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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

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Page 1: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

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

Page 2: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

25 years of independent rating of 3 335 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 %

Page 3: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

New drugs with a negative benefit-harm ratio

• in 1990 …………………. 1,5 %

• in 2003 …………………. 9,0 %

• in 2004 …………………. 10,0 %

• in 2005 …………………. 22,0 %

Page 4: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

Decades of DTDA : direct-to-doctor advertising

• drug benefits modified (exagerated) in 30 % of visits by med’reps

• 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) --

Page 5: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

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

Page 6: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

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 1996 --

Page 7: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

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

Page 8: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

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.

Page 9: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

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

Page 10: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

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)

Page 11: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

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

Page 12: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

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 »

Page 13: No rational use of drugs without access to data The European campaign for transparency in drug regulation Danielle Bardelay - La revue Prescrire HAI Europe

Let us disseminate our Joint Declaration :

• Relevant health information for empowered citizens 

– endorsed by HAI, ISDB, AIM, BEUC, MiEF --