Author: Lauren Kane, Research Assistant, ERC funded PatentsInHumans Project, School of Law & Criminology, ALL Institute, Maynooth University
Tuberculosis (TB) is a serious bacterial infection of the lungs, which is responsible for over 1.2 million deaths per year globally, currently representing the leading cause of death from an infectious agent at the global level. For context, in contrast, influenza (the flu) leads to between 290,000 to 650,000 deaths annually. There are effective antibiotic treatments for TB, however, issues around access to some TB medicines have recently come into sharp focus. A policy report published in June 2025 by Médecins Sans Frontiéres (MSF),[1] entitled “Bridging the Gap: Securing Access to Essential TB Medicines in the EU and EEA,” (hereinafter referred to as ‘MSF Report, Bridging the Gap (2025)) has highlighted challenges for the treatment of TB in the European Union/European Economic Area (EU/EEA) due to such access issues, including related to the high prices of certain TB medicines. Concerningly, MSF highlights in this report that despite their inclusion in the World Health Organisation (WHO) Essential Medicines List and WHO treatment guidelines, numerous medicines to treat TB are unaffordable or unavailable in the EEA. There are several factors behind this, which will be returned to later. However, due to space limitations, this blog article will primarily focus on one key factor contributing to this problem; the role of intellectual property rights in relation to the high prices of TB medicines and impacts for patient treatment. It will also consider avenues suggested by MSF to tackle the high prices of TB medicines in Europe, more generally.
Access to TB Medicines in Europe: Impacts on Patients and TB Incidence?
Although TB incidence was previously on a path of continuous decline in the EU and EEA, recent trends suggest this is reversing, with TB incidence increasing in the European region. This increase has been attributed to several factors, including the disruption to healthcare services experienced during the COVID-19 pandemic, and the increased migration flow from countries with high incidence of TB to the EU/EEA due to geopolitical conflict and war. Against this backdrop, a key challenge in this field is insufficient access to effective and affordable medicines to treat TB, which also increases the likelihood of ongoing transmission within populations.
In this context, the MSF report highlights that gaps in TB treatment in the EU first became apparent when MSF started assisting Ukrainian refugees and other migrants in Poland in 2022. These gaps in access to essential medicines were identified not just in Poland, but throughout the EU/EEA, and included limited availability of newer “all-oral regimens,” lack of availability of medicines suitable for children, and limited availability of shorter preventive treatments. (MSF Report, Bridging the Gap (2025), p.4)
Due to such gaps in access to these medicines, many doctors in the EU are finding themselves unable to follow the most recent WHO recommendations on the best standards of care for patients who have TB. This has serious consequences, both for the health of those affected, and for wider society. At the individual patient level, the lack of access to medicines, means patients who have TB face increased risks of disease progression, and death. At a population level, lack of access to TB medicines increases the likelihood of the disease spreading within the population, which not only places greater burdens on health care systems, but may also contribute to the rise of multidrug-resistant bacteria. This also has repercussions for human rights, such as the individual right to health, as ensuring the availability and accessibility of medicines are key components of the fulfilment of this right, as protected by Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). Indeed, access to “essential medicines” as defined by the WHO Essential Medicines List is considered to be a non-derrogable obligation in this context.
MSF emphasises that to save lives, and meet global TB elimination targets, there is an urgent need for greater access to newer and better tests and treatments for TB worldwide, noting that:
“While many low and middle-income countries with high TB burdens are taking steps to improve testing and treatment access, inadequate access to new TB medicines and the slow adoption of regimens recommended by the World Health Organisation (WHO) in the European Union/European Economic Area (EU/EEA) threaten to fuel the emergence of drug-susceptible TB (DS-TB) and drug-resistant TB (DR-TB) in the region and beyond.” (Médecins Sans Frontiéres, “Bridging the Gap: Securing Access to Essential TB Medicines in the EU and EEA” (2025), p.4)
Barriers to Access to TB Medicines in Europe: MSF Findings
Specifically, the MSF report identifies the following barriers to accessing medicines to treat TB in the EU/EEA: (1) limited awareness of TB burden and political will; (2) complex regulatory requirements and low demand for TB medicines in the EU/EEA, for example, the existing “profit driven” market approach frequently fails to meet demand when it comes to medicines which are needed in small quantities, which offer little incentive for manufacturers as they are less profitable to register and supply; (3) EU and national regulatory systems are not well adapted, for instance, manufacturers are often disincentivised from applying for EU marketing authorisation (which is mandatory to place medicines on the market in the EU) because of the high costs associated with gathering clinical and other data to garner European Medicines Agency (EMA) approval; and (4) monopolies and lack of transparency leading to unaffordable TB medicine prices. In response, MSF makes targeted recommendations in relation to how the issues raised may be addressed. Comprehensive exploration of these recommendations are beyond the scope of this short blog article to explore, however, you can read more about them in MSF’s full report, available at this link.
