Welcome to our 2023 end-of-the-year blog, our annual and highly-biased run-through of notable access to medicines events of the year that is about to end.
As we close the year, several multilateral negotiations that are relevant for access to medicines, in particular the WHO negotiations on a new pandemic accord and the WTO talks about expanding the Ministerial Decision on Covid-19 and the TRIPS Agreement to therapeutics and diagnostics – rolled over from 2022 and will likely still be ongoing in the New Year.
January
The Intercept reported that Twitter (these days called X) was pressured by the company BioNTech along with the German government to mute campaigners’ voices that called for access to medicines and vaccines. Their concerns were aimed at the launch of an international push for sharing intellectual property such as patents associated with coronavirus vaccines. The target included advocacy campaigns in support of the World Health Organization’s Covid-19 Technology Access Pool. Read the details in the Intercept report.
February
On 21 February, the Dutch Pharmaceutical Accountability Foundation (PAF) took the bold step to take AbbVie to court, claiming the company’s pricing policy had harmed the Dutch healthcare system and the people who make use of it. The Foundation has calculated that AbbVie overcharged the health care system by as much as € 1.2 billion for its blockbuster medicine Humira (adalimumab). An English translation of the subpoena is available here. The case is ongoing, working its way through the court. The next court proceedings are expected to be in May 2024.
March
A new study, Pharma’s Pandemic Profits, published by SOMO on 27 February showed that, in 2022, pharma’s Covid-19 revenues amounted to close to US$100 billion. The study describes how these gains are largely due to decades of research funded by public investment, billions in grants for development and production, and tens of billions in Advanced Purchase Agreements (APAs) with governments. The results of the SOMO study prompted ML&P to suggest that it may be reasonable to reallocate some of pharma’s Covid-19 profits, generated by public spending, to antibiotic drug development. This suggestion was made in response to the European Commission’s plans to create a system for Transferable Data Exclusivity Vouchers to entice pharma to invest in antibiotic R&D, as mentioned above.
April
The European Commission surprised the world with a proposal to establish an EU-wide mechanism for compulsory licensing in crisis situations. While an important step forward, some features still need fixing. For example, the proposal limits the supply of products produced under the new mechanism to EU countries only. Legal scholar Olga Gurgula explained on our blog why this restriction on export needs to be dropped.
The WHO and UNITAID published a new country briefing paper, prepared with input from ML&P, which provides guidance to countries on how they can access lower-priced generic versions of Covid-19 therapeutics. This guidance is particularly relevant for countries that are excluded from the Medicines Patent Pool (MPP) licences and cannot benefit directly from the generic production that is enabled through the MPP licences. The briefing is available in English, French and Spanish here.
WHO officially launched the mRNA vaccine technology transfer hub in South Africa to develop mRNA vaccines and transfer the know-how to other countries with the capacity to produce.
May
On the 5th of May, the WHO declared an end to the “public health emergency of international concern” status of Covid-19, which meant it was downgraded to a “global health threat”.
June
The Philippines announced the creation of the “Group of Equity” at the WHO Pandemic Accord meeting. The group of countries called on all WHO member states to ensure that equity is the central outcome of the negotiations.
Rwanda signed a host country agreement for the African Medicines Agency with the African Union, bringing the establishment of the agency one step closer to reality.
July
On 17 July 2023, Chile, on behalf of a group of 62 WHO member states called for a more transparent, inclusive process for civil society engagement with the WHO negotiations of a pandemic treaty at the Intergovernmental Negotiating Body (INB). As a result, NGOs and other relevant stakeholders are allowed on the premises of the WHO during meetings of the INB. However, the doors remain closed during most of the deliberations.
August
The WHO Covid-19 Technology Access Pool announces three new licensing agreements acquired through the Medicines Patent Pool. The batch of licensors included, for the first time, a private company. The agreements concern early-stage innovations and do not lead at this moment to the production of products that can be used to prevent, diagnose or treat Covid-19.
The launch of Open AI’s Chat-GPT4 in March sparked a global conversation on artificial intelligence and how it might change many fields in the near future. One thoughtful take by James Love, published in Scientific American in August, argued that We Need Smart Intellectual Property Laws for Artificial Intelligence, and in particular, that we must consider carefully how intellectual property rules impact the use of data to train artificial intelligence systems. And avoid one-size-fits-all legislation wherein rules that make sense in art or music are also applied to the very different fields of medical and scientific research.
September
Johnson & Johnson announced that it would no longer enforce its patent on the tuberculosis medicine bedaquiline in low and middle-income countries. This announcement comes after a decade of campaigning and after a successful patent challenge in India MSF explains. Bedaquiline received its first marketing authorisation in December 2012 and was the first new TB drug in 50 years.
Access to technology and know-how that is needed to produce pandemic countermeasures is a hotly debated theme at the WHO Pandemic Accord negotiations. ML&P has published a briefing on the need to ensure that the new accord includes provisions to access trade secrets, or confidential know-how, that is firmly hidden in companies’ vaults but may be required in a response to a pandemic threat or outbreak. ML&P also published a commentary in the Financial Times to alert a wider audience of the need to ensure access to trade secrets when needed for an efficient response to a pandemic threat.
