The first link for a new drug to reach Spain goes through the EMA . However, if the process is already slow in this country, we must add the delay of the European regulatory body in the authorization of new therapeutics: Europe takes an average of two years to approve medicines. When compared to its counterpart in the United States, the situation is very different. The FDA takes a year and a half less to give a technical yes to new therapies than the EMA.
The EMA’s procedures are much more rigid than the FDA’s. This is the main reason for the temporary difference of one organism compared to another. The American agency has accelerated approval mechanisms for drugs against rare diseases and for those that have no cure. In fact, in 2019, it authorized around 60% of the fast-track requests submitted to it.
The European body also has emergency mechanisms, but they are not as flexible as the American ones . During the most critical months of the pandemic, the EMA launched an exceptional instrument (rolling review) to speed up the approval process for vaccines against Covid-19. However, its use does not seem to have been transferred to those diseases where there are no advances in treatment.
Accelerated approval mechanisms constitute the main divergences between one agency and another . “One of the fundamental differences between the EMA and the FDA is manifested in the existence of accelerated approval mechanisms, which are reserved particularly for drugs that may be more effective for incurable diseases or for unknown treatment,” the report states. The European Medicines Agency (EMA): how to overcome mistakes of the past’ prepared by Citizen Europe.
Oncological and hematological drugs are the most authorized by fast track. While twelve drugs for cancer and five for hematological diseases were approved in the United States, the European authorities only approved seven oncological drugs and two related to hematology.
lack of transparency
Transparency is another of the differences that govern both institutions . The proposal criteria for the members of the Board of Directors of the EMA is open, which may cause political criteria or government affinity to be produced. The national component is deeply rooted in the European organization , since the members that make it up are proposed by the Member States.
The situation is very different in the United States, where there are no territorial parameters in the organization of the FDA . “We have to go to a concept of transparency that is supervised by an autonomous body. The agency lacks a common framework for action. The political and territorial component in the FDA is minimal. However, in the EMA, the Cyprus’ vote than that of countries with top-level research centers such as Belgium, France or the Netherlands”, explains José Carlos Cano Montejano, president of Europa Ciudadana.
These issues are collected in the report ‘The European Medicines Agency: how to overcome mistakes of the past’, prepared by Europa Ciudadana, an academic think tank specializing in European Affairs. It highlights the lack of independence in the election of the members of its committees, the lack of transparency in some processes or the slow pace in the approval of new drugs.