Select Committee on European Union Fortieth Report


MEDICAL DEVICE DIRECTIVES (5072/06)

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

  Thank you for your Explanatory Memorandum (EM) and Initial Regulatory Impact Assessment (RIA) dated 20 January which were considered by Sub-Committee G on 2 March.

  We note that the negotiations are at a very early stage and are surprised to see from your Initial RIA that these negotiations could last more than two years. We wonder why such a protracted timescale is envisaged.

  Although we see that the UK has strongly supported this initiative from the outset and is satisfied that the Proposal reflects the UK position, we agree that every effort should be made to ensure that the requirements are necessary and proportionate and that the wording of the text achieves what is intended.

  As you know, we already hold the Commission's Proposal for a Regulation on Advanced Therapy Medicinal Products (15023/05) under scrutiny. I wrote to you about this on 2 February. We will want to pay particular attention to the possibility of overlaps or regulatory gaps between this Proposal and that one, as indicated in your EM and the Commission documentation.

  We are also particularly concerned about any ethical implications of this Proposal, which your EM does not mention. The Commission Impact Assessment briefly mentions the need for careful examination over the principle of "informed consent" as it applies to reprocessed devices, as well as some liability considerations over such devices. We would be glad if you would explain the ethical and legal considerations involved in this and how the Government propose to tackle them during the negotiations. More generally, we would welcome a statement on the Government's overall view of the ethical considerations which apply to this Proposal and how they should be addressed.

  The Commission's EM refers to concerns highlighted during the 2003 review over the competence, consistency of performance and transparency of the Notified Bodies. We would be glad to know more about who these bodies are, how they work and to what extent you believe that the Proposal offers a workable solution to these problems.

  We would also welcome your comments on the extent to which the Proposal adequately covers the respective responsibilities of the EMEA and national authorities and how good coordination between the two will be achieved.

  Your EM also contains an unexplained reference to considering "how to police the requirement of having to provide the named patient with the statement of conformity" We would be grateful for an explanation of the meaning and significance of this sentence.

  We would also be glad if you could explain how the text is intended to keep pace with scientific and technological changes.

  We note that you intend your Initial RIA to become an "ever-evolving document" which will need to be adjusted in the light of negotiations. It would be helpful to know how you intend to present that "ever-evolving document" for Parliamentary scrutiny. We will want to examine the likely impact, especially on small organisations, very carefully and would expect to see some preliminary conclusions in a revised RIA based on the indicative costings which you expect to emerge from the next phase of your consultations.

  In the meantime, we will retain this document under scrutiny and would be grateful if you would report significant developments.

2 March 2006

Letter from Rt Hon Jane Kennedy MP to the Chairman

  Thank you for your letter of 2 March 2006 raising various points on the Explanatory Memorandum (EM) and Regulatory Impact Assessment (RIA) dated 20 January. I shall deal with each of your points in turn.

  You question the prediction, in the EM, that negotiations on the European Commission's proposal to revise the Medical Devices Directives could take two years. As you will appreciate, at this early stage in the process any prediction as to how long completion will take is inevitably imprecise. However, the prediction was based on a number of factors. Firstly, experience of two earlier attempts to extend the scope of the Medical Device Directive to include animal and human tissue. Both attempts failed but only after lengthy and protracted negotiations. The estimate reflects our experience of how long it can take to negotiate broadly comparable pieces of legislation bearing in mind the co decision process. Second, the issue of products containing tissues and cells affects the negotiation of both the Medical Devices Directive and the Advanced Therapy Medicinal Products (ATMP) Directive. It seems realistic to predict that it may take time to achieve a consistent view across both sets of negotiations. Thirdly, the impact the new Accession Member States would have was unclear. In particular there were some early indications that some would take the opportunity to argue for more far reaching and fundamental revision of the Directive than those measure being proposed by the Commission. Finally, we are aware that the European Parliament may not have completed its scrutiny until towards the end of the year.

  In fact, the Austrian Presidency has given the dossier high priority. There have already been five meetings of the Working Group and first reading has been completed. The Presidency plans to reach some sort of political agreement at the June Health Council.

  If this is successful, the speed towards completion will then depend upon handling by the Finnish Presidency, progress of the discussions on the ATMP Regulation and any amendments proposed by the parliament.

