Oireachtas Joint and Select Committees
Tuesday, 24 September 2013
Joint Oireachtas Committee on Health and Children
Medicines and Medical Products: Discussion with Irish Medicines Board
I remind delegates, members and those in the Visitors Gallery that mobile phones must be switched off as they interfere with the broadcasting of the meeting. They are also a source of interference for members of staff who must wear headsets and it is not fair on them if they are left on. I welcome viewers watching on UPC.
Apologies have been received from Deputies Ciara Conway, Caoimhghín Ó Caoláin and Mary Mitchell O'Connor and Senator Imelda Henry.
Our discussion today is with the Irish Medicines Board, IMB. I welcome its chief executive, Mr. Pat O'Mahony, as well as Dr. Joan Gilvarry, Mr. John Lynch, Ms Ann Tobin, Ms Orla Keane, Mr. Nigel Fox and Ms Siobhán Molloy. It is always welcome to have the board on the same path as the committee because its representatives are always very frank, honest, open and positive in discussion. I thank Mr. O'Mahony and his team for coming before the joint committee.
The Oireachtas Joint Committee on Health and Children welcomes the co-operation of the Irish Medicines Board to participate regularly with it. Members regularly seek to invite the board to come before the committee to discuss items of concern. Recently the committee raised concerns about DePuy hip replacements, PIP breast implants and the importance of illegal prescription medication. We look forward to hearing an update on these issues. In April we met the board to discuss the issue of organ donation and on Thursday will formulate our response to the Government consultative process regarding the move to a soft opt-out system of organ donation. The delegates may comment on this, but they do not have to do so.
By virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of the evidence they are to give to the joint committee. If they are directed by it to cease giving evidence on a particular matter and continue to so do, 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 ruling of the Chair and parliamentary practice 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 invite Mr O'Mahony to make his opening remarks.
Mr. Pat O'Mahony:
I thank the Chairman. Dr. Gilvarry looks after human products monitoring, that is, post-market safety monitoring, while Mr. Lynch is the director of compliance who looks after inspections and audits in sampling and enforcement. We are grateful for the opportunity to update the joint committee on the work of the Irish Medicines Board, in particular, as requested, on the illegal importation of prescription medicines, DePuy hip replacements and other related matters.
Some consumers seek to purchase prescription medicines over the Internet and such Internet supply of medicines is illegal in Ireland. The key concern is that consumers risk their health by attempting to obtain medicines from unauthorised sources. Unauthorised medicines have been shown to contain too little or too much of the active ingredient, while others contain the wrong active ingredient. Consumers, therefore, put their health in danger. They expect to buy quality medicines, but often receive substandard, unauthorised and falsified products.
The IMB has a targeted enforcement programme and acts to detect the illegal supply of prescription medicines, supported by Revenue's Customs service through its active vigilance at ports and postal hubs. We also endeavour to highlight to consumers via the media on a regular basis the risks and dangers in seeking to purchase medicines from unauthorised sources. Many countries have similar targeted enforcement and information campaigns and a good illustration of the collective international action in this area is Operation Pangea, now in its sixth year. It is co-ordinated by Interpol and targets illegal Internet pharmacies on a global basis. It was initiated in 2008, when Ireland was one of eight countries involved. This year more than 100 countries took part in an international week of action directed at online sales of counterfeit and illegal medicines. The Irish part of this operation is conducted on a joint interagency approach involving the IMB, the Garda Síochána and Revenue's Customs service. In one week in Ireland this year we seized more than 183,000 tablets, capsules and vials, with an estimated value of just over €500,000. A similar pattern has been seen globally during Operation Pangea. In 2012, 3.7 million items of illegal and counterfeit medicines were seized and in 2013 this figure increased to 9.8 million items, with a total value of US$36 million. In both years these actions resulted in arrests throughout the globe and the detention of thousands of potentially harmful medicines. The types of medicines seized globally mirror those seized during our ongoing activities in Ireland in co-operation with Revenue. For the first six months of this year a total of 670,000 Internet supplied tablets, capsules and vials, with an estimated value of more than €2 million, were seized in Ireland. These products threaten public health.
