)

Article 15a Consultation Forum The Commission shall ensure a balanced participation of Member States’ representatives and relevant provider organisations, user associations, inter- governmental and non-governmental organisations as well as representatives of indigenous and local communities in the implementation of this Regulation. Those parties shall contribute, in particular, to defining and reviewing delegated acts pursuant to Articles 4(5), Article 9(8), and Article 14a(3), and to the implementation of Articles 5, 7 and 8, and any guidelines for establishing mutually agreed terms. The parties shall meet in a consultation forum. The rules of procedure of that forum shall be established by the Commission.

Amendment 74 #

Proposal for a regulation
Article 16 – paragraph 3

Amendment 75 #

Proposal for a regulation
Article 16 a (new)

Article 16a Amendment to Directive 2008/99/EC Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law1 is hereby amended, with effect from …*, as follows: (1) The following point is added to Article 3: "(j) biopiracy" (2) The following indent is added to Annex A: "– Regulation (EU) No …/2013 of the European Parliament and of the Council of ... on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union". ____________ * OJ: one year after the date of entry into force of this Regulation. 1 OJ L 328, 6.12.2008, p. 28.

Amendment 76 #

Proposal for a regulation
Article 17 – paragraph 2

2. Articles 4, 7, and 9 shall apply one year after the date of entry into force of this Regulation Access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation (Nagoya Protocol): Union implementation and ratification 2012/0278(COD) GENERAL CONTEXT The loss of biodiversity is constantly increasing and accelerating. It has been calculated that one in four species of mammals, one in eight birds and more than one in three amphibians are threatened with extinction worldwide (IUCN, 2012). Almost 60% of ecosystems have deteriorated in the past 50 years (FAO, 2010). Quite aside from the ethical and moral implications, the economic and social impact of this state of affairs is immense: by 2050 economic losses caused by loss of biodiversity will amount to 7% of global GDP (TEEB 2010). Paradoxically, biological diversity offers an inexhaustible reservoir of innovations and discoveries in terms of scientific research and technological applications as well as healthcare products, foodstuffs, cosmetics and other products. It is thus imperative to conserve biodiversity, not only for the sake of humanity in both the Global North and Global South but also for the socio-economic vitality of Europe and its people, who benefit directly from its use. In order to help conserve biodiversity, and the peoples and knowledge associated with it, we must ensure today that the benefits arising from the utilisation of genetic resources and the associated traditional knowledge are shared fairly and equitably. This benefit-sharing must contribute to the conservation of biological and cultural diversity in situ and ensure its sustainable use for local populations. It is in this spirit that the Nagoya Protocol on Access and Benefit-Sharing was signed in 2010, on the occasion of the 10th Conference of the Parties to the Convention on Biological Diversity. THE RAPPORTEUR’S PROPOSAL With this proposal for a regulation from the Commission, the European Union is now undertaking to transpose the Nagoya Protocol. The rapporteur believes it important for the resulting regulation to stick as closely as possible to both the spirit and text of this international treaty. The Commission proposal constitutes a solid basis for an effective system at European level. However, if we wish to comply fully with the Nagoya Protocol, we will have to strengthen certain mechanisms, as the rapporteur proposes. If the issue of access to resources is left to the sovereignty of the Member States, we must establish a clear Community framework for the fair and equitable sharing of benefits derived from the use of natural resources. The draft regulation that the rapporteur has submitted to the European Parliament is intended to address the various situations and needs currently known, expressed or anticipated by all European stakeholders as well as our partners in third countries. The amendments tabled herein are intended to benefit primarily European citizens by guaranteeing traceability and ethical conduct, compliance with international legal obligations and the fair and equitable sharing of benefits. What is more, the adoption of a clear legal framework will be beneficial for all users, including public and private economic stakeholders, since it will provide both sustainable access to genetic resources and legal certainty throughout the chain of custody. The framework will also provide public and private research collections and institutions – key players in the European chain of custody – with simple rules that are tailored to their needs. In accordance with the relevant provisions of the Nagoya Protocol, this regulation must thus apply to all stakeholders, including not-for-profit research institutions, as these transmit genetic resources and valuable information to users who seek an assurance of traceability and legal certainty. Finally, the amendments tabled by the rapporteur aim to reinforce international equity and the confidence of third country suppliers, and thereby to boost trade between them and user countries in the European Union. The fair and equitable sharing of benefits arising from the utilisation of their genetic resources goes beyond the sharing of financial benefits and will allow environmental conservation, social progress and sustainable use of resources in situ. KEY LINES OF ACTION Improving the chain of custody of genetic resources and the associated traditional knowledge Ensuring the integrity of the chain of custody is essential if we wish to guarantee traceability and legal certainty for users. This means that a genetic resource must at all times be used in accordance with the terms agreed with the supplier. If any other use is considered, then a new contract for access and benefit-sharing must be drawn up beforehand to reflect the relevant changes. The rapporteur proposes retaining checks whenever applications for marketing authorisation are made and whenever public or private research credits are granted, so as not to disadvantage public research institutes and universities. Reporting obligations must also be introduced covering the signing of the access and benefit- sharing contract to alert the relevant authorities whenever a genetic resource comes under the European system. Checks with the competent authorities must also be carried out whenever a patent application is made. This will chiefly concern the national patent offices, but the European Patent Office, which processes the majority of patents, will also be involved, and an agreement between it and the European Union must be secured. Improving the chain of custody in this manner would prevent imposing a greater administrative burden as a result of the checks, as it would enable a clearly defined and functional follow-up process. Moreover, this will guarantee the avoidance of penalties at the end of the process, for example in cases where an application for marketing authorisation is denied to a company that has invested substantial resources in research and development but is proven to have used a genetic resource without due authorisation. Increasing transparency and legal certainty The rapporteur stresses the fundamental importance of outlawing biopiracy, the illegal acquisition and use of genetic resources, in Europe. Such practices not only lead to human tragedies; they also run counter to the principles of fairness and the values of the European Union, compromise the international image of the Member States and our relations with supplier countries, and undermine the legal situation of European users. Due diligence requires users to take all necessary steps to comply with the proposed legislation. These rules should, however, be supplemented by prohibition of biopiracy, with a view to gradually acting as an effective deterrent. This two-pronged approach will ensure greater reliability and a smoother functioning of access and benefit-sharing mechanisms. This entails setting a legal definition of the offence of biopiracy and establishing appropriate sanctions. The European Union will thereby have a system at its disposal which is very similar to that laid down by Parliament in accordance with Regulation (EU) No 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down the obligations of operators who place timber and timber products on the market. New utilisations of genetic resources and associated traditional knowledge and progressive compliance The fair and equitable sharing of benefits arising from any utilisation of genetic resources and associated traditional knowledge is enshrined in the Convention on Biological Diversity and the Nagoya Protocol. The rapporteur therefore proposes that each new utilisation that has not been defined before the entry into force of this regulation should be covered by an access and benefit-sharing contract. Such a requirement would allow all genetic resources in Europe to gradually come into compliance. Much of the world’s genetic resources are indeed already found in European collections. The Commission proposal does not cover these resources, and this poses several major problems. The most important problem, according to the rapporteur, is that some uses of resources that may have been acquired illegally could thus be legalised. It is also important, on the one hand, not to place users who already apply the principle of benefit-sharing at a disadvantage with respect to those who do not yet do so and, on the other hand, to ensure that a genetic resource in a European collection can in the future still be subject to benefit-sharing in its country of origin. This system will help encourage third countries to open their doors to secure and sustainable access to genetic resources and associated traditional knowledge. A Union fund for the sharing of benefits and the strengthening of the multilateral global process The rapporteur believes it to be essential for users to take the necessary steps to secure an access and benefit-sharing contract in the event of a new utilisation of any genetic resource. She does, however, recognise that the origin of some genetic resources, such as ‘historical’ genetic resources or those acquired in areas beyond national jurisdictions, cannot be traced. To address this situation, the rapporteur proposes the establishment of a Union benefit-sharing fund, which will be financed by the users of genetic resources, with a view to preserving global biodiversity. This Union fund will ultimately contribute to establishing a global multilateral benefit-sharing mechanism, as set out in Article 10 of the Nagoya Protocol. All proposals tabled by the rapporteur aim to ensure that the European Union assumes a leading role in current and future international negotiations by taking a progressive stance with a view to setting up, as soon as possible, an ambitious global multilateral mechanism to meet the challenges of preserving biodiversity and its sustainable use.(1) to (4), Article 7, and Article 9 shall apply one year after the date of entry into force of this Regulation. Or. en EXPLANATORY STATEMENT

