The EU Commission's legislative proposal on implementing the Nagoya Protocol in the Union

1. The EU Commission's legislative proposal on implementing the Nagoya Protocol in the Union • Background • Preparatory work done in support of the proposal and important findings • Main features of the legislative proposal • Next steps

2. I. Background • The European Union and all of its 27 Member States are Parties to the Convention on Biological Diversity • The Nagoya Protocol was adopted by the consensus of the Parties to the Convention on Biological Diversity on 29 October 2010. • The Council of the EU and the European Parliament repeatedly urged the Commission to propose measures for Union implementation and ratification of the Nagoya Protocol • The EU and 24 Member States signed the Nagoya Protocol while it was open for signature (2/2011- 2/2012), expressing their political commitment to swift implementation and ratification.

3. II. Preparatory work done in support of the proposal and important findings • Consultation with EU stakeholders • Bilateral consultations with other Parties • Conferences and workshops • Consultant report including sectoral studies to develop "EU baseline" • Commission Impact Assessment

4. Sectoral studies to develop "EU Baseline" • Step 1 - Sector analysis (Annex 3 of Consultant Study) • Pharmaceutical Industry • Culture collections • Botanic gardens • Plant Breeding/Seed sector • Biocontrol • Horticulture • Academic Research • Cosmetics Industry • Animal Breeding Industry • (Industrial) Biotechnology • Food and Beverage Industry • Step 2 – Establishment of "EU Baseline" (Annex 8 of IA)

5. Some characteristics of the "EU Baseline" • Genetic resources used for a wide range of purposes, by a wide range of actors with different interests • Multiple actors intervene at different stages of the value chain (collecting, basic research, applied research, product development) • Future interest in R&D on genetic resources stable or increasing, while demand for ‘in situ’ access declining in most sectors • Use of TKaGR of limited importance, expected to decline further • In situ access mostly done by university-based researchers and scientists affiliated with ex situ collections. • Commercial users rarely collect in the wild • Ex situ collections play a fundamental in the EU genetic resources value chain for both non-commercial and commercial users • ABS best practices exist particularly up-stream in the EU user-chain. Currently less relevant for downstream activities • >> The "EU Baseline" served as benchmark for analyzing impacts and for identifying the best performing implementing measures

6. Focus of the Impact Assessment • Different measures were analyzed with particular focus on the access and the user compliance pillar of the Protocol • Starting point: maximizing research and development opportunities on genetic resources will maximize benefits in support of conservation and sustainable use of biological diversity • Main IA criteria – in accordance with better regulation principles - were: • EU compliance with the Protocol • Legal certainty for users • Enabling conditions for research and development • Correspondence of measures with existing practices • Distribution of impacts and costs in the value chain, particularly focusing on academic researchers and SMEs • Administrative burden and costs

7. III. Main features of the legislative proposal • General obligation on users to exercise due diligence • Establishing a system of EU trusted collections • Formally recognizing best practices • Monitoring user compliance and checkpoints • Union platform on access • Enabling a collaborative approach to implementation

8. General due diligence obligation on users Article 4 All users would be obliged to exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources used were accessed in accordance with applicable legal requirements and that, where relevant, benefits are fairly and equitable shared upon mutually agreed terms. All users would need to seek, keep and transfer to subsequent users information relevant for access and benefit-sharing. Users would be obliged to draw consequences from such information. Breaches of the due diligence obligation would be sanctioned.

9. Establishing a system of EU trusted collections Article 5 Lowering the risk that illegally acquired genetic resources are used in the Union. Collections wishing to be included in the register of Union trusted collection would commit to supply fully documented samples of genetic resources to third persons for their use. Users acquiring a genetic resource from a Union trusted collection would be considered to have exercised due diligence as regards the seeking of all necessary information. System of EU trusted collections would be particularly beneficial for academic researchers and small or medium sized enterprises.

10. Formally recognising best practices Article 8 Associations of users may request the Commission to recognise a specific combination of procedures, tools or mechanisms overseen by an association as best practice. Competent authorities of the Member States would be obliged to 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. Formal recognition of best practices would raise legal certainty and lower costs for users and public administration

11. Monitoring user compliance and checkpoints Article 7 Users would be obliged to declare at identified points that they complied with their due diligence obligation. Article 9 Competent authorities of Member States would check on a risk-based approach whether users comply with their obligations under this Regulation. Article 11 Infringements of the Regulation by users would be sanctioned by effective, proportionate and dissuasive penalties.

12. IV. Next steps • Ordinary legislative procedure • EU ratification