The figures for 2012 are typical of current trends in illegal supplies. Among the medicines seized were sedatives, weight loss drugs, anabolic steroids and erectile dysfunction products. The document we have provided for committee members contains a five year summary. We thought we were making an improvement on the overall figures in 2012, but based on the figures we have to date, the figures for 2013 will run ahead of this.
Most of the provisions of the falsified medicines directive which updates the rules for manufacturing, importing, placing on the market and the wholesale distribution of medicines came into effect on 2 January 2013, since we last met the committee. The directive introduces new safety features on outer packaging, increased regulation of active substances and regulation of Internet sales of medicines. These controls, when fully implemented, will be of assistance in further protecting the legal supply chain for medicines, but in our view the IMB will need to continue its education and enforcement activities relating to illegal supplies to the benefit of public health.
There is no one reason people seek to purchase medicines from unauthorised sources. For some, it relates to the anonymity of the transaction, while for others, it is the thought they are saving money. Whatever the reason, in order to seek to protect consumers’ health, we will continue to focus on enforcement efforts in this area.
In earlier appearances before the committee we had the opportunity to outline the current legal controls for medical devices here and across Europe. We highlighted the fact that pre-market approval for medical devices rested with a network of notified bodies which were usually operated as commercial private entities. While the competent authorities such as the IMB designate the scope of these individual notified bodies, the system is recognised to have substantial shortcomings. Post-market monitoring of medical devices, once they are on the market, is conducted by competent authorities such as the IMB. It is also recognised that the operation of this system across Europe requires improvement.
This focus on the current regulatory system for medical devices and its shortcomings has been as a result of high profile issues such as those relating to breast and hip implants. These have highlighted the need to further develop and strengthen the regulatory system. A complete revision of the European legislation is now under way, with the publication of two proposals for new regulations which will replace the existing directives and regulations. Work has commenced on these regulations at the European Council and the European Parliament and substantial progress was made during our Presidency. However, as we know that this revision of the legislation is not expected to be in place at European level for at least another four to five years, it is necessary to implement more immediate and urgent measures. These are set out in the European Commission’s 2012 joint action plan for immediate actions on medical devices, sometimes referred to as the Dalli action plan, which was devised to strengthen the regulatory system in the interim period.
The joint plan has resulted in significant action since its publication. Further developments are required to ensure continued strengthening of the system and enhanced patient safety and protection. It is anticipated that the Commission will build on the principles of the existing joint plan and is expected to make a formal proposal shortly, with details of additional actions to develop the regulatory system in 2014 and beyond. This is called action plan 2. The key elements of the Commission’s joint plan for medical devices relate to enhancing the functioning and oversight of notified bodies, further developing market surveillance of medical devices by competent authorities, improving co-ordination and enhancing communication and transparency in the system.
Our own activities in this important area have increased substantially recently and include a number of initiatives undertaken during the Irish Presidency. These will be further developed in the short to medium term. This will require a reconfiguration of our resources, as well as some additional resources. Additional funding has been secured from the Exchequer in 2013 to meet some of the required recruitment needs and we are requesting some further funding for 2014. Importantly, it is anticipated that, from 2015 onwards, these additional funding needs will be met by the introduction of a fee model to the medical devices sector. I remind members that in all of the work we do on medicines fees are charged to the industry which fully fund that work, whereas our work on medical devices is still funded from the Exchequer. Some seven countries in Europe already have a fee regime in place and, while we are continuing efforts to seek a common agreement at European level for the introduction of fee models and systems, if this is not achieved in time, we anticipate that a national fee arrangement will be introduced in Ireland in 2015.