Amendment 81 #

Proposal for a regulation
Recital 5

(5) The Convention recognises that states have sovereign rights over natural resources found within their jurisdiction and the authority to determine access to their genetic resources. The Convention imposes an obligation on all Parties to facilitate access to genetic resources over which they hold sovereign rights. It also makes it mandatory for all Parties to take measures to share in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Party providing these resources. Such sharing shall be upon mutually agreed terms. The Convention also addresses access and benefit-sharing in relation to the knowledge, innovations and practices of indigenous and local communities relevant for the conservation and sustainable use of biological diversity. Genetic resources should, indeed, be utilized in a balanced and sustainable manner, and local communities legitimately involved, for it is only in that way that opportunities, developments, and benefits arising from their utilization can be shared fairly and equitably among all Parties.

Amendment 82 #

Proposal for a regulation
Article 3 a (new)

Article 3a Concept of traceability Genetic items have to be defined at the molecular level with enough resolution to allow the unequivocal identification of their origin and destiny. Although a protocol of traceability requires proper recording of sequences of events or usages for any item, the traceability of any genetic entity requires its fingerprinting at the DNA level.

Amendment 83 #

Proposal for a regulation
Article 3 b (new)

Article 3b Definition of catalogue Genetic catalogues are made of individuals belonging to certain species. The next item of importance are local populations (landraces, ecotypes, endemisms, varieties, or even subspecies). Genetic catalogues require as for traceability an unbiased method of bar- coding that should be based on DNA sequencing technologies.

Amendment 84 #

Proposal for a regulation
Article 4 – paragraph 2 – point a – introductory part

(a) seek, keep and transfer to subsequent users: (1) the internationally recognised certificate of compliance, where genetic resources were accessed by Parties to the Nagoya Protocol which have exercised their sovereign rights as provided for in Article 6 of that Protocol; or, failing this, (b) information on:

Amendment 85 #

Proposal for a regulation
Article 9 – paragraph 2

2. The checks referred to in paragraph 1 of this Article shall be conducted in accordance with a periodically reviewed plan following a risk-based approach. When developing this risk-based approach, Member States shall consider that the implementation by a user of a best practice recognised under Article 8(2) of this Regulation or under Article 20(2) of the Nagoya Protocol reduces that user’s risk of non-compliance.deleted

Amendment 86 #

Proposal for a regulation
Article 9 – paragraph 3

3. Checks ~~may~~shall be conducted when a competent authority is in possession of relevant information, including on the basis of substantiated concerns provided by third parties, concerning non-compliance of a user with this Regulation.

Amendment 87 #

Proposal for a regulation
Article 14 – paragraph 1 – point d a (new)

(da) compile a catalogue of available genetic resources originating in Member States, pursuant to Article 7 of the Convention on Biological Diversity, in order to establish their biological diversity. They shall, in addition, encourage third countries to produce catalogues of their genetic resources with a view to improving the transparency of user access.

Amendment 88 #

Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 1 (new)

Once the fund to be set up under the Convention on Biological Diversity, or any other fund established for the same purpose, has entered into operation, they shall endeavour to ensure that such funds provide sources of financing for research and the compilation of genetic resource catalogues.

source: PE-510.587

2013/05/17 DEVE 9 amendments...

Amendment 81 #

Proposal for a regulation
Recital 5

(5) The Convention recognises that states have sovereign rights over natural resources found within their jurisdiction and the authority to determine access to their genetic resources. The Convention imposes an obligation on all Parties to facilitate access to genetic resources over which they hold sovereign rights. It also makes it mandatory for all Parties to take measures to share in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Party providing these resources. Such sharing shall be upon mutually agreed terms. The Convention also addresses access and benefit-sharing in relation to the knowledge, innovations and practices of indigenous and local communities relevant for the conservation and sustainable use of biological diversity. Genetic resources should, indeed, be utilized in a balanced and sustainable manner, and local communities legitimately involved, for it is only in that way that opportunities, developments, and benefits arising from their utilization can be shared fairly and equitably among all Parties.

Amendment 82 #

Proposal for a regulation
Article 3 a (new)

Amendment 83 #

Proposal for a regulation
Article 3 b (new)

Amendment 84 #

Proposal for a regulation
Article 4 – paragraph 2 – point a

(a) seek, keep and transfer to subsequent users information on: (1) the date and place of access of genetic resources and traditional knowledge associated with such resources; (2) the description of genetic resources or traditional knowledge associated with such resources used, including available unique identifiers; (3) the source from which the resources or the knowledge were directly obtained as well as subsequent users of genetic resources or traditional knowledge associated with such resources; (4) the presence or absence of rights and obligations related to access and benefit- sharing; (5) access decisions and mutually agreed terms, where applicable;the internationally recognised certificate of compliance, where genetic resources were accessed by Parties to the Nagoya Protocol which have exercised their sovereign rights as provided for in Article 6 of that Protocol; or, failing this:

Amendment 85 #

Proposal for a regulation
Article 4 – paragraph 2 – point a a (new)

(aa) seek, keep and transfer to subsequent users information on: (1) the date and place of access of genetic resources and traditional knowledge associated with such resources; (2) the description of genetic resources or traditional knowledge associated with such resources used, including available unique identifiers; (3) the source from which the resources or the knowledge were directly obtained as well as subsequent users of genetic resources or traditional knowledge associated with such resources; (4) the presence or absence of rights and obligations related to access and benefit- sharing; (5) access decisions and mutually agreed terms, where applicable;

Amendment 86 #

Proposal for a regulation
Article 9 – paragraph 2

2. The checks referred to in paragraph 1 of this Article shall be conducted in accordance with a periodically reviewed plan following a risk-based approach. When developing this risk-based approach, Member States shall consider that the implementation by a user of a best practice recognised under Article 8(2) of this Regulation or under Article 20(2) of the Nagoya Protocol reduces that user’s risk of non-compliance.deleted

Amendment 87 #

Proposal for a regulation
Article 9 – paragraph 3

Amendment 88 #

Proposal for a regulation
Article 14 – paragraph 1 – point d a (new)

Amendment 89 #

Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 1 (new)

source: PE-510.587

2013/05/30 ENVI 115 amendments...

