Thailand issues compulsory license to manufacture lopinavir/r: WHO criticised for challenging this essential access to treatment
On 29 January, Kaiser Daily News reported that Thailands Ministry of Public Health had issued a compulsory license to produce a lower-cost version lopinavir/r (manufactured and marketed by Abbott Laboratories as Kaletra).
According to Health Minister Mongkol na Songkhla, the compulsory license was signed into law under World Trade Organization regulations that allow governments to declare a national emergency 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 governments commitment to providing universal access to care is facing increasingly high drug costs.
The lower-priced version could reduce costs from $347 to $120 per patient monthly, and could save the country as much as $24 million annually, and make the drug much more widely available. Approximately 108,000 people living with HIV/AIDS in Thailand depend on GPO-VIR, a generic, first-line antiretroviral produced by the countrys Government Pharmaceutical Organization. Around 20% (20,000 HIV-positive people) have developed resistance to their first combination and are dependent on access to lopinavir/r.
Many health care activists were shocked when instead of supporting this development, the World Health Organization cautioned the Thai government on its decision.
WHO Director-General Margaret Chan during a visit to Thailands National Health Security Office said the country should negotiate the price of Kaletra with Abbott before issuing a compulsory license and encouraged the nations public health ministry to improve its relationship with drug companies. Id like to underline that we have to find a right balance for compulsory licensing, Chan said, adding, We cant be naive about this. There is no perfect solution for accessing drugs in both quality and quantity.
Nimit Tienudom, president of Thailands AIDS Access Foundation, said that Chans 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.
When it comes to global access to ARVs, WHOs new Director-General, Margaret Chan, has gotten off on a very bad foot by chastising the Thai government for issuing its compulsory license for lopinavir/r.
Chan is quoted as saying that the Thai government had not negotiated with Abbott, as if there hadnt already been years of negotiation and on this issue, especially in middle income countries where Abbott charge $2000 or more for Kaletra, compared to $500 a year in Africa.
Thailand, one of the few countries to meet its 3×5 target (over 50% of the population in need is on ARVs), is facing an immediate emergency with respect to the need for a second line boosted protease inhibitor regimen for people who fail first line therapy.
Chan also makes an incorrect correlation between drug quality and quantity, implying that Thai GPO lopinavir/r will necessarily be inferior to Abbotts.
Sources: Kaiser daily news:
Thai Health Ministry Breaks Patent, Issues Compulsory License for Abbotts Antiretroviral Kaletra:
WHO Cautions Thailand Against Issuing Compulsory License for Abbotts Antiretroviral Kaletra:
A formal letter of complaint over this issue was sent by the International Treatment Preparedness Coalition, signed by over 400 advocate organisations.
In a speach at the Global Justice conference sponsored by the Student Global AIDS Campaign, Student Trade Justice Campaign, Stephen Lewis called the actions of Margaret Chan deplorable and highlighted why signals that the DG is siding with big pharma over the issue of generic medications is a serious problem.
An eight minute segment of the speach is posted at: