Select Committee on European Scrutiny Twenty-Second Report





COM( 01)606

Commission Report on the experience gained as a result of the operation of the procedures for granting marketing authorisations for medicinal products laid down in Regulation (EEC) No. 2309/93, in Chapter III of Directive 75/319/EEC and Chapter IV of Directive 81/851/EEC.





Draft Regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.

Draft Directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.

Draft Directive amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.

Legal base:(a) —

(b)Articles 95 and 152(4) EC; co-decision; qualified majority voting

Document originated:(a) 23 October 2001

(b) 26 November 2001

Forwarded to the Council:(a) 24 October 2001

(b) 26 November 2001

Deposited in Parliament:(a) 13 November 2001

(b) 3 January 2002

Department:Health and Environment, Food and Rural Affairs
Basis of consideration:EMs of 17 January 2002
Previous Committee Report:None
To be discussed in Council:No date set
Committee's assessment:Politically important
Committee's decision:For debate in European Standing Committee C


  3.1  In order to remove obstacles to the internal market in pharmaceuticals, whilst at the same time ensuring a high level of public health protection, the Community has gradually developed a harmonised legislative framework for human and veterinary medicinal products. The present system was established under Council Regulation (EEC) No. 2309/93[6], and entered into force in 1995. It is based on two separate procedures for the granting of marketing authorisations for such products:

  • a centralised procedure, granted by a Commission decision under Regulation 2093/93, and based on a scientific evaluation from the European Agency for the Evaluation of Medicinal Products (EMEA), leading to a single marketing authorisation valid throughout the whole Community: this procedure is mandatory for medicinal products developed through biotechnological processes, but optional for certain other categories;

  • a decentralised (mutual recognition) procedure under Council Directives 2001/82 and 2001/83/EC for those medicinal products not eligible for the centralised procedure or where the applicant chooses not to follow that procedure: this has to be used where an application for a marketing authorisation concerns two or more Member States, with one carrying out the scientific evaluation which the others are required to recognise (subject to the right to raise objections).

  3.2  Regulation 2309/93 also obliged the Commission to report within six years of its entry into force on the operation of the two authorisation procedures, and the Commission says that, although there was no obligation on it to review the legislative framework as well, the possibility of this being done was deliberately left open. Consequently, these two documents comprise respectively a Commission Report providing the evaluation required under Regulation 2309/93, and proposals to amend the procedures both in that Regulation and in the Community codes relating to human and veterinary medicines set out in Directives 2001/83 and 2001/82 respectively. The Report also deals with other aspects of pharmaceutical legislation going beyond the authorisation procedures, but which the Commission says are relevant to it.

The current document

  • (a) Commission Report

  3.3  This is based on an exercise carried out by independent consultants, and seeks to assess the operation of Regulation 2309/93 against four major objectives — public health protection; developing the internal market in pharmaceuticals and establishing a framework favourable to the competitiveness of the European industry; meeting the challenges of enlargement; and simplifying the authorisation system and improving its transparency. Overall, it concludes that the procedures, particularly those under the centralised system, have worked well, and that there is no need to make fundamental changes to the current system with its dual structure. However, it does also contain a number of detailed observations.

  3.4  In the case of the centralised system, the Report recommends that the scope should be extended so as to become mandatory for all new active substances which have not been part of an authorised medicinal product in any of the Member States, and that the procedure should in future be open — on an optional basis — (a) to any other product which constitutes a significant innovation or where there is a Community interest in granting a centralised authorisation, and (b) to generic medicinal products of centrally authorised products. It also suggests that the development of new technologies requires greater flexibility in the authorisation process, and that this should be accelerated, with greater use made of fast track procedures and conditional authorisations. In parallel with this, it suggests that the present requirement for marketing authorisations to be renewed every five years should be replaced by one involving a continuous five-year administrative renewal, backed up by strengthened 'pharmacovigilance'[7] and supervision requirements.

