Welcome to our annual, highly biased overview of noteworthy events in the field of medicines law and policy.
In 2022, Covid-19 remained a central concern in global health and medicines policy. As a result there was much activity at the multilateral institutions to discuss ways to improve how the world should respond to pandemic threats. A major outcome of this activity was the move towards negotiations on a pandemic treaty at the World Health Organization, in which equitable access to pandemic countermeasures will likely take centre stage.
Other highlights from 2022 are listed below by month.
Tone deaf to the concerns about access to medical tools to combat the Covid-19 pandemic, the pharmaceutical industry called on the European Commission to seek stronger IP protection in free trade agreements. “Stronger” here refers to exceeding what is required in international law and matching the EU’s overly generous IP protection.
The Lancet reported that antimicrobial resistance caused nearly 5 million deaths in 2019, making it a leading cause of death globally.
Pfizer announced it expected to see a record US$100 billion in revenue in 2022 because of Covid-19 vaccines and therapeutics sales. Overall, Pfizer’s Covid vaccines alone are expected to be worth US$ 50 billion in sales.
Meanwhile, the BMJ reported that BioNTech, the biotech company that developed the Pfizer mRNA Covid-19 vaccine, was lobbying to terminate the activities of the South Africa based mRNA technology transfer hub on the claim that it would infringe on patents. These efforts failed and the hub has successfully replicated Moderna’s mRNA Covid-19 vaccine. For more on this story read Al Jazeera’s piece.
March was a sad month for public health and Medicines Law & Policy (ML&P). On 10 March, David Banta passed away. David was a medical doctor and the founding father of Health Technology Assessment. He was an important contributor to the work of ML&P. He shared a drive to ensure better access to new, innovative and often overpriced medicines and medical technologies. He was always ready to provide insight and feedback on ML&P’s work, and was often a first reviewer on our technical publications. He was the husband of director Ellen ’t Hoen and a friend to the rest of the team.
The US National Institutes of Health on 3 March committed to sharing several technologies with a World Health Organization Covid-19 Technology Access Pool (C-TAP). The decision by the NIH is a decisive indicator of support for knowledge, intellectual property and technology sharing from the world’s largest biomedical research institution.
Health Action International published the TRIPS Flexibilities Navigator. Based on information provided by Medicins Law & Policy, the tool provides information on the use of compulsory licensing by EU member states.
On 17 March, 35 generic drug producers signed a licence agreement with the Medicines Patent Pool to produce a generic version of Pfizer’s oral COVID-19 treatment nirmatrelvir, which in combination with a low dose of ritonavir (Pfizer’s brand name Paxlovid) can be supplied in 95 low- and middle-income countries. Countries excluded from the agreement where patents on Paxlovid are in force, can nevertheless access the low-cost generic supply using compulsory licensing. However, countries taking that route risk meeting with fierce opposition from Pfizer.
On 4 April, Nature reported that Pfizer denied access to its Covid-19 antiviral Paxlovid for use in clinical trials carried out by the Drugs for Neglected Diseases Initiative (DNDi) in Africa. The trials carried out in ten African countries were set up to find Covid-19 treatments that are effective in resource-poor settings.
Dutch non-profit organisation Wemos in April launched its Covid-19 response database, which monitors and evaluates the impact of initiatives intended to ensure or improve global access to Covid countermeasures.
Katrina Perehudoff, assistant professor and co-director of the Law Centre for Health and Life, was awarded a grant from the Dutch Research Council to study how the EU can improve access to medicines globally. ML&P is an implementing partner of the project.
WHO published a new set of guidelines on the evaluation of biosimilars. The document aims to set normative standards for medicines regulatory authorities on the registration of generic versions of biological products, known as biosimilars. Many high-priced cancer treatments are biologic medicines so guidance on making lower-cost similar versions is welcome.
On May 5, it was a year ago that the United States Biden-Harris administration surprised the world when it announced support for waiving intellectual property protections for Covid-19 vaccines as part of a so-called “TRIPS Waiver”, which had first been proposed by the governments of India and South Africa in October 2020. The move was in stark contrast to the positions of other high-income countries, such as European Union countries, the United Kingdom, Switzerland, Canada, Australia, Norway, and Japan that continued fiercely opposing a TRIPS Waiver. Yet, a year later no progress could be reported.
