This document discusses possible elements to be considered in patent laws in order to develop a health-sensitive approach that facilitates access to drugs, especially by the poor.
The main premises considered in the preparation of this document have been the following:
• The granting and exercise of patent rights should be consistent with the basic goals and interests of the society, particularly promotion and protection of public health.
• There is no single patent system. While recognizing its international obligations, each country should shape its patent law according to its socio-economic needs and objectives, including in relation to public health.
• Although the TRIPs Agreement imposes various constraints, it leaves considerable room for countries to design their national laws to address public health concerns.
• Developing patent rules to improve access to medicines, particularly by the poor, is an important public health objective.
• The improvement of access to medicines requires a pro-competitive approach in several aspects of patent legislation.
• Such an approach should aim, as a priority objective, to ensure that patents are granted on developments that constitute true technical contributions, and that patent rights are not unduly used to block innovation and legitimate competition by generic products. In other words, a pro-competitive, public health-sensitive patent law should be primarily based on a proper application of the patentability requirements, supplemented by a set of exceptional measures (such as exceptions to patentability and compulsory licenses).
• Patent laws should contain appropriate mechanisms to correct excesses in the exercise of patent rights.
• A health-sensitive legal regime should allow governments to act efficiently in cases of emergency, including epidemic crises.
Implementing a public health approach to patent policy requires not only appropriate legislation, but personnel - in parliaments, patent offices, public health ministries, the private sector and the courts - equipped to handle patent legislation design and implementation.
While all the issues presented in this document are important for the design of a public-health sensitive patent law, priority should be given to those relating to the patentable subject matter and the treatment of the specific cases concerning pharmaceuticals (Sections 2, 4 and 5), to the crafting of exceptions to patents rights, especially for experimentation and early working (Section 7), and to the development of a sound compulsory licensing system (Section 10). A national law that dealt appropriately with these issues would constitute an important step forward.
Public health goals can be significantly advanced through North-South co-operation, involving both the public and private sectors, through official assistance, licensing of technology, joint ventures and other modalities. The climate, scope and effectiveness of such co-operation, however, may be significantly enhanced if developed countries abandoned the use of unilateral actions for obtaining the protection of commercial interests of their patent holders in developing countries. International cooperation in this area should recognize the fundamental right of any person to have access to basic health care, and the corresponding obligation of governments to protect and promote public health.