“The real blockades to vaccine access [in India] are state inaction, dearth of raw materials and low production capacity…. The current government’s failure to communicate realistic potential of the vaccination drive and the need for social distancing led to giving a false sense of confidence to the public, which aggravated the outbreak to the point of systemic collapse.”
The horrific second wave of COVID-19 in India has compelled the government to introduce an expedited vaccination drive from May 1, 2021, where all citizens above the age of 18 (and not just priority groups) will be eligible to register. The program also came with the promise of an introduction to several new vaccines in the market. A majority of the states also decided to roll out the vaccine for free.
Unfortunately, reports that stock had run out followed shortly in several states. States like Maharashtra and Delhi had to keep the drive on hold. Bengaluru also faced supply problems ahead of the drive.
A popular proposition is that patent restrictions and exclusivity of “know-how” are a barrier to adequate production of vaccines.
What is the Blockade to Vaccine Access in India?
Last October, India and South Africa made a motion before the World Trade Organization (WTO) for waiver of patents related to COVID-19 technology. Government and non-government stakeholders such as the World Health Organization (WHO) and Medecins Sans Frontieres (MSF) have also been advocating and lobbying for waiver. This was also a significant talking point in the telephonic conversation between Prime Minister Narendra Modi and U.S. President Joe Biden (as per the Indian government’s transcript), which was in the backdrop of the Biden administration’s trade restrictions on export of raw materials for the vaccines. This motion before the WTO has faced opposition from several members, including the United States and Europe.
The idea behind patent waiver is to take away control over manufacture and pricing from private entities and equip the governments to produce as per demand. However, critics of patent waiver argue that the waiver hinders expansion and production by private entities, as they miss out on their incentive to invest in R&D and production. This is particularly relevant in the case of the COVID-19 vaccines, where the healthcare systems are entirely dependent on the ingenuity of private entities. Given that there are reports that the vaccine may require periodic “tweaking” due to the mutations, it is crucial that the private entities are equipped and motivated to continually invest in R&D.
In response to the proposal for patent waiver, WTO Director General Ngozi Okonjo-Iweala has proposed a “third way deal,” which is an industry driven voluntary licensing system. So far, this system has met with great success in India. The Serum Institute of India, which is manufacturing Oxford/Astrazeneca’s vaccine, is currently the largest COVID-19 vaccine manufacturer in the world and is working on alliances in the international market. Several other leading manufacturers, such as Dr. Reddy’s, Zydus Cadilla and Panacea Biotech, are also racing to collaborate with international private entities to manufacture the vaccine and boost access. India’s indigenous vaccine by Bharat Biotech is also being produced in great numbers.
However, the projections of vaccine production have not been realized and supply is evidently falling short of demand.
The other reason for the proposal of patent waiver is to allow local manufacturers to reverse engineer the product/process. Vaccines are complex biologicals which are known to be difficult to reverse engineer. There is no academic evidence to suggest that COVID-19 vaccines can be reverse engineered by a manufacturer without access to the proprietary know-how of the innovator. A group of researchers from Stanford University attempted to reverse engineer the Moderna vaccine from a sample. As per reports, although they were able to extract the mRNA sequence of the vaccine, they were unable to reverse engineer it in finished form, as the recipe is Moderna’s confidential know-how. Further, reverse engineered vaccines would also have to undergo their clinical trials and regulatory compliances, which is not conducive to creating expedient access. Therefore, mere waiver of patents cannot be the solution to the issue of access to vaccines. .
Several proponents have also argued that since India is experiencing a national emergency, warranting an urgent vaccination drive, the Controller of Patents should suo motu grant a compulsory license for manufacture of vaccines under Section 92 of the Patents Act. But this becomes unnecessary when India has its own indigenous vaccine and prominent vaccine owners of the world are collaborating with multiple licensees in India.
Identifying the Real Problems
The real blockades to vaccine access are state inaction, dearth of raw materials and low production capacity. Vaccine raw materials are currently being imported from the United States. With the increase in global demand for vaccines, demand for suppliers has also increased. Experts from the United States argue that trustworthy vaccine suppliers cannot spring up in such a small span of time. However, a logical corollary that arises from this is that the current government and vaccine manufacturers have failed to accurately project the production capacity and have over-promised.
India’s vaccine market is almost entirely dependent on bulk government orders. There is criticism that the current government did not iron out the details of regulatory requirements or commit orders for the private vaccine manufacturers ahead of time, and therefore, the manufacture did not commence until the end of 2020. By this time, most countries were ready to place orders and stock. This put us behind schedule, and eventually unable to keep up with a national emergency.
A correct assessment of the production capacity is crucial to plan social distancing at macro levels, investments in healthcare, infrastructure and medical resources. The current government’s failure to communicate realistic potential of the vaccination drive and the need for social distancing led to giving a false sense of confidence to the public, which aggravated the outbreak to the point of systemic collapse.
As a side note, discrimination in the vaccine drive is evident from the fact that registrations are only being accepted online, which is clearly disadvantaging people who are illiterate or do not have access to the internet. On April 30, 2021, the Supreme Court of India also raised concerns on this point in the course of the hearing in the suo motu case pertaining to all issues in the second wave.
