MSF response to the licensing deal announced between US pharmaceutical firm Merck Sharp & Dohme and Cipla for the HIV medicine raltegravir
Raltegravir is an important HIV medicine currently used to treat patients who have failed both first- and second-line antiretroviral treatment. It was among the first HIV medicines to be patented in India, and with the patent not expiring before 2022, open generic competition on this medicine is blocked. Middle-income countries currently pay more than US$5,000 per patient per year for raltegravir, with MSF paying over $1,700 per patient per year for raltegravir in our treatment programmes in India.
While the terms and conditions of the deal between Merck and Cipla have not been made public, it is clear from their statement that this is not a licence to open up production and supply of a generic version of raltegravir. Rather, it is a deal that will allow Merck to use Cipla's extensive marketing and distribution network in India to sell its patented product under a different brand name. There is no clarity on what the price of the product will be.
Merck and Cipla need to make the terms of the deal public so the Indian government, people living with HIV, groups working on access to medicines, treatment providers and other affected organisations and stakeholders can make an independent assessment of the agreement and any restrictive conditions it entails.
The process of pursuing a compulsory licence for this drug should be continued, as Merck's past deals for raltegravir (with Mylan/Emcure) do not have a track record of boosting generic production or the availability of affordable versions of the drug in a significant way for Indian patients or those in other developing countries. It appears that Merck is signing this deal to prevent the Ministry of Health from recommending a compulsory licence for public non-commercial use of raltegravir to the Ministry of Commerce, which would allow open generic competition on the drug. Raltegravir is on the list of patented drugs a committee constituted on compulsory licensing in the Ministry of Health is looking into.
MSF response to the licensing deal between Merck and Cipla:
“The licence deal between Merck and Cipla is a huge disappointment because it does not allow for generic competition among multiple producers that could lead to the dramatic 90% price decreases we’ve seen for other HIV medicines in India and other developing countries. India’s Ministry of Health should still pursue a compulsory licence on raltegravir to allow broad competition so that truly affordable generic versions of this drug are available to people across the developing world.
It is not up to companies to decide what reasonable a price or terms are—it’s the government that needs to decide whether or not such marketing arrangements between Indian companies and large pharmaceutical companies undermine or improve access to medicines at affordable prices.”
– Leena Menghaney, Coordinator, Médecins Sans Frontières Access Campaign, India