I want to update the committee on the position on hip implants. In 2012 we outlined to the committee the details of the worldwide recall of DePuy ASR 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 revision rates at five years. At the time approximately 3,500 ASR hips had been implanted in Ireland. The IMB has since worked closely with the HSE and Irish orthopaedic surgeons in regard to the recommendations for individual patient follow-up. When we met the committee just over a year ago on this topic, the HSE outlined that at the time 96% of patients had attended review appointments and that over 350 had had revision surgery, with a further 166 scheduled. We understand all patients have now been reviewed and up-to-date revision rates are expected from the HSE shortly. The IMB continues to assess the reported incidents received and analyse data generated from revisions, joint registry data and clinical studies. Independent analysis of explanted devices which have been returned for investigation is being conducted at the London Implant Retrieval Centre.
The ASR recall experience has been central to the wider international discussions on metal-on-metal hip implants. Since our last attendance, the research in this area suggests increased revision rates associated with larger diameter head metal-on-metal hip implants. Device wear is experienced with all types of hip replacement implants 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 European Scientific Committee on Emerging and Newly Identified Health Risks, 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 and the committee's opinion is expected shortly. The IMB will consider, with the HSE and orthopaedic surgeons, any implication of the review for Irish patients.
I will now give a short update on the position on PIP breast implants. In March 2012 we provided the committee with an overview of the PIP breast implant issue. During my presentation I outlined the fraudulent activity of the French PIP company which had resulted in breast implants with non-approved, non-medical grade silicone being placed on worldwide markets. In February 2012 the SCENIHR published a scientific opinion on the safety of PIP breast implants which stated these implants did not pose any significant risk to human health and, in particular, had no cytotoxicity or genotoxicity. This conclusion has been supported by substantive tests conducted since we last addressed the committee. The work of the SCENIHR has continued and includes a detailed examination of test results, a review of the data provided by member states relating to PIP revision surgeries and rupture rates. The SCENIHR also engaged with the health care professionals involved in the implanting and explanting of these products. It is anticipated that the findings of this second comprehensive review will be published within the next week or so.
The IMB has continued to closely monitor the testing conducted and examined the published test results. Throughout this process, it has kept the hospitals, clinics and patient action groups informed of developments. In total, 1,550 women were implanted with the PIP devices in Ireland since 2001 through private cosmetic hospitals and clinics. During the spring and summer of 2012 the IMB and the Department of Health’s Chief Medical Officer met the patient-led PIP action group to discuss their concerns and obtain feedback on the follow-up and services being provided for them. Poor communication, waiting times, limited access to records and charges for diagnostic testing by some implanting centres were the principal concerns raised. Members will know that one of the clinics involved has been to the High Court and gone out of business since. The Department of Health has informed us that, following concerns regarding the limited progress made by the Harley Medical Group, the Department commenced arrangements, with ministerial approval, for the provision of an alternative care package for this group of women. At the time this was to be provided through the National Treatment Purchase Fund. We now understand discussions are close to being finalised between the Department and the HSE in this regard.
The advice of the IMB and the Department to the women affected which is based on the available scientific evidence remains consistent: there is no current evidence of health risks associated with PIP implants and concerned women should seek clinical advice from their GP and surgeon. As we said on the last occasion, despite the fact that there is no scientific evidence, we still fully appreciate the concerns of these patients.
Regarding the list of interchangeable medicines, the committee is aware that the Health (Pricing and Supply of Medical Goods) Act 2013 provides for the introduction of a system of interchangeable medicines and for the introduction of reference pricing for authorised medicines. This legislation was commenced in June 2013.
The role of the IMB under this legislation is to establish, publish and maintain a "list of interchangeable medicines" on our website. Medicines on the interchangeable list may be substituted for each other safely to assist in providing savings for those paying for medicines and for the health service. The IMB has no role in reimbursement or in setting prices of medicines under this legislation. This is the responsibility of the HSE. We were asked by the Department and the HSE to prioritise medicines. We have started that process and a number of lists have already been published and we have set out a list of 20 priority medicines. We are at the consultation stage in respect of other lists, which is provided for in the legislation. The process at the IMB is progressing well. The IMB will be adding further active substances to the list on a continual basis.
