Thanks to members of the European Parliament who defend patients'
interests and public health many amendments supported by Medicines
in Europe Forum were adopted on 27 November 2003 in Brussels.
Useful amendments have been adopted
All amendments related to transparency of medicines agencies and
access to information in their possession have been adopted; also
those related to the public funding of pharmacovigilance activities
and information by agencies; those related to the extension of the
centralised procedure for marketing authorisation to all new substances
4 years after implementation of the regulation; those ensuring a
minimum of 80 days for a thorough analysis of dossiers by rapporteurs
in the marketing authorisation committees; those strengthening the
pharmacovigilance system through patient direct reporting of side
effects when their health professionals fail to report; those ensuring
clearer and more user-friendly leaflets, including for blind people;
Members of Medicines in Europe Forum are delighted at these new
advances that complete those obtained at the first reading. But
they rise against the fact that no amendment guaranteeing compassionate
use programmes for patients with no therapeutic alternative.
Other amendements protecting the pharmaceutical
industry endanger health care systems
The Forum also observes that industry lobbies and their supporting
MEPs continue to fiercely defend their two dearest points: maintaining
the system leading to inadequate evaluation of new medicines (no
obligation to carry out comparatives trials), and undue prolongation
of commercial exclusivity for companies.
An unprecedented protectionist weapon
The amendments adopted on November 27 (owing to a tiny majority
for some of them) would result in an internationally unprecedented
protectionist weapon: indeed they would allow drug companies to
protect clinical trial data for 11 years. Three further years of
protection could also be granted for a new indication of an old
substance, and three years could also be granted, as a nice little
jackpot, for any switch from prescription to over-the-counter (OTC)
Such protection is not supported by sound elements, and it goes
well beyond reasonable reward of research investment. But it has
been clearly demonstrated that it would threaten all welfare and
health insurance systems of European member states, with dramatic
consequences for household budgets. They would have a particularly
bad impact on the economy of those member states joining the EU
Medicines in Europe Forum calls MEPs who will decide on these measures
(in plenary in mid December), and the health ministers from member
states involved in the co-decision process, to confirm the advances
that were voted by the Commission.
Halt to the protectionist spiral
Medicines in Europe Forum calls MEPs and ministers to put a halt
to the protectionist spiral that would threaten health systems.
In addition it would be counter productive in terms of revival of
the pharmaceutical industry: reorienting research and development
towards needed medicines is the only way to revitalize this industry
in the long term. It would be unacceptable to grant drug companies
undue data protection, and to consequently maintain high prices
for medicines, without any obligation to evaluate the comparative
merits (added therapeutic value) of medicines in a given condition.
In a final spurt of effort MEPs and ministers are still in a position
to guarantee access to good quality health care at reasonable cost
for EU citizens. Civil society, well represented in Medicines in
Europe Forum, count on them.
©Medicines in Europe Forum
1 December 2003