Amendment 77 #

Proposal for a regulation
Recital 2 a (new)

(2a) The European Union recognises the interdependence of all countries with regard to genetic resources for food and agriculture, as well as their special nature and importance for achieving food security worldwide and for the sustainable development of agriculture in the context of poverty alleviation and climate change and acknowledging the fundamental role of the International Treaty on Plant Genetic Resources for Food and Agriculture and the FAO Commission on Genetic Resources for Food and Agriculture in this regard.

Amendment 78 #

Proposal for a regulation
Recital 2 b (new)

(2b) It is recognised practice to exchange all plant genetic resources for food and agriculture for research, breeding and training purposes under the terms and condition of the Standard Material Transfer Agreement (SMTA) established under the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) as determined in the Memorandum of Understanding for the establishment of the European Genebank Integrated System (AEGIS); in accordance with Article 4.3 of the Protocol, it is acknowledged that such a practice is supportive of, and does not run counter to, the objectives of the Convention and the Protocol.

Amendment 79 #

Proposal for a regulation
Recital 3 a (new)

(3a) Competence and responsibility for the practical implementation of measures to safeguard indigenous and local communities in access and benefit sharing arrangements would remain with Member States and their courts.

Amendment 80 #

Proposal for a regulation
Recital 6

(6) The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity (the Nagoya Protocol) is an international treaty adopted on 29 October 2010 by the Parties to the Convention. The Nagoya Protocol significantly expands the general rules of the Convention on access and monetary and non-monetary benefit- sharing for the usetilisation and any subsequent commercialisation of genetic resources and traditional knowledge associated with genetic resources.

Amendment 81 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER

Proposal for a regulation
Recital 6

(6) The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity (the Nagoya Protocol) is an international treaty adopted on 29 October 2010 by the Parties to the Convention. The Nagoya Protocol ~~significantly expand~~further elaborates the general rules of the Convention on access and benefit- sharing for the use of genetic resources and traditional knowledge associated with genetic resources.

Amendment 82 #

Proposal for a regulation
Recital 6

(6) The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity (the Nagoya Protocol) is an international treaty adopted on 29 October 2010 by the Parties to the Convention. The Nagoya Protocol s~~ignificantly expands~~ets out in greater detail the general rules of the Convention on access and benefit- sharing for the use of genetic resources and traditional knowledge associated with genetic resources.

Amendment 83 #

Proposal for a regulation
Recital 6

(6) The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity (the Nagoya Protocol) is an international treaty adopted on 29 October 2010 by the Parties to the Convention. The Nagoya Protocol ~~significantly expand~~further details the general rules of the Convention on access and benefit- sharing for the use of genetic resources and traditional knowledge associated with genetic resources.

Amendment 84 #

Proposal for a regulation
Recital 6

(6) The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity (the Nagoya Protocol) is an international treaty adopted on 29 October 2010 by the Parties to the Convention. The Nagoya Protocol ~~significantly expand~~further details the general rules of the Convention on access and benefit- sharing for the use of genetic resources and traditional knowledge associated with genetic resources.

Amendment 85 #

Proposal for a regulation
Recital 8 a (new)

(8a) Unauthorised acquisition of genetic resources, or unauthorised utilisation or subsequent commercialisation of products based on such resources or associated traditional knowledge should be prohibited.

Amendment 86 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER

Proposal for a regulation
Recital 8 b (new)

(8b) Unauthorised acquisition of genetic resources, or unauthorised utilisation or subsequent commercialisation of products based on such resources or associated traditional knowledge are made subject to criminal sanctions in accordance with Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law1. __________________ 1 OJ L 328, 6.12.2008, p. 28

Amendment 87 #

Proposal for a regulation
Recital 11

Amendment 88 #

Proposal for a regulation
Recital 11

Amendment 89 #

Proposal for a regulation
Recital 11

Amendment 90 #

Proposal for a regulation
Recital 11

(11) It is important to define, in accordance with the Nagoya Protocol, that usetilization of genetic resources refers to research and development on the genetic or biochemical composition of ~~samples of genetic material, which includes research and development on isolated compounds extracted from genetic material that was accessed in a Party to the Nagoya Protocol~~genetic resources.

Amendment 91 #

Proposal for a regulation
Recital 13

(13) There is currently no internationally agreed definition on ‘traditional knowledge associated with genetic resources’ or on ‘holding’ such knowledge by an indigenous and local community. International definitions of those terms and concepts are being negotiated in the Intergovernmental Committee of the World Intellectual Property Organization. Therefore, in order to ensure flexibility and legal certainty for providers and users, this Regulation should make reference to traditional knowledge associated with genetic resources as described in benefit- sharing agreements.deleted

Amendment 92 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER

Proposal for a regulation
Recital 14

(14) With a view to ensuring an effective implementation of the Nagoya Protocol, all users of genetic resources ~~and traditional knowledge associated with such resources~~ should have to exercise due diligence to ascertain that the genetic resources ~~and associated traditional knowledge~~ used were accessed in accordance with applicable legal requirements and to ensure that, where relevant, benefits are shared. However, given the diversity of users within the Union it is not appropriate to oblige all users to take the same measures for exercising due diligence. Therefore, only minimum features of due diligence measures should be set out. The specific choices taken by users on the tools and measures applied for exercising due diligence should be supported through the recognition of best practices as well as complementary measures in support of sectoral codes of conduct, model contractual clauses, and guidelines with a view to increasing legal certainty and reducing costs. The obligation on users to keep information relevant for access and benefit-sharing should be limited in time, consistent with the time-span for an eventual innovation.

Amendment 93 #

Proposal for a regulation
Recital 14

(14) With a view to ensuring an effective implementation of the Nagoya Protocol, all users of genetic resources and traditional knowledge associated with such resources should have to exercise due diligence to ascertain that the genetic resources and associated traditional knowledge used were accessed in accordance with applicable legal requirements and to ensure that, where relevant, benefits are shared. However, given the diversity of users within the Union it is not appropriate to oblige all users to take the same measures for exercising due diligence. Therefore, only minimum features of due diligence measures should be set out. The specific choices taken by users on the tools and measures applied for exercising due diligence should be supported through the recognition of best practices as well as complementary measis applies in particular to subsequent users, to whom the due diligence obligation should apply only if they access and use genetic resources in ~~support of sectoral codes of conduct, model contractual clauses, and guidelines with a view to increasing legal certainty and reducing costs~~the same way as the initial user. The obligation on users to keep information relevant for access and benefit- sharing should be limited in time, consistent with the time-span for an eventual innovation.

