Welcome to Medicines Law & Policy’s end of the year blog, our highly biased annual overview of memorable medicines law and policy events.
January
At the January World Trade Organization’s TRIPS Council meeting, it became clear that the WTO was pulling the plug on extending the Decision on the TRIPS Agreement of June 2022 to diagnostics and therapeutics. The June Decision resulted from a year and a half of intense talks after India and South Africa, in October 2020, tabled a proposal for a waiver of countries’ obligations under TRIPS for the duration of the pandemic. The Decision, however, only addressed vaccines, and extending it to diagnostics and therapeutics was postponed. In January, it became clear that it was never going to happen.
Also in January, Medicines Law & Policy (ML&P)responded to the US Health and Human Services (HHS) Department request for comments on the draft Pandemic Agreement.
February
The 8th meeting of the Intergovernmental Negotiating Body (INB) tasked with the negotiations for a new pandemic agreement took place. ML&P raised the need to address one of the key intellectual property (IP) problems relating to the sharing of vital know-how and trade secrets, the absence of which could block worldwide production of vaccines and other pandemic countermeasures. ML&P made a proposal to solve this issue. INB meetings continued to take place throughout 2024.
Knowledge Ecology International published its database of US government contracts that reference selected Federal Acquisition Regulation (FAR) 52.227 clauses related to the non-voluntary use of third-party patents. Use of patents without the consent of the patent holder was granted numerous times in US government contracts for the development and supply of Covid-19 vaccines. The KEI database is a notable resource in the context of the Pandemic Agreement talks, where proposals to ensure access to intellectual property and know-how remain controversial. For details on how the US uses FAR see this briefing note on the ML&P website. ML&P’s TRIPS Flexibilities Database was updated to reflect the use of FAR.
The 4th Fair Pricing Forum took place from 6-8 February. Ellen ‘t Hoen spoke in the opening plenary about the experience of the HIV crisis and the work it took to bring down the prices of antiretrovirals. Katrina Perehudoff presented on the need for transparency, cooperation, and civil society engagement to achieve fair pricing.
March
The European Parliament’s amendments to the proposed EU regulation for EU-wide compulsory licensing strengthened the provisions for access to know-how and trade secrets when needed to respond to a crisis. This is important because a patent license alone may not provide sufficient information needed to enable manufacturing for certain technologies. In the words of the Parliament:
“This Regulation should guarantee that the Commission has the authority to oblige rights-holders to provide all necessary information to facilitate the rapid and efficient production of critical crisis-related products, such as pharmaceuticals and other health-related items. This information should encompass details about know-how, particularly when it is essential for the effective implementation of compulsory licensing. While patent licensing alone might suffice to enable other manufacturers to quickly produce simple pharmaceuticals, in case of more intricate pharmaceutical products, such as vaccines during a pandemic, it is often insufficient. Where it is essential for the implementation of the compulsory licence, an alternative producer will also require access to know-how.”
See also our blog on this topic here.
A commentary in BMJ Global Health rejected the European Commission’s proposal for transferable data exclusivity vouchers as a way to incentivise research into needed new antimicrobials. One concern is that it will likely keep important medicines high-priced while failing to guarantee innovation targeted at antimicrobial resistance.
April
Colombia issued a compulsory licence (CL) for dolutegravir, an essential medicine for the treatment of HIV. The CL will allow Colombia to procure from generic manufacturers, including companies that produce with a license agreement from the Medicines Patent Pool.
On 11 April, Moderna announced that it abandoned its efforts to build a mRNA production facility in Kenya. The move was met with a stern reaction from the African CDC which said Moderna’s “commitment is in fact not to vaccine equity and access to vaccines”. Moderna is also not collaborating with the South Africa based mRNA vaccine technology transfer hub.
May
In the final hours of the 77th World Health Assembly (WHA), WHO member states adopted the amendments to the International Health Regulations (2005). The objectives of the IHRs are to: “prevent, prepare for, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risk and which avoid unnecessary interference with international traffic and trade.” The amendments are meant to apply the lessons of Covid-19 and ensure better preparedness and greater equity and solidarity in the response to outbreaks of diseases.
