Patents, Compulsory License and Access to Medicines: Some Recent Experiences
Access to medicines, which is part of the human right to health services, has emerged as a major public health issue, especially with the impact of patents on the prices of drugs. The patenting of medicines has become more prevalent after the establishment of the Trade-related Intellectual Property Rights (TRIPS) Agreement in the World Trade Organisation in 1995. That agreement made it compulsory for WTO members to include medicines in their regime for product and process patents.
A few years ago, there was a public outcry after public health and development organizations highlighted how the monopoly granted by patents enabled the maintenance of excessive prices of medicines for HIV-AIDS. The cost of treatment of patented drugs per patient per year was US$10,000-15,000 in developed countries, whereas some generic producers in developing countries were able to provide them for as low as US$300. The generic cost has now dropped to US$100-150. If developing countries are able to make or import these generic drugs at cheaper cost, that would significantly increase access to medicines.
Whilst mandating that WTO members have to allow patenting for medicines, the TRIPS Agreement does contain flexibilities. For example, if patented drugs cost too much, the government authorities can take measures such as issuing a compulsory license to an agency or company to manufacture or import a generic version of that patented drug, which can then be made more available to patients more cheaply.
At the WTO's Ministerial Conference in 2001, the Doha Declaration on the TRIPS Agreement and Public Health was adopted as a response to the public concerns. The Declaration reaffirmed and clarified the flexibilities available under TRIPS Agreement, and proclaimed: "We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health…. We affirm that the Agreement can and should be interpreted in a manner supportive of WTO Members' right to protect public health and in particular, to promote access to medicines for all." It spells out several flexibilities that WTO members can use to the full, such as the right to grant compulsory licenses and the freedom to determine the grounds for these.
If the Doha Declaration is to benefit patients of AIDS and other ailments in developing countries, these countries now have to establish appropriate provisions in their national patent legislation by using "to the full" the flexibilities in the TRIPS Agreement. They also need to formulate and implement national policies aimed at providing access to medicines for all. In doing so they would be operationalising, at national level, the aims of Doha Declaration. If such laws and policies are not introduced, the gains made at international level through the Declaration will not translate into actual benefits for patients.
In other words, whilst in recent years the goal for access to medicines had been significantly fought at the international level, action is now equally or even more important at the national level, where policy makers should focus on policy and practical measures to get medicines to poor patients.
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