Amendment 94 #

Esther de LANGE

Proposal for a regulation
Recital 14

(14) With a view to ensuring an effective implementation of the Nagoya Protocol, all users of genetic resources and traditional knowledge associated with such resources should have to exercise due diligence to ascertain that the genetic resources and associated traditional knowledge used were accessed in accordance with applicable legal requirements and to ensure that, where relevant, benefits are shared. However, given the diversity of users within the Union it is not appropriate to oblige all users to take the same measures for exercising due diligence. Therefore, only minimum features of due diligence measures should be set out. ~~The specific choices taken by users on the tools and measures applied for exercising due diligence should be supported through the recognition of best practices as well as complementary meas~~Particularly in the case of subsequent users, for whom the due diligence obligation should only apply in the case such users access and use genetic resources in ~~support of sectoral codes of conduct, model contractual clauses, and guidelines with a view to increasing legal certainty and reducing costs~~the form as originally accessed by the initial user. The obligation on users to keep information relevant for access and benefit-sharing should be limited in time, consistent with the time-span for an eventual innovation.

Amendment 95 #

Proposal for a regulation
Recital 16

(16) The specific choices taken by users on the tools and measures applied for exercising du diligence should be supported through the recognition of best practices. Best practices developed by users should play an important role in identifying due diligence measures that are particularly suitable for achieving compliance with the system of implementation of the Nagoya Protocol with high legal certainty and at low costs, as well as complementary measures in support of sectoral codes of conduct and model-contractual clauses. Users should be enabled to build on existing access and benefit-sharing codes of conduct developed for the academic sector and different industries. Associations of users should be able to request that the Commission determines whether a specific combination of procedures, tools or mechanisms overseen by an association may be recognised as best practice. Competent authorities of the Member States should consider that the implementation of a recognised best practice by a user reduces that user's risk of non-compliance and justifies a reduction in compliance checks. The same should apply to best practices adopted by the collective of the Parties to the Nagoya Protocol.

Amendment 96 #

Proposal for a regulation
Recital 17

(17) Users should declare at identified points in the chain of activities that ~~constitute use that~~ they have exercised due diligence. Suitable points for such declarations are the recei~~ving of public research fund~~pt of research funding, when applying for intellectual property rights at relevant national, regional or international institutions, whenre a market approval for a product developed on the basis of genetic resources is requested or at the time of commercialisation where a market approval is not required. Notably, the declaration made upon occasion of requesting market approval would not constitute part of the approval procedure as such and would be directed to competent authorities established under this Regulation.

Amendment 97 #

Proposal for a regulation
Recital 18

(18) Collecting of genetic resources in the wild is ~~mostly~~ undertaken ~~for non- commercial purposes by university-based researchers or collector~~by private collectors and companies, often serving commercial purposes, and by academic researchers or scientific institutions serving non- commercial purposes. In the vast majority of cases and in almost all sectors, access to newly collected genetic resources is gained through intermediaries, collections, or agents that acquire genetic resources in third countries.

Amendment 98 #

Proposal for a regulation
Recital 18

(18) Collecting of genetic resources in the wild is ~~mostly~~ undertaken both for commercial purposes and with commercial intent by companies with specific expertise in the field of exploration, harvest and extraction, as well as for non- commercial purposes by university-based researchers or collectors. In the vast majority of cases and in almost all sectors, access to newly collected genetic resources is gained through intermediaries, collections, or agents that acquire genetic resources in third countries, both commercially and non-commercially.

Amendment 99 #

Proposal for a regulation
Recital 18

(18) Collecting of genetic resources in the wild is mostly undertaken for non- commercial purposes by university-based researchers or collectors. In the vast majority of cases and in almost all sectors, access to newly collected genetic resources is gained through intermediaries, collections, or agents that acquire genetic resources in third countries. This Regulation should ensure that the provisions of mutually agreed terms for the initial access relevant for third party transfer are followed by all parties involved. To this effect, subsequent utilisation or commercialisation also require prior informed consent and mutually agreed terms.

Amendment 100 #

Proposal for a regulation
Recital 19

(19) Collections are major suppliers of genetic resources and traditional knowledge associated with genetic resources used in the Union. A system of Union ~~trust~~registered collections should be set in place. It would ensure that collections included in the register of Union ~~trust~~registered collections effectively apply measures to only supply samples of genetic resources to third persons with documentation providing evidence of legal acquisition and the establishment of mutually agreed terms, where required. A system of Union ~~trust~~registered collections should substantially lower the risk that illegally acquired genetic resources are used in the Union. Competent authorities of Member States would verify if a collection meets the requirements for recognition as Union ~~trust~~registered collection. Users that acquire a genetic resource from a collection listed in the Union register should be considered to have exercised due diligence as regards the seeking of all necessary information. This should prove particularly beneficial for academic researchers as well as small and medium sized enterprises.

Amendment 101 #

Proposal for a regulation
Recital 20

(20) Competent authorities of Member States should check whether users comply with their obligations. In that context, competent authorities should accept internationally recognised certificates of compliance as evidence that the genetic resources covered were legally acquired and that mutually agreed terms were established. When an international certificate is not available, other legally acceptable forms of compliance should be considered evidence that the genetic resources covered were legally acquired and that mutually agreed terms were established. Competent authorities should also keep records of the checks made and relevant information should be made available in accordance with Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information.13

Amendment 102 #

Proposal for a regulation
Recital 22 a (new)

(22a) The principle of benefit-sharing as enshrined in Article 10 of the Nagoya Protocol should be implemented by the Union pending the establishment of a global multilateral mechanism as envisaged in the Protocol. Until global multilateral benefit – sharing mechanism is in place, a Union benefit-sharing fund should be established to collect benefit- sharing contributions and channel them to the conservation of biological diversity globally. To that end, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of detailed criteria and rules for benefit-sharing in situations where genetic resources originate from areas beyond the jurisdiction of the Member States, or the country of origin of such resources cannot be established, or it is not possible to grant or obtain prior informed consent. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

Amendment 103 #

Proposal for a regulation
Recital 28

(28) The objectives of this Regulation are to minimise the risk that illegally genetic resources ~~or traditional knowledge associated with genetic resources~~ are used in the Union, and to support the fair and equitable sharing of benefits resulting from the use of genetic resources ~~or traditional knowledge associated with genetic resources~~ upon mutually agreed terms. These cannot be achieved by the Member States individually, and can therefore, by reasons of their scale and to ensure functioning of the internal market, be better achieved at Union level. The Union may therefore adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve its objectives.

Amendment 104 #

Proposal for a regulation
Article 1 – paragraph 1

This Regulation establishes rules governing compliance with access and benefit-sharing for genetic ~~resources and traditional knowledge associated with genetic~~ resources, in accordance with the provisions of the Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation to the Convention on Biological Diversity (the Nagoya Protocol).

Amendment 105 #

Proposal for a regulation
Article 1 – paragraph 1

Amendment 106 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER

Proposal for a regulation
Article 1 – paragraph 1

Amendment 107 #

Proposal for a regulation
Article 1 – paragraph 1

This Regulation establishes rules governing proper access and benefit- sharing for genetic resources and traditional knowledge associated with genetic resources, in accordance with the provisions of the Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation to the Convention on Biological Diversity (the Nagoya Protocol).

