Thailand is entirely within its rights to issue compulsory licenses for antiretroviral drugs, World Health Organization Director-General Margaret Chan has admitted in a letter to the Thai government. Sent on February 7th, the letter apologises for reporting of comments by Dr Chan that appeared critical of the Thai government’s decision to issue compulsory licenses for efavirenz and for Kaletra over the past two months.
The decision to issue compulsory licenses was a measure to reduce the cost of antiretroviral drugs for Thailand's extensive public sector HIV treatment programme.
During a visit to Bangkok last month, Dr Chan was reported to have said: “I'd like to underline that we have to find a right balance for compulsory licensing. We can't be naïve about this. There is no perfect solution for accessing drugs in both quality and quantity.''
However, Dr Chan has told the Thai government that her comments were misrepresented and “should not be taken as a criticism of the decision of the Royal Thai government to issue compulsory licences, which is entirely the prerogative of the government, and fully in line with the TRIPS agreement.”
“WHO unequivocally supports the use by developing countries of the flexibilities within the TRIPS agreement that ensure access to affordable, high quality drugs. This includes the use of compulsory licensing, as described in paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health.”
“The decision whether to issue a compulsory license for a pharmaceutical product is a national one. There is no requirement for countries to negotiate with patent holders before issuing a compulsory licence. As a global community we need to ensure the right balance between the immediate and urgent pressing need to provide affordable medicines to the many that need them, and the need to provide continuous incentives for innovation. It is in this regard that I noted that prior negotiations with industry is a pragmatic approach that may ensure countries have access to high quality medicines at affordable prices.”
The letter concludes: “Where there are urgent needs, the bottom line is that people need access to medicines.”
As reported yesterday, the Thai government is now in negotiation with Abbott, the manufacturer of Kaletra to determine if a price reduction can be agreed.