58. The representative of the European Communities said that the Peruvian contribution on national experiences was very useful to better understand the issue. He said that, at the December meeting, his delegation had indicated that it would submit a proposal to WIPO on "Disclosure of Origin or Source of Genetic Resources and Associated Traditional Knowledge in Patent Applications". This proposal had been sent to WIPO in the context of the invitation of the WIPO Director-General to submit proposals before 15 December in order to prepare a contribution to the Secretariat of the Convention on Biological Diversity. The objective of the EC proposal was to formulate a way forward that should ensure an effective, balanced and realistic system for disclosure in patent applications. The outline of the EU proposal was as follows: (1) a mandatory requirement should be introduced to disclose the country of origin or source of genetic resources in patent applications; (2) the requirement should apply to all international, regional and national patent applications at the earliest stage possible; (3) the applicant should declare the country of origin or, if unknown, the source of the specific genetic resource to which the inventor had had physical access and which was still known to him; (4) the invention must be directly based on the specific genetic resources; (5) there could also be a requirement on the applicant to declare the specific source of traditional knowledge associated with genetic resources, if he was aware that the invention was directly based on such traditional knowledge and, in this context, a further in-depth discussion of the concept of "traditional knowledge" was necessary; (6) if the patent applicant failed or refused to declare the required information, and despite being given the opportunity to remedy that omission continued to do so, then the application should not be further processed; (7) if the information provided was incorrect or incomplete, effective, proportionate and dissuasive sanctions should be envisaged outside the field of patent law; (8) a simple notification procedure should be introduced to be followed by the patent offices every time they received a declaration and it would be adequate to identify in particular the Clearing House Mechanism of the CBD as the central body to which the patent offices should send the available information.
59. Commenting on document IP/C/W/438, he said that a disclosure of origin requirement was sufficient at this stage. There were serious problems with the introduction of a system where patent applicants should provide evidence of prior informed consent since it would impose an unreasonable burden on them. He sought clarification on the role that patent offices should play in such a system. In the view of his delegation, the request to verify whether patent applicants complied with legal rules related to the material used in their invention would overburden patent offices and create problems of legal interpretation.
60. With regard to the question of how furnishing evidence of prior informed consent would facilitate achieving the objectives of the CBD and ensure a harmonious relationship between the CBD and the TRIPS Agreement, and whether contractual arrangements could suffice to achieve the objectives of the CBD, his delegation took the view that the implementation of the CBD required a combination of legislative and/or regulatory approaches, setting the general rules, and of contractual approaches. Regarding the question of how the evidence of prior informed consent should be provided, he felt there was some incoherence between "requiring, as a condition for acquiring patent rights, that applicants furnish evidence of prior informed consent" (paragraph 8) and "requiring applicants to provide information known to them or which they should reasonably know" (paragraph 9) and sought a clarification of this point.
61. As to the nature of the obligation that should satisfy the requirement of prior informed consent, the developing country paper said that the declaration indicating that prior informed consent was obtained from the relevant national authorities would be accompanied, for example, by a certificate or duly certified contract between the applicant and the national authorities of the country of origin. The creation of an internationally recognised certificate of origin could certainly be a good idea, but was not relevant at this stage. In this respect, he would like to draw the attention of the Council to the recommendation adopted by the 3rd meeting of the CBD Ad Hoc Open-Ended Working Group on ABS that had been held in Bangkok on 14-18 February 2005, which had called for further studies and pilot projects as well as for views on the creation of a certificate of origin/source/legal provenance, scheduled to be discussed at the next ABS meeting in March 2006 in Spain.
62. As to what the obligation should be if there was no national regime in the country of origin, he said that in many countries such national regimes did not exist or, where they did, they were not fully operational. In these countries, certificates of evidence could not be delivered. This was one of the reasons why his delegation thought it was premature to consider a requirement to provide evidence of prior informed consent. As regards the legal effect of not providing evidence of prior informed consent, his delegation was not in favour of sanctions that would include the revocation of the patent.
