Select Committee on European Union Fortieth Report


ADVANCED THERAPY MEDICINAL PRODUCTS (15023/05)

Letter from the Chairman to Rt Hon Jane Kennedy MP, Minister of State, Department of Health

  Your Explanatory Memorandum and Initial Regulatory Impact Assessment dated 14 December 2005 were considered by Sub-Committee G on 9 February.

  We note that these important proposals are at an early stage of consideration, that the Government is still studying and carrying out consultations on them and that Working Group discussions about them have only just started.

  We agree with your view that any legislation in this area should be proportionate and risk-based. We would also expect the most thorough attention to be paid to all ethical aspects of the Proposal and will want to be satisfied that all the relevant interested parties in the UK have been fully consulted.

  Although we note your initial view that it may be difficult to establish detailed costs and assess the overall impact of the proposal, we expect the Government to make every effort to carry out as thorough a regulatory impact assessment as possible. We will want to examine that assessment very carefully.

  We also note that the Government is reviewing the appropriateness of the proposed Treaty base (Article 95) in the light of the ECJ judgement of 6 December 2005 in the "Smoke Flavourings" case (ECJ C-66/04).

  In the circumstances, we are holding this document under scrutiny. We look forward to receiving the results of your further study and consultations about the proposal, as well as your emerging conclusions on the appropriateness of the proposed legal base. We would also be glad to know when you expect to be in a position to submit a revised Regulatory Impact Assessment and what timescale is envisaged for the Working Group discussions.

10 February 2006

Letter from Rt Hon Jane Kennedy MP to the Chairman

  I am writing further to your letter of 10 February 2006 following your committee's consideration of the explanatory memorandum and initial regulatory impact assessment submitted by the Department of Health on 14 December 2005.

  Negotiations on the European Commission's proposals for a Regulation on advanced therapies/tissue engineering are at an early stage, having commenced in the Council of Ministers working party in January 2006 under the Austrian Presidency. The Presidency has indicated that the dossier will be given priority in the first half of 2006 and there will be regular negotiating sessions throughout this period. Since the Commission published its proposals for advanced therapies/ tissue engineering in November 2005, proposals have also been published for an amending Directive following the review of the Medical Devices Directives. There is a linkage between both sets of legislative proposals and my officials are considering them in the round.

  To inform the development of the UK position, the Department of Health/Medicines and Healthcare products Regulatory Agency has had extensive dialogue with a range of stakeholders including hospitals, academic researchers, medical charities, industry and consumer groups. The position I outline below very much reflects the concerns that have been raised with us by interested parties. Overall, discussions with a range of stakeholders confirm that there is broad support for legislation on tissue engineering but that further clarification of, and/or adjustment to, the proposals is desirable in a number of areas, especially relating to issues of definition and scope of the proposals. There is also a strong concern to ensure that regulation is proportionate; products should not be subject to a more onerous regime than is justified. Further meetings with stakeholders are planned to take place on a regular basis during the negotiations to work through the complex issues arising from the proposals.

  Our overall objective in the negotiations is to achieve a coherent regulatory framework in the interests of public health and in order to provide the regulatory clarity industry requires to attract investment in this innovative area of bioscience.

  I can assure the committee that the Government will be mindful of the ethical aspects of the proposals. We wish to protect the UK position in relation to the use of embryonic stem cells in accordance with existing safeguards. The Commission's proposals envisage that there would be national flexibility over whether to prohibit the use of particular kinds of cells. Given the divergence of views within Europe this seems a realistic way forward and mirrors the outcome reached on the recent Tissues and Cells Directive.

  Our assessment of the two sets of current legislative proposals is that, while they have a number of benefits, in aggregate they do not fully address an existing problem, that some products containing human or animal tissue/cells and used for medical purposes fall into gaps between the medicines and medical devices regulatory regimes. We believe that some of these products would continue to be inadequately regulated under the current proposals. In negotiations we have raised the issue of "gap" products and are seeking a resolution that ensures products can be regulated in a way that is coherent, proportionate and reflects the characteristics of the product. More generally, we will seek to ensure that the specific provisions of the Regulation and, if it is agreed, the follow up technical requirements and guidelines are proportionate and risk-based.

