Explanatory Memorandum to COM(2012)52 - Amendment of Directive 2001/83/EC as regards pharmacovigilance - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2012)52 - Amendment of Directive 2001/83/EC as regards pharmacovigilance. |
|---|---|
| source | COM(2012)52  |
| date | 10-02-2012 |
On 15 December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation shall apply in July 2012.
The adopted measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions that reinforce the coordinating role of the European Medicines Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns.
However, recent pharmacovigilance events in the European Union, in particular the so-called “Mediator case”, have shown the need for a further improvement of the pharmacovigilance system.
Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system which should be addressed.
In particular, Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatism being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level.
Moreover, marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns.
Finally, the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, 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.
2. OBJECTIVE OF THE COMMISSION'S PROPOSALS
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 address weaknesses identified in the EU pharmacovigilance system and provide for more transparency and efficiency of the system in cases where safety concerns are identified.
3. EXPLANATORY DOCUMENTS ACCOMPANYING THE NOTIFICATION OF TRANSPOSITION MEASURES AND BUDGETARY IMPLICATION
As the proposed Directive aims to amend only a very limited number of legal obligations of Directive 2001/83/EC, correlation tables or other explanatory documents are not required to accompany the notification of transposition measures by the Member States.
The proposals have no implication for the budget of the Union.
The proposals only make minor adjustments to the system set forth by the 2010 pharmacovigilance legislation. They do not require additional human or administrative resources for the functioning of the pharmacovigilance system.