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The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019

Consolidated Text As Enacted Cited authorities 17 Cited in Amendments 4 Related
Vincent
JurisdictionUK Non-devolved
CitationSI 2019/483
Year2019
  • These Regulations may be cited as the Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019 and come into force on exit day.
    • (1) Section 32 of the Human Tissue Act 2004 (2) For subsection (3A) substitute—
    • (3A) The Authority may not designate a person under subsection (3) if doing so would be incompatible with the principles set out in—
    • (a) Article 12 of Directive 2004/23/EC of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, or
    • (b) 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,
      • and for the purposes of this subsection as it applies in relation to Great Britain, those Articles of those Directives are to be read subject to the modifications set out in subsections (3B) and (3C) .
    Article 12 of Directive 2004/23/EC of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, orArticle 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,(3) After subsection (3A) insert—
    • “(3B) Article 12 of Directive 2004/23/EC is to be read as if—
    • (a) in paragraph 1—
    • (i) for the first subparagraph there were substituted—
        Donations of tissues and cells shall be voluntary and unpaid.
      ;
    • (ii) in the second subparagraph, the second sentence were omitted;
    • (iii) the third subparagraph were omitted;
    for the first subparagraph there were substituted—
      Donations of tissues and cells shall be voluntary and unpaid.
    ;    in the second subparagraph, the second sentence were omitted;the third subparagraph were omitted;in paragraph 2, for the first subparagraph there were substituted—
      Any promotion and publicity activities in support of the donation of human tissues and cells shall comply with any directions of the Authority or any provision of any enactment which relates to such activities.
    ;    “Member States shall endeavour to ensure that” were omitted;for “is” there were substituted “ shall be ”.“Member States shall ensure that” were omitted; andfor “are” there were substituted “ shall be ”.in paragraph 2, the second sentence were omitted;“Member States shall prohibit” were omitted; andat the end there were inserted “shall be prohibited”;“Member States shall ensure that” were omitted; andfor “is” there were substituted “ shall be ”.(1) The Quality and Safety of Organs Intended for Transplantation Regulations 2012 the existing text becomes paragraph (1) ;n the definition of “the Directive”, at the end insert “, as it applies in relation to Northern Ireland”;in the definition of “the Implementing Directive”, at the end insert “, as it applies in relation to Northern Ireland”;after the definition of “procurement activity” insert—
      “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;
    ;    after paragraph (1) insert—
    • (2) In these Regulations, F12as 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.
    .    In these Regulations, F12as 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.(3) For regulation 4 (designation of the competent authority) substitute—
      (4) Designation of the competent authority in relation to Northern IrelandIn relation to Northern Ireland, the Authority is designated the competent authority for the purposes of the Directive.
    .    In relation to Northern Ireland, the Authority is designated the competent authority for the purposes of the Directive.(4) In regulation 5 (licensing requirement) , at the end insert—
    • (6) Schedule 1A (which specifies information to be collected in certain circumstances for the purposes of paragraph 5 of Schedule 1) has effect.
    .    Schedule 1A (which specifies information to be collected in certain circumstances for the purposes of paragraph 5 of Schedule 1) has effect.(5) In regulation 6 F6 (application of the 2004 Act in relation to licences under Schedule 1) , for “the Directive and the Implementing Directive”, in each place where those words appear, substitute “F14these 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”.(6) In regulation 12 F7 (guidance) , in paragraph (1) for “the Directive and the Implementing Directive” substitute “ F15these 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”.(7) In regulation 13 (8) For regulation 18 (organs sent to or received from another country) , substitute—
      (18)
    • (1) Where an organ is sent to a Member State from Northern Ireland, the Authority shall ensure that—
    • (a) information on organ and donor characterisation that is specified in Part A of the Annex to the Directive;
    • (b) information that has been collected by a registered medical practitioner or a person acting under their supervision that is required by Part B of the Annex at the time when the organ is sent to a Member State; and
    • (c) information to ensure the traceability of the organ,
      • is transmitted to that Member State in conformity with the requirements of Articles 4, 5, and 6(1) of the Implementing Directive.
    information on organ and donor characterisation that is specified in Part A of the Annex to the Directive;information that has been collected by a registered medical practitioner or a person acting under their supervision that is required by Part B of the Annex at the time when the organ is sent to a Member State; andinformation to ensure the traceability of the organ,the requirements of Article 4 of the Implementing Directive in relation to information transmitted to the Authority in accordance with that Directive in respect of the organ have been complied with; andinformation to ensure the traceability of the organ is transmitted in accordance with Article 6(2) of that Directive.Where an organ is sent from Northern Ireland to, or received in Northern Ireland from, a Member State, the Authority shall ensure the reporting of serious adverse events and reactions in conformity with the requirements of Articles 4 and 7 of the Implementing Directive.can be traced from the donor to the recipient; andmeet quality and safety standards that are equivalent to those required by these Regulations.can be traced from the donor to the recipient; andmeet quality and safety standards that are equivalent to those required by these Regulations.For the purposes of paragraphs (4) and (5) , the Authority may conclude agreements with countries outside the United Kingdom.(9) In regulation 19 (European Union network of competent authorities) , after “The Authority shall,” insert “in relation to Northern Ireland,(10) In regulation 24 (review) omit subsection (2) .(11) After regulation 24 insert—
      (PART 5A) Power to amend data sets specified in Schedule 1A F18in relation to Great Britain(24A) Power for appropriate authority to amend Schedule 1A F19in relation to Great Britain
    • (1) F20An appropriate authority in Great Britain may by regulations amend—
    • (a) the minimum data set specified in Part A of Schedule 1A (organ and donor characterisation) where the appropriate authority considers, on the basis of scientific evidence, that the amendment is justified by a serious risk to human health;
    • (b) the complementary data set specified in Part B of that Schedule where the appropriate authority considers, on the basis of scientific evidence, that it is appropriate to do so.
    the minimum data set specified in Part A of Schedule 1A (organ and donor characterisation) where the appropriate authority considers, on the basis of scientific evidence, that the amendment is justified by a serious risk to human health;the complementary data set specified in Part B of that Schedule where the appropriate authority considers, on the basis of scientific evidence, that it is appropriate to do so.In this regulation—“appropriate authority” means—
    • (a) in relation to England, the Secretary of State;
    • (b) in relation to Wales—
      • (i) the Welsh Ministers; or
      • (ii) the Secretary of State acting with the consent of the Welsh Ministers;
    • (c) in relation to Scotland—
      • (i) the...

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