Jerry Buttimer (Cork South Central, Fine Gael)
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We have received apologies from Deputies Catherine Byrne and Regina Doherty and Senators Imelda Henry and Jillian van Turnhout.

I remind members, witnesses and those in the Visitors Gallery to leave their mobile phones in the off position or airplane mode, rather than in silent mode, as they interrupt the broadcasting of the proceedings and interfere with the quality of the broadcast. They also cause angst to members of staff who must wear headsets.

The purpose of the meeting is to consider some European Union legislative proposals regarding the regulation of medical devices - COM (2012) 541 and COM (2012) 542 - and the pricing of medicinal products for human use - COM (2013) 168. We considered this issue earlier in the year and will now receive an update and clarification on same. We also requested an update on the position on De Puy hips and PIP breast implants, information on which was circulated to members in advance of the meeting.

I welcome from the Department of Health Mr. Paul Barron, assistant secretary; Ms Teresa Cody and Mr. Patrick Creedon, primary care unit; and Mr. Hugh Drumm, medicines unit; from the Health Service Executive Dr. Ian Carter, national director for acute services; from the Irish Medicines Board Mr. Pat O’Mahony, chief executive; Dr. Joan Gilvarry, director of human products monitoring; and Dr. Niall MacAleenan, clinical assessment manager and medical devices lead. They are all very welcome and I thank them for being here.

Witnesses are protected by absolute privilege in respect of their evidence to the joint committee. However, if they are directed by it to cease giving evidence on a particular matter and continue to do so, they are entitled thereafter only to qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against a person or an entity by name or in such a way as to make him, her or it identifiable. Members are reminded of the long-standing parliamentary practice and ruling of the Chair to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official by name or in such a way as to make him or her identifiable.

I thank the delegates for their attendance and invite Mr. Barron to make his opening statement.

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.

Mr. Pat O'Mahony:

I am accompanied by Dr. Niall MacAleenan who is clinical assessment manager at the Irish Medicines Board and also the medical devices lead person for the authority. We are grateful for the opportunity to update the joint committee, as requested, on the PIP breast implant and the DePuy ASR hip recall issues. In addition, we would like to take the opportunity to provide committee members with an overview of the implementation of the European Commission’s joint plan for immediate action on medical devices which was put in place in response to these crises. Members may recall that in September we provided an update on the PIP breast implant issue. We advised that we anticipated imminent publication of the report from the European scientific committee on emerging and newly identified health risks - its second comprehensive review of these implants. The SCHENIHR committee's report, published on 29 October, states:

There is currently no convincing medical, toxicological or other data to justify removal of intact PIP implants as a precautionary approach. Implant removal in the absence of malfunction may be considered for women who are experiencing significant anxiety because they have a PIP breast implant. However, the decision to remove an intact PIP implant for this reason should be based on an individual assessment of the woman's condition by her surgeon or other treating physician after consultation.

In 2012 and, more recently, September 2013 we outlined to the committee the details of the worldwide recall of DePuy ASR and ASR XL hip implants. The recall of these products was based on data from the National Joint Registry of England and Wales which showed higher than expected implant revision rates at five years. At the time of our update, approximately 3,500 ASR hips had been implanted in Ireland. The IMB has since worked closely with the HSE and Irish orthopaedic surgeons on the recommendations for individual patient follow-up. When we met the committee in July 2012, the HSE had outlined that at the time 96% of patients had attended review appointments and over 350 had had revision surgery, with another 166 scheduled for surgery. We understand all patients have been reviewed and the HSE representatives will give details of updated figures for revision surgeries.

The IMB continues to assess the reported incidents received and analyse data generated from revisions, joint registry data, as well as from clinical studies. Independent analysis of explanted devices which have been returned for investigation is being conducted in the United Kingdom at the London Implant Retrieval Centre. The ASR recall experience has been central to wider international discussions on metal on metal implants. The research in this area suggests increased revision rates associated with large diameter-head metal on metal hip implants. Mechanical wear of an implant is experienced with all types of hip replacement implant over time, as the femoral head and acetabular cup component surfaces rotate against each other.

With a metal on metal hip system, this can lead to the production and accumulation of cobalt and chromium metal ions within the area surrounding the implant. While many patients have no significant reaction to these materials, for some, there may be an inflammatory response which can lead to problems such as local bone and tissue reactions.

