Covid Vaccines: The Victory and Battle Ahead
May 20, 2021
The US, EU, Japan, Switzerland and Norway after much reluctance had ultimately agreed to support the joint proposal of India and South Africa which was duly supported by 120 other WTO members. — Prof. Bhagwati Prakash Sharma & Dr. Jaya Sharma
India has secured an unprecedented victory in the General Council of the World Trade Organisation (WTO) on May 5, 2021, when the US, European nations and Japan agreed to fall in line and seconded India’s proposal to waive patents from over the Covid-19 vaccines, after fiercely resisting in 10 consecutive meetings held in last six months. It is a victory for global mankind to pave way for augmenting supply of covid vaccines. The US, EU, Japan, Switzerland and Norway after much reluctance had ultimately agreed to support the joint proposal of India and South Africa which was duly supported by 120 other WTO members. Moreover, 110 senators of the President Joe Biden’s Democratic Party, 60 former Heads of States and 100 Nobel Laurettes from across the world have put pressure upon Biden – Harris administration. An online petition duly signed by 2 million signatories from across the world was also moved.
Need to Move Fast to Fulfil the Mission
In view of the urgency arising out of rapid rise in infections as well as death toll, the decision makers at home and worldwide need to take certain steps on priority to frame laws for transfer of technology and freeing the vaccines as well as drugs from patent led monopolies or oligopolies. Otherwise, the US nod is a big shot in arm but it is not of much avail unless the final text is finally approved. Still, it may take some time to get the final text approved, as the final meeting of the TRIPs Council is slated for June 6-8. In WTO, rules related to international intellectual property rights can be changed only through consensus, which means that there are still long weeks of negotiations ahead. But, the defection of the US from the nay-sayers on May 5 has added the requisite diplomatic heft to put adequate momentum behind the proposal, which had remained stuck so far despite support from over 120 nations.
WHO Director-General Tedros Adhanom Ghebreyesus too has also opined that such waivers are part of the WTO toolbox and has asserted that there’s no better time to use them than during the once-in-a-century pandemic that has taken 3.2 million lives, infected more than 437 million people and devastated economies, according to Johns Hopkins University. Even today 15 crore persons across the world and 2.2 crore in India are infected. All of them have been swinging between life and death. India has also lost 2.35 lac lives. Practically speaking the entire 7.4 billion global humanity stays threatened from a tragic death from Corona, if infected. It is so, inspite of the fact that fairly effective medicines to cure the Covid-19 and vaccines to prevent fresh infections are on the market shelf. The major hurdle is that the patentees, holding a patent-based monopoly over these drugs and vaccines are neither able to supply these drugs and vaccines at affordable prices and in adequate quantity nor they have been granting enough licences to companies desirous and capable to manufacture and thereby overcome the shortages.
Need for Fast Vaccination
It would not be out of place to mention without praise that Israel has completely unmasked its 8.76 million population by vaccinating 80% of adults in a short span of time. So, now that country is almost safe from any potential Covid-19 infections. Likewise, after the patent waiver from Covid-19 vaccines, turns into a reality and if the supplies are augmented in fairly reasonable time, India as well as the world would get respite from the most dreaded Covid-19 pandemic. But it would be feasible if the vaccine patentees would also agree at an earliest date to transfer the technology as well and help companies, desirous and capable to manufacture these vaccines to world over to augment the supplies.
No Patent Waiver Yet Approved for Drugs
The proposal agreed upon in the General Council of the WTO – a 164 member nation body – aims at waiving patents from vaccines alone. This proposal has not yet been covering the medicines from patent waiver clause, likely to be passed in TRIPs Council. So, the companies desirous and capable to manufacture the Covid-19 drugs shall have to apply for compulsory license in their respective countries to manufacture the drugs, wherever the national law permits. India has the provisions for compulsory license under sections 84, 92 and 100 of the Indian Patents Act -1970 which were added at the time when provision for 7 year process patents were replaced by 20 year product patents in pursuance of the Agreement on Trade Related IntellectualPatents (TRIPs). The provisions for compulsory license were incorporated in the Doha ministerial conference of 2001. But grant of compulsory license would take its due time. The applicants should apply first to the patentee for voluntary license and shall also have to develop the process of synthesis by its own R&D.