Amendment 108 #

Proposal for a regulation
Article 2 – paragraph 1

This Regulation applies to genetic resources over which states exercise sovereign rights ~~and to traditional knowledge associated with genetic resources~~ that are accessed after the entry into force of the Nagoya Protocol for the Union. It also applies to the benefits arising from the use of such genetic ~~resources and to traditional knowledge associated with genetic~~ resources.

Amendment 109 #

Proposal for a regulation
Article 2 – paragraph 1

This Regulation applies to genetic resources ~~over which states exercise sovereign rights~~ and to traditional knowledge associated with genetic resources that are accessed or utilised inside or outside of the jurisdiction of the countries of origin after the entry into force of the Nagoya Protocol for the Union. It also applies to the benefits arising from the usetilisation of such genetic resources and to traditional knowledge associated with genetic resources, as well as subsequent applications and commercialisation.

Amendment 110 #

Proposal for a regulation
Article 2 – paragraph 2

This Regulation does not apply to genetic resources for which access and benefit- sharing is governed by a specialised international instruments to which the Union is a Party.

Amendment 111 #

Gaston FRANCO

Proposal for a regulation
Article 2 – paragraph 2

This Regulation does not apply to genetic resources from countries which are not signatories of the Nagoya Protocol and which have no access law in conformity with the requirements of the Nagoya Protocol in place. This Regulation does also not apply to genetic resources which are available as commodities, or for which access and benefit- sharing is governed by a specialised international instrument to which the Union is a Party. Due regard should be paid to useful and relevant ongoing work or practices under other international organisations, provided that they are supportive of and do not run counter to the objectives of the Convention and this Protocol.

Amendment 112 #

Proposal for a regulation
Article 2 – paragraph 2 a (new)

Given the specific nature of biodiversity in the agricultural sphere, its characteristics and its problems, which call for specific solutions, this Regulation shall not apply to genetic resources for food and agriculture in so far as these fall within the scope of existing or future specialised instruments under Articles 4, 8c, 19 and 20 of the Nagoya Protocol.

Amendment 113 #

Proposal for a regulation
Article 3 – paragraph 1 –point 1 a (new)

(1a) Definition of catalogue: genetic catalogues are made of individuals belonging to certain species. The next items of importance are local populations (landraces, ecotypes, endemism's, varieties, or even subspecies). Genetic catalogues require as for traceability an unbiased method of bar-coding that should be based on DNA sequencing technologies.

Amendment 114 #

Proposal for a regulation
Article 3 – paragraph 1 a (new)

(1a) "commercialisation" means the first making available of a product on the Community market.

Amendment 115 #

Proposal for a regulation
Article 3 – paragraph 1 – point 1 b (new)

(1b) Concept of traceability: genetic items have to be defined at the molecular level with enough resolution to allow the unequivocal identification of its origin and destiny. Although a protocol of traceability requires a proper pipe of events or usage for any item, the traceability of any genetic entity requires its fingerprinting at the DNA level.

Amendment 116 #

Proposal for a regulation
Article 3 – paragraph 1 – point 4

(4) "access" means the acquisition of genetic resources ~~or of traditional knowledge associated with genetic resources~~ in a Party to the Nagoya Protocol in accordance with the applicable domestic access and benefit-sharing legislation or regulatory requirements of that Party.

Amendment 117 #

Proposal for a regulation
Article 3 – paragraph 1 – point 5

(5) "user" means a natural or legal person using genetic ~~resources or traditional knowledge associated with genetic~~ resources;

Amendment 118 #

Proposal for a regulation
Article 3 – paragraph 1 – point 7

(7) "mutually agreed terms" means the contractual arrangement concluded between a provider of genetic resources ~~or of traditional knowledge associated with genetic resources~~ and a user of such resources or knowledge, that sets out specific conditions for the fair and equitable sharing of benefits arising from such use, and that may also include further conditions and terms for the use of such resources or knowledge;

Amendment 119 #

Proposal for a regulation
Article 3 – paragraph 1 – point 8

(8) "traditional knowledge associated with genetic resources" means traditional knowledge held by an indigenous or local community that is relevant for the use of genetic resources and that is as such described in the mutually agreed terms applying to the use of genetic resources;deleted

Amendment 120 #

Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)

(8a) "illegally acquired genetic resources" means genetic resources and traditional knowledge associated with genetic resources acquired in contravention of the applicable international and national legislation or regulatory requirements on access and benefit-sharing in the country of origin, or the applicable customary laws, protocols and procedures of indigenous and local communities.

Amendment 121 #

Proposal for a regulation
Article 3 – paragraph 1 – point 8 b (new)

(8b) "biopiracy" means utilisation, or subsequent commercialisation, of illegally acquired genetic resources or products derived from such resources or traditional knowledge associated with genetic resources.

Amendment 122 #

Gaston FRANCO

Proposal for a regulation
Article 3 – paragraph 1 – point 12 a (new)

(12a) "commodity" means, for the purposes of this Regulation, a genetic resource freely traded as a product of commerce.

Amendment 123 #

Gaston FRANCO

Proposal for a regulation
Article 3 – paragraph 1 – point 12 b (new)

(12b) "research and development" means the investigation and study of the genetic or biochemical composition of genetic resources in order to establish facts and reach conclusions, including the creation of innovations and practical applications. This does not cover any scientific work carried out for compliance with health and safety regulatory requirements.

Amendment 124 #

Proposal for a regulation
Article 4 – paragraph 1

1. Users shall exercise due diligence to ascertain that genetic resources ~~and traditional knowledge associated with genetic resources~~ used were accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that, where relevant, benefits are fairly and equitably shared upon mutually agreed terms. Users shall seek, keep, and transfer to subsequent users information relevant for access and benefit- sharing.

Amendment 125 #

Proposal for a regulation
Article 4 – paragraph 1 a (new)

1 a. Illegally acquired genetic resources shall be prohibited in the Union.

Amendment 126 #

Proposal for a regulation
Article 4 – paragraph 1 a (new)

1a. The due diligence referred to in paragraph 1 shall not apply to subsequent uses of the product developed from the original resource (e.g. a plant variety) if the product is not a usable genetic resource.

Amendment 127 #

Proposal for a regulation
Article 4 – paragraph 1 a (new)

1 a. In the case of genetic resources originating from areas beyond national jurisdictions, or where the country of origin cannot be established, or where it is not possible to grant or obtain prior informed consent, new users shall provide benefit-sharing to a Union benefit- sharing fund dedicated to the conservation of biological diversity globally, until a global multilateral benefit-sharing mechanism is established pursuant to Article 10 of the Nagoya Protocol.