The SCENIHR has been mandated to conduct a review of the safety of metal on metal implants. This investigation is focusing on the potential health effects caused by metal ions resulting from the implanted medical device. We advised the committee in September that the opinion from the SCENIHR was expected shortly. We have recently been informed that it is now expected in mid-December. The IMB will consider, with the HSE and orthopaedic surgeons, the implications of the review for Irish patients.

I wish to provide the committee with an overview of the implementation of the European Commission's joint plan for immediate actions which was published in early 2012 in response to the crises relating to the PIP breast and metal on metal hip implants previously mentioned. At the time, as a result of the issues identified by the PIP breast and metal on metal hip implant crises, the Commission took a series of initiatives which included a stress test of the then draft proposals to revise the medical devices legislation to assess its ability to manage such issues; mandating specific reviews of the scientific and safety aspects to be conducted by the SCENIHR; and publication of the joint plan for immediate actions to strengthen and restore confidence in the regulatory system for medical devices. The joint plan recognises the need to further develop and strengthen the existing regulatory system in advance of the broader revision of the legislation which is ongoing. Focusing on measures to strengthen oversight of notified bodies, increase market surveillance activities for medical devices and increase inter-authority collaboration and information exchange, the purpose of the joint plan was to enhance the existing regulatory framework. These objectives were set out as a series of short and medium-term actions for member states, competent authorities and the Commission.

The implementation of the joint plan is nearing completion across Europe. Overall, it is judged to have been a highly successful programme resulting in significant action and development of the regulatory regime since its publication. In the context of the important area of notified bodies, the plan has led to the introduction of a voluntary joint assessment scheme for the designation and oversight of notified bodies. The assessments involve an independent review by the European Commission, assisted by appropriate experts selected from member states. The purpose of the review is to assess the competency and performance of national designating authorities such as the IMB and ensure they are applying designation criteria in a harmonised way. Some 20 joint assessments have been conducted to date in 2013 across Europe. The programme continues to have a positive tangible impact on the oversight and functioning of European notified bodies. In addition, the Commission has published its recommendation for notified bodies. This provides guidance for those bodies on best practices relating to their assessment and monitoring activities.

The joint plant has also led to the introduction of new and enhanced legislative requirements for notified bodies and the authorities responsible for their oversight. These include a more specific definition of operational requirements for notified bodies and mandatory joint assessments to be conducted on an ongoing basis. There is also a requirement for notified bodies to conduct unannounced inspections of the manufacturing facilities for which they are responsible. The positive impacts of these inspections have been evident throughout the Europeand Union. The plan also put in place a requirement for notified bodies to update their contracts with manufacturers to ensure proactive communication of important vigilance-safety information. This requirement has yielded positive benefits in terms of increased proactive communication throughout the European network.

In the context of market surveillance, co-operation between authorities and communication, the joint plan has resulted in the establishment of a forum, led by the European Commission, for a regular exchange and sharing of information on emerging safety issues. The forum has been operational since July 2012 and successful in further developing collaboration and achieving a collective resolution of key issues.

The joint plan has also given rise to a review of the scope of current market surveillance activities on medical devices conducted by member states. This has provided a platform from which a co-ordinated approach to surveillance can be developed, allowing for enhanced co-operation and targeted proactive market surveillance, including joint activities. Under the plan, there has also been a detailed review of the European regulatory authority structures to promote co-operation, communication and work-sharing. This review is nearing completion. It will not only enhance co-operation and communication between authorities but also seek to increase the management and transparency of the system.

Another initiative for authorities to promote as part of the joint plan has led to an increase in the number of reports received by the IMB from health care professionals on medical device issues. Dialogue with clinical societies and professional bodies on medical devices has increased and become commonplace at European level. It allows for key input and advice from expert clinicians and device users.

The plan has led to increased discussion on the use of registers for medical devices at European level. This is under way and the European Commission's so-called cross-border PAtient REgistries iNiTiative, PARENT, initiative is seeking to ensure such registers are appropriately established and have datasets which can be compared and analysed cumulatively across the European Union.

The IMB has been strongly committed to the joint plan from the time of its introduction and contributed significantly at both national and European level to ensure realisation of its objectives. The IMB considers that the plan has been critical in ensuring the existing regulatory system is enhanced to provide for increased levels of protection for patients. We are also committed to the future development of the plan which we believe can play a vital role in ensuring continued strengthening of the regulatory framework in the interim period prior to the adoption of the new legislation.

