History and key documents
The Commission's proposals are being considered by the European Council and European Parliament under the co-decision procedure.
The new Parliament's Committee meetings commenced in September 2009.
The full text of the pharmaceutical package adopted by the Commission and the supporting documents are available on the DG Enterprise & Industry's webpage.
5 December 2008
DG Enterprise & Industry announced that it would ask the College of Commissioners to adopt the revised pharmaceutical package proposals on 10 December 2008.
November and December 2008:
Pressure from European patient, consumer and health professional organisations - including a letter to the President of the European Union, co-signed by the Picker Institute and 19 other organisations - plus opposition by the Commissioners for Health and Communications caused the European Commission to further postpone adoption of the 'pharmaceutical package' that had been re-scheduled for 26 November.October 2008:
DG Enterprise & Industry had been scheduled to present its tripartite "pharmaceutical package" of proposals, covering information for patients, pharmaco-vigilance and counterfeiting, to European Commissioners on 21 October.Picker Institute Europe issued a 
briefing to European Commissioners and Cabinet representatives, to inform discussions during the preliminary Cabinet meetings. It wrote a letter, with other UK organisations, to Baroness Ashton, the UK's newly appointed European Commissioner for Trade.
DG Enterprise & Industry delayed presentation of the package, citing a need to make 'some technical changes'.
September - October 2008:
DG Enterprise & Industry finalised proposals to amend Directive 2001/83/EC to allow direct to consumer communication by pharmaceutical companies about prescription-only medicines.June 2008:
The European Council published its conclusions on DG Enterprise & Industry's report on current practice with regard to provision of information to patients on medicinal products. Council called on the Commission toand stressed:
February to April 2008:
DG Enterprise & Industry consultation on "the key ideas of a legal proposal on information to patients".Picker Institute Europe response to the Legal Proposal on Information to Patients.
DG Enterprise & Industry published a summary of consultation response; and published all the consultation responses.
December 2007:
DG Enterprise & Industry submitted its final report to the European Parliament and European Council. The "Communication from the Commission concerning the Report on current practices with regard to the provision of information to patients on medicinal products", was published together with background information in the Commission Staff Working document.October 2007:
European Commission Legislative and Work Programme 2008 published - includes "pharmaceutical package" comprising:- communication on the future of the single market in pharmaceuticals for human use
- directive on Pharmaceuticals - Information to patients
- strengthening and rationalising EU Pharmacovigilance.
April to June 2007:
DG Enterprise and Industry published its draft report on current practices with regard to the provision of information to patients on medicinal products.Picker Institute Europe response to the draft report on current practices.
DG Enterprise & Industry summary of consultation responses October 2007.
2005-2008: European Pharmaceutical Forum
Following the G10 Medicines Group, the European Commission established a three-year High Level Pharmaceutical Forum, with three working groups - information to patients, pricing and reimbursement, and relative effectiveness.
The Forum first met in September 2006 and held its third and final meeting October 2008, publishing a report of its conclusions and recommendations. The information to patients working group recommendations cover: enhancing the quality of information; increasing the accessibility and dissemination of information; generating information by making best use of all actors; and maintaining the working group momentum.
2002: The G10 High Level Group report
The G10 High Level Group on Innovation and Provision of Medicines was appointed by the European Commission to "discuss the major issues relevant to the right balance of health objectives and industry competitiveness in Europe".
Medicines provision was one of the areas of concern that the Group was asked to discuss, to include patients' access to information and the impact of developments in information and communication technology.
The Group met three times between March 2001 and February 2002. The patients' representative was Angela Coulter, then chief executive of the Picker Institute.
The Group published its final report in May 2002. With regard to prescription-only medicines, the Group recommended that the restriction on advertising to the general public should continue, and that:
"Consideration should be given by the European Institutions, as part of their current review of the pharmaceutical legislation, to:
- in co-operation with all stakeholders to produce a workable distinction between advertising and information that would allow patients actively seeking information to be able to do so, and to develop standards to ensure the quality of such information; and
- the establishment of a collaborative public-private partnership involving a range of interested parties. The information should be carefully piloted and evaluated to assess the extent to which it meets the needs of patients."
The European Commission published its response to the G10 High Level Group report in July 2003, stating that the prohibition on advertising prescription medicines to the public would remain, and that the Commission would "explore, with stakeholders, a range of approaches to provide a realistic and practical framework for the provision of information on prescription and non-prescription medicines".
June 2003:
the European Council of Health Ministers rejected the Commission's proposal to amend Directive 2001/83/EC to allow direct to consumer communication about prescription-only medicines for HIV/AIDS, diabetes and asthma.October 2002:
The European Parliament's report rejected the Commission's proposal to amend Directive 2001/83/EC to allow direct to consumer communication about prescription-only medicines for HIV/AIDS, diabetes and asthma. MEPs replaced the Commission's proposed amendment (see Amendment 101, Article 1 Paragraph 54) with a new amendment (see Article 88, paragraph 6a (new) Directive 2001/83/EC).July 2001:
The European Commission adopted a proposal to amend Directive 2001/83/EC allow a five year pilot of direct to consumer pharmaceutical company "patient oriented and controlled information" about prescription-only medicines to treat HIV/AIDS, diabetes, asthma and chronic bronchitis.2001: European Directive 2001/83/EC
Title V111, comprising Articles 86 - 100, of Directive 2001/83/EC of the European Parliament and of the European Council covers advertising of medicinal products for human use, superseding Directive 92/98/EC.
Article 88 states that Member States shall prohibit the advertising to the general public of medicinal products which are available on medical prescription only.
Title V111 does not cover or prohibit:
- product labelling and accompanying package leaflets
- correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product
- factual, informative announcements and reference material,provided they include no product claims
- information related to human health or diseases that does not refer to medicinal products.
Article 88a of Directive 2001/83/EC, introduced by the European Parliament in 2002, states that:
"within three years ......the Commission shall, following consultations with patients' and consumers' organisations, doctors' and pharmacists' organisations, Member states and other interested parties, present to the European Parliament and the Council a report on current practice with regard to information provision - particularly on the internet - and its risks and benefits for patients.
"Following analysis of the above data, the Commission shall, if appropriate, put forward proposals setting out an information strategy to ensure good quality, objective, reliable and non-promotional information on medicinal products and other treatments and shall address the question of the information source's liability."
Earlier European Directives
European Council Directive 92/28/EEC extended the prohibition on television advertising to other media, introducing a Europe-wide ban on advertising to the general public of prescription-only medicines. Directive 92/28/EEC was repealed and superseded by Directive 2001/83/EC.
European Council Directive 89/552/EEC concerning television broadcasting activities prohibited television advertising of prescription-only medicines.