Dp 22 medicinteknikdirektivet 9124 06

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COUNCIL OF THE EUROPEAN UNION		Brussels, 12 May 2006
Interinstitutional File: 2005/0227 (COD)	9124//06 LIMITE
	ECO 83 SAN 102 CODEC 450

NOTE

from :	General Secretariat
to :	Coreper/Council
No. Prev. doc. :	DS 338/1/06 REV 1 ECO, SAN, CODEC
No. Cion prop. :	15023/05 ECO 147 SAN 192 CODEC 1100
Subject :	Preparation of the Council (EPSCO) on 1 and 2 June 2006: Proposal for a Regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 - Progress report

1. – On 4 May 2006, the Working Party on Pharmaceuticals and Medical Devices examined a draft progress report prepared by the Presidency and the General Secretariat of the Council. The aim of the examination was to prepare for the Permanent Representatives Committee and the Council (EPSCO) a progress report that the Working Party could agree upon. Based on the outcome of this examination, the draft progress report was amended and distributed to delegations together with an invitation to comment in writing.

2. – By 10 May 2006, eight delegations (DK, DE, ES, IT, PL, PT, SE, UK) had replied to this invitation. The draft progress report set out in the Annex to this Note has been further adjusted to take these written comments into account.

3. – It was noted that the Spanish delegation reserved its position on point 8 of the draft progress report as well as on bullet points 1 and 4 under point 9.

The Permanent Representatives Committee is invited to

- – resolve the outstanding issues concerning points 8 and 9 in the Annex to this Note;

- – verify that delegations can agree to the report as redrafted and set out in the Annex to this Note;

- – agree to forward the progress report from the Working Party to the Council (EPSCO) for consideration at its session on 2 June 2006.

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ANNEX

Draft Progress Report from the Working Party on Pharmaceuticals and Medical Devices

on the

Proposal for a Regulation on advanced therapy medicinal products

I. – INTRODUCTION

1. – The Commission submitted its proposal for a Regulation on advanced therapy medicinal products to the Council and the European Parliament on 16 November 2005. The proposal is based on Article 95 of the Treaty.

2. – The European Parliament is expected to give its first-reading opinion during the autumn 2006.

3. – Under the Austrian Presidency, the Working Party on Pharmaceuticals and Medical devices has started a detailed examination of the proposal. During eight meeting days, the Working Party has discussed all articles of and annexes to the proposal, in order to identify important issues for further consideration.

4. – At this stage several delegations have scrutiny reservations on certain articles and almost all delegations have linguistic reservations. The Danish, Maltese and United Kingdom delegations have parliamentary scrutiny reservations.

5. – Delegations’ detailed comments on various articles, as recorded during the meetings or provided in writing, will be set out in footnotes to the proposed legal text in a separate document, the first version of which will be presented before the end of the Austrian Presidency. This document is intended to provide a basis for the continued examination of the proposal.

II. – STATE OF PLAY

6. – In general, delegations have welcomed the proposal as an important legislative initiative aiming at creating a single, integrated legal framework that fully takes into account the scientific and technical characteristics of the three fields of advanced therapies, namely gene therapy, somatic cell therapy and tissue-engineering, as well as the specificities of the economic operators concerned, thereby facilitating the free movement of advanced therapy products in the Community, and improving patients’ access to these innovative therapies.

7. – There is general support in the Working Party that gene therapy, somatic cell therapy and tissue engineered products, both of human and animal origin, should be regulated together in a single regulation on advanced therapy medicinal products. There is also strong support for the principle that this regulation should be without prejudice to national legislation prohibiting or restricting, on ethical grounds, the use of certain cells, tissues and advanced therapy medicinal products derived from them.

8. – The Working Party, in its first examination, reached broad agreement that

advanced therapy products should be evaluated through a centralised procedure involving the European Medicines Agency (EMEA), the evaluation leading to a Community marketing authorisation;

a Committee for Advanced Therapies (CAT) should be established within the EMEA with the task -among others - to advise the Agency’s Committee for Medicinal Products for Human Use (CHMP) on the assessment of all advanced therapy medicinal products;

some of the members of CAT should be elected among the members of the CHMP, CAT should also have members representing clinicians and patients associations.

9. – Furthermore, the Working Party in this examination generally agreed to the following elements of the Proposal:

a Committee for Advanced Therapies composed of members coming from all Member States;

application to advanced therapies of the existing regulatory principles as regards clinical trials and good manufacturing practice, with appropriate adaptations at technical level;

amendment of the existing pharmaceutical legislation to establish specific technical requirements as regards tissue engineered products;

establishment of incentives related to scientific advice provided at a reduced fee, recommendation on classification of products, and certification of quality and non-clinical data.

Combined products

10. – The Working Party thoroughly discussed how to regulate combined products consisting of a medical device and viable cells or tissues of human or animal origin. A majority of delegations, argued that – in view of the fact that viable cells contained in a combined product would always have a pharmacological, immunological or metabolic effect – all such products should fall under this regulation (Article 2(1(d))). This group further argued that the risks resulting from the use of such products were best handled through the legislation on medicinal products. Several other delegations however stressed that the principal mode of action must determine whether a combined product should be regulated as a medical device or as a medicinal product, in line with the existing approach for regulating combination products.

11. – The majority of the Working Party came to the preliminary conclusion that products containing non-viable material of human or animal origin and which act primarily by physical means should not be considered to be advanced therapy medicinal products, even though concerns about a possible legal gap were raised.

12. – There was broad agreement that, subject to further examination of how to ensure that all necessary medical device expertise could be brought into the evaluation procedure, combined advanced therapy products falling under the present Regulation should be assessed as a whole under the auspices of the EMEA (“one stop shop”).

Hospital exemption

13. – Point (1) of Article 28 introduces an exemption from the requirements of Directive 2001/83/EC on the Community code relating to medicinal products for human use, for advanced therapy medicinal products that are both prepared in full and used within the same hospital, provided that this takes place in accordance with a medical prescription for an individual patient. As an example, products prepared in a pharmaceutical enterprise not falling under this exemption would require clinical trials in order to receive a marketing authorisation before being used, but similar products prepared for the same use under the exemption would not. Some delegations, while in favour of the principal idea behind such an exemption, saw a need for further examination. Other delegations argued in favour of enlarging this exemption to products prepared and used in a network of hospitals. A third group of delegations preferred to widen the scope of the Regulation by deleting the proposed exemption. Further examination of this point therefore seems necessary, in particular as concerns the understanding of the concepts involved, e.g. of industrial production in the specific context of advanced therapies, and as concerns the desirability and scope of the exemption.

Other considerations

14. – The annexes of the Regulation are subject to adaptation in view of scientific and technical progress through a comitology procedure. Since the decision on the scope of the Regulation must remain the competence of the legislator, it was further concluded that the parts of the present Annex I that define tissue engineered products must be included in the legal text itself. There is general agreement that the list of non-substantial manipulations, which must remain subject to adaptation, should be indicative and reviewed for its scientific correctness.

III. – CONCLUSION

The Council is invited to take note of this Progress Report and to instruct its preparatory bodies to, building on the general agreements already reached, pursue the examination of this proposal, in particular as concerns the various options for the "hospital exemption" (pt 13) and for the "combined products" (pt 10), with the aim of reaching swift agreement on the proposal.

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