WHO cautions Thailand against issuing compulsory license for antiretroviral Kaletra

Feb 7 2007

The World Health Organization on Thursday cautioned the Thai government on its decision to allow the country to produce a lower-cost version of Abbott Laboratories' antiretroviral drug Kaletra by granting a compulsory license for the drug, the Bangkok Post reports (Treerutkuarkul, Bangkok Post, 2/2).

Thailand's Ministry of Public Health last week said that it had broken a patent on Kaletra by issuing a compulsory license and Health Minister Mongkol na Songkhla announced that the compulsory license was signed into law and took effect on Jan. 26.

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 (Kaiser Daily HIV/AIDS Report, 1/30).

WHO Director-General Margaret Chan during a visit to Thailand's National Health Security Office said the country should negotiate the price of Kaletra with Abbott before issuing a compulsory license and encouraged the nation's public health ministry to improve its relationship with drug companies.

"I'd like to underline that we have to find a right balance for compulsory licensing," Chan said, adding, "We can't be naive about this. There is no perfect solution for accessing drugs in both quality and quantity."

Nimit Tienudom, president of Thailand's AIDS Access Foundation, said that Chan's position was "disappointing" and that WHO "should have supported drug access and promoted the study of quality and inexpensive drugs for the sake of the global population rather than supporting pharmaceutical giants."

Mongkol did not comment on Chan's position, according to the Post.

Approximately 108,000 of people living with HIV/AIDS in Thailand depend on GPO-VIR, a generic, first-line antiretroviral produced by the country's Government Pharmaceutical Organization.

About 20,000 HIV-positive people have developed resistance to the drug and require Kaletra.

The country's Pharmaceutical Research and Manufacturers Association has said that it disapproves of the license and that it could lead to Thailand's isolation from the global biotechnology community, the Post reports (Bangkok Post, 2/2).