Joint Committee on Statutory Instruments Fifth Report


Memorandum by the Department of Health


  1. The Committee has requested a memorandum on five points relating to the Good Laboratory Practice Regulations 1997 ("the Regulations").

    (1)   Explain why the definition in regulation 2(1) of "sponsor" includes the reference to an "entity" as well as a "person", given that the Interpretation Act 1978, in Schedule 1, defines "person" in legislation as including a body of persons corporate or unincorporate.

  2. The reason for referring to "entity" as well as "person" is that the Department considers it possible that not all study sponsors will be legal persons. This could happen, for example, where a study is commissioned by an entity which is an "undertaking" for the purposes of European Community law, (e.g. some form of joint venture) but not a legal person for the purposes of UK domestic law.

    (2)   In relation to regulation 6(1)(a), explain what is meant by the opening words ("he is regarded by the Secretary of State as being a member of the programme") and how the operator is to know that he is so regarded.

  3. Before the Regulations came into force, membership of the UK's good laboratory practice ("GLP") compliance programme was voluntary. Each applicant to joint the programme was the subject of an initial inspection visit to see if the UK GLP monitoring authority was prepared to provide endorsement of a claim by the laboratory that it complied with the principles of GLP. If the monitoring authority was prepared to provide such an endorsement, the laboratory received a written statement to that effect, in the form set out in Article 2.2 of Council Directive 88/320/EEC (copy enclosed), known as a compliance statement. Thereafter, the laboratory became subject to bi-annual inspections, after which their compliance statement was either renewed or the laboratory's membership of the compliance programme was suspended, depending on the outcome of the inspection visit.

  4. All holders of a valid compliance statement immediately before the Regulations came into force are "regarded" by the Secretary of State as being existing members of the programme for the purposes of regulation 6(1)(a) in respect of the premises to which the compliance statement relates. The Department accepts that it is not clear on the face of the Regulations that possession of a valid compliance statement was the criterion for existing membership, but considers that this was clearly understood by existing members, for whom acquisition of a compliance statement was the essential reason for joining the voluntary programme. Existing members were also advised that they would not need to apply to rejoin the programme when they were consulted as part of the public consultation exercise on the draft Regulations earlier this year.

      (3)   Given that the functions of the Secretary of State which he delegates to inspectors are described in regulation 3(b) as being "to enforce compliance with the Regulations", explain why this phrase is not used in regulation 9(2) to describe the purposes, (i.e. the limitations) for which all the powers conferred on inspectors by that regulation are exercisable. In particular -

      (a)   explain why paragraph (2)(d), (e) and (f) use the phrase "relevant in relation to the proper exercise by the inspector of his powers" instead of the phrase quoted from the above regulation 3(b); and

      (b)   explain what the opening words of regulation 9(2) - "In enforcing compliance with these Regulations" add to the words "for the purpose of enforcing compliance with these Regulations" which limit the power of entry on premises conferred by paragraph (a) of regulation 9(2).

  5. The phrase used in regulation 3(b) is not used in each of the sub-paragraphs in regulation 9(2) because it was desired, for policy reasons, to limit inspectors' powers further than simply repeating the wording of regulation 3(b) in each case would allow.

  6. To take the examples quoted by the Committee: so far as the use of the phrase "relevant in relation to the proper exercise by the inspector of his powers" is concerned, this is to make it clear that the inspectors' powers under (2)(d), (e) and (f) are limited to "relevant" evidence only, ie evidence considered "relevant" by application of general principles of the law of evidence (inspectors would not, for example, be able to require the production of scientific data not related to safety studies). The significance of this limitation can be seen by contrasting sub-paragraphs (c) and (e): under (c), samples of any substance may be taken, provided that the sample is taken for the purpose of establishing whether or not the Regulations are being complied with; under (e), all the substance may only be taken if it is "relevant" evidence - and by virtue of regulation 9(7), an inspector must, where it is reasonably practicable, take a sample before taking possession of all of the substance. Thus, the greater interference with property rights may only be exercised in more limited circumstances. The additional wording at the end of paragraph 2(a) was included in an attempt to make it clearer that visits had to be linked to enforcing compliance with the Regulations (eg, inspectors would not be entitled to visit parts of a test facility where studies other than safety studies were being carried out). The Department accepts that in some cases (such as in paragraph (2)(a)) these express limitations would arguably be implied, but it has nevertheless sought in each case to put the matter beyond doubt.

    (4)   Given that, under the terms of his appointment under regulation 10, a particular inspector's powers may be limited to enforcing compliance with the Regulations in some respects only, explain what words (if any) in regulation 9 acknowledge this further limitation on an inspector's powers under that regulation.

  7. The Department confirms that a particular inspector's power may be limited to enforcing compliance with the Regulations in some respects only. The Department considers that such a limitation is necessarily implied from the words "duly appointed in accordance with regulation 10" which, in the Department's view, necessarily imports a reference to the (perhaps somewhat limited) extent of the inspector's authority. Furthermore, inspectors must act reasonably, in accordance with general principles of public law, and the Department considers that these principles preclude inspectors exercising rights which they do not need to exercise in order to discharge their (perhaps somewhat limited) functions.

    (5)   Regulation 16(5) empowers the Secretary of State, "in exceptional circumstances", to waive, reduce or refund fees otherwise payable. Is it intended, by the quoted words, that it is enough that exceptional circumstances exist in his opinion or must the exceptional circumstances exist in fact?

  8. The intention is that the exceptional circumstances must exist in fact. If they do exist in fact, then the Secretary of State has a discretion as to whether or not to waive, reduce or refund fees otherwise payable - a discretion which he must, in accordance with general public law principles, exercise reasonably.

17th June 1997

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