The Quality and Safety of Organs Intended for Transplantation Regulations 2012

Made: 11th June 2012

Laid before Parliament: 14th June 2012

Coming into force in accordance with regulation 1(2) and (3)

The Secretary of State is a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to health protection measures regulating the use of material of human origin .

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of, as read with paragraph 1A of Schedule 2 to, the European Communities Act 1972 .

It appears to the Secretary of State that it is expedient for the reference to part B of the Annex to Directive 2010/53/EU of 7th July 2010 of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation to be construed as a reference to that Annex as amended from time to time.

PART 1 — Citation, commencement and extent

Citation and commencement

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• (1) These Regulations may be cited as the Quality and Safety of Organs Intended for Transplantation Regulations 2012.

• (2) Except as provided under paragraph (3), these Regulations come into force on 27th August 2012.

• (3) These Regulations come into force on 12th July 2012 so far as necessary to enable anything to be done for the purposes of granting, refusing or reconsidering licence applications, or varying, suspending or revoking licences in respect of activities required by virtue of these Regulations to be authorised by a licence from 27th August 2012, including but not limited to—

• (a) giving directions under section 23(1) of, or paragraph 2(4)(c) to (f) of Schedule 3 to, the 2004 Act;

• (b) publishing guidance under regulation 12;

• (c) establishing the Framework under regulation 13; and

• (d) the fixing of fees.

Extent

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• (1) Subject to paragraphs (2) and (3), these Regulations extend to England and Wales, Northern Ireland and Scotland.

• (2) Regulation 25(2), (3), (4) and (7) extends to England and Wales and Northern Ireland only.

• (3) Regulation 29 extends to Scotland only.

PART 2 — Interpretation and designation of the competent authority

Interpretation

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• (1) In these Regulations—

• “the 2004 Act” means the Human Tissue Act 2004 ;

• “the 2006 Regulations” means the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 ;

• “the 2006 Scotland Act” means the Human Tissue (Scotland) Act 2006 ;

• “the 2006 Scotland Regulations” means the Human Organ and Tissue Live Transplants (Scotland) Regulations 2006 ;

• “the 2007 Regulations” means the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ;

• “the Authority” means the Human Tissue Authority established under section 13 of the 2004 Act;

• “consent”, in respect of a donor, means , where retrieval of an organ takes place —in England or Northern Ireland, appropriate consent as defined in the 2004 Act ; ...in Scotland, the authorisation referred to in Part 1 (transplantation etc.) of the 2006 Scotland Act or, as the case may be, the authorisation or lack of unwillingness of the donor referred to in the 2006 Scotland Regulations ; orin Wales, express consent where that is required under any of sections 4 to 7 of the Human Transplantation (Wales) Act 2013 or, where express consent is not required, deemed consent under section 4 or 9 of that Act;

• “the Directive” means Directive 2010/53/EU of the European Parliament and of the Council of 7th July 2010 on standards of quality and safety of human organs intended for transplantation , as it applies in relation to Northern Ireland;

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

• “donation” means donating organs for the purposes of 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 relevant information on the characteristics of the donor needed to evaluate the donor's suitability for donation, in order to undertake a risk assessment and to minimise the risks for the recipient, and optimise organ allocation;

• “the Implementing Directive” means Commission Implementing Directive 2012/25/EU laying down information procedures for the exchange, between Member States, of human organs intended for transplantation , as it applies in relation to Northern Ireland;

• “licensed activity”, in relation to a licence, means an activity which the licence authorises under Schedule 1;

• “licence holder” means a person who holds a licence under Schedule 1;

• “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; and 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 for transplantation, in order to undertake a risk assessment and minimise the risks for the recipient, and optimise organ allocation;

• “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;

• “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 a donated organ becomes available for transplantation;

• “procurement activity” means all or any of the following activities, undertaken for the purposes of procurement—donor characterisation;organ characterisation;preservation of an organ;making arrangements to transport an organ;retrieval of an organ;

• “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 Authority;

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

• “serious adverse event” means any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for a patient or 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 that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity;

• “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—identify the donor and the licence holder who retrieved the organ from the donor;identify the licence holder who implanted the organ in the recipient;identify the recipient at the premises at which the organ is implanted into the recipient; andlocate and identify all relevant non-personal information relating to products and materials coming into contact with that organ;

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

• “transplantation activity” means all or any of the following activities, undertaken for the purposes of transplantation—organ characterisation;preservation of an organ;making arrangements to transport an organ;implantation of an organ.

