India’s strength lies in making affordable generics not only for its domestic market but also for developing countries, and by omitting drugs, the waiver loses its relevance, according to public health experts.
Access to life-saving generic antivirals and effective therapies, including baricitinib and nirmatrelvir (Paxlovid) in developing and poor countries will be a huge challenge, due to patent barriers and restrictive licensing agreements from multinational corporations, have they added. Rich countries have cornered a substantial share of the global supply of these Covid-19 therapies, raising concerns of impending inequity.
In addition, the availability of generic Paxlovid has slowed considerably as domestic companies have faced hurdles in sourcing the reference product to be able to conduct clinical studies. These studies are a crucial part of the quality assurance of regulatory bodies in India, WHO and others.
Significantly, the waiver, which only applies to vaccines at this stage, ignores key treatment and diagnostic tests and only covers patents, excluding important intellectual property barriers such as trade secrets. .
Calling the brokered deal ‘narrow, insufficient and impractical’, public health campaigners and world luminaries said it would not do enough to make cheap generic vaccines and treatments available developing countries. That is why they asked India and South Africa to reject the negotiated pact.
India is a leading supporter of a temporary patent waiver sought from the World Trade Organization on all Covid-19 medical tools, including vaccines, tests and treatments. Interestingly, the negotiated draft deviated significantly from the initial submission in October 2020 by India and South Africa, but could potentially end the deadlock over the proposal.
Maaza Seyoum, Global South Organizer of the People’s Vaccine Alliance, told TOI: “It is not the complete waiver of intellectual property rules that India and South Africa are demanding. Instead of removing barriers, the proposal shamefully adds more. It contains new, stricter conditions on the use of existing flexibilities in the TRIPS agreement, making it more difficult to produce life-saving generic Covid-19 vaccines. It adds a requirement to identify and specify every patent associated with a vaccine – adopting it would be a step backwards from existing Indian law. India has led the fight for the right to manufacture COVID-19 vaccines and treatments outside of big pharma, inspiring a global movement for vaccine equity. So much progress has been made, but to accept this proposal would be to throw it all away. Prime Minister Modi should bring the EU and US back to the table to grant a meaningful waiver that reflects the scale of the global health crisis we face.
Ironically, the draft promises an easier path for compulsory licensing (LC) for vaccines, which are most relevant and used for therapeutic purposes. Countries and generic manufacturers use the CL route to introduce a patented medicine to meet public health needs, when the innovator does not readily provide a license. “This (benefit) might have no relevance (to countries) because therapeutics are not part of the deal at present,” the expert added.
Anjela Taneja, People’s Vaccine Alliance member in India, said: “The agreement defers a decision on intellectual property for treatments and diagnostics that are equally important to saving lives. IP barriers are likely higher for treatment with only 427 of 5,293 COVID-19 patents
vaccine filings; indeed, 92% were not for vaccines. Removing intellectual property barriers for treatments, tests and other medical technologies (such as genomic surveillance) will have an even faster impact (via generics) compared to vaccines”.
The leaked text leaves the door open for possible inclusion of treatments and diagnostics at a later stage. ‘But delaying the decision on treatments is unacceptable, as many people will not have access to generic antivirals, and countries are paying high prices for access to life-saving treatments like baricitinib due to patent monopolies that block more affordable generic versions,’ a statement from an international humanitarian agency, MSF said.
The proposed compromise would require authorization from governments on a product-by-product basis, which was one of the shortcomings of the existing mechanism in a pandemic context and makes its use very cumbersome. There is also a new obligation to identify all patents covered by the authorization, which is not required today under WTO trade rules, he added.