Explanatory Memorandum to COM(2001)404-1 - 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 - Main contents
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| dossier | COM(2001)404-1 - Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and ... |
|---|---|
| source | COM(2001)404  |
| date | 26-11-2001 |
1. On 1 January 1995, new Community procedures concerning the authorisation and surveillance of medicinal products came into force, superseding various procedures based on voluntary cooperation between the relevant national authorities i. The European Agency for the Evaluation of Medicinal Products (the Agency) plays a central role in this system. Its aims include pooling the scientific expertise of Member States in order to ensure a high degree of protection for public health, ensuring free movement of pharmaceuticals, and making certain that Europeans have access to new generations of medicinal products.
Five years on, these goals are still relevant. But both the international and the European stakes have changed. Science is progressing radically, and new therapies are on the horizon. The existing legislation must therefore be adapted and thought must be given to a basic outline for the procedures for authorising the products to be placed on tomorrow's market.
Regulation (EEC) No 2309/93 provided for possible changes to these procedures. Its Article 71 states: "Within six years of the entry into force of this Regulation, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation, in Chapter III of Directive 75/319/EEC [medicinal products for human use] and in Chapter IV of Directive 81/851/EEC [medicinal products for veterinary use]".
On the basis of the provisions in Article 71 of Regulation No 2309/93, Cameron McKenna and Andersen Consulting were asked to carry out an audit of the Agency's procedures and operations. The results of this work are analysed and developed in the Commission report on the operation of Community procedures for authorising the placing of medicinal products on the market (COM...).
2. Given the experience acquired between 1995 and 2000 and the analysis of the comments by the various parties concerned (competent authorities of the Member States, pharmaceutical companies, doctors' and pharmacists' organisations and patient and consumer associations), it appeared necessary for the Commission to adapt certain provisions of Regulation (EEC) 2309/93. The word 'adapt' should be emphasised, as although some procedures and administrative provisions must be amended or replaced by new ones, neither the general principles nor the basic structure of the 'centralised' procedure and, therefore, the Agency, as established by the founding act of 1993, are called into question.
The functioning of the Single Market in the pharmaceuticals field and the maintenance of a high level of public health protection remain the two main, inseparable objectives of this legislation and any proposed amendment must be judged in this light. The legislation will be of growing benefit to patients by providing them with faster access to increasingly innovative medicinal products, whilst guaranteeing a high level of safety, and to the pharmaceutical industry - the source of this innovation through its investment in research and development - by allowing it to become more competitive, since it will endeavour to benefit as effectively as possible from Community integration.
3. Another new dimension to be considered since the 1993 context is the enlargement of the European Union. As in other areas, the future enlargement obviously raises the question of whether certain procedural arrangements for the regulation of medicinal products are appropriate and particularly whether it will be possible in a context designed in 1993 for 12 states for 20, 25 or 28 Member States to conduct scientific debates and take decisions effectively. For example, it is imperative that the procedure by which the Commission takes decisions under the centralised procedure, the composition of the scientific committees and the Agency's Management Board should be reviewed, as should their internal rules of procedure, in order to maintain (or even increase) efficiency and transparency.
4. The amendments linked to accommodating the enlargement of the Community should therefore be set against the ever present need to maintain and strengthen the internal market and to prevent any undermining of the progress achieved so far, particularly since 1995. Moreover, in this field, where the immense technical and scientific progress of the future will be inconceivable without the globalisation of research and development and to some extent the assessment rules, there is no alternative to integrating the management of resources and taking decisions at Community level.
5. Consequently, alongside the considerations linked to the experience of six years of implementation of the centralised procedure and the operating of the Agency, account should also be taken of the current progress of applied sciences in the pharmaceutical field (particularly in the field of biotechnology) and also probable future developments (for example, the increased development of the technologies underlying gene therapy, current developments in pharmacogenomics and xenogenic somatic therapy trials). These considerations should also be viewed in the light of ever-increasing globalisation, in particular between the world's three major pharmaceutical 'regions', namely Europe, North America and Japan. Globalisation in research and development, which is still limited primarily to the new, potentially very innovative medicinal products, is doubtless the result of the internal strategies of big pharmaceutical companies, but it also reflects genuine scientific and economic necessities.
6. Furthermore, scientific globalisation must not be allowed to overshadow its counterpart, the globalisation of certain regulatory practices, in particular scientific and technical criteria for the assessment of medicinal products. The increasingly rapid spread of new technologies in R&D in the field of medicinal products now requires an adaptable regulatory environment based on stable, well-defined principles which are of a genuinely international dimension. This 'global' dimension of regulatory requirements is clearly one of the main changes since the beginning of the 1990s, when the current Community system for marketing authorisation was designed. No regulatory environment for authorising medicinal products can now be considered modern, effective and sustainable if it is developed in isolation. The Commission and the Member States are already participating very actively in the context of the ICH i and the VICH i in international discussions on technical and scientific requirements for human and veterinary medicinal products. However, it is also very important for the regulatory framework of the Community marketing authorisation system to take due account of this new global environment in order to allow the EU to play a full role on the international stage, in particular alongside its American and Japanese partners.
