The rising and emergent issue of high medicine prices and its effect on the sustainability of health care systems is getting more and more consideration in many countries around the world. Regulators are ready to play their part in solving the crisis and in facilitating sustained access of patients to safe and useful medicines.
In the article published in the New England Journal of Medicine (NEJM) two representatives of the European Medicines Agency (EMA), i.e. its Executive Director and Senior Medical Officer, as well as Heads of two national agencies discuss possible regulatory interventions.
The pricing of medicines is clearly out of their dispatch, medicine regulators cannot overlook the recent debate on the cost of medicines and can make a role to reasonably priced care, give details the authors in their article entitled ‘Drug regulation and pricing – can regulators influence affordability?
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.
According to the authors of the article, there are five main ways European regulators can help:
- Facilitate the quick sanction of generics and biosimilars, as this facilitate competition and drives down prices;
- Works to guarantee ‘me-too’ products (medicines comparable to already approved options) keep on coming on the market at reasonable speed, again to drive down prices through augmented competition.
- Support companies to carry out clinical trials that both assure the needs of regulators (i.e. make obvious quality, safety and effectiveness of the medicine) as well as the health-technology-assessment bodies(i.e. support the revelation of the value once the medicine is authorized, to guide payers in their reimbursement decisions).
- Assist the collection of other data that are important for payers by taking their needs into account when asking companies to conduct post-approval studies.
- Maintain higher competence of research and development in the area of medicines: by development a better model of medicines, it is anticipated that companies would potentially be able to decrease 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.
Date: 12/05/2016