The end of 2025, a tumultuous year for global public health, is here, and it’s time for the usually highly biased Medicines Law & Policy report of the key events for the year.
January
Focus on TRIPS Flexibilities and the Bolar Exception: The South Centre published a research paper in January 2025 addressing how intellectual property rights restrict access to essential medicines and exploring the “Bolar exception” as a legal mechanism to enable earlier generic drug entry into the market. The Bolar exception allows generic drug makers to conduct the testing and filing needed for regulatory approval to market a generic medicine before the patent term on the originator has expired, and is a critical legal flexibility to ensure the timely entry of generic drugs to a market. The paper argues for a broader implementation of these exceptions to improve access to affordable medicines and reduce healthcare costs.
On 20 January, the second Trump administration took office in the United States and began implementing sweeping policy changes that would have a profound impact on public health, including a withdrawal from the World Health Organization and major cuts to essential programmes supporting global public health, including USAID and the President’s Emergency Fund for AIDS Relief (PEPFAR).
On 29 January, in a much-needed bright spot, the WHO congratulated Guinea on eliminating sleeping sickness, which was done in part with a medicine developed by the Drugs for Neglected Diseases initiative (DNDi).
February
On 1 February, the New York Times reported on the effects of Trump’s withdrawal of global health funding for lifesaving treatment and prevention programmes for TB, malaria and HIV.
On 13 February, the first batch of generic dolutegravir to treat HIV, arrived in Colombia under a compulsory license issued in April 2024, according to a post on social media site X from the Colombian president Gustavo Petro which featured a photograph of 300,000 pills arriving in boxes. See more here [in Spanish].
On 14 February, the drug company Leadiant lost its appeal against a EUR 19.6 million fine issued in 2021 by the Dutch competition authority, the Authority for Consumers and Markets (ACM), for abuse of its dominant economic position in the market related to the product Chenodeoxycholic acid (CDCA), a treatment for cerebrotendinous xanthomatosis (CTX), a rare genetic metabolic disease. CDCA had been marketed in the Netherlands by Leadiant since July 2017 for € 140 per capsule or € 153,300 per patient per year. CDCA is, however, cheap to produce and was on the market from 1976 until at least 2008 under the brand name Chenofalk for the treatment of gallstones. The Chenofalk product cost € 0.28 per capsule or € 308 per patient per year before Leadiant acquired marketing rights and promptly raised its price. The case was brought by the Pharmaceutical Accountability Foundation in the Netherlands on 7 September 2018. For details, see here.
March
In an important decision for people suffering from spinal muscular atrophy, the Delhi High Court ruled that the generic drug maker, Natco, is allowed to make a generic version of Roche’s spinal muscular atrophy drug, risdiplam. The court cited public-interest considerations and held that the public good impact of access to risdiplam outweighs the importance of increasing the profits of a company. Without the production by Natco, the drug would not be available in India at an affordable price.This ruling opens the road for Natco’s production and supply of risdiplam. Roche appealed the decision at India’s Supreme Court. Also see here.
On 3 March, Ugandan NGO Afya Na Haki released a report entitled Technological Needs for Pharmaceutical and Vaccine Production in Low and Middle-Income Countries: An African Perspective. The report highlighted the historical progression of Africa’s health systems, from traditional medicine practices to modern pharmaceuticals, and examines what might be needed to meet the African Centres for Disease Control’s goal of manufacturing 60% of the continent’s vaccine needs by 2040. The report was an important contribution ahead of the 4th WHO World Local Production Forum, which was held in April.
April
In December 2021, the member states of the World Health Organization (WHO) decided “to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”, known as the Pandemic Agreement. On 16 April 2025, after over three years of talks, the WHO member states successfully concluded the Pandemic Agreement, which was then sent to the World Health Assembly (WHA) in May for adoption.
ML&P published a report titled “Pharmaceutical patents and data exclusivity in an age of AI-driven drug discovery and development” which examined how rapid advances in artificial intelligence are already having – and are likely to continue to have – a profound effect on life sciences research. The report then asks how the patent system should respond as AI takes on a greater role in drug discovery and research; and in particular, how cost savings resulting from AI could affect the pharmaceutical innovation incentive system based on market exclusivity.