ML&P also raised the need to address access to confidential know-how at the TRIPS Council Informal Thematic Session for External Stakeholders held at the WTO on 28 September.
October
The US International Trade Commission (USITC) published its long-awaited study carried out upon request of the US Trade Representative Katherine Tai titled COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities (Inv. No. 332-596, USITC Publication 5469, October 2023) to shed light on the question whether the WTO Covid-19 Decision should be expanded to therapeutics and diagnostics. ML&P’s highlights from this report are gathered here. The report offers ample argumentation in favour of extending the June 17 Decision. Despite this, the talks remain in a stalemate which begs the question of whether it is lack of political will, or lack of evidence that is at the root of the inaction at the WTO. Ironically, some WTO Members now argue that expanding the WTO Decision is no longer relevant because the Covid-19 pandemic is coming to an end. For the current state of play see this update by KEI.
Meanwhile, Colombia moved to issue a compulsory licence for the HIV medicine dolutegravir marketed by ViiV. ViiV has a licence agreement with the Medicines Patent Pool but Colombia is not included in the territory of the agreement. However, generic companies that produce under a MPP licence, may nevertheless supply to countries outside the scope of the licence when they issue a compulsory licence. ML&P is following the developments and continues to track the use of compulsory licensing for health in the TRIPS Flexibilities Database.
Also in October, the Drugs for Neglected Diseases Initiative (DNDi) received the Princess Asturias Award for International Cooperation, a prestigious Spanish award that is nicknamed “the Nobel for international cooperation”. Later in the year, in December, the European Medicines Agency would adopt a positive scientific opinion on the DNDi’s fexinidazole, a new oral treatment of an acute form of sleeping sickness, which should replace the painful and toxic arsenic-based medication that has been the only treatment option so far.
The Biden Administration’s Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence, issued on 30 October, also deals with important issues regarding artificial intelligence and intellectual property and, for example, tasks the US Patent and Trademark Office with urgently providing new guidance on the extent to which artificial intelligence can be regarded as contributing to inventorship by the end of February 2024, an issue that may affect the pharmaceutical sector.
November
Some WHO member states, including the EU argued at the WHO Pandemic Accord talks in November that discussions on IP belonged at the WTO and not the WHO. ML&P commented in a blog describing the extensive involvement of the WHO in IP issues that silencing IP debates at the WHO is a cynical stratagem considering the current WTO deadlock on whether to extend the Ministerial Decision on the TRIPS Agreement (which only applies to vaccines) to therapeutics and diagnostics.
In November, the Netherlands and the WHO hosted the second World Local Production Forum. At the Forum, the WHO announced plans to revamp the Covid-19 Technology Access Pool (C-TAP) and to rename it the Health Technology Access Pool (H-TAP). The WHO did not disclose how it will ensure adequate resourcing necessary for success, nor was there a discussion of how the new multilateral Pool would relate to the Medicines Patent Pool. ML&P’s Ellen ‘t Hoen spoke at the Forum on the need to ensure access to IP licences and manufacturing know-how and moderated a well-attended discussion organised by WEMOS on the role of satellite production sites.
2023 also saw the launch of an international campaign to increase access to cystic fibrosis (CF) treatments, which are currently only available at monopoly prices from Vertex. Vertex’s list price for its most recent CF treatment is US$ 325.000 per patient per year. Access to this treatment is almost exclusively available in rich countries such as the US and the more affluent European countries. Availability of generic versions would lead to a 90% price discount, but patents and other exclusive rights stand in the way of increasing generic supply. Groups of parents of children with cystic fibrosis and patients have joined forces to fight Vertex’s monopoly. In November, campaigners and academics raised the issue of lack of access to CF treatment globally at the North American CF Conference in November. Here is a brilliant presentation at the NACFC about the global access situation of CF medicines and how to improve it.
December
While the US vigorously opposed any weakening of IP at multilateral fora, it is taking steps at home to exercise so-called “march-in rights” under the 1980 Bayh-Dole Act that allow the government to compulsory licence patents on government-funded innovations such as medicines or vaccines. The US plans to exercise these rights to “impact price and better promote equitable access to prescription drugs” according to the U.S. Secretary of Health and Human Services, Xavier Becerra. Government agencies are seeking input for the proposed measure. Campaigning groups have been asking for the use of march-in rights to increase access to medicines that have been developed with government financial contributions for years. Here is a useful explainer by James Love of KEI.
A report by AccessIBSA and the Third World Network was published looking at the case of biologic medicines in India. It argues that intellectual property reform is needed to ensure access to biosimilars to account for additional barriers to entry for biologics, including trade secrets and regulatory barriers.
Throughout 2023, countries continued to meet at the WHO to negotiate a new Pandemic Accord to be better prepared when the next pandemic occurs. The last session of the year took place in December. ML&P was present and witnessed the stalemate on issues related to access to pandemic countermeasures. The talks need to come to a conclusion by May 2024 when the new Pandemic Accord will be presented at the World Health Assembly.
Happy New Year!