  3.5  The Report also comments upon the operation of the EMEA. It says that, in general, the EMEA is seen by industry and Member State authorities as having made a considerable contribution to the centralised system, but it goes on to suggest that the structure of its scientific committees needs to be altered, and that the composition of these committees and of the EMEA's Management Board need to be reviewed to reflect the Community's future enlargement. In addition, the Report envisages a widening of the EMEA's tasks, so as to include advice on any issue regarding the marketing authorisation of medicinal products; ensuring that such authorisations are observed in the case of parallel distribution; co-operation with the World Health Organisation on the assessment of products intended for third country markets; and the imposition of sanctions where holders of market authorisations fail to observe the obligations placed upon them.

  3.6  As regards the decentralised system, the Report notes the clear support for the mutual recognition procedure and the flexibility this provides, especially in the veterinary sector, for the products of smaller companies intended for only a limited part of the European market. However, it also notes concerns about the length of the authorisation procedure, the problems which have arisen where Member States do not recognise an authorisation given by another Member State because of fears that this could involve a risk to public health, and the extent to which those problems have been exacerbated both by the differing interpretations placed by Member States on what constitutes such a risk, and by shortcomings in the arbitration procedures. In particular, the Report comments that, where a Member State objects to an authorisation, this often results in the product being withdrawn in that country, thus preventing a thorough evaluation of the objection.

  3.7  Other points identified in the Report on the decentralised procedure include shortcomings in the pharmacovigilance measures, the need for a clearer definition of generic medicinal products, changes in the procedures governing advertising, a simplified procedure for homeopathic medicines, and a range of issues arising on the availability of veterinary medicines.

  • (b) Legislative proposals

  3.8  Following from the conclusions in its Report, the Commission has put forward in the second of these documents three legislative proposals:

  • a draft Regulation, which would replace Regulation 2093/93, and set out amended Community procedures for authorising human and veterinary medicines;

  • a draft Directive amending Directive 2001/83 on the Community code relating to human medicines;

  • a draft Directive amending Directive 2001/82 on the Community code relating to veterinary medicines.

  3.9  As regards the authorisation of human and veterinary medicines under Regulation 2093/93, the Commission proposes:

  • that the centralised procedure should remain compulsory for products resulting from biotechnical processes, in particular those using recombinant DNA technology, and any medicine which contains a protein obtained using such technology;

  • that this procedure would in future also be compulsory for any new active substance appearing on the Community market,

  • that it would be optional for other medicinal products involving therapeutic innovation, and be open also to products which, although innovative, may be of benefit if authorised from the outset at Community level, particularly where these cannot be supplied without a prescription;

  • that Member States would be able to authorise at national level the generic form of products authorised by the Community, provided harmonisation is maintained, thus giving the manufacturers of such products a choice between the two procedures.

  3.10  These changes in the scope of the centralised procedure would be accompanied by a number of procedural changes aimed at speeding up the approval process. First, where the Commission proposes to follow the relevant scientific advice, Member States would in future simply be consulted, their existing regulatory powers being confined to cases where the Commission proposes to disregard that advice. Secondly, two new ways of obtaining a marketing authorisation would be introduced. One would enable applicants to apply for an accelerated assessment, where this is justified on public health grounds, whilst the other would enable provisional authorisations of one year to be given, subject to strict conditions and annual reassessment, to products shown as likely to be of considerable benefit to patients. Also, as suggested in the Commission's Report, the five-yearly renewal of authorisations would be abolished, but pharmacological vigilance procedures would be strengthened, and updated safety reports submitted more frequently.

  3.11  The Commission also proposes changes in the remit of the EMEA and in its administrative and scientific structures. The former would involve giving the EMEA a number of additional tasks going beyond the assessment of medicinal products. In particular, it would increase, and systematically develop, the scientific advice it provides at the research and development phases of new products, and it would participate in implementing at Community level programmes set up for the compassionate use of human medicines used for serious conditions where treatment is difficult or involves serious side-effects. In addition, the EMEA would be able to increase and develop its support for the Commission and Member States on international scientific cooperation, both through the World Health Organisation and more generally, coupled with new procedures aimed at preventing or resolving conflicts between the EMEA's scientific opinions and those of other scientific bodies.

  3.12  The changes in its structures would be made principally with enlargement in mind, in that there would in future be only one national representative on its scientific committees rather than two as at present, but with the possibility of other experts being co-opted. Similarly, changes would be made to the Management Board, so as to provide for four representatives each from the Member States, Commission, European Parliament and "civil society" (the pharmaceutical industry and consumers), as the Commission says is now the case with many other Community agencies.

