COVID-19 Drug Regulation Patent

Indian Govt. Permits Manufacture of Covaxin by Haffkine Institute – But Why Not Others Too?


(This post has been co-authored with Swaraj Barooah)

Logo of the Haffkine Institute (image from here)

In what seems like a  whiff of good news amidst the debacle surrounding availability of  COVID-19 vaccine in India, the Central Government has permitted the Haffkine Institute to manufacture Covaxin, on  a “technology transfer” basis, for a period of one year. This is definitely needed and hopefully will address the vaccine shortage in the country to some extent. But does this mean that the Central Government had the IP and technology transfer rights over Covaxin all this time? 

Haffkine Institute claims to be one of the oldest “biomedical research institutes” in the country. It was established in 1899 by Dr. Waldemar Mordecai Haffkine, a student of Louis Pasteur, to fight off the Cholera epidemic in Bombay and Poona back in the 1890s (poetic eh?). Presently, the institute is governed under the aegis of the Maharashtra Government (also see here), with the Minister of Medical Education of the State serving as the President of the Governing Council.  While the details of this arrangement between the Central Government and Haffkine Institute are still a bit unclear, this newspaper report suggests that the initiative for the collaboration was taken by the Maharashtra government through a request last month. It was during this press conference the Chief Minister asserted that the Haffkine institute is capable of producing 22.8 Cr. doses of vaccines annually and should be given permission to manufacture Covaxin. Subsequently, this request was apparently approved by the Prime Minister

Necessary but not Sufficient 

While India is waxing eloquent about the importance of not letting IP be a barrier in access to medicines during this pandemic, things are a bit murkier with regard to IPRs on publicly funded research back home. Readers may remember the piece by Anupriya and Swaraj (here) which discussed this issue in a bit more depth. 

Covaxin is developed by a collaboration between ICMR and Bharat Biotech and considering the public money involved, suggestions were made that the Centre should acquire the IP on it and make them available as public goods. The earlier mentioned blog post noted the lack of clarity on the ownership of Covaxin, and asserted that in case the Indian government does own the rights to Covaxin, India must forgo them for the sake of its rapid dissemination to the public, both in India and abroad. The wording of the current “approval” to manufacture Covaxin for the next one year, seems to indicate that the Central Government has the rights to be able to give the permission. It’s unclear what the details are though. Is this a license – and if so, what are the details and royalty charges, etc? Is there a temporary waiver of the relevant IP, along with the technology transfer to the Haffkine Institute? Is the government somehow only the custodian of the know-how, but not the IP? Why are they only giving this permission to Haffkine Institute – and why did it take one month to give this permission? If any readers have more clarity on these questions, please do let us know. 

Significantly – if the Central government has the authority to give this permission to Haffkine Institute – what is stopping them from opening this out to institutes and production facilities across the country and the world? 

Permitting the institute to manufacture the vaccine on a “technology transfer basis” creates a presumption that the Centre has the control over the IP behind Covaxin. In this vein, it is somewhat problematic to see why the government decided to hold back and not make available science for the vaccine as suggested above. Doing so would have enabled other entities capable of manufacturing vaccines, to contribute and ramp up production of Covaxin extensively. It would certainly mark a big step towards universal vaccination, especially for the non-rich countries that are being relegated to second class citizens on the world stage. India is currently one of the 24 countries which meets the requirements of the WHO vaccine assessment tool for manufacturing vaccines, and is one the few countries where approved vaccines for COVID are being manufactured. As this Business Today article notes, India houses at least 7 capable vaccine manufacturers (SII, Bharat Biotech, Panacea Biotech, Sanofi’s Shanta Biotech, Biological E, Hester Biosciences and Zydus Cadila) apparently capable of manufacturing 8.2 billion doses altogether.  And who knows how many capable manufacturing sites exist world wide. In current circumstances, if the rights on the Covaxin are made available publicly then other entities too can contribute in production of the vaccine, and prevent this arrangement to be just one off.  

On the other hand, Bharat Biotech is also making a version of Covaxin with the US company Ocugen Inc. And that would, conversely, indicate that Bharat Biotech had the rights over Covaxin’s IP. But then why would Haffkine Institute require permission from the Central Government to go ahead? There is an urgent need for clarity on this basic question of who actually owns the various rights, with Covaxin.  And regardless of the specifics – if the Indian government could give permission to one institute, surely it can arrange this for others as well. 

In these times of increased privatisation and with many declaring that the days of PSUs are over, it’s worth noting that Maharashtra, in their effort to get something done on this front, seems to be relying on a health sector PSU in this time of crisis. In this 2017 piece, Murali Neelakantan suggested that to create a market for drugs and ensure their availability at affordable prices “PSUs should participate with other Indian manufacturers”. He notes “this will ensure that the government gets value for money when it is a monopoly buyer in an extremely large market which is currently fragmented with various different entities issuing tenders. It will also ensure that there is technology transfer from patent holders to Indians.” In fact, just before Covid became a household name, the state of California put out a bill that would allow the state of California to create its own generic drug label, in an effort to bring down drug prices. 

As per this article, the approval for the arrangement came from the Secretary of Union Science and Technology Department, as “approval was given by the experts.” But who are these experts, and precisely what arrangement did the approval approve? 

The Mint reported that the Haffkine institute has a laboratory, but not a production facility of the required the bio-safety level 3 (BSL3). While we are unsure what the exact implications are, it prima facie sounds like the institute is not equipped appropriately currently. 

This article reports that the Centre will make available the equipment for production, and the state government has approved a budget of 150 crores for expansion of the production facilities. This is a laudable effort for the long term, however, the success in the next one year for which this arrangement is approved, though hopeful, is perhaps not going to be a simple task. 

Regardless, this arrangement hopefully will mark a dent in this vaccine shortage crisis. Forgetting the possible hypocrisy on the international front (in not keeping this open/widely shared in line with India’s demands for the waiver), on the national front it would perhaps be wise for India to start considering more seriously the ways of extending technology transfer to more manufacturing sites, as well as how to look into the government procurements of vaccine related IP as suggested by Prashant earlier, here

2 comments.

  1. AvatarMegha Banerjee

    The only reason that government (ICMR) does not allow other pvt. Drug manufacturing companies to manufacture may be restrictions on ICMR and other other govt. Agencies to create competitors for Bharat Biotech. It is all play of collaboration agreement between ICMR and Bharat Biotech. May be – the collaboration agreement allows government units or government supported entities to manufacture the drug, but does not give rights to transfer technology to a private company. When it comes to government units having the capability of manufacturing, funding may be a primary requirement which seems to be satisfied by Maharasthra government.

    Regarding patents, I am not sure whether the patent application has even been published. How does Bharat biotech or government give access to patents without even publication? In the current scenario, it is more about technology transfer than patent licensing.

    Reply
  2. AvatarPraharsh Gour Post author

    Hey Megha,
    Thank you for your comments and pointers.
    The scenario suggested by you are exactly the same thing we have raised concern about. Seemingly the whole business is based on a bunch of maybe (s) and this lack of transparency is alarming. There is no certainty on who owns the IP, on any underlying IP rights which might be in the process of being registered or on the considerations which need to be fulfilled by an entity to be permitted to manufacture Covaxin.

    Reply

Leave a Reply

Your email address will not be published.