Months after South Africa and India proposed a bold waiver of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights or TRIPS, which would have allowed manufacturers and countries to bypass restrictive intellectual property rules, negotiations dominated by the United States and the European Union resulted in a draft text that is fatally flawed on all scores.
The original waiver proposal brought to focus the IPRs that were preventing adequate supplies, affordable pricing, and equitable distribution of Covid vaccine, medicines, and tests. Unfortunately, that comprehensive vision has been watered down through a long process of obstinate delay and disinformation, particularly by the European Union, the United Kingdom, and Switzerland, but also by fence-sitting by the United States, Japan, Norway, and other rich countries, many of which wanted the waiver to focus on vaccines alone. Because of the protracted negotiations and lack of progress, the Director-General of the WTO brokered closed negotiations between so-called Quad Members – the EU, the US, South Africa, and India. The result is the leaked text which is now being circulated back to capitols for final assessment and to WTO member states excluded from the Quad negotiation
Although the major concern with the draft text that should involve India and other developing countries focuses on excluded products (therapeutics and diagnostic tests), IPRs (especially trade secrets but also copyright), and countries (all WTO-developed country members, plus China, and perhaps, because of a drafting error, WTO’s Least Developed Country members and non-WTO States), there are also puzzling and problematic TRIPs-Plus elements that actually reduce previously-available flexibilities and impose new, onerous obligations on countries wishing to make use of the “compromise” solution.
Why the draft lacks substance
The TRIPS-Plus elements should, obviously, be corrected to prevent enduring harm to the existing system of TRIPS flexibilities. For instance, pretending to expand the scope of permissible compulsory licences by allowing a single authorisation for involuntary use to cover “the subject matter of multiple patents necessary for the production or supply of a COVID-19 vaccine,” paragraph 3(a) of the draft text actually restricts freedom. Otherwise, countries would have to allow even broader “authorizations for use of the subject matter of a patent” under Article 31 of the TRIPS Agreement. Such discretion is not limited to compulsory licences on single patents, products, or final products and their components. Countries actually have broader discretion to issue authorisations on multiple products and even an entire class of products.
Even worse, paragraph 3(a) requires the compulsory licence applicant to list all relevant patents on all underlying components, the final vaccine product, and the process of production. Neither Article 31 nor Article 31 bis of the TRIPS Agreement nor the law of the United States, UK, or Germany currently require any such listing, plus such a requirement is onerous and impractical in the Covid emergency. On its face, the text only allows the listing of granted patents, but the vast majority of Covid-related patents have not even been published (because of an 18-month non-publication window), let alone being granted. Companies are still free in many countries to file additional patents even on known vaccines.
Thus, compulsory licencing applicants will need to continuously scan patent offices for newly filed, published, and granted patents and repeatedly amend their applications. The listing requirement is bad enough in a single country, but to enable access to patent-blocked components manufactured in other countries, the same kinds of applications and patent listings (with updating) might be required by compulsory licensees in those countries as well.
Paragraphs 3(d) and (f) of the draft impose additional TRIPS-Plus measures on the WTO member states, including India. First, paragraph 3(d) requires anti-diversion measures, which are not otherwise required by Article 31 licences but only Article 31 bis licences. Second, paragraph 3(f) imposes duties to notify the WTO about compulsory licensees, the vaccines and the components covered, the duration of the licence, the quantities being produced, and the countries supplied. Again, there is no such requirement under Article 31 licences nor is any conceivable public purpose served by such a requirement.
Also read: No consensus in WTO after India proposes virtual ministers’ meet on Covid vaccine IPR waiver
‘Illusion of access’
The lack of explicit inclusion of the LDC members of the WTO and non-WTO countries (which include other LDCs as well) is an inexcusable omission that showed the rushed and flawed drafting of the proposed text. Failing to explicitly cover the poorest countries in the world and imposing multiple TRIPS-Plus procedural barriers that put sand in this supposedly expeditious solution shows the ideological commitment of the EU and the US to the illusion of access rather than its substance.
It would be bad enough to let the TRIPS-Plus solutions stand, but it is calamitous to agree to a “compromise” text that provides no real solutions for either vaccine or tests and treatments. For the past year and a half, it has been painfully obvious that copy-cat manufacturing of Covid vaccines requires access to confidential information and data, trade secrets, and manufacturing know-how. Moderna offered to waive its patent protections on its mRNA vaccine in October 2020, but no company has thereby become capacitated to quickly bring an equivalent, quality-assured vaccine to market.
Instead, the WHO mRNA vaccine technology transfer hub in South Africa is having to go through a painful and multi-year process of recreating the commercial-scale technology platform from scratch. The EU has steadfastly refused to address the issue of mandatory access to trade secrets and thereby undermined real access to vaccines. The US has passively acquiesced, even though it had previously committed verbally to the waiver of all relevant intellectual property barriers, including trade secrets and copyright.
Touting the draft text as freeing access to vaccines is a flat out lie, but this is compounded by the decision to delay the consideration of an Intellectual Property solution for diagnostic tests and medicines. At the same time when Europe and the US are testing more often than low-income countries and hoarding new outpatient antivirals like Merck and Ridgeback’s Molnupiravir and Pfizer’s Paxlovid, they are cynically pretending that there is something unknown about the Global South’s need for more antigen rapid diagnostic tests and multiple medicines already authorised and available in rich countries. This is post-colonial hypocrisy and neglect at its worst.
Also read: World has moved on from US, EU’s drug monopoly. India and China are changing IP regulations
No more ‘pharmacy of the world’
As icing on this very unappetising cake, the draft text is also highly protectionist. It reserves to Big Pharma all developed country markets and China. Capable Indian vaccine manufacturers will not be able to sell to approximately 50 per cent of the global population, whereas northern monopolists will be free to sell anywhere and everywhere. India won’t be the ‘pharmacy of the world’ as described by Prime Minister Narendra Modi, but it will only be a minor player to some low and middle-income countries.
Indian civil society and policymakers still have time to shout a defiant ‘no’ against this blatant attempt to not only water down India and South Africa’s bold TRIPS waiver proposal but to drown them. The draft text is sloppy and fails to deliver any of the health technologies needed to beat Covid. Tear it up, and either get a viable waiver or condemn the WTO to the irrelevance it so richly deserves with special mention for the EU and US politicians and pharmaceutical company executives who have manufactured this draft.
Prof. Brook Baker is a senior policy analyst for Health GAP (Global Access Project) and teaches law at Northeastern University. Views are personal.
(Edited by Humra Laeeq)