7. All these regulatory and technical considerations must, of course, take account of the fact that one of the main objectives of the development and operating of the single market in medicinal products is to achieve tangible benefit to patients' health. The centralised system of authorisation has demonstrated its ability in the assessment of the quality, safety and efficacy of medicinal products. The time within which the medicinal products are made available is satisfactory, as described in the abovementioned Commission report. The average length of procedures is approximately 270 days, which is entirely comparable with the approval periods of the other major non-Community systems, such as the US 'Food and Drug Administration'. Furthermore, these periods have been considerably reduced for categories of medicinal products authorised under the centralised procedure compared with the situation prior to 1995, when the same medicinal products were mostly covered by the concertation procedure set up by Directive 87/22/EEC i.
Although the adoption of Regulation (EC) 141/2000 of the European Parliament and of the Council on orphan medicinal products i helped improve the conditions of access by patients to certain new medicinal products, there is still scope under the centralised procedure to further increase the availability of new treatments. The introduction of an accelerated authorisation procedure for certain medicinal products of major interest to public health because of their innovative nature or because they fall into a category where there are few alternative therapies, and the introduction of a conditional authorisation allowing early marketing of the medicinal products as soon as the results of the studies available show there are significant benefits for patients, will allow European citizens to benefit as early as possible from research.
8. However, it would not be possible to introduce these new provisions to the detriment of patient safety, the need for market surveillance and the strengthening of pharmacovigilance. The analysis of the risk/benefit balance for any new medicinal product must remain the basis for any administrative decision regarding it, irrespective of the authorisation procedure applied. Although the provisions in force have provided a high level of safety, some of the existing procedures need to be improved to increase the overall efficiency of the pharmacovigilance and market surveillance system, particularly to take account of the emergence of new therapies and an increase in the size of the market to be monitored as a result of the forthcoming enlargement of the European Union. At the heart of this system, the Agency must be given a stronger role. The Commission's procedures for taking decisions or adopting emergency measures must also be amended in this context, in order to increase speed and efficiency. In more concrete terms, it is proposed to increase the frequency of periodic safety reporting, to expand the reporting requirements for adverse reactions, in particular for serious adverse reactions, to make the use of a common international terminology for pharmacovigilance reporting more widespread, and to promote the general use of a database for this information.
9. In the veterinary field, most of the above considerations apply, subject to alterations linked to particular technical or scientific aspects. In this sector, a growing problem lies in the availability of veterinary medicinal products for certain species of animal or certain indications. Although this mainly concerns the revision of the Directive (consolidation) i and the revision of Council Regulation (EEC) No 2377/90 i, in the case of the procedures for implementing certain provisions and the definition of the field of application of the centralised procedure, the present proposal lays down exemptions or arrangements to take account of specific cases, such as certain immunological medicinal products for regional use or those used in the treatment of diseases covered by Community prophylactic measures.
10. Generally speaking, there are four main objectives to the revision of pharmaceutical legislation. They are based on the conclusions of the Commission Report which are particularly relevant to the centralised procedure and the Agency's responsibilities.
// * To guarantee a high level of health protection for the people of Europe, particularly by providing patients, as swiftly as possible, with innovative and reliable products and through increased market surveillance thanks to a strengthening of monitoring and pharmacovigilance procedures. In the case of veterinary medicinal products, to improve animal health, particularly by increasing the number of medicinal products available.
* To complete the internal market in pharmaceutical products taking account of the implications of globalisation and to establish a regulatory and legislative framework that favours the competitiveness of the European pharmaceuticals sector.
* To meet the challenges of the future enlargement of the European Union.
* To rationalise and simplify the system as far as possible, thus improving its overall consistency and visibility, and the transparency of procedures and decision-making.
Contents
Even though the proposed changes do not affect the broad thrust and main lines of Regulation (EEC) No 2309/93 and are, in principle, no more than improvements made on the basis of experience gained in the operation of the system, it is nevertheless true that the text will have to undergo numerous modifications which will change its current presentation. Moreover, the adoption of the two consolidated directives in the human and veterinary health sector will mean having to replace all references to all the old directives with references to the new articles in the consolidated directives. If all the articles concerned were amended, there would be a risk of ending up with a very complicated and practically unreadable proposal. Against this background, it is proposed to repeal Regulation (EEC No 2309/93 (Article 78) and, for reasons of clarity, to replace it with a new act modelled on the regulation in force but enriched with all the new elements and adjustments to the consolidated directives. This represents a recasting of Regulation (EEC) No 2309/93, as a great many provisions are being amended and the regulation in force will be replaced by the new regulation.
In this connection, the grounds for this proposal follows the pattern of those for Regulation (EEC) No 2309/93, amended only on the basis of the new elements introduced into the operative provisions.
A. Centralised procedure for medicinal products for human use
1