There will be certain circumstances in which medicines are not considered interchangeable, for example, where there are clinically significant differences between them or where medicines cannot be safely substituted for other medicines. These criteria will always be taken into account in the decision-making process conducted by the IMB. The IMB has published a detailed guide outlining the process involved in establishing a list of interchangeable medicines and a questions and answers document. These documents are available on our website.
The IMB has also published an information leaflet called Our Advice on Generic Medicines which provides members of the public with details on the safety, quality and effectiveness of generic medicines. This is one of a number of IMB consumer leaflets providing advice on the safe purchase and use of medicines. Printed copies of this leaflet have been supplied to all community pharmacies.
Members may also be aware that this legislation contained a provision for a name change for the Irish Medicines Board, IMB. When this section is commenced in the second quarter of 2014, the IMB will then be named the Health Products Regulatory Authority, or HPRA. This new title more accurately reflects the range of regulatory activities we undertake.
Let me stress that the best interests of patients and consumers are our primary concern and all our actions and activities are focused on this. I thank the Chairman and members for their attention. We will be pleased to answer questions.
I thank Mr. O'Mahony for his excellent presentation, updating us on some of the issues.
We have received apologies from DeputiesCiara Conway, Caoimhghín Ó Caoláin, Regina Doherty, Mary Mitchell O'Connor, Billy Kelleher and Robert Troy and Senator Colm Burke.
Deputy Ó Caoláin wanted very much to be present at this meeting but due to unforeseen circumstances he cannot be here. I thank Mr. O'Mahony for his presentation. It was very informative. I am glad we will have the opportunity to discuss some of the issues with his team.
Mr. O'Mahony raised the issue of the illegal importation of prescription medicines, which very clearly is a dangerous matter. It would have serious consequences and ramifications for those who consume such medicines. I commend the work the IMB has done with the Garda and the Revenue Commissioners. I note that 758,276 dosage units were detained this year and that is a reflection of the good work and co-operation the IMB is getting.
Clearly prescription drugs are in demand for a number of reasons. I know that many people experience problems because of the high cost of drugs. I am sure other members have dealt with many people who had a medical card, which was awarded on discretionary grounds but now withdrawn, coming into their constituency offices telling them they are not taking their medication. I am sure they will try to source the medicines where they are cheaper. I am also aware that people are travelling to the North because drugs are a great deal cheaper across the Border. This is less of an issue because it is legal to do so. Is it possible to discern the primary causes for the importation of medicines? Does that affect how the issue is being tackled?
The concerns about hip replacements were commented on widely in the media last year. The IMB stated in 2012 that the root cause of the problem had not yet been clearly identified. Has it been identified at this stage? Does the IMB have information on the number of patients who are affected by the faulty mechanism and whether they have been compensated or supported otherwise?
I welcome the delegation. I wish to add to the comments of my colleague, Deputy McLellan, on the illegal importation of drugs. That 758,000 dosages were intercepted by customs is alarming because although I realised we had a problem, I did not realise the scale and nature of it. Were the drugs imported for individual use or were they intended to be traded? The IMB stated in the presentation that it does not know the reasons for the importation of the drugs, but what are we doing to counteract it? Many people who go on holidays within Europe will buy the same brand of medicines from a pharmacy at a much cheaper price. The price of medicines in Ireland is an issue for people. I can understand that the message has gone out that this is a way of saving money. I am concerned about people wanting to be anonymous, given the description of some of the drugs, but is that an issue that must be looked at in a wider context?
