Frontline Volume 18 - Issue 24, Nov. 24 - Dec. 07, 2001
India's National Magazine
from the publishers of THE HINDU


Table of Contents

COLUMN

How to save lives without even trying

A new WTO Ministerial Declaration on TRIPS and public health may increase the ability of developing countries to control the monopolistic activities of multinational drug companies and allow cheaper production of generic and life-saving drugs.

AT last, some good news. Of course, as always, it could have been even better - but it has come from a source which has given people across the world little reason for joy or relief for several years now. The Doha Ministerial Meeting of the World Trade Organisation produced an overall Declaration with very mixed and confusing signals, reflecting the power of large corporate lobbies from the rich countries as well as the "holding operation" by some developing countries which has at least pushed negotiations on contentious issues such as investment and competition policy back by two years.

But it has also led to one declaration which can be construed as a victory not only for developing countries but for people across the world. This is the WTO Ministerial Declaration on the TRIPS Agreement and Public Health, which is probably the strongest international statement so far on the need to ensure that national patent laws protect public health interests and provide affordable medicines to those in need.

While this declaration certainly does not go far enough in terms of providing legally binding commitments and changing the wording of the TRIPS text itself, and remains a political document rather than a legal one, there is no doubt that it will provide an important framework for the subsequent use of the TRIPS agreement by large companies in the developed world, especially in matters relating to public health. Similarly, while it is still vague about the possibilities for the export of cheaper drugs produced using compulsory licensing (an issue which affects the Indian drug industry directly) it leaves open the chance that this can be decided positively by the TRIPS Council eventually.

In many ways, the declaration represents a sea change in the balance of official power at the WTO. The language of the declaration would have been quite unthinkable a year ago or even several months ago, when it appeared as if the immense power of the large multinational drug companies was such as to force international rule-making bodies to succumb to their pressure.

The declaration begins by stressing the need for the TRIPS Agreement to be part of the wider national and international action to address important public health problems, and noting the concerns about the effects of intellectual property protection on prices. The crucial point made in the declaration is that the TRIPS Agreement "can and 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 for all."

Critical elements of this argument then involve certain areas of flexibility, the interpretation of which in the existing TRIPS agreement has been hotly debated. The declaration makes many of these points very clear in a positive way. Thus, it emphasises that (a) each member-country has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted; and (b) each member-country has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.

These are crucial issues. The first one, for example, was the subject of a dispute brought to the WTO by the United States against the patent laws of Brazil and Argentina, which the U.S. argued were too permissive in terms of allowing compulsory licensing. This dispute was settled bilaterally, but future case law is bound to be affected by this new declaration. It will also allow the Indian government, for example, to bring in much greater scope for compulsory licensing in the new patent Act which is under consideration in Parliament, in accordance with the flexible interpretation of TRIPS.

THE issue of what constitutes a national emergency had also become contentious, when the large multinational drug companies had argued that even the desperate conditions of South Africa, where HIV-AIDS has now affected millions of people, did not warrant the declaration of a national emergency. The U.S. government at the time had gone so far as to argue that only a pandemic (affecting at least five countries) rather than an epidemic, and one in which at least 10 per cent of the population could be shown to be affected, could constitute a national emergency. It is ironic that this argument came from the government of a country that is seriously considering the declaration of national emergency after four people have died of anthrax. Perhaps this recent experience has served to soften U.S. opposition to the present wording.

KEVIN FRAYER/ AP
The newly made anthrax medication, ciprofloxacin tablets, at a pharmaceutical company in Toronto. Drug-maker Apotex was asked by Health Canada to make one million tablets. The Canadian government eventually reached an agreement with Bayer AG to buy their patented version and not abrogate the patent.

The declaration even repeats a point frequently made by small developing countries, by recognising that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing. Accordingly, the declaration even instructs the WTO TRIPS Council "to find an expeditious solution to this problem and to report to the General Council before the end of 2002".

As Daniel Berman of the non-governmental organisation Medecins sans Frontieres put it : "Since Seattle there has been a seismic shift. Two years ago many developing countries felt they were powerless against the will of the wealthy countries and their drug companies. Here in Doha more than 80 countries came together and negotiated. It was this solidarity that led to a strong affirmation that TRIPS "can and should be interpreted and implemented in such a manner as to protect public health".

"In practical terms it means that countries are not at the mercy of multinationals when they practise price gouging. The threat of punitive action against a country that attempts to address its health needs has been dramatically reduced. With this declaration it is doubtful that a wealthy country would dare file a dispute against a developing country or use one of the safeguards such as compulsory licensing. Now patent holders either offer prices that make their drugs accessible or risk losing their monopoly rights. The victory in Doha is really for people who need or will need access to life-saving or extending medicines."

OF course this is no more than a start. The real challenge now is to make sure that this agreement is implemented and its meaning is not distorted by legal jugglery. One major problem is that the declaration remains a political one. It has been pointed out that developing countries at Doha were unable to extract a clear declaration that public health and access to medicines are more important than protecting the commercial interests of pharmaceutical companies, because opposition from rich countries crippled the legally binding language that was originally sought by the majority of WTO-member countries.

And apart from this there is the question of political will within countries. Governments - including the Indian government - have been known to go well beyond their WTO commitments in their subservience to the interests of large corporations, for reasons which are not just legalistic. Now it is up to governments to use the power that they have been given by the declaration, to bring down the cost of medicines and increase access to life-saving treatments.

But even here, the scenario may be a more optimistic one than many of us had dared to believe earlier. Perhaps the most significant message of this declaration is that public pressure can be effective, and can cause changes both to international regimes and to national policies. Concerted social pressure coming from a wide range of sources in both developed and developing countries played a large role in discrediting the TRIPS agreement, especially with respect to access to essential drugs, and has now culminated in this declaration.

That lesson - which is a greatly encouraging one - should be the cornerstone of all future public action, because it shows people across the world that whatever be the strength of the opposition, finally their will and their just demands can indeed prevail.


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