The TRIPS Agreement was negotiated during the Uruguay Round and, like the General Agreement on Tariffs and Trade (GATT) and the General Agreement on Trade in Services (GATS), is included as an annex to the WTO Agreement.

Each of these three agreements has its own body (council), subsidiary to the WTO General Council. TRIPS is one of the nine negotiation areas in the Doha Round that have their own negotiating groups. The Doha Ministerial Declaration set out the following negotiation mandate:

18. With a view to completing the work started in the Council for Trade-Related Aspects of Intellectual Property Rights (Council for TRIPS) on the implementation of Article 23.4, we agree to negotiate the establishment of a multilateral system of notification and registration of geographical indications for wines and spirits by the Fifth Session of the Ministerial Conference. We note that issues related to the extension of the protection of geographical indications provided for in Article 23 to products other than wines and spirits will be addressed in the Council for TRIPS pursuant to paragraph 12 of this declaration.

The US and the Cairns countries oppose the establishment of any multilateral register for wine and spirits that contains more than simply geographical indications. One important reason for this reluctance is the proposal to extend the protection that currently applies to wine and spirits to other products (e.g. basmati rice, parma ham, and various cheeses with particular geographical origins), under the negotiation mandate for “implementation questions”. An extension of this type has in practice become part of the EU’s demands in the agricultural negotiations, and its position is supported by, among others, Switzerland. The US and the Cairns countries fear that a legally binding wine and spirits register could in future be extended and used to bar their agricultural products from the European market.

As a result, there has been little movement or activity in the TRIPS negotiations during the Doha Round. There has, however, been progress on several important questions related to the TRIPS Agreement outside the formal Doha mandate. A brief account of the background to the TRIPS Agreement and these issues follows.

1. Background – the TRIPS Agreement

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement) is largely based on existing international conventions administered by the World Intellectual Property Organization (WIPO), a specialised agency of the UN. The most important aspect of the TRIPS Agreement is that it imposes certain minimum requirements in relation to the protection of intellectual property rights that members must implement in their national law. The TRIPS Agreement protects things such as patents, trademarks, and copyright against use or copying without permission. The TRIPS Agreement provides that patents may be granted if the invention is new, substantially different to previous inventions, and can be industrially exploited. If a patent is granted, the patent-holder has a limited period (generally 20 years) in which he has the exclusive right to exploit the patented invention. This monopoly encourages innovation and research. Patents are particularly important for products that are expensive to develop but easy to copy, such as pharmaceuticals.

The economic and social effects of patents have long been debated. In the absence of alternative products, the monopoly provided by the patent will generally result in higher prices for consumers. At the same time, the development of new products and production processes will benefit society. The TRIPS Agreement seeks to balance the long-term goal of stimulating research and the development of new products with the short-term goal of ensuring market access on reasonable terms for products and production processes that have already been patented.

Some developing countries claim that patents and other intellectual property rights do not contribute to development or poverty reduction. They believe that such rights distort competition in favour of large, established companies, and that they limit the opportunities the poorest nations have to develop competitive business sectors. The counter-argument that is often made is that the business sector will be reluctant to invest in developing countries that do not sufficiently protect intellectual property rights. Moreover, protecting such rights is a means of promoting research and development. The WTO has recognised that, for the poorest nations, the costs of protecting intellectual property rights can outweigh the benefits. The least-developed countries have therefore been granted an extended deadline (July 2013) for implementing the TRIPS Agreement. The deadline in respect of pharmaceutical patents has been extended to 2016.

2. TRIPS and public health

In recent years, considerable international attention has been focused on public health catastrophes in developing nations, particularly in relation to HIV/AIDS. In the WTO, the focus has been on the TRIPS Agreement, and especially on the patent rules. In certain circumstances, and subject to the payment of “adequate remuneration”, the TRIPS Agreement gives anyone the right to exploit (i.e. manufacture or import) patented products without the patentee’s consent. This is known as compulsory licensing. An important condition for the granting of a compulsory licence is that the patentee is not willing to sell or enter voluntarily into a production licence agreement on reasonable terms.

In advance of the 2001 Ministerial Conference in Doha, attention focused on the limited opportunities the TRIPS Agreement offered developing countries to exploit its compulsory licensing provisions, particularly in relation to patented pharmaceuticals. The problem is that Article 31(f) of the TRIPS Agreement limits the export of products manufactured under a compulsory licence. This primarily affects developing countries, which generally lack the technical and financial resources they need to be able to produce advanced pharmaceuticals on the basis of compulsory licences themselves.

The problem of the TRIPS Agreement and public health has been discussed in the WTO, and a separate Ministerial Declaration on this subject was adopted at the Doha Ministerial Conference in the autumn of 2001. The Declaration emphasises that TRIPS should not prevent WTO members from taking measures to protect public health, and that all countries have the right to issue compulsory licences. The main problem, i.e. that countries without their own production capability are in practice unable to import compulsorily-licensed pharmaceuticals, was referred to the Council for TRIPS for further discussion.

Norway has emphasised strongly that the TRIPS Agreement should not stand in the way of measures to protect public health, but that account has to be taken of the importance of the patenting system to the development of new pharmaceuticals. Norway has therefore been one of the promoters of the 2001 Ministerial Declaration on the TRIPS Agreement and public health and the effort to find a solution to the export prohibition on compulsorily-licensed pharmaceuticals.

In August 2003, after several rounds of negotiations, the WTO approved a waiver in relation to the TRIPS Agreement. It enables pharmaceuticals manufactured under compulsory licence to be exported to poor countries that lack sufficient production capability. In December 2005, the WTO decided that the waiver should be made permanent by amending the TRIPS Agreement. The changes will come into force once two-thirds of the members have ratified them. In the meantime, the 2003 waiver enables individual members to set up systems to export medicines manufactured under compulsory licence to poor countries. In May 2004, Norway became the first country to implement such a system.

3. TRIPS and the Convention on Biological Diversity (CBD)

The TRIPS Agreement allows for the patenting of inventions of which genes, micro-organisms, and microbiological processes form a part. This raises some problems in relation to the CBD, as one its main aims is to ensure the fair and equitable sharing of the benefits derived from the use of genetic resources. The CBD provides that countries that own genetic resources may make the granting of access to those resources subject to their prior consent.

In June 2006, Norway proposed amending the TRIPS Agreement so that it more strongly supports the goal of a fairer sharing of the benefits of genetic resources. Through this proposal, Norway is supporting the calls of a number of developing countries for the TRIPS Agreement to be amended so that patent applicants have to provide information on the origin of genetic resources or traditional knowledge on which the invention is based. Norway is the first OECD country to support amendment of the TRIPS Agreement on this point, and the proposal was very well received by a number of developing countries in the Council for TRIPS.

The Norwegian proposal provides that patent applicants have to provide such information on origin before the patent application can be processed. Details of whether the country of origin requires its permission to be obtained before it grants access to the country’s genetic resources, and whether such permission has been obtained, also have to be given. These provisions will make it easier to achieve the CBD’s goal of a fairer sharing of the benefits derived from the use of genetic resources.

4. Norwegian submissions

• Norwegian proposal on TRIPS and the CBD
• Presentation of the proposal

5. Other documents

• Excerpts from the Patent Act as of 1 February 2004 and Travaux Preparatoires
• Consultation – Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (excerpts)
• Regulations amending the Patent Regulations (in accordance with the decision of the WTO General Council of 30 August 2003, Paragraphs 1(b) and 2(a))
• Explanatory notes to Regulations amending the Patent Regulations

Updated: 13 July 2006