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As the second wave of COVID sweeps through India and citizens anxiously await vaccines, there is much confusion and controversy about the price of vaccines and the central government’s vaccine-procurement policy. The controversy is primarily centred on the issue of differential pricing strategy adopted by vaccine manufacturers like Serum Institute of India (SII) and Bharat Biotech, both of whom are offering the vaccine at a much lower price to the central government as compared to state governments, which in turn are getting the vaccine at a lower price than the private market.
The issue has also been taken up by the Supreme Court in suo moto proceedings, where the court appears to be nudging the government to invoke price controls and compulsory licensing to check the prices of vaccines.
Legally speaking, drug prices can be controlled through one of three options.
The first option is the Drug Price Control Order, 2013 (DPCO) which is issued under the Essential Commodities Act, 1955.
These drugs are exempted from the DPCO for a period of 5 years. This would mean that Bharat Biotech’s vaccine – Covaxin – is automatically excluded from the DPCO, since it was developed indigenously and in collaboration with the government scientific establishment like the Indian Council for Medical Research (ICMR) and the National Institute for Virology (NIV). The government can obviously amend the DPCO without much trouble to exclude this exemption that covers Covaxin. If the government decides to include SII’s Covishield in the list of drugs under price control, it cannot claim an exemption similar to Covaxin, since the former was developed in the UK and not India.
In the case of the COVID vaccines, most state governments have already announced that they will ensure free provision of the vaccines, so retail prices are of concern, only for the sale of vaccine in the private market.
Even presuming that the DPCO, 2013 does not apply to wholesale prices, the central government — or more specifically, the Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers — can always announce a specific DPCO under the Essential Commodities Act, 1955 to tackle the specific issue of pricing COVID vaccines.
The second option put forth by some, including courts, is for the government to influence prices by issuing compulsory licences for the patents covering the COVID vaccines. Theoretically, this would increase the number of manufacturers and also the supply of vaccines at a reduced price, since the Controller of Patents can fix the sale price of vaccines produced under a compulsory licence.
It is difficult if not impossible to replicate vaccines without being provided biological samples by the company that developed the vaccine in the first place. If by some possibility the vaccine could be reverse-engineered, it would have to go through clinical trials once again — and that will take time and money. It is, therefore, unlikely that compulsory licensing is a viable option for vaccine technology.
The third option, which has received lesser attention, involves using contractual clauses in the government’s funding agreement with Bharat Biotech, to force the company to lower its rates. We do not know if such a clause exists in the funding agreement because the government has not made the agreement public.
A market where there is only one buyer, gives the buyer enormous leverage in price negotiations. It is a form of de-facto price control.
This decision to fragment the buyer’s market, by forcing the states to negotiate separately with the vaccine manufacturers, is ‘bad economics’, as discussed in this piece by Ashish Kulkarni and Murali Neelakantan.
(The writer is a lawyer with interest in IP, drug regulation, transparency and politics. He tweets @Preddy85. This is an opinion piece and the views expressed above are the author’s own. The Quint neither endorses nor is responsible for them.)
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