The 77th WHA also gave member states more time to conclude the negotiations for the pandemic agreement, which continued to be stuck on issues related to technology transfer to enable scale-up of production of pandemic products, access to pathogens, and benefit sharing. The new deadline was set at either a special WHA in December 2024 or, at the latest, the 78th WHA in May 2025.
June
The Dutch NGO WEMOS published a case study on the BioNTech Africa project. The project was meant to strengthen the production capacity of mRNA vaccines by establishing modular factories in shipping containers. The study was carried out in collaboration with Afya na Haki (Uganda), Great Lakes Initiative for Human Rights and Development (GLIHD, Rwanda) and Health Development Initiative (HDI, Rwanda).
The study looked specifically at whether the BioNTech project was designed to enhance the sovereignty and self-reliance of the country, region and continent in the long term. The study concluded that the project responded to the need to increase production capacity, including for active pharmaceutical ingredients (APIs), and had the potential to help strengthen regulatory capacity. However, it also found that it remained unclear whether it would enhance self-reliance in the region.
BioNTech is aided in its work on production capacity in Africa with a US$ 145 million grant from the foundation Coalition for Epidemic Preparedness Innovations (CEPI), announced in May 2024. BioNTech’s total profit from COVID-19 vaccines in 2021 and the first nine months of 2022 was approximately USD 19.8 billion. According to SOMO, the company primarily sold its vaccines in the USA and the European Union.
On 20 June, STAT News reported that Médecins Sans Frontières (MSF) is closing down their Access Campaign, effective as of 31 December 2024. It is to be replaced by a unit that will focus on the direct needs of MSF programmes at the expense of a more ambitious agenda for policy change. The announcement provoked an outcry in the global health community, asking MSF to reconsider its decision in a letter signed by 120 organizations and 287 individuals working in global health.
July
At the 10-11 July World Trade Organization’s TRIPS Council, Colombia proposed to carry out a long overdue review of the implementation of the TRIPS Agreement under Article 71.1. The review process will kick off in 2025. You will find our recommendations for the review here.
The British Medical Journal published a memorial piece on Zafrullah Chowdhury, a medical doctor and life-long advocate for access to medicines who passed away in April 2023. He was instrumental in the design and adoption of Bangladesh’s essential medicines policy. He had a keen eye for the needs of neglected populations and was a leader of the People’s Health Movement, as well as one of the founders of Health Action International.
August
On 14th August, the WHO declared Mpox a public health emergency of international concern (PHEIC) under the International Health Regulations (2005) (IHR). To secure access to available vaccines and expand production, UNICEF issued an emergency tender for Mpox vaccines for up to 12 million doses.
Nigeria was the first country to receive a donation of Mpox vaccines manufactured by Bavarian Nordic and donated by the US. Nigeria accounts for 1% of Africa’s confirmed Mpox cases. Nigeria was first in line because of its swift regulatory approval and vaccination planning. High-income countries had started to build Mpox vaccine stockpiles to be prepared for an outbreak. Some countries, listed here by Reuters, pledged to donate vaccines. Others, such as the Dutch minister of Health, who looks over a stockpile of 100.000 vaccines in a country with 0 cases of Mpox, initially did not want to part with even only 10% of it. She had to reverse that decision after an intervention by the Dutch parliament.
On 6th August, Spotlight reported that Cheri Nel had dropped her legal case against Vertex. Nel had asked the Gauteng Division of the High Court in Pretoria to grant a compulsory license to allow generic versions of a cystic fibrosis medicine called Trikafta to be imported into South Africa. She dropped the case because Vertex had offered a lower price, US$ 22.000 instead of the US$300.000 list price. This is still a hefty cost for most people, but the only other alternative, a generic version produced in Argentina, has also become more expensive because of hyperinflation. The price had gone up from US$60.000 to US$100.000 per patient per year, meaning that a compulsory licence would not have opened the door to less costly products. It is estimated that only 25 -33% of people with cystic fibrosis will be able to benefit from the Vertex offer. For the vast majority of patients, the Vertex price remains prohibitive. The case in South Africa was part of a global campaign for access to cystic fibrosis treatments launched in 2023.