Amendment 128 #

Proposal for a regulation
Article 4 – paragraph 2 – point a – point 1

(1) the date and place of access of genetic ~~resources and traditional knowledge associated with such~~ resources;

Amendment 129 #

Proposal for a regulation
Article 4 – paragraph 2 – point a – point 1 a (new)

(1a) The internationally recognised certificate of compliance, in the case of genetic resources acquired from Parties to the Nagoya Protocol that have regulated access to their genetic resources in compliance with Article 6 of the Nagoya Protocol, or,

Amendment 130 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER, Esther de LANGE

Proposal for a regulation
Article 4 – paragraph 2 – point a – point 2

(2) the description of genetic resources ~~or traditional knowledge associated with such resources~~ used, including available unique identifiers;

Amendment 131 #

Proposal for a regulation
Article 4 – paragraph 2 – point a – point 3

(3) the source from which the resources or the knowledge were directly obtained ~~as well as subsequent users of genetic resources or traditional knowledge associated with such resources~~;

Amendment 132 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER

Proposal for a regulation
Article 4 – paragraph 2 – point a – point 5

(5) access ~~decision~~permits and mutually agreed terms, where applicable;

Amendment 133 #

Proposal for a regulation
Article 4 – paragraph 2 – point a – point 5

(5) access ~~decision~~permits and mutually agreed terms, where applicable;

Amendment 134 #

Proposal for a regulation
Article 4 – paragraph 2 – point a – point 5

(5) access ~~decision~~permits and mutually agreed terms, where applicable;

Amendment 135 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER

Proposal for a regulation
Article 4 – paragraph 2 – point a – point 5

(5) access ~~decision~~permits and mutually agreed terms, where applicable;

Amendment 136 #

Proposal for a regulation
Article 4 – paragraph 2 – point c

Amendment 137 #

Proposal for a regulation
Article 4 – paragraph 4

4. Users acquiring a genetic resource from a collection listed in the Union register of trusted collections referred to in Article 5(1) shall be considered to have exercised due diligence as regards the seeking of information relevant to access and benefit- sharing for genetic ~~resources and traditional knowledge associated with genetic~~ resources.

Amendment 138 #

Christa KLASS, Elisabeth JEGGLE, Elisabeth KÖSTINGER, Herbert DORFMANN, Esther de LANGE

Proposal for a regulation
Article 4 – paragraph 4

4. Users acquiring a genetic resource from a collection listed in the Union register of ~~trusted~~ collections referred to in Article 5(1) shall be considered to have exercised due diligence as regards the seeking of information relevant to access and benefit- sharing for genetic resources and traditional knowledge associated with genetic resources.

Amendment 139 #

Proposal for a regulation
Article 4 – paragraph 4 a (new)

4a. The obligations referred to in paragraphs 1 to 3 of this Article shall apply to subsequent users only if they access and use genetic resources in the same way as the initial user.

Amendment 140 #

Sophie AUCONIE

Proposal for a regulation
Article 4 – paragraph 4 a (new)

4a. Where a genetic resource has been incorporated into a new plant variety that has been placed on the market, the requirements set out in paragraphs 1 to 3 shall not apply to users of that new plant variety. The requirements applicable to the first user incorporating the genetic resource are therefore waived.

Amendment 141 #

Proposal for a regulation
Article 5

Article 5 Union trusted collections 1. The Commission shall establish and maintain a Union register of trusted collections. That register shall be internet- based, easily accessible to users, and shall include the collections of genetic resources identified as meeting the criteria of Union trusted collection. 2. Each Member State shall, upon request by a collection under its jurisdiction, consider the inclusion of this collection in the Union register of trusted collections. After verifying that the collection meets the criteria set out in paragraph 3, the Member State shall notify the Commission without delay of that collection's name, contact details, and type. The Commission shall without delay include the information thus received into the Union register of trusted collections. 3. In order for a collection to be included in the Union register of trusted collections, a collection owner shall demonstrate its capacity to: (a) apply standardised procedures for exchanging samples of genetic resources and related information with other collections, and for supplying samples of genetic resources and related information to third persons for their use; (b) have samples of genetic resources and related information supplied to third persons for their use only with documentation providing evidence that the resources and the information were accessed in accordance with applicable legal requirements and, where relevant, mutually agreed terms for the fair and equitable sharing of benefits; (c) keep records of all samples of genetic resources and related information supplied to third persons for their use; (d) establish or use unique identifiers for samples of genetic resources supplied to third persons; (e) use appropriate tracking and monitoring tools for exchanging samples of genetic resources and related information with other collections. 4. Member States shall regularly verify that each collection under their jurisdiction included in the Union register of trusted collections effectively applies the measures set out in paragraph 3. Member States shall inform the Commission without delay if a collection under their jurisdiction included in the Union register no longer complies with paragraph 3. 5. Where there is evidence that a collection included in the Union register of trusted collections does not apply the measures set out in paragraph 3, the Member State concerned shall without delay identify remedial actions in dialogue with the owner of the collection concerned. The Commission shall remove a collection from the Union register of trusted collections when, in particular on the basis of information provided pursuant to paragraph 4, it has determined that a collection included in the Union register of trusted collections faces important or persistent difficulties to comply with paragraph 3. 6. The Commission shall be empowered to adopt implementing acts to establish the procedures for implementing paragraphs 1 to 5 of this Article. The implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2).deleted

Amendment 142 #

Proposal for a regulation
Article 5 – title

Union ~~trust~~registered collections

Amendment 143 #

Proposal for a regulation
Article 5 – paragraph 1

1. The Commission shall establish and maintain a Union register of ~~trusted~~ collections. That register shall be internet- based, easily accessible to users, and shall include the collections of genetic resources identified as meeting the criteria of Union ~~trust~~registered collection.

Amendment 144 #

Proposal for a regulation
Article 5 – paragraph 2

2. Each Member State shall, upon request by a collection holder under its jurisdiction, consider the inclusion of this collection, or part of it, in the Union register of ~~trusted~~ collections. After verifying that the collection meets the criteria set out in paragraph 3, the Member State shall notify the Commission without delay of that collection's name, contact details, and type. The Commission shall without delay include the information thus received into the Union register ~~of trust~~ed collections.

Amendment 145 #

Proposal for a regulation
Article 5 – paragraph 3 – introductory part

3. In order for a collection to be included in the Union register of trusted collections, a collection owner shall, in regard to specimens accessed according to Article 2 of this Regulation, demonstrate its capacity to:

Amendment 146 #

Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 1

Member States shall regularly verify that each collection under their jurisdiction included in the Union register of ~~trusted~~ collections effectively applies the measures set out in paragraph 3.

Amendment 147 #

Proposal for a regulation
Article 5 – paragraph 5 – subparagraph 1

Where there is evidence that a collection included in the Union register of ~~trusted~~ collections does not apply the measures set out in paragraph 3, the Member State concerned shall without delay identify remedial actions in dialogue with the owner of the collection concerned.

Amendment 148 #

Proposal for a regulation
Article 5 – paragraph 5 – subparagraph 2

The Commission shall remove a collection from the Union register of ~~trusted~~ collections when, in particular on the basis of information provided pursuant to paragraph 4, it has determined that a collection included in the Union register of ~~trusted~~ collections faces important or persistent difficulties to comply with paragraph 3.

Amendment 149 #

Proposal for a regulation
Article 5 – paragraph 6

6. The Commission shall ~~be empowered to~~ adopt implementing acts to establish the procedures for implementing paragraphs 1 to 5 of this Article, as well as to consider procedures for registering collections located in third countries that fulfil the criteria for Union Trusted Collections so as to support global implementation of the Nagoya Protocol. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2).

