Latest developments
1 December 2009
The pharmaceutical package was discussed by Member States' Health Ministers at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council meeting. The post-meeting press release states that "with regard to the third part of the "pharmaceutical package", the proposals for a regulation and a directive concerning the information to the general public on medicinal products, the Presidency recalled the strong concerns of many member states. The Commission made it clear that it is prepared to show flexibility in order to find a common basis for the future negotiations."
The European Parliament's environment, public health and food safety (ENVI) committee is expected to vote on the proposals in early April 2010.
27 November 2009
A European Council press release describing the next European Commission's portfolio responsibilities also announced that responsibility for Pharmaceutical Products will move from DG Enterprise and Industry (ENTR) to the Directorate General for Health and Consumer Policy (DG Sanco). This means that the European Medicines Agency will also be within DG Sanco. John Dalli of Malta is the new Health Commissioner designate, replacing Androulla Vassiliou when the new Commission is approved by the European Parliament.
November 2009
The MHRA published its consultation report.
August 2009
Picker Institute Europe submitted a 
response to the MHRA's consultation on the draft Directive.
30 June 2009
The Committee of the Regions draft opinion will be discussed at the Commission for Sustainable Development meeting.
10 June 2009
The European Economic and Social Committee published its final opinion on the proposals, which Council requested as part of the co-decision procedure.
9 June 2009
The Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council's conclusion was that:
"As regards the proposed regulation and directive concerning provision of information by marketing authorisation holders, many ministers expressed concerns that had already been raised in the working group. While agreeing that there is a need to improve the information to the general public on prescription-only medicinal products, many delegations fear that the suggested system will be overly burdensome for competent authorities without leading to significant improvements in the quality of the information provided to patients. In addition, many delegations hold that the distinction between "information" and "advertising" is not sufficiently clear and therefore fear that the proposals will not provide sufficient guarantees that the prohibition of advertising of prescription-only medicinal products to the general public will not be circumvented."
28 May 2009
The Presidency progress report to the European Council stated that:
- "a large majority of delegations do not support the Proposals since they do not consider them as an appropriate way of providing patients with objective and unbiased information on prescription-only medicinal products."
- "a majority of these delegations do not consider the Proposals as an appropriate basis for continued negotiations, although some delegations in this group would be prepared to discuss the Proposals if they would be significantly changed."
The report also states that "two delegations have welcomed the Proposals in guarded terms and underlined the need for rules regarding information to the general public." Picker Institute Europe understands that these are the UK and Lithuanian delegations.
15 May 2009
The Committee of the Regions published its draft opinion , which Council requested as part of the co-decision procedure.
9 and 17 February 2009
Proposals discussed by the European Parliament's Environment, Public Health and Food Safety (ENVI) Committee.
10 December 2008
The European Commission adopted a substantially revised draft Directive on 10 December 2008. Following intense last minute negotiations between the Directorates General for Enterprise and Industry and Health and Consumer Affairs, the 'information to patients' proposal was much improved.
Picker Institute Europe, along with other patient and consumer organisations, remains concerned about the lack of any clear distinction between 'information' and 'advertising', and the potential for 'back door' advertising of prescription-only medicines. We will continue to work to influence the European Council's and Parliament's scrutiny of the Commission's proposals.