Skip to main content
Normal View

Joint Committee on Health and Children debate -
Thursday, 21 Jan 2016

Health Products Regulatory Authority: Chairman Designate

I remind members, witnesses and those in the Visitors Gallery to turn off their mobile telephones so that they do not interfere with the broadcasting of the proceedings and staff. As members and those who are watching at home and online will be aware, we are in public session.

As part of our scrutiny role, the Joint Committee on Health and Children meets with key appointees in the areas of health and children before their appointment. The first part of our meeting this morning is to meet with the chairperson designate of the Health Products Regulatory Authority, HPRA. As members are aware, the HPRA comes into this committee regularly and plays an expanding role in the regulation and monitoring of health products in Ireland. Ms Ann Horan is very welcome to our meeting and I thank her for being here. Ms Horan has been a board member of the authority for the past five years and this is a good opportunity to discuss her views on her future vision for the HPRA.

Witnesses are advised that, by virtue of section 17(2)(l) of the Defamation Act 2009, they are protected by absolute privilege in respect of their evidence to the committee. If they are directed by the committee to cease giving evidence in relation to a particular matter and they continue to do so, they are entitled thereafter only to a qualified privilege in respect of their evidence and they are directed that only evidence connected with the subject matter of these proceedings is to be given. They are asked to respect the parliamentary practice to the effect that, where possible, they should not comment on, criticise or make charges against any person by name or in such a way as to make him or her identifiable. Members are reminded of the long-standing rule of the Chair that members should not comment on, criticise or make charges against any person or entity by name or in such a way as to make him, her or it identifiable.

I invite Ms Horan to make her opening remarks.

Ms Ann Horan

I thank the Chairman and members for the opportunity to address the committee. I will use my opening statement to explain the process which led to my selection as chairperson designate of the Health Products Regulatory Authority, HPRA, and my qualifications and suitability for the role. I have also been asked to give a short briefing on the work of the HPRA and my ambitions for the authority.

The role of chairperson of the HPRA, a part-time non-executive role, was advertised in early October on the Public Appointments Service website, As a current HPRA board member, I decided to apply for the role and, in mid-December, I was honoured to receive a call to advise that I had been selected by the Minister of State, Deputy Kathleen Lynch, as her preferred candidate. I subsequently received a letter confirming my selection and an invitation to appear before the committee today. As part of the application process, I was required to write a letter to the Minister for Health outlining my suitability and qualifications for the role. I am using much of the same wording here to make my case to this committee.

Over the past five years, I served as a board member of the HPRA and chairperson of the audit committee. During that time, I gained a clear understanding of the work of the authority, its strategic direction and imperatives and a healthy respect for the management and team of experts who run the day-to-day operations of the HPRA. At board meetings, I have always been vocal and challenging while remaining constructive and supportive of management in the performance of their roles. I have been called on a number of times for advice by the chief executive and the director of finance and I am generally invited to participate on key committees including the performance evaluation committee and the selection committee for the new chief executive. I was instrumental in securing the approval of the board for a number of key initiatives and I have an excellent attendance record and always prioritise my board meetings above other diary commitments.

A copy of my CV was circulated to the committee in advance of this meeting and I do not intend to go through the details now although I am of course happy to take questions. In summary, my career experience to date includes senior executive roles in banking, small business, regulation and education. I have served on boards including Dublin City University, the Institute of Bankers, South Dublin Chamber of Commerce and chaired associations including the UK based Factors and Discounters Association and the International Women’s Forum. I am a chartered certified accountant, FCCA, and I have a master's degree in finance from Dublin City University. These roles developed my expertise in the areas of leadership, strategic planning, financial control, risk management, corporate governance and technology and helped improve my communication, decision-making, influencing, negotiation and people management skills. I have proven ability to operate in both the public and private sectors and I have direct experience in the areas of regulation and investment management.

In January 2015, after six exciting and successful years establishing and running, as chief executive, the DCU Ryan Academy for Entrepreneurs, I decided that my work was done and that it was time to hand over the reins. I took time out in 2015 to enjoy a better quality of life, travelling and spending time with my family and friends and limited my professional time to a small number of voluntary roles in various organisations, including the HPRA, the South Dublin Chamber of Commerce and South Dublin County Council.