  In your letter you expressed particular concern about the ethical implications of this proposal which I take to relate to tissue engineering. I am sorry that the EM did not cover this. The Commission's current proposal covers medical devices which contain human tissue engineered products, as defined in the ATMP Regulation, and which act ancillary to the device. The ethical considerations applying to the proposed ATMP Regulations equally apply here.

  Article 28(2) of the proposed Regulation on ATMPs amends the Medicines Directive 2001/83/EC in order that under national legislation Member States may prohibit or restrict the use of any specific type of human or animal cells (eg germ cells or embryonic stem cells) or the sale supply or use of medicinal products consisting of or derived from these cells. This is consistent with the similar provision in Article 4(3) of the Tissues and Cells Directive 2004/23/EC setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

  The proposed Regulation on ATMPs requires that the donation, procurement and testing of human cells or tissues used in these products are carried out in accordance with the Directive 2004/23/EC. Chapter III of Directive 2004/23/EC concerns donor selection and evaluation and includes: principles governing tissue and cell donation, consent, data protection and confidentiality and selection, evaluation and procurement. Article 13 on consent requires that procurement of human tissues or cells shall be authorised only after mandatory consent or authorisation requirements in the Member State concerned have been met. It continues that Member States shall, in keeping with their national legislation, take all measures to ensure that donors, their relatives or any persons granting authorisation on behalf of donors are supplied with all appropriate information. The information requirements for living and deceased donors are then detailed in the Annex to the Directive.

  On the specific point of informed consent as it applies to reprocessed devices contained in the Commission's Impact Assessment, you will wish to note that this related to an earlier suggestion that the scope of the Medical Devices Directive be extended to include the reprocessing of single use devices. For a number of reasons however, including ethical and liability considerations and after discussions with stakeholders, the Commission has now decided not to propose such a change. However, we are aware that the European Parliament is being lobbied on this matter and it may well be that they will want to suggest such a revision themselves, so we have included our comments about your point on informed consent anyway.

  The Medicines and Healthcare products Regulatory Agency advises users always to follow the manufacturer's instructions including those for reprocessing.

  However, if the device in question has been CE marked for re-use, then the reprocessing would not be considered to be a safety issue or present any increased risk to the patient. Under these circumstances, although the details of the procedure and the use and principles of working of the main devices used in that procedure would fall within the information to be given as part of informed consent, the fact that the device has been reprocessed in line with the manufacturer's instructions would not fall within the information to be supplied to the patient as part of informed consent. However, if a device CE marked for single use had been reprocessed, then there is the potential, under these circumstances, for an increased risk to the patient. In this case, the fact of reprocessing and the associated potential risks would fall within the principles of informed consent and should be discussed with the patient. In considering what information to provide, case law and DH guidance advises that a patient should be informed of any material or significant risks that might affect the judgement of a reasonable patient. More recently, the House of Lords has ruled that breach of the duty to inform patients of the significant risks will deny the patient the chance to make a fully informed decision. This means that the doctor may be found at fault even if the failure to explain the risks fully did not cause the damage suffered by the patient.

  You also asked about Notified Bodies. These are independent certification bodies used by manufacturers, of all but the lowest risk medical devices, to check that the essential requirements contained in the Directive are met before the device can be affixed with a CE-marking and placed onto the European market. The Notified Bodies are designated by their national Competent Authority (in the UK this is the MHRA) who also regularly monitor their actual performance to ensure that they are performing their tasks to an acceptable standard.

  The 2003 review, to which you refer, identified a number of problems affecting Notified Bodies. In particular it noted an uneven and inconsistent level of performance but concluded that the authorities responsible for their designation and monitoring were best placed to address these matters. Accordingly, Member States and the Commission set up the Notified Body Operations Group (NBOG) under the Chairmanship of the UK. The group had a remit to improve the overall performance of Notified Bodies by identifying and promulgating examples of best practice between Notified Bodies and those organisations responsible for their designation and control. Such has been NBOG's success that the Commission has not proposed any change to the current text relating to Notified Body activities and no changes have been suggested during first reading by Member States.

  You also ask about the respective responsibilities of the European Medicines Agency (EMEA) and national authorities and co-ordination between the two. The current text of the Medical Device Directive requires the EMEA and national medicine regulatory authorities to assess the safety and quality and usefulness of medicinal substances and stable blood derivatives incorporated within a device and which acts ancillary to the device. The Commission's proposals would extend the competence of the EMEA even further by requiring it to assess the safety and quality of a tissue engineered product added to a device with an ancillary action. These views are given by the EMEA and the national medicines agencies to the Notified Body who has to take such opinions into account when deciding whether or not to issue an EC Certificate of Conformity to the medical device manufacturer. Co-ordination therefore occurs primarily between the EMEA and national medicines regulatory agencies and the notified bodies and is already a feature of the existing regulatory systems. We are not aware of any particular problems in practice in the level and effectiveness of this co-ordination.

