NOTICES OF AMENDMENTS
given up to and including
Thursday 24th June 2004
New Amendments handed in are marked thus *
CONSIDERATION OF BILL
HUMAN TISSUE BILL, AS AMENDED
NEW CLAUSES
Powers of court to dispense with need for consent
Mr Secretary Reid
NC7
To move the following Clause:—
'(1) If the High Court is satisfied—
| (a) | that relevant material has come from the body of a living person, |
| (b) | that it is not reasonably possible to trace the person from whose body the material has come ("the donor"), |
| (c) | that it is desirable in the interests of another person (including a future person) that the material be used for the purpose of obtaining scientific or medical information about the donor, and |
| (d) | that there is no reason to believe— |
| (i) | that the donor has died, |
| (ii) | that a decision of the donor to refuse to consent to the use of the material for that purpose is in force, or |
| (iii) | that the donor lacks capacity to consent to the use of the material for that purpose, |
it may order that subsection (2) apply to the material for the benefit of the other person.
(2) Where material is the subject of an order under subsection (1), there shall for the purposes of this Part be deemed to be consent of the donor to the use of the material for the purpose of obtaining scientific or medical information about him which may be relevant to the person for whose benefit the order is made.
(3) The Secretary of State may by regulations enable the High Court, in such circumstances as the regulations may provide, to make an order deeming there for the purposes of this Part to be appropriate consent to an activity consisting of—
| (a) | the storage of the body of a deceased person for use for the purpose of research in connection with disorders, or the functioning, of the human body, |
| (b) | the use of the body of a deceased person for that purpose, |
| (c) | the removal from the body of a deceased person, for use for that purpose, of any relevant material of which the body consists or which it contains, |
| (d) | the storage for use for that purpose of any relevant material which has come from a human body, or |
| (e) | the use for that purpose of any relevant material which has come from a human body.'. |
Interpretation of Part 1
Mr Secretary Reid
NC6
To move the following Clause:—
'In this Part, "excepted material" means material which has—
| (a) | come from the body of a living person, or |
| (b) | come from the body of a deceased person otherwise than in the course of use of the body for the purpose of anatomical examination.'. |
Activities involving material from adults who lack capacity to consent
Mr Secretary Reid
NC8
To move the following Clause:—
| (a) | an activity of a kind mentioned in section 1(1)(d) or (f) involves material from the body of a person who— |
| (ii) | lacks capacity to consent to the activity, and |
| (b) | neither a decision of his to consent to the activity, nor a decision of his not to consent to it, is in force, |
there shall for the purposes of this Part be deemed to be consent of his to the activity if it is done in circumstances of a kind specified by regulations made by Secretary of State.'.
Duties in relation to carrying out functions
Mr Secretary Reid
NC9
To move the following Clause:—
'(1) The Authority must carry out its functions effectively, efficiently and economically.
(2) In carrying out its functions, the Authority must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed).'.
Power of Human Tissue Authority to assist other public authorities
Mr Secretary Reid
NC10
To move the following Clause:—
'(1) The Authority may if it thinks it appropriate to do so provide assistance to any other public authority in the United Kingdom for the purpose of the exercise by that authority of its functions.
(2) Assistance provided by the Authority under this section may be provided on such terms, including terms as to payment, as it thinks fit.'.
Determination of consent for removal, storage and use of organs from adults for purpose of transplantation
Dr Evan Harris
Mr Stephen Pound
Mr Eric Forth
Dr Nick Palmer
Mr Kenneth Clarke
Dr Jenny Tonge
NC1
To move the following Clause:—
'(1) Where part of a body of an adult lying in a hospital or other institution is or may be suitable for use for transplantation, it shall be the duty of the person having the control and management of the institution to ensure that, before any organ is removed from the body, each of the conditions specified in subsection (2) is met.
(2) Those conditions are—
| (a) | that the deceased was, immediately before he died, ordinarily resident in England, Wales or Northern Ireland; |
| (b) | that the deceased did not, during the relevant period, lack the capacity to decide to make his organs unavailable for removal for the purpose of transplantation; |
| (c) | that, where the person to whom the duty under subsection (1) applies knows, or has reason to believe, that— |
| (i) | the body of the deceased person, or |
| (ii) | relevant material which has come from the body of a deceased person, |
| | is, or may be, required for purposes of functions of a coroner, the consent of the coroner has been obtained; |
| (d) | that it has been duly ascertained that the deceased— |
| (i) | had decided to make his organs, or the relevant organ, available for removal for the purpose of transplantation and had had that decision duly recorded in the register, or |
| (ii) | had not had a decision to make his organs, or the relevant organ, unavailable for removal for the purpose of transplantation duly recorded in the register; and |
| (e) | that no person with a right to signify an objection under the provisions of section [duties to persons who stood in a qualifying relationship in relation to transplantation] has done so. |
(3) Where each condition in subsection (2) is met, "appropriate consent" shall have been determined for—
| (a) | the removal of organs, or the relevant organ, for the purpose of transplantation, |
| (b) | the storage for use for the purpose of transplantation of such organs and of associated tissue, and |
| (c) | the use for the purpose of transplantation of such organs and of associated tissue. |
(4) Where a body is transferred to another institution prior to the removal of any organ, the duty under subsection (1) shall also be transferred to the person having the control and management of the institution to which the body has been transferred.
