WTO drug-access agreement will not solve oncology problems

Newsdesk WTO drug-access agreement will not solve oncology problems The one remaining barrier to allowing developing countries access to generic medicines was finally overcome on Aug 30, 2003, on the eve of the 5th Minesterial Conference of the World Trade Organisation (WTO) in Cancún, Mexico, when the USA agreed to waive a clause limiting generic drug use to domestic markets. Since the “Doha declaration”—a ground-breaking agreement conceding that WTO members should put public health interests above commercial ones—was signed in 2001, USA-led wranglings about the flexibility it conferred to developing countries to evade product patents have prevented its widespread adoption. The central assertion of the agreement is that intellectual property rights (laid out in the Trade Related Aspects of Intellectual Property Rights agreement; TRIPS) should not prevent WTO members from taking measures to protect public health. This allows countries that are not able to produce drugs themselves to import generic versions for their population under “compulsory license”, which disregards patents that may exist on pharmaceutical products. Among other moves aimed at introducing additional limitations to the Doha declaration, WTO members have been fighting to exclude Brazil, South Africa, and the Philippines from the list of countries eligible to import generic drugs, because their large populations and high burdens of disease make them potentially lucrative markets for pharmaceutical companies. Fortunately however, these objections have now been overruled. The TRIPS agreement is one of the treaties on trade that are annexed to the WTO convention and are therefore binding to all members. It establishes minimum standards in intellectual property that must be incorporated into the national law of member states by 2005—or 2016 for countries on the World Bank’s list of those least developed. As soon as the agreement comes into force in member states, production of unauthorised copies of patented drugs is prohibited; rule-breakers risk incurring WTO sanctions. The main

586

argument for encouraging less developed countries to adopt strong intellectual property protection laws in line with TRIPS was that this practice would help feed R&D in these countries. However, years of experience shows this may not be the case. “The profits obtained by pharmaceutical companies in South America are huge”, says Agnaldo Anelli, head of oncology at the Cancer Hospital of São Paulo, Brazil, “but investment in social areas is microscopic”. Brazil is the third largest buyer of Bristol Myers Squibb’s Taxol (paclitaxel), but according to Anelli, none of the profits are fed back

into Brazilian research. “Investment is limited to expansion of international clinical trials that have suffered poor recruitment in the USA or Europe”, he says. In countries like Brazil, the vast majority of people do not have health insurance and are therefore forced to rely on public-health systems. In reality, says Anelli, many patients do not receive adequate treatment because hospitals refuse to accept huge deficits—a result of undercompensation by the government for health services. For example, Anelli explains, “treating metastatic lung cancer with gemcitabine and cisplatin costs US$86 000 per cycle, but the reimbursement is US$35 400”. Salaries of nurses, pharmacists, and costs of

essential equipment are not accounted for, he says. Availability of generic drugs will help ease this cost burden in part, but more expensive treatments such as monoclonal antibodies and tyrosine kinase inhibitors are still likely to be out of reach. In South Africa, high prices are compounded by a weak currency and manipulation of so-called “single-exit pricing”, says Paul Ruff, who is head of medical oncology at the University of Witwatersrand, South Africa. “We are told that the reason drugs are so costly in South Africa is that R&D is expensive, which is true, and that the weak Rand means our local costs are very high”. But since the Rand has gone up in value by over 40%, there has been no corresponding drop in drug prices. “Some prices have even gone up”, Ruff adds. Ruff believes that high prices will encourage competition between companies producing generic versions of drugs, which in turn may bring the original prices down, but it may have the dual effect of promoting production of rogue drugs. He maintains that it is essential for compulsory licensing to be accompanied by adequate controls otherwise “we would have a flood of unregulated, untested, and often dangerous generics”. The WTO drug deal was seen as a victory by member states and contributed to an optimistic start to the Minesterial Conference in Cancún. However, Médicins Sans Frontièrs (MSF)—a long-time supporter of developing countries efforts to implement the Doha declaration—believes that the complex rules of the new agreement may actually hamper access to medicines. They also claim that developed countries now have greater opportunities to stop developing countries issuing compulsory licenses. However, the Aug 30 decision is only a temporary waiver; a permanent amendment to TRIPS is scheduled for 2004. It remains to be seen whether public health will be such a prominent concern when TRIPS is fully implemented in 2016. Hannah Brown

THE LANCET Oncology Vol 4 October 2003

http://oncology.thelancet.com

For personal use. Only reproduce with permission from The Lancet.