sexta-feira, março 23, 2007

Lancet sobre OMS e Abbott na Tailândia

Lancet, 24 March 2007

WHO must defend patients' interests, not industry

Paul Cawthorne a, Nathan Ford a, Jiraporn Limpananont b, Nimit Tienudom c and Wirat Purahong d

Is WHO's Director-General, Margaret Chan, more concerned about the needs of patients or the interests of industry? Addressing an audience in Bangkok in February, she stressed the need to negotiate with drug companies over access to medicines, and that the use of compulsory licensing to import and manufacture generic versions of patented drugs must be "balanced".1

Her statement was in reference to the Thai government's recent issuing of compulsory licences for efavirenz, lopinavir/ritonavir, and clopidogrel. Thailand is one of the few developing countries that have achieved universal access to antiretrovirals, but access to efavirenz (needed by around 15% of people on treatment) and lopinavir/ritonavir (for the increasing number of people who need second-line) are limited because of high price.

There are several reasons why Chan's comments are misplaced. First, the Thai Government does not need to be advised to negotiate: it has been in regular contact with the industry over high prices of its drugs in Thailand, but these negotiations have led nowhere. The best price for originator's efavirenz is still twice the price available from Indian generic sources (US$500 per patient a year vs $224). The best offer for originator's lopinavir/ritonavir is $2000 per patient a year, five times more than WHO's estimate of manufacturing costs.2 The Thai Ministry of Health estimates that the price of clopidogrel would fall by over 90% if made generically. These are substantial price differences in a country where the average annual wage is $1400 a year.

Second, direct negotiations with companies are not as successful as Chan thinks. She cited Brazil as a positive example where negotiations with drug companies have led to price reductions. However, the prices negotiated by Brazil for antiretrovirals are up to four times more expensive than prices available on the international market, and treatment costs are rising. In 2003, three patented drugs (lopinavir/ritonavir,nelfinavir, and efaviren) took up 63% of the total antiretrovirals budget. In 2005, imports accounted for 80% of Government expenditures on antiretroviral drugs.3

Company deals have also stunted the development of local generic manufacturing capacity, which is reflected by the fact that no new generic AIDS drug has been produced in Brazil since 2002.

Third, it is up to a government to decide when to issue a compulsory licence. World Trade Organization agreements nowhere state that negotiations are a precondition to use of a compulsory licence by a government,4 and even the US Government is not questioning the legality of the Thai compulsory licence.5

The need for "balance" presumably refers to industry's claim that patents are required to reimburse the costs of innovation. We cannot say precisely how much it costs to research and develop these drugs, but we do know that they have already made billions of dollars: last year alone sales of efavirenz, were $791 million,6 while sales for lopinavir/ritonavir were over $1.1 billion.7

The US Government and the multinational drug industry have put pressure on the Thai Government over its intellectual property laws since 1985, and as a result Thailand has implemented patent protection sooner and stronger than required by the World TradeAgreements.8 During this time, past WHO Director-Generals were silent over the need to find a balance to protect public health. We do not believe it is the role of the Director-General of WHO to be protecting the interests of industry the moment there is a challenge - a legitimate and legal challenge - to their drug monopolies.

WHO is well aware of the high cost of new drugs for Thailand. A recent WHO evaluation9 projected that second-line therapy for a quarter of all HIV-infected patients will be absorbing three-quarters of the treatment budget by 2020, and the cost of antivirals with second-line regimens could reach $500 million a year if current prices remain. In response to these rising drug costs, the World Bank has recommended that Thailand should use compulsory licensing.10

Improving access to expensive medicines is not just an issue for people with HIV/AIDS. The Thai Minister of Public Health recently announced that he is considering issuing compulsory licences for up to 11 more AIDS, cancer, heart and cardiovascular, and neuropathic drugs and antibiotics.11

Not surprisingly, the drug industry is pressuring the Thai Government to reverse its position. Abbott Laboratories, which resisted all efforts by Government and health groups to negotiate an affordable price for lopinavir/ritonavir, has taken steps that show little regard for public health in Thailand. The company withdrew all pending drug-registration dossiers and announced that it will not register any new drugs in Thailand until the Government reverse its decision to issue compulsory licences.12

Thailand, indeed all developing countries, need WHO to put patients first, and encourage and support member states to use flexibilities in patent laws to improve access to drugs. In a recent letter to the Minister, Chan clarified that WHO unequivocally supports the use of compulsory licensing.13

This is a welcome clarification that should be followed up by WHO's active technical and political support for Thailand's efforts. In particular, WHO should denounce the actions of Abbott. Protecting the high price of one new drug by withholding access to all others is an unacceptable and unethical practice that no-one concerned about public health should stay silent about.

We declare that we have no conflict of interest.
1. Treerutkuarkul A. WHO raps compulsory licensing plan: Govt urged to seektalks with drug firms. Bangkok Post. Feb 2, 2007: Feb 14, 2007)..
2. Pinheiro E, Vasan A, Kim JY, Leed E, Guimier J-M,Perriens J. Examining the production costs of antiretroviral drugs. AIDS 2006; 20: 1745-1752.MEDLINE
3. Okie S. Fighting HIV‹lessons from Brazil. N Engl JMed 2006; 354: 1977-1981.
4. World Trade Organization. Declaration on the TRIPS agreement and publichealth. Nov 20, 2001: Feb 14, 2007)..
5. Letter from Ambassador Susan Schwab. United States Trade Representative, to Congressman Allen. Jan 17, 2007: Feb 14, 2007)..
6. Bristol-Myers Squibb. Bristol-Myers Squibb company reports financial results for the fourth quarter and twelve months of 2006 and announces EPS guidance for 2007 Feb 14, 2007)..
7. Abbott. Abbott reports strong fourth-quarter results and record operating cash flow in 2006. 2006: Feb 14, 2007)..
8. Wilson D, Cawthorne P, Ford N, Aongsonwang S. Global trade and access to medicines: AIDS treatments in Thailand. Lancet 1999; 354: 1893-1895. Full Text Full-Text PDF (58 KB) MEDLINE CrossRef
9. World Health Organization. External review of the health sector response to HIV/AIDS in Thailand. August, 2005: Feb 14, 2007)..
10. Revenga A, Over M, Masaki E, et al. The economics of effective AIDS treatment: evaluating policy options for Thailand. Jan1, 2006: Feb 14, 2007)..
11. Treerutkuarkul A. Ministry pushes ahead with patent breaking. BangkokPost. Feb 13, 2007: (accessed Feb 14, 2007)..
12. Zamiska N. Abbott escalates Thai patent rift: firm pulls plans to offer new drugs in spat with regime. Wall Street J March 142007;.
13. Letter from Dr Margaret Chan to Dr Mongkoi NaSongkhla. . Feb12, 2007: Feb 14, 2007).

a. Médecins Sans Frontières, Bangkok 10240, Thailand
b. Faculty of Pharmaceutical Sciences, ChulalongkornUniversity,Bangkok,Thailand
c. AIDS Access Foundation, Bangkok, Thailandd. Thai Network of People Living with HIV/AIDS,Bangkok, Thailand

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