Select Committee on European Communities Report


64.  PROPOSED DIRECTIVE ON HARMONISATION OF CLINICAL TRIALS

Letter from Lord Tordoff, Chairman of the Committee, to Baroness Jay of Paddington, Minister of State, Department of Health

  Sub-Committee C has considered your Explanatory Memorandum of 14 October on the above proposal. It has noted that the Commission is putting it forward as a Single Market measure under Article 100a of the EC Treaty rather than under Article 129 (Public Health).

  The Committee would be grateful if the Government could provide an explanation of why Article 100a is considered to be a satisfactory legal basis for a measure which is more obviously to do with health than with the Single Market.

  The Committee is concerned that the connection with the Single Market is too indirect and that the Directive, if adopted under Article 100a, might set an unsatisfactory precedent.

18 December 1997

Letter from Baroness Jay of Paddington, Minister of State, Department of Health, to Lord Tordoff, Chairman of the Committee

  Thank you for your letter of 18 December 1997 in which you ask on behalf of Sub-Committee C of the Select Committee on the European Communities for an explanation of why the Government considers Article 100a to be a satisfactory legal base for this Directive. The Committee has also suggested that Article 129 might represent a more suitable legal base.

  To address the second point first, Article 129 of the EC Treaty is not considered to be a proper legal basis for the adoption of this proposal because paragraph 4 of Article 129 specifically excludes its use in respect of measures harmonising laws and regulations of the Member States. Even though Article 129 will be amended when the Treaty of Amsterdam is ratified, it will still only allow for its use in harmonisation in the areas of blood products, organs and other human tissues, and will not therefore be appropriate for this measure.

  As far as the use of Article 100a is concerned, the Government is of course concerned to ensure that Commission proposals are brought forward under the appropriate Treaty base. When the Commission first brought forward this proposal officials considered carefully whether use of Article 100a could indeed be justified in relation to this particular Directive. The conclusion was that the measure is relevant to the establishment and functioning of the internal market, as required by Article 100a and is therefore properly proposed under that Article.

  As you are aware, most European medicines legislation has been introduced under Article 100a as part of the development of the internal market. The main aim of this legislation is to ensure harmonisation of Member State practices in carrying out their functions in respect of the safety, quality and efficacy of medicinal products and thereby facilitating the free movement of goods. Current legislative and administrative practices relating to the commencement of clinical trials differ significantly between Member States. The Government accepts that in as much as these differences can impact on the speed with which Europe-wide trials can be conducted and therefore on the availability of medicinal products within the EU—including those used in clinical trials—harmonisation of Member State procedures is a legitimate aim and appropriate for a measure under Article 100a.

  In general terms, the Government is vigilant in ensuring that the Commission does not introduce measures that have the potential to impact inappropriately on Member States' responsibilities for the delivery of healthcare and we are continuing to pay particular attention to the progress of this Directive to ensure that it does not stray into areas beyond current Commission competence.

22 January 1998

Letter from Lord Tordoff, Chairman of the Committee, to Baroness Jay of Paddington, Minister of State, Department of Health

  Thank you for your letter of 22 January explaining the Government's position as regards the compatibility of the proposed Directive with Article 100A.

  For the sake of the record, when referring to Article 129 in my letter of 18 December I was not suggesting that that Article permitted a directive harmonising Member States' laws and regulations.The concern of the Sub-Committee was that the connection between the proposed Directive and the development of the internal market might be too tenuous. If so, an alternative approach, perhaps under Article 129, might have been considered.

  This letter lifts the scrutiny reserve on this proposal.

5 February 1998


 
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