• (2) In these Regulations, as they apply in relation to Great Britain, a reference to ensuring compliance with these Regulations includes a reference to ensuring compatibility with the principles set out in Article 13 of Directive 2010/53/EU of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation as modified by section 32(3C) of the 2004 Act.

Designation of the competent authority

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In relation to Northern Ireland, the Authority is designated the competent authority for the purposes of the Directive.

PART 3 — Licensing

Licensing requirement

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• (1) No person shall carry out a procurement activity or a transplantation activity otherwise than under the authority of a licence under Schedule 1.

• (2) The authority conferred by a licence extends to the licence holder, any person designated by the licence holder and any person acting under the supervision of either of them.

• (3) The Authority shall specify in the licence which procurement activity or transplantation activity a person may undertake under the licence.

• (4) The Authority shall permit a person making an application for two or more—

• (a) procurement activities;

• (b) transplantation activities; or

• (c) procurement activities and transplantation activities, to make single application in respect of the activities,

to make a single application in respect of the activities.

• (5) Schedule 1 has effect.

• (6) Schedule 1A (which specifies information to be collected in certain circumstances for the purposes of paragraph 5 of Schedule 1) has effect.

Application of the 2004 Act in relation to licences under Schedule 1

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• (1) The provisions of the 2004 Act referred to in paragraph (2) shall apply, subject to the modifications specified in paragraphs (4) and (5), in relation to a licence under Schedule 1 to these Regulations as they apply to licences under paragraph 1 of Schedule 3, (licences for the purposes of section 16) to that Act.

• (2) The provisions are—

• (a) section 19(1), (2), (5) and (7) (right to reconsideration of licensing decisions);

• (b) sections 20 to 24 (which relate to appeals and powers to give directions);

• (c) section 37(1) to (5) (directions); and

• (d) paragraphs 2(4)(c) to (f) and (5), 5, 7 to 11, and 13 of Schedule 3 (licences for the purposes of section 16).

• (3) In their application by virtue of this regulation, those provisions extend to Scotland (as well as to the rest of the United Kingdom).

• (4) In their application by virtue of this regulation—

• (a) section 19 (right to reconsideration of licensing decisions) shall apply as if in subsection (2) the words “, or designated individual,” were omitted ...;

• (b) section 23 (conduct of licensed activities) shall apply as if subsection (1) were limited to directions that the Authority considers necessary to ensure compliance with these Regulations, as they apply in relation to Great Britain, and with the Directive and the Implementing Directive, as they apply in relation to Northern Ireland;

• (c) section 24 (changes of licence circumstance) shall apply as if subsection (1) were limited to directions that the Authority considers necessary to ensure compliance with these Regulations, as they apply in relation to Great Britain, and with the Directive and the Implementing Directive, as they apply in relation to Northern Ireland and as if for subsections (2)(b) and (3)(b) there were substituted—

(b) on any other person who has authority to act under the licence;

• (d) section 37 (directions) shall apply—

• (i) as if the reference in subsection (1) to “this Part” were to these Regulations; and

• (ii) as if any reference in subsection (5) to a licence were to a licence under Schedule 1 to these Regulations;

• (e) paragraph 2(4)(c) to (f) and 5 (characteristics of licence) of Schedule 3 shall apply as if it were limited to directions that the Authority considers necessary to ensure compliance with these Regulations, as they apply in relation to Great Britain, and with the Directive and the Implementing Directive, as they apply in relation to Northern Ireland;

• (f) paragraph 7 (power to revoke licence) of that Schedule shall apply as if sub-paragraphs (1)(b) and (2)(b), (e) and (f) were omitted and as if for sub-paragraph (2)(b) there were substituted —

(b) if it is satisfied that the licence holder has failed to discharge, or is unable because ofincapacity to discharge, any of its duties,

• (g) paragraph 8 (power to vary licence) of that Schedule shall apply as if sub-paragraphs (1), (2)(b), (3) and (4) were omitted;

• (h) paragraph 9 (power to suspend licence) of that Schedule shall apply as if for sub-paragraph (3) there were substituted the following sub-paragraph—

(3) Notice under sub-paragraph (1) shall be given to the licence holder or to any otherperson who has authority to act under the licence.

