Academic journal article Bulletin of the World Health Organization

Flexibilities Provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights

Academic journal article Bulletin of the World Health Organization

Flexibilities Provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights

Article excerpt

In 1995, when the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) came into effect, all but the least-developed members of the World Trade Organization (WTO) (1) were bound to provide intellectual property protection for pharmaceutical products. The proponents of the Agreement had argued that the global strengthening of such protection would spur innovation. However, after the Agreement came into effect, there was a fall in the number of new medicines being approved annually.

So far, the main impact of the Agreement on TRIPS has been on the prices of medicines. In the absence of competition, prices can be fixed--by the owners of the relevant intellectual property rights--on the basis of what the market can bear. Although treatment of hepatitis C with sofosbuvir can cost as much as 84 000 United States dollars (US$) per patient in countries where the drug has patent protection, it is expected to cost less than US$ 300 in countries where the product has not been covered by a valid patent. (2)

To minimize the problems caused by the Agreement, academics, governments of low-income countries, many nongovernmental organizations, the World Health Organization (WHO) and other United Nations organizations pay special attention to the Agreement's so-called flexibilities. (3-4) In this issue of the Bulletin, Ellen't Hoen and others summarize the use of some of these flexibilities over 15 years. (5) These flexibilities--e.g. compulsory licenses, government use for non-commercial purposes, non-exclusive protection of test data and parallel imports--can be used to mitigate the detrimental impact of the Agreement's provisions on market dynamics and access to medicines.

The right of WTO members to exploit such flexibilities was confirmed at WTO's Ministerial Conference in 2001. (3) After 2015, both the United Nations Secretary-General's High Level Panel on Access to Medicines (6) and the panel that conducted a review of WHO's global strategy and plan of action on public health, innovation and intellectual property (7) highlighted the importance of the flexibilities in the Agreement on TRIPS. The extent to which such flexibilities have already been incorporated into national laws and practice shows substantial variation. Several compulsory licenses--allowing a company to produce a patented product or process without the consent of the patent owner--have been issued for medicines, mainly to treat infections with human immunodeficiency virus.' Most of these licenses have led to substantial reductions in the costs of treatment. The use of such licenses is not limited to low- and middle-income countries. In Germany, for example, the Federal Court of Justice confirmed a compulsory license that allowed Merck to continue the commercialization of an antiretroviral drug for which another company, Shionogi, held a patent. …

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