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Can Regulators Influence the Affordability of Medicines?

Top EMA and EU national authority representatives discuss options in a NEJM article
13 May 2016
Bioethics, legal and economic issues

The growing problem of high medicine prices and its impact on the sustainability of health care systems is getting more and more attention in many countries around the globe. Regulators are willing to play their part in solving the problem and in facilitating continued access of patients to safe and effective medicines. In an article published on 12 May in the New England Journal of Medicine (NEJM) the representatives of the European Medicines Agency (EMA), as well as Heads of two EU national agencies discuss possible regulatory interventions.

Even though the pricing of medicines is clearly out of their remit, medicine regulators cannot ignore the current debate on the cost of medicines and can make a contribution to affordable care, explain the authors in their article entitled “Drug regulation and pricing – can regulators influence affordability?”.

According to the authors, there are five main ways European regulators can help:

  • Enable the rapid approval of generics and biosimilars, as this facilitates competition and drives down prices;
  • Work to ensure ‘me-too’ products (medicines comparable to already approved options) continue to come on the market at reasonable speed, again to drive down prices through increased competition;
  • Encourage companies to conduct clinical trials that both satisfy the needs of regulators (i.e. demonstrate quality, safety and efficacy of the medicine) as well as the health-technology-assessment bodies (i.e. support the demonstration of the value once the medicine is authorised, to guide payers in their reimbursement decisions);
  • Facilitate the collection of other data that are important for payers by taking their needs into account when asking companies to conduct post-approval studies. This could for example help payers when considering outcome-focused deals that tie the price of a medicine to the result for patients;
  • Support higher efficiency of research and development in the area of medicines: by fostering a better model for the development of medicines, it is expected that companies would potentially be able to reduce the price of their medicines. This could also mean reflecting on new approaches to medicines’ development, such as the adaptive pathways approach that is being explored by EMA.

The article, co-authored by EMA’s Executive Director Guido Rasi, its Senior Medical Officer Hans-Georg Eichler, the Executive Director of the Dutch Medicines Evaluation Board Hugo Hurts and the president of the German Federal Institute for Drugs and Medical Devices Karl Broich, is available in open access in the NEJM.


Eichler H-G, Hurts H, Broich K, et al. Drug Regulation and Pricing — Can Regulators Influence Affordability? N Engl J Med 2016; 374:1807-1809.

Last update: 13 May 2016

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