Amendment 150 #

Proposal for a regulation
Article 5 – paragraph 6

6. The Commission shall be empowered to adopt implementing acts to establish the procedures for implementing paragraphs 1 to 5 of this Article, and to consider proposing procedures for registering collections located in third countries that fulfil the criteria for Union Trusted Collections so as to support global implementation of the Nagoya Protocol. The implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2).

Amendment 151 #

Proposal for a regulation
Article 6 – paragraph 3

3. The Commission shall designate a focal point on access and benefit-sharing responsible for providing information to applicants seeking access to genetic resources ~~and traditional knowledge associated with such resources~~ in the Union and to liaise with the Secretariat of the Convention on Biological Diversity.

Amendment 152 #

Proposal for a regulation
Article 6 – paragraph 3 – point 1 (new)

(1) The focus point designated by the Commission in point 3, shall ensure consultation with the relevant Union bodies established under, and national authorities implementing, Regulation (EC) No.338/97.

Amendment 153 #

Proposal for a regulation
Article 7 – paragraph 1

1. Member States and the Commission shall request all recipients of public research funding involving uses of genetic resources ~~and traditional knowledge associated with genetic resources~~ to declare that they will exercise due diligence in accordance with Article 4.

Amendment 154 #

Proposal for a regulation
Article 7 – paragraph 1

1. ~~Member States and the Commission shall request a~~All recipients of public research funding involving ~~uses~~the utilization of genetic resources and or of traditional knowledge associated with genetic resources ~~to declare that they will exercise due diligence in accordance with~~shall, upon approval of such funding, declare to the funding authority that they will fulfil or have fulfilled their obligations under Article 4.

Amendment 155 #

Proposal for a regulation
Article 7 – paragraph 2

2. ~~Users shall declare to the competent authorities established under Article 6(1) that they exercised due diligence in accordance with Article 4 on the occasion of request~~Member States and the Commission shall request users seeking market approval for a product developed onvia the ~~basis~~use of genetic resources or traditional knowledge associated with ~~such~~genetic resources~~, or at the time of commercialisation~~ to declare and provide evidence that they have fulfilled the obligations under Article 4. They shall equally request such information before the product is placed on the market where a market approval is not required.

Amendment 156 #

Proposal for a regulation
Article 7 – paragraph 2

2. Users shall declare to the competent authorities established under Article 6(1) that they exercised due diligence in accordance with Article 4 on the occasion of requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources, or at the time of commercialisation where a market approval is not required. This declaration shall not be required if the country of origin of the genetic resource used does not insist on Prior Informed Consent and Mutually Agreed Terms in accordance with Article 6 of the Nagoya Protocol.

Amendment 157 #

Proposal for a regulation
Article 7 – paragraph 2

Amendment 158 #

Cristina GUTIÉRREZ-CORTINES, Pavel POC

Proposal for a regulation
Article 7 – paragraph 3

3. Competent authorities shall transmit to the Commission every two years the information received on the basis of paragraphs 1 and 2. The Commission shall summarise the information received and make it available to the Access and Benefit-sharing Clearing HouseAccess and Benefit Sharing Clearing House Mechanism, to the Commission and/or the competent authorities of the State concerned the information received on the basis of paragraph 1 and 2.

Amendment 159 #

Proposal for a regulation
Article 8

Article 8 Best practices 1. Any association of users may submit an application to the Commission for recognising as best practice a combination of procedures, tools or mechanisms developed and overseen by it. The application shall be supported by evidence and information. 2. Where, on the basis of information and evidence supplied to it by an association of users , the Commission determines that the specific combination of procedures, tools or mechanisms, when effectively implemented by a user, enables the user to comply with its obligations set out in Articles 4 and 7, it shall grant recognition as best practice. 3. An association of users shall inform the Commission of any changes or updates made to a recognised best practice for which it was granted recognition in accordance with paragraph 2. 4. If evidence from competent authorities of the Member States or other sources indicates repeated cases where users implementing a best practice fail to comply with their obligations under this Regulation, the Commission shall examine in dialogue with the relevant association of users whether the repeated cases of non-compliance indicate possible deficiencies in the best practice. 5. The Commission shall withdraw the recognition of a best practice, when it has determined that changes to the best practice compromise a user's ability to meet the conditions set out in Articles 4 and 7, or when repeated cases of non- compliance by users relate to deficiencies in the practice. 6. The Commission shall establish and keep up to date an internet-based register of recognised best practices. That register shall list in one section best practices recognised by the Commission in accordance with paragraph 2 of this Article and display in another section best practices adopted on the basis of Article 20(2) Nagoya Protocol. 7. The Commission shall be empowered to adopt implementing acts to establish the procedures for implementing paragraphs 1 to 5 of this Article. The implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2).deleted

Amendment 160 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER

Proposal for a regulation
Article 9 – paragraph 2

2. The checks referred to in paragraph 1 of this Article shall be conducted in accordance with a periodically reviewed plan following a risk-based approach. When developing this risk-based approach, Member States shall consider that the implementation by a user of a best practice recognised under Article 8(2) of this Regulation or under Article 20(2) of the Nagoya Protocol reduces that user's risk of non-compliance.deleted

Amendment 161 #

Proposal for a regulation
Article 9 – paragraph 2

2. The checks referred to in paragraph 1 of this Article shall be conducted in accordance with a periodically reviewed plan following a risk-based approach~~. When developing this risk-based approach, Member States shall consider~~ the key principles of which shall be laid down by the Commission in accordance with the procedure set out in Article 15(2). This approach shall take into account the fact that the implementation by a user of a best practice recognised under Article 8(2) of this Regulation or under Article 20(2) of the Nagoya Protocol reduces that user's risk of non-compliance.

Amendment 162 #

Proposal for a regulation
Article 9 – paragraph 2

2. The checks referred to in paragraph 1 of this Article shall be conducted in accordance with a periodically reviewed plan following a risk-based approach. When developing this risk-based approach, ~~Member States shall consider~~the key principles shall be laid down by the Commission in accordance with the procedure referred to in Article 15(2). Such an approach shall take into account that the implementation by a user of a best practice recognised under Article 8(2) of this Regulation or under Article 20(2) of the Nagoya Protocol reduces that user's risk of non-compliance.

Amendment 163 #

Cristina GUTIÉRREZ-CORTINES, Santiago FISAS AYXELÀ, Julie GIRLING

Proposal for a regulation
Article 9 – paragraph 2

2. The checks referred to in paragraph 1 of this Article shall be conducted in accordance with a periodically reviewed plan following a risk-based approach~~. When developing this risk-based approach, Member States shall consider~~ of which the key principles shall be laid down by the Commission in accordance with the procedure referred to in Article 15(2). Such an approach shall take into account that the implementation by a user of a best practice recognised under Article 8(2) of this Regulation or under Article 20(2) of the Nagoya Protocol reduces that user's risk of non-compliance.

