The TRIPs Agreement and Pharmaceuticals. Report of an ASEAN Workshop on the TRIPs Agreement and its Impact on Pharmaceuticals. Jakarta, 2-4 May 2000
(2000; 91 pages) View the PDF document
Table of Contents
View the documentEXECUTIVE SUMMARY
View the documentI. INTRODUCTION
Open this folder and view contentsII. GENERAL ISSUES
Close this folderIII. TECHNICAL ISSUES
View the document3.1 General overview of the TRIPs Agreement
View the document3.2 Standards for patentability
View the document3.3 Compulsory license
View the document3.4 Parallel import
View the document3.5 Exceptions to the exclusive rights
View the document3.6 Enforcement
View the document3.7 Opposition procedures
View the document3.8 Increasing access to HIV/AIDS drugs - Thailand’s experience
View the document3.9 Undisclosed information
View the document3.10 Trademarks, public health and drugs
View the document3.11 State practice and WTO participation
View the document3.12 TRIPs Review
Open this folder and view contentsIV. SPECIAL ISSUES
View the documentVI. RECOMMENDATIONS
Open this folder and view contentsANNEXES

3.12 TRIPs Review

The TRIPs Agreement has an in-built agenda, which means that the Agreement itself provides for its review after some period, which has already elapsed. So irrespective of the launching of another Round of Trade Negotiations, there will be negotiations in the framework of the TRIPs, which may lead to changes in the Agreement.

Article 27.3(b)

Probably the most important area of revision is the revision of Article 27.3(b), which relates to plants, animals and biotechnology. The Article - and its revision - is very important for developing countries, since it has an impact on such different issues as breeders rights, farmers rights, patenting of (human) genes and recognition of informal or indigenous systems of innovation, notably with regard to biodiversity. Most of these issues however are beyond the scope of this report and will not be addressed here.

Box 13 National legislation

With regard to TRIPs Article 27.3.b, countries could consider to specify in their national legislation that the following shall not be patentable:

• plants and animals, in whole or any part thereof, including DNA, cells, seeds, varieties and species

• the human body and all its elements, in whole or in part.


In the context of pharmaceuticals, the most important issue relates to naturally occurring products and biotechnology. The current TRIPs text allows the interpretation that substances which already exists in nature (such as insulin, growth hormone etc.) are discoveries, not inventions, and can not be patented, even when produced via bio-technological methods15. It would seem that this is the best option for developing countries (with the possible exception of those developing countries which have bio-technological capabilities) to follow in their national legislation.

15 The biotechnological methods themselves however may be patentable.

Many developing and least developed countries are seeking a formal clarification and/or assurance that plants, animals, micro-organisms and parts thereof are not patentable. Some countries have granted protection to non-naturally occurring living organisms and their parts (including genes). During the review, developing countries should, at the very least, ensure that the status quo is maintained. This may however not be easy, since a number of developed countries would like to expand the patentability of “life”.

Non-violation clause

There is however another important provision which is under review in this in-built agenda. This provision is the so-called non-violation clause. In the GATT tradition, this has been a principle, according to which a country may bring a complaint against another country even when there is no formal violation of an Agreement, when it is considered that the reasonable expectations of the first country have been frustrated. This clause was included in the TRIPs Agreement under a moratorium, which stated that within a period of five years member countries should review in which way this non-violation clause could be applied. In this context, non-violation means that even if a country’s legislation is in conformity with the TRIPs Agreement, a second country may complain that the implications of a particular clause are infringing the spirit of the TRIPs Agreement.

This is an undesirable situation, since the TRIPs rules are quite clear and, more importantly, establish private rights, so there seems to be no reason for TRIPs to contain a clause for non-violation complaints between governments. In fact many countries have already expressed a view like this, for instance Canada has proposed to extend the moratorium until further review is done, and some other countries have proposed to eliminate this provision.

Amendment of TRIPs

The last point related to the review of the Agreement relates to the amendment of the Agreement. Some governments have proposed that the mandated review should not just discuss the implementation of the existing rules, but also discuss the revision of the rules, because many (developing) countries are not happy with the present rules. This possibility exists. There is nothing in the WTO system that would prevent a group of countries from promoting the revision of the rules. So these Agreements are not fixed forever, they can be changed, there is a mechanism that is provided for.

For instance Venezuela submitted a proposal to the Ministerial Conference in Seattle to exclude from patentability the Essential Drugs as listed by WHO. Although it is not clear whether this proposal is a good one or not (there are different views on this, including among public health advocates, because of the very limited scope of the list and the fact that the more expensive drugs are not included), it shows there are such possibilities.

But there is a strategic discussion to be held, before any such proposal is made, on the bargaining power which developing countries have to promote and obtain a change of the TRIPs Agreement which is favorable to their interests. Furthermore, obviously, the implications for developing countries of any specific proposal should be thoroughly evaluated beforehand.

Transitional period

While not part of the built-in agenda, an important topic during the discussions related to the TRIPs review will be the issue of the extension of the transitional period for developing countries. There is no agreement on this. But the majority of the developing countries have not yet amended their legislation in a way that fulfills the TRIPs requirements. In other words, the majority of the developing countries are today in violation of some part of the TRIPs Agreement, since their transitional period ended on 1st January 2000. But so far, few developing countries have had the time, the political support, infrastructure and the technical advise needed to implement this complex Agreement.

For instance in Latin America and the Caribbean, only two countries have more or less amended their legislation in order to cover all the areas in the way the TRIPs Agreement requires. Therefore, the reality is that developing countries need some additional transition period. The fact that there is no consensus to grant this, creates an undesirable, dangerous situation, because any of these countries may, anytime, be brought to a Panel and could eventually be sanctioned on the basis of non-compliance.


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