  3.13  The other main changes proposed to Council Regulation 2309/93 would confer two new powers on the Commission. First, whereas the withdrawal of a product from the market if an urgent safety issue arises is currently a matter for Member States' licensing authorities, the Commission would in future be able to do this on its own initiative. Secondly, it would also have the power, when requested to do so by the EMEA, to levy fines on the industry for failure to observe certain obligations, though these are not currently specified.

  3.14  In addition to these changes, which would apply broadly speaking to centralised authorisations of all types of medicine, the proposals in the second and third parts of this document deal with the decentralised procedures and other aspects of the regulatory regime as they affect human and veterinary medicines.

  3.15  In the case of human medicines, Directive 2001/83/EC would be amended so as:

  • to amend the definition of a medicinal product, and of generic products, in order to reflect new technologies and methods of administration, and to include food supplements, cosmetics and certain medical devices;

  • to harmonise key elements of the mutual recognition procedure, such as the summary of product characteristics, patient information leaflets, and packaging and labelling requirements, and to enhance the status of the group established to facilitate such recognition;

  • to shorten the timescales within which Member States may assess applications;

  • to introduce across the Community a harmonised "data exclusivity" period of ten years[8], after which a manufacturer of generic medicines may use licensing data submitted by an originator company, and permit research and development (but not the marketing) of generic products before patent expiry;

  • to introduce, on a pilot basis for five years (to be monitored by the EMEA), the communication of information to patients on prescription-only medicines available to treat AIDS, asthma and other pulmonary disorders, and diabetes.

  3.16  Many of these changes would also be made to the arrangements for veterinary medicines set out in Directive 2001/82/EC. In addition, however, the following changes would apply only to veterinary medicines:

  • a single market authorisation would be able to cover various dosage strengths, pharmaceutical forms, administration routes and presentations;

  • there would have to be a six month period between an application for a Community maximum residue level (MRL) and an application for a marketing authorisation;

  • foodstuffs taken from test animals would be subject to an appropriate withdrawal period, including a safety factor;

  • all veterinary medicines indicated for use in food-producing animals should be available only on prescription;

  • changes would be made to the prescription "cascade"[9]: one would allow veterinary surgeons treating food-producing animals to use veterinary medicines authorised in another Member State as an alternative to an authorised human medicine (subject to controls on import, distribution, dispensing and provision of product information), whilst the other would allow equidae never having been intended for food production to be treated as non food-producing animals;

  • the need for a veterinary prescription for all new veterinary medicines which contain an active substance authorised for use for less than five years will in future apply where the authorisation is less than seven years;

  • the requirement for detailed records to be kept of all retail sales of prescription-only medicines for both food-producing animals and pets.

The Government's view

  3.17  In their joint Explanatory Memorandum of 17 January 2002, the Parliamentary Under-Secretary of State at the Department of Health (Lord Hunt of Kings Heath) and the Parliamentary Under-Secretary of State at the Department for Environment, Food and Rural Affairs (Lord Whitty) say that the Government shares the Commission's overall aims, but has reservations about the details of some of the proposals and the impact these will have on the balance between national and Community regulatory bodies. The UK will therefore be seeking to ensure that the changes are evolutionary, allowing all Member States and the Commission to play appropriate roles in the new system, and preparing that system for enlargement.

  3.18  On the scope of the two procedures, they say that the proposal to extend the centralised procedure will reduce the flexibilities available under the mutual recognition procedure, and therefore fundamentally change the balance between the two approaches. As a consequence, the latter would in practice be limited to processing generic authorisations and extensions to existing licences. They also suggest that, although an attempt is also being made to streamline the mutual recognition process, these reduced flexibilities may make it less attractive to industry, and they go on to express concern that, in an enlarged Community, each Member State will be allocated a smaller share of centralised applications, which will adversely impact on their ability to maintain effective regulatory bodies. Another concern is that, as regards veterinary medicines, the proposal would restrict industry's flexibility to take account of differences in species, farming techniques, environmental factors and disease patterns among Member States when developing new products, which it is feared would severely limit the development of medicines containing new active ingredients for minor species and pet animals.

