The Medicines in Europe Forum thanks all Euro-MPs who showed consideration
for patients' interest and public health and, despite pressure,
forced the adoption of welcome provisions, particularly those in
favor of greater visibility by citizens of medicines agencies' decisions
and workings. Unfortunately bigpharma lobbies and health ministers
defending national interests joined force to impose decisions that
will endanger health care and welfare systems of all member states.
The four key players of the Forum (patients groups, family and consumer
bodies, mutual insurance systems, and health professional organizations)
come back on the positive and negative decisions in the adopted
Patients groups welcome the formal possibility for patients desperately
lacking treatments to use not-yet-authorized drugs in compassionate
use programs but deplore the rejection of all provisions that would
have enforce application of these programs. Indeed the adopted texts
fail to compel member states and companies to help patients. Rejection
of patient direct reporting of side effects to authorities is also
a negative outcome: patients are not yet recognized as legitimate
partners in pharmacovigilance.
Family and consumer bodies
Family and consumer bodies are delighted at the massive rejection
of an initial proposal by the Commission, i.e. de facto allowing
of direct-to-consumer advertising for prescription-only medicines.
Although it is to be feared that some proposals of the Commission
about public oriented information might go in the wrong way, the
European situation is currently not as bad as in the USA or New
Zealand. Consumers welcome the measures (vainly opposed by the Commission)
favoring informative labeling such as the International Nonproprietary
Name (INN) or use of Braille on drug packaging.
Health professionals are happy with the obligation to re-evaluate
drugs after 5 years on the market (10 years if safety problems occur)
while bigpharma pushed for unlimited marketing authorization. They
also welcome the continuation of the time frame for examining marketing
applications, against shortening proposals by companies. They welcome
the steps towards greater transparency of decisions and documents
of regulatory agencies (centralized or national) but highly regret
that nearly total secrecy will still prevail in pharmacovigilance
matters. They condemn the stubborn refusal by the Commission to
allow comparison of new drugs with older ones, therefore encouraging
unbridled marketing of medicines with unknown therapeutic merits.
Mutual insurance organizations
Mutual insurance organizations and those in charge of welfare systems
faced a powerful pharmaceutical lobby pushing for a prolongation
of commercial exclusivity for originator drugs. To good purpose
the bigpharma lobby used clever gimmicks: modification of generic
definition, introduction of a fake definition of 'biogeneric' in
order to prevent generic development, and outrageous prolongation
of clinical data protection. Appeal to common sense by new Member
States was of no avail: the adopted measures will result in huge
financial problems. The consequence will be even more dramatic if
the principle of a 'single EU drug price' is adopted. Vigilance
is therefore needed.
The Medicines in Europe Forum, who was created at the start to this
legislative review, has learned a great deal about EU institutions.
It regrets that the Parliament has so little weight as compared
to the Commission and the Council of ministers. The Forum is determined
to influence the coming debates on medicines, particularly on the
single drug price and disguised advertising to the general public.
©Medicines in Europe Forum 1 January 2004