18, Jun 2021 | Adeeti Singh
As news about availability of vaccines against Covid-19 broke out, a sense of relief dawned upon all of us. But the vaccination drive in India is more complicated than just showing up at a nearby vaccination centre and getting a shot. Our vaccine policy, which has already seen multiple changes, has recently been revised, after strict judicial intervention.
Earlier the Centre’s policy stated that 50 percent of the vaccines would be procured by the Union, 25 percent would have to be procured by the states and Union Territories (UT), and the remaining 25 percent would be given to private hospitals. The Centre stated that they will procure 50 percent of vaccines and distribute across states “only” for the age group of above 45 years. For the 18 to 44 age group, the centre said that it will decide the quantity to be allocated to the states through the manufactures, based on the population of this age group in each state.
This compelled the states to float global tenders in order to procure vaccines for the 18 to 44 age group at a higher price than the Centre, and only the Centre was allowed to decide the number of vaccines the state could purchase. Another concern was that some vaccine manufacturers refused to deal with the states directly, rendering them helpless.
But according to the new plan, the Central Government will now procure 75 percent of the vaccines and the remaining 25 percent will be made available to private hospitals. The state governments and Union Territories will now get hold of vaccines free of cost and the allocation of doses will be based on certain aspects such as population, disease burden and the progress of vaccination.
The states/UTs shall also be provided with advance information of vaccine doses to be supplied to them. “States/UTs should similarly, further allocate doses well in advance to districts and vaccination centres,” say the new guidelines. These guidelines will come into effect from June 21, and will be reviewed from time to time.
As already mentioned, one of the main elements of this revised policy is that the Government of India will procure 75% of the vaccines “being produced by the manufacturers in the country.” This essentially covers only Covishield and Covaxin. It remains silent on imported vaccines, the manner in which it will be imported, and allocated across states.
This revision announcement comes days after the Supreme Court had ruled that excluding the 18-44 age group from free vaccines is “prime facie arbitrary and irrational”. It further asked the Centre to file an affidavit explaining how they devised such a policy, with documents and files supporting their stance.
To address the issues related to vaccine registration, the new guidelines state that all government and private vaccination centres would also provide onsite registration facility, available both for individuals as well as groups of individuals.
After the sudden spike in coronavirus cases and ravaging death rates, one thing is clear- we need to vaccinate our people and we need to vaccinate them fast. Despite experiencing the worst Covid-19 surge in the world, India has managed to fully vaccinate a mere 3.4 percent (approximate percentage as of June 13) of its vast eligible population. With new and rather late amendments removing unnecessary burden on the states, the question remains as to why private hospitals still get 25 percent of vaccines reserved for the uber rich who can afford to pay more than Rs. 1,000 per dose.
This policy gives enough leeway to private players in order to make super profits out of a public good. According to an Indian Express report, in May, mere nine corporate hospital groups cumulatively bought fifty percent of the total 1.20 crore doses of vaccines procured by private hospitals and the remaining 50 percent was sold to just about 300 odd private hospitals, ringing accessibility alarms. Smaller private hospitals in larger cities and metros have reportedly raised this disparity issue.
“We ordered 30,000 doses, we got only 3,000. Big hospitals with stronger networks and resources have managed to make better deals with manufacturers,” said Dr. Vaibhav Deorgirkar, Medical Director in Hindu Sabha Hospital, Mumbai to The IE. The policy still needs to provide a detailed explanation with respect to allocation to private hospitals.
Keeping 25 percent reserved for the private sector is also against India’s 70 years old successful Universal Immunisation Programme (UIP), under which every single percentage of vaccines were centrally procured and distributed through the states free of charge.
India’s inadequate order for vaccines
India’s vaccination campaign, started on January 16, with all frontline workers. Initially two vaccines were allowed for emergency use- Covishield (an Oxford AstraZeneca vaccine manufactured by the Indian company Serum Institute of India) and Covaxin (developed by Bharat Biotech). In April, the Russian developed vaccine- Sputnik V was granted approval for use in India as the third vaccine.
