We will deal with the following matters of EU scrutiny proposals: COM (2012) 48 and COM (2012) 49, proposals for a directive and a regulation on medical information to the general public on medicinal products subject to medical prescription. On the basis of recent developments at EU level on the proposals as outlined today, it is proposed that no further scrutiny of these proposals is warranted. I propose the Department is requested to keep the committee informed of developments on the proposal. Is that agreed? Agreed.
COM (2012) 84 is a proposal for a directive relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems. The proposed directive is intended to replace the existing 1989 transparency directive, which established minimum pricing and procedural safeguards to ensure decisions on national cost-containment measures on pricing and reimbursement for medicinal products are taken in an open and transparent manner. Concerns have been expressed by the Department of Health and other members states regarding proposed additional administrative requirements by this directive, which it states has the potential to partially delay State-aided access to new medicines. On the basis of the information supplied by the lead Department, it is proposed that the proposal warrants further scrutiny. It is suggested that officials from the Department of Health be invited to attend a committee meeting to assist the committee in further scrutiny of the EU proposal. Is that agreed? Agreed.