India’s Covid Vaccine TRIPs Somewhere Between Doha And Riyadh
A seasonal influenza vaccine is administered with a syringe, on Nov. 24, 2020. (Photographer: Alex Kraus/Bloomberg)

India’s Covid Vaccine TRIPs Somewhere Between Doha And Riyadh

BloombergQuintOpinion

The pandemic has once again highlighted the conflict between intellectual property rights and public health with scientists, health activists and lawyers calling for an “Open Covid Pledge” so that (i) patents and other IPR barriers to the widespread manufacture and distribution of the vaccines are suspended and (ii) all knowhow and trade secrets are shared. Most of us naively believed that this conflict was settled in the Doha Declaration which specifically addressed the issue of IPR and public health with a unanimous declaration by all the members of the World Trade Organization that countries could, and should, use compulsory licensing or CL and other flexibilities and exceptions to patent monopolies. However, it seems from the recent discussions at the WTO that the Doha declaration seems to be understood by the developed world as non-binding and even if it was binding doesn’t go far enough to address the barriers to widespread access to medicines to treat Covid-19.

Why Is This Relevant Now To Vaccines?

As of 2010, there were more than 10,000 “global” patents that mentioned “vaccines” and since we don’t have any vaccine approved for Covid-19 yet, we don’t know how many more will be relevant to the new vaccines for Covid. From past experience of vaccines, it is very likely that there will be several patents that will prevent manufacturers from freely producing these vaccines. It is likely that these patents will be granted in most countries and these patents will be barriers for countries to freely manufacture and distribute vaccines. When these vaccines are approved in the United States, the Food and Drug Administration will list all the patents for each of the vaccines and until then we will not know what the IPR barriers are for the productions of each of those vaccines.

Surely, India can’t be expected to look at the Orange Book to figure out if the vaccines that are required for India are “protected” by U.S. patents and then check if there are similar patents for those vaccines in India! Form 27 of the Patent Act is therefore the only way in which the government and other stakeholders will know how the patents granted have been worked in India to consider whether the government needs to step in to address the current public health emergency.

The response by patent holders to the recent proposals to amend Form 27 of the Patent Act, 1970 to ensure that patent holders disclose how the grant of the patent has actually helped society is an indication of how disconnected patent holders have become from the fundamental rationale for a patent. There seems to however be no complaints about the U.S. FDA’s Orange Book listing all the patents that relate to a drug being approved. The Parliamentary Standing Committee on Commerce is scheduled to review IPR law in India and its report could make interesting reading if it takes a serious look at IPR barriers in the context of Covid-19.

Does India Have Any Leverage Against Patent Holders?

The Indian Patent Act has provisions to protect against possible abuse by the patent holder, so that,

  1. if the patented product is not widely available at a reasonable price, it can be compulsorily licensed by the government to another person to manufacture and distribute,
  2. government can have the patented product manufactured for non-commercial use,
  3. the patent can be revoked in public interest, and
  4. notify patents for public non commercial use in an emergency.

These anti-abuse provisions have rarely been enforced in India and as a result, patent holders had no fear of punishment for any abuse of monopoly. To this day, the Indian government has not attempted ‘government non-commercial use’ or GNCU and as a result there is limited access to patented drugs in the public healthcare system.

It will be interesting to see how, and if, the Indian government uses the TRIPs flexibilities of CL and GNCU as leverage to negotiate with the vaccine manufacturers given that even the few of the vaccines that have been developed outside India can be manufactured in India and India has not been willing to pay anything more than $3 per dose, a fraction of the $32-37 that Moderna seems to be expecting. What if these pharma MNCs don’t agree to supply the vaccine to the Indian government at the price that that the government is willing to pay?

What Can The Indian Government Do To Prioritise Vaccines For India?

Indian vaccine manufacturers produce more than 80% of the world’s vaccines and that means that India has the most leverage in terms of vaccine manufacturing capacity. The government could direct these Indian manufacturers to deliver a sufficient quantity of vaccines for distribution by the government and in the Indian retail market before allowing them to be exported to other countries. This is quite easily done under the Essential Commodities Act. The government frequently imposes export curbs for basic goods like vegetables, so this is not a radical idea. The Indian vaccine manufacturers would be bound by this order of the government which will override all contractual obligations of the manufacturers to the pharma MNCs that own the IPR to the vaccines.

How Can Government Make Sure That Vaccines Are Available In India?

Section 26B of the Drugs and Cosmetics Act empowers the central government to “regulate or restrict the manufacture, sale or distribution” of the vaccine thereby giving the government control over the manufacture and sale of the vaccine. This includes restricting the quantities of the vaccines in the ‘retail market’ until all the public health needs of the country are met. The government can ensure that it has sufficient quantities of the vaccine for those who need to be prioritised and for those who cannot afford to pay for the vaccine. If these vaccines have patent barriers, then the Indian government can notify these patents for GNCU under the Patents Act and the vaccines could be legally manufactured in India for the government despite the patents. It is only after the government has sufficient stocks of the vaccines that the vaccines would be sold in the Indian retail market and only after sufficient quantities are widely available in the Indian retail market will export be permitted.

How Can Government Make Sure That Vaccines Are Affordable In India?

There is a fear that vaccines will be unaffordable in India. This issue is easily addressed by the government providing free and subsidised vaccines for those who cannot afford it under the PMJAY and other similar state level schemes. The Drug Price Control Order, 2013 requires the vaccine manufacturer to get the retail price approved by the National Pharmaceutical Pricing Authority before it is launched in the Indian retail market and the NPPA can fix a price that is affordable for everyone.

Chance For Reform

The pandemic has highlighted the challenges that the global patent system poses to public health and it would be a great outcome of the pandemic if it results in reforming the patent system around the world. Transparency in the compulsory licensing and GNCU process and mandatory full disclosure by patent holders of ‘working the patent’ would be a good place to start. It is likely that the EU will make some progress on equitable access to healthcare. Will the Parliamentary Standing Committee on Commerce discuss how to improve the working of India’s IPR laws?

Before we get excited about implementing the Riyadh Declaration on Health Intelligence and Digital Health, we do need to make an earnest attempt to implement TRIPS and the Doha Declaration. Will the pandemic see the government make an attempt at “government non commercial use”, a well-known TRIPS flexibility so that drugs and vaccines that have patent barriers are accessible to everyone? Will the government use the leverage it has under the Essential Commodities Act, The Drug Price Control Order, 2013 and the Drugs & Cosmetics Act to make the vaccines affordable?

For of all sad words of tongue or pen,

The saddest are these: "It might have been!"

Ah, well! for us all some sweet hope lies

Deeply buried from human eyes;

And, in the hereafter, angels may

Roll the stone from its grave away!

- Maud Muller, by John Greenleaf Whittier (1856)

Murali Neelakantan is an expert in healthcare laws. He was Global General Counsel at Cipla and Glenmark, and Senior Partner at Khaitan & Co.

The views expressed here are those of the author and do not necessarily represent the views of Bloomberg Quint or its editorial team.

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