The Way Forward
In today’s atmosphere, where there is a desperate need for a strategic solution to the second wave in India, the vaccination drive is being pitched as a quick fix for the catastrophe. The predicament is much more complex and requires a holistic assessment. As the first priority, the government needs to act fast to address the dearth of raw material supplies. It also needs to come to a realistic assessment of timelines for the drive, accept international help to be able to cope with the shortage of basic treatment necessities and testing facilities (in addition to boosting in house production and supply chain), and take stricter measures to control the spread and impose social distancing.
So far, the current government has only shown a tendency to pat itself on the back for declining numbers in 2020 and gloss over the negative state of affairs thereafter. It is important to steer conversations from high-level political debate on IPR limitations (which are not helpful or even relevant to the issue at hand) and work on the concerns on the ground, which urgently need attention.
Image Source: Deposit Photos
Join the Discussion
13 comments so far.
AnonMay 12, 2021 04:56 pm
yes – you are correct, It is in the story that incorrectly focuses ONLY on “patent waiver” (particularly, “Last October, India and South Africa made a motion before the World Trade Organization (WTO) for waiver of patents related to COVID-19 technology. ” that the LINK is correct in pointing out that the waiver is in fact more than merely a patent waiver).
However, everyone should be abundantly clear that “patent only” is simply NOT the aim here. (as I mentioned – I do believe that you personally understood this)
IshanMay 11, 2021 06:11 pm
@anon : well, for the first thing, please do note that the article does not talk about IP waiver. It only references to patent waivers, and never goes on to make a distinction between IP and patent waivers. That is your and my understanding about the IP vs patent waivers – and I think we are on the same page with respect to IP waivers. That’s the only reason I mentioned about technology transfer in combination with patent waivers (that covers your point of non-patent IP). Hope it makes sense. I welcome your additional thoughts on this.
AnonMay 11, 2021 05:15 pm
May I correct your writing and note that the larger term of IP waiver is distinct from (and includes) patent waiver.
You seem to be aware that it is NON-patent IP that is important, so understanding the distinction between patent waiver and IP waiver does not undercut any concerns you may have, and merely makes the dialogue more precise.
I would add that many have made a similar error in judgment in thinking that “patent waiver” is the be all and end all, and the larger attempted conversion goes well beyond patents.
IshanMay 11, 2021 01:56 pm
When patent waiver would happen, of course it would be a combination of waiver plus technology transfer. Most of the patents would in fact have the details of know how and how to manufacture the vaccine. So, a waiver (including tech. transfer) would obviate the need for any requirement of reverse engineering. Do not really agree with the author’s understanding of the parent waivers or compulsary licensing. To sum up, further issues of reverse engineering with patent waivers is not correct, as pointed out by the author.
shirish aryaMay 7, 2021 12:20 am
This is heavily one sided commentary. To believe “market forces” alone will relieve us out of this situation would truly be a grave mistake. The are multiple stumbling blocks in the race to vaccinate the world, but to say IP has no relevance at all is balooney. The joint global production capacity is it being fully and completely being leveraged – simple answer is NO. How can we create 10 bn+ vaccines when the production capacity is only in few millions. UN and WHO in particular should create a framework where IP is not a stumbling block, long term protection to IP creators are given (even though it may still not be fool proof) but creates some safety and global production capacity and distribution is fully leveraged. Non-action is not an option even if all parties are not completely happy.
XtianMay 6, 2021 08:37 am
Informative article. Can you provide more details on ” India’s indigenous vaccine by Bharat Biotech is also being produced in great numbers.”
How many vaccines are being produced by Bharat?
Are they not effective?
What is Bharat’s limiting factor in not being able to satisfy the demand?
Why isn’t the Indian gov’t doing more to help Bharat rather than trying to import foreign technology and “start from scratch” on a new vaccine?
DamonMay 6, 2021 07:37 am
Quite a wrong understanding of the situation and failed attempt write anything anyhow? When did the India asked for IP waiver for itself – for vaccines or pharmaceuticals? Also many factually incorrected information – Maharashtra and Delhi – never stopped the immunization, rather ramped up with some exceptional slow down here and there! Author should also have taken care about the representation of the flag – which seems in conflict with the relevant laws!
VRINDA PATHAKMay 6, 2021 04:43 am
Very well articulated, eva. Very proud of you.
Amiya PatnaikMay 6, 2021 04:35 am
Very well articulated. Government n manufacturers have to move proactively with speed
Rakesh AnandMay 6, 2021 04:26 am
Great analysis of the current situation. Nicely described.
AnonMay 5, 2021 09:04 pm
A non – yes, you alight upon one of the deeper drivers.
A nonMay 5, 2021 05:24 pm
Really well done. Kudos. Absolutely agree that the patents are not the problem here. I know there are some government manufacturing sites on India but to me “equip the governments to produce as per demand” really means grant Dr Reddy and Ranbaxy huge lucrative contracts and then they retain the know how forever. You cannot un-ring a bell.
AnonMay 5, 2021 12:28 pm
Quick post of a link to a prior chain (that contains several outstanding links) to make retrieval easier: