Activities of Anna ROSBACH related to 2012/0278(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union PDF (679 KB) DOC (983 KB)
Amendments (25)
Amendment 77 #
Proposal for a regulation
Recital 2 a (new)
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)
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)
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 81 #
Proposal for a regulation
Recital 6
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 expandfurther 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 91 #
Proposal for a regulation
Recital 13
Recital 13
Amendment 92 #
Proposal for a regulation
Recital 14
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 103 #
Proposal for a regulation
Recital 28
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
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 108 #
Proposal for a regulation
Article 2 – paragraph 1
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 116 #
Proposal for a regulation
Article 3 – paragraph 1 – point 4
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
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
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
Article 3 – paragraph 1 – point 8
Amendment 124 #
Proposal for a regulation
Article 4 – paragraph 1
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 128 #
Proposal for a regulation
Article 4 – paragraph 2 – point a – point 1
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 130 #
Proposal for a regulation
Article 4 – paragraph 2 – point a – point 2
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 137 #
Proposal for a regulation
Article 4 – paragraph 4
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 149 #
Proposal for a regulation
Article 5 – paragraph 6
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 151 #
Proposal for a regulation
Article 6 – paragraph 3
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 153 #
Proposal for a regulation
Article 7 – paragraph 1
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 157 #
Proposal for a regulation
Article 7 – paragraph 2
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.
Amendment 171 #
Proposal for a regulation
Article 9 – paragraph 7 – subparagraph 2
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 178 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. A Union platform on access to genetic resources and traditional knowledge associated with genetic resources is hereby established.
Amendment 185 #
Proposal for a regulation
Article 14 – paragraph 1 – point c
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 187 #
Proposal for a regulation
Article 16 – paragraph 3
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.