Supreme Court: The 3-judge bench of Dr. DY Chandrachud, L. Nageswara Rao and S. Ravindra Bhat, JJ has, in a bid to understand the vaccination policy for COVID-19, has sought clarification from the Central Government on various aspects enumerated below. While doing so, the Court clarified that,
“This Court is presently assuming a dialogic jurisdiction where various stakeholders are provided a forum to raise constitutional grievances with respect to the management of the pandemic. Hence, this Court would, under the auspices of an open court judicial process, conduct deliberations with the executive where justifications for existing policies would be elicited and evaluated to assess whether they survive constitutional scrutiny.”
Vaccine Procurement and Distribution among Different Categories of the Population
Asking UoI to undertake a fresh review of its vaccination policy, the Court has sought clarification on the following:
- The roadmap of projected availability of vaccines till 31 December 2021;
- The preparedness with respect to specific needs of children in the event of a third wave of the pandemic in terms of medical infrastructure, vaccination trials and regulatory approval, and compatible drugs;
- Whether under the policy of the UoI, it is permissible for State/UT Governments or individual local bodies to access vaccine supplies of foreign manufacturers;
- The number of crematorium workers vaccinated in phase 1. A targeted drive can be conducted for vaccination of the remaining crematorium workers;
- The State/UT Governments are diverting the vaccines (procured by them at a higher price than Central Government) for the persons in the age group of 18- 44 years to vaccinate persons above 45 years of age, due to a shortage of vaccines being supplied by the Central Government. The manner in which the Central Government will factor this quantity and price differential into their subsequent allocation and disbursal of vaccines to States/UTs for the persons above 45 years of age; and
- The mechanism for redistribution, if the 25:25 quota in a particular State/UT is not picked up by the State/UT Government or the private hospitals.
Effects of Vaccination by Private Hospitals under the Liberalized Vaccination Policy
“… we are not opposed to the involvement of private hospitals in the vaccination drive. Private health care institutions have an important role as well. The UoI has correctly noted in its affidavit that these hospitals will reduce the burden on government facilities. This was also happening earlier for the vaccination of those above 45 years of age, where the Central Government was providing these hospitals with vaccines and they were allowed to charge patients a nominal fee (Rs 250). However, the issue is about the effect of privatizing 50% of all vaccines available for the 18-44 age group.”
- The manner in which Central Government will monitor the disbursal of vaccines to private hospitals, specifically those who have hospital chains pan India. Further, whether (i) private hospitals are liable to disburse vaccines pro rata the population of States/UTs; and (ii) the mechanism to determine if private players are genuinely administering the lifted quota in that State/UT alone. The UoI shall place on record any written policy in relation to this.
- Whether the Central Government conducted a “means-test” of the demographic of a State/UT to assert that 50% of the population in the 18-44 age group would be able to afford the vaccine. If not, the rationale for private hospitals being provided an equal quota for procurement as the State/UT Governments.
- The manner in which the Centre and States/UTs shall ensure an equitable distribution of vaccines across sections of the society, and how this factors into the rationale of equal apportionment between State/UT Governments and private hospitals.
- The nature of the intervention with respect to the final, end-user price that is being charged by private hospitals, especially when a cap on procurement by the private hospitals has been set.
Basis and Impact of Differential Pricing
“If the Central Government’s unique monopolistic buyer position is the only reason for it receiving vaccines at a much lower rate from manufacturers, it is important for us to examine the rationality of the existing Liberalized Vaccination Policy against Article 14 of the Constitution, since it could place severe burdens, particularly on States/UTs suffering from financial distress.”
While the Court commended the co-operative efforts of the UoI and the private manufacturers in developing and distributing vaccines which are critical to mitigate the pandemic, it sought clarifications on the process of development and augmentation of vaccine production and its pricing for States/UTs and private hospitals.
- Since the Central Government has financed (officially, Rs 35 crores to BBIL and Rs 11 crore to SII for phase 3 clinical trials) and facilitated the production (or augmentation of production) of these vaccines through concessions or otherwise, it may not be accurate to state that the private entities have alone borne the risk and cost of manufacture. Additionally, the Central Government would have minimized the risks of the manufacturers by granting Emergency Use Authorization to the vaccines, which should factor into its pricing.