I decided not to return to a full-time role for the time being but to take on one serious part-time challenge. The role of chairperson of the HPRA was my first choice in this regard having spent the past five years growing to appreciate and understand the organisation. I have the time and interest to lead the board at what I see as an exciting time in its history and I feel I would be an ideal person to support the new chief executive, Dr. Lorraine Nolan, who took up her role earlier this month.

My fellow HPRA board members are experts in the fields of human and veterinary medicines and medical devices. I look forward to employing my business and governance skills in particular in leading the board and ensuring the HPRA and our various stakeholders benefit from the guidance and leadership of this group of experts.

I will move on now to the work of the HPRA and our strategic plan. The HPRA is the independent regulator of health products in Ireland. Our role is to protect and enhance public and animal health, by assessing the safety, quality and effectiveness of health products on behalf of the public so as to ensure the benefits they provide outweigh any potential risks. We regulate a wide range of health products, including human and veterinary medicines, medical devices, blood and components, tissues and cells, organs for transplant and cosmetics. For some products, such as medicines, we regulate across the entire product life cycle from clinical trials right through to use by health care professionals, patients and animal owners. For others, our role starts when the product first comes to market. We monitor these products and act upon any safety issues that are identified. In all cases, our core focus is on effective regulation. This means harnessing the best scientific and clinical knowledge available to us through our specialist staff and experts nationally and our participation at European committees.

In addition to protecting public health, a robust regulatory system is important for Ireland as a major international location for the life science sector. We know that the pharmaceutical industry alone accounts for over 50% of all exports, with nine out of ten of the largest pharmaceutical companies having operations here. Ireland also has a large and vibrant medical device manufacturing industry. The HPRA’s regulatory role supports the sector’s continued success by monitoring compliance with good practice and adherence to legal requirements.

The HPRA board approved a new strategic plan for the period 2016 to 2020 at its meeting in December. The timing of this plan coincides with the term of my proposed appointment as chairperson. Our five-year vision, as expressed in this plan, is to be a leader in effective and innovative regulation, both nationally and internationally, and a recognised centre of excellence for the quality, efficiency and scientific rigour of our work. Through successful implementation of this plan, we will continue to optimise our regulatory processes and systems to keep pace with product and manufacturing developments and play our role in enhancing access to health products and providing high-quality, timely information to health care professionals and their patients. Underpinning all of this will be a focus on recruiting, retaining and developing the best scientific and administrative staff to deliver on our core mission of protecting and enhancing public and animal health.

Over the period of the plan, changes in the regulatory environment will provide challenges and opportunities for the organisation. The most significant of these relates to European and national legislation. Medical device legislation will be substantially revised, as will the legislation for veterinary medicines. Increasingly, efficiencies will be gained within the European Union by centralised assessments and more effective solutions will be possible through EU co-operation on issues such as medicine shortages - which affect many countries as well as Ireland - and early access to new medicines which have important benefits for patients. Our communication and stakeholder engagement will be shaped by society’s growing expectations of regulators, while technology advances have the potential to transform the manufacturing and capability of health products. These advances will challenge us to ensure that we continue to regulate innovative products effectively.

I see my role as chairman to work with the board to support the chief executive and the executive team in the implementation of the plan. Specifically, I will work to ensure that the HPRA has sufficient resources and expertise to carry out its functions effectively. I will use my leadership position on the board to ensure that the authority benefits from the expertise and knowledge of the board and the various scientific advisory committees. Communications is an important aspect of my role and I will ensure that the HPRA has an effective communications policy and that we work closely with our colleagues in the Departments of Health and Agriculture, Food and the Marine and the HSE for the benefit of patients and the public good.

I thank Ms Horan for her comprehensive statement and compliment her on her impressive CV.

I wish Ms Horan well. Debate on the issue of service on boards is ongoing but I will not ask her to comment on that matter. We certainly need people of quality to put their names forward. Sometimes we play too much politics in this area and place too much emphasis on how people are selected. However, we need individuals of a high quality and calibre, although I accept that such persons could quite easily be doing other work. There is a certain calling to public duty and service in this regard but I am not so naive that I do not know that there are many people who are consistently "on the circuit" at the same time. It is important to acknowledge that people with experience, competence and quality should be encouraged to play their part in serving at various levels in public administration.

