The European legislative framework impacts the level of guarantees afforded to citizens of the European Union in terms of the quality and safety of their healthcare. It is certainly too sensitive a matter to give free rein to vested interests.
The sustained, two-year effort by European citizens, first and foremost among them La Revue Prescrire, its subscribers and its parent organisation the Association Mieux Prescrire, as well as the other members of the Medicines in Europe Forum, led to major progress in the European medicines regulations published on 30 April 2004.
Here are selected elements of the campaign posted on the Prescrire website from July 2002 and last updated on 15 November 2005.
"Priority Medicines for the Citizens of Europe"
(18 November 2004)
Position statement by the Medicines in Europe Forum on the Dutch EU Presidency initiative
> Download the pdf (105Ko).
The most important changes in the new legislation
(1 July 2004)
We list the most important changes affecting patients and health professionals, comparing the new Directive and Regulation with the previous wording, and pointing out the most negative proposals that were rejected.
> Download the pdf (179 Ko)
For a policy on medicines that puts patients first
(1 December 2003)
Knowing which are the active ingredients of a drug, being informed on the added therapeutic value of a new drug, benefiting from a compassionate use programme when it is vital, reporting an adverse effect, contributing to transparency of agencies by joining their board, these are a few of patients needs.
> Download the pdf (74 Ko)
Information on "added therapeutic value" must be publicly accessible
(15 November 2003)
New drugs appearing on the market should have been compared to available treatments for the same condition. Information on "added therapeutic value" is essential for patients, health care providers and those who pay for medicines.
> Download the pdf (79 Ko)
We don't want "secret remedies"
(1 November 2003)
Patients must know exactly what drugs they are using. The international non proprietary name (INN) of each active substance must appear on the packaging, the patient information leaflet and the advertisements.
> Download the pdf (67 Ko).
Excessive protectionism for some drug companies is unacceptable
(15 October 2003)
If amendments excessively prolonging commercial exclusivity for drug companies were voted, it would have huge consequences on health care systems in all EU member states. This unjustified escalation must be prevented.
> Download the pdf (129 Ko)
Getting ready for EU Parliament second reading
(1 September 2003)
The Medicines in Europe Forum intends to convince the Parliament, by next autumn, to defend these amendments that the Council did not take on board.
> Download the pdf (148 Ko).
European Directive on Medicines: we must remain vigilant!
(1 May 2003)
On 2-3 June 2003 the European Council of health ministers will give an opinion on the Directive and Regulation that will form the legal framework for human medicines throughout the European Union in years to come. The wording of these texts will have enormous implications for patients, health professionals, and health insurance systems (social security and mutual insurance). The Medicines in Europe Forum recalls the areas in which the European Directive on human medicines must be reinforced.
> Download the document (zip, 11 Ko)
The European Commission counter-attacks with its second draft Regulation
(15 January 2003)
The Commission rejected many of the amendments voted by the European Parliament, including important amendments supported by Medicines in Europe Forum, of which la revue Prescrire is an active member.
> Download the Situation Update at 31 December 2002 (zip, 12 Ko).
The European Parliament opts for public health at first reading
(1 November 2002)
On 23 October 2002, European Members of Parliament in Strasbourg placed European citizen's interests uppermost, rejecting the bulk of the draft Directive and Regulation on medicinal products for human use prepared by the European Commission's DG Enterprise, which was behaving like spokepersons for industry. The Parliament adopted texts placing drugs firmly within the field of public health.
Read the petitions
(14 July 2002)
Many European Members of Parliament have not yet had the time to examine the relevant texts. Others, influenced by the powerful industrial lobby, remain to be convinced that patients' interests must be placed uppermost, and ministers of Member States must be made more aware of the stakes involved.
> Download the petition to the President of the European Parliament (pdf, 53 Ko).
> Download the petition to the European Deputies (pdf, 57 Ko).
Medicines policy in danger
(14 July 2002)
An independent analysis of the proposed changes to European medicines policy, under the influence of the industrial lobby and the guidance of the European Commission's Enterprise Directorate.
> Download the pdf (354 Ko)
©Medicines in Europe Forum November 2005
