Joint Committee on Statutory Instruments Seventh Report


APPENDIX 6

Memorandum by the Department of Health

THE GOOD LABORATORY PRACTICE REGULATIONS 1999 (S.I. 1999/3106)

  1. The Committee has requested a memorandum on four points relating to the Good Laboratory Practice Regulations 1999 ("the Regulations").

    (1) In regulation 2(1), the definition of "regulatory study" begins "means a non-clinical experiment or set of experiments" and continues [c] "compliance with the principles of good laboratory practice is required in respect of that experiment...". Explain whether some words (such as "in respect of which") have been omitted at the beginning of paragraph (c) to continue the sense of the opening words.

  2. The Department agrees that the words supplied could have been added at the beginning of sub-paragraph (c) but considers that their omission does not detract from the meaning of the provision. The three sub-paragraphs of the definition, linked by the "and" at the end of sub-paragraph (b), have to be read together. The conditions in all three sub-paragraphs have to be met for an experiment to be a "regulatory study", and so there are no circumstances in which the full-out words at the start of the definition would need to be read just with the words of sub-paragraph (c).

    (2)  In regulation 5, paragraph (4) begins "The reasons referred to in paragraph (3) are that—" and continues [(b)] "to ensure fulfilment of a Community obligation". Explain whether some words (such as "it is necessary to do so in order") have been omitted at the beginning of paragraph (b) to continue the sense of the opening words.

  3. The Department accepts that paragraph (4) is defectively drafted: the word "that" should not have been included in the full-out words at the start of the paragraph. Alternatively, words such as those suggested by the Committee should have been used at the start of sub-paragraph (b). However, the Department considers that the sense of the provision is still clear (i.e. sub-paragraph (b) is clearly still a reason "....set out in paragraph (4)" for the purposes of paragraph (3)).

    (3)  Regulation 6(3) specifies three circumstances in which the monitoring authority may withdraw membership of the Good Laboratory Practice compliance programme and paragraph (4) requires notice to be given to the member so that he can make representations. Explain why prior notice and the opportunity to make representations is not conferred in the circumstances specified in paragraph (3)(c).

  4. A requirement to give prior notice and the opportunity to make representations in all cases is not conferred in the circumstances specified in paragraph (3)(c) because of the nature of the reason for the withdrawal of membership, i.e. "....a failure to adhere to the principles of good laboratory practice which....may contribute towards precipitating a danger to animal or human health or the environment...". Circumstances could arise where the danger to animal or human health or the environment was such that urgent action had to be taken, subject to review by the courts of the monitoring authority's decision (i) to withdraw membership for the reason set out in paragraph 3(c), and (ii) not to give prior notice and the opportunity to make representations, notwithstanding that there was no statutory duty to do so. An example might be the withdrawal of membership in respect of a field site at which dangerous levels of toxic chemicals were seeping through to the water table.

    (4)  Regulation 10(2)(d) allows the disclosure of confidential information obtained under the Regulations to a "police force" (i.e. the collective body of constables "maintained by a police authority": see section 101(1) of the Police Act 1996). Is the intention that disclosure is only to be lawful if it is made to the police authority? Or to the chief constable of a force? Or to any member but for the specific purpose of criminal proceedings?

  5. Disclosure is allowed under regulation 10(2)(d) to any member of a police force, not just the chief constable. The permission does not cover disclosure to a police authority, but disclosure to a police authority may in any event be permissable under regulation 10(1), where there is a lawful authority for the disclosure. The permission is not expressly limited to the specific purpose of criminal proceedings, but in practice, given the nature of police forces' duties, disclosure would only happen in the context of actual or potential criminal investigations and/or actual or potential criminal proceedings.

2 December 1999


 
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