I was interested in everything Ms Horan had to say but one issue stood out. She indicated that her five-year vision for the HPRA, as expressed in this plan, is for it "to be a leader in effective and innovative regulation, both nationally and internationally, and a recognised centre of excellence for the quality, efficiency and scientific rigour of our work". She also made reference to the industries in Ireland in the area of life sciences, pharmaceuticals and medical devices. There is no doubt that across the country this is a critical component in terms of employment. In addition, because of the types of companies located here, the industry sends out a strong signal internationally that we have a good, educated workforce and all that flows from that.

Equally, regulation and the regulatory underpinning required in this area is important. What role does Ms Horan see for the HPRA in the years ahead in terms of regulation? Does she see it as having a role in enforcement or does she see a need for it to go beyond that and be a leader in ensuring not only that regulation is adhered to but that it is evolving? I have often found that while our regulatory authorities are very good at enforcement, they seem reluctant to accept that they should evolve, just as life and circumstances in the broader industrial and commercial world evolve. We have seen an example of imbalance in previous times where the banking industry had evolved but the regulatory system had not caught up with it.

The HPRA is concerned with issues of public, human and animal health. In regard to veterinary regulations, what crossover is there between the HPRA and the Department of Agriculture, Food and the Marine and other agencies involved in this area? Is there duplication or possible duplication of regulation between the various stakeholders and agencies, many of which are statutorily based? Is there potential for streamlining in that regard? I do not expect a detailed response on this but has Ms Horan made any observations in this regard? I often wonder whether the various regulators overlap and would like to hear her comment on that. Again, I wish her the best of luck in her position.

I wish Ms Horan well in her new post. She has been a member of the board of the HPRA for some time. When did she first take up a position as a member of the board?

I will not repeat the comments made by Deputy Kelleher. We place huge trust in and depend on the reliability of entities entrusted with scrutiny and regulation regarding health products. In recent years, however, we have had a number of disturbing issues relating to health products, the consequences of the use of certain health products, for example, DePuy hip replacement products and Poly Implant Prothèse, PIP, replacement breast enhancement products.

While the jury may be out, the parents have concerns about the HPV vaccine. Do vaccines as health products come under the scrutiny of the Health Products Regulatory Authority of Ireland, HPRA? The REGRET organisation represents the parents of those young girls who have had adverse consequences to the vaccine for cervical cancer. In the context of the PIP breast reconstruction and enhancement products, the HPV vaccine and many others - I did not write down a list in advance - who takes an overview on the HPRA's effectiveness? It would dent public confidence in the exercise if those matters have come under the scrutiny of the HPRA. What does Ms Horan say to the committee as chair of the HPRA board to address any residual concerns about any of the examples I have cited? I could add other cases but they will suffice as examples of the areas of concern I have. I repeat my good wishes to Ms Horan on her upcoming responsibilities.

I also welcome Ms Horan to her critically important role. I have been very involved in new drug development and I founded the country’s first national clinical research group so I have had extensive dealings over the years with the Irish Medicines Board, IMB, as it was then, now the HPRA. Over the past decade in general it has conducted its business in a professional fashion.

I must for the record say that what Deputy Ó Caoláin outlined as the side effects are alleged. This is a very important issue because at this point we have a vast wealth of international data suggesting that the HPV vaccines are very safe and have had a colossal impact in reducing the potential for cancer-causing viral infection in young girls and boys. I honestly know that Deputy Ó Caoláin means well and that many people have been approached directly by various representatives of the anti-vaccine movement, which is part of a larger anti-vaccine movement that is causing real problems around the world right now. I would not want this committee to appear in any sense to endorse the position that there is a proven danger associated with what I believe is one of the most important public health initiatives undertaken in recent years, namely, HPV vaccination.

Ms Horan should not take this in any sense as a criticism but perhaps she would clarify the position as people will ask about her own role as a fairly senior and influential person in the banking sector at a time when the sector collectively – I do not say it was every individual as I am sure there were dissenting voices - was involved in what we now know was a catastrophic failure, mainly of competence rather than of ethics, on the part of the banking sector in this country, which had awful consequences. I am delighted that Ms Horan was able to leave it and to do something else. Many people did not have that opportunity and found that they were in hock with negative equity mortgages that they-----

The Senator is straying.

I am not. I am discussing aspects of the curriculum vitae of the person who is here before us today.

