Countries should find balance between affordable drugs, development incentives, WHO Director-General says in letter to Thai Health Minister

World Health Organization Director-General Margaret Chan in a letter to Thai Health Minister Mongkol na Songkhla said that although the Thai government was fully within its rights to issue a compulsory license for Abbott Laboratories antiretroviral drug Kaletra, countries should find the "right balance" between providing affordable medicines and incentives for drug companies to develop new treatments, Reuters reports (Reuters, 1/13).

Mongkol last month signed the compulsory license, which allows Thailand to produce a lower-cost version of Kaletra, into law. World Trade Organization regulations allow governments to declare a "national emergency" and issue compulsory licenses without consulting the foreign patent owner. Thailand, which has 580,000 people living with HIV/AIDS, has won international recognition for its quick launch of a national drug program that treats more than 82,000 HIV-positive people. However, the government's commitment to providing universal access to care is facing increasingly high drug costs. The compulsory license could save the country as much as $24 million annually. According to a joint statement released earlier this month by the health ministry and Abbott, the two sides agreed in principle to reduce the price of Kaletra in Thailand to increase access to the drug among HIV-positive people who have developed resistance to other antiretrovirals. The lower price will apply only to Thailand's public health programs and will not apply to private hospitals, people with high incomes or foreign patients. Abbott offered to lower Kaletra's cost to $167 per patient monthly, although representatives from the health ministry said that was still too high. Abbott and the ministry agreed to meet for further negotiations in one month (Kaiser Daily HIV/AIDS Report, 2/9).

Chan's Letter, Reaction

In the letter, Chan said the Thai government was fully within its rights under WTO regulations to issue compulsory licenses. However, she added that she "firmly believe[s] that the pharmaceutical industry -- generic manufacturers and research and development companies -- are part of the solution." Countries are not required to negotiate with patent holders before issuing a license, but "prior negotiations with industry is a pragmatic approach that may ensure countries have access to high quality medicines and at affordable prices," Chan said. According to Reuters, Chan's letter in part was a response to some HIV/AIDS advocates who have criticized her for not supporting Thailand's decision during her visit to the country two weeks ago. "We expected that [Chan] would have congratulated Thailand for its efforts ... to increase public health and access to medicines for its people," a coalition of more than 400 AIDS advocates and groups wrote in a letter to Chan last week (Reuters, 2/13). In addition, Mongkol on Monday said that a Ministry of Health panel is examining drugs, including HIV/AIDS medications, that the country needs and could make or buy generic versions of while completing negotiations with pharmaceutical companies. He added that if the pharmaceutical companies reduce the cost of their drugs to a level the country is "satisfied" with, Thailand will not enforce the compulsory license. "We don't call this a threat but a negotiation for the country's benefit," he said (Wong-Anan, Reuters, 2/12). Thailand's Pharmaceutical Research and Manufacturers' Association on Thursday said it believes the government is planning to issue compulsory licenses for an additional 11 drugs, including antiretrovirals. The decision to issue compulsory licenses is "major and regrettable," the association said in a statement, adding that the health ministry's "actions risks limiting development of next-generation treatments and could lead to the proliferation of low-quality medicines." A senior health ministry official would not confirm if the government is planning to issue the licenses for the additional drugs (AFP/Nation, 2/15).