The Human Tissue (Quality and Safety for Human Application) Regulations 2007

Made: 24th May 2007

Coming into force

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 ;

A draft of this instrument was laid before Parliament in accordance with paragraph 2(2) of Schedule 2 to that Act and approved by a resolution of each House of Parliament;

Accordingly the Secretary of State, in exercise of the powers conferred by section 2(2) of that Act, makes the following Regulations:—

PART 1 — CITATION, COMMENCEMENT, EXTENT AND INTERPRETATION

Citation and commencement

1

• (1) These Regulations may be cited as the Human Tissue (Quality and Safety for Human Application) Regulations 2007.

• (2) Except as provided by paragraph (3), these Regulations shall come into force on 5 July 2007.

• (3) These Regulations shall come into force on the day after the day on which they are made so far as necessary to enable anything (including the fixing of fees) to be done for the purposes of granting, varying, suspending or revoking licences in respect of activities required by virtue of these Regulations to be authorised by a licence on the commencement date.

Extent and application

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• (1) These Regulations extend to England and Wales and Northern Ireland.

• (2) Parts 1 to 5 and 7 of, and the Schedules to, these Regulations also extend to Scotland.

• (3) These Regulations shall not apply in relation to the processing, preservation, storage, distribution, import from third countries and export from the United Kingdom of tissue or cells for use in manufactured products, including medical devices, to the extent that such activities are regulated by—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) the Human Medicines Regulations 2012;

• (c) the Medical Devices Regulations 2002, ...

• (d) the Medicines for Human Use (Clinical Trials) Regulations 2004 , ...

• (e) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC , or

• (f) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

• (4) Paragraph (3) does not limit the application of the amendments made by Part 6 of these Regulations.

Designation of the competent authority

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The Human Tissue Authority (in these Regulations referred to as “the Authority”) is designated , in relation to Northern Ireland, the competent authority for the purposes of the first, second, third and fourth Directives so far as they relate to tissue and cells.

References to Directives

4

In these Regulations—

• “the first Directive” means Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells ,

• “the second Directive” means Commission Directive 2006/17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council of 8 February 2006 as regards certain technical requirements for the donation, procurement and testing of human tissues and cells , as amended by Commission Directive 2012/39/EU, and

• “the third Directive” means Commission Directive 2006/86/EC implementing Directive 2004/23/EC of the European Parliament and of the Council of 24 October 2006 as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells—in relation to Great Britain, as it had effect immediately before 29th April 2015 (the date on which the amendments made by Commission Directive 2015/565/EU came into force); andin relation to Northern Ireland, as amended by Commission Directive 2015/565/EU;

• “the fourth Directive” means Commission Directive 2015/566 of 8th April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.

Interpretation of other terms

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• (1) In these Regulations—

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

• “the Authority” means the Human Tissue Authority;

• “autologous graft” means tissue or cells removed from and applied in the same person within the same surgical procedure;

• “blood” means whole human blood collected from a donor and processed either for transfusion or for further manufacturing;

• “blood component” means a therapeutic constituent of human blood (red cells, white cells, platelets and plasma) that can be prepared by various methods, but does not include lymphocytes intended for use for the purpose of haematopoietic stem cell transplantation;

• “a case of emergency” means any unforeseen situation in which there is no practical alternative other than to urgently import ... from a third country or to export from the United Kingdom to a third country tissues or cells for immediate application to a known recipient whose health would otherwise be seriously endangered;

• “the commencement date” means 5 July 2007;

• “cells” means individual human cells or a collection of human cells when not bound by any form of connective tissue, including cell lines grown outside the human body but not including—gametes,embryos outside the human body, orblood and blood components;

• “designated individual”, in relation to a licence under Schedule 1, means the individual designated in the licence as the person under whose supervision the licensed activity is authorised to be carried on;

• “distribution” in relation to tissues or cells intended for human application means transportation or delivery to any person in or outside the United Kingdom for human application, and related terms are to be interpreted accordingly;

• . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• “human application”, in relation to tissue or cells, means use on or in a human recipient, including use in extracorporeal applications but not including use for autologous graft;

• . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• “importing licence holder” means a licence holder who is authorised by that licence to import tissues or cells intended for human application ... from a third country;

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

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

• “relevant third party premises” has the meaning given by regulation 6(2);

• “serious adverse event” means any untoward occurrence which may be associated with the procurement, testing, processing, storage or distribution of tissue or cells intended for human application and which, in relation to a donor of tissue or cells intended for human application or a recipient of tissue or cells—might lead to the transmission of a communicable disease, to death, or life-threatening, disabling or incapacitating conditions, ormight result in, or prolong, hospitalisation or morbidity;

• “serious adverse reaction” means an unintended response, including a communicable disease, in a donor of tissue or cells intended for human application or a recipient of tissue or cells, which may be associated with the procurement or human application of tissue or cells and which is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity;

• “storage” means maintaining tissue or cells, whether by preservation or in any other way, for more than 48 hours, and “store” is to be interpreted accordingly;

• “tissue” means all constituent parts of the human body formed by cells, but does not include—gametes,embryos outside the human body, ororgans or parts of organs if it is their function to be used for the same purpose as the entire organ in the human body;

• "third country” means—in relation to the import of tissues or cells into, or the export of tissues and cells from, Great Britain, a country other than the United Kingdom;in relation to the import of tissues or cells into Northern Ireland, a country other than Northern Ireland or an EEA state; andin relation to the export of tissues or cells from Northern Ireland, a country other than the United Kingdom or an EEA state;

• “third country premises”, in relation to Northern Ireland, means premises in a country other than Northern Ireland or an EEA state on or from which a third country supplier procures, tests, processes, stores, distributes or exports tissues or cells that are intended for import into Northern Ireland for human application;

• “third country supplier” means—in relation to tissues or cells intended for import into Great Britain for human application, a person in a country other than the United Kingdom who has an agreement with an importing licence holder for exporting such tissues or cells to Great Britain; andin relation to tissues or cells intended for import into Northern Ireland for human application, a person in a country other than Northern Ireland or an EEA state who has an agreement with an importing licence holder for exporting such tissues or cells to Northern Ireland;

• “third party” has the meaning given by regulation 6(2); and

• “third party agreement” has the meaning given by regulation 6(1).

