March 2, 2007

Thai Health Ministry Takes 'Bold Step' In Breaking Patent, Issuing Compulsory License For Antiretroviral Kaletra, Editorial Says

Thailand's Ministry of Public Health is "taking a bold step" in ensuring that the country "takes full advantage" of the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights agreement by breaking the patent on Abbott Laboratories' antiretroviral drug Kaletra, a Bangkok Post editorial says (Bangkok Post, 1/31). The health ministry on Monday said that it has broken a patent on Kaletra by issuing a compulsory license to produce a lower-cost version of the drug. According to Health Minister Mongkol na Songkhla, the compulsory license was signed into law and took effect on Friday. WTO 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). The editorial "applaud[s] the government for using all legal methods possible to ensure Thai patients get the cheapest and best drugs available." However, the editorial says that the government also "should be careful not to unnecessarily further push away foreign investment," adding that even though the government is "not legally required to negotiate with drug companies before issuing a compulsory license doesn't mean it should not do so." The Thai government should "insist on procuring quality drugs" from World Health Organization-approved factories, especially for HIV/AIDS medications, according to the editorial. Although Thailand's Government Pharmaceutical Organization's factories do not meet WHO standards, Thai officials say their generic antiretrovirals are of high quality, the editorial says, adding that it "would be nice to remove the cloud of suspicion." According to the editorial, Thailand should import generic antiretrovirals from India until a new GPO facility that meets WHO standards is complete. This would allow the government to procure antiretrovirals with funds from the Global Fund To Fight AIDS, Tuberculosis and Malaria, which "refuses to finance Thai-produced drugs because they don't meet international standards," the editorial says. According to the editorial, the money the government saves by using drugs produced in India "could be used to expand patient education." The editorial adds that "[m]uch of the resistance to Thai generic HIV/AIDS drugs is attributed to patients who misunderstand how to take the drugs" and that there is little point in "expanding drug coverage if the drugs will prove ineffective due to incorrect usage" (Bangkok Post, 1/31).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

No comments: