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

Photo of John CrownJohn Crown (Independent) | Oireachtas source

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.

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