SFLC.in has assisted in the filing of a writ petition challenging the Liberalised Pricing and Accelerated National COVID-19 Vaccination Strategy before the Kerala High Court on the 27th April, 2021. The matter came up before the vacation bench of Justices Ashok Menon and Murali Purushothaman. A notice has been issued to the respondents in this matter. The petition has been filed by Dr K P Aravindan, a member of the expert panel on COVID-19 constituted by the Government of Kerala and Dr. Praveen G Pai, a Public Health Specialist. The petition was moved by the petitioners after the Liberalised Pricing and Accelerated National COVID-19 Vaccination Policy opened vaccinations for citizens between 18-45 years of age from 1st May, 2021.
The liberalised pricing policy has allowed a multi-track procurement process and a differential vaccine pricing mechanism where vaccines will be supplied by the two Vaccine Manufacturers, Serum Institute of India (SII) as well as Bharat Biotech to the Center, the States and private hospitals. The vaccine is currently priced at Rs. 250 for private hospitals inclusive of administrative cost of Rs. 100. The state Governments get the vaccine free of cost from the Centre. The Vaccination strategy has removed the price cap of Rs. 250 and has also made states to compete with each other and the private sector for the 50 % what remains after procurement by the centre. Moreover the Serum Institute of India which manufactures CoviShield has said that it will supply the Vaccine at a rate of Rs. 400 per vaccine to State Governments and Rs. 600 to private hospitals. Bharat Biotech which sells Covaxin will sell the vaccine at Rs. 600 for State Governments and Rs. 1200 for Private Hospitals. Both vaccines will be available for Rs. 150 to the Central Government. Prior to this policy, ALL vaccines were being procured by the Central Government at a rate of Rs 150 per vaccine. It has been widely accepted by the scientific community worldwide that vaccination is the only way to control the spread of COVID-19 and to minimize mortality from infections.
The writ petition was moved on the following grounds, among others:
(i) The decision to allow vaccine companies to have a three tier price structure with differential pricing for the central and state governments will result in low coverage of the targeted population thereby putting at risk the entire population of India. This will consequently lead to a violation of Right to health and right to life.
(ii) Charging for vaccines for the 18-45 age group amounts to an unreasonable classification and is arbitrary
(iii) The vaccines ought to fall under the National Essential Medicines list which is a list of essential drugs that have their prices capped. The prices of the vaccines can also be capped keeping in mind the provisions of the The Drugs (Prices Control) Order, 2013
(iv)The cost of the Vaccine in India is the highest in the world. The Oxford AstraZeneca Vaccine being manufactured by the Serum Institute of India is a publicly funded vaccine and charging an exorbitant price is unjustifiable and mere profiteering.
(v)The Government should take steps to ensure that more manufacturers should be given access to the technology and the vaccines reach the target population as quickly as possible. The government in its capacity as the giver and protector of intellectual property rights, has an inherent power to allocate intellectual property rights for the fulfilment of a public purpose, which in this case is the imminent and necessary task of universal immunization of the citizens of India. There are at least 19 capable vaccine manufacturers as listed in the National Health Profile, 2019
(VI)The writ petition greatly emphasizes on Open Access, Open knowledge and the Open COVID Pledge. The Open COVID pledge is an initiative through which multiple businesses, researcher’s, academics, lawyers have come together to pledge that their Intellectual property can be used free of charge to solve the COVID 19 pandemic and minimize the impact of the pandemic. This was in the spirit of “Open Science” and “Open Source Software”. Some of the founding adopters of the pledge are companies like Facebook, Amazon, IBM, Intel, Microsoft, Hewlett Packard Enterprises among others. The government should share its intellectual property in COVAXIN for the fight against COVID-19,enable technology transfer and capacity building, to facilitate rapid development and dissemination of the vaccine to the public both in India and abroad.
(VII) India along with South Africa had filed a request to the World Trade Organization on October 2, 2020 requestinga waiver of provisions related to patents and trade secrets for the Vaccines to help prevent, contain and treat COVID-19 pandemic. In light of this petition, it is obligatory for the Government to apply the same principles at home with respect to Technology under their control. The decision on this petition remains inconclusive in light of resistance from U.S. and European companies.
