Wednesday, 2 October 2019

Ceisteanna (186)

Jack Chambers


186. Deputy Jack Chambers asked the Minister for Health if clarity will be provided on a clinical drug trial relating to Duchenne muscular dystrophy for which Dublin would be a trial site (details supplied); the reason the drug trial was not carried out in Dublin; if this was due to a decision by the company; if so, the reason provided for the decision not to use Dublin as a trial site; the efforts under way to have Dublin reinstated as a trial site; if his attention has been drawn to the distress caused to families of persons with the condition by the decision not to carry out this drug trial here; and if he will make a statement on the matter. [40096/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

The requirements for the conduct of clinical trials in the EU are set out in Directive 2001/20/EC, which is transposed into national law by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (S.I. No. 190 of 2004), as amended.

As Minister for Health, I have no role in the authorisation of clinical trials, nor in the determination of what clinical trials are conducted in Ireland and their location. The decision to proceed with a clinical trial at a site within the EU, which is in compliance with the regulations, is a decision made by a commercial entity.