To be fair to Ms Horan she left Bank of Ireland in 2005-----

That is correct.

-----which was well in advance of any impending-----

You are a bit of a historical revisionist, Chairman. Most people would say the rot in the banking sector began well before 2005. Anyway, we are not going into that.

The collapse had not happened. To be fair to the witness and to protect her, it is beyond the remit of today’s meeting to bring up those matters.

I wish you would not interrupt me, Chairman. I put in a disclaimer to say there were dissenting voices and there were people who spoke out. The question will be asked. We are not here to be a rubber-stamping body but to offer scrutiny of people who come to public appointments at a time when this kind of public appointment – not Ms Horan’s in particular – but other ones have been the subject of great scrutiny. These are valid questions to ask and I am sorry if I am upsetting anyone. If you wish me to leave, Chairman, I will.

Just for the record, I never asked Senator Crown to leave. He is not upsetting me at all. I am just trying to protect the witness, which is my job. It is my duty to chair the meeting.

I am not attacking the witness. Does Ms Horan feel she needs protection from me?

Ms Horan should be careful how she replies to that.

Ms Ann Horan


Deputy Ó Caoláin would have some authority on that one. I am sorry but I did not know Ms Horan was coming in today. I have been wrestling with my own personal bias for the past half an hour since I found out that Ms Horan would be here because there is a great big elephant in my room regarding what was the Irish Medicines Board, IMB, and is now the HPRA. An unbelievable episode occurred in 2002 and I believe when one looks at the record only one conclusion can be reached. A senior member of the board of the then IMB told me that this is what happened. After I had blown the whistle on the clear-cut and well documented episode of financial fraud involving clinical research materials, of which I notified the IMB and which it began to investigate, it then suddenly and for no reason two weeks later stopped the investigation and investigated me, the whistleblower. Some very strange epiphenomena occurred around that time, one of which was the attempt by multiple journalists using FOI to get access to the records of the IMB and the records were completely redacted with big black lines. We were told at the time it was because of commercial sensitivity.

When I got permission from the companies who were involved in the research to absolve the IMB of abusing any commercial sensitivity I notified the Irish Medicines Board of same and the records still came back in a redacted fashion. It is now 13 years later and there is no commercial sensitivity. I ask Ms Horan to make those records freely available because I believe something very bad happened at that time and some strange connections were unearthed between the finance committee of the body in question and senior members of the IMB at that stage as well. There were a lot of unanswered questions. As the subject was obtuse and arcane and involved an area of clinical research which was not something that was well developed in Ireland there was not a big constituency looking at the scrutiny of clinical research. We now know that regulation was not something we did particularly well at that time and there was huge neglect of all kinds of institutional abuse which was taking place and I believe that was an example of it. I ask Ms Horan to look back at those records. I will approach her under FOI and ask her if she has access to the old IMB records to make them available in an unredacted fashion because there can be no commercial sensitivity 13 years later.

I thank Ms Horan for the work she has done to date and wish her well in her new appointment. The big question I have to ask relates to research and development and her view on it in this country. There is a lack of co-ordination. The HSE, for example, does not have any person in charge of research. It is an organisation with 100,000 people that is providing medical care for the entire country and there is no head of research. I tabled a Commencement matter recently in the Seanad seeking that someone would be put in charge of research and development. The reason I did it is because a large food company in this country did not have anyone in charge of research and put someone in place. The person now has a budget of €20 million for innovation and development. That is because the private sector is able to respond far more quickly whereas the public sector seems to have a problem responding and planning for change.

It might not relate to Ms Horan’s role but given that she is coming from the private sector and much of the research and development taking place affects the public sector, especially the health care area, how does she envisage the development of the private sector working with the health care sector in conjunction with the university sector? How does she envisage that evolving and how can we work towards getting all those three sectors together in order to be far more innovative and productive in what we achieve? One of the downfalls in this country is that we do not have the required level of co-ordination. I was in China a number of years ago to look at how research is carried out. The industry, the university sector and government agencies all work together but here everyone goes off in a different direction.

The sectors can help one another, but this is not happening. How does Ms Horan see this developing in her role? It is an extremely important thing that we need to do in this country.

