Eoin Ó Broin (Dublin Mid West, Sinn Fein)
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127. To ask the Minister for Health the national laws and regulations that give effect to the clinical trial of an investigational medicinal product reporting requirements set out in the EU Clinical Trial Regulation, article 37(4) specifying the name and applicable article(s) of all relevant laws and regulations. [26361/24]

Eoin Ó Broin (Dublin Mid West, Sinn Fein)
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128. To ask the Minister for Health the national laws and regulations that define the penalties for infringements of the EU Clinical Trial Regulation, as set out in article 94 specifying the name and applicable article(s) of all relevant laws and regulations. [26362/24]

Eoin Ó Broin (Dublin Mid West, Sinn Fein)
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129. To ask the Minister for Health to provide the penalties that he will be able impose for infringements of clinical trial of an investigational medicinal product reporting requirements specifying the penalties, for example the maximum fine(s) that can be imposed. [26363/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 127, 128 and 129 together.

The Clinical Trial Regulation (Regulation 536/2014) (CTR) repealed the Clinical Trial Directive (2001/20/EC) (CTD) on 31 January 2022, subject to a transition period for clinical trials started under the CTD prior to this date. This transition period will come to an end on 31 January 2025 and any ongoing trials approved under the CTD must be compliant with the CTR.

The CTR was transposed into Irish law via European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) Regulations 2022 – S.I. No. 99 of 2022. This SI was subsequently amended by the European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) (Amendment) Regulations 2022 (S.I. No. 418 of 2022) and the European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) (Amendment) Regulations 2022 (S.I. No. 727 of 2022), the latter of which was repealed by the European Union (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2024 (S.I. No. 3 of 2024).

SI 99 of 2022 sets out penalties which could be imposed if a person is guilty of an offence under those Regulations. Part 12 deals with Offences, Penalties and Enforcement, with Regulation 49 covering penalties specifically.

As stated in Regulation 49:

(1) A person guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding €3,000, or to imprisonment for a term not exceeding six months, or both. (2) A person guilty of an offence under these Regulations shall be liable on conviction on indictment to a fine not exceeding €300,000, or to imprisonment for a term not exceeding 3 years, or both.

Regulation 48 details Offences under the Regulations, including failure to meet reporting requirement, such as those set out in Article 37(4). These reporting requirements are covered in Regulation 48(1)(r) and (aa).

Eoin Ó Broin (Dublin Mid West, Sinn Fein)
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130. To ask the Minister for Health to provide the legal and regulatory requirements to make the results of interventional clinical trials that are not a clinical trial of an investigational medicinal product (including medical device trials and non-drug trials) public and to provide the exact name and applicable article(s) of all relevant laws and regulations. [26364/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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The exact nature of the question being asked is a little unclear, however in framing a general response on the publication of information pertaining to clinical trials, it should be noted that there are relevant obligations in place with respect to clinical trials authorised under the Clinical Trials Directive (CTD). It should also be noted that all trials authorised under the CTD must end or transition to the Clinical Trials Regulation (536/2014) by 31st January 2025. The Clinical Trials Regulation (CTR) came into effect in the EU on 31 January 2022.