I note the announcement today by the European Commission that it has adopted the two measures to improve the safety of medical devices. That is welcome. The European Commission added that it now has a clearer basis for unannounced audits, sample testing or joint assessments by notified bodies. Would the IMB comment on whether we should be reassured now the Commission has put this in place or are there questions that we should be putting to the European Union?
I join with others in thanking the delegation from the IMB for making a presentation to us today. The issue of the cost of drugs is raised on a daily basis, and people are looking to buy drugs more cheaply. The State has lost significant revenue because of the importation of illegal drugs. It would be better to bring the cost of drugs down to a level at which people could buy them. The Garda and the Customs and Excise must be commended for doing a very good job. Was the flyer that Mr. O'Mahony displayed dealing with the importation of illegal drugs or prescription drugs?
The dissemination of information causes me concern. Do we give people the right information? Do we point out the dangers of taking drugs that were not prescribed by a GP or medical professional? I still see people giving drugs to their relatives and friends if things are not going right for them. We should make it very clear to people that when they take somebody's drugs, it could be lethal.
I met two people in the past six months that have had to have their replacement hips replaced. My main concern is that they had waited for the initial procedure for such a long time and then had to go through it again. One woman had to have the hip socket removed and then wait for a number of weeks for the infection to clear before the implant was replaced. That is gruesome.
Can the witnesses give an indication of how many people are affected by toxicity levels in the bloodstream and what is being done for those patients? Some of my other questions have already been asked.
I thank the Chair. I welcome the witnesses. This is always an opportunity to be educated in the field of medicine and terminology we do not normally hear at the committee. In his contribution Mr. O'Mahony referred to the seizure of drugs bought online, including €500,000 worth of drugs in one week. Three or four months ago I read an article in one of the UK newspapers on the same issue. A projected estimate for the volume of medicines being brought into the UK via Internet shopping was staggering. The article also described it as frightening because of the ambiguity of the contents. The witnesses will have anticipated my question. If this is what Revenue is managing to apprehend or acquire, what is the projected figure in financial terms for medicines coming into the Republic on a yearly basis? I compliment the witnesses on the leaflet posted to us, to which my colleague, Deputy Catherine Byrne, referred. It is very well written. I should not say this but most politicians use very large bins for the material they receive. However, this is one leaflet I am keeping.
We are beginning to make progress on generic medicines. All of us will be aware of the Bill to introduce generic drugs, which is very welcome. Following years of talk by politicians on the issue, we are finally getting the legislation. Given that 62% of Irish adults had a holiday abroad this year - I would prefer they stayed at home or went to Cork - one has only to speak to a person outside the local school or supermarket to realise the volume of medicines brought in this summer is absolutely phenomenal. Can a figure be put on the amount?
Mr. Pat O'Mahony:
I will deal with a few issues and hand over to my colleagues. On the issue of the leaflet, we had a series of leaflets which are widely available and are on our website. The leaflet to which I referred is about generic medicines. It explains to the public the concept of generic medicines and our judgment that they are safe. There is also a leaflet on the dangers of buying medicines online which can be read on our website. Drawing together some of the comments raised, it might be useful to state that three years ago we did some research on consumer attitudes and repeated the exercise this year. The research shows that in the past 12 months, approximately 2% of the population have bought medicines online. In that sense 98% have not done so, therefore, it is not a major issue. However, tens of thousands of people are purchasing medicines illegally online.
Mr. Pat O'Mahony:
It is an important question. The net issue it illustrates is that only a small proportion of people access the Internet for the purchase of medicines. In our well-conducted research we put some very detailed questions to more than 1,000 people. Many people access the Internet for advice on medical conditions and also for medicines. However, the number of people who say they are conscious of the risks and do not buy is also very high. Only 2% admit to purchasing medicines on the Internet.