In the context of future developments to build on the existing regulatory system, it is anticipated that the European Commission will publish a report on the implementation of the joint plan either during this month or early in 2014. In response to appeals from several authorities, including the IMB, the Commission has indicated its intention to build on the principles of the existing plan and is shortly expected to make an additional formal proposal with details of further actions to develop the regulatory system during the period 2014 to 2015. Specific areas which the IMB has proposed for inclusion in the future development of the plan include placing further emphasis on practical measures to enhance market surveillance of medical devices; a continued focus on notified body oversight; enhanced emphasis on clinical data for medical devices and, in particular, assessment by notified bodies; and the development of further mechanisms for improving the availability of information on medical devices, particularly in the context of adverse incidents and safety issues.

The IMB will work to optimise and develop the regulatory activities conducted for medical devices at national and European level. This will include ongoing provision of dedicated support for developments at European level. We recognise that, in order to meet increasing challenges and requirements, it is necessary to continue to review and improve our approach to providing for regulatory oversight. Specific objectives in this regard include developing cross-organisational, that is, within the IMB, co-ordination of medical device activities to ensure a sufficient focus on new and emerging requirements; developing existing resource capabilities in line with advances in technology and innovation; and fostering and developing international collaboration within the medical device authority network at both European and international level. This will ensure our continued capability in providing a robust and relevant system of regulation for medical devices which affords the appropriate level of protection for patients and device users.

We will be pleased to take whatever questions members may wish to pose.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I welcome our guests. The briefing note we have received refers to proposals designed to ensure all medical devices are safe for patients and restore public confidence in the European medical devices regulatory system. It is fair to state said confidence has been significantly dented and that it is important that it be restored. The debacles involving DePuy hip implants and PIP breast implants have had an impact on Irish people and I have no doubt that this impact has been replicated - it may even be more pronounced - in other jurisdictions.

The briefing note sets out several bullet points under the briefing summary. One I highlighted is that of more powers and obligations for notified bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections and sample testing. That would most certainly address the issue of the PIP implants where wholly and totally inappropriate material was being used, which would have been established if such unannounced factory inspections were taking place regularly and we had a robust examination and testing of the quality of materials and their suitability for in vitrouse by humankind.

Mr. Pat O'Mahony might update us on where things are with regard to both of these matters. Can we have some assurance as to the steps that are being taken collegially across the European Union? These directives are part of the response I expect, yet as Mr. Paul Barron indicated, the Department of Health has concerns about the original drafting and some other member states still have concerns about it. In his address to the committee, Mr. Paul Barron mentioned that member states had concerns regarding many of the proposed measures. Will he elaborate on which member states they are? Clearly, we must number among them. He also indicated in the course of his opening statement that some of these concerns were shared and that he believes the Department's concerns have been ameliorated by amendments that have been adopted by the Commission. The phrase he used is that they "went a long way towards resolving our main concerns". Will he elaborate on what concerns remain? He did not suggest that they were all addressed comprehensively. Are they of such minor nature that he considers we should have no issue with the adoption of directives at this point and that we are in a position to proceed positively with the proposals?

Mr. Barron made the point that the ENVI 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". He indicated that the Council does not have a position on this issue as yet. It is ancillary, I guess, to the substantive issue being addressed, but what of the Department of Health's view on that specific area? I would be grateful if he could give us a further insight into that.

Séamus Healy (Tipperary South, Workers and Unemployed Action Group)
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I have two brief questions. At what stage are we at in being able to guarantee that these difficulties will not arise again? Are there pre-inspections and unannounced inspections of materials and the manufacturing of these implants?

Colm Burke (Fine Gael)
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I thank the delegates for their presentations. I wish to briefly touch on one or two issues. On the issue of the defective devices, a system know as RAPEX was set up under the toys directive, which provides that if a defective item is identified in a country, that country has an obligation to notify the other 27 member states. The RAPEX system is a fast-track procedure for ensuring the market becomes aware of defective toys. Is a similar procedure or structure available or in place in respect of medical devices?

My second question relates to the Irish Medical Devices Association. Following a meeting of 27 November 2012, more than 12 months ago, it wrote to the Irish permanent representative at the time and expressed concern that the product scrutiny as structured in the Commission proposal would not increase patient safety. It expressed that concern in 2012. What is its position on the Commission's proposal and what is being talked about among the member states? Is the medical devices industry happy with the progress that is being made or does it still have some concerns that need to be dealt with? We are taking those concerns on board as we have a large number of people employed in the medical devices industry. The delegates may have touched on this but I would like further clarification.

