A Chara, - I was surprised and disturbed by the claim reported in your account of the closure of the Elan Clinical Pharmacology Unit in Athlone (Business & Finance, November 4th) that the Irish Medicines Board was supposed to be partially responsible for the closure. While we regret the closure of this facility with its associated job losses we completely reject such an allegation.
We consider it particularly insulting to the members of our clinical trials sub-committee who voluntarily give their valuable time without payment to provide an invaluable service to assure the safety of those members of the public who participate in clinical trials in Ireland. We all benefit tremendously from the availability of safe and effective medicines and the unsung heroes of this process are all those who participate in such trials. Assuring the safety of trial subjects through thorough independent review is surely a praiseworthy effort, and is one of the goals of our organisation.
In addition, national legislation (Control of Clinical Trials Act, 1987, 1990) requires the IMB as the controlling authority to observe certain strict time limits. Where a problem is identified during the review process, additional data will be requested in the interests of public safety. Your report mentions delays of "four or six weeks" without any reference to this critical public health responsibility. Furthermore, in the same issue of The Irish Times a commercial supplement from the Irish Pharmaceutical and Healthcare Association (IPHA) shows that in 1990 the average clinical development phase of a new medicine took 6.7 years; in this context, four to six weeks is inconsequential. We are restricted on confidentiality grounds from providing comments on specific details regarding Elan. We would, however, comment that:
While the clinical trials subcommittee does not normally meet in August and December (as these hard-working individuals deserve some holiday time) we do deal with urgent matters on an ad hoc basis during these periods and have specifically facilitated Elan a number of times in this regard.
Over the past numbers of years we have reviewed and approved significantly more trials for Elan than for any other company.
We met Elan earlier this year to assist the company with its applications and to reinforce our willingness to facilitate it at all times.
It is clear that neither legislation nor the operations of the IMB, both of which are necessary to protect public health, can be blamed for this unfortunate commercial decision to close. - Yours, etc., Dr Frank Hallinan,
Chief Executive,
Irish Medicines Board,
Earlsfort Terrace,
Dublin 2.