On May 12, 2016, an article was published in the New England
Journal of Medicine ("NEJM") in which two
representatives of the European Medicines Agency ("EMA")
as well as heads of two national agencies discuss potential ways
regulators can intervene to influence the pricing of medicinal
products. Despite recognizing that "drug regulators aren't
supposed to be concerned with pricing," the authors identify
five main ways in which European regulators can "contribute to
keeping drug spending sustainable":
- By enabling the rapid approval of generics and biosimilars, as this facilitates competition and drives down prices;
- By working to ensure that "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;
- By encouraging 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 authorized, to guide payers in their reimbursement decisions);
- By facilitating the collection of other data that are important for payers by taking their needs into account when asking companies to conduct postapproval studies; and
- By supporting higher efficiency of research and development in the area of medicines. The authors explain that by fostering a better model for the development of medicines, companies would potentially be able to reduce the price of their medicines. The authors suggest that could also mean reflecting on new approaches to medicines' development, such as the adaptive pathways approach that is being explored by EMA.
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