(5) In dealing under section 23(1) with the matters mentioned in this section and sections [register of personal decisions about availability of organs for purpose of transplantation] and [duties to persons who stood in a qualifying relationship in relation to transplantation], the Authority shall, in particular, lay down the standards expected in relation to the performance of the duty imposed by subsection (1).
(6) The person to whom the duty under subsection (1) applies may designate another person to perform activities in relation to that duty.
(7) It shall be the duty of the person to whom the duty under subsection (1) applies to secure that any person designated under subsection (6) to perform activities is a suitable person to participate in the carrying-on of those activities.
(8) This section shall not be read as making unlawful anything which is lawful apart from this section.
(9) For the purposes of this section a person lacks capacity in relation to a decision to make his organs unavailable for removal for the purpose of transplantation if during the relevant period he is unable to make a decision for himself in relation to the matter because of an impairment of or a disturbance in the functioning of the mind or brain.
(10) In this section and sections [register of personal decisions about availability of organs for purpose of transplantation] and [duties to persons who stood in a qualifying relationship in relation to transplantation]—
| | "associated tissue" means tissue the removal of which is integral to the removal of an organ for the purpose of transplantation; |
| | "death" has the meaning given in accordance with the provisions of section 23(2)(d) and cognate expressions shall be construed accordingly; |
| | "organ" means any part of a human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body and includes a part of an organ; |
| | "the register" means the register maintained in accordance with the provisions of section [register of personal decisions about availability of organs for purpose of transplantation]; |
| | "the relevant period" has the meaning prescribed by regulations, but the period so prescribed shall not include the period that— |
| (a) | begins with the occurrence of an accident that causes the death of the person concerned, and |
| | "the removal of an organ" includes the removal of any associated tissue removal of which is integral to the removal of the organ for the purpose of transplantation.'. |
Register of personal decisions about availability of organs for purpose of transplantation
Dr Evan Harris
NC2
To move the following Clause:—
'(1) It shall be the duty of the Authority to maintain a register of persons deciding to make all their organs, or specified organs—
for removal for the purpose of transplantation.
(2) Any person who decides to make all his organs, or specified organs—
for removal for the purpose of transplantation may inform the Authority in a prescribed manner.
(3) Any person who has informed the Authority of his decision under subsection (2) but then makes another decision may inform the Authority in a prescribed manner.
(4) Upon receipt of information in accordance with subsection (2) or (3) the Authority shall—
| (a) | confirm to the relevant person in writing that the information has been received, and |
| (i) | an appropriate entry is made in, or removed from, the register, or |
| (ii) | the appropriate entry is amended. |
(5) The Secretary of State may by regulations prescribe the ways in which an adult may provide information to the Authority for the purposes of this section, including opportunities to provide such information when a person is—
| (a) | registering for the receipt of, or receiving, primary medical services, |
| (b) | applying for a driving licence, or |
| (c) | making an application for a passport. |
(6) The Authority shall take such steps as it considers appropriate to promote public awareness of the register and of the means by which a person may make an entry in the register.
(7) Where the authority is satisfied that—
| (a) | a person in relation to whom information is held on the register has died, and |
| (b) | a period of one month has elapsed since his death, |
the Authority may remove the entry in respect of that person from the register.
(8) Information held by the Authority in accordance with the provisions of this section may only be made available to—
| (a) | the person in respect of whom the information is held, |
| (b) | a person in a qualifying relationship to the person specified in paragraph (a) when that person is deceased, |
| (c) | a person to whom the duty under section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation] applies, and |
| (d) | such other persons as may be prescribed by regulations. |
(9) A person commits an offence if he—
| (a) | makes information held by the Authority in accordance with the provisions of this section available other than to the persons specified in subsection (8), |
| (b) | does anything which causes an entry— |
| (i) | not to be made in the register after the Authority has been informed in a prescribed manner, |
| (ii) | to be removed without due authorisation, or |
| (iii) | to be false or incomplete. |
(10) A person guilty of an offence under subsection (9) shall be liable to—
| (a) | imprisonment for a term not exceeding 12 months, or |
| (b) | a fine not exceeding the statutory maximum, or |
