Activities of Pavel POC related to 2012/0278(COD)
Plenary speeches (1)
Access to genetic resources and the fair and equitable sharing of benefits arising from their utilization in the Union (debate)
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 (22)
Amendment 80 #
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 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 84 #
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 89 #
Proposal for a regulation
Recital 11
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 that was accessed in a Party to the Nagoya Protocolgenetic resources.
Amendment 96 #
Proposal for a regulation
Recital 17
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 receiving of public research fundpt 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
Recital 18
(18) Collecting of genetic resources in the wild is mostly undertaken for non- commercial purposes by university-based researchers or collectorby 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 100 #
Proposal for a regulation
Recital 19
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 trustregistered collections should be set in place. It would ensure that collections included in the register of Union trustregistered 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 trustregistered 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 trustregistered 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 106 #
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 114 #
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
(1a) "commercialisation" means the first making available of a product on the Community market.
Amendment 134 #
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 138 #
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 142 #
Proposal for a regulation
Article 5 – title
Article 5 – title
Union trustregistered collections
Amendment 143 #
Proposal for a regulation
Article 5 – paragraph 1
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 trustregistered collection.
Amendment 144 #
Proposal for a regulation
Article 5 – paragraph 2
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 trusted collections.
Amendment 145 #
Proposal for a regulation
Article 5 – paragraph 3 – introductory part
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
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
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
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 159 #
Proposal for a regulation
Article 8
Article 8
Amendment 163 #
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 172 #
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. Such interim measures must be effective, proportionate and dissuasive.
Amendment 177 #
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 190 #
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.