Explanatory Memorandum to COM(2011)632 - Amendment of 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 - Main contents
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| dossier | COM(2011)632 - Amendment of Regulation (EC) No 726/2004 as regards information to the general public on medicinal products for human use ... |
|---|---|
| source | COM(2011)632  |
| date | 11-10-2011 |
1. Background
On 10 December 2008, the Commission adopted a proposal for a Regulation of the European Parliament and of the Council on information to the general public on medicinal products subject to medical prescription. This proposal was forwarded to the European Parliament and the Council on 10 December 2008.
The Economic and Social Committee gave its opinion on 10 June 2009 and the Committee of the Regions, 7 October 2009.
The European Parliament adopted a legislative resolution at its first reading on 24 November 2010.
2. Objective of the Commission's proposal
The general policy objectives of the proposals to amend Directive 2001/83/EC and Regulation (EC) No 726/2004 are in line with the overall objectives of the EU pharmaceutical legislation. These are intended to ensure the proper functioning of the internal market for medicinal products for human use and to better protect health of EU citizens. Following this line, the proposals aim specifically to:
· Provide for a clear framework for provision of information by marketing authorisation holders about their prescription-only medicines to the general public with a view to enhancing the rational use of these medicines, while ensuring that the legislative framework continues to prohibit direct-to-consumer advertising of prescription-only medicines.
This aim shall be achieved by:
· Ensuring the high quality of information provided by coherent application of clearly defined standards across the EU.
· Allowing information to be provided through channels addressing needs and capabilities of different types of patients.
· Allowing marketing authorization holders to provide in an understandable way objective and non-promotional information about the benefits and the risks of their medicines.
· Ensuring that monitoring and enforcement measures are in place to ensure that information providers comply with the quality criteria, while avoiding unnecessary bureaucracy.
This amended proposal is in line with those objectives and further reinforces the rights of patients. In particular, the marketing authorisation holders will have the obligation, and no longer the possibility, to make available certain information, such as the labelling and the package leaflet.
3. Commission opinion on the amendments adopted by the European Parliament:
On 24 November 2010, the European Parliament adopted 12 amendments on the proposal for a Regulation on information to the general public on medicinal products subject to medical prescription. The Commission considers that a majority of the European Parliament's amendments are acceptable in full, in principle, or in art, as they maintain the aims and overall scheme of the proposal.
The Commission therefore accepts in full or in part, the following amendments of the European Parliament:
Recital 1 is modified in accordance with amendment 1, which underlines that in the Commission Communication transmitted on 20 December 2007 concerning the 'Report on current practices with regard to the provision of information to patients on medicinal products' the need for a more precise distinction between advertising and information was highlighted.
Amendment 2 specifies in recital 2 that the new Title introduced in Directive 2001/83/EC is intended to place emphasis on the rights and interests of patients.
In accordance with Amendment 6, it has been specified in Article 20b, paragraph 1, that although the pre-control of information is performed by the Agency for centrally approved medicinal products, the monitoring of the information rests with Member States. It is appropriate to ensure consistently that the Agency is also responsible for the control of the information made available through Internet websites registered in the Member States. Specific provisions are introduced to clarify the operation of this control mechanism in such case of information made available through Internet websites registered with the Member States. The Commission acknowledges that a number of Member States have expressed concerns in relation to the conformity with their national constitutions. The Commission is prepared to enter into a dialogue with those concerned to find suitable solutions while fully respecting the objectives of this Regulation.
Following Amendment 7, the word 'disseminated' has been replaced by 'made available' within Article 20b, paragraph 2.
Amendment 9 provides for the procedure regarding cases when the Agency requests for changes within the information submitted for control and for the fees applicable which should be proportionate to the additional work. Considering that the normal delay is 60 days, the subsequent delay should be of 30 days.
Amendment 10 modifies Article 57, paragraph 1, concerning the so-called EudraPharm database and provides that it should be available in all EU languages. Such a change has been introduced as regards the lay-out of the database; on the other hand, the information contained in the database will be available in the languages of Member States where the medicinal product is authorised. In another respect, it is not necessary to further specify that the information provided is designed for non-experts, as it is already provided that it should be worded in an appropriate and comprehensible manner in accordance with article 57.
Amendment 12 provides that EudraPharm should be actively promoted to European citizens. This should be done through the development of the European medicines web-portal established by Regulation (EU) No 1235/2010 as the central point of access to information about medicinal products. On the other hand, it is not appropriate that information available on marketing authorisation holder websites is reproduced on EudraPharm, which is a public database.
Pharmacovigilance
In addition to the changes introduced on the basis of the European Parliament resolutions regarding the Commission proposals on information to patients, the Commission considers that limited changes to Regulation 726/2004 in the area of pharmacovigilance should be introduced.
Regulation (EC) No 726/2004 has been recently amended by Regulation (EU) No 1235/2010 to revise the EU pharmacovigilance system. Regulation (EU) No 1235/2010 having as legal basis Article 168(4)(c) of TFUE; the amended proposal should also be based on Article 168(4)(c) of TFUE. Regulation (EU) No 1235/2010 substantially strengthens the legal framework for the surveillance of medicinal products in the EU. However, in view of recent pharmacovigilance events in the EU, the Commission has detected certain areas where the legislation could be further strengthened. Therefore:
– The new public list of medicinal products subject to additional monitoring introduced by Regulation (EU) No 1235/2010 will not necessarily include all medicinal products subject to post-authorisation safety conditions; competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance. For the sake of fuller transparency as regards products under special surveillance, Article 23 should be modified to systematically include medicinal products that are subject to conditions and requirements with regard to safety.
– Article 13 is modified and a new Article 14b is introduced to avoid that the voluntary withdrawal of a marketing authorisation or product by the holder could lead to safety issues not being addressed in the EU, by clarifying information obligations of the marketing authorisation holder.
– Article 20 is modified to clarify the respective scopes of this provision and the EU procedures foreseen in Directive 2001/83/EC.
4. Conclusion
Having regard to Article 293 of the Treaty on the functioning of the European Union, the Commission modifies its proposal as follows: