Oireachtas Joint and Select Committees

Thursday, 21 January 2016

Joint Oireachtas Committee on Health and Children

Health Products Regulatory Authority: Chairman Designate

9:30 am

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-----

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