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Medicines in Europe:
the different steps of the campaign
(2002-2004)
 

The European legislative framework, published on 30 April 2004, determines the level of guarantees offered to EU citizens on marketing authorisation, risk management, and information on medicines.

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Here are the main elements of the campaign posted on our website from July 2002, and last updated on 15 November 2005.

"Priority Medicines for the Citizens of Europe"
The most important changes in the new legislation
The legislative framework that will apply to medicines in the enlarged Europe has been adopted
Second reading at European Parliament: the big push from pharmaceutical industry lobbies
For a policy on medicines that puts patients first
'Added therapeutic value'
We don't want 'secret remedies'
Excessive protectionism for some drug companies is unacceptable
Getting ready for EU Parliament second reading
The European Council of Health Ministers partly agreed with the Parliament
European Directive on Medicines: we must remain vigilant!
An appeal to Ministers: don't forget the fundamentals!
The European Commission counter-attacks with its second draft Regulation
The initial direction of the Council of Ministers
The governments involved
Members of the European Parliament opt for public health
Lobby the European Parliament!
A decisive autumn
Texts of the petitions
Medicines policy in danger

"Priority Medicines for the Citizens of Europe" (18 November 2004)
Position statement by the Medicines in Europe Forum on the Dutch EU Presidency initiative
For further information: Click here
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.
For further information: Click here
The legislative framework that will apply to medicines in the enlarged Europe has been adopted (1 January 2004)
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 texts.
For further information: Click here
Second reading at European Parliament:
the big push from pharmaceutical industry lobbies

(1 December 2003)
Useful amendments have been adopted. Other amendements protecting the pharmaceutical industry endanger health care systems.
For further information: Click here
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.
For further information: Click here
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.
For further information: Click here
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.
For further information: Click here
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.
For further information: Click here
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.
For further information: Click here
The European Council of Health Ministers partly agreed with the Parliament (15 June 2003)
On June 2 and 3, 2003, the European Council of Health Ministers examined the draft Directive and Regulation on medicines for human use
For further information: Click here
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.
For further information: Click here
An appeal to Ministers: don't forget the fundamentals! (1 March 2003)
The working party preparing the decisive meeting of the Council of Ministers on 2-3 June 2003 is meeting regularly and productively, but several key matters concerning public health have not yet been taken into account.
The Medicines in Europe Forum recalls the areas in which the European draft Regulation on human medicines must be improved.
For further information: Click here
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.
For further information: Click here
Initial direction of the Council of Ministers (15 December 2002)
Initial direction of the Council of Ministers does not contradict options of Members of Parliament.
For further information: Click here
Governments involved (1 December 2002)
December 2002: representatives of Member States within EU Council of Health Ministers work on the draft Regulation, then on the draft Directive, before the second reading in European Parliament due in 2003.
For further information (in French): Click here
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.
For further information: Click here
Lobby the European Parliament! (15 October 2002)
On 2 October 2002 the Committee on the Environment, Public Health and Consumer Policy of the European Parliament adopted several amendments favouring public health. But key items were rejected thanks to industrial lobbies.
For further information (in French): Click here
A decisive autumn 2002 (1 October 2002)
Many European Members of Parliament clearly perceived the risks linked with the draft Directive and Regulation; scrutiny of the texts and the numerous amendments (more than 600) delayed voting by the Committee on the Environment, Public Health and Consumer Policy of the European Parliament.
For further information (in French): Click here
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.
For further information: Click here

Medicines policy in danger (14 July 2002)
For an independent analysis of the proposed changes to European medcines policy, under the influence of the industrial lobby and the guidance of the European Commission's Enterprise Directorate, download la revue Prescrire's file, free of charge
For further information: Click here

 

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