No rational use of drugs without access to data

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 25th Anniversary Conference

2
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

3
New drugs with a negative benefit-harm ratio

• in 1990 . 1,5
• in 2003 . 9,0
• in 2004 . 10,0
• in 2005 . 22,0

4
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) --

5
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

6
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 --

7
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

8
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.

9
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

10
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)

11
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

12
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 

13
Let us disseminate our Joint Declaration

• Relevant health information for empowered
  citizens 
• endorsed by HAI, ISDB, AIM, BEUC, MiEF --