The net issue is that most of the drugs that come in via the Internet, that is, the illegal route, are the lifestyle drugs to which we have referred. The sedatives, Zopiclone and so on, mentioned in the report are coming in and are sold illegally on the street. There are also drugs and steroids for weight loss, body building and erectile dysfunction. They are largely individual importations. While a large-scale operation is rare, we have had a number down through the years. We might have one or less per year which would then be repackaged for reselling either out of Ireland or within Ireland. This is largely about people who do not want to talk to their doctor about erectile dysfunction, about steroids for body building or weight loss products because they are not lawful. They do not necessarily want to have that discussion with their pharmacist, health care professional or doctor. Those are the people who are being exploited by purchasing illegally on the Internet. While the figures are substantial, the number is a tiny proportion of the value of the overall market. The issue of people going abroad is a separate matter.
May I ask Mr. O'Mahony, before he moves on to the issue of people going abroad, about the search engine where people type in whatever they are looking for? Has consultation taken place either at EU or national level with search engine providers, Google, Yahoo or whoever, in terms of a disclaimer, given that in his presentation he said there is no control over the type or quality of ingredient in the drugs being imported?
Mr. Pat O'Mahony:
Much activity takes places between those who facilitate the payment from the purchaser to the seller and the Internet providers. Operation Pangea co-ordinated by Interpol around the world puts a specific focus on all those areas. We regularly report websites, following which they are closed down. Every week we have websites closed down. However, the reality is that these people establish a new website the next day and another the next day. We have a constant battle with the criminals involved in this trade.
There are two elements to this issue. Education is ultimately the best way of influencing people. The results of our consumer attitudes survey indicate that our constant messaging is telling people that this is a risky business in which to be engaged. The other issue is whether we can prevent such activity, as we do by seizing the products. We would not pretend to suggest we are seizing all the products coming in. Customs and Excise has a good system of profiling particular countries and products from particular sources which have particular types of stamps and so, but the criminals are constantly trying to find ways of getting products through. We are vigilant in this area and have a number of staff allocated to this work. I was asked once by a journalist on a radio programme if we were giving the issue a disproportionate amount of effort and whether the buyer should beware. Our view is that this is a public health concern and many incidents have been reported where people are damaged by these products. Often we cannot speak about them publicly because of issues of patient confidentiality.
During the past few years we have become aware of quite a number of people who have been badly damaged by some of these products. The public health message is constantly being delivered to the public and we take every opportunity we get to try to hammer it home.
With regard to individual purchases, anecdotally one is well aware that people go on holiday and purchase medicines abroad. It depends on what country they visit. In Germany medicines are more expensive than in Ireland, which is the reason we have parallel trading out of Ireland to Germany. In certain other countries such as Greece or others in southern Europe certain medicines are substantially cheaper, while others are the same price or more expensive. Consumers can buy these medicines legally. If they have a particular prescription regime and can acquire the same medicine from a pharmacy abroad, that is perfectly legal. Where someone brings a suitcase from abroad with a couple of years supply of medicine, we see this as a commercial operation, but if somebody comes through with a three month supply of medication, that is seen as an accepted practice.
I have covered the issue of leaflets. We are not involved in pricing, but prices in this country are dropping substantially. They are dropping as products come off patent, new deals are put in place and the issue substitution is followed up on.
Mr. Pat O'Mahony:
The first 20 active ingredients we were asked to look at are included in 1,500 individual medicines, a substantial number of authorised medicines in Ireland. Our process has gone well and we now have a number of lists published. However, as the committee may be aware, the HSE must set the reference price, but it has not yet done so. It is some months behind us. It has a process that it must go through under the legislation. I believe the reference prices for the first list of items will issue in October or November. Is that correct?
Mr. Pat O'Mahony:
No, it is built into the legislation. It allows for our process and the HSE to then engage in its process.
If I have missed out on any of the issues raised, I will be very happy to answer any follow-up question. However, I would like to ask Dr. Gilvarry to comment on the metal-on-metal hip implants and what we know about the root cause of the problem being the larger piece of metal on metal hips and any evidence on the toxic effects of the minerals building up in people's blood.
