Documents considered by the Committee on 2 November 2011 - European Scrutiny Committee Contents


4 Information about prescription-only medicines

(a)

(30308)

17499/08

+ ADDs 1-2

COM(08) 663

(b)

(30290)

17498/08

+ADDs 1-2

COM(08) 662


(c)

(33231)

15477/11

COM(11) 633

(d)

(33230)

15476/11

COM(11) 632


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

Amended draft Directive amending Directive 2001/83/EC as regards information to the general public on medicinal products subject to medical prescription and as regards pharmacovigilance

Amended draft Regulation amending Regulation (EC) No. 726/2004 as regards information to the general public on medicinal products for human use subject to medical prescription and as regards pharmacovigilance

Legal base(a)  and (b) Article 95 EC; co-decision; QMV

(c)  and (d) Articles 114 and 168(4)(c) TFEU;

co-decision; QMV

Document originated(c) and (d) 11 October 2011
Deposited in Parliament(c) and (d) 17 October 2011
DepartmentHealth
Basis of considerationEM of 21 October 2011
Previous Committee Report(a) and (b) HC 19-v (2008-09), chapter 7 (28 January 2009)

(c) and (d) None

Committee's assessmentPolitically important
Committee's decision(a)  and (b) Cleared

(c)  and (d) Not cleared; awaiting further information

Background and previous scrutiny

4.1  In order to ensure the quality, safety and efficacy of medicines, medicinal products require a marketing authorisation before they may be placed on the market. In 2001, the Council adopted a Directive (the 2001 Directive) establishing procedures for Member States to authorise and supervise within their own territories the marketing, manufacture, importation and distribution of medicines for human use. An authorisation given by a Member State or States in accordance with the Directive is valid only in that Member State or States. Title VIII (Articles 86-100) of the Directive contains rules on the advertising of non-prescription medicinal products to the general public, but prohibits advertising of products which are only available on medical prescription. The Directive does not specify what information on prescription-only drugs can be made available to the public. As a result, Member States are free to determine what information may be disseminated to the public, and who may disseminate it.

4.2  In 2004, the Council adopted a Regulation (the 2004 Regulation) establishing procedures for the Commission, assisted by the European Medicines Agency, to authorise and supervise the use, across the EU, of certain medicinal products intended for human and veterinary use. The 2004 Regulation does not, however, include any rules on the information to be provided to the general public about medicinal products authorised in accordance with this EU-wide procedure.

4.3  In 2007, the Commission published a report on the provision of information to the public on medicinal products which highlighted significant divergences between Member States on the information provided and on who may provide it. The Commission considers that these divergences create legal uncertainty for those wishing to market a medicinal product in several, or all, Member States and mean that patients and the general public have unequal access to information.

4.4  The Commission therefore put forward two proposals in 2008 — documents (a) and (b) — to amend the 2001 Directive and 2004 Regulation with a view to establishing a harmonised set of rules for the provision of information on prescription-only medicines. The Commission's proposals were considered by our predecessors in January 2009.[19] In summary, the main changes proposed to the 2001 Directive were:

  • the introduction of a new Title VIIIa dealing with the provision of information to the general public on prescription-only drugs;
  • a description of the information that the holders of a marketing authorisation may disseminate on prescription-only drugs (for example, a summary of the product's characteristics and packaging leaflet, as approved by the national authority responsible for granting a marketing authorisation, information on pricing and on a product's environmental impact, and factual information on adverse reactions);
  • a prohibition on radio or TV advertising of prescription-only drugs;
  • provision for information to be made available in health-related publications, on internet websites concerning medicinal products, and in response to requests for information from members of public;
  • clarification of the conditions governing the dissemination of information on prescription-only drugs (for example, information must be objective and unbiased, evidence-based and verifiable, up-to-date and reliable, and it must be accessible to the general public and comprehensible); and
  • the introduction of a requirement for Member States to ensure that effective monitoring arrangements are in place to verify that information disseminated on prescription-only drugs complies with the provisions of Title VIIIa, and to take adequate and effective measures to sanction any cases of non-compliance.

4.5  As regards the 2004 Regulation, the Commission proposed introducing two new Articles which would:

  • apply the provisions contained in Title VIIIa of document (a) to the dissemination of information on prescription-only drugs for human use authorised under the 2004 Regulation; but
  • some medicinal product-related information would be subject to prior vetting by the European Medicines Agency before being disseminated to the public.

4.6  The previous Government told our predecessors that it broadly supported the aims of the Commission's proposals, notably the emphasis on the provision of high quality, non-promotional information on prescription-only drugs. It noted, however, that the UK took a less restrictive approach than many other Member States to the dissemination of information by pharmaceutical companies. The Government doubted whether the Commission's proposals would broaden to any great extent the information provided to the public in the UK, but said that it would seek to ensure that they had no adverse effect on current practice in the UK. The Government also expressed concern that the proposal to subject the provision of certain product-related information to prior vetting by the European Medicines Agency was disproportionate and risked creating conflict between decisions taken by the Agency under the Regulation, on the one hand, and by national competent authorities pursuant to the Directive, on the other, particularly with regard to the distinction between advertising and information.

