Bangkok

2. Bangkok A Strong Generic Competition for a Sustainable Agriculture and  an Innovative Dominant Industry

3. I Changing context • World population • Strain on natural resources • Globalisation • More science

4. I Forces at work • Public opinion • Food safety & public health • Environmental concern • Surge for intellectual property rigths

5. I From TRIPS to national legislations • Bilateral agreements • Multilateral approach

6. II The European experience • Legislation with influence on the ability to manufacture, market and use PPP • REACH • Classification and labeling legislation • Major accident prevention directive (Seveso) • Transport regulation • Legislation resulting from ‘Envir.& health strategy’ (SCALE) ? • Worker protection legislation • Water Framework Directive and daughter legislation • EU marine strategy • Regulation on persistent organic pollutants (POP) • Environmental liability directive • Prior Informed Consent regulation (PIC) • Waste legislation • Etc.

7. II The European experience • Directive 91/414/EEC • Thematic strategy for the sustainable use of plant protection products aiming at • single market, harmonized rules • high standards for the protection of public health and the environment

8. II The European experience two major points of contention • Data protection • A fully harmonised and centralised process for the registration of PPP

9. II The European experience take a step back, and consider with objectivity & proportionality… • What are the aims and objectives of the regulation ?

10. II The European experience a directive rightly criticised • Achievements: 400 actives substances removed • REACH : an unbearable threat

11. II The European experience the facts • The ghost of an INDEPENDANT generic industry • A thriving dominant industry • Consumers’ anxiety • Farmers’distrust of the regulation

12. II The European experience Ensuring return on investment • R&D IP • Data : function & justification

13. II The European experience Justification for an exclusive use of data • Reviewing existing substances • Ever-greening • Provisional autorisation • When it extends beyond patent • Does not promote innovation

14. II The European experience So that the innovative industry innovates in the interest of health and the environment By hindering the preservation or the arrival of generics, the protection of data hinders innovation and comes to oppose the essential objectives aimed by the EU directive.

15. II The European experience For an EU review that does not preclude plant diversity • Minor crops • Minor uses • Resistance phenomena

16. II The European experience For an objective re-evaluation exempt from conflicts of interests. • Public authority

17. II The European experience For a PPP regulation consistent with those of other regulated products. • C-114/04 point 24; pharma & plant protection • Centralised MA • Free movement of agricultural produce Thus, and indeed beyond differences of opinion and corporatist interests, the revision of directive 91/414/EEC has to exclude the protection of data and include the notion of centralised MA if only not to be inconsistent with the objectives it sets and with the community provisions of which it is an integral part.

18. II The European experience

19. III PROPOSED AMENDMENTSas from Commisssion communication 17th July 2006 • National provisional authorisation of PPP containing a new active substance • Mutual recognition of PPP substance already approved • Comparative assessment of PPP • Data sharing for the renewal of approval of an active substance • Informing neighbours on PPP use

20. III PROPOSED AMENDMENTSas from Commisssion communication 17th July 2006 • National provisional authorisation • It is proposed to remove the national provisional authorisation

21. III PROPOSED AMENDMENTSas from Commisssion communication 17th July 2006 • Mutual recognition of PPP substance already approved • « It is proposed that mutual recognition becomes the norm and that Member States within a zone could only amend the authorisations in accordance with already existing legislation on the protection of the health of distributors, users or workers. »

22. III PROPOSED AMENDMENTSas from Commisssion communication 17th July 2006 • Comparative assessment of PPP • « Identification at EU level of substances candidates for substitution and comparative assessment of plant protection products at national level. Clear criteria are also foreseen for identification of substances candidates for substitution. »

23. III PROPOSED AMENDMENTSas from Commisssion communication 17th July 2006 • Data sharing for the renewal of approval of an active substance • « It is proposed to simplify the system. Data protection for 10 years after the first authorisation is maintained. This will mean 10 years exclusivity for new substances (as is the case today) and 10 years exclusivity for new authorizations (new formulation or new use, as is already the case now). All provisions on data protection at renewal of approval are removed. • Also, studies on vertebrates may not be repeated. Companies can agree between themselves on the sharing of vertebrate data and the cost thereof. If they do not agree, Member States use the data anyhow for a second applicant and companies have to go to national courts if they want to be compensated. »

24. III PROPOSED AMENDMENTSas from Commisssion communication 17th July 2006 • Informing neighbours on PPP use • « It is proposed that the authorisation may provide for an obligation to inform neighbours who notified their interest to be informed. Moreover records have to be kept by farmers on all plant protection products used and to be made available on request to neighbours and the drinking water industry.  »

25. IV CONCLUSION • C-112/02 Judgment of 01/04/2004, Kohlpharma (Rec.2004,p.I-3369) • Canada; Brazil; India

26. Thank you www.audace.org

27. Bangkok A Strong Generic Competition for a Sustainable Agriculture and  an Innovative Dominant Industry 27th 28th July 2006