Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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317. To ask the Minister for Health the channels available to members of the public to raise concerns or make complaints regarding beliefs concerning widespread malpractice and policy failure in the health service, in the area of medical research and the trial use of certain drugs, or similar medical or drug related research undertaken by other areas in the public service such as the education sector; and if he will make a statement on the matter. [38433/16]

Simon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) is the agency responsible for the authorisation of clinical trials with medicinal products (medicines) conducted in Ireland. In addition to an authorisation from the HPRA, clinical trials also require a positive opinion from an ethics committee that is recognised by the Department of Health, prior to being commenced. The types of trials authorised range from first-in-man trials for new medicines to studies with medicines which already have marketing authorisations.

Clinical trials in Ireland are governed by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004, S.I. No. 190 of 2004. These Regulations transposed into Irish law the provisions of Council Directive 2001/20/EC and superseded the Control of Clinical Trials Acts 1987–1990 for clinical trials using medicinal products.

The Regulations require that all clinical trials covered by the provisions of the Regulations are designed, conducted and reported in accordance with the principles of Good Clinical Practice (GCP), a set of internationally recognised ethical and scientific quality requirements that must be observed for clinical trials involving human subjects. Compliance with GCP provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are accurate and credible.

As the competent authority for the Regulations, the HPRA may carry out GCP inspections of trial sites in order to establish compliance with relevant legislation and guidelines. A trial site can be defined as any location where trial-related activities are conducted. Therefore, an inspection can occur at an investigator site, sponsor company site, laboratory site, manufacturing site or at other establishments deemed appropriate by the regulatory authority. The HPRA also requires that an annual safety report is submitted for any trial which is ongoing in Ireland.

Any member of the public who has concerns over the conduct of a specific clinical trial for a medicinal product should contact the HPRA in the first instance. Members of the public may raise concerns relating to the areas which the HPRA regulates directly with the HPRA by letter, e-mail or phone, or alternatively, by contacting the Office of the Ombudsman.