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The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.
Representatives from the European Medicines Agency (EMA), the Dutch Medicines Evaluation Board, and the German Federal Institute for Drugs and Medical Devices discuss how regulatory bodies may be able to intervene in drug pricing in an article published in the New England Journal of Medicine. The article is in response to the growing concern of high drug prices and the affect these prices can have on patients’ access to medicines.
The authors suggest in the article that regulators may be able to help the drug pricing situation by enabling rapid approval of generic and biosimilar versions of drugs as well as the approval of drugs comparable to already approved medications, which encourages competition. EMA says in a press release that regulators could also “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,” and encourage companies to conduct more thorough clinical trials. The authors also suggest that regulators could support higher efficiency in R&D.