Robust supply chains are the link between India and vaccine manufacturing

India and the US are discussing a partnership to build a new supply chain for vaccines, ingredients and other components. The absence of supply chains at present is probably why India does not want to invoke compulsory licensing and is, instead, pushing for a 3-year IPR waiver on vaccines and related medical supplies.

India, South Africa, 60 other countries, all members of the World Trade Organization (WTO) have proposed a three-year waiver of IPRs on vaccines, diagnostics, therapeutics, raw materials, etc. to fight the Covid pandemic.

However, India is not keen on exploring the compulsory licensing route permitted under Section 92 of the Patent Act 1970 and the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, possibly because of supply chain constraints – there is no way that India, or for that matter, any other country can tie up supplies of a host of patented products, patented inputs and drug components in short supply globally to successfully set up manufacturing facilities for drugs being compulsorily licensed.

Government makes its stand

The government’s affidavit in response to queries on the subject from a Supreme Court bench comprising Justice D.Y. Chandrachud, L Nageswar Rao and S Ravindra Bhat makes it clear that it does not favour this route. The bench had asked why the government was not using its emergency powers for compulsory licensing under Section 92 of the Patents Act 1970.

“Any exercise of statutory powers either under the Patents Act 1970 read with TRIPS and the Doha Declaration or in any other way can only prove to be counter-productive at this stage. The Central government is very actively engaging itself with global organisations at a diplomatic level to find a solution in the best possible interest of India,” the affidavit states.

“It is earnestly urged that any discussion or a mention of exercise of statutory powers either for essential drugs or vaccines having patent issues would have serious, severe and unintended consequences in the country’s efforts being made on global platforms using all its resources, goodwill and good offices through diplomatic and other channels,” it adds.

Supply chain constraints can nullify benefits

A senior government official said reverse engineering the vaccines in India will not be easy. The first and biggest hurdle is time: It takes time to reverse engineer any drug. Then, many of the ingredients that go into making these vaccines are also protected by patents. Those, too, will have to be reverse engineered. And finally, some of the inputs are in short supply globally. Finding reliable sources to supply these in bulk will also be a Herculean task.

As the supply bottleneck problems faced by the Serum Institute of India (SII) showed, it is by no means an easy task to create fresh supply chains at such short notice. That issue was resolved only after Indian Prime Minister Narendra Modi spoke to US President Joe Biden and Washington lifted its supply restrictions.

India, US discussing supply chain partnership

That conversation has now been picked up by Indian Foreign Minister S. Jaishankar and the US Secretary of State Anthony Blinken, who have been discussing a supply chain partnership that will enable India to significantly ramp up the production of both Covishield, the Astra Zeneca vaccine being produced by SII and Covaxin, the indigenously developed vaccine being made by Bharat Biotech (BB).

The two had a 45-minute meeting in London on May 4 on the side-lines of the G-7 foreign ministers’ meeting, to which India had been invited as a guest country.

A large part of the conversation centred around cooperation of combating the pandemic and on setting up supply chains for vaccines and raw materials.

“Good to meet in person my old friend @SecBlinken. Detailed discussion on the global Covid challenge, focussing on expanded vaccine production capacity and reliable supply chains,” Jaishankar tweeted after the meeting.

EU may join initiatives on supply chains

Following those talks, the US shipped inputs for 20 million doses of Covishield to SII. India and the US will take that discussion forward this week. There is a possibility that some European nations may also join this effort at building new global supply chains for vaccines, their components and other medicines, with India as the location where the vaccines will be manufactured and from where they will be despatched across the globe.

India produces an average of 70-80 million doses of vaccines every month. This can be ramped up significantly if the supply chain bottlenecks that currently hobble production are removed. Indian missions across the world, especially in Europe and Japan are frantically searching for reliable suppliers who can ship vaccine components in the quickest possible time.

It is to obviate these supply chain constraints that India, South Africa and 60 other members of the WTO have co-sponsored a resolution seeking a complete waiver from patents of various Covid-related vaccines, medicines, diagnostics, therapeutics, medical devices and other health technologies.

With the US on board only for a waiver on vaccines and China likely to back this demand, the issue can take on a strategic dimension. If the EU, Japan and other countries continue to oppose this initiative, they will lose their moral authority to lecture the world on human rights. Then, they will lose considerable goodwill and leverage in India. And if China throws its weight behind this proposal, it could hand China a major diplomatic victory and increase its influence in many parts of the world.

The fresh proposal, which goes beyond what the original draft contained, seeks to add specificity to the resolution and sets the stage for further discussions. The TRIPS Council expected to look at the new proposal at an informal meeting on May 31. Justifying the demand for a three-year patent waiver, India and its co-sponsors said any waiver has to provide a long enough window to set up viable manufacturing facilities. This includes setting up supply chains for technology, ingredients and services.

---

Source: India Global Business | 24 May, 2021