European Scrutiny Committee Contents


11 Information about prescription-only medicines

(a)

(33231)

15477/11

COM(11) 633

(b)

(33230)

15476/11

COM(11) 632


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(Both) Articles 114 and 168(4)(c) TFEU; co-decision; QMV
DepartmentHealth
Basis of considerationMinister's letter of 21 December 2011
Previous Committee ReportHC 428-xl (2010-12), chapter 4 (2 November 2011)
Committee's assessmentPolitically important
Committee's decisionNot cleared; further information requested

Background and previous scrutiny

11.1 The Commission's proposals are intended to amend two EU laws — a 2001 Directive and a 2004 Regulation — which establish procedures for authorising and supervising the marketing, manufacturing, importation and distribution of medicines for human use. These laws prohibit direct advertising to the public of medicines which are only available on prescription, but do not regulate the provision of non-promotional information. As a result, Member States are free to determine whether such information may be provided to the public and, if so, who may provide it. The Commission believes that the absence of a regulatory framework at EU level has led to significant divergences between Member States, creating legal uncertainty for those wishing to market a medicinal product in more than one Member State and providing patients and the general public with unequal access to information. The Commission's proposals, which have been amended to incorporate elements suggested by the European Parliament at its First Reading, therefore seek to establish a clear legal framework for the provision of information on prescription-only drugs.

11.2 Our Forty-fifth Report describes the content and previous scrutiny of the Commission's original proposals,[103] which were first presented in December 2008, as well as the changes included in its amended proposals. The Parliamentary Under-Secretary for Quality at the Department of Health (Earl Howe) told us that the Government supported the general objectives underlying the Commission's original proposals. These were to:

  • ensure the provision of high quality information through the coherent application of clearly defined standards across the EU;
  • allow information to be provided in a way that addresses the needs and capabilities of different types of patients;
  • allow the holders of marketing authorisations to provide objective and non-promotional information on the benefits and risks of their medicines; and
  • ensure that monitoring and enforcement arrangements are in place to verify, without unnecessary bureaucracy, that those providing information to the public comply with the quality criteria.[104]

11.3 He added, however, that the Government had not yet finalised its policy position on the Commission's amended proposals and said that he would write to inform us once it had done so.

11.4 We noted that the Commission's amended proposals appeared to place greater emphasis on patients' right to obtain easily accessible and objectively verifiable information on prescription-only drugs without, however, addressing a fundamental difference of opinion which had emerged between Member States on who should be responsible for providing that information. Whilst it seems that some Member States question whether it is appropriate for manufacturers of medicines to provide the public with information on their prescription-only drugs, others (including the UK) consider that it is legitimate for them to do so, provided that the information is not designed to promote the prescription, sale or supply of those drugs.

The Minister's letter of 21 December 2011

11.5 The Minister first sets out the position taken by the previous Government on the Commission's original proposals, following a wide consultation with the public and interested parties. He says that the then Government:

  • welcomed the retention of the prohibition on the direct advertising to the public of prescription-only medicines, as well as the recognition that pharmaceutical companies could be an appropriate source of information;
  • supported the establishment of a framework for the provision of information by industry on the safe use of medicines; and
  • emphasised the need to ensure that any changes to existing EU legislation would not threaten current practice in the UK.

11.6 The Minister states that these objectives remain valid, but adds that the Commission's amended proposals raise three specific concerns. The first is the role envisaged for the European Medicines Agency which is responsible, under the 2004 Regulation, for authorising and supervising the use of certain medicinal products across the EU. The Commission's amended draft Regulation envisages that the Agency would vet information provided by drugs manufacturers on all centrally authorised prescription-only drugs before that information may be made available to the public. The Minister considers that a blanket approach to the vetting of information is "not proportionate to the risk of non-compliant information and is overly bureaucratic."

11.7 Second, the Minister believes that controls on the advertising of medicinal products (including those centrally authorised by the European Medicines Agency) "are a matter of national responsibility" and that "a regulatory role at a European level would threaten the established role of Member States in the enforcement of (national) advertising controls." We understand that the concern, here, is to ensure that national enforcement bodies are responsible for determining where the boundary lies between information which is factual and objective and information which is misleading or promotional in nature.

11.8 Third, the Minister suggests that the scope of the Commission's proposals may be too narrow, since they would only apply to the provision of information by the holders of marketing authorisations and their agents, thus excluding "third parties with a commercial interest such as slimming and sexual health clinics." He says that existing controls on the advertising of prescription-only medicines in the UK encompass these third parties, so any limitation of their application would present a potential risk to public health.

11.9 In conclusion, the Minister indicates that maintaining existing UK controls will be the Government's main priority in negotiations, whilst also seeking to ensure that "any proposals are proportionate and genuinely enhance consistency and support for safe medicines taking across the Community." He says that he will provide further information once the Government has completed its stakeholder consultation and produced an assessment of the likely costs and benefits of the Commission's proposals.

Conclusion

11.10 We thank the Minister for clarifying the Government's position. We think that the issues which he has highlighted raise legitimate concerns which will need to be addressed in the course of negotiations. We agree that there should be no reduction in the existing level of safeguards applicable in the UK on the provision of non-promotional information on prescription-only drugs and that this should be a priority for the Government. We look forward to receiving further progress reports as negotiations continue as well as, in due course, information on the outcome of the Government's consultation on the amended proposals and its analysis of the likely costs and benefits. Meanwhile, the proposals remain under scrutiny.





103   See (30308) 17499/08 and (30290) 17498/08: HC 19-v (2008-09), chapter 7 (28 January 2009).  Back

104   See the Minister's Explanatory Memorandum of 24 October 2011.  Back


 
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