European Union (Quality and Safety of Human Organs intended for Transplantation) Regulations 2012

• Jurisdiction: Ireland
• Citation: IR SI 325/2012
• Year: 2012

ARRANGEMENT OF REGULATIONS

Part 1

Preliminary

1. Citation

2. Interpretation

3. Scope

4. Responsibility for functions under Directive

Part 2

Authorisation to carry out prescribed activities

5. Carrying out of prescribed activities

6. Grant of authorisation

7. Removal, variation and addition of conditions

8. Substantial change in prescribed activity

9. Suspension or revocation of authorisation

10. Compliance notice

11. Responsible person

Part 3

Quality and safety of organs

12. Framework for quality and safety

13. Procurement organisations

14. Organ procurement

15. Organ and donor characterisation

16. Transport of organs

17. Transplantation centres

18. Traceability

19. Reporting system and management concerning serious adverse events and reactions

20. Healthcare personnel

Part 4

Donor and recipient protection and donor selection and evaluation

21. Principles governing organ donation

22. Consent requirements

23. Quality and safety aspects of living donation

24. Protection of personal data, confidentiality and security of processing

Part 5

Recording and reporting of activities under regulations

25. Reporting obligations of HSE

26. Reporting obligations of IMB

27. Reporting to Commission

Part 6

Organ exchange with third countries and European organ exchange organisations

28. Organ exchange with third countries

29. European organ exchange organisations

Part 7

Enforcement, offences and penalties

30. Interpretation of Part 7

31. Inspections and requests for information

32. Authorised officers

33. Taking of samples, etc. by authorised officers

34. Certificate of result of test, etc. of sample, etc.

35. Offences

36. Penalties

37. Defence of due diligence

38. Summary proceedings may be brought by IMB

Schedule

S.I. No. 325 of 2012

EUROPEAN UNION (QUALITY AND SAFETY OF HUMAN ORGANS INTENDED FOR TRANSPLANTATION) REGULATIONS 2012

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 31st August, 2012.

I, JAMES REILLY, Minister for Health, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving effect to Directive 2010/53/EU of the European Parliament and of the Council of 7 July 20101 , hereby make the following regulations:

Part 1

Preliminary

Citation

1. These Regulations may be cited as the European Union (Quality and Safety of Human Organs intended for Transplantation) Regulations 2012.

Interpretation

2. (1) In these Regulations—

“Act” means the Irish Medicines Board Act 1995 , as amended by s. 197 of the Finance Act 1999 (No. 2 of 1999), Regulation 3 of the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 ( S.I. No. 304 of 2001 ), Regulation 2 of the European Communities (Medical Devices) (Amendment) Regulations 2001 (S.I. 444 of 2001), Regulation 3 of the European Communities (Medical Devices) (Amendment) Regulations 2002 (S.I. 576 of 2002), the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006) and the European Communities (Amendment of the Medicines Board Act 1995) Regulations 2007 ( S.I. No. 542 of 2007 );

“authorisation” means an authorisation granted by the IMB in accordance with Regulation 6;

“authorised officer” means—

(a) a person appointed under Regulation 32, or

(b) an officer of Customs and Excise;

“Commission” means the Commission of the European Union;

“Data Protection Directive” means Directive 95/46/EC of the European Parliament and of the Council of 24 October 19952 , as amended by Regulation (EC) No. 1882/2003 of the European Parliament and of the Council of 29 September 20033

“Directive” means Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010;

“disposal” means the final placement of an organ where it is not used for transplantation;

“donation” means donating organs for transplantation;

“donor” means a person who donates one or several organs, whether donation occurs during lifetime or after death;

“donor characterisation” means the collection of the relevant information on the characteristics of the donor needed to evaluate his or her suitability for organ donation, in order to undertake a proper risk assessment and minimise the risks for the recipient, and optimise organ allocation;

