Transcript No rational use of drugs without access to data

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 3 335 new drugs
•
•
•
•
•
•
•
Bravo :
A real advance :
Offers an advantage :
Possibly helpful :
Nothing new :
Not acceptable :
Judgement reserved :
0,30 %
2,34 %
6,81 %
14,60 %
69,02 %
3,18 %
3,83 %
New drugs with a negative
benefit-harm ratio
•
•
•
•
in 1990
in 2003
in 2004
in 2005
………………….
………………….
………………….
………………….
1,5 %
9,0 %
10,0 %
22,0 %
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) --
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 1996 --
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 --