Dáil Éireann Debate, Tuesday - 30 June 2020
520. Deputy Róisín Shortall asked the Minister for Health the status of the national research ethics committees Bill; the persons or bodies consulted during the drafting of the Bill; if input from patient advocate groups or representatives was sought; and if he will make a statement on the matter. [13426/20]
Amharc ar fhreagraThe General Scheme of the National Research Ethics Committees Bill was approved for formal drafting by the government on 25 July 2019. At the same meeting, the government approved the drafting of an amendment to the Clinical Trials of Medicinal Products Regulations 2004 (as amended) (S.I 190 of 2004) to similarly reform the REC structure for such clinical trials.
The reason for the twin track parallel legislative process was that the clinical trials of medicinal products legislation derives from an EU Directive and the reform of the Research Ethics Committee (REC) system in that area was, therefore, most appropriately retained with the 2004 Regulations which deals with all aspects of those clinical trials, for example authorisation to carry out the trial by the Health Products Regulatory Authority.
The government also decided, in terms of drafting, that priority should be afforded to amending SI 190 because of new EU legislation in that area that is expected to take effect in 2021 that necessitates the type of REC reform envisaged.
As a result of the need to deal with urgent COVID-19 related legislation, drafting of the above measures has been temporarily paused in the Office of Parliamentary Counsel. However, I am committed to progressing them and in that regard wish to assure the Deputy that there will be engagement on the Bill with patient groups.
