Transcript A rational Medicines policy for Europe

A rational Medicines Policy
for Europe
Danielle Bardelay
Medicines in Europe Forum
HAI Seminar - The Hague 18 November2004
Therapeutic advance ?
• « The practices of the pharmaceutical
industry and regulators blurr the distinction
between genuine therapeutic advance and
mere innovation »
– (ISDB - International Society of Drug Bulletins Declaration on therapeutic advance in the use of
medicines Paris 15 -16 November 2001) -
A clear difference between:
• newly marketed
substance, or
indication, or
formulation, etc.
• industrial
innovation
(chemistry,
biotechnology)
• therapeutic
advance :
« a new treatment
that benefits the
patient when
compared to
existing options »
– (ISDB Declaration) -
23 years of independent rating
of 2871 new drugs (by La revue Prescrire)
•
•
•
•
•
•
•
Bravo :
A real advance :
Offers an advantage :
Possibly helpful :
Nothing new :
Not acceptable :
Judgement reserved :
0,24 %
2,68 %
7,56 %
15,85 %
66,63 %
2,79 %
4,25 %
Convergent analysis
• US National Institute for Health Care Management :
76 % of new drugs classified as non-priority for
review by the FDA
• Canadian Patented Medicine Prices Review Board :
just 6 % breakthrough medications
• The content of reviews on new drugs published by La
revue Prescrire and the Swedish Medical Product
Agency bulletin is broadly similar (Int J Risk & Safety in
Medicine 2004)
Concerns with cost
• prices of 12 new anticancer drugs approved
by the European medicines Agency between
1995 and 2000 (Garattini S British Medical Journal 2002):
– 3 to 350 times as much as reference drug
– for « few or non substantial advantages
over existing preparations »
Concerns with safety
•
•
•
•
•
•
•
triazolam story
fenfluramin - phentermin story
amineptine story
cerivastatin story
rofecoxib story (+ valdecoxib, parecoxib, etc.)
SSRI antidepressants story
next ?… new antidiabetics, or anticoagulants,
or immunosuppressants, or Ritaline°... ?
Dramatic lack of :
• adequate comparative evaluation :
– no idea of the added therapeutic value
• transparent pharmacovigilance :
– no real prevention of side effects
• prevention of medication errors :
– no proper use of drugs
• primary prevention to limit risk factors :
– little success in disease limitation
Priority to relevant evaluation
• pre-marketing evaluation
– because post-marketing means uncertain
(FDA statistics on fulfilment of conditions)
• comparative evaluation
– versus best available option (at right dose, etc.)
(WHO report on Priority Medicines)
• focused on benefits and on risks
Areas for priorities
• rare diseases : the Orphan Drug Regulation is
already here. A survey on fairness of its
implementation is needed.
• pediatric diseases : the coming Regulation
may help for small groups of children. But other
groups already have too many drugs.
• elderly, pregnant women, patients with
renal failure, etc. require specific evaluation
Areas for priorities (continued)
• cancer, multiple sclerosis, Alzheimer
disease, severe viral infections : their
severity is not an excuse for poor evaluation.
• acute and chronic pain : also not an excuse
for the extremely poor current evaluation.
• groups of old useful drugs : require
additional evaluation (for ex : on doses) but
companies are not interested (for ex : diuretics).
• drug utilization studies.
Priority to pharmacovigilance
• transparency of agencies, access to
data, visibility of decision making
• attention paid to patients direct reporting
• visible implementation of decisions
(warnings, cautions, etc.)
Priority to prevention of
medication errors
• not all errors are linked to dangerous
professional practices
• safer packaging, relevant and understandable
patient leaflets are needed (Council of Europe
working group)
• promotional biased patient « information »
pushed by companies is not needed
Priority to primary prevention
• diabetes, obesity, cardiovascular diseases,
lung (and other) cancers in Europe will not
disappear with help of more new drugs
• nutritional, environmental, infectious, primary
prevention is the priority (WHO Strategy 2004)
• cost of prevention campaigns and cost of
drug reimbursement should be compared
Restoring confidence
• more and more patients and health
professionals consider drug agencies and
health authorities as unreliable
• the Dutch Presidency initiative is an
opportunity for restoring confidence :
– choice of research priorities
– attribution of financial support
– follow up of supported research
–
should be fully transparent
Medicines in Europe Forum
• will closely follow up this initiative on priority
medicines
• hopes that patients needs will be seriously
considered
• hopes that neglected diseases more frequent
outside Europe will really be considered
• and thanks HAI warmly for this seminar which
raises patient oriented priorities.