Pádraig Mac Lochlainn (Donegal North East, Sinn Fein)
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P00057/12, a petition from Mr. Jason O’Sullivan, concerns his wish to take Roaccutane off the market because of its possible side effects. We have had the opportunity to consider this petition. I ask members to summarise the position or make recommendations.

Michael Healy-Rae (Kerry South, Independent)
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I know Mr. Jason O'Sullivan. Before taking the drug, he was leading a perfectly normal, healthy and happy life. He took it in good faith and, unfortunately, the health implications for him have been absolutely disastrous. To say that his life has been turned upside down is a complete understatement. Every minute of every day, he is affected very adversely by the drug.

Let me quote the statement of a mother whose son was also affected by the drug:

I am a nurse and what I will put here will be in layman's terms or basically more generalised language to make it as direct and understandable to as many people as possible. Please read this.

I have a son who took Accutane. Basically, my son took the drug for two months instead of the full four but his personality changed dramatically. He became extremely aggressive, violent and suicidal, and his entire life started going down the drain. It is like his survival instincts had completely reversed and he could only focus on the most negative aspects of life, to the point where his physical actions were out of control and severely detrimental to him. Paranoia led him to becoming extremely violent, verbally abusive and self-consumed, and even caused him to suffer from such disorders as agoraphobia, body dysmorphic disorder, depression and even delusions. He closed himself off from the world, lost his career and all of his friends and pushed everyone out of his life. As a registered nurse, I was able to realise, as he changed, where it might have come from, through research.

That is but one other case. The number of suicides directly related to the use of the drug leads me to contend it is highly questionable whether it should be made available at all. While the drug company may say a very small number of people have such an adverse reaction, one suicide is one too many.

I know Mr. Jason O'Sullivan and what the drug has done to his life. If a person were to be knocked down in the morning and killed outright, it would be a better solution than having this problem in one's head and system without being able to do anything about it. The key point is that those who look at a person suffering from the side effects of the drug cannot see the disorder. It is not like cancer, which may make one thin and the treatment for which makes one go bald. The people in question look perfect. They cannot sleep at night, however. If they do, they are more tired when they wake up the next morning. They are more tired than they would be if they had not gone to bed at all. What the drug does to one's mind is absolutely frightening. This is why I believe passionately that we should be able to do something to try to help the petitioner. Where else can he go? It is not as if he is looking for redress for himself. He is not asking this in his petition. What he is saying is that he wants the drug withdrawn. I know from my dealings with him that he wants to stop other young people from having their lives torn asunder by taking the drug.

Susan O'Keeffe (Labour)
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I echo Deputy Healy-Rae's concerns about this case. Obviously, Mr. O'Sullivan has had an extremely traumatic experience. The drug Roaccutane has been on the market for 30 years, and there have been a number of events such as those described. The matter this committee should be considering is oversight in so far as it relates to the Irish Medicines Board. I see from the petition that Mr. O'Sullivan has had contact with the board. I recommend that we first establish what correspondence exists between the board and Mr. O'Sullivan and ask the latter to allow us to see it before we decide as a committee how we can approach the board and take on board the petition in the correct manner. It is important that we get this right. Mr. O'Sullivan has suffered. As Deputy Healy-Rae stated, he is not being selfish and his desire is that other people will not suffer as he has done. This is in the spirit of petitions.

Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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Since this committee is not an expert committee, I suggest that we write to the Irish Medicines Board specifically to find out its procedures in authorising new drugs coming onto the market and to establish the steps it takes to monitor continually the adverse effects of drugs that are on sale. When it is established that there are serious adverse effects, how is a drug withdrawn from the market? What plateau must be reached before a drug is refused a licence for the Irish market?

Pádraig Mac Lochlainn (Donegal North East, Sinn Fein)
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There are two recommendations. Are they agreed? Agreed.

The next petition is P00082/12, which concerns the secondary use of patient information and the risks associated with electronic health records. The committee has had a chance to deliberate at length on this petition. I ask members to summarise their recommendations.

Susan O'Keeffe (Labour)
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This petition is from Mrs. Neary, who is concerned that data on the tissue of patients who attend public hospitals can be used for medical research purposes without proper patient consent. That is one aspect of her petition.

This is obviously a very complex matter concerning how tissue is controlled, who has access to it and where consent is, or is not, given for its use. She has raised matters that are genuinely of public concern.

I understand that a White Paper is pending on this matter and that HIQA is also involved in setting a national standard for guidance in the use of health and social care settings concerning this particular issue. In fact, the petitioner will be making a submission to HIQA. Given the complexity of the matter, I would like to see the petitioner before this committee in the first instance so that we might better assess how we can proceed with regard to this petition. There are a number of aspects to it and we are not specialists. She has done a lot of research and I think the committee could benefit from hearing from her in the first instance. That would be my recommendation.

Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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The petitioner has raised quite a number of issues on data protection. HIQA has published its own draft report entitled, Draft National Standard Demographic Dataset and Guidance for use in health and social care settings in Ireland, which is open for public consultation at the moment. It is a very tight timeframe because 12 April is the deadline for consideration and feedback. I suggest that, as we will not achieve that deadline in this instance, we should write to HIQA making it aware that we are beginning deliberations on this petition. We should ask that prior to HIQA finalising its report, as well as the White Paper or whatever comes from this report, HIQA should take into consideration the points we are raising. We should contact HIQA on an ongoing basis as we progress with this.

It is frightening what can be done with data that is stored electronically. It can be circulated quite quickly. If people have the computer programmes to interrogate data when it comes back, one can then undo some of the anonymising of data that is supposed to occur. We need to protect against that, especially where the consent of the person involved has not been given, as is the case with most of the health data in this country.

Pádraig Mac Lochlainn (Donegal North East, Sinn Fein)
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I think the committee is agreed on those recommendations. We will reconvene on Wednesday, 17 April 2013 to conclude with the petitions that were before us today. We have five more to consider on that date.

I thank members for attending the meeting which now stands adjourned until 4 p.m. on Wednesday, 17 April 2013.