I welcome Ms Horan before this committee and thank her for having put her name forward for this position, for having outlined to us her rationale and background and for the information that was sent to us in advance. I will not repeat what my colleagues have said. One query which I previously brought up with the Minister for Health regarding the Health Products Regulatory Authority, HPRA, relates to the promotion of so-called health products and Ms Horan's role in addressing this. Specifically, the issue I have is with the so-called miracle mineral solution, MMS, and the chlorine dioxide, CD, protocol, which are effectively what I would call in plain English industrial-strength bleaches. However, they are being promoted as cures or treatments for autism, and there is no cure for autism; it is a medical condition, and that is a fact. People are going around promoting these treatments, feeding into certain parents' wishes to do their best for their children, but some people are misinformed and the treatments are very dangerous for and harmful to children. I find it very difficult that there is nothing we can do to regulate or outlaw the use of these types of cures or treatments. When I last asked about this, apparently the HPRA were investigating, so I ask Ms Horan whether she has any update on this or any commitment regarding what we can do about these issues.

I thank Ms Horan very much and welcome her. Having listened to her presentation, I believe it is very clear why the Minister of State, Deputy Kathleen Lynch, decided to appoint her. For any job that is applied for now, we must have the right person, and sometimes the right person comes from another background or has previous experience in other areas and on boards of companies and so on. Sometimes we frown on that because we believe it is just the old thing again of appointing people to boards. If someone is the right person, I do not see why he or she should not have the opportunity to apply for a position, even if he or she has been on boards before, so I am not one of these people who jump up and down about people being appointed. As long as the appointee is the right person in the right place and he or she has the right qualifications, that is all that matters to me. I was very interested by Ms Horan's statement that she decided not to take a full-time position but one serious part-time challenge instead, namely chairperson of the HPRA. We need people like Ms Horan who want to dedicate themselves to doing a particular job at a particular time to the best of their ability, and the fact that she has been a board member of the HPRA is an added bonus for us all.

Senator van Turnhout already alluded to drugs that are available online and come through different sources, as well as various kinds of medication that are promoted not through the medical end of things but through different channels. That was one of the points I wanted to raise, particularly in light of the events of the last few days, when five young people ended up seriously ill in a hospital after taking legal highs. Deputy Ó Caoláin also mentioned the DePuy hip replacements and PIP breast implants. One serious issue I have seen in the last few weeks is the drug trial in France, in which people were prescribed a particular drug on a trial basis, and many of their lives are now changed forever. I am not sure whether monitoring such things is part of Ms Horan's role or that of her organisation. It could be; I am still reading through the pages. However, I believe we need regulatory boards and people who are prepared to stand up and challenge people when they make statements about certain medications brought onto the market that are not fit for human consumption. That must be very much part of the HPRA's role as well.

I do not always agree with Senator Crown but I totally agree with him on vaccination. I have two young girls who have both been vaccinated against cervical cancer. Unfortunately, in all walks of life - we only have to think back to when we had our children vaccinated against measles, mumps and rubella, and other diseases, when they were small - any drug or injection can have side effects, and for some people those effects can be very detrimental, as we have seen in France.

I wish Ms Horan well in her job. She has a huge role to play in the future of this country and in being able to limit people who are promoting certain alternative medicines. I am not knocking alternative medicine, but some alternative medicines lead people into very dangerous areas. I hope the HPRA can do something about legal highs, particularly for young people. I heard a lovely doctor this morning on the radio - I believe he was from Cork but I cannot remember - speaking about the young people who have been seriously affected in the last two days by taking legal highs and about education. Even with education, it is not enough to do it in schools. As parents and grandparents, we need to be always giving our children advice on the dos and don'ts and the rights and wrongs of taking any kind of medication. This is probably not in her field, but I wish Ms Horan well in her forthcoming position and I believe that Deputy Lynch has been very studious in designating her.

I thank Ms Horan very much and wish her the very best in her new post.

John Lynch, who was the director of compliance in the HPRA, talked about the dangers of slimming pills. I ask that Ms Horan please look into this in her post, because the lists of ingredients for these pills seem to be falsified. Some people taking these tablets seem to think that they are simply herbal treatments or stimulants, and I want Ms Horan to be able to point out, especially to young women, the dangers in this regard. We know, for example - and Mr. Lynch also said he believes this to be the case - that there is a drug contained in these tablets called sibutramine, that this drug was banned worldwide in 2010 and that, even though the ingredients lists are on the packages, they are falsified. They do not state exactly what women are taking. I believe Mr. Lynch said that women are playing Russian roulette with their lives. I ask that Ms Horan please look into this as a matter of urgency.

