The European Commission adopts revised proposals setting out clearer rules on information on prescription-only medicines

The European Commission adopts revised proposals setting out clearer rules on information on prescription-only medicines

In December 2008, the Commission adopted proposals for a Directive and a Regulation on information to the general public on medicinal products subject to medical prescription. In November 2010, the European Parliament adopted a legislative resolution regarding these proposals at its first reading. On the basis of these amendments, the Commission adopted on 10 February 2012 two amended proposals (Directive and Regulation). At the COREPER meeting of 23 May 2012, the COREPER had taken note of the impossibility to reach a qualified majority on this file. On 21 May 2014, the Commission withdrawn the two amended proposals (OJ CL 153, 21.05.2014, p.3).

For more detail on this process see below.

21/05/2014
Information to patients: withdrawal.

Publication in the Official Journal of the withdrawal of the two amended proposals; OJ C 153 21. 05. 2014, p. 3 .

09/07/2012
Information to patients and Pharmacovigilance.

On 28 June 2012, the Commission adopted a corrigendum to the amended Commission proposal for a Regulation as regards information to the general public on medicinal products subject to medical prescription.

This corrigendum rectifies mistake in the cross references of Article 2, paragraph 2 of the Regulation.

10/02/2012
Information to patients and Pharmacovigilance.

On 10 February 2012, the Commission adopted:

• An amended Commission proposal for a Directive as regards information to the general public on medicinal products subject to medical prescription
• An amended Commission proposal for a Regulation as regards information to the general public on medicinal products subject to medical prescription
• A Commission proposal for a Directive as regards Pharmacovigilance
• A Commission proposal for a Regulation as regards Pharmacovigilance

The adoption of these proposals follows Commissioner Dalli's announcement on 2 December 2011 at the Council on Employment, Social Policy, Health and Consumer Affairs (EPSCO) of the split of the amended proposals on information to patients, which were adopted on 11 October 2011, into two parts relating to "Information to Patients" and "Pharmacovigilance" respectively. The split of the proposals aims to facilitate the discussion of the proposals by the co-legislators. The four proposals will be now discussed by the European Parliament and the Council of Ministers.

11/10/2011
The European Commission adopts revised proposals setting out clearer rules on information on prescription-only medicines.

• Text of the amended proposal (Directive)
• Text of the amended proposal (Regulation)
• Press release
• Q&A: Information to patients on prescription-only medicines

The revised proposals amend the original Commission proposals of 2008 and take into account the European Parliament's amendments to the original proposals for legislation on information to patients.

The revised proposals sets out a clear framework whereby companies with marketing authorisation for a product may - and to some extent must - provide good quality and objective information on their prescription-only medicines to the general public. As a result, the proposals should lead to better empowered patients, more rational use of medicines, whilst, at the same time, maintaining the ban on advertising prescription-only medicines. It also seeks to further strengthen the current system for monitoring the safety of medicines, known as pharmacovigilance.

The revised proposals will now be debated by both the European Parliament and the Council of Ministers.

10/12/2008
The European Commission adopts two legal proposals on the provison of information to patients.

• Press release
• Brief background information
• Summary of the proposal
• Text of the proposal (Directive)
• Text of the proposal (Regulation)
• Impact assessment: volume 1 - volume 2
• Executive summary of the Impact assessment

26/05/2008
Outcome of the public consultation on the key elements of a legal proposal on information to patients.

DG Enterprise and Industry conducted a public consultation between 5 February and 7 April 2008 on the key ideas of a legal proposal aiming at ensuring that all EU citizens have access to good-quality, objective, reliable and non-promotional information on prescription-only medicinal products.

A summary of the outcome of this consultation is available here.

Responses to the public consultation are available here.

05/02/2008
Commission launches a Public consultation on the key ideas of a legal proposal on information to patients.

The "Report on current practices with regard to the provision of information to patients on medicinal products", published on our website for public consultation in 2007, revealed the need to harmonise the way in which information on medicinal products is made available in the EU in order to ensure that all patients have equal access to information on medicinal products.

With this in mind, DG Enterprise and Industry invites you to give your opinion on the key ideas of a legal proposal aiming at ensuring that all EU citizens have access to good-quality, objective, reliable and non promotional information on prescription-only medicinal products:

• Consultation paper

20/12/2007
Communication from the Commission concerning the Report on current practices with regard to the provision of information to patients on medicinal products.

The Communication from the Commission to the European Parliament and the Council concerning the Report on current practices with regard to the provision of information to patients on medicinal products, in accordance with Article 88a of Directive 2001/83/EC, as amended by Directive 2004/27/EC on the Community code relating to medicinal products for human use COM(2007)862, has been adopted today and transmitted to the European Parliament and the Council. The Communication is supported by a Commission Staff Working Document SEC(2007)1740.

All linguistic versions of the Communication COM(2007)862 are available here.

The Commission Staff Working Document SEC(2007)1740 is available here.

19/10/2007
Outcome of the public consultation on a Draft report on current practices with regard to the provision of information to patients on medicinal products.

DG Enterprise and Industry conducted a public consultation between 19 April and 30 June 2007 on a Draft report on current practices with regard to the provision of information to patients on medicinal products, as required under Article 88a of Directive 2001/83/EC, as amended by Directive 2004/27/EC on the Community code relating to medicinal products for human use.

A summary of the outcome of this consultation is available here.

19/04/2007
Consultation on the Draft report on current practices with regard to the provision of information to patients on medicinal products.

DG Enterprise and Industry launches a public consultation on a Draft report on current practices with regard to the provision of information to patients on medicinal products, as required under Article 88a of Directive 2001/83/EC, as amended by Directive 2004/27/EC on the Community code relating to medicinal products for human use.

The consulation document is available here.

Additional information:

• Information to patients

European citizens are increasingly attentive towards new developments in public health which can positively affect their well-being. What is more, information can be easily collected by people, through different channels, such as newspapers, the mass media and the internet. As people play a leading role in the decisions about their own treatment, the dissemination of appropriate high-quality information has became of primary importance.

To ensure adequate information to patients on diseases and treatment options, the European Commission has been looking at different ways of improving the quality and accessibility of information within the High Level Pharmaceutical Forum and with the adoption of legal proposals on information to patients.

• A non-legislative approach
• A legislative approach
• Further information on EU activities in this area in the Health EU Portal

The EU legal framework for medicinal products guarantees high standards of quality and safety. It also promotes the functioning of the internal market, with measures that encourage innovation and competiveness in Europe. It is based on the principle that medicinal products may be placed on the market only following a marketing authorisation granted by the competent authorities. A large body of legislation has developed around this principle with the progressive harmonisation of requirements implemented across the whole European Economic Area.

Today, medicinal products are authorised at EU level by the European Commission or at national level by the competent authorities of EU countries. Special rules exist for the authorisation of medicinal products for paediatric use, orphan medicines, traditional herbal medicines, vaccines and clinical trials. Once placed on the market, the safety of a medicinal product continues to be monitored throughout its entire lifespan through the EU system of pharmacovigilance.

The European Medicines Agency, established in 1995, underpins the centralised authorisation procedure and supports coordination between national competent authorities. The Agency is the hub of a European medicines network comprising over 40 national regulatory authorities guaranteeing a constant exchange and flow of information regarding the scientific assessment of medicinal products in the EU.