ATMPs are technological innovations, they revolutionize the treatment of diseases that used to be often incurable. Although they can offer promising health benefits, they are also a source of major risks for patients. They are manufactured in a customized way with high technicity and generally, only one shot is enough to treat the patient. As a result of curing mostly orphan diseases, the scope of use of these products is narrow.

These are some of the reasons why ATMPs are extremely expensive and why they do not fit in the current regulatory and economic framework. Public authorities have different types of contracts with pharmaceutical companies, so-called “managed entry agreements” (MEA). Most of the European countries are convinced that financial agreements are the best solution to reduce prices, but some of them prefer performance-based contracts to manage uncertainties. Unfortunately, confidentiality is a barrier to evaluating objectively their strengths and weaknesses. Greater transparency and an extended collaboration between states could help them negotiate better with drug laboratories.

Furthermore, not only certain types of contracts could reduce obstacles to access to ATMPs. Making a reform in national health insurance systems, developing international competition law, emphasizing the importance of prevention and the role of international organizations would also have a huge impact in letting patients use life-saving therapies as soon as they entered the market.