“European organ exchange organisation” means a non-profit organisation, whether public or private, dedicated to national and cross-border organ exchange, in which the majority of its member countries are Member States of the European Union;

“framework for quality and safety” means the framework established by the HSE pursuant to Regulation 12;

“HSE” means the Health Service Executive established under section 6 of the Health Act 2004 (No. 42 of 2004);

“IMB” means the Irish Medicines Board established under section 3 of the Irish Medicines Board Act 1995 (No. 29 of 1995);

“Member State” means a Member State of the European Union;

“operating procedures” means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end outcome;

“organ” means a differentiated part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with a significant level of autonomy. A part of an organ is also considered to be an organ if its function is to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation;

“organ characterisation” means the collection of the relevant information on the characteristics of the organ needed to evaluate its suitability, in order to undertake a proper risk assessment and minimise the risks for the recipient, and optimise organ allocation;

“prescribed activity” means any activity relating to the donation, testing, characterisation, procurement, preservation, transport or transplantation of organs intended for transplantation to the human body;

“preservation” means the use of chemical agents, alterations in environmental conditions or other means to prevent or retard biological or physical deterioration of organs from procurement to transplantation;

“procurement” means a process by which the donated organs become available;

“procurement organisation” means a healthcare establishment, a team or a unit of a hospital, a person, or any other body which undertakes or coordinates the procurement of organs, and is authorised to do so by the IMB in accordance with these Regulations;

“recipient” means a person who receives a transplant of an organ;

“responsible person” means a person who has been designated under Regulation 11 as the responsible person for a procurement organisation or transplantation centre;

“serious adverse event” means any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation—

(a) that might lead to the transmission of a communicable disease,

(b) that might lead to death or life-threatening, disabling or incapacitating conditions for patients, or

(c) which results in, or prolongs, hospitalisation or morbidity;

“serious adverse reaction” means an unintended response, including a communicable disease, in the living donor or in the recipient, that might be associated with any stage of the chain from donation to transplantation—

(a) that is fatal, life-threatening, disabling or incapacitating, or

(b) which results in, or prolongs, hospitalisation or morbidity;

“transplantation” means a process intended to restore certain functions of the human body by transferring an organ from a donor to a recipient;

“transplantation centre” means a healthcare establishment, a team or a unit of a hospital or any other body which undertakes the transplantation of organs and is authorised to do so by the IMB in accordance with these Regulations;

“traceability” means the ability to locate and identify the organ at each stage in the chain from donation to transplantation or disposal, including the ability to—

(a) identify the donor and the procurement organisation,

(b) identify the recipient(s) at the transplantation centre(s), and

(c) locate and identify all relevant non-personal information relating to products and materials coming into contact with that organ.

(2) In these Regulations, unless otherwise indicated—

(a) a word or expression which is also used in the Directive has the same meaning as it has in the Directive,

(b) a reference to a Regulation is to a Regulation of these Regulations,

(c) a reference to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, and

(d) a reference to the Schedule is to the Schedule to these Regulations.

Scope

3. (1) Subject to paragraph (2), the requirements of these Regulations shall apply to the donation, testing, characterisation, procurement, preservation, transport and transplantation of organs intended for transplantation into the human body.

(2) Where the organs referred to in paragraph (1) are used for research purposes, the requirements of these Regulations shall only apply where they are intended for transplantation into the human body.

(3) These Regulations shall apply without prejudice to the Data Protection Acts 1988 and 2003 in so far as those Acts transpose the Data Protection Directive.

Responsibility for functions under Directive

4. (1) The IMB shall perform—

(a) the functions of the State under Articles 5(2) and 9(4) of the Directive, and

(b) the functions of the competent authority under Articles 9(2), 11(2) and (3) and 17(2)(b) and (c) of the Directive.

(2) The HSE shall perform—

(a) the functions of the State under Articles 4, 6(2), 7(5) and (6), 10, 11(1), 15(3) and (4), 18(1) and (2) and 20 of...