Advanced therapies are opening up new possibilities in the treatment of serious diseases, particularly in oncology. At the same time, their development is bringing familiar global health challenges back to the fore, related to pricing and access to medicines, technology and the knowledge required to produce them, as well as the distribution of that knowledge.
A few weeks ago, we discussed these issues in the first session of our Advanced Therapies Series, “Decoding CAR-T Access: Patents and Lessons from Global Health.” The conversation helped structure a debate that still occupies limited space on the global agenda, despite its implications.
This type of personalised cancer treatment is based on modifying a patient’s own immune cells so that they can recognise and attack tumour cells, and has opened new options in cases where other therapies had not worked. At the same time, access to these therapies is heavily conditioned by their price.
Available treatments range between $300,000 and $400,000 per patient. These figures not only limit access in lower-resource settings, but also threaten the sustainability of health systems that, in principle, are able to absorb high-cost innovations.
Despite this, the problem is not only economic. As in many other areas, it is also about how innovation is organised. Research, clinical trials and patents are concentrated in a small number of countries, led by the United States and China. Other regions, such as Latin America and Africa, are largely absent from this ecosystem. This creates a double gap, limiting access to treatments while also shaping who produces knowledge and under what conditions it can be used.
Intellectual property plays a critical role in this context. CAR-T therapies are protected by a dense patent landscape that covers everything from biological components to manufacturing processes and methods of administration. For many countries, this means navigating an environment in which developing local alternatives can be legally complex.
In the session, we were joined by José Daniel Rengifo, from the National University of Colombia, who presented a detailed analysis of CAR-T-related patent applications in his country. His research shows that legal flexibilities exist to limit certain forms of protection, and highlights how these tools can lose effectiveness if not applied with clear criteria. It is not only a question of what the law says, but of how it is interpreted and implemented.
A complementary perspective was provided by Giulia Segafredo, from the Medicines Patent Pool, who focused on voluntary licensing and technology transfer models. Her experience shows that these mechanisms have expanded access to treatments in areas such as HIV and hepatitis C, with significant price reductions and availability across dozens of countries. She also highlighted their more recent application in oncology, including agreements such as the one on nilotinib for the treatment of leukaemia, which have enabled the entry of generic manufacturers and substantial price reductions in different settings.
At the same time, she explained why applying these models to CAR-T therapies is not straightforward. Unlike other medicines, their production depends on complex processes, often embedded within hospital settings, requiring infrastructure, specialised personnel and quality systems that are difficult to replicate in the short term.
All of this points to a broader gap. Unlike other areas such as HIV, tuberculosis or neglected diseases, there are currently no international organisations or frameworks specifically designed to address access to advanced therapies, facilitate technology transfer or regulate pricing with equity as a central objective. In the absence of such frameworks, access remains shaped by market dynamics that tend to reinforce existing inequalities.
The proposals discussed during the session move in that direction. They range from refining patent examination criteria to strengthening technology transfer and integrating advanced therapies into global health strategies. These are not new approaches in other fields, but in this context they remain underdeveloped. Meanwhile, CAR-T therapies continue to advance in clinical practice. The gap between that progress and real-world access conditions remains, for now, part of the same problem.
Here you can read a more detailed summary of the webinar. You can also download it from this link.
