Health and intellectual property rights.

A new and comprehensive treaty on intellectual property rights was established in 1994, within the framework of the World Trade Organization (WTO). It is called the Agreement on Trade-Related Aspects of Intellectual Property Rights-the TRIPS agreement for short. It requires all WTO member countries to adopt in their laws minimum standards of protection for patents, trademarks, copyrights and other intellectual property rights. It has substantially limited the freedom that countries enjoyed until then to design and implement their own intellectual property systems. The agreement established a common set of standards for all countries, without differentiating on the basis of socioeconomic and technological development. Developing countries, however were allowed a transition period in which they could delay implementation of the new standards for specified amounts of time. Although it has many implications for public health, the TRIPS agreement was negotiated with little or no participation from public health authorities. The obligations it sets forth to protect inventions include the following: recognizing patents for pharmaceuticals without distinction between imported and locally produced products; granting patent protection for at least 20 years from the date of application; limiting the scope of exemptions from patent rights; and effectively enforcing patent rights through administrative and judicial mechanisms. Under this agreement all WTO member countries are now bound to grant patents for pharmaceutical products. This obligation did not exist under previous international conventions. The agreement also provides compulsory protection against "unfair commercial use" of data submitted for the marketing approval of new pharma­ ceutical products. Complying with the TRIPS agreement in these respects has posed a special challenge for developing countries and raised considerable concerns from a public health perspective. These may be summarized as follows. First, the patent holder can exclude direct competition, and charge higher prices for patented medicines than would have prevailed in a competitive market. Life-saving drugs can thus be made unaffordable, as has been seen particularly dramatically in the case of HIV/AIDS in sub-Saharan Africa. Second, most developing countries are excluded from the benefits of protection for inventions because they lack the scientific infrastructure and the capital needed for research and development of patentable pharmaceuticals is beyond the reach of most of them. Third, the pharmaceutical companies that do invest in R&D focus mainly on the diseases likely to yield the highest return for their shareholders. Diseases of the poor, such as malaria, tuberculosis and bloody diarrhoea are thus neglected. Fourth, …