A call for a compulsory licence on Novartis’ blood cancer drug Gleevec, has been made by Colombian civil society groups, at a World Health Organisation meeting in Geneva. .
In an open letter to Bhanu Pratap Sharma, India’s Health Secretary who chairs the discussion, civil society groups Ifarma Foundation, Misión Salud and CIMUN have drawn attention to a situation they faced in Colombia involving Gleevec.
“Since November 2014 the undersigned organizations requested the Ministry of Health of Colombia to declare the access to Imatinib (Gleevec(R)) owing to/ out of public interest with compulsory licence purposes,” the note from the organisations said.
After a 15-month process, the Health Ministry acknowledged that access to Imatinib is a matter of public interest, a prerequisite for a compulsory licence, the letter added.
“Nevertheless there is enormous pressure from developed countries, from Big Pharma and even from Colombian trade authorities trying to block the public interest declaration and the compulsory license. It combines inaccuracies, distortions of international trade rules and even threats of trade claims under the dispute settlement mechanism. We are waiting in the very next hours of days a final decision, but there are reasons to fear the worst.” the letter said.
A compulsory licence (CL) allows a government to get a third party to make a drug in the interest of public health. The third party would in turn have to pay a royalty to the innovator for making versions of the drug which it would sell at a much lower price.
Glivec is not an unfamiliar drug in India. It went through a long and litigious journey under the amended Patents Act (2005) here. The Supreme Court eventually dismissed the company’s plea for patent protection on the drug. However, India did issue a CL on another drug, Bayer’s advanced kidney cancer drug, Nexavar. Natco was allowed to make it at a lesser price, but on payment of a royalty to Bayer.
The WHO’s Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) meet is now underway in Geneva. At the meeting, between May 2 and 4, representatives of governments and civil society groups discussed different methods to approach the inefficiencies that exist in research.
Recent public health emergencies have amplified the uphill task that governments face when they have had to scramble for medicines and vaccines at the very last hour. The problem is especially critical when it comes to neglected diseases or diseases afflicting less developed countries.