Last month, the European Medicines Agency (EMA) and European Union healthcare payers came together for the first time to discuss synergies for fostering timely and affordable access to medicines. The meeting took place at the EMA headquarters in London and marked an important first step in a bid to streamline drug availability for EU citizens.
Under the current EU system, patients often face significant delays accessing important new treatments after they have been approved for commercial use. This problem exists because drug availability is governed by sequential processes. First, a drug must receive approval for use from the EMA. Then, before it can reach the patient, the drug must be assessed by healthcare payers at the national and regional level, so that pricing and reimbursement decisions can be made.
This means that, during the drug testing phase, drug companies usually focus more on collecting the safety and efficacy data needed by the EMA, as the EMA is the first agency to review their products. Efforts to generate sufficient evidence around cost-effectiveness will usually take a backseat. As a result, further research must be conducted, post approval, to allow companies to collect the data needed by healthcare payers. This can be a very time-consuming process, in certain circumstances, and can be extremely detrimental for patients desperately awaiting treatment.
EMA Executive Director, Professor Guido Rasi, has said that he is hopeful that collaboration and open-discussion between the regulatory agency and national payer organizations will help solve this issue. During the meeting’s opening statements, Rasi made the following remarks:
“Regulators, HTA bodies and payers – we all perform an important task in one way or the other as gatekeepers for medicines to the healthcare systems in the EU. But we also have an increasingly important role as enablers of medicine development. Our cooperation can help medicine developers to address some of the inefficiencies of the current system of clinical research so that they become better at generating the evidence each of us needs for good decision-making.”
To inform the general public of the topics that were discussed and the strategies for improvement that were put forward, a report on last month’s meeting will be published in due course.