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Last month, Malaysia issued a compulsory licence (CL) on multinational drugmaker Gilead's Hepatitis C drug Sofosbuvir for government use.
This government action aimed at improving access to the drug in Malaysia has in fact rekindled discussions in India, a region not unfamiliar with CLs or Sofosbuvir.
India’s first pharmaceutical CL was issued in 2012 on Bayer’s advanced kidney cancer drug Nexavar. The CL allowed Natco to make a less expensive version of the drug on a payment of a royalty to Bayer. Subsequently though, discussions on CLs fell silent despite the government identifying more drugs for similar action. And this was attributed to “concerns” raised by the US.
As for Sofosbuvir, India hit the headlines on the expensive Hepatitis C drug when Gilead partnered with local companies to make less expensive versions of the drug.
In the latest case, Malaysia's CL on Sofosbuvir allows drugmakers to make the Hep C drug, with a royalty payment to Gilead. The action was necessitated because 500,000 patients in Malaysia were infected with Hepatitis C, even as 2,000 new cases were reported annually. “To make matters worse, the cost of treatment for Hepatitis C is exorbitantly expensive and making it less accessible to the patients,” said Malaysia's Health Minister S Subramaniam, on what he called a major public health concern in Malaysia. Following the CL, the price on the drug is expected to come down from about $12,000 for a 12-week course to $300.
The latest CL is Malaysia's second use of this option. The last time being in 2003 when Malaysia instigated the Rights of Government under Patent Act 1983 for anti-retroviral drugs used to treat HIV infection. “This sets Malaysia to be the first country to initiate such a move in the world," a note quoting the Malaysian health minister said.
Commenting on the “government use licence”, Edward Low with Positive Malaysian Treatment Access and Advocacy Group (MTAAG+) told BusinessLine that public health should be run on rules set by the government and not corporates. And that is the key take away for India from the Malaysian experience, say health experts, calling for a technical discussion on CLs in the interest of public health.
Technical committee India needs to revisit the discussion on CLs as the future holds challenges in terms of access to new drugs used in tuberculosis (TB) treatment or expensive vaccines used in immunisation, says humanitarian organsation Médecins Sans Frontières’ Leena Menghaney, South Asia Head of its Access Campaign.
A technical committee should look at CLs for non-commercial or government use, she said, especially since strategies like negotiating prices with an originator company will not bring down prices as much as generic competition does. Generic drugs are similar to an innovator medicine, but less expensive since they do not include the cost of research.
In the case of new TB medicines, last year the government partnered with Janssen India on Bedaquiline. But a public health initiative should not be dependent on any one company, she said, calling for an end to secrecy around such deals so more generic makers could participate in the interest of wider access to patients.
On the vaccines front, MSF is calling for a CL on the pneumoccocal conjugate vaccine (PCV). About two months ago, Pfizer received a patent on its PCV marketed as Prevenar13.
Industry veteran DG Shah with the Indian Pharmaceutical Alliance points out that a CL required two things, capability to make the drug and willingness on the part of government to use the CL option. “India has the first,” says Shah, adding that the Indian government was not inclined to use the second option as it would spoil its relation with other governments, namely the US. W
hat worries Shah in the recent Malaysian CL incident is that companies around the world are building their capabilities to step up and supply public health needs. And that means India’s role as “pharmacy to the world” could soon be faced with some serious competition from drug companies located in other parts of the world.
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