• “tissue establishment” means a tissue bank or a unit of a hospital or another body which procures, tests, processes, preserves, stores or distributes human tissues and cells;

• “traceability” means the ability to—identify and locate tissues and cells during any step from procurement to use for human application and disposal;identify the donor and recipient of particular tissues and cells;identify any person who has carried out any activity in relation to particular tissues and cells; andidentify and locate all relevant data relating to products and materials coming into contact with particular tissues and cells and which can affect their quality and safety.

• (2) Subject to paragraph (1) and except as otherwise provided in these Regulations, words and expressions used in these Regulations have the same meaning as in Article 3 of the first Directive, Article 1 of the second Directive, Article 2 of the third Directive and Article 2 of the fourth Directive (definitions).

• (3) Subject to paragraphs (1) and (2) and except as otherwise provided in these Regulations, words and expressions used in these Regulations have the same meaning as in the 2004 Act as amended by these Regulations and the Human Fertilisation and Embryology Act 2008.

• (4) For the purposes of these Regulations—

• (a) a person who, from any premises, controls the provision of services for transporting or delivering tissues or cells to any person in or outside the United Kingdom for human application is to be taken to distribute tissues or cells on those premises; and

• (b) any reference in these Regulations to a requirement of any provision of the first, second, third or fourth Directive—

• (i) in the application of these Regulations in relation to Great Britain, is to be read as a reference to a requirement which that provision would require to be imposed if the provision formed part of the law of England and Wales or Scotland;

• (ii) in the application of these Regulations in relation to Northern Ireland, is to be read as a reference to a requirement which that provision requires to be imposed in relation to the procurement, testing, processing, storage, distribution, import or export of tissue or cells intended for human application.

References to third party agreements etc

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• (1) For the purposes of these Regulations a third party agreement is an agreement in writing between a licence holder (or the designated individual on behalf of the licence holder) and another person, which is made in accordance with any directions given by the Authority under section 23(1) of the 2004 Act for the purpose of securing compliance with the requirements of Article 24 of the first Directive (relations between tissue establishments and third parties), and under which the other person—

• (a) carries on a licensed activity (other than storage or import ... from a third country), on behalf of the licence holder, or

• (b) supplies to the licence holder any goods or services which may affect the quality or safety of tissue or cells.

• (2) In these Regulations—

• “relevant third party premises”, in relation to a licence under Schedule 1, means any premises (other than premises to which the licence relates)—on which a third party procures, tests, processes or distributes, ... or from which a third party exports from the United Kingdom to a third country, tissue or cells on behalf of any person authorised by a licence to carry on that activity, orfrom which a third party provides any goods or services which may affect the quality or safety of tissue or cells to any person in connection with licensed activities carried on by that person; and

• “third party” means a person with whom a licence holder has a third party agreement.

PART 2 — LICENSING OF ACTIVITIES RELATING TO THE USE OF TISSUE FOR HUMAN APPLICATION

Licensing requirement

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• (1) No person shall store tissue or cells intended for human application otherwise than under the authority of a licence under Schedule 1.

• (1A) Subject to paragraphs (4) and (5), no person may import ... from a third country tissues or cells that are intended for human application otherwise than under the authority of a licence under Schedule 1.

• (2) Subject to paragraphs (4) and (5), no person shall do an activity to which this paragraph applies otherwise than—

• (a) under the authority of a licence under Schedule 1, or

• (b) in pursuance of a third party agreement.

• (3) Paragraph (2) applies to the procurement, testing, processing, distribution... or export from the United Kingdom to a third country of tissue and cells intended for human application.

• (4) The Authority may authorise any person to distribute, import from a third country or export to a third country tissues or cells directly from where the procurement takes place to an organisation responsible for human application for immediate human application where that authorisation relates to tissues or cells specified by the Authority.

• (5) Where the Authority is satisfied that there is a case of emergency, it may authorise any person to distribute, import ... from a third country or export from the United Kingdom to a third country tissues or cells.

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (7) Schedule 1 shall apply in relation to licences for the purposes of this regulation.

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

8

• (1) The provisions of the 2004 Act mentioned in paragraph (2) shall apply, subject to the modifications specified in paragraphs (4) to (7), in relation to a licence under Schedule 1 as they apply in relation to licences under paragraph 1 of Schedule 3 (licences for the purposes of section 16) to that Act.

• (2) The provisions mentioned in paragraph (1) are—

• (a) section 17 (persons to whom licence applies),

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

• (c) sections 20 to 24 (which relate to appeals and powers to give directions),

• (d) section 37(1) to (5) (directions), and

• (e) 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 its application by virtue of paragraph (2)(c), section 22 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.

• (5) In its application by virtue of paragraph (2)(d), section 37(1) and (5) of the 2004 Act shall be read—

• (a) as if the reference in subsection (1) to Part 2 of the 2004 Act were to these Regulations, and

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