Editorial

WTO Patent Rules and Acess to Medicines: The Pressure Mounts
Oxfam Policy paper on WTO Patent Rules and Access to Medicines

Public outrage over the exorbitant prices of HIV/AIDS drugs in Africa is focussing public attention on the harmful role of global patent rules in blocking poor people's access to vital medicines. In response to mounting public pressure, World Trade Organisation (WTO) members have taken an unprecedented step in agreeing to hold a special meeting to discuss the impact of global patent rules on access to medicines. They will meet on 20 June at the WTO in Geneva.

The WTO has the power to change patent rules. As a result, this meeting, and the forthcoming WTO Ministerial in Qatar, offers the best opportunity yet to shift the balance of global patent rights in the interests of public health. The outcome of the meeting will have a critical effect on poor people's access to medicines.

Inventors need some protection but under the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) they are getting far too much. Briefly stated, the Agreement, which is the product of one of the most successful corporate lobbying campaigns in history, creates effective legal monopolies for patent holders across the world, enforceable by trade sanctions. This will drive up the price of vital medicines in poor countries, benefiting narrow corporate interests at the expense of public health.

The winners will be the large northern-based companies where innovation is concentrated and which account for 90 per cent of pharmaceutical patents. The strengthened protection provided by the Agreement allows them to sell their new medicines at higher prices for longer periods in more countries. The losers are the millions of people in poor countries who will be further excluded from access to these vital medicines, and their cash-strapped government health services.

It is not suprising that the TRIPS Agreement is fast becoming the epicentre of a battle which pitches some of the world's most powerful pharmaceutical companies, backed by rich governments, against some of the world's most vulnerable people. More widely, there is a growing sense that the Agreement is fundamentally unfair and unbalanced - a fact which threatens to bring not only the patent system but also the whole multilateral rules-based system into disrepute, and which policy makers ignore at their peril.

What is certain is that TRIPS will need serious revision if it is to stem the growing public backlash against patent rules. The recent controversy over the attempts by 39 pharmaceutical companies to block a law which allowed the South African government to shop around for cheaper patented products in other countries, and which the companies claimed violated the TRIPS Agreement, gave the world a graphic illustration of why the rules need to change.

Oxfam is calling for TRIPS to be reformed so that developing-country governments have the unambiguous right to obtain the cheapest possible life-saving medicines without facing the threats of legal challenges or trade sanctions experienced by South Africa and Brazil. To this end, Oxfam is asking WTO members to agree to:

- an in-depth review of the health and development impacts of TRIPS, with a view to reducing the length and scope of pharmaceutical patent protection in developing countries, or exempting developing countries from pharmaceutical patenting
- a moratorium on trade disputes with developing countries over TRIPS compliance until a review of TRIPS is concluded, and the concerns of developing countries about its implementation are addressed
- a commitment by rich countries not to exert bilateral pressure on developing countries to implement unnecessarily strict and potentially harmful intellectual property standards (whether through bilateral or regional trade agreements, or by other means)
- outlaw the use, or threatened use, of bilateral trade sanctions for enforcing unnecessarily strict and potentially harmful levels of intellectual property protection in developing countries, such as the 'Special 301' provisions of the USA's trade act
- stronger public-health safeguards and exceptions to give developing countries the option of reducing the length and scope of pharmaceutical patenting on public health grounds. These should include:
- a strengthened and meaningful public-health safeguard in Article 8;
- the option to exempt vital medicines from patenting on public-health grounds under Article 30;
- an easing of the conditions for compulsory licensing, including restrictions on the production of medicines for export to another country where a compulsory licence has been issued, and the development of fast-track procedures for public-health purposes.
longer transition periods for developing countries before they have to implement TRIPS, based on their attainment of development milestones rather than arbitrary dates.
These are modest proposals. If agreed, they would merely mark a return to the situation for poor countries prior to TRIPS. This would not, as the pharmaceutical companies claim, significantly reduce R&D into the diseases of poverty, nor jeopardise patent protection in richer countries.

Of course, reforming TRIPS is not a panacea. A broad package of measures is needed to improve access to medicines and to ensure adequate R&D into treatments for poverty-related diseases. These include massive investment in public-health services, public funding of R&D, and comprehensive systems of tiered pricing.

Nor will reform of TRIPS provide any guarantee that all governments will take positive action to improve poor people's access to medicines. It will, however, remove a key legal obstacle that currently constrains poor governments from obtaining the cheapest possible medicines for their citizens, and allow market forces to reduce prices through generic competition.

