Patents versus Patients:

November 14, 2006

Download Full Report: Patents versus Patients: Five Years After the Doha Declaration


Five years ago, members of the World Trade Organisation (WTO) signed a ministerial agreement to ensure that intellectual property rules would no longer obstruct developing countries' efforts to protect public health. Since then, however, little has changed. Patented medicines continue to be priced out of reach for the world's poorest people. Trade rules remain a major barrier to accessing affordable versions of patented medicines (generic medicines). The prevalence of debilitating and life-threatening diseases in poor countries is growing, but medicines are simply not available. Urgent action is needed.

Disease and ill health continue to ravage poor people worldwide. In 2005 there were approximately four million new HIV infections. Non-communicable diseases (NCDs) have unleashed a new epidemic of suffering across the developing world. Pandemics, such as avian influenza, are a serious threat to people in rich and poor countries alike.

Access to affordable, quality medicines is critical for patients in poor countries suffering a disproportionately high burden of disease. Most poor people pay for medicines out-of-pocket, so even slight price rises mean that life-saving medicines are unaffordable.

During the late 1990s, developing-country officials and civil-society groups grew increasingly concerned about the impact of intellectual property rules, introduced through the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, on access to medicines. Intellectual property rules create monopolies for medicines sold by multinational pharmaceutical companies, keeping inexpensive, generic medicines, which can reduce the cost of medicine in a sustainable way, off the market.

Responding to increased public outrage, developing-country governments demanded that the World Trade Organisation (WTO) address this critical issue as part of the launch of a new global trade round negotiation. As a result, WTO members unanimously enacted the ‘Doha Declaration on the TRIPS Agreement and Public Health' on November 14, 2001, asserting that intellectual property rules should not prevent countries from protecting public health. The Declaration affirmed that developing countries could enforce public health safeguards to enable price reductions via generic competition. It also directed member countries to facilitate access to generic medicines by poor countries with insufficient drug manufacturing capacity, a measure known as the ‘Paragraph 6 Public Health Solution'.

Since 2001, however, rich countries have failed to honour their promises. Their record ranges from apathy and inaction to a dogged determination to undermine the Declaration's spirit and intent. The USA, at the behest of the pharmaceutical industry, is uniquely guilty of seeking ever-higher levels of intellectual property protectionin developing countries.

The USA has negotiated numerous bilateral and regional free trade agreements (FTAs) that impose what are known as ‘TRIPS-plus' intellectual property rules, weakening or eliminating the public health safeguards allowed under TRIPS. Patented medicines thus have even higher levels of intellectual property protection than required under TRIPS, delaying the availability of affordable generics. The USA has also pressured countries for greater patent protection through threats of trade sanctions and through the WTO accession process.

While other rich countries, and particularly the member countries of the European Union, have not pursued a TRIPS-plus agenda, their inaction has left the USA free to impose stricter intellectual property rules on poor countries. This apathy is inconsistent with the EU's commitments under the Declaration, but is not surprising since EU pharmaceutical companies benefit from TRIPS-plus commitments that developing countries must enact through national legislation to comply with TRIPS-plus commitments in their agreements with the USA.

The ‘Paragraph 6 Public Health Solution' has not facilitated delivery of affordable, generic medicines to poor countries with insufficient or no drug manufacturing capacity. Rich-country intransigence during negotiations created barriers that made the solution almost unworkable, and these countries are in no hurry to make the solution work. Canada, which first implemented the solution, made it even more complicated.The USA has not enacted legislation, while the EU only approved regulations implementing the solution in mid-2006.

The pharmaceutical industry has significantly benefited from the US trade agenda, as the US agenda reflects the industry's priorities by aiming to eliminate or weaken the TRIPS safeguards in order to extend its monopolies over medicines. The industry has also pursued TRIPS-plus rules in developing countries that have no obligation to implement higher levels of intellectual property protection. Having successfully lobbied the US government to impose these more stringent rules in developing countries, the industry is now actively pushing for their enforcement, including through the threat of trade sanctions.

This is the case in the Philippines and in India, which have not signed any TRIPS-plus trade agreements and are therefore only required to implement TRIPS standards of intellectual property protection. Yet the pharmaceutical company Pfizer is challenging the Filipino government's right to use TRIPS safeguards in an attempt to extend the company's monopoly on the hypertension drug, Norvasc. The pharmaceutical company, Novartis, which has made progress in some areas regarding access to medicines in developing countries, is challenging public health safeguards in Indian patent law. Furthermore, it is engaged in litigation to enforce a patent for a cancer drug, Glivec, for which generic versions could be available at one-tenth the originator's price.

Despite pressure from industry and rich-country governments, many developing countries – bolstered by effective civil-society groups and political will – are succeeding in introducing and enforcing TRIPS safeguards. Kenya introduced an Intellectual Property law in 2001 that drastically reduced prices for HIV medicines, and law-makers last year tabled an amendment to this law that would have repealed important TRIPS safeguards. In India, civil-society groups helped introduce TRIPS safeguards, preserving generic competition that is vital to millions of poor people in India and other developing countries.

Unfortunately, some countries that have used TRIPS safeguards in the past have now stopped doing so. Malaysia, which once used compulsory licensing (allowing governments to temporarily override a patent and authorise production of generic copies) to lower the price of antiretroviral drugs (ARVs), has now ceased challenging pharmaceutical companies' high prices. Countries that remain firm in their commitments, like Kenya and India, are threatened by external pressures.

On the five-year anniversary of the Doha Declaration, there is an urgent need to reinvigorate the spirit that produced the Declaration. The abysmal record of rich countries and the pharmaceutical industry remains a central concern of civil-society groups and developing-country governments. To ensure future access to inexpensive medicines for poor people, Oxfam recommends:

• Five years after the adoption of the Doha Declaration, the WTO review the impact of the TRIPs agreement on the affordability and availability of medicines in developing countries. The review should be supported by independent studies by the WHO and other relevant international organisations, in consultation with governments and public interest groups.

• The USA stop coercing developing countries into adopting ‘TRIPS-plus' intellectual property protections through bilateral and regional trade agreements, threats of trade sanctions, and the WTO accession process.

• G-8 countries provide technical, political and economic support to poor countries to enact TRIPS safeguards and resist TRIPS-plus rules; encourage WTO talks to ensure that IP rules represent the interests and needs of poor countries; and ensure that the Paragraph 6 solution (which permits manufacturing countries to export generic versions of patented medicines to developing countries with insufficient or no domestic manufacturing capacity) is made workable.

• Rich countries incorporate the Paragraph 6 solution into their own national legislation and provide technical, political, and economic support to poor countries to enact and enforce TRIPS safeguards and resist TRIPS-plus rules.

• Developing countries, including India, China, Brazil, and South Africa, resist TRIPS-plus rules in FTAs, prevent introduction of TRIPS-plus rules in national legislation, and fully implement TRIPS safeguards to ensure production of generic medicines for domestic consumption and for export to other developing countries.

• Pharmaceutical companies stop lobbying rich-country governments to promote stricter intellectual property rules worldwide, and stop pressuring poor countries to accept stronger intellectual property rules that undermine public health.

• UN specialised agencies such as UNCTAD, WIPO, and WHO provide independent technical assistance and support to poor countries to enact TRIPS safeguards

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