I ask Senator Crown to be very brief in his contribution, because he has contributed already.

Ms Horan might also ask Mr. Lynch why I was told I could not have legal representation when he came to do the investigation of the event that I reported, as was my statutory duty, to the Irish Medicines Board in 2002-----

That is a different matter altogether, to be fair.

-----and exactly what terms of reference he was given and why certain areas were blocked off to the investigation-----

That is not part of the committee's business this morning.

-----and others were pursued.

It would be remiss of me not to acknowledge in the public Gallery the new chief executive of the HPRA, Dr. Lorraine Nolan. She is very welcome. I thank her for being here. On the committee's behalf and on my own, I express our appreciation and thanks to Pat O'Mahony, who has been most courteous, professional and personable to the members of this committee. We wish him well in the new phase of his life. I am sure Dr. Nolan will have a starring role in the Joint Committee on Health and Children during the term of the next Parliament. I congratulate her on her appointment and wish her well.

Ms Ann Horan

There are a lot of questions, so I will try to go through them in the order in which they were asked and make my best effort.

I thank the members of the committee for all their good wishes. They are very much appreciated. Deputy Kelleher asked me about the role of enforcement versus being a leader in the evolution of health products and regulation, and that is a very important point and something of which the HPRA is very cognisant. In our new strategic plan, for example, we are very much looking to be leaders and to keep up to date with developments and the regulation of these things. The regulation of medical devices is a good example. There is new legislation relating to this, and our focus is very much on influencing this legislation so that it will make sense and be easy to enforce. That legislation is right at its early stages. The overlap between the various agencies is another area that is very much part of our strategic plan. We are aware that this involves two Departments, the Health Service Executive and our organisation, and in many areas it is very important that we work together. It is a key focus of our strategic plan that we encourage and take a lead in negotiations.

I do not think there is too much duplication at the moment but there is always the potential for it. There is also the potential for confusion if people do not know what the various roles are.

Deputy Ó Caoláin asked when I took up my position on the board of the HPRA. That was in January 2009, so I have been there for five years. The Deputy commented on some of the issues with health products, mainly medical devices, which we do not authorise but we do monitor. With products like that, there will always be issues. What we can do is have the best staff, scientific advice, evidence and data, and look at it from the point of view of benefits outweighing risks. One cannot have absolutes when dealing with health.

I thank Senator Crown and others for clarifying the importance of the HPV vaccine. I am a parent, as are many of my fellow directors and other staff in the HPRA, and we have huge sympathy for any parent who has a sick child. Having said that, we cannot deny people the opportunity to have this vaccine, because here is no evidence to suggest there is any link between the vaccine and some of the effects that were mentioned, and we will continue to go with the scientific evidence. This is something we will continue to monitor, and it is a very serious issue which takes up a lot of board time for us, as we discuss it quite regularly.

Senator Crown asked about my role in the banking sector. As the Chairman commented, I left banking in 2005. I was never involved, I have to say, in property or any of the areas that had any issues. I had a very successful banking career. I enjoyed 30-odd years of it and one day woke up and thought that maybe there was something more to life. However, my record is unblemished and I do not think I have anything to be concerned about. I am not aware of the episode in 2002 that the Senator mentioned, but I can check and see whether information can be made available.

In response to Senator Burke, the importance of research and development is-----

Senator Burke has tabled a Commencement debate in the Seanad and apologises for having to leave.

Ms Ann Horan

I will answer the question anyway. The whole area of research is very important to us at the HPRA and we have been involved in setting up an organisation called Regulatory Science Ireland. That body brings together the various universities, the private sector and the public sector to promote research in regulatory science and to make sure that we stay ahead and that we work well with the industry. I think that is the area that Senator Burke was asking about.

Senator van Turnhout mentioned the miracle mineral solution. It is not an authorised product in this country. As with any of these things, we do our best to try to promote discussion of the issues around it and to do whatever we can, but it is not authorised.

