Pharmaceutical research and development: a new system is needed.

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The system in operation since the late 20th cen- tury for stimulating pharmaceutical research and development (R&D) is increasingly showing seri- ous limitations. In particular, the new drugs it pro- duces 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 estab- lish alternative systems. The European Alliance for Responsible R&D and Affordable Medicines, a coalition gathering con- sumer, 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 afford- able 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: pro- viding 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 Euro- pean 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.