May
On 21 May, the World Health Assembly adopted the Pandemic Agreement. The passage of the agreement faced a brief last-minute hiccup when Slovakia called for a vote in a technical committee about whether or not to pass the Agreement to the plenary for adoption. What followed, however, was a clear outpouring of support, with 124 member states voting in favour of the agreement. While 11 members (Bulgaria, Egypt, Iran, Israel, Italy, Jamaica, the Netherlands, Paraguay, Poland, Russia and Slovakia) abstained from voting, there were no objections. The adoption of the Agreement is an important milestone, but there is still more work to be done before the ratification process can commence because the Pathogen Access and Benefit Sharing section of the agreement, contained in an annex, still needs to be finalised before the Agreement can be sent to member states for ratification.
Also on 21 May, Wemos and Health Action International launched a joint report on the progress countries have made to implement the 2019 World Health Assembly resolution 72.8 “Improving the transparency of markets for medicines, vaccines, and other health products”. The report is a follow-up on a WHO Health Evidence Network report “What is the evidence on legal measures to improve the transparency of markets for medicines, vaccines and other health products (World Health Assembly resolution WHA72.8)”, published in 2021.
June
On 18 June, the US FDA approved injectable lenacapavir for pre-exposure prophylaxis of HIV infection. It had previously been approved as a treatment for HIV, and its oral version had been available for prevention. Injectable lenacapavir (LEN-LA), however, offers six months of protection which makes it a truly transformative medicine because it has the potential to end the HIV pandemic. Unfortunately, lenacapavir’s patent-holder Gilead Sciences decided to forgo working with the Medicines Patent Pool to increase access to the medicine in favour of bilateral licensing agreements it issued in 2024.
July
On 9 July, the Amsterdam District Court declared the Dutch Pharmaceutical Accountability Foundation (PAF) inadmissible in its ongoing court case against drug maker AbbVie, without engaging with the substance of the case. PAF’s lawsuit against AbbVie alleges that the company acted unlawfully in its price setting for the blockbuster drug Humira, and as a result took as much as €1 billion in excess profits from the Netherlands health system. For background, see here.
Also on 9 July, the Intergovernmental Working Group (IGWG) tasked with negotiating a Pandemic Access and Benefit Sharing system as a part of the Pandemic Agreement met for the first time. Subsequent meetings were held in September, November and December. For more information, see here.
On July 14, WHO published new guidelines recommending LEN-LA for all people at risk of HIV infection.
On 19 July, The Lancet released an evaluation finding that over 21 years USAID was associated with a 65% reduction in mortality from HIV/AIDS, 51% reduction in mortality from malaria, and 50% reduction in mortality from other neglected tropical diseases, and had overall been responsible for saving 92 million lives. The evaluation predicted that funding cuts by the Trump administration could – if not immediately reversed – result in 15 million additional deaths by 2030, including 4.5 million among children younger than five years old.
August
South African cystic fibrosis patient advocacy groups asks the Competition Commission to reopen their investigation into Vertex Pharmaceuticals for failure to provide access to its medicines to treat the disease.
September
The 2025 versions of the WHO Model Lists of Essential Medicines (EML) and Essential Medicines for Children (EMLc), which provide guidance for countries on medicines selection and procurement, for the first time included a cystic fibrosis medicine: in particular, combination treatment elexacaftor + tezacaftor + ivacaftor (sold under the brand name Trikafta). This is an important win for campaigners such as the Right to Breathe campaign and Just Treatment, who have worked diligently to increase access to cystic fibrosis medication. Such medication has been out of reach in many countries due to a list price of over $370,000 per patient per year asked by Vertex Pharmaceuticals as well as the company’s’ reluctance to register the medicine in some LMICs.
In Peru, civil society organisations and patient advocates have asked the government to take steps to issue a compulsory licence for Trikafta.
Also newly added to the EML was cancer treatment pembrolizumab and several glucagon-like peptide-1 (GLP-1) receptor agonists for the treatment of diabetes and obesity. Absent from the list is risdiplam, which Knowledge Ecology International has proposed for inclusion in 2023 and 2025; the Expert Committee requested it be re-submitted in 2027 pending the gathering of further peer-reviewed studies.