- The manner in which public financing is reflected in the procurement price for the Central Government, which is significantly lower than price for the State/UT Governments and private hospitals. Given that the R&D cost and IP have either been shared between the Central Government and the private manufacturer (in case of Covaxin) or the manufacturer has not invested in R&D of the vaccine (in case of Covishield), the manner in which the pricing of vaccines has been arrived at, with the Central Government refusing to intervene statutorily. The justification for intervening in pre-fixing procurement prices and quantities for States/UTs and private hospitals, but not imposing statutory price ceilings.
- Comparison between the prices of vaccines being made available in India, to their prices internationally.
- Whether ICMR/BBIL formally invited contracts for voluntary licensing and if so, whether they have they received viable offers. The manner in which the UoI is independently trying to assist manufacturers for developing BSL3 labs which are essential for Covaxin production.
Vaccine Logistics
- The manner in which cold storage equipment capacity is being balanced between the Central and State/UT Governments. The manner in which the States/UTs are managing the logistical burden for vaccinating persons aged between 18-44 years, along with persons aged over 45 years.
- Whether cold storage facilities in India have increased for the COVID-19 vaccination drive; the present numbers, and comparison with the numbers prior to March 2020;
- Whether the cold storage equipment is indigenously manufactured or is imported. If it is imported, the steps which have been taken to start indigenous manufacturing.
- The steps being taken to improve the cold storage management for vaccines which may require lower temperature to be stored, compared to the ones which currently have approval in India.
Digital divide
“… there exists a digital divide in India, particularly between the rural and urban areas. The extent of the advances made in improving digital literacy and digital access falls short of penetrating the majority of the population in the country. Serious issues of the availability of bandwidth and connectivity pose further challenges to digital penetration. A vaccination policy exclusively relying on a digital portal for vaccinating a significant population of this country between the ages of 18-44 years would be unable to meet its target of universal immunization owing to such a digital divide. It is the marginalized sections of the society who would bear the brunt of this accessibility barrier. This could have serious implications on the fundamental right to equality and the right to health of persons within the above age group.”
- It may not be feasible to require the majority of our population to rely on friends/NGOs for digital registrations over CoWIN, when even the digitally literate are finding it hard to procure vaccination slots.
- The issue of over-crowding may also arise at CSCs in rural areas where people would have to visit constantly in hope of a vaccine slot opening up.
- Certain vaccination centres may be earmarked for on-site registrations for the population aged between 18-44 years without the existing conditions prescribed in the circular dated 24 May 2021, potentially with a view to prioritize those with co-morbidities/disabilities/other socio-economic vulnerabilities. Alternatively, whether specific daily quotas may be introduced for on-site registration at each centre or specific centres.
- This policy may not allay the issue of hesitancy which may arise from approaching a State authority (such as the District Immunization Task Force) to obtain registration for the vaccination. Whether on-site registration with selfattestation of age to ensure widespread vaccination can be provided.
- The CoWIN platform and other IT applications like Aarogya Setu should be made available in regional languages. The timeline for ensuring the availability of the platform in multiple regional languages.
- Conducting a disability audit for the CoWIN website and other IT application like Aarogya Setu to ensure that they are accessible to persons with disabilities.
Final directions
The Court directed UoI to file an affidavit, with each of the abovementioned issues responded to individually and no issue missed out.
The affidavit should also provide the following information:
- The data on the percentage of population that has been vaccinated (with one dose and both doses), as against eligible persons in the first three phases of the vaccination drive. This shall include data pertaining to the percentage of rural population as well as the percentage of urban population so vaccinated;
- The complete data on the Central Government‟s purchase history of all the COVID-19 vaccines till date (Covaxin, Covishield and Sputnik V). The data should clarify: (a) the dates of all procurement orders placed by the Central Government for all 3 vaccines; (b) the quantity of vaccines ordered as on each date; and (c) the projected date of supply; and
- An outline for how and when the Central Government seeks to vaccinate the remaining population in phases 1, 2 and 3.
- The steps being taken by the Central Government to ensure drug availability for mucormycosis.
The affidavit is to be filed within 2 weeks.
[In re: Distribution of Essential Supplies and Services During Pandemic, 2021 SCC OnLine SC 411, decided on 31.05.2021]
Appearances before the Court
Mr Tushar Mehta, learned Solicitor General
Mr Jaideep Gupta and Ms Meenakshi Arora, learned Senior counsel and Amici