September
Health Action International (HAI) hosted a seminar on public sector production of CAR-T therapy. Researchers provided fascinating insights into the role of the public sector and university hospitals in locally producing the treatment, leading to better patient experience and lower costs to the healthcare system. You can watch it here:
October
On 17 October, Innovarte and Knowledge Ecology International (KEI) hosted a side event to the Thirty-Sixth Session of WIPO’s Standing Committee on the Law of Patents (SCP). The briefing examined state practices involving compulsory licensing of biomedical inventions, data, cell lines, and know-how including the application of relevant exceptions in articles 30, 31, 39, 40 and 44 of the WTO TRIPS Agreement. The programme included speakers from civil society (including Medicines Law & Policy), industry and an intergovernmental organisation. The recording of the event can be found here.
The WIPO secretariat prepared a very readworthy report for the SCP meeting titled “Constraints faced by developing countries and least developed countries (LDCs) in making full use of patent flexibilities and their impacts on access to affordable especially essential medicines for public health purposes.”
November
Round 12 of the INB for the Pandemic Agreement took place in November. Technology transfer continued to be a sticking point. There was even no agreement on how to define technology transfer, and there were also questions in the hallways as to how to define “know-how”. In an intervention at the INB meeting, ML&P offered a definition based on wording used by WIPO, hoping it would be palatable to a larger number of parties.
The Access to Medicines Index, published in November, showed that more companies have business strategies that take low and middle-income countries into account – so-called inclusive business models – but this is not reflected in their licensing strategies. Voluntary licensing is declining. Between June ‘22 and May 2024 only two new licensing agreements were entered into, while the Medicines Patent Pool has a priority list of at least ten products for voluntary licensing. The Lancet asked ML&P to comment on the matter.
December
The 12th INB resumed on December 2-6 but did not conclude the negotiations on the WHO Pandemic Agreement, which will continue in the new year. For details, see here. Medicines Law & Policy remains concerned about inadequate language on transfer of technology and know-how and hopes the resumed negotiations in 2025 can come to a strong conclusion.
The GEP Foundation in Argentina filed an opposition against the granting of patents on lenacapavir, a long-acting HIV medicine sold by Gilead. GEP has now opposed 5 of the six patent applications for lenacapavir in Argentina. Studies have shown that Lenacapavir offers 100% efficacy for pre-exposure prophylaxis (PrEP) when given as injections every 6 months which means it has the potential to end HIV. Gilead has entered into license agreements with generic manufacturers, but those agreements have a limited geographical scope. Most middle-income countries, for example, are excluded. The Lancet reported that at this year’s International AIDS Conference, which was held in Peru, the President of the International AIDS Society voiced concern that most of Latin America was excluded from the Gilead agreements. The GEP Foundation’s opposition procedures aim to clear the roadblocks to producing generic lenacapavir in Argentina. In November, Andrew Hill, from Liverpool University, published a pricing study on lenacapavir estimating that the drug could be mass produced for less than $100 per person per year, despite a current list price of up to $44,819 per person per year.
Melissa Barber of Yale University published a look back at technology transfer as a critical part of the history and rationale for the creation of the World Health Organization. This is timely considering that negotiations about facilitating technology transfer continue to be one of the most difficult to resolve sections of the under-negotiation Pandemic Accord.
MSF has held several meetings with groups and individuals who have voiced their concerns about the organisation’s plans to close the door of its Access Campaign. Politico has the report.
Meanwhile, Reuters reported that President-elect Trump is discussing ending US childhood vaccination programmes. This will harm children in the US but will likely also have consequences globally.
Happy New Year!