Amendment 164 #

Proposal for a regulation
Article 9 – paragraph 3

Amendment 165 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER

Proposal for a regulation
Article 9 – paragraph 4 – introductory part

4. The checks referred to in paragraph 1 shall include ~~at least~~:

Amendment 166 #

Christa KLASS, Elisabeth JEGGLE, Elisabeth KÖSTINGER, Herbert DORFMANN

Proposal for a regulation
Article 9 – paragraph 4 – introductory part

4. The checks referred to in paragraph 1 shall include ~~at least~~:

Amendment 167 #

Proposal for a regulation
Article 9 – paragraph 4 – point c

Amendment 168 #

Proposal for a regulation
Article 9 – paragraph 5

5. Competent authorities shall accept an internationally recognised certificate of compliance as evidence that the genetic resource it covers has been accessed in accordance with prior informed consent and that mutually agreed terms have been established, as required by the domestic access and benefit-sharing legislation or regulatory requirements of the Party to the Nagoya Protocol providing the prior informed consent. In the event that an internationally recognised certificate is not available, other legally acceptable forms of compliance should be considered enough evidence that the genetic resources covered were legally obtained and that mutually agreed terms were established.

Amendment 169 #

Julie GIRLING

Proposal for a regulation
Article 9 – paragraph 5 a (new)

5 a. The Implementing Rules will define procedural safeguards with respect to the procedures under Articles 7 and 9 to 11.

Amendment 170 #

Proposal for a regulation
Article 9 – paragraph 6

6. Users shall offer all assistance necessary to facilitate the performance of the checks referred to in paragraph 1~~, notably as regards access to premises and the presentation of documentation or records~~.

Amendment 171 #

Proposal for a regulation
Article 9 – paragraph 7 – subparagraph 2

Additionally, depending on the nature of the shortcomings detected, Member States may take immediate interim measures, including inter alia seizure of illegally acquired genetic resources and suspension of specific use activities. These interim measures must be effective, proportionate and dissuasive.

Amendment 172 #

Proposal for a regulation
Article 9 – paragraph 7 – subparagraph 2

Additionally, depending on the nature of the shortcomings detected, Member States may take immediate interim measures, including inter alia seizure of illegally acquired genetic resources and suspension of specific use activities. Such interim measures must be effective, proportionate and dissuasive.

Amendment 173 #

Proposal for a regulation
Article 9 – paragraph 7 – subparagraph 2

~~Additionally, d~~Depending on the nature of the shortcomings detected, Member States may take immediate appropriate interim measures, including inter alia seizure of illegally acquired genetic resources and suspension of specific use activities.

Amendment 174 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER

Proposal for a regulation
Article 11 – paragraph 1 a (new)

1 a. Member States shall allow the parties to make allegations or to appeal the decisions taken under Articles 7 and 9 in cases of alleged infringements.

Amendment 175 #

Proposal for a regulation
Article 12 – paragraph 2

2. The competent authorities shall exchange information on the organisation of their checking system for monitoring user compliance with this Regulation, on serious shortcomings detected through checks referred to in Articles 9(4) and 10(1) and on the types of penalties imposed in accordance with Article 11 with the competent authorities of other Member States and with the Commission.

Amendment 176 #

Proposal for a regulation
Article 12 – paragraph 2

Amendment 177 #

Proposal for a regulation
Article 12 – paragraph 2

Amendment 178 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER

Proposal for a regulation
Article 13 – paragraph 1

1. A Union platform on access to genetic resources ~~and traditional knowledge associated with genetic resources~~ is hereby established.

Amendment 179 #

Proposal for a regulation
Article 13 – paragraph 1

1. A Union platform on access to genetic resources and traditional knowledge associated with genetic resources is hereby established. Member States which plan to adopt rules governing access to their genetic resources shall first conduct an assessment of the impact of those rules and submit the results to the Union platform for consideration under the procedure laid down in paragraph 5 of this Article.

Amendment 180 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER

Proposal for a regulation
Article 13 – paragraph 1

1. A Union platform on access to genetic resources and traditional knowledge associated with genetic resources is hereby established. Member States who envisage adopting access rules as regards their genetic resources shall first conduct an impact assessment of these rules and submit the result of this assessment to the Union platform for consideration, pursuant to the procedure laid down in paragraph 5 of this Article.

Amendment 181 #

Proposal for a regulation
Article 13 – paragraph 2

Amendment 182 #

Proposal for a regulation
Article 13 – paragraph 2

Amendment 183 #

Proposal for a regulation
Article 14 – paragraph 1 –point a a (new)

(aa). Create a catalogue of the available and original genetic resources from each Member State in accordance with Article 7 of the Convention on Biodiversity. The objective will be to have a better knowledge of biodiversity. At the same time they will support third countries in developing a catalogue of their genetic resources with the aim of improving transparency in the access to genetic resources.

Amendment 184 #

Proposal for a regulation
Article 14 – paragraph 1 –point a b (new)

(a)(b) endeavour to ensure, once the fund to be set up under the Convention on Biological Diversity, or any other fund established for the same purpose, has entered into operation, that such funds provide sources of financing for research and the compilation of genetic resource catalogues.

Amendment 185 #

Proposal for a regulation
Article 14 – paragraph 1 – point c

(c) support the development and use of cost-effective communication tools and systems in support of monitoring and tracking the use of genetic resources ~~and traditional knowledge associated with genetic resources~~ by collections and users;

Amendment 186 #

Proposal for a regulation
Article 16 – paragraph 3

3. Every ~~ten~~five years after its first report the Commission shall, on the basis of reporting on and experience with the application of this Regulation, review the functioning and effectiveness of this Regulation. In its reporting the Commission shall in particular consider: a) the administrative consequences for public research institutions, small or medium-sized enterprises and micro- enterprises~~. It shall also consider the need for further Union action on access to genetic resources and traditional knowledge associated with genetic resources~~; b) the need to review the implementation of the provisions of this Regulation concerning traditional knowledge associated with genetic resources in light of developments in other relevant international organizations, including, inter alia, the World Intellectual Property Organization, provided that they do not run counter to the objectives of this Regulation, of the Convention on Biological Diversity and the Nagoya Protocol; c) the need for further Union action on access to genetic resources and traditional knowledge associated with genetic resources with the view to implement in full the rights of indigenous and local communities in accordance with Articles 5.2, 6.2, 7 and 12 of the Nagoya Protocol.

Amendment 187 #

Christa KLASS, Herbert DORFMANN, Elisabeth JEGGLE, Elisabeth KÖSTINGER

Proposal for a regulation
Article 16 – paragraph 3

3. Every ten years after its first report the Commission shall, on the basis of reporting on and experience with the application of this Regulation, review the functioning and effectiveness of this Regulation. In its reporting the Commission shall in particular consider the administrative consequences for public research institutions, small or medium-sized enterprises and micro-enterprises. It shall also consider the need for further Union action on access to genetic ~~resources and traditional knowledge associated with genetic~~ resources.

Amendment 188 #

Proposal for a regulation
Article 16 – paragraph 3

Amendment 189 #

Proposal for a regulation
Article 16 – paragraph 3

Amendment 190 #

Proposal for a regulation
Article 16 – paragraph 3

Amendment 191 #