  The reference to "how to police the requirement of having to provide the named patient with the statement of conformity" relates to the Commission's proposal to require a statement containing information about the device to be given to each patient receiving a custom made device. In practice the proposal would place a legal obligation on, for example, a dentist to provide the statement. Failure to do so would be a criminal offence. We believe that in practice such an obligation would be difficult, if not impossible, to effectively enforce. You will wish to note, however that in negotiations our concerns were shared by several other Member States and has resulted in the proposal being provisionally amended to say that statement should only be given to the patient on request.

  As far as keeping pace with scientific and technological changes, the Medical Devices Directive already requires manufacturers to make their device in accordance with state of the art and contain a provision to enable the Directives to be amended if scientific or technological changes warrant such amendments. Finally, and in accordance with Cabinet office guidance, our RIA is an "ever-evolving document" in that it will constantly be updated as negotiations progress. We are working with stakeholders to assess the possible costs that might be associated with the proposed revision proposal. The RIA has been posted on the MHRA website along with the Commission's proposals and we have requested comments.

  We will keep the Committee informed as negotiations develop and provide you with a revised RIA on the basis of the current consultation exercise.

21 April 2006

Letter from the Chairman to Rt Hon Jane Kennedy MP

  Thank you for your letter dated 21 April which was considered by Sub-Committee G on 4 May at the same time as your letter dated 25 March about the related Advanced Therapy Medicinal Products (ATMP) Directive (reference 15023/05).

  We are grateful to you for giving such a thorough explanation in response to the queries raised in my letter dated 2 March. Your promise to keep us informed as negotiations develop, and to submit a revised RIA based on your current consultation exercise, is most welcome.

  We note that, on the one hand, you say that experience shows that negotiations on the Directives could last up to two years and are complicated by issues arising from the parallel negotiation of the ATMP Directive and by uncertainty over the position of new Member States. Yet, on the other hand, you say that the Austrian Presidency plans to reach "some sort of political agreement" at the June Health Council.

  We find this surprising and potentially worrying. It is clear from your letter that a great deal of clarification of the proposals is still needed and the sensitivity of such issues as tissue-engineering arising from the ATMP Directive is bound to be an additional complication. We would be most reluctant to contemplate granting scrutiny clearance to enable "political agreement" as soon as June if serious issues, especially related to ethical considerations, had not been fully and satisfactorily resolved by then.

  We would be grateful for your thoughts on this apparent dilemma and will continue to hold the document under scrutiny for the time being.

5 May 2006

Letter from Andy Burnham MP, Minister of State for Delivery and Reform, Department of Health to the Chairman

  Thank you for your letter of 5 May to Jane Kennedy responding to her letter of 21st April.

  In your letter you express concerns at the Austrian Presidency's intentions to try and achieve "some sort of political agreement" at the Health Council during their Presidency. Your concern was that there were sensitive issues still to be resolved before any sort of agreement could be reached. The Health Council took place on 1-2 June, and in the event the Presidency simply presented a Progress Report, on which there was no discussion, which highlighted all the issues still to be resolved including the tissue engineering elements referenced in your letter. The latest position on those discussions is covered in a separate letter from me in answer to your letter on the Advanced Therapy Medicinal Products Regulation.

  I will continue to keep you up to date as negotiations progress and will provide you with a revised RIA as promised.

13 June 2006

Letter from the Chairman to Andy Burnham MP

  Thank you for your letter dated 13 June. This was considered by Sub-Committee G on 29 June together with your separate letter of the same date on the related question of the Advanced Therapy Medicinal Products (ATMP) Regulation (reference 15023/05) to which I am replying separately.

  We are glad to see that the Austrian Presidency did not, after all, attempt to achieve "some sort of political agreement" at the June Health Council. Our view remains that much more careful and detailed consideration is needed, especially over the sensitive issues such as tissue engineering and the potential linkage with the ATMP Directive.

  We will continue to hold this document under scrutiny and look forward to your further progress reports as negotiations proceed under the Finnish Presidency. We also look forward to seeing your revised RIA as promised.

3 July 2006



 
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