The third issue on which I wish to touch is that of insurance. It comes back to the issue of breast implants. I introduced a Private Members' Bill that provided for placing an obligation on all people involved in medicine to have adequate insurance. The Department intends to move forward with that proposed legislation over the next six to nine months. On the current structure in place covering medical devices, the people involved in plastic surgery in Ireland, in particular Peter Meagher, are concerned about the number of people coming from abroad, providing a service and not having adequate cover. They are also concerned that we do not have the power to close the operations of those practitioners if they are not providing a structured service. They carry out the procedure but provide no backup support in the event of anything going wrong and, as a result, our health service has to deal with those difficulties afterwards. How far advanced are we in ensuring that in respect of everyone who provides medical care in this country - we are talking about the use of medical devices - there is a structure in place and adequate insurance cover and supervision in place? I understand the legislation in place does not cover all that area. How long will it take the Department to come on board with regard to that amending legislation?

Jerry Buttimer (Cork South Central, Fine Gael)
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I call Mr. Barron to respond first to be followed by Mr. O'Mahony.

Mr. Peter Barron:

There is a bit of confusion here and I hope I did not cause it. The part of my opening remarks to which Deputy Ó Caoláin referred related to the transparency directive which is the directive that deals with the terms under which medical products are covered by health insurance systems. On the second page of my presentation, I stated that the Department had concerns about the original Commission proposal but the Commission proposal, to which I am referring, is the transparency directive rather than the medical device directives. I apologise if I caused confusion over that.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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My mistake. I accept that.

Mr. Peter Barron:

Our concern about that particular proposal was around the timeframes. Very tight timeframes are being proposed for - in our case - the HSE to come to a decision on whether a product should be placed on the reimbursement list. Our view was that the timescales originally proposed would be too onerous on our system. Thankfully, the proposed timeframes have been changed to give us some more time.

The timeframes now proposed under the legislation marry up with the timeframes in the Health (Pricing and Supply of Medical Goods) Act that was enacted during the summer. Our concerns on that score have been addressed.

A question was asked about what I said towards the end of my statement on the environment, public health and food safety, ENVI, committee. There was one error in my statement, which I dealt with when I delivered it. I said the proposals were examined by the ENVI committee in the European Parliament, and I then said the ENVI committee had voted in favour of pre-market authorisation, but that is a mistake. When I delivered the statement I said the ENVI committee had spoken in favour of pre-market scrutiny. The difference between the two is that pre-market authorisation would mean it would have to be authorised by a third party before it could be placed on the market. That is not where the committee is at. The committee is looking for pre-market scrutiny, which would fall somewhere short of authorisation. Again, I apologise for that.

Some of the other points might be more relevant to the IMB. Deputy Healy asked what was the current position with regard to unannounced inspections. The IMB might be in a better position to deal with that. In response to Senator Burke, my understanding is that there is a RAPEX alert system, but my colleagues from the IMB might address that. He also asked about the views of industry. It is fair to say that the industry, both at Irish level and at European level, is quite exercised about the proposals. There is an intensive lobbying campaign under way, particularly at European level. There are concerns among those in the industry that the proposals, if adopted in their current form, could give rise to delays in products coming on the market and additional costs. I could go into more detail but that is a good summary of the position.

Senator Burke also asked about plastic surgery. He is aware there are concerns about plastic surgery and cosmetic clinics. The Department intends to address that through legislation on the licensing of hospitals and health facilities generally. The intention is that the legislation would be broad enough to cover the activities of the cosmetic surgery operators to which the Senator referred. The proposals on that are at a very advanced stage in the Department. We would hope to go to the Government in the new year. In the meantime our chief medical officer has agreed some advice for people considering cosmetic surgery. The advice has been agreed with the Irish Association of Plastic Surgeons and it is on the Department’s website.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I have a brief supplementary question, although it is not directly related to the point to which Mr. Barron has just responded. We are advised in one of the briefing notes that there are four categories of medical device. They indicate that class 1 encompasses everything from sticking plasters to the items on which Mr. Barron and I depend. It goes all the way up to class 3, which concerns implants. If the highest level is three, is there a fourth category?

