No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe 25th Anniversary Conference

25 years of independent rating of new drugs Bravo : 0,30 % A real advance : 2,34 % Offers an advantage : 6,81 % Possibly helpful : 14,60 % Nothing new : 69,02 % Not acceptable : 3,18 % Judgement reserved : 3,83 %

New drugs with a negative benefit-harm ratio in 1990 …………………. 1,5 % in 2003 …………………. 9,0 % in 2004 …………………. 10,0 % in 2005 …………………. 22,0 %

Decades of DTDA : direct-to-doctor advertising drug benefits modified (exagerated) in 30 % of visits by medreps drug risks presented (even partially) in less than 30 % of visits –15 years of results of the Medical representatives observation network of readers of La revue Prescrire (2006) --

Access to evidence : a priority a priority to be able to distinguish between therapeutic advance and useless (or dangerous) new drugs no « evidence based » health care when evidence is hidden

A shocking declaration ? « In principle, information available within regulatory agencies should be freely available to the public » –« Statement of the International working group on transparency and accountability in drug regulation » HAI - Dag Hammarskjöld Foundation, Uppsala

2001 : a project of European Directive on medicines accelerated marketing autorisation indefinite autorisation ! more flexibility for mutual recognition longer data protection lifting the ban on DTCA (presented as disease and treatment awareness) !! and … not a word on transparency

Citizens reactions HAI-EPHA seminar against DTCA in Europe creation of the Medicines in Europe Forum (consumers, patients, health professionals, payers) intensive lobbying (Parliament, Council of ministers, etc. other actions : petitions, posters in committee meetings, black faxing, etc.

Bad surprise for EU Commission and EFPIA much longer procedure than expected 600 amendments historical vote on DTCA : article rejected by 494 members of Parliament against and 42 in favor all amendments on transparency adopted

Just an example « (…)In addition, the Member States shall ensure that the competent authority makes publicly accessible its rules of procedures and those of its committees, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes, and explanations of votes, including minority opinions » (article 126b of Directive 2004/27/CE)

End of the battle for openess ? not yet ! transposition in national law is not automatically correct (France had « forgotten » the points on transparency!) implementation sometimes requires some pressure

Provisional conclusions even if sometimes considered as stage-armies, our networks can be very effective ! let us try again on the present concern : DTCA, which is coming back with a new costume of « patient information »

Let us disseminate our Joint Declaration : Relevant health information for empowered citizens –endorsed by HAI, ISDB, AIM, BEUC, MiEF --