To: Pascal Lamy
Directorate-General for Trade
From: Genetic Resources Action International (GRAIN)
Date: 26 February 2003
Subject: EU concept paper to the World Trade Organisation TRIPS Council regarding patents on seeds and traditional knowledge
Dear Mr Lamy,
We are writing this letter to set the record straight, from our own perspective, on the latest EU submission to the review of TRIPS Article 27.3(b). 
Recent media coverage is erroneously projecting a message that the EU is now coming to the rescue of developing country governments in seeking far-reaching changes to the TRIPS Agreement. Suddenly, we are being told that the European Union has proposals on the table that will arrest the problem of bio-piracy, curb the power of the biotechnology industry, and safeguard the right of poor farmers to freely use patented seeds. 
One source of this disinformation appears to be your own article in the January 2003 edition of Our Planet, a journal produced by the United Nations Environment Programme.  You therefore have your own responsibility to rectify the factual misrepresentations of the initiative coming from the EU.
THE DISCLOSURE ISSUE
A number of developing countries have tabled proposals to amend TRIPS so that patent applicants are required to “disclose” where genetic materials or traditional knowledge involved in a claimed invention came from. This disclosure requirement is supposed to make clear not only the country where the bioresources and local knowledge originated, but also provide proof of prior informed consent of the people from whom they were taken. Several developing countries have already enacted such a requirement in their national patent or plant variety rights legislation. Developed countries continue to resist the idea.
You claim that the EU now supports creating such an obligation under the TRIPS Agreement. This is not correct. What the EU actually proposes in its concept paper of September 2002 is to create a separate and essentially voluntary mechanism for disclosure of origin. A "self-standing" measure is how the EU describes it. This falls far short of what developing countries have been requesting in at least two respects.
(1) The EU wants to strictly limit the content of what is disclosed in patent applications to the country of origin only. You dismiss the need for patent seekers to indicate who were the original holders of the biological material or the knowledge. You also dismiss the need for patentees to provide documentary proof of prior informed consent from the people affected.
(2) The EU insists that even this very limited form of disclosure must never serve as a condition for patentability nor to judge what constitutes a legitimate patent. As the concept paper says, "Failure to disclose, or the submission of false information should not stand in the way of the grant of the patent and should have no effect on the validity of the patent, once it is granted."  In other words, the EU can only accept the principle of disclosure provided it is ineffective. Worse, the EU paper is explicitly saying that providing false information in patent applications about the origin of the genetic material is perfectly acceptable. This logic is extended later on in the EU's paper to traditional knowledge as well. 
This shows that the EU does not want to do anything to stop biopiracy. The "disclosure" mechanism you offer would allow patents to be granted on any genetic material or knowledge misappropriated from indigenous or farming communities. And it would do so even when the patent applicant intentionally withholds or falsifies information about the original source.
CREATING A NEED FOR FARMERS´ EXEMPTIONS
The other part of the EU paper which has been misconstrued for the public is the question of whether or not farmers should be allowed to save, reuse and sell seeds if they are patented or subject to sui generis plant variety protection (PVP) schemes. The message getting across is that the EU wants poor farmers spared of any restrictions on seed saving that come with the implementation of TRIPS.
The EU paper, in fact, does no more than suggest that the impact of seed patents on certain farmers in developing countries could be minimised through limited “exemptions”. These exemptions could be permitted, it is said, in national plant variety protection or patent laws by virtue of TRIPS Article 27.3(b) and 30 respectively.
It is true that such an approach is possible under TRIPS. After all, the EU has such exemptions in its own legislation. However, you fail to mention that nothing in the TRIPS Agreement requires developing countries to introduce either patents on seeds or restrictive PVP laws  in the first place. In other words, you are telling developing countries that if they do allow patents on plants and if they do adopt UPOV-type PVP laws, then they can have exemptions for small farmers. What you fail to say is that if they prohibit seed patenting and avoid restrictive UPOV-type plant variety laws, as is their right under TRIPS, there would be no need for the exemptions.
The fact is that, despite TRIPS, an increasing number of developing countries are being coerced to accept the patenting of plants and the rigours of UPOV in their own countries through bilateral deals. Through so-called free trade agreements, partnership agreements, bilateral investment treaties and other means, the United States and Europe are putting direct pressure on developing countries to adopt and enforce higher standards of intellectual property protection than the WTO prescribes. A preliminary survey that GRAIN conducted with colleagues in 2001 identified more than 20 such “TRIPS-plus” agreements affecting or potentially affecting biological diversity.  Almost half of them were initiated by the EU. To name one example, under the EU-South Africa bilateral trade agreement of 1999, South Africa is required to recognise patents on biotechnological inventions.  To name another example, under the EU-Tunisia partnership agreement of 1998, Tunisia is required to join UPOV.  By pushing developing countries to adopt such TRIPS-plus intellectual property regimes, the EU in fact creates the need for the exemptions then offered to soften the blow.