  3.19  The Ministers also highlight a number of other concerns, notably:

  • that the shortening of the period for assessment might have a detrimental impact on public health and animal welfare;

  • that the proposal on compassionate medicines might impact adversely on the UK's own regime for unlicensed medicines for human use;

  • that the proposals to harmonise the summary of product characteristics, patient information and packaging would reduce the scope to take account of such factors as national markets and differences in prescribing habits;

  • that the replacement of licence renewal by periodic safety updates should not take place without an assurance that all public health needs would be met;

  • that adequate Community legislation already applies to food supplements, cosmetics and medical devices, and that it it therefore unnecessary to include these within the scope of the measures now proposed;

  • that the proposed changes to the EMEA's structures and on pharmacovigilance could increase the powers of the Commission at the expense of those of Member States, as could the proposal allowing the Commission to levy fines on the industry.

  3.20  Finally, the Ministers deal at greater length with a number of the proposals primarily affecting veterinary medicines. They say that, although the introduction of a six-month delay between the application for a Community MRL and a marketing authorisation is intended to alleviate situations where the latter may be refused because an MRL application has not been determined, industry believes that the timing should be for the applicant to determine. They consider that the requirement that all medicines intended for food-producing animals should be available only on prescription would have a significant impact in the UK, where they say that sales of such products have taken place without difficulty for many years, without a veterinary prescription, through such outlets as registered agricultural merchants, saddlers and pharmacies. They suggest that additional costs would arise, which might deter farmers from obtaining the necessary medicines and encourage recourse to the illegal use of cheaper unauthorised products, and that the UK will therefore seek to modify the proposal to cover existing national practices. Likewise, the Ministers say that the Commission has not produced any evidence to support the proposal for prescription-only status for new products where an active substance has been authorised for less than seven years, rather than five as at present. In the absence of such evidence, the UK is likely to oppose the proposal, though it is, on the other hand, likely to support the suggestion that foodstuffs can be taken from test animals, subject to an appropriate withdrawal period. It also supports in principle the changes proposed to the prescribing cascade, though it will wish to see further clarification on its operation and of its impact on the availability of authorised products.

  3.21  The Ministers have also provided with their Explanatory Memorandum a partial Regulatory Impact Assessment, though this is inevitably in somewhat by and large terms. In particular, although it identifies potential benefits from the proposal for public and animal health (and animal welfare), for consumers, and for the economy as a whole (arising from the encouragement to a strong pharmaceutical industry), it is not able at this stage to quantify these: likewise, it identifies the current costs arising principally from the fees charged by national authorities and the EMEA for product authorisations, but says that the costs arising from the new requirements can be clarified only when the outcome of the negotiations is clearer.

  3.22  The Assessment does, however, comment on the results of the consultations which it says the Government has carried out since the Commission indicated it would be bringing forward proposals in this area. It suggests that there is general support for the broad aims, but that industry is generally opposed to the wider scope for the centralised procedure (and other aspects which could limit its commercial freedoms), though it does support the fast track system, the procedural changes which would reduce timescales for assessment, and the abolition of licence renewal. There is also support for a ten year data exclusivity period and bringing clarity to the rules governing generics, but with a division in the latter case between the innovative and generic industries on the length of the period for data exclusivity and the detail of the procedural changes. On the other hand, the Assessment says that there is strong opposition from the veterinary industry, and from farmers, to the proposal to make all products for food-producing animals available only on prescription.


  3.23  We are grateful to the Ministers for their very full Explanatory Memoranda, from which it is evident that the area covered by these documents is not only detailed and complex, but also of some significance. For that reason, we are recommending that the documents be debated in European Standing Committee C, where it seems to us that the central point at issue is the future relationship between the centralised and decentralised procedures (and hence between the powers exercised on the one hand by the Commission and the EMEA and on the other hand by the Member States). This in turn also gives rise to a number of more detailed questions which the Standing Committee may wish to explore, especially those touched upon in paragraphs 3.18-3.22 above.

6   OJ No. L.214, 24.8.93. p.1. Back

7   Aimed at identifying adverse reaction to medicinal products. Back

8   An extra year's exclusivity would be allowed if, within the first eight years, a new indication is found for a product which brings significant benefits in comparison with existing products. Back

9   This requires another veterinary product, a medicinal product for human use, or a product prepared extemporaneously to be used in that order of priority. Back

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