• On 8 March 2011, Prescrire offered 57 recommendations to reorient medicines policy in favour of patients. A large number of Prescrire's recommendations have been included in the final recommendations offered by the delegation from France's National Assembly, by the French Senate, by the delegation mandated by the French President, and by France's General Inspectorate of Social Affairs (IGAS, Inspection Générale des Affaires Sociales), as well as by "Les Assises du médicament", the national conference on medicines policy convened for the occasion.
   
• France's health ministry has incorporated a large proportion of the "Assises du médicament" conference’s proposals, also recommended by the other delegations, and this is laudable.
  
  
• However, several essential points are missing from the proposed measures:
  • development of robust, publicly funded clinical research. Firstly, it does not make sense to allow pharmaceutical companies to provide most of the essential clinical evaluation data on their own drugs: this places them in a position of major conflict of interest. Secondly, financing by pharmaceutical companies reinforces numerous ties between companies and experts. This evaluation must eventually be entrusted mainly to public authorities;
  • public access to clinical evaluation and pharmacovigilance data, indispensable for the transparency of decision-making and to allow for a plurality of assessments outside those of the official agencies;
  • strengthening of the public pharmacovigilance system;
  • a change in the way community pharmacists work and the way they are compensated, allowing them to wholly fulfil their role as healthcare professionals, well placed in the healthcare delivery system to avoid numerous adverse drug effects.
• Several points need to be spelled out:
  • registers of conflicts of interest ("the French Sunshine Act") must be searchable by the healthcare professional's name and not just by company name;
  • development of monitoring programmes and education for healthcare professionals must include patient safety (safe practices to prevent healthcare-related errors), and not just adverse effects of drugs and other healthcare products;
  • transparency is non-negotiable: video recordings of the various proceedings must be made available in whole, and not just limited to "critical health issues": medicines are by definition a "critical health issue".
• Prescrire will evaluate the impact of reforms based on the facts, and most notably in the short term by their translation, without watering-down, into the promised legislation. This is a precondition for constituting a concrete step towards better access to quality care for all. Also in the short term, France must ensure that its representatives to the European Medicines Agency are in a position to bring about the needed changes.
   
• Prescrire will maintain its independence and will continue its demanding evaluation of medicines' risk-benefit balances and of any therapeutic progress they may represent, as well as of decisions by agencies and political authorities.
   
• The various political missions and the "Assises du médicament" conference have demonstrated that French society is ready for profound changes in the area of medicines policy.
  
  
• Today it is up to France's political establishment to avoid crushing the hopes that it has raised. What's more, it has an historic opportunity to set a new course in medicines policy, in France and in Europe, first and foremost in the interest of patients.

©Prescrire 30 June 2011