There was news about how the Indian Government did not place sufficient orders for immunising people, completely ignoring the suggestions of experts. But the government rubbished this claim and stated in May that, 100 percent advance payment of Rs. 1,732.50 crores were released to Serum Institute of India (SII) on April 28 for only 11 crore doses of Covishield which was also received by them on the same date. As on May 3, against the last order of 10 crore doses for supplies of Covishield, 8.744 crore doses have been delivered to the Centre.
With respect to Covaxin, 100 percent advance payment of Rs. 787.50 crores for 5 crore Covaxin doses during May, June and July, was made. “As on date (May 3) against the last order of 2 crore doses for supplies of Covaxin vaccine, 0.8813 crore doses have been delivered till 03.05.2021,” the Centre said in their press release.
But 110 million doses of Covishield and 50 million of Bharat Biotech, barely scratch the surface for our vast population. The vaccination drive has slowed down in rural areas where the infection has been growing rapidly. The order placed in January (15 million) also reflects the government’s ignorance towards the second wave and the population of India. Even though the announcement of India’s grand vaccination drive came as early as August 2020, the Centre placed its first order only in January.
The vaccine shortage in India seems like an artificial shortage. Covaxin, our domestic vaccine has been developed by Bharat Biotech in collaboration with Indian Council for Medical Research (ICMR), and thus, it is safe to say that it is jointly/partly owned by the government of India. It could be manufactured at a larger scale by distributing the knowledge to various manufacturers. Creating this duopoly, depending only on two key manufacturers to produce vaccines for 1.3 billion in addition to its global commitments, is not a rational model. India, has crossed the second wave’s peak, but continues to witness thousands of deaths every day.
Dr. Harshvardhan had announced that his government aims to vaccinate (2 doses assumption) around 30 crore Indians. As on date (June 14), the CoWin portal displayed 25,14,71,066 total vaccination doses administered, with 20,44,25,100 having received the first dose and 4,70,45,966 administered their second dose.
The Government also announced that it had placed orders for 44 crore doses of Covishield (25 crores) and Covaxin (19 crores) which will be delivered by their makers between August and December 2021. The affidavit submitted by the Centre on May 9 stated that Serum Institute of India has ramped up production from 5 crore doses per month to 6.5 crore doses per month and further ramp-up is expected by July. Similarly, Bharat Biotech has increased production from 90 lakh per month to 2 crore doses per month and further increase is expected upto 5.5 crore doses per month by July 2021. If this is true, both manufacturers are well within their means to produce more vaccines and a larger order could have been placed.
Covaxin, Sputnik V beneficiaries in a quandary
In May, the 27 countries in the European Union agreed to ease travel restrictions for non-EU visitors who are fully vaccinated against Covid-19 but this does not necessarily benefit Indians, especially students, who have been administered Covaxin and Sputnik as it has not been recognised under WHO’s emergency use list. This may delay their admission process in universities abroad, not making them eligible for travel just yet.
As WHO has stated that more information about the vaccine developed by the Hyderabad-based Bharat Biotech is required, it is unclear what additional information WHO is looking for. One reason is that the efficacy results from the phase 3 trial of Covaxin has yet not been published. However, Dr V K Paul, who heads the country’s Covid task force, has told the media that this will done in the next “7-8 days”.
WHO’s apprehension can be explained through Dr. Jammi Nagaraj Rao who highlighted some concerns regarding Covaxin’s efficiency for The Wire Science. He said that the reaction to the Bharat Biotech’s analysis of an 80.6 percent efficacy should be tempered because it is based on interim data of just 43 cases of Covid-19 among the 25,800 people who had been recruited for the trial. Another issue was that the preliminary results announced by Bharat Biotech failed to mention confidence intervals (CI) for the efficacy figure, which describes the range in which the efficacy can vary.
Intellectual Property Rights concerned with the vaccine
The Centre’s affidavit reflects a contradiction in India’s push for IPR waiver on vaccines. If Intellectual Property Rights for the vaccine are waived, more manufacturers can get into the race and supply will increase manifold. Hence there is a push globally, for licensing other producers instead of relying on the manufacturing capacities of a few companies who have other obligations.