• (i) paragraph 10 (procedure in relation to licensing decisions) of that Schedule shall apply as if sub-paragraph (2)(b) were omitted; and

• (j) paragraph 11 (notification of licensing decisions) of that Schedule shall apply as if sub-paragraphs (1)(b) and (3)(b) were omitted and as if for sub-paragraphs (2)(b) and 4(b) there were substituted—

(b) any other person who has authority to act under the licence.

• (5) In its application by virtue of this regulation, section 22 (appeal on a point of law) of the 2004 Act is to have effect in Scotland as if the reference to the High Court were a reference to the Court of Session.

Extension of other provisions of the 2004 Act to Scotland

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• (1) The following provisions shall extend to Scotland (as well as to the rest of the United Kingdom), so far as they relate to activities within section 14(1)(i) of the 2004 Act—

• (a) section 14 (remit of the Human Tissue Authority); and

• (b) section 15(a), (b), (d), (e) and (f) (general functions), subject to the modifications in paragraph (2).

• (2) In its application by virtue of paragraph (1) section 15(e) and (f) of the 2004 Act is to be read as including a reference to advising the Scottish Ministers.

Breach of requirement to hold a licence

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• (1) A person who contravenes regulation 5(1) commits an offence unless that person reasonably believes that—

• (a) the activity being undertaken is not an activity to which regulation 5(1) applies; or

• (b) they are acting under the authority of a licence under Schedule 1.

• (2) A person guilty of an offence under paragraph (1) shall be liable—

• (a) on summary conviction to a fine not exceeding the statutory maximum; or

• (b) on conviction on indictment—

• (i) to imprisonment for a term not exceeding 2 years,

• (ii) to a fine, or

• (iii) to both.

Preconditions to grant of a licence

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• (1) The Authority may not grant a licence under Schedule 1 unless the following requirements are met.

• (2) The Authority must be satisfied that the applicant—

• (a) meets the relevant conditions in Schedule 1 and will continue to do so; and

• (b) meets any other conditions or requirements that the Authority has imposed.

• (3) A copy of the conditions to be imposed by the licence must have been shown to, and acknowledged in writing by, the applicant for the licence.

Duty of the licence holder

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It shall be the duty of the licence holder to secure compliance with—

• (a) the conditions of the licence granted by the Authority to the licence holder under paragraph 1 of Schedule 1; and

• (b) any requirements imposed by directions given under section 23(1) (conduct of licensed activities) or 24(1) (changes of licence circumstance) of, or paragraph 2(4)(c) to (f) (characteristics of licence) of Schedule 3 to, the 2004 Act, as applied by regulation 6.

Directions

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• (1) The Authority shall give directions to a licence holder under section 23(1) (conduct of licensed activities) of the 2004 Act, as applied by regulation 6, in accordance with Schedule 2.

• (2) The Authority shall revise directions given by virtue of paragraph (1) as it considers necessary.

• (3) Schedule 2 has effect.

Guidance

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• (1) The Authority shall publish such guidance to licence holders as it considers necessary to ensure compliance with these Regulations, as they apply in relation to Great Britain, and with the Directive and the Implementing Directive, as they apply in relation to Northern Ireland .

• (2) The Authority shall keep the guidance published under paragraph (1) under review and prepare revised guidance when it considers it necessary to do so.

• (3) The Authority shall publish the guidance under this regulation in such a way as, in its opinion, is likely to bring it to the attention of licence holders.

PART 4 — Other obligations of the Authority

Framework and compliance with licensing conditions and directions

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• (1) The Authority shall establish and keep updated a framework which shall specify how their requirements for the quality and safety of organs for transplantation shall be met ....

• (2) The framework shall cover all stages of the chain from donation to transplantation or disposal and shall include information about the—

• (a) procurement activities and transplantation activities that are required to be carried on under the authority of a licence under Schedule 1;

• (b) licensing application process;