Natco Pharma’s Initiative Deserve Praise
An Indian company the Natco Pharma has already got Central Drugs Standard Control Organisation (CDSCO) approval for emergency use of Baricitinib tablets for Covid-19 treatment. Baricitinib in combination with Remdesivir, is used for treatment of Covid-19 positive patients. The Indian drugmaker Natco Pharma has received emergency use approval for Baricitinib tablets, 1 mg, 2 mg and 4 mg strengths, from Central Drugs Standard Control Organisation (CDSCO) in India. It has also completed the formal process of applying for voluntary license with an offer of 7% royalty to the original patent holder, the American company Eli Lilley. After fulfilling all these formalities, it has then applied for the compulsory license for manufacture of Baricitinib tablets in India. Baricitinib, in combination with Remdesivir, is used for treatment of Covid-19 positive patients. The company had earlier on May 3 stated that, it intends to launch the product in less than a week, so as to make it available to the patients across India, the release said.
India has a unique and historic precedence of grant of compulsory license on humane considerations when a compulsory license to the same company Natcowas granted. It is the Indian company, Natco Pharma, which then in 2012 offered to manufacture and sell kidney and liver cancer drug, Nexavar at a price of Rs. 8800 against the German patent holder Bayer’s price of Rs. 2,80,000.
India Has Championed the Cause of Humanity in Past Also
The incorporation of provisions for compulsory license in the agreement on TRIPs of the WTO also had a long historic battle of the developing countries, then also under the leadership of India at WTO. It started when the patent holders of drugs for AIDs were charging exorbitantly high prices whereby the treatment cost per patient was as high as $15000 per annum. At that time Indian pharma companies offered these drugs at a price to cost $350-450 per patient per annum. So, the developing countries fiercely contested for right to grant compulsory licenses in cases of health emergencies and other public health problems, in the Doha Biannual Ministerial Conference of 2001, under the leadership of India. After hecticly resisting, the industrialised countries had fallen in line on the very first day of Doha meeting and passed a supplementary declaration for compulsory license.
This time as well the consensus for waiver of patents over Covid vaccines has evolved at the behest of India, with hectic support from 120 developing countries over the proposal originally moved by India and South Africa in October 2020. However, in the TRIPs Council much more follow-up actions would be needed to ensure universal access to vaccines, as the final approval is expected to be made in TRIPs Council scheduled in early June this year.
Urgent Steps Needed
The comprehensive steps needed today can be enumerated as under:
A. At the International level efforts need to be expedited for:
— Waiving of Intellectual Property Rights i.e., waiving of Patent Rights on Covid medicines as well. The waiver of patent from Vaccines too should get the final approval at the earliest
— Development of group like G16 created by India against Singapore Issues to be thought of. It can be a G120.
— Invoking of Section 7 of Agreement on TRIPS, which speaks for transfer of technology by the companies to developing countries to facilitate usage of innovations by potential users. (Mere Waiving of IPRs/patents wouldn’t be enough, as the development of process to manufacture these medicines and vaccines would be a time-consuming process. So, technology transfer along with the grant of voluntary licenses, either free or at nominal royalty is need of hour.)
B. At the national following actions need to be initiated by the Government:
1. Issue of order under Sections 92 and 100 of the Indian Patents Act to facilitate Compulsory Licensing to enable applicants to manufacture Covid medicines and Vaccines inspite of any patents held by any other entity.
Under section 84 Compulsory license can be applied for 3 years old medicines only. So, the issue of Order under Sections 92 and 100 is most imperative as the Vaccines and some medicines are less than 3 years old.
2. An appropriate law to mandate technology transfer and grant of voluntary licenses by the holders of patents to the companies desirous and competent to manufacture Covid medicines and Vaccines.
3. Bharat Biotech has developed its Vaccine from the genetic resources and major know-how of ICMR and government’s financial support. So, it’s know-how needs to be shared with companies desirous and capable to manufacture Covaxin.
4. Two Industry Consortia need to be evolved with liberal financial support of government - one comprising pharma manufactures and the other consisting of molecular biotech firms, desirous to participate in the development of process of synthesis of Covid medicines and the other for Vaccine development.
The complete know-how so developed must be accessible to all participating companies. Even companies desirous to join later, should also be allowed on payment of Consortium fee.
Prof. Bhagwati Prakash Sharma is the VC of Gautam Buddha University, Noida.