Thirteen Report of Session 2012-13 - European Scrutiny Committee Contents

28   Information about prescription-only medicines




COM(12) 48




COM(12) 49

Draft Directive amending Directive 2001/83/EC as regards information to the general public on medicinal products subject to medical prescription.

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.

Legal base(Both) Articles 114 and 168(4)(c) TFEU; co-decision; QMV
Basis of considerationMinister's letter of 9 August 2012
Previous Committee ReportsHC 428-liv (2010-12), chapter 3 (14 March 2012);

HC 428-xlvii (2010-12), chapter 11 (18 January 2012); HC 428-xl (2010-12), chapter 4 (2 November 2011)

Discussion in CouncilProposals withdrawn
Committee's assessmentPolitically important
Committee's decisionCleared


28.1  Documents (a) and (b) are Commission proposals to amend two EU laws — a 2001 Directive and a 2004 Regulation — which establish procedures for authorising and supervising the use of medicinal products in order to ensure their quality, safety and efficacy. Although the existing laws prohibit direct advertising to the public of medicinal products which are only available on prescription ("prescription-only drugs"), they do not specify whether non-promotional information on prescription-only drugs may be made available to the public. As a result, Member States are free to determine what information may be provided to the public and who may disseminate it.

28.2  The Commission considers that the absence of EU rules has resulted in significant divergences between Member States and created legal uncertainty for those wishing to market medicinal products in more than one Member State, fragmenting the internal market and impeding patients' access to information on prescription-only drugs. Its proposals seek, therefore, to establish a harmonised set of EU rules which ensure that patients and the general public have access to the same information and that the information provided is objective, evidence-based, up-to-date and reliable.

28.3  The Government told us that the proposed new rules on information requirements were controversial in many Member States, that progress was therefore likely to be slow, and that its main priority would be to ensure that any new EU rules did not undermine existing safeguards in the UK. The Government highlighted elements of the Commission's proposals which it considered to be disproportionate or which encroached on Member States' responsibility for determining where the boundary lies between information which is factual and objective and information which is misleading or promotional in nature. Our earlier Reports provide a more detailed overview of the content of the proposals and the Government's position.[152]

28.4  We asked the Government to provide progress reports on the negotiations and, in due course, to inform us of the outcome of its consultation of stakeholders and its analysis of the likely costs and benefits of the Commission's proposals.


28.5  The Parliamentary Under-Secretary of State for Quality (Earl Howe) informs us:

"The Danish Presidency has reported to the Commission that Member States have been unable to reach agreement in Council and the proposals have consequently fallen. The UK priority in negotiation was to ensure that any changes did not threaten existing UK practice and this has been achieved."


28.6  Negotiations on these and previous Commission proposals have revealed a fundamental difference of opinion amongst Member States on who should be entrusted to disseminate information to the public on prescription-only drugs, with some questioning whether it is legitimate for drugs companies to do so. We note that the Danish Presidency was unable to bridge these differences and that the proposals have been withdrawn. We therefore clear both documents from scrutiny.

152   See head note. Back

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Prepared 2 November 2012