32 Amendments of Herbert DORFMANN related to 2012/0278(COD)
Amendment 38 #
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 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 #
Proposal for a regulation
Recital 11
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 Protocolgenetic resources.
Amendment 40 #
Proposal for a regulation
Recital 11 a (new)
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 42 #
Proposal for a regulation
Recital 14
Recital 14
Amendment 43 #
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 practiis is the case in particular for subsequent users where the due diligence obligation should only apply in the case such users access as well as complementary measnd use genetic resources in support of sectoral codes of conduct, model contractual clauses, and guidelines with a view to increasing legal certainty and reducing coststhe 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 47 #
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 48 #
Proposal for a regulation
Article 2 – paragraph 2 a (new)
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 50 #
Proposal for a regulation
Article 4 – paragraph 2 – point a – subpoint 3
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 #
Proposal for a regulation
Article 4 – paragraph 2 – point a – subpoint 5
Article 4 – paragraph 2 – point a – subpoint 5
(5) access decisionpermits and mutually agreed terms, where applicable;
Amendment 52 #
Proposal for a regulation
Article 4 – paragraph 2 – point c
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 54 #
Proposal for a regulation
Article 5 – paragraph 3 – point e a (new)
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 57 #
Proposal for a regulation
Article 9 – paragraph 2
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 #
Proposal for a regulation
Article 9 – paragraph 4 – introductory part
Article 9 – paragraph 4 – introductory part
4. The checks referred to in paragraph 1 shall include at least:
Amendment 59 #
Proposal for a regulation
Article 12 – paragraph 2
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 #
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. 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 #
Proposal for a regulation
Article 13 – paragraph 2
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. In particular, the platform should advocate that where competent authorities leave requests for access unanswered, the due diligence obligation shall be deemed to be fulfilled and access should be without any further obligations.
Amendment 62 #
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 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.
Amendment 82 #
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 expandsets 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 87 #
Proposal for a regulation
Recital 11
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 Protocolgenetic resources.
Amendment 93 #
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 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 coststhe 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 107 #
Proposal for a regulation
Article 1 – paragraph 1
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 131 #
Proposal for a regulation
Article 4 – paragraph 2 – point a – point 3
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 #
Proposal for a regulation
Article 4 – paragraph 2 – point a – point 5
Article 4 – paragraph 2 – point a – point 5
(5) access decisionpermits and mutually agreed terms, where applicable;
Amendment 136 #
Proposal for a regulation
Article 4 – paragraph 2 – point c
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 139 #
Proposal for a regulation
Article 4 – paragraph 4 a (new)
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 161 #
Proposal for a regulation
Article 9 – paragraph 2
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 165 #
Proposal for a regulation
Article 9 – paragraph 4 – introductory part
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
Article 9 – paragraph 4 – point c
(c) on the spot checks, including field audits;
Amendment 175 #
Proposal for a regulation
Article 12 – paragraph 2
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 179 #
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. 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 181 #
Proposal for a regulation
Article 13 – paragraph 2
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. In particular, the platform should advocate that where competent authorities leave requests for access unanswered, the due diligence obligation shall be deemed to have been fulfilled and access shall be granted without any further obligations.
Amendment 188 #
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 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.