Documents considered by the Committee on 28 January 2009 - European Scrutiny Committee Contents

7 Information about prescription-only medicines




COM(08) 663




COM(08) 662

+ ADDs 1-2

Draft Directive amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use

Draft Regulation amending, as regards information for the general public on medical products for human use subject to medical prescription, Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation and supervision of medical products for human and veterinary use and establishing a European Medicines Agency

Commission staff working documents: impact assessment and summary of assessment

Legal base(Both) Article 95 EC; co-decision; QMV
Document originated(Both) 10 December 2008
Deposited in Parliament(a) 12 January 2009

(b) 22 December 2008

Basis of consideration(Both) EM of 14 January 2009
Previous Committee Report(Both) None
To be discussed in Council(Both) None
Committee's assessment(Both) Politically important
Committee's decisionBoth) Not cleared; further information requested


7.1 In 2001, the Council adopted a Directive setting out the rules for the authorisation and supervision by Member States of medicinal products for human use.[27] Title VIII (Articles 86 to 100) of the Directive are concerned with the advertising of medicines. Article 88(1) prohibits the advertising to the general public of products which are available only on medical prescription. Title VIII does not, however, contain rules about the provision of information on prescription-only medicines. So Member States are free to make their own rules on the subject.

7.2 A Regulation of 2004 lays down the procedure for the Commission and European Medicines Agency to authorise and supervise certain medicinal products for human and veterinary use. The Regulation contains no provisions on the provision of information to the general public about products authorised in accordance with the Regulation.

7.3 In 2007, the Commission published its Report on current practices with regard to the provision of information to patients on medicinal products.[28] It found that some Member States apply strict rules, while others allow several types of non-promotional information to be made available to the public. Some Member States give public authorities (such as regulatory agencies) a prominent part in the dissemination of information, while others allow partnerships between public and private organisations. The differences between Member States' rules create difficulties for manufacturers who wish to market a product in several Member States or throughout the EC.

Documents (a) and (b)

7.4 So the Commission proposes a draft Directive and a draft Regulation (documents (a) and (b)) with the aim of providing a clear framework for the provision of information about prescription-only medicines and encouraging the rational use of them. The Commission's explanatory memoranda on the two measures say that this aim would be achieved by;

  • ensuring that information of a high quality is provided by the application throughout the EC of defined standards;
  • allowing the information to be provided through channels which suit the needs and capabilities of different types of patients;
  • allowing the holders of marketing authorisations to provide objective and non-promotional information about the benefits and risks of their medicines; and
  • ensuring that monitoring and enforcement arrangements exist to check, without unnecessary bureaucracy, that the providers comply with the quality criteria.

7.5 The proposals take account of the extensive consultations the Commission held in 2006 and 2007 with pharmaceutical companies, Member States, regulators, patients' organisations and others. In the 2007 consultations:

  • 47% of respondents said that the pharmaceutical industry is not an appropriate source of information about prescription-only medicines;
  • but most respondents considered that the industry should be allowed to provide information to patients who seek it;
  • there was a consensus that pharmaceutical companies should be allowed to publish summaries of product characteristics and patient information leaflets on their websites; and
  • 6% of respondents explicitly supported the use of television and radio to disseminate information about prescription-only medicines, whereas 35% did not.[29]

7.6 The main amendments proposed to the 2001 Directive are set out in a new Title VIIIa, headed Information for the general public on medicinal products subject to medical prescription. The new Title includes

  • a definition of the information that holders of marketing authorisations may disseminate (such as the summary of product characteristics and the packaging leaflet, as approved by the national authority responsible for granting marketing authorisations; and information about the environmental impact of the product);
  • a prohibition on the dissemination of the information by radio or television;
  • a provision restricting the means of publication to the internet, written answers to requests for information from a member of the public or health-related publications;
  • the conditions with which the information should comply (for example, the information should be objective, based on evidence, up-to-date, and verifiable);
  • a requirement that the information should contain specified statements that, for example, the information is disseminated by the holder of the marketing authorisation and that the product is available only on prescription;
  • a requirement for Member States to ensure that there are monitoring arrangements to ensure that the information complies with the provisions of Title VIIIa; and
  • a duty for Member States to ensure that there are appropriate measures to ensure the application of Title VIIIa and penalties for non-compliance with it.

The advertising of prescription-only drugs would continue to be banned.

7.7 Document (d) contains the Commission's proposals for amendments to the Regulation of 2004. It applies Title VIIIa of document (a) to the medicinal products for human use authorised under the 2004 Regulation subject to the vetting of product-related information by the European Medicines Agency (rather than the national regulatory authorities) before the information is disseminated.

The Government's view

7.8 In her Explanatory Memorandum of 14 January, the Minister of State for Public Health at the Department of Health (Dawn Primarolo) tells us that the Government supports the provision to patients of non-promotional information of high quality. It also supports a ban on the advertising of prescription-only medicines.

7.9 The Minister says that the UK has adopted a less restrictive approach than many other Member States to the information which pharmaceutical companies may disseminate to the public. The Government will want to ensure during the negotiation of documents (a) and (b) that the UK's current practices are not affected adversely.

7.10 The Minister draws our attention to a discrepancy between the two documents. Document (a) makes Member States responsible for ensuring that there are adequate arrangements to monitor the compliance of information with the requirements of the proposed Title VIIIa. But document (b) requires the vetting to be done before the information is disseminated and gives the responsibility to the European Medicines Agency. The Government considers that the vetting arrangements proposed by the Commission are disproportionate and that they run the risk of creating conflict between the European Medicines Agency and the national courts about, for example, what is advertising and what is information.

7.11 The Government will hold public consultations on documents (a) and (b) and on a draft Impact Assessment of the effect of the proposals on the UK.


7.12 We recognise that differences in Member States rules about the provision of information on prescription-only medicines might lead to the distortion of the single market for medicinal products. We also recognise that patients may want objective and factual information and that it could properly be provided by the manufacturers so long as they comply with conditions such as those proposed in document (a).

7.13 The Government has some concerns about these documents and it would be surprising if other Member States did not have their own reservations. The negotiations on the proposals are only just beginning. It would be premature, therefore, for us to reach a view on the documents at this stage. We should be grateful, if the Minister would provide us with progress reports on the negotiations and a note on the responses to the Government's consultations. Meanwhile, we shall keep both documents under scrutiny.

27   Directive 2001/83/EC: OJ No. L 311, 28.11.01, p.67. Back

28   (29830) 5242/08. Back

29   See page 4 of ADD 1. Back

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