Yes, please do. The reason I ask is that in my in-box I have a plethora of e-mails, including spam. Also, in recent times I have seen advertisements on some social media websites. Has the IMB considered publishing on Facebook its excellent leaflet to educate people, young people in particular, who might be using anabolic steroids or weight loss drugs so as to highlight the dangers associated with them? It is right that there is a need to educate young people. My focus in this regard is on them.
Mr. Pat O'Mahony:
The discussion in regard to the use of social media is very interesting. Those of us of a certain age are perhaps not as adept as younger people at using them. However, across medicine regulators generally this matter has now been discussed at a number of high level meetings. Mr. Nigel Fox is our communications person and we have begun to look at our social media offering. As part of the launch of our new name, in the first or second quarter of next year when we will have a new website, we are looking at what engagement we might have with social media. This is something at which we need to look and I welcome the Chairman's comments on it.
Dr. Joan Gilvarry:
Since we were before the committee this time last year, we have a lot more information on the issue. However, we do not yet have a clear answer; it is multifactorial. We are coming closer to an answer and it has to do with the size of the head of the femur and the shallowness of the cup into which it goes. However, it is also very much dependent on the patient's condition, patient selection and the technique of the surgeon. Surgeons tell us that with metal on metal, there is contrition and that they must get it perfect when inserting the hip, whereas the older process allowed for some contrition. It, therefore, has to do with patient selection and the implantation technique used, but the need for post-operative follow-up and rehabilitation also come into play. With biomechanical design, we are coming closer to the issue being the size of the head of the femur and the shallowness of the cup into which it goes. Mr. O'Mahony referred to the SCENIHR report. The expert committee in Europe has reviewed the situation in the past year; we contributed to the review and expect its outcome to be published within the next couple of days. I think it will reflect what I have said, that the cause is multifactorial, but it is mainly due to the size of the femur head.
With regard to the need for follow-up, we tried to get current numbers from the HSE. We know that some 350 people underwent revision surgery about this time last year and that another 166 were lined up to have the procedure done. In recent discussions with the HSE it told us it had reviewed every patient. I am aware that the revision surgery is carried out free of charge, but I do not know whether the patients have been compensated. However, I am aware that there are ongoing legal proceedings in that regard.
Dr. Joan Gilvarry:
The HSE confirmed last week that 100% of the affected patients had been reviewed.
Dr. Joan Gilvarry:
That was the position this time last year. When we were here in July 2012, that was the number at the time. In the past couple of weeks the HSE has not been able to ascertain the figures for us, but it is putting them together. It is trying to get them from private and public hospitals, but it does not have a handle on the exact figures and was not willing to give us uncertain figures to share with the committee.
Mr. Pat O'Mahony:
I will ask Mr. Lynch to comment on the organ issue. Before doing so, I wish to pick up on an issue raised by Senator Jillian van Turnhout regarding the direction in which the process is heading with regard to medical devices and the joint assessment of notified bodies and whether we are making any progress in that regard. In the joint action on which we are working across Europe and in which the IMB is engaged and involved, there are joint assessments of all the notified bodies involved. The process is under way and by now assessments of more than 20 notified bodies have been made. Our notified body will be assessed before the end of the year. By the end of the year, all of the notified bodies which give pre-market approval for devices will have had a joint assessment. What this assessment brings about for the first time is that instead of just a local, national competent authority visit, there will be a visit by an expert from another competent authority in another country. There will also be a visit by an expert from the European Commission. Therefore, three separate groups will come to take part in a week-long assessment or whatever else is involved. This is already generating substantial improvements in the system and we will see it deliver for us over a period. Unannounced audits can also take place and they are happening. A range of other improvements are taking place in regard to communication and how the system is run. We are working hard on these. The position on medical devices will change, but we have a long way to go with regard to the regulatory environment for such devices.