AVOIDING THE FUNDAMENTAL ISSUE
The EU paper fails to address the most important problem on the table. Since the review began, developing countries have not only proposed technical adjustments to TRIPS 27.3(b). They have also raised the fundamental issue: whether life forms should be patentable at all. The African Group in particular has tabled a proposal to amend TRIPS so that it prohibits patents on all living organisms in all the WTO member states. This is the most logical solution to bio-piracy: addressing the problem at the source.
The EU paper, on the contrary, says that TRIPS presently reflects a carefully negotiated balance and that a reopening of the discussion may give rise to counterclaims from those who would like to see patents on life made mandatory with no exclusions possible.  The EU's message seems to be that TRIPS is cut in stone and can never be changed except in the direction of even stronger patent rules.
This standpoint has no basis in the built-in mandate for the review of Article 27.3(b), which simply says that the provisions shall be reviewed, without any qualifier or limitation. Nor can it find support in the expanded mandate from Doha, which specifically emphasises the development dimension and the balance of interests between technology producers and users. 
The EU is ignoring the very issue which should be at the centre of the review: whether or not the patenting of life forms, as required by TRIPS, stands the test of social legitimacy and whether or not it will further sustainable development. It is our conviction, and that of many other NGOs and civil society groups, that it most emphatically does not.
However much you try to avoid it, this issue will not go away
Thank you for your attention.
 European Commission, “Communication by the European Communities and their Member States to the TRIPs Council on the review of Article 27.3(b) of the TRIPs Agreement, and the relationship between the TRIPs Agreement and the Convention on Biological Diversity (CBD) and the protection of traditional knowledge and folklore - A Concept Paper”, Directorate-General for Trade, Brussels, 12 September 2002
 Council of the European Union, “Agreement on Trade, Development and Cooperation between the European Community and its Member States, of the one part, and the Republic of South Africa, of the other part”, 8731/99, 9 July 1999, Article 46
 “Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the Republic of Tunisia, of the other part”, Official Journal L 097, 30/03/1998, Annex 7, paragraph 1
 “We instruct the Council for TRIPS, in pursuing its work programme including under the review of Article 27.3(b), the review of the implementation of the TRIPS Agreement under Article 71.1 and the work foreseen pursuant to paragraph 12 of this declaration, to examine, inter alia, the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore, and other relevant new developments raised by members pursuant to Article 71.1. In undertaking this work, the TRIPS Council shall be guided by the objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement and shall take fully into account the development dimension.” Paragraph 19, WTO Ministerial Declaration, adopted in Doha, Qatar, on 14 November 2001
BACKGROUND NOTE FROM GRAIN:
While discussions at the World Trade Organisation on access to drugs are deadlocked, the European Union is making strides in the media right now with an alleged "solution" to biopiracy and whether or not farmers can save patented seeds.
The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) makes it mandatory on all member states to start patenting life forms. Micro-organisms must be patentable. Plants and animals escape this fate. Plant varieties -- the seeds farmers sow -- must fall under some kind of intellectual property system, be it patents or a sui generis (of its own kind) regime.
This provision of the TRIPS Agreement, contained in Article 27.3(b), is under review since 1999. The Doha Ministerial Conference expanded the mandate of that review to traditional knowledge and the relationship between TRIPS and the Convention on Biological Diversity. However, the review is not getting far. Many discussion papers and proposals have been tabled, but there doesn't seem to be any direction to the debate. With so much energy focused on the public health ramifications of TRIPS, it's not hard to understand why.
Last September, the EU sent a concept paper to the TRIPS Council on the review of Article 27.3(b). While we didn't see much new in it back then, it is now making the news. To counterbalance some of the misguided media reports, we are issuing an open letter to Pascal Lamy, the EU's Commissioner for Trade.
Pages with information about WTO TRIPS, by:
MEMBRE DE LA COMMISSION EUROPEENNE
SW D (2003) 1115
Dear Sir or Madam,
Thank you for your letter of 26 February 2003 on the EU Communication to the WTO on the review of Article 27.3(b) TRIPs, the relationship between the TRIPs Agreement and the Convention on Biological Diversity (CBD) and the protection of traditional knowledge.
