Introduction

NGOs have raised the profile of concerns that intellectual property rights (IPRs) can have a profound and adverse effect on public health and access to medicines. NGOs have also provided important support for developing countries, particularly at the level of multilateral institutions, where NGOs have assisted developing country delegates in their attempts to negotiate solutions to problems perceived to result from the impact of patents and other intellectual property rights on access to medicines. NGOs have also been quick to highlight the constraints on the use of in-built TRIPS flexibilities designed to ensure access to medicines.

As one of the two project case studies, the research will gather empirical evidence of the activities of NGOs in relation to IPRs, access to medicines and public health and will investigate NGO engagement with multilateral institutions, particularly the World Trade Organisation (WTO), the World Intellectual Property Organisation (WIPO), and the World Health Organisation (WHO).

The issues
Access to medicines, especially in developing countries and least-developed countries, is a real and growing concern. Many medicines that could save or extend lives are unavailable, inaccessible, or unaffordable to those who need them most. There is a pressing need for measures to ensure access to existing medicines and the development of new medicines that effectively address the global disease burden.

In recent years, the impact of IPRs on access to medicines is an issue on which public health and development NGOs have increasingly focused their efforts. In particular, NGOs have raised concerns about the impact of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on access to affordable medicines.

NGOs have also highlighted the extent to which bilateral and regional trade agreements (FTAs) often include intellectual property provisions, commonly referred to as "TRIPS-plus" provisions, that exceed obligations under the TRIPS Agreement itself.

The TRIPS Agreement
TRIPS was one of several WTO agreements concluded in 1994 at the end of the Uruguay Round of multilateral trade negotiations. Although all WTO Members are signatories to TRIPS, it has been suggested that the negotiating process leading to the Agreement was unbalanced and characterised by the disproportionate influence of the global patent-reliant pharmaceutical industry. Developing countries, at the time under intense pressure to conclude the package of multilateral agreements and with little expertise in negotiating complex intellectual property provisions, were unable to see their interests reflected in TRIPS. Accordingly, the Agreement soon became subject of criticism by public health and development NGOs and by public health experts.

The obligations contained in the TRIPS Agreement that require WTO Members to grant patents for pharmaceutical products have been the most contentious as regards to the protection of public health and access to medicines. Patented medicines cost much more than the equivalent, unpatented, "generic" versions. TRIPS provisions provide for strong protection of patents on medicines, limiting the extent to which countries can produce, import and export generic medicines. With rising prices for patented medicines, the problem of access to medicines in developing countries becomes more acute.

TRIPS flexibilities
The TRIPS Agreement, however, does include a number of flexibilities that can be used to ensure access to medicines in developing countries. One of the most significant flexibilities has been the transitional periods which delay the obligation to grant patents for pharmaceutical products. The TRIPS Agreement allowed developing country WTO Members that did not grant patents for pharmaceutical products at the time TRIPS entered into force a transitional period, ending on 1 January 2005, before they were required to do so. The transitional arrangements were conditional on developing country WTO Members allowing the filing of patent applications (the so-called “mailbox” provisions) and on conferring an exclusive marketing right to the maibox patent applicant for a maximum period of 5 years.

TRIPS also granted transitional arrangements to least-developed country WTO Members which, unlike the developing country transitional arrangements, were not limited to the granting of patent for pharmaceutical products but were of more general application in relation to TRIPS obligations as a whole. Least-developed countries which were given until 1 January 2005 to apply virtually all TRIPS provisions. Subsequently, the deadline by which least-developed countries must grant patents for pharmaceutical products has been extended until 1 January 2016.

Other TRIPS flexibilities include provisions with regards to compulsory licensing and parallel importation.

A compulsory licence can be granted by a government to allow a third party to produce a generic version of a patented pharmaceutical product without the consent of the patent holder, in doing so allowing low-price generic pharmaceuticals to be produced.

Moreover, under TRIPS countries can determine how they approach exhaustion of rights. In doing so, developing countries can adopt in their national regimes an international exhaustion principle to allow parallel imports. Parallel importation allows patented pharmaceutical products that are in the market in one country to be imported into another country without the approval of the patent holder, which under certain conditions would allow for a patented medicine to be imported and sold in the market at a lower price than the patent holder sells it in that market.

However, developing countries have not been effectively utilising effectively the flexibilities to protect public health and to promote access to medicines. Why is this so?

Problems in utilising TRIPS flexibilities
One of the main problems for WTO Members with regard to the provisions on compulsory licensing is that, although TRIPS allows WTO Members to issue compulsory licences to permit generic drug companies to manufacture a patented product without the authorisation of the right holder, in doing so creating a mechanism for cheap generic medicines to be made available at a lower cost than the equivalent patented products, TRIPS also requires that medicines produced under compulsory licence conditions should be predominantly for the supply of the domestic market of the WTO Member authorising such use. This constitutes a major problem for WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector, these countries being unable to make effective use of compulsory licensing under the TRIPS Agreement.

The use of this and other TRIPS flexibilities remain problematic because the procedural requirements for implementing the appropriate national legal provisions are complex and burdensome, particularly for developing countries which often lack the necessary technical and legal expertise and administrative capacity. In addition, FTAs often contain provisions that limit the capacity of developing countries to effectively issue compulsory licenses or allow parallel importation.

The role of NGOs
Public health and development NGOs have been actively pursuing an agenda to support developing countries in their efforts to negotiate solutions to the problems that respond to the concerns on the impact of higher prices for patented medicines and the constraints on effectively utilising the flexibilities contained in the TRIPS Agreement. The activities of NGOs have raised the profile of the access to medicines debate and have been an important factor in supporting developing countries.

NGOs played a significant role in the processes leading up to the adoption by WTO Members of a Declaration on TRIPS and Public Health at the 4th Ministerial Conference in Doha on 14 November 2001, which affirmed that "the TRIPS Agreement should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines", and reaffirmed "the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose."

Furthermore, Paragraph 6 of the Declaration on TRIPS and Public Health reconginsed that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement, and instructed the Council for TRIPS to find "an expedious solution" to the problem.

A Decision of the Council for TRIPS of 27 June 2002 formalised Paragraph 7 of the Declaration on TRIPS and Public Health by exempting least-developed country WTO Members from their obligations to provide patent protection for pharmaceutical products until 1 January 2016.