On the issue of EU scrutiny, COM (2012) 48, concerns a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards information to the public on medicinal products subject to medical prescription. COM (2012) 49, concerns a regulation of the European Parliament and of the Council amending regulation (EC) No. 726/2004 as regards information to the public on medicinal products for human use subject to medical prescription. COM (2012) 48 and COM (2012) 49 are linked proposals for a directive and a regulation regarding information to the public on prescription-only products. These revised proposals stem from COM (2011) 632 and COM (2011) 633 which were considered by this committee in January 2012 and which have been amended to exclude the pharmacovigilance aspects. It was agreed by the committee at the meeting that no further scrutiny of the COMs was warranted.
Due to lack of progress on proposals COM (2011) 632 and COM (2011) 633 at working group level, that legislative package has now been separated and recast into two separate sets of proposals regarding, first, information to patients and, second, pharmacovigilance.
COM (2012) 48 and COM (2012) 49 relate to information to patients legislation only. The aim of the proposals is to provide a clear framework for the provision of quality information on prescription-only medicines, while continuing to prohibit direct-to-consumer advertising of prescription-only medicines. The revised proposals contain no substantive changes from the proposals already considered by this committee other than the changes outlined.
It is proposed that these amended proposals warrant further scrutiny. Is that agreed? Agreed. We will request that officials from the Department attend to explain fully the proposals to the committee. Is that agreed? Agreed.
COM (2012) 51 is a regulation of the European Parliament and of the Council amending Regulation EC No. 726/2004 as regards pharmacovigilance. COM (2012) 52 is a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards pharmacovigilance. COM (2012) 51 and COM (2012) 52 are linked proposals for a directive and a regulation which form part of a cohesive proposal to amend the EU pharmaceutical code as regards pharmacovigilance. The aim of the proposed directive and regulation is to strengthen existing pharmacovigilance legalisation to eliminate weakness in the system. The committee considered proposals on COM (2011) 632 and COM (2011) 633 in January 2012 which included pharmacovigilance and information to patients elements in the scope of the proposals. It was agreed then by the committee that no further scrutiny of the proposal was warranted.
Due to a lack of progress on those proposals at EU working group level, that proposed legislative package has been separated and recast into separate sets of proposals regarding, first, information to patients and, second, pharmacovigilance. These proposals for a directive and regulation relate to pharmacovigilance aspects only. In view of the fact that Ireland welcomes these proposals as the measures, as the measures are designed to strengthen the pharmacovigilance system, it is proposed that these proposals do not warrant scrutiny. Is that agreed? Agreed.