Dáil Éireann Debate, Tuesday - 15 October 2019
349. Deputy Louise O'Reilly asked the Minister for Health if his or the HSE's attention has been drawn to the reason an organisation (details supplied) decided against rolling out a clinical trial of suvodirsen, an investigational therapy for boys with Duchenne muscular dystrophy; and if he will make a statement on the matter. [41699/19]
Amharc ar fhreagraThe 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, as amended.
As Minister for Health, I have no role in the authorisation of clinical trials, nor in the determination of which clinical trials are conducted in Ireland or the specific location of such trials. 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 solely by the sponsor of the clinical trial.
The Health Products Regulatory Authority (HPRA) is responsible for the assessment of clinical trials with medicinal products conducted in Ireland. The HPRA is aware that Suvodirsen is currently undergoing clinical trials in a number of EU member states as an investigational treatment for patients with Duchenne muscular dystrophy. There are currently no clinical trials of Suvodirsen authorised to take place in Ireland; however, the HPRA has advised that it would welcome applications from the trial sponsor.