On 24 September, a global coalition of activists called for a $40 a year generic version of ‘HIV-ending’ medicine lenacapavir be made available to all low- and middle-income countries. The demand is based on cost studies by Dr Andrew Hill of Liverpool University, released in June 2025, that showed that the product can be made for US$25 per person per year, as well as an announcement of a partnership between Unitaid, the Clinton Health Access Initiative (CHAI), Wits RHI and Dr Reddy’s to produce and sell a $40 version in 120 low- and middle-income countries starting in 2027. This agreement left out countries such as Argentina, Brazil, Mexico and Peru, where HIV infections are rising and where patent holder Gilead ran clinical trials that were necessary to secure the registration and marketing of lenacapavir. Dr Hill has called on Gilead to work with the Medicines Patent Pool to make large-scale low-cost production possible. So far, Gilead has not licensed its lenacapavir IP to the MPP.
October
The Lancet Commission on accelerating progress on essential medicines was launched. The first meeting of the Commission took place in Brussels in October. ML&P’s Ellen ‘t Hoen and Katrina Perehudoff are both commissioners. Follow the work of the Commission on its website.
The Indian Supreme Court upheld NATCO’s right to produce and market its generic version of risdiplam, a medicine used in the treatment of spinal muscular atrophy. According to the Times of India, Natco’s resdiplam reduces the price by 97% compared to Roche’s price. The medication needs to be taken lifelong.
A cystic fibrosis medicines buyers club launched, promising to provide generic versions of a $370,000 per patient per year originator medicine at $6,375 per patient per year. Beximco in Bangladesh will be the producer. More information is available here https://www.cfbuyersclub.org and here. Only one month earlier, the cystic fibrosis medicines were added to the WHO Essential Medicines List.
On 28 and 29 October, the Building Bridges for Medicines Justice conference took place at the University of Amsterdam. It was organised by Katrina Perehudoff, and Ellen ‘t Hoen delivered a keynote address. The landmark conference brought together civil society and academics to collaboratively tackle the pressing global need to ensure sustainable, equitable and affordable access to medicines.
Also in October, the Socially Acceptable Spending on Medicines programme (MAUG) in the Netherlands, an initiative of the National Health Care Institute (ZIN), the Dutch Healthcare Authority (NZa) and the Authority for Consumers and Markets (ACM) presented a new framework (in Dutch) to evaluate whether the price and expenditure for a new medicine are ‘socially acceptable.’ An English write-up of the report is here.
November
In an article in the New Yorker on 5 November, Harvard School of Public Health Professor Atul Gawande wrote that the Trump administration’s dismantling of USAID had already caused 600,000 deaths, two-thirds of them children, and warned that this “public man-made death” would continue to grow as long as aid financing is not restored. An impact tracker being maintained by Boston University epidemiologist and mathematical modeller Brooke Nichols as of the time of this blog estimates 218,570 adult deaths and 454,568 child deaths due to the US withdrawal of funding support for health programmes.
On 7 November, Health Policy Watch reported that the Trump administration was negotiating bilateral “Pandemic Access and Benefit Sharing” deals (without meaningful Benefit Sharing) in exchange for foreign aid. This move has the potential for upending the multilateral talks taking place with the WHO in Geneva, though in practice has not been addressed directly by the Intergovernmental Working Group tasked with completing them.
December
On World AIDS Day, 1 December, UNAIDS announced a theme of “Overcoming disruption, transforming the AIDS response” to highlight the impact of donor funding cuts to the HIV response. This was an important moment to highlight the alarm in response to the UN Secretary General report for the UN80 Initiative, which announces the plan to “sunset” – a gentle term for ‘closing down’ – UNAIDS by the end of 2026. UNAIDS has collated reactions to the plan to close down UNAIDS here, which document the grave threat to the HIV response that shutting UNAIDS represents.
From 5-9 December, the WHO held its final IGWG of the year on the Pandemic Access and Benefit Sharing system with little progress; the group has decided to reconvene in January for an ‘extended’ session to try and move forward on a text that has so far seen very few lines of convergence. ML&P has contended that this is in part because the text of the Pandemic Agreement had failed to fully iron out a system for the sharing of intellectual property, technology, and know-how.
On 3 December, the launch of a new Centre for Knowledge Governance in Geneva brought together many working across various areas of international intellectual property policy developments.
Happy new year!
Medicines Law & Policy brings together legal and policy experts in the field of access to medicines, international law, and public health. We provide policy and legal analysis, best practice models and other information that can be used by governments, non-governmental organisations, product development initiatives, funding agencies, UN agencies and others working to ensure the availability of effective, safe and affordable medicines for all.