Also in May, the Initiative for Medicines, Access & Knowledge (I-MAK) published its latest report in the “Overpatented, Overpriced” series on Keytruda. The report shows that 8 additional years of monopoly rights cost the US public more than US$137 billion.
On 17 June, the World Trade Organization Ministerial Conference came to a decision regarding the proposed waiver to the TRIPS Agreement to facilitate more rapid access to Covid-19 products during the pandemic. The decision the WTO Ministerial Meeting took, in the end, was not a waiver; it was rather a diplomatic compromise that mostly repeated existing rights countries have under the TRIPS Agreement. See ML&P’s observations on the decision here.
On the occasion of the ministerial, ML&P updated the TRIPS Flexibilities Database with 10 new instances of compulsory licences since 2020. All of these concerned Covid-19 related products. There is one instance of compulsory licensing related to a Covid-19 vaccine, and that concerned the US government shielding Moderna from patent infringement suits so it could proceed with developing and supplying its mRNA vaccine. The lack of vaccine CLs can be explained by the fact that access to the patents alone is not enough to replicate a vaccine.
On 15 July, ML&P in collaboration with a group of global health experts, published seven recommendations for sharing intellectual property, know-how and technology in BMJ Global Health. The article is intended to raise critical points for the ongoing Intergovernmental Negotiating Body to draft and negotiate a “WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response” ( aka “the pandemic treaty”).
After telling the world that patents are not an issue with Covid-19 vaccines, Moderna decided to sue Pfizer and BioNTech over a coronavirus vaccine patent, claiming the two companies unlawfully copied Moderna’s inventions. The crucial background is that the science behind mRNA vaccines was supported by the National Institutes of Health and developed by NIH scientists. The story is interesting and illustrates that medical innovations are often the result of work done by many driven researchers looking for solutions, not seeking to own them.
On 23 August, The Intercept reported that Covid-19 vaccine juggernaut Moderna, and others benefit from emergency conditions to ensure access to patents it may not own to develop a mRNA vaccine. In a way, it had its own little patent waiver. The piece was based on work by Knowledge Ecology International, which identified 62 pandemic-related contracts in which compulsory licences were granted to pharmaceutical companies, most of whom then turned around and fiercely defended their right to defend their own IP, even if doing so slowed vaccine roll-out and prolonged the pandemic.
The WTO held its annual Public Forum from 27-30 September, with the focal topic being a sustainable and inclusive Covid recovery. ML&P together with KEI hosted a workshop on the Creation and Protection of Public Goods for Health, which was written up in Health Policy Watch. KEI has proposed a WTO Agreement on the Supply of Knowledge as a Global Public Good, which can be found here.
A Lancet Commission report on Covid-19 and lessons for future pandemics found that there were multiple failures of international cooperation in the Covid-19 response, including in ensuring equitable access to countermeasures.
The OECD published its working paper “Exploring the consequences of greater price transparency on the dynamics of pharmaceutical markets” based on a roundtable, literature review, and interviews, to which representatives of ML&P were invited to contribute. Overall, the OECD reported sparse evidence and little consensus among experts about what information should be disclosed, for what purpose, and how this could impact markets. We think it is time for states to move beyond reflection towards action to implement the WHA 72.8 Transparency Resolution in line with the recommendations in our 2021 WHO report on the evidence on legal measures to improve the transparency of markets for medicines, vaccines and other health products.
The death of 70 children in Gambia linked to contaminated cough syrup from an Indian producer shows the dangers of substandard medicines and the need for robust regulatory systems again.
Ellen ‘t Hoen presented to the INB’s special informal session on intellectual property and access to pandemic response products. Her statement is here. Video recordings of the INB’s informal sessions can be found here.
The Medicines Patent Pool signed a licence agreement with Novartis for the drug nilotinib for the treatment of chronic myeloid leukaemia. It is the first MPP agreement for a cancer medicine. That is good news in principle, but there is not a lot of patent life left on nilotinib and unless Novartis and other cancer drug manufacturers licence all of their important cancer drugs this may not be the paradigm shift some are hoping for.
