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.