However, attempts by developing countries to change TRIPS so that it better reflects broader social and developmental objectives have been blocked by some rich countries, particularly the US. These countries continue to repeat pharmaceutical industry scaremongering that any tampering with new global patent rules will reduce company profits and undermine R&D.

If the USA or other rich countries block proposals to reform patent rules aimed at protecting public health, developing countries should push the issue to a vote at the forthcoming 4th Ministerial. They have little to lose. It is true that if the USA believes its commercial interests are being prejudiced at the WTO, it's commitment to multilateralism may weaken. But it would be far more damaging for public health and the multilateral system if developing countries renounced their efforts to seek pro-health and development reforms of TRIPS on these grounds. Moreover, the USA is already using bilateral pressure, including the threat of trade sanctions to ratchet up intellectual property standards outside the WTO.

You can download an .rtf format file (48 Kb) of this paper from:
http://oxfam.org.uk/policy/papers/wtorules.rtf

World Health Report 2000
Methodological concerns and recommendations on policy consequences of the World Health Report 2000

Celia Almeida, Paula Braveman, Marthe R Gold, Celia L Szwarcwald, Jose Mendes Ribeiro, Americo Miglionico, John S Millar, Silvia Porto, Nilson do Rosario Costa, Vincente Ortun Rubio, Malcolm Segall, Barbara Starfield, Claudia Travessos, Alicia Uga, Joaquim Valente, Francisco Viacava.

This article will be published in the May 26 issue of The Lancet.

Introduction

The authors of the WHO's World Health Report 20001 have placed on the WHO agenda a commitment to the laudable goals of assessing health systems, monitoring inequalities in health, and achieving equity in health-care financing. Their proposition that health services should be responsive to people's expectations is a welcome one. While these commitments should be sustained, we believe that the approaches taken toward these ends in the World Health Report are seriously flawed. We aim to suggest changes to the approach in the World Health Report to ensure that measurement strategies supporting public health policy throughout the world are scientifically sound, socially responsible, and practical.

Both the conceptual basis and methodological approaches to the World Health Report composite index of health system goal attainment and its individual components, and the indices of health system performance, have major problems. Data needed to calculate four of the five component measures for overall goal attainment were absent for 70-89% of countries, but this was not acknowledged in the report. Because all the measures are new, and imputed values for the 70-89% of countries without data were based on new methods involving multiple non-standard assumptions, readers deserve to know the underlying assumptions, methods, and key limitations, which were not adequately acknowledged. The measures of health inequalities and fair financing do not seem conceptually sound or useful to guide policy; of particular concern are some ethical aspects of the methodology for both these measures, whose implications for social policy are cause for concern. The use of the composite indices for guiding policy is not evident, mainly because of the opacity of the component measures.

In response to criticisms of the report from member states, the WHO Executive Board on Jan 19, 2001, recognised the need to establish a technical consultation process that would obtain input from member states and a small advisory group for the cross-country assessments of health systems (www.who.org, accessed May 15, 2001); we do not know what steps have been taken in that process. The Lancet published an article by Navarro in November, 2000,2 that analysed the World Health Report, focusing mainly on a series of important policy concerns. Little attention was given to methodological discussion. We therefore focus on the methodological and related conceptual issues of the report, in the hope of making an additional, constructive contribution to a thorough process of consultation that must now be opened up by WHO.

Conclusion

The positive contribution of the World Health Report 2000 is its stimulation of fresh thinking about a range of issues relevant to measuring health-system performance. The goals to improve average levels of health as well as distribution of health in populations, and to monitor progress toward these goals, are sound ones. Our comments are offered in the hope that they will help WHO, guided by its member states, to move ahead with an open process of conceptualisation, measurement, and documentation in studying health systems that can serve as a sound basis for policy, planning, and advocacy in the search for health and equity; unfortunately, the World Health Report 2000 does not provide such a basis. As researchers, our recommendations have largely focused on methodological concerns. However, we firmly believe that a strong and sustained response will be needed not only from the research community but from advocates for health and development globally, and particularly from the member states to whom WHO must be accountable. We hope that this paper helps to clarify key concerns on several serious issues related to the methodology of the report. Although we have focused on methodological concerns, these issues are not simply matters of technical and scientific concern, but are profoundly political and likely to have major social consequences.

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