Fifty-ninth Report of Session 2010-12 - European Scrutiny Committee Contents


3 Information about prescription-only medicines

(a)

(33230)

15476/11

COM(11) 632

(b)

(33231)

15477/11

COM(11) 633

(c)

(33689)

6549/12

COM(12) 48

(d)

(33690)

6550/12

COM(12) 49


Amended proposal for a 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

Amended proposal for a 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 proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards information to the general public on medicinal products subject to medical prescription

Amended proposal for a Regulation of the European Parliament and of the Council 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(All) Articles 114 and 168(40(c) TFEU; co-decision; QMV
Document originated(a)  and (b) 11 October 2011

(c)  and (d) 10 February 2012

Deposited in Parliament(a)  and (b) 17 October 2011

(c)  and (d) 22 February 2012

DepartmentHealth
Basis of considerationEM of 6 March 2012
Previous Committee ReportHC 428-xlvii (2010-12), chapter 11 (18 January 2012); HC 428-xl (2010-12), chapter 4 (2 November 2011)
Discussion in CouncilNo date set
Committee's assessmentPolitically important
Committee's decision(a)  and (b) Cleared

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

Background and previous scrutiny of documents (a) and (b)

3.1  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.

3.2  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.

3.3  In addition to new rules on the provision of information on prescription-only drugs, the Commission proposals also include a number of changes to the pharmacovigilance provisions of the 2001 Directive and 2004 Regulation which establish systems for monitoring the safety and efficacy of medicinal products.

3.4  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 Forty-fifth and Fifty-second Reports provide a more detailed overview of the content of the proposals and the Government's position.

3.5  We thought that the Government had raised legitimate concerns and asked for progress reports on how they were being addressed during negotiations. We also asked for information, in due course, on the outcome of the Government's consultation of stakeholders and its analysis of the likely costs and benefits of the Commission's proposals.

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

3.6  Documents (c) and (d) are new Commission proposals which are the same, in substance, as documents (a) and (b), but they no longer include the proposed changes to the provisions of the 2001 Directive and 2004 Regulation on pharmacovigilance which are now the subject of separate proposals.[32] The content of the proposed rules on the provision of information on prescription-only drugs remains unchanged. The Commission anticipates that, by splitting its proposals in this way, it will be easier to reach agreement on the far less contentious changes it has proposed to the pharmacovigilance provisions.

3.7  The Parliamentary Under-Secretary for Quality (Earl Howe) suggests that the new proposals are unlikely to make much headway because they remain controversial in many Member States. His analysis of the policy implications is unchanged, but he adds that the impact of any new legislation is likely to be less significant for the UK than other Member States, as the UK takes a less restrictive approach to the provision of information.

Conclusion

3.8  We note that the Commission's proposals to introduce common EU rules on the provision of information on prescription-only drugs, and the Government's position, are as described in our earlier Reports.[33] As we have indicated previously, we think that the Government has identified some legitimate concerns which will need to be addressed in the course of negotiations. We therefore look forward to hearing what, if any, progress is being made during negotiations and to receiving further information on the outcome of the Government's consultation of stakeholders and its analysis of the costs and benefits of the Commission's proposals. Meanwhile, documents (c) and (d) remain under scrutiny but we are content to clear documents (a) and (b) as they have been superseded.




32   See (33691) and 33692), chapter 15 of this Report.  Back

33   See headnote.  Back


 
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