Deputy Byrne mentioned the very sad issue in France this week regarding the clinical trial. The HPRA is involved in regulating clinical trials. There is new legislation that we are currently in discussion with the Government about. That will be around bringing together the legislation from Europe. All I can say about the clinical trial in France is that it was at a very early stage and that is the highest-risk stage, when medicine that has been tested on animals is starting to be tested on humans. There are definitely risks there. We do not have a huge amount of those types of trials in Ireland, although we could have. Basically, we do not know what happened in France but we are monitoring the situation. It is obviously very serious and is something we are looking into.

Deputy Mitchell O'Connor asked about an appearance by John Lynch, the director of compliance at the HPRA. I do not know about that particular issue. Slimming pills, like the miracle mineral solution, are not authorised. We do our best to highlight the dangers around them. Part of our role and part of our strategic plan is providing good, quality information to health care professionals but also to members of the public, to warn of the dangers of these kinds of products.

I think I have gone through all of the questions, unless there is something I have missed.

One of the questions that I asked Ms Horan was what she would bring to her new position that would assuage any outstanding fears or concerns. We will not reopen the point about the HPV vaccine, but we will most certainly refer again to the experiences of the DePuy hip replacements and the PIP implants. Her comment that there will always be issues with health products does not give me the expectation that anything is necessarily going to change. I do not think that we should work on the basis that there will always be a risk factor, a percentage instance of less than satisfactory performance, inappropriate application or whatever. It is very important that the HPRA's role and function is understood and appreciated across the board. In relation to oversight of the HPRA, I have asked if there has been any re-evaluation of the attention given to the research into any of the products that we have mentioned - or any others that we have not - to see if lessons could be learnt or if better scrutiny, investigation, and testing could be employed. That is the particular area on which I would like to hear some additional comment, if the witness can oblige.

As a former member of staff at Bank of Ireland myself, I am only teasing Ms Horan with this last comment. She said she took up her board position in January 2009. She went on to say that was five years. It is seven years this month.

Ms Ann Horan

I am sorry, Deputy.

As I would always say, that is accountants for you. We will say no more.

Ms Ann Horan

I started at the DCU Ryan Academy in 2009. I was confusing the two.

I wish to raise the issue with Ms Horan of support groups for people who have suffered after receiving DePuy hip replacements. A number of women in Cork have expressed concern that there is no support group in Cork. Perhaps Ms Horan could ask the HPRA to look at that as well.

Ms Ann Horan

Does the Chairman want me to comment on Deputy Ó Caoláin's contribution?

Ms Ann Horan

To echo Senator Crown, in the last ten years - and certainly in the last five years that I have been involved with it - the HPRA has been a very impressive organisation. We have a board of experts and a very strong management committee, and I am absolutely delighted with Dr. Nolan's appointment. She has a curriculum vitae that is second to none and she has wonderful experience. We have 300 highly dedicated staff members, many of whom are doctors or pharmacists. It is a very impressive organisation and I would not take up this role if it were not, because, as the committee knows, I am not an expert in health. I am an expert chairperson, hopefully. I am taking on an organisation I can stand over that has a very strong reputation.

The DePuy hip replacements and the PIP implants are medical devices, as I mentioned before, and thus are not something that we license in this country but something that we monitor. I did not mean to downgrade the risks involved in any way. A number of years after the DePuy hip replacement was authorised there was an indication that after five years there was some leakage of metal and metal products and therefore there were recalls. In a lot of cases, recalls are precautionary, as opposed to being an indication that there are any great issues.

What I bring is leadership of the board, while ensuring all the times that we have the best staff and scientific knowledge, that we really play our role in Europe and on the international scene, that we remain up to date and that no issues arise, or, where they do, that they are dealt with very quickly and effectively and there are no attempts to cover up or other such activity. I bring integrity and leadership. I bring with me a wonderful organisation.

I thank Ms Horan for the quality of her presentation and engagement. It is quite clear she is a person of exceptional quality and expertise. We very much welcome her appointment and thank her. I thank Dr. Nolan for the promptness of the replies we have received to our correspondence with the HPRA regarding DePuy hip replacements and the medical use of cannabis. We appreciate that.

The committee will be writing to the Minister for Health to inform him of its deliberations this morning and will forward him a copy of the transcript of the meeting. On behalf of all the members, I wish Ms Horan every success in her appointment. We look forward to working with her in whatever capacity or role we have in the future.

Sitting suspended at 10.45 a.m. and resumed at 11.00 a.m.End of Take