Mr. Paul Barron:

The categories are 1, 2a, 2b and 3.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I knew there was a catch. I would never think of that.

Mr. Pat O'Mahony:

It is not very intuitive.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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It is catch-you-out time for us.

Mr. Pat O'Mahony:

I am grateful to the members for the opportunity to answer a few questions. First, I made it very clear the previous times I appeared before the committee that as the competent authority for patient safety we were very unhappy with the situation with regard to medical devices at that time and how pre-market approval was operating. As Deputy Ó Caoláin said, it suffered a severe dent. Two things happened in response to that: one is the proposal for the new legislation, and the other is what is happening, as I have described, under the joint plan.

Mr. Barron has captured the issues on the legislation. In essence, we rely on the policy lead from the Department and it is still early days for the proposals. Much of what is required is captured in the legislation. To respond to the question about the scrutiny mechanism, it was in the Commission's proposal, which was that a certain percentage of files that would be looked at by the notified bodies would also be examined by another committee as a separate pair of eyes. The proposal as I understand it from the ENVI committee is that there is the scrutiny mechanism and a centralised committee looking at all high-risk devices. We still do not know where that debate will end.

From a competent authority perspective, whatever the outcome is along those lines that would increase protection for patients, that would be perfectly okay with us, and we will work within that system. There will be resource implications, but we will work within it. In the certain knowledge that legislation takes time, we are trying to make real progress on the joint plan in the meantime. Since we last met, as I described, all this stuff has been going on around joint assessments of the notified bodies. We identified before that the big weakness in the pre-market piece was the lack of consistency across notified bodies across Europe. As I said in the note, up to 20 countries have now had visitations. The joint visitation consists of the Commission, the national competent authority and experts from other competent authorities. It is a very rigorous review of the approach of the national authority and the notified body. They have targeted first of all the notified bodies involved with high-risk or class 3 devices. That has worked very well and progress has been made during the second half of this year, and a legislative basis is being provided now by the Commission to make that mandatory, which is very helpful.

With regard to unannounced inspections, the answer is that they are under way. Our own notified body, the NSAI, is doing that, and it is happening across Europe. With regard to the RAPEX system, we are also involved with cosmetics and others are involved with food in other areas, and the RAPEX system is in place for that. The Commission has in place a similar system for medical devices, which it is currently suggesting will remain as the system. It is similar to RAPEX but it has a different title and it operates in a different way, but it means that if an issue is notified in a country it will be disseminated throughout the rest of the competent authorities via this process.

I will make a quick comment on insurance. The new proposals make provision for a manufacturer's liability if the manufacturer goes bankrupt. It would have applied, for example, in the PIP case. There is also a requirement in the proposal for notified bodies to have specific insurance to cover their liabilities. The issue of health professionals such as surgeons does not seem to be addressed in the current proposal. The fundamental issues raised in the question about insurance are captured in the current Commission proposal. They are the main questions to which I needed to respond.

Colm Burke (Fine Gael)
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Unannounced scrutiny has been set up, but where does that leave us in terms of imported products? I refer to products coming in from outside the European Union, for which we will not have the same powers of inspection. How will we control that area? If there is a lower level of scrutiny in non-European jurisdictions, does that cause problems from an industrial point of view for medical device companies in this country? How is the issue being addressed?

Mr. Pat O'Mahony:

I am very happy to deal with Senator Burke's query because all of the work in which we are currently engaged at a very high level in Europe is about having a common system across Europe. Dr. MacAleenan has recently been appointed to the management board of an international body on medical devices. We are very pleased about that, as there are just three European nominees - one from France, one from Germany and one from Ireland.

If a product is coming in from outside Europe it must still have a CE mark in order to come onto the market in Europe, which requires the company to submit the file to a notified body. The notified body has the authority and the power to carry out inspections, no matter where the plant is located.

On the question of putting any industry here at an advantage or a disadvantage, that is a fundamental part of free trade in Europe and whatever rules apply here have to apply right across Europe.

Jerry Buttimer (Cork South Central, Fine Gael)
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Are there any other comments or questions? I welcome the representatives of the IMB who are in the gallery - Ms Anne Tobin, vigilance and compliance manager; Dr. Caitríona Fisher, manager, chief executive's office and quality manager; and Mr. Nigel Fox, communications and information manager - as well as Ms Siobhán Molloy, director of Weber Shandwick. I thank the witnesses for their attendance.