  The other key issue relates to the proposed exemption for hospitals under the Regulation. The proposal would exempt products from the requirements set out in the Regulation where the product is both prepared in full and used in a hospital in accordance with a medical prescription for an individual patient. Our discussions with stakeholders and in the early negotiations in the Council have indicated that the proposed exemption raises complex issues. On the one hand, it is desirable to ensure a consistent level of public health protection irrespective of where a product is made and used. On the other hand, there is a need for sufficient flexibility to ensure that hospitals can carry out their normal activities, with clinicians taking professional responsibility for treatments and therapies they deem to be in the interests of patients. Our position is that it may be better to link the proposed exemption to the characteristics of the activity rather than to specific institutional arrangements. My officials are exploring possible solutions in discussions at national level and are promoting our position in negotiations in Europe.

  My officials are working with stakeholders to assess the possible costs that might be associated with the proposed Regulation. We would hope to be in a position to update the initial regulatory impact assessment once this information has been provided and hopefully by the summer. However, given that in large measure tissue engineering is very much at an early developmental stage, we envisage that it is likely to remain problematic for industry to produce reliable cost estimates.

  The committee will be aware of the Government's previous position on Article 95. However, in light of the judgement of the European Court of Justice (ECJ) given on 6 December 2005 in ECJ C-66/04 UK-V-European Parliament and Council of the Union "Smoke Flavourings", the Government's preliminary view is that we are now unlikely to have any convincing arguments on legal base and may therefore have to accept that article 95 is appropriate in this case. We will confirm our position on legal base in due course.

  I would be pleased to keep the committee informed of significant developments in negotiations.

25 March 2006

Letter from the Chairman to Rt Hon Jane Kennedy MP

  Thank you for your letter dated 25 March which was considered by Sub-Committee G on 4 May together with your letter dated 21 April about the related Medical Devices Directive review (reference. 5072/06). We note that negotiations on both Proposals are being kept in step.

  We are glad to know that your negotiations are being informed by close and continuing consultation with the relevant stakeholders which have highlighted several important potential problems, including those of "gap" products and exemption for hospitals which remain to be resolved.

  Thank you for your assurance that the Government will be mindful of the ethical implications of these Proposals, to which you already know that we attach the highest importance. We support your overall objective to secure a coherent regulatory framework that will protect public health and give industry the regulatory clarity needed to attract investment. We also share your wish to ensure that regulation is proportionate and risk-based and hope that it will be cast in terms that are likely to work well in practice.

  While we also note what you say about the difficulty of producing reliable cost estimates, we continue to hope the Government will make every effort to carry out as thorough a revision of the Regulatory Impact Assessment as possible.

  You should be well aware from previous correspondence of our views on the legal base question. We note what you say about the potential impact of the ECJ "Smoke Flavourings" ruling and look forward to learning your definitive view when you have completed your consideration of the position.

  We are also grateful for your promise to keep us informed of significant developments in negotiations and would be glad to know when a Council decision might be expected. We will continue to hold the Proposal under scrutiny in the meantime.

5 May 2006

Letter from Andy Burnham MP, Minister of State, Department of Health to the Chairman

  I am writing in response to your letter of 5 May 2006 following your committee's consideration of Jane Kennedy's letter of 25 March 2006.

  Negotiations on the European Commission's proposals for a Regulation on advanced therapies/tissue engineering have progressed under the Austrian Presidency. First reading was completed under the current Presidency. We do not anticipate early agreement on the proposed Regulation in the Council working group. The two key issues that have dominated negotiations so far relate to the proposed exemption for hospitals and the scope of the proposals.