This Communication addresses a number of issues which are of particular concern to developing countries, and highlights a number of avenues to address these issues: by reinforcing or optimising existing national and international instruments; by making full use of the flexibility provided by the TRIPs Agreement; through possible accommodations to the TRIPs Agreements (disclosure of origin); or by the creation of new protection regimes (traditional knowledge).
The EU has never claimed that it was looking for far reaching changes to the TRIPs Agreement. Neither have we ever claimed that the TRIPs Agreement is cast in stone. We have never excluded making amendments to the TRlPs Agreement in those cases where the flexibility of the TRIPs Agreement was not adequate to solve a problem. For example, the EU has proposed an amendment to the TRIPs Agreement to allow for compulsory licensing of medicines for export, and the EU is prepared to enter into negotiations on disclosure of origin requirements.
The EU is, together with Norway, the only industrialised member which has been responsive to concerns expressed by developing countries on the interplay between the TRIPs Agreement and the Convention on Biological Diversity. Other industrialised countries have constantly downplayed this issue. The EU has not.
The EU does not advocate a on-size-fits-all approach as regards biotech patenting. The Communication acknowledges that the TRIPs Agreement, and in particular its Article 27, leaves a considerable degree of flexibility for Members to define and determine the patentability of biotechnological inventions and/or to provide for exceptions. This would allow them to modulate protection of biotechnological inventions in function of their economical and social objectives.
True, the EU is not in favour of drastically modifying Article 27.3(b) of the TRIPs Agreement in order to prohibit patents on biotechnological inventions. Clearly, those developing countries which have tabled a proposal to negotiate the insertion of a disclosure of origin requirement in the TRIPs Council share this view, for if inventions based on genetic resources (as is the case for biotech inventions) could not be patentable, there would be no need for a disclosure requirement.
The major concerns expressed in the WTO relate to the interplay between the TRIPs Agreement and the Convention on Biological Diversity. In particular, developing countries want to make sure that they can have effective control over the conditions on access to their genetic resources and the sharing of the benefits arising from their use. This is not antinomic to patents being granted on inventions incorporating genetic resources, which is why the CBD specifically refers to intellectual property. In many cases, the existence of a patent will facilitate the effective sharing of the benefits.
But I agree that this presupposes that there is full transparency on the origin of genetic resources used in inventions. Hence the EU's willingness to engage in negotiations on disclosure of origin.
As regards disclosure, you will note that the EU is prepared to discuss the idea and even to enter into negotiations, since the proposal by India, Brazil, China and others referred to in your letter is part of the outstanding implementation issues in the context of the Doha Development Agenda.
Contrary to what you claim, we are prepared to consider a disclosure requirement, not a voluntary mechanism. This requirement would be "self-standing" as we indeed believe that it is not necessary to make it a patentability criterion. This would not prevent such disclosure requirement from being obligatory .Neither would it prevent non-respect of this requirement having legal effects. A disclosure requirement does not need to be linked to patentability criteria to be effective. One can very well imagine legal effects, other than the refusal of the patent, which would have a sufficient deterrent effect on misappropriation of genetic resources or traditional knowledge (for example through civil and administrative sanctions). The paper also makes clear that providing false information would be tantamount to negating the disclosure requirement. So your assertion that the EU paper is, I quote, "explicitly saying that providing false information in patent applications about the origin of the genetic material is perfectly acceptable", is incorrect.
As regards farmers' exemptions, the EU took the view that the TRIPs Agreement is sufficiently flexible to allow small farmers to save, replant, exchange, share and resell protected seed. This would indeed safeguard the right of poor farmers to freely use patented seeds. Contrary to what you claim, this is different from the farmers' privilege in the EU which, as you are certainly aware, does not extend to exchanging or selling protected seeds.
Finally, I am surprised by your interpretation of the trade agreement between the EU and South Africa as requiring the latter to provide for the patenting of all biotechnological inventions. This is certainly not how we read this Agreement. In any event, the possibility to obtain patents on biotechnological inventions in South Africa existed well before the agreement with the EU was negotiated.
The EU has made and will continue to make serious efforts to address the concerns expressed by a number of WTO Members as regards the interplay between intellectual property and biodiversity. The fact of the matter is that, even if they did not agree on all points, many developing countries have welcomed the EU paper as a constructive contribution to the debate.
I would appreciate if you would publish this response on your website.