[Suo Moto COVID crisis] Application In Supreme Court Seeking Allocation Of Vaccine To States by Centre; Relaxing Intellectual Property Barrier To Large Scale Production

  • Sakshi Shukla
  • 10:42 AM, 30 Apr 2021

An Intervention Application has been moved by Jan Swasthya Abhiyan, a network of organisation & individuals working actively for health issues, in the matter of Re: Distribution of Essential Supplies and Services During Pandemic.

Primary reasons for shortage of vaccine as stated by the interveners are; limited number of manufacturers, vaccine pricing and grant of patents creating hurdle in large scale manufacture.

The petition seeks directions on;

  1. Scaling up the production of vaccines against coronavirus;
  2. Single Procurement window of the vaccines by the Central Government;
  3. Allocation of vaccines to the States by the Central Government;
  4. Distribution of the vaccines to the States;
  5. Ceiling prices of vaccines against COVID 19.

Applicant enumerates the total prospective production and inoculation achieved and awaited; “… with the passage in the last three months only 30 percent of the 40 crores of the persons above the age of 65 years have been inoculated with the first dose. It is estimated that in the last 100 days 14.19 crores inoculations have taken place. Of these about 2.4 crores have taken the 2nd dose. This is roughly 1.8% of the total population.”

With respect to importation of vaccine from Russia and production taken up in alliance with Dr Reddy’s Laboratories and its partners, Panacea Laboratories and Virchow, to produce factually around 1900 million doses, the application says; “… there is no clarity with regard to how many of these doses are available to the Indian market because these agreements are contract manufacturing license to supply to RFID.”

“In any event it is necessary that the Respondent No. 1 must transparently disclose its plan about the persons who need to be vaccinated the anticipated need and the local production capacity and how it proposes to ramp it up”, applicant adds.

Further, on inviting international manufacturers and clearances, the applicant adds; “the Government has turned only to the manufacturers abroad and invited them with fast track approvals. Though that cannot be faulted with, it is necessary that India does not find itself in the same position again. For that it is necessary that local production be encouraged, both in the public sector and in the private sector. Public sector units must be provided with funds to ramp up their capacities. The Respondent No. 1 must disclose its plans to increase production capacities of vaccines of public sector units and how much investment it is proposing to make in the public sector units”

On Production, Procurement and Distribution, the applicant states;

“For the last 70 years the Indian vaccine procurement system was worked on the basis that Respondent No. 1 procures all the vaccines from public manufacturers and distributes it through the States to all free of charge as a part of the immunization programme. For the first time in the history of India there is a differentiation between the States and the Government of India to procure diagnostics, therapeutics or vaccines. The money for purchasing the vaccines and medicines comes from direct and indirect taxes and from international assistance and does not brook any difference between the States and the Central Government.”

With respect to distribution of vaccine amongst States, it is added that decision of the Union promotes inequities and infringes rights of citizens under Article 14 and 21 of the Constitution;

“It implies that richer States can go to the market and purchase the vaccines and poorer and smaller states will be left to the arbitrary whims and fancies of the private companies. This would mean that some citizens in India would be able to get the vaccines early and others may not get it at all. Further by pushing people between 18-45 years to vaccines at the financial health of state or at high price in the private sector is arbitrary and results in the denial of vaccines. The decision is therefore in violation of Articles 14 and 21 of the Constitution of India.”

On Intellectual Property as a barrier to large scale access of vaccines, the applicant states;

  1. Trade Secrets should be made available
  2. DCGI should be directed to issue approval in accordance with law
  3. Prices should be set under the Drug Price (Control) Order

Grounds preferred

  1. Limited Access/Availability of Medicines for COVID 19 treatment violates Article 21 of the Constitution.
  2. Vaccine distribution program of the Government should make vaccines available to all free of charge.
  3. Decision of the Union to not procure all the vaccines required for free distribution through the States infringes Right to Health and Life of citizens.
  4. Vaccines to be subject to price control under the Drug Price Control Order issued under the Essential Commodities Act.
  5. COVID 19 is a public health emergency and the government is obligated to issue an order of Government authorization under Section 100 or a compulsory license for non-commercial public use under Section 92(1) of the Patents Act to respond to National Emergency.
  6. Amendment vide order dated January 3, 2019, para 32 DPCO, is in violation of Article 14 and 21

The application is filed by Advocate Astha Sharma, drawn by Advocate(s) Rajeshwari Hariharan and Nupur Kumar, settled by Senior Advocate Anand Grover.