  The committee will be aware that the proposed exemption for hospitals has raised a range of complex issues. On the one hand, it is desirable to ensure a consistent level of public health protection irrespective of where a product is made and used. On the other hand, there is a strong case for ensuring there is the necessary flexibility to ensure that current tissue engineering activities that are carried out in hospitals can continue. There is also recognition that an exemption expressed in ill defined terms could offer a loophole for those wishing to avoid regulation. Given the complexities of the proposed exemption, our position is that it might be preferable to link the exemption to the characteristics of the activity rather than to specific institutional arrangements. No real consensus has emerged among Member States on this issue to date.

  The committee will be aware of our concerns that under the proposals some products containing human or animal tissues/cells and used for medical purposes would fall into gaps between the medicines and medical devices regulatory regimes. We have raised this issue in negotiations and there is acknowledgement that some products would indeed fall into a regulatory gap. We will continue to seek a resolution that ensures products can be regulated in a way that is coherent and reflects the characteristics of the products. As you know, we are pursing a single approach on this issue across the two separate negotiations on this Regulation and on the revision of the Medical Device Directives, on which I am writing separately to you.

  In negotiations there was a proposal—which has attracted significant support—that all products containing viable human or animal cells and tissues should be regulated as medicines, and all products containing non viable cells and tissues should fall under the devices regulatory framework. We are concerned that this approach would cut across existing arrangements for deciding the regulatory category of products (included combination medicine/medical device products) and we have argued that a product should be regulated on the basis of its mode of action and intended purpose. We expect to receive confirmation of the priorities for the Finnish Presidency in the very near future and I would be pleased to keep the committee informed of significant developments in negotiations.

  I can assure you that my officials will continue to work with stakeholders to assess the possible costs that might be associated with the proposed Regulation. I believe it is important to emphasise that much of this type of activity is at an early developmental stage and we know from our ongoing discussions with stakeholders that it is likely to remain problematic to produce reliable cost estimates. We would hope that once the final shape of the proposed regulatory framework begins to emerge it may prove more realistic to develop cost estimates. We are, however, committed to updating the regulatory impact assessment to reflect developments in negotiations in Europe and to include any estimates provided by stakeholders, including from industry.

  In relation to legal base, the European Court of Justice (ECJ) has recently given its judgment in the ENISA case. The UK lost its arguments on legal base in this case. Therefore, as previously stated the Government's preliminary view is that we are now unlikely to have any convincing arguments on legal base. We will confirm our view on the proposed legal base for the Regulation in due course.

13 June 2006

Letter from the Chairman to Andy Burnham MP

  Thank you for your letter dated 13 June which was considered by Sub-Committee G on 29 June.

  We note that negotiations have been continuing under the Austrian Presidency and that no real consensus has emerged so far over the proposed exemptions of hospitals, although there has apparently been some acknowledgement of the problem of the regulatory gap between the regulatory regimes for some products containing human or animal tissues or cells.

  We are glad the Government is continuing to adopt a single approach to the related issues of this Regulation and the Medical Devices Directive (reference 5072/06), about which I am also replying to your separate letter of the same date.

  We also note your concerns over the proposal that all products containing viable human or animal cells and tissues should be regulated as medicines while those containing non-viable cells and tissues should fall under the devices regulatory framework. We have some sympathy with your argument that products should be regulated on the basis of mode of action and intended purpose.

  We are glad to see that your officials are continuing to work with stakeholders to try to assess the possible costs, though we accept the difficulty of making realistic cost estimates when many of the activities involved are at an early development stage and when the final shape of the proposed Regulatory Framework remains unclear.

  We also note that the recent ECJ judgment in the ENISA case seems to support the Government's preliminary view, as reported in Jane Kennedy's letter to me dated 25 March, that the Government is now unlikely to have any convincing arguments on the legal base. But we look forward to receiving your definitive view on that as soon as it is reached.

  Finally, we note that the Government expect confirmation of the Finnish Presidency's priorities in the very near future and welcome your assurance that we will be kept informed of significant developments in your negotiations.

  We will continue to hold this item under scrutiny pending your further reports.

3 July 2006



 
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