The court had observed that Centre's vaccine policy was detrimental to the right to health and that the same should be revisited to conform with the mandate of Articles 14 and 21 of the Constitution.
The top court had questioned the rationale behind the differential pricing of vaccines for Centre, State Governments and private hospitals.
The central government has submitted that its vaccination policy was formulated based on widespread consultations with experts, state governments and vaccine manufacturers.
The 91-page affidavit brings out some interesting facts:
1. For the time in history, India is conducting its biggest vaccination drive. The Government of India admits that for this the country does not have the luxury of a detailed planning time like other vaccines administered in the past over a period of decades.
2. The Government of India submits that it will make all possible efforts in procuring vaccines from other countries. However, it may be kept in mind these efforts of procurement from other countries have their own challenges as, unlike other vaccines in the past, every country of the world needs vaccines for its domestic use at this juncture.
3. As per the new policy, vaccine manufacturers would supply 50% of their monthly production to the Government of India and would supply the remaining 50% doses to ‘other than Government of India channels’, i.e. state governments, private hospitals and hospitals of industrial establishments. Under this policy, vaccination for groups between the ages of 18 to 44 years will be permitted under the ‘other than Government of India Channel’.
Out of this 50% quota, state governments will only get 25% while private hospitals balance 25%. The quantity of doses available for ‘Other than Government of India Channel’ has been worked out on a pro-rata state wise population of 18 to 44 years basis.
4. The Government of India makes a point in the affidavit that both manufacturers have taken financial risk in developing and manufacturing these vaccines and it is prudent to take decisions on pricing through negotiations in a transparent consultative process keeping statutory provisions as a last resort.
5. Central government submits that by nature of its large vaccination programme it places large orders as opposed to the state government and this reality has some reflection in prices negotiated.
6. Central government submits that it has negotiated with manufacturers to ensure pricing is uniform throughout the country. This will not have any ultimate impact on the beneficiary as he / she will be getting vaccination free of cost with the central government bearing it for 45+ and state government for 18-44.
7. The Government of India submits in court that procurement of vaccines from other countries is essentially its responsibility. For such procurement, significant efforts are being made at several levels, including through diplomatic channels, both within and outside the country.
8. The court had asked GoI to submit a breakup of the current and projected availability of stocks for the next six months and a timeline for achieving immunization of the 18-44 age group.
The Government of India has argued that at present the availability of vaccines for next 6 months would be difficult to project as it depends upon the successful augmentation in existing manufacturing capacity of two vaccine manufacturers, the procurement of other vaccines from other countries and its quantity etc.
As per Niti Ayog, 2 billion doses will be available between August and December.
9. The Court had also suggested that the Government should invoke powers under the Patents Act, such as compulsory licensing, to make COVID-19 vaccines and drugs more affordable and accessible amid a public health emergency.
The Government of India submits in court that Covaxin was developed under a PPP between ICMR and Bharat Biotech. The MoU includes a 5% royalty for ICMR on a net sales basis and prioritisation of in-country supplies. The product intellectual property rights are shared.
As per reports, Bharat and ICMR have agreed to share the formula for manufacture of vaccines and GoI has invited pharma companies to produce Covaxin.
10. Central government submits that no governmental aid, assistance or grant is made either for research or development of either Covaxin or Covishield. However, they were given some financial assistance for conducting clinical trials. ICMR’s total expenditure on such assistance is Rs 46 crore.
To sum up, the Government of India has reiterated that no judicial interference is needed, and the Supreme Court should trust the wisdom of the executive. The action now moves to court where proceedings have been postponed as Justice Chandrchud has turned COVID-19 positive.