It is generally accepted that pharmaceutical products cannot be regarded as ordinary goods or products. In the first place this is because consumers are not in a position to judge, for example, the quality of drugs, hence the need for a monitoring and surveillance system ensured by the State. Secondly, this is because drugs play a significant social role in that they are an integral part of the realization of a fundamental human right - the right to health. That is why they are classified as essential goods, to emphasize that they have to be accessible for all people.
The concept of accessibility is very important. It means that policies pursued must aim to make drugs available for all who wish to have them, and at affordable prices. If the objective is accessibility, then the best possible supply must be ensured. This objective coincides with the general objective of the GATT for the last 40 years - seeking to eliminate barriers to trade so that consumers have the greatest possible access to all the goods available in the world.
The general paragraphs in the TRIPS Agreement (preamble and general provisions) stress the need to promote adequate and effective protection of intellectual property rights, but to do so as part of a series of broader economic objectives. The protection of intellectual property rights is not an absolute and exclusive obligation. The preamble to the Agreement states that:
“Members, desiring to reduce distortions and impediments to international trade, and taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade;” (authors’ emphasis).
The protection of intellectual property rights should be adapted to this objective of not generating undue distortions. Protection of intellectual property rights under the TRIPS Agreement should not lead to any discrimination in international trade.
It also states that “Recognizing the underlying public policy objectives of national systems for the protection of intellectual property, including developmental and technological objectives...”
This means that the protection of intellectual property rights is not an end in itself but has a functional role to play in relation to the priority objectives of public policy for which these rights were created. It should be harnessed to the service of development.
Article 7 - Objectives, but also Article 8 (2), clearly indicates the subordination of the protection of intellectual property rights to public policy objectives in other areas of the State’s activity, especially social and economic welfare, which depends in part on national health and social policies. This Article also stresses that the interests of all sectors involved must be taken into account. It states:
“The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.”
Article 8 - Principles - in paragraph (1) allows national regulations to be adapted to the fundamental objectives of public policy set by governments in certain domains, provided these regulations are not contrary to the provisions of the Agreement. Public health and nutrition receive a special mention among these objectives, which amounts to express recognition of measures that might be adopted to guarantee accessibility. By virtue of this Article:
“Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.”
Paragraph (2) of this fundamental Article should also be mentioned, in so far as it once again expresses the need for a well-balanced interpretation of measures to protect intellectual property rights. These should be protected in such a way that they do not give rise to abuses detrimental to the necessary balance between national objectives and sectoral interests for which the State is the guarantor. Thus, in accordance with Article 8.2:
“Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.”
At this point, Article 1 - Nature and Scope of Obligations - is of critical importance, for it establishes that Member States are not obliged to grant greater protection than that set out in the Agreement. It also recognizes that Member States are entirely free within the framework of their own legal systems and practices as to how they implement the obligations to which they have subscribed. The Article states that:
“Members shall give effect to the provisions of this Agreement. Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement. Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.”
These general provisions were included in the Agreement to make for a balance between the rights of patent holders and their obligations vis-à-vis society. Member States may therefore base certain particular provisions of their national regulations on these principles. They can also bring their regulations into line with the obligations of the Agreement in such a way that their national objectives for the protection of intellectual property also accord with those imposed in other sectors of State activity which the latter deems to be necessary, provided such regulations do not contravene the Agreement.
From a social and health policy perspective, the provisions open up the possibility of establishing national regulations, taking into account the imperative of guaranteeing the best possible access to drugs.