4.7  The previous Committee noted that the Commission's proposals were put forward on an internal market legal base and recognised that differences in the rules applied by Member States on the provision of information on prescription-only drugs might lead to distortions within the internal market. Our predecessors also considered that there was a case for allowing manufacturers of prescription-only drugs to provide objective and factual information in line with the conditions proposed in Title VIIIa of document (a). As negotiations were expected to be long and detailed, the Commission's proposals were held under scrutiny and the Government was asked to provide progress reports.

4.8  Progress since then has been slow, mainly because a division has emerged between Member States which question whether it is appropriate for manufacturers of medicines to provide the public with any information about prescription-only drugs and those, including the UK, which consider that it is legitimate to do so provided that the information is not designed to promote the prescription, sale or supply of prescription-only drugs.

The amended proposals — documents (c) and (d)

4.9  The Commission's amended proposals incorporate a number of changes proposed by the European Parliament at its First Reading. In its accompanying explanatory memorandum, the Commission says that its objective, as with its earlier proposals, is to provide a clear framework for the provision of information on prescription-only drugs by:

  • ensuring that information provided to the public is of a high quality and is based on clearly defined standards applicable across the EU;
  • allowing information to be provided through channels which meet 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 risk of their medicines; and
  • ensuring that monitoring and enforcement arrangements exist to verify, without unnecessary bureaucracy, that those providing information to the public comply with the quality criteria.

THE MAIN CHANGES PROPOSED TO THE 2001 DIRECTIVE — DOCUMENT (C)

4.10  The Commission's amended proposal — document (c) — includes the following main changes:

  • the introduction of an obligation on the holders of a marketing authorisation to make certain information available to the public, notably information on the characteristics of a prescription-only medicinal product as well as the associated labelling and packaging leaflet (all subject to approval by the Member State responsible for granting the marketing authorisation);
  • the provision of additional information, for example, on pricing or on environmental impact, would be permitted but would not be mandatory;
  • extension of the prohibition on radio or TV advertising to include a ban on the advertising of prescription-only drugs in the printed media, but with provision for printed material to be made available on request or through a healthcare professional;
  • the introduction of a general requirement for prior approval of information provided by the holder of a marketing authorisation to the public by the competent national authorities, except where adequate control mechanisms are already in place (and have been since at least 31 December 2008); and
  • a tightening of controls on information contained in internet websites provided by the holders of marketing authorisations.

4.11  In addition to these changes, the Commission also proposes amending some of the provisions of the 2001 Directive concerning "pharmacovigilance" — that is, the process for monitoring and assessing the risks and benefits of medicines, including the reporting of any adverse reactions, and for taking remedial action. The main consequence of these changes would be to introduce an automatic procedure for informing all Member States, the Commission and the European Medicines Agency if specific safety issues arise with regard to a medicinal product authorised in accordance with the 2001 Directive. The automatic procedure is intended to ensure that all Member States in which the product in question has been authorised for use have the opportunity to assess and act on any safety concerns which may have arisen within one Member State.

4.12  The Commission believes that the inclusion of these changes to the pharmacovigilance provisions of the 2001 Directive also necessitate a change to the legal base for the amending Directive. It therefore proposes adding Article 168(4)(c) TFEU — which provides for EU measures setting high standards of quality and safety for medicinal products and devices for medical use — to Article 114 TFEU on the internal market.

THE MAIN CHANGES PROPOSED TO THE 2004 REGULATION — DOCUMENT (D)

4.13  The changes in the Commission's amended proposal would strengthen the role of the European Medicines Agency in vetting the information provided by the holders of marketing authorisations before it is made available to the public, including information published on their internet websites.

4.14  As with the 2001 Directive, the Commission also proposes amending some of the provisions of the 2004 Regulation concerning "pharmacovigilance" and to introduce Article 168(4)(c) TFEU as an additional legal base. The main consequence would be to publish more information on special surveillance measures which apply to certain medicinal products after they have been authorised for use.

The Government's view

4.15  The Parliamentary Under-Secretary for Quality at the Department of Health (Earl Howe) tells us that the Government supports the objectives of the Commission's proposals, as summarised above in paragraph 4.9. He adds, however, that the Government has not yet finalised its position on the amended proposals put forward by the Commission and is conducting a further public consultation which will help to inform its view. He says that the Commission's proposals remain controversial in many Member States and that progress is likely to be slow as a result.

Conclusion

4.16  As the Commission's original proposals — documents (a) and (b) — have been superseded by new amended proposals, we are content to clear the former from scrutiny.

4.17  The amended proposals appear to place greater emphasis on patients' right to easily accessible and objectively verifiable information on prescription-only drugs without, however, addressing the fundamental difference of opinion between Member States on who should be responsible for providing that information. We look forward to receiving the Government's analysis of the amended proposals, including their practical implications for patients and the general public in the UK, and an assessment of the probable costs and benefits. Meanwhile, documents (c) and (d) remain under scrutiny.




19   See headnote.  Back


 
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Prepared 10 November 2011