WHO raps compulsory licensing plan

Govt urged to seek talks with drug firms

APIRADEE TREERUTKUARKUL

The World Health Organisation yesterday cautioned Thailand over its move to adopt compulsory licensing for producing generic versions of heart disease and anti-Aids drugs.

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

Speaking during a visit to the National Health Security Office, Dr Chan said she truly felt that the pharmaceutical industry was part of the solution to better drug access and that the government should open negotiations with drug firms over the issue.

She encouraged the Public Health Ministry to improve the public-private partnership in order to give the public better access to drugs. Public Health Minister Mongkol na Songkhla declined to comment on the issue.

The president of Aids Access Foundation, Nimit Tienudom, dismissed the WHO director-general's standpoint. ''It's disappointing. The organisation 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.''

The ministry last week endorsed a policy for the compulsory licensing of two drugs _ Kaletra, an advanced anti-Aids drug, and Plavix, a treatment for heart disease by invoking Article 51 of the 1992 Patent Law to import or produce a generic version of the two drugs.

In November, the ministry issued the same law to import and produce the anti-Aids drug Efavirenz, resulting in a reduction in the price from 1,400 baht to 700 baht per monthly course.

Plavix will cost just six baht per tablet under compulsory licensing, while the original price was 70 baht. The patented regimen of the second-line anti-retroviral drug costs 11,580 baht a month per patient and this could be cut to a third under compulsory licensing.

Thailand is the first developing country to invoke compulsory licensing under the World Trade Organisation's rules for a non-Aids related drug. The WTO allows a government to declare a ''national emergency'' and license the production or sale of a patented drug for state use. The patent holder would receive royalties equal to 0.5% of the annual sales, according to the ministerial plan.

About 108,000 of 500,000 people living with HIV/Aids depend on GPO-VIR, the generic version of the first-line anti-retroviral therapy produced by the Government Pharmaceutical Organisation. An estimated 20,000 HIV-positive people have developed resistance to the drug, and need a combination of lopinavir and ritonavir, which is marketed as Kaletra.

However the country's Pharmaceutical Research and Manufacturers Association disapproves of the decision, claiming that compulsory licensing could result in more companies relinquishing patents for heart and anti-Aids drugs and that it could lead to the isolation of Thailand from the global biotechnology investment community.

Kaletra is manufactured by Abbott Laboratories, and Plavix by Sanofi-Aventis and Bristol-Myers Squib.

Bangkok Post
Friday February 02, 2007