UPDATES FROM COURT HEARINGS
14th May 2021
The matter was listed on 14th May 2021 for hearing in the court of Justices R. Vijayaraghavan & M.R.Anith. Today's hearing saw SFLC.in's legal director Prasanth Sugathan arguing the case. He argued that a technology transfer can be done for Covaxin(produced by Bharat Biotech) which will help in producing more vaccines and in turn vaccinating more citizens. He pointed out that there are 19 capable manufactures including Kerala State Drugs and Pharmaceuticals Limited (KSDP) who can produce the vaccine with help of technology transfer for COVAXIN. It was furthure argued that the differential pricing policy is violative of Article 14 as it creates two classes in the policy - the center and the state. The vaccination policy will lead to a competition among the states as well. It was also pointed out that Dr. VK Paul of Niti Ayog has said that the technology transfer can be done to anyone willing to produce the vaccine. It was also brought to the Court's notice that Vaccinations have gone down since the new vaccine policy was roled out. It was also pointed out by the petitioner's that it is citizen's money which is being spent by the State to procure the vaccines while profiteering is happening for SII and Bharat Biotech.
The bench asked the Central Government to provide a timeframe within which State of Kerala will get its allocated vaacines. The court also placed an oral request to ensure Technology Tranfer so as it make sure that COVAXIN can be produced by other manufactures as well. There was a show of concern on the number of people yet to get their vaccination. The court raised an important point on the manufacture COVAXIN for which level 3 of Bio Safety Facility was required. It questioned whether there were sufficient facilities available which could comply by BSF level 3 (Bio safety Facility) to safely produce the vaccine.
The cousel for the Central Government stated that these were policy decisions lying with the Central government and seeked time to produce the government's stand.
24th May 2021
The matter was listed today along with other matters on vaccination in front of the Bench comprising of Justices K Vinod Chandran and MR Anitha. The bench pointed out the Indian Express article which said that Rs. 99000 crores has been given to the Central Government by RBI and inquired why a part of this amount cannot be used to vaccinate people. The Additional Solicitor General on this said that this is a matter of policy and an expert body will be looking into this. It was added by the ASG that the vaccines for those citizens above 45 years of age were procured for free. For those between 18-44 years, it has to be procured by the States according to the Policy. SFLC.in's legal director Prasanth Sugathan submitted that since the new policy has come into place, the number of vaccinations has gone down despite the fact that the new policy was to "incentivize" the vaccine manufacturers. It was further added by Advocate Sugathan that a number of private companies have been providing vaccinations to their employees but the public isn't getting vaccination through government channels. The reason behind this is that state governments are competing with each other for vaccines. The court observed that the Central government has excess funds from RBI which they should use to procure vaccines from manufacturers and distribute them to the poor. The court directed the ASG to obtain a response from the government on this. The court was informed that a global tender for vaccines has been floated by Kerala Government to which the Court responded that the process will take time. The matter has been listed for hearing on 1st June, 2021. The Central government in the meanwhile has to file its response by 26th May 2021
2nd June 2021
The matter was listed today with other matters in front of the bench comprising of Honorable Justices A. Muhamed Mustaque and Kauser Edappagath. SFLC.in's legal director Prasanth Sugathan argued the matter. Prasanth contented that the new policy was supposed to bring an incentive to the private manufacturers yet the numbers have gone down ever since the policy has been implemented. It was further added that prior to the policy the total number of vaccines administered by the State of Kerala has been around 11 lakh, the number has gone down to 3.7 lakh doses now. The attorney for the State of Kerala added that the Central government is encouraging black marketing as there are different rates for vaccines now. He added that there should be uniform pricing and companies
State Attorney for the Kerala Government contends that the Central Government is encouraging black marketing by fixing different rates for the vaccine. There must be uniform pricing. Companies cannot be allowed to earn profits during the pandemic.
Justice Mustaque noted that the state government is ready to buy the vaccine at a price but the problem is the nonavailability of the vaccine. It is only private players who have access to the vaccine. Justice Mustaque also questioned how vaccines are available to private players but not to the state governments.
ASG has sought time to file a response. It was also argued by Prasanth that under the Drug Prices Control Order the central government has the authority to fix the prices of drugs. State Attorney brought to Courts notice that out of 30 lakh covaxin and 80 Lakh Covisheild vaccines demanded by the State of Kerala only 8,84,290 doses have been made available.
The 3 tier vaccination policy was brought to Court's attention. It was also raised by Prasanth that ICMR receives 5% Royalty of the sales of Covaxin. Prasanth further asked why can't technology transfer be done if there are other manufactures ready to manufacture the vaccines. Prasanth also brought Mr. V.K Paul (from Niti Ayog's) statement to the Court's notice where he said the government is open to technology transfer to ramp up production of Covaxin. Vaccine manufacture needs to be done on a war footing.