To understand the policy better, India and South Africa had on October 2, 2020 proposed a relaxation in the norms of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to ensure quick and affordable access to vaccines and medicines for developing countries.
The two countries had highlighted that some World Trade Organisation members had carried out urgent legal changes to their national patent laws to expedite the process of issuing compulsory/government use licences. The Hindu quoted the members stating, “Internationally, there is an urgent call for global solidarity, and the unhindered global sharing of technology and know-how in order that rapid responses for the handling of Covid-19 can be put in place on a real-time basis.”
This was also followed by the United States support for an intellectual property waiver. India too, as mentioned, pushed for the patent waiver for optimised supply of vaccines and drugs, but the affidavit filed by the Union government on May 9, 2021 rather protects these IP Rights.
It states, “When there is a surge in cases and in demand of patented medicines/drugs/vaccines from all over the world the solution needs to be found out essentially at an executive level engaging at diplomatic levels. Any exercise of statutory powers either under the patents act 1970 read with TRIPS agreement and Doha declaration or in any other way can only prove to be counter-productive at this stage, the central government is very actively engaging itself with global organisations at a diplomatic level to find out a solution in the best possible interest of India.”
Infact the government even urged that “any discussion or a mention of exercise of statutory powers either for essential drugs or vaccines having patent issues would have serious, severe and unintended adverse consequences in the countries efforts being made on global platform using all its resources, good-will and good-offices through diplomatic and other channels.”
This goes against the country’s communication with South Africa in October last year. Intellectual property expert K.M. Gopakumar, in an interview to The Hindu, explained, “The very purpose of the TRIPS waiver proposal is to end the monopoly on production and supply of medical products, including vaccines, and facilitate the scale-up of production of diverse manufacturers. The reluctance of the government to license the Covaxin technology to all potential producers and scale up its production reinforces vaccine monopoly. This approach of the government not only contradicts its position as a co-sponsoring country of the TRIPS waiver proposal but also compromises the moral high ground and negotiating capital at WTO.”
Section 92 of the Indian Patents Act is a special provision that enables the Central Government to issue compulsory licenses for the manufacture of patented drugs in a situation of national emergency or a circumstance of extreme urgency. What can be more urgent than thousands of lives lost each day? Similarly, section 100 of the Patents Act enables Central Government to use patented inventions for government purposes. The government can still takeover the invention of drugs and vaccines under this provision or can license through the patent controller. But these sections have not been invoked yet.
The Supreme Court has wondered about the same issues and even flagged it during the suo motu hearing in April. LiveLaw quoted Justice Ravindra Bhat saying, “This is an exact case where we should go for compulsory licensing. This is a situation of Public Health Emergency.” He also observed that India was in the forefront of TRIPS negotiations regarding provisions on compulsory licensing, and the present scenario was perhaps a fit case for using it.
He also referred to the Natco case, where the India Government granted compulsory license to Hyderabad-based drug producer Natco to produce a life-saving drug called Nexavar for kidney cancer, that was patented by a German company-Bayer.
The Central government’s formula of procuring vaccines centrally is a welcome move for all states that no longer have to compete with fellow Indian States and also other nations in the market. But reserving 25 percent for private hospitals, will continue to create transparency and accessibility problems, beyond the reach of most Indians. Entry 29 of the List III of the Seventh Schedule obliges the Central government to assist the states “to control interstate spread of infectious diseases”. This is not a favour, but an obligation of the Centre that is duty bound to control the spread, that can effectively be done by vaccinating people against the virus at the earliest.
Unless the Centre takes over the entire 100 percent procurement of vaccines and makes it available to all for free, the policy will continue to exacerbate inefficiency and unnecessary delays. The Supreme Court is yet to opine on this new set of guidelines in the suo motu matter and may raise concerns about the 25 percent reservation.
Currently, as India is struggling to expand its vaccination before the onset of the next wave, most states have started unlocking in a phased manner.