Dr. Joan Gilvarry:
It is difficult to give a straight answer on this issue. We expect the results of the SCENIHR report to tell us whether there are defined health risks associated with the metal ions released, the cobalt and chromium released with the metal on metal hips. With regard to the numbers affected, it is not an exact science and all we can do is go back through all of the hospital records. From the HSE, we reckon that approximately 8,000 patients in Ireland have had metal-on-metal hip replacements. One improvement since we were here this time last year is that now we have a national joint registry which was set up and opened by the Minister under the National Office of Clinical Audit in the RCSI. Therefore, in the future we will have exact numbers for revisions and hip and knee replacements and have immediate access to these data. This improvement has been sought for some time and is welcomed by the orthopaedic community.
Mr. John Lynch:
The committee will be aware that the IMB is the competent authority for the authorisation of the organ centres and the National Procurement Service. We have no specific view on whether there should be an opt-out of the consent process. As a State agency, it is appropriate for us to work within whatever system the Government decides. However, we emphasise the importance of a robust system of consent to ensure the safety and quality of the organs so that the recipient is protected. We agree that members of the public need a clear explanation about what the opt-out system entails and what safeguards are in place for the donor or the donor's family in the event that the donor is unable to make a decision.
Mr. John Lynch:
That particularly relates to lifestyle. Obtaining consent and finding out about a donor's lifestyle may happen at an exceedingly difficult time, as has been made clear to us by those who are directly involved in the process, but it is important that we have that information so that the recipient of an organ, organs or tissues and cells are safeguarded in so far as is possible.
It is a sensitive time, as Mr. Lynch noted, and one must tread carefully.
On PIP breast implants, Mr. O'Mahony referred to the poor communication and waiting time difficulties being experienced by some people. Has the situation improved? Was only a small number of people affected? I would be concerned if some of the women involved are not getting the full after-care that they deserve or are entitled to.
Mr. Pat O'Mahony:
The Chairman will recall from the presentation by Dr. Tony Holohan, Chief Medical Officer, to the committee that those issues related to the Harley Medical Group. The Harley Medical Group has gone out of business; it has closed up shop in Ireland. The individual clients of the Harley Medical Group no longer receive a service - the files are with the liquidator. Our understanding from our colleagues in the Department of Health is that the Department and the HSE are in the advanced stages of establishing a clear treatment pathway for all the affected ladies, but the patients have been left in limbo as far as the Harley Medical Group is concerned. I mentioned the issues that people complained of at the time. Those are not historical but refer to when the issues came to light and they were dealing with Harley at the time and they were getting very unsatisfactory reactions, treatment and service from Harley-----
Mr. Pat O'Mahony:
No, Harley has gone out of business in the UK and Ireland.
It is inevitable that the HSE, the Exchequer and the Department need to review the patients and provide ongoing care for them, which is what we understand the Department has in essence agreed to do. We also understand from recent correspondence that that will be part of the Estimates for next year's budget.
I appreciate that that is not within your jurisdiction.
As Members have no further questions, I thank all the witnesses for their time and the quality of their presentation, as well as for their work and commitment. It is important that we keep a vigilant eye on the issues, particularly on the importation of medicines. As Deputy Maloney said, the IMB's leaflets are to be commended. I have seen the leaflets; indeed, I have a couple of them in my office. I hope that the IMB will consider, as part of an engagement strategy, giving some of them to TDs and Senators for their constituency offices.
I assure those present that I did not put my leaflets in the bin - I just did not get any. I usually ask for extra copies of such leaflets because I find it helpful to give them out to people at my constituency office.
That is important for the IMB's engagement with the Oireachtas and Members outside the committee. The old cliché about hiding one's light under the bushel applies to the IMB's work - it is important it shines a light on what it does well. As Pat O'Mahony said, the process is ongoing and the board is looking at different ways in which to engage with people, and we thank the board for its efforts.
We will look at pre-budget submissions at the committee's next meeting.