S.I. No. 256/2018 - European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018

• (a) commission of the offence was due to a reasonable mistake or the reliance on information supplied to him or her, or to the act or default of another person, an accident or some other cause beyond his or her control, and

• (b) he or she exercised due diligence and took all reasonable precautions to avoid commission of the offence.

• (7) If reliance on the defence provided by paragraph (6) involves the allegation that the commission of the offence was due to reliance on information supplied by another person or to the act or default of another person, the person charged with the offence shall not, without leave of the court, be entitled to rely on that defence unless, not less than seven working days before the hearing, he or she has served on the prosecutor written notice providing information identifying, or assisting in the identification of, that other person.

Penalties

• (a) on summary conviction to a fine not exceeding class A or to imprisonment for a term not exceeding one year or both, or

• (b) on conviction on indictment to a fine not exceeding €225,000 or imprisonment for a term not exceeding 3 years or both.

• (2) Where a person is convicted of an offence under these Regulations, the court shall, unless it is satisfied that there are special and substantial reasons for not so doing, order the person to pay to the Authority, as the case may be, the costs and expenses, measured by the court, incurred by the Authority in relation to the investigation, detection and prosecution of the offence, including costs and expenses incurred in the taking of samples, the carrying out of tests, examinations and analyses and in respect of the remuneration and other expenses of employees, consultants and advisors engaged by the Authority.

• (3) An order for costs and expenses under paragraph (2) is in addition to, and not instead of, any fine or penalty the court may impose under paragraph (1).

Summary proceedings may be brought by Authority

PART 7 AMENDMENT, REVOCATIONS AND TRANSITIONAL PROVISIONS

Amendment of Health Act 2007

• (a) in paragraph (m)(ii), by substituting “Disability Act 2005;” for “Disability Act 2005.”, and

• (b) by inserting the following paragraph after paragraph (m):

• “(n) to exercise such powers and perform such functions of the State and the competent authority under Council Directive 2013/59/Euratom of 5 December 2013 as are conferred on the Authority by the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 ( S.I. No. 256 of 2018 ).”.

Amendment of European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004

• (a) in Regulation 3—

• (i) in paragraph (1), by inserting “and to the conducting of medical and biomedical research under Regulation 8(2) of the Ionising Radiation Regulations” after “of these regulations”, and

• (ii) in paragraph (3), by inserting “, except in the case of trials carried out for the purposes of the Ionising Radiation Regulations” after “non-interventional trials”,

• (b) in Regulation 4(1), by inserting the following definition:

“‘Ionising Radiation Regulations’ means the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 ( S.I. No. 256 of 2018 );”,

• (c) in Regulation 6—

• (i) by inserting after paragraph (3) the following paragraph:

• “(3A) Ethics committees may be established pursuant to paragraph (2) or (3) for the purposes of Regulation 8(2) of the Ionising Radiation Regulations, either solely for that purpose or in addition to their function in relation to clinical trials.”, and

• (ii) in paragraph (5), by inserting “or Regulation 8(2) of the Ionising Radiation Regulations” after “under these Regulations”,

• (d) in Regulation 7—

• (i) in paragraph (3)(b), by inserting “, or that the committee may act as an ethics committee for the purposes of Regulation 8(2) of the Ionising Radiation Regulations” after “may act as an ethics committee”,

• (ii) by inserting after paragraph (3) the following:

• “(3A) In granting recognition to an ethics committee for the purposes of Regulation 8(2) of the Ionising Radiation Regulations, where the committee does not propose to consider clinical trial research, the Supervisory Authority shall specify any other conditions or limitations that apply to that committee.”,

• (iii) in paragraph (4)(b), by inserting “, or direct that the committee may, instead or in addition, act as an ethics committee for the purposes of Regulation 8(2) of the Ionising Radiation Regulations” after “may act as an ethics committee”,

• (iv) in paragraph (4)(c), by inserting “or (3A)” after “paragraph (3)”,

• (v) in paragraph (5), by inserting “, where applicable, or that the committee may act as an ethics committee for the purposes of Regulation 8(2) of the Ionising Radiation Regulations” after “may act as an ethics committee”, and

• (vi) by inserting after paragraph (5) the following paragraph:

• “(6) An ethics committee to which recognition has been granted under this Regulation on the commencement of the Ionising Radiation Regulations shall be deemed to have also been recognised for the purpose of those Regulations.”,

• (e) in Regulation 8(b), by inserting “or Regulation 8(2) of the Ionising Radiation Regulations” after “under these Regulations”, and

• (f) in paragraph 1(1) of Schedule 2—

• (i) by substituting for the definition of “expert member” the following:

“‘expert member’ means a member of an ethics committee who is a health care professional or who has professional qualifications or experience relating to—

• (a) the conduct of, or use of statistics in, clinical research, unless the said qualifications or experience relate only to the ethics of clinical research or medical treatment, or

• (b) in the case of a committee acting as an ethics committee for the purposes of Regulation 8(2) of the Ionising Radiation Regulations, medical exposure to ionising radiation for medical or biomedical research;”, and

• (ii) in the definition of “lay member”, by inserting “, or advise on medical exposure to ionising radiation” after “or conduct of clinical research”.

Revocations

• (a) the European Communities (Medical Ionising Radiation Protection) Regulations 2002 ( S.I. No. 478 of 2002 );

• (b) the European Communities (Medical Ionising Radiation Protection) (Amendment) Regulations 2007 ( S.I. No. 303 of 2007 ); and

• (c) the European Communities (Medical Ionising Radiation Protection) (Amendment) Regulations 2010 ( S.I. No. 459 of 2010 ).

• (2) References in other enactments to Regulations revoked under paragraph (1) shall, where the context so admits, be construed as references to these Regulations.

Transitional provisions

• (2) Notwithstanding Regulation 8(3) and (4), specific justification is not required in the case of medical radiological procedures to be performed as part of a health screening programme which has begun prior to the commencement of these Regulations.

GIVEN under my Official Seal,

8 January 2019.

SIMON HARRIS,

Minister for Health.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations give effect to Council Directive 2013/59/EURATOM of 5 December 2013 which lays down basic safety standards for protection against the dangers arising from exposure to ionising radiation. In particular, these Regulations provide for requirements in relation to medical exposures and enforcement of such requirements.

These Regulations revoke the European Communities (Medical Ionising Radiation Protection) Regulations 2002, and the amendments thereto.

These Regulations amend the Health Act 2007 and the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004.

These Regulations may be cited as the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018.

Footnotes