Abstract

• The system in operation since the late 20th century for stimulating pharmaceutical research and development (R&D) is increasingly showing serious limitations. In particular, the new drugs it produces are unaffordable and often offer only minor or even no benefits to patients.
   
• This system is under increasing criticism, not only from non-governmental organisations, but also from international institutions. A number of interesting proposals have been put forward to remedy the flaws in the current system or to establish alternative systems.
   
• The European Alliance for Responsible R&D and Affordable Medicines, a coalition gathering consumer, patient, and public health organisations, has called for the creation of an R&D system driven by global public health needs that would deliver high-quality, universally accessible and affordable drugs.
   
• The first stage would involve: securing affordable prices in all countries through effective price controls and greater use of the flexibilities written into intellectual property agreements; requiring proof that new drugs represent a therapeutic advance before granting marketing authorisation; and demanding transparency over the costs of pharmaceutical R&D and drug pricing.
   
• In the long term, a global mechanism would need to be established, which would include: providing the public funds necessary to support needs-driven approach to pharmaceutical R&D; establishing new methods that "delink" R&D costs from the end price of health products to make them affordable; and creating a global observatory to track R&D spending, identify areas of health needs and encourage coordinated research efforts in areas of high priority.
   
• The Council of Europe, the Council of the European Union, the World Health Organization (WHO) and the Organization for Economic Cooperation and Development (OECD) are concerned over the price of new drugs in particular and are calling for a partial or complete overhaul of the system.
   
• The health technology assessment agencies of Belgium (KCE) and the Netherlands (ZIN) have not shied away from proposing radically new systems for stimulating R&D.

©Prescrire 1 May 2017

"Pharmaceutical research and development: a new system is needed" Prescrire Int 2017; 26 (182): 130-135. (Pdf, subscribers only)