The court in an interim order said the vaccine manufacture to states needs to be prioritized. The matter is listed for next Tuesday i. e 9th June 2021. A copy of the order is attached.
7th June 2021
The matter was listed in front of Division Bench comprising of Honorable Justices ANIL K.NARENDRAN,HONOURABLE MR.JUSTICE ZIYAD RAHMAN A.A. The vaccination numbers for the State of Kerala were submitted to the bench. It was also brought to the Court's attention that there have been different vaccination policies announced by the Central Government. The latest policy announced by the Prime Ministers will be implemented from 22nd June. You can read the details of the policy here. It was also submitted to the bench that under the latest policy, Central Government will be providing free vaccines to the State Government. Private hospitals can still procure vaccines directly from the manufacturers. Prasanth Sugathan, SFLC.in's legal director appearing on behalf of the petitioners submitted that the Intellectual property in regard to the Vaccines are held by ICMR and through a technology transfer production can be ramped up. This is a long-term project and infrastructure needs to be built. It was further submitted by Prasanth that India has submitted a petition to the World Trade Organization to waive off IP rights to deal with COVID.
10th June 2021
The matter was listed in front of Division Bench comprising of Honorable Justices ANIL K.NARENDRAN,HONOURABLE MR.JUSTICE ZIYAD RAHMAN A.A. It was brought to the Court's attention that 3 lakh more people have been vaccinated between the last date of hearing i.e 8th June till date. It was brought to the Court's attention that there is a lack of transparency in the allocation process due to multiple guidelines, the Central government is asked to bring clarity on that aspect. It was also raised that there is a supply problem in respect of vaccines. Court was also cognizant of the fact that finding slots have been difficult through the COWIN app even though on the spot vaccination is now permitted under the new guidelines. Kerala has been the number 1 state when it comes to full utilization of vaccines. Prasanth Sugathan, on behalf of SFLC.in brought to Court's notice that the indigenous vaccine COVAXIN is priced the highest with the cap of 1410 whereas COVISHEILD and Sputnik V are priced at 780 and 1145 respectively. Prasanth submitted that the price of COVAXIN should be capped using the Drug Price Control Order. SFLC.in had filed an RTI which revealed that 5% royalty is received by ICMR of the net sales of COVAXIN. Another RTI asking for the MOU was denied. This points towards the lack of transparency as submitted by Prasanth. The court has asked the Central Government to make submissions and the matter is now to be listed tomorrow i.e 11th June 2021.
11th June 2021
The matter was listed in front of Division Bench comprising of Honorable Justices ANIL K.NARENDRAN,HONOURABLE MR.JUSTICE ZIYAD RAHMAN A.A. It was submitted that in the State of Kerala the daily number of vaccinations being done is around 1.5 lakhs, which can go up to 2.5 lakhs subject to availability of sufficient quantity of vaccine. It was submitted by SFLC.in's legal Director Prasanth Sugathan that on-spot registrations need to take place due to the wide-scale digital divide and people with the fastest fingers first are the only ones who seem to secure a spot. There needs to be provisions made for them so as to ensure that they also get a slot for vaccination.
24th June, 2021
The case was listed before the Division Bench of the Kerala High Court, comprising of Hon'ble The Chief Justice Mr. S. Manikumar and Hon'ble Mr. Justice Shaji P. Chaly.
The Central Government Standing Counsel (appearing on behalf of the Learned ASG) Adv. P. Vijayakumar, prayed for an adjournment. He submitted that the new Vaccine Policy had been rolled out and some more time may be granted, as we need to wait to see the effects of the new policy.
Adv. Prasanth Sugathan submitted that the Hon'ble Court had earlier issued a very specific direction, asking the Learned ASG to place on record certain documents and the said direction which was issued on 14.05.2021, was reiterated on 08.06.2021.
Adv. Vijayakumar said that the office which had to file the statement and the documents, was occupied in the preparation of the Affidavit which had to be submitted before the Hon'ble Supreme Court. He asked for 3-4 days to be granted and sought for the matter to be listed after 10 days.
The Hon'ble Court directed the case to be listed after 10 days.
Lawyers from SFLC.in:, Mishi Choudhary, Prasanth Sugathan, Apurva Singh, Radhika Jhalani, and Kushagra Sinha as well as Varsha Bhaskar appeared for the petitioner.
A copy of the petition is attached.
We would like to thank Mr. K.M GopaKumar, Mr. Murali Neelakantan and Mr. Arul Scaria for their support and guidance.