On 25 November, the INB secretariat published a “conceptual zero draft” text of “the WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response” (we continue to call it the “Pandemic Treaty”) for discussion by the Intergovernmental Negotiating Body. There is a lot of good stuff in there. Let’s see next year what will survive. Let’s hope that there is no repeat of the systemic lobbying pressure from pharmaceutical companies on processes at the WTO.
An April 2022 version of the UK-India Free Trade Agreement’s IP chapter was leaked in November and immediately labelled by Médecins sans Frontières as “disastrous” and likely “to drastically harm access” to needed generic medicines and by Indian IP blog Spicy IP as being “ridiculous[ly] TRIPS plus”. India’s generic drug industry has thrived – and been able to supply much of the world with affordable generic medicines – partly because India does not have an IP maximalist approach.
The 2022 Access to Medicines Index found that companies continue to make baby steps to increase access to some of their products in some low-income countries. They also found that despite the windfall profits experienced during Covid-19, investment in R&D for emerging infectious diseases (EIDs) remained insufficient. The pipeline for R&D projects covering EIDs (excluding Covid-19 and other coronaviral diseases). Already in 2021, the Peoples Vaccine Alliance revealed that the companies behind two of the most successful Covid-19 vaccines —Pfizer/BioNTech and Moderna— were making combined profits of $65,000 every minute. One would expect a significant amount of these profits to be reinvested in infectious diseases research. Instead, pharma is campaigning for additional incentives. For example, EFPIA wants to see new provisions in the EU’s pharmaceutical legislation that would allow pharma companies to extend the market monopoly for existing products to raise money for antibiotic drug research through transferable exclusivity vouchers. The delay in generic competition such vouchers would cause will increase healthcare cost for certain groups of patients in the EU in an unpredictable manner. Here is the generic industry’s take on it. The European consumer groups also do not like the vouchers and 14 EU member states have registered their opposition to the Commission’s plans to introduce the exclusivity vouchers. We recommend policy makers reread the 2016 report by the Jim O’Neill Commission.
At the end of a three-day meeting, WHO Member States agreed to develop the zero draft (so one that is no longer conceptual) of a legally binding pandemic accord in early 2023. The next meetings of the INB are scheduled for February 2023. Here you can find more information about the negotiation process and recordings of previous meetings.
The WHO reported that Ebola trial candidate vaccines arrived in Uganda a record 79 days after the outbreak was declared on 20 September. This represents a global milestone in global capacity to respond to emergency outbreaks.
The December 2022 issue of Health and Human Rights journal features articles by ML&P’s Ellen ‘t Hoen (on technology transfer) and Katrina Perehudoff (on the right to science and access to Covid vaccines) as well as the Pharmaceutical Accountability Foundation’s Rosalind Turkie on upholding human rights by holding pharma accountable. Read the issue here.
The Interfaith Center of Corporate Responsibility, representing a coalition of ethical shareholders, has filed proposals at nine pharmaceutical companies seeking reports on the link between their patent protection strategies and access to medicines. The information requested would detail decisions for filing secondary and tertiary patents, which companies seek after the main patents expire. Such secondary and tertiary patents are often part of a strategy to delay generic competition.
High-income countries, along age-old battle lines on the multilateral stage, continue to oppose expanding the WTO Decision (AKA “the Waiver”) to therapeutics and diagnostic technologies. The US plans to embark on an investigation that will likely prevent any progress for the next nine months. The sense of pandemic urgency has evaporated rather rapidly in the countries that have ample access to Covid-19 vaccines. Expanding access to vaccines has an element of self-interest (“No one is safe, until everyone is safe”) that expanding access to treatments lacks.
To sum it all up, the continued Covid-19 crisis in 2022 has not brought us a new world marked by greater equality and social justice, equitable access to health technologies, and where knowledge is created and shared for the greater good. Let’s keep it on the to-do list for 2023.
Happy New Year!
Updated on 30 December to clarify that the US announcement of support for a TRIPS waiver for covid vaccines happened in May 2020.