Mr. Paul Barron:

I thank the joint committee for the invitation to discuss three proposals under deliberation at EU level. The first is for a draft directive on the terms on which medicinal products are covered by the public health insurance systems of member states. This is generally referred to as the transparency directive. The second and third proposals relate to general medical devices and in vitro diagnostic medical devices, respectively.

I will begin with the transparency directive. In March 2012 the European Commission adopted the proposal for a new transparency directive to replace Directive 89/105/EEC. It deals with measures regulating the terms on which medicinal products are covered by the public health insurance systems of member states. The Commission’s view is that since 1989 reimbursement systems have become increasingly complex and that a new directive is required to address these complexities. It is also intended to incorporate European Court of Justice case law which has developed and is relevant to the directive.

Member states had concerns about many of the proposed measures and the administrative burden which would be placed on member states arising from the proposal. On 6 February 2013 the European Parliament introduced amendments in an attempt to address these concerns. These amendments were largely adopted by the European Commission in its modified proposal adopted on 20 March.

Under the Irish Presidency, the working party on pharmaceuticals and medical devices chaired by Ireland held four discussions on the modified proposal, about which many delegations continue to express various degrees of concern. Further detailed discussions are required at the working party before the proposal will have support at the Council.

The Department of Health had substantial concerns about the original Commission proposal. However, the amendments proposed by the European Parliament which were largely adopted by the Commission went a long way towards resolving our main concerns.

I will now deal with the medical devices proposals published by the Commission in September 2012. There are two related proposals, one of which is to regulate general medical devices, while the second is to regulate invitro diagnostic medical devices. The proposals are designed to provide a legislative framework for the manufacture and placing on the market of both medical devices and in vitro diagnostic medical devices in order to ensure a high level of protection for patients and health care professionals.

Under existing legislation, medical devices, unlike medicines, are not subject to pre-market authorisation by a regulatory authority before being placed on the market. Instead, medical devices undergo a conformity assessment to confirm that they meet specified safety and performance requirements. Assessments are conducted by independent certification bodies, known as notified bodies, which are designated and regulated at national level. One of the main criticisms of the current regulatory system is that notified bodies operate to different standards. It has also been suggested it may be possible for notified bodies to undertake conformity assessments of categories of medical devices for which they may not have the requisite expertise. Consequently, it is recognised that improved and harmonised regulatory oversight of notified bodies is needed.

The Commission has proposed a scrutiny mechanism whereby new applications for conformity assessment of high risk devices, once the assessment of the notified body is complete, could be subject to a second look by the medical devices co-ordination group, a new expert committee composed of member state officials and chaired by the Commission. It is intended that this mechanism will serve to increase the scrutiny of new high risk medical devices as they come on to the European market and allow for enhanced oversight of the performance of notified bodies. The Council does not yet have a position on this issue.

The Commission proposes a rigorous process for approving notified bodies, with strict standards to be met by notified bodies, strengthened criteria for determining the scope of competence of a notified body such as the types of device a notified body may assess, and a joint approach to assessment of notified bodies. The European Parliament ENVI committee and member states both support improved oversight and regulation of notified bodies.

To date, the Council working party on pharmaceuticals and medical devices has met on 16 occasions during the Cyprus, Irish and Lithuanian Presidencies. The examination of the medical devices proposals constituted one of the four key priorities of the Irish Presidency health agenda. During the Irish Presidency substantial progress was made in the examination of the two proposals. In parallel, informal technical expert meetings were organised by the Irish Presidency to discuss technical aspects, submit wording suggestions and help in identifying key issues.

In the European Parliament the proposals were examined by the Committee on the Environment, Public Health and Food Safety, known as ENVI. This committee has voted in favour of pre-market authorisation for high risk medical devices via a centralised EU structure of notified bodies approved by the European Medicines Agency. The Council does not yet have a position on this issue. The ENVI report has proposed many useful amendments. On 22 October the European Parliament voted on the reports and amendments submitted to the plenary session. The vote on the First Reading resolution was postponed; however, a mandate was given to the rapporteurs to commence negotiations with the Council.

The Department of Health is actively engaged in the negotiations on the medical devices proposals, with the support of our colleagues in the Irish Medicines Board. We support the development of a robust legislative framework for medical devices in Europe which will ensure all medical devices placed on the European market are safe for both patients and health care professionals and that European patients have access to new innovative treatments. In our view, a proportionate balance must be achieved in the new regulatory system between ensuring appropriate pre-market oversight of the conformity assessment of high risk devices before being placed on the market and facilitating innovation in the sector and timely access by patients to new treatments.

We will be happy to take questions from members.