Instead, as noted, this blog article focuses on one key factor identified, namely, the issue of monopolies, and specifically, how intellectual property rights (IPRs) over such medicines can be used in ways which contribute to their high prices, in some cases making these medicines unaffordable and/or supplies unavailable. It will also consider MSFs recommendations for tackling high prices of such medicines.
High Prices of TB Medicines in Europe: The Potential Impact and Role of IPRs?
The role of patents (and other IPRs) as a factor contributing to high cost of health-technologies, is a key area we are currently examining within the ERC PatentsInHumans project led by Prof McMahon. For context, patents are a form of intellectual property right, which enable the rightsholder to prevent others from using the patented technology, generally for a period of 20 years. This means that such rightsholders may become the only provider of a particular medicine for this period, if they refuse to licence to others, thereby enabling potential monopoly control over the medicine. A key role of such rights is to incentivise the development of new medicines. However, in practice, such exclusive rights can also be used to enable rightsholders to set and maintain high prices for crucial medicines (as there is no competition). This creates access barriers for patients, with resultant impacts on their health and well-being, and related bioethical implications.
In the TB context, TB medicines such as delamanid, bedaquiline, and pretomanid come with high price tags. For example, a 6-month course of pretomanid could cost in the region of €15,000 – €35,000; linezolid could cost between €5,000 – €10,000; delamanid prices for this period range between €30,000 – €35,0000, and bedaquiline may cost between €20,000 – €25,000 (MSF Report, Bridging the Gap (2025), p. 11). As such, MSF notes that a full course of the WHO recommended six-month BPaLM (bedaquiline, pretomanid, linezolid, moxifloxacin) regimen may cost in excess of €45,000 per patient in the EU (MSF Report, Bridging the Gap (2025), p.10). Indeed, the report notes that secondary patents remain over drugs such as delamanid and bedaquiline in the EU/EEA, which is likely delaying the introduction of lower priced generic alternatives. Moreover, some of these medicines, such as bedaquiline and pretomanid, were mostly developed using public funding, and it has previously been argued that, particularly in cases where health technologies have been developed using public funding, efforts should be made to ensure affordable downstream access for patients, in recognition of the important role public resources have played in their development.
Avenues Identified by MSF Report to Alleviate High Prices of TB Medicines
In terms of measures which could potentially address these high prices and thus improve downstream access to such medicines, MSF recommends that there should be greater transparency in this area, including the publication of all net prices without rebates or discounts, and full disclosure of research and development (R&D) costs, which should also include details in relation to any public funding contributions. Moreover, the policy report proposes that public investments in R&D should be monitored, and States should ensure that all drugs developed using public funds are made affordable and accessible in all EU member states.
Crucially, as part of the move to address this area, the role of IPRs is a key factor that should also be considered around how to ensure greater access to TB medicines, balancing incentives to develop such medicines with the need to ensure downstream access to medicines developed. In relation to this, MSF has recommended that civil society should campaign for reform of the patent system. Moreover, the report proposes that civil society organisations should challenge secondary patents, and evergreening practices, and advocate for the EU pharmaceutical legal framework to be updated in a manner which would prevent these types of access barriers in the future (MSF Report, Bridging the Gap (2025), p.16).
Access to TB Medicines: The Need to Consider and Embed Public Interests with Access to Medicines Frameworks.
Ultimately, difficulties with obtaining access to medicines for the treatment of tuberculosis raises serious public health concerns. We must reconsider the current paradigm, to work towards a more person-centered approach to healthcare innovation which prioritises the well-being of patients and the overall public good.
As part of this approach, in this and other areas, the role and impact of IPRs over access, development and use of health-technologies, must be carefully considered. As noted, how intellectual property rights such as patents can be used over medicines, and how this can impact patients’ interests, including by contributing to high prices, is a key issue explored by the ERC PatentsInHumans Project. This project aims to develop a deeper understanding of the bioethical issues posed by patents, and how such patents may be used, over technologies related to the human body. It reflects on how to better balance the role of IPRs to incentivise the development of medicines, in certain contexts, with the need to ensure reasonable and affordable access to medicines developed.
You can find out more about the PatentsInHumans project, including ongoing work at: www.patentsinhumans.com
This research is funded by the European Union (ERC, PatentsInHumans, Project No. 101042147). Views and opinions expressed are however those of the author only and do not necessarily reflect those of the European Union or the European Research Council Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.
[1] MSF is an international humanitarian agency founded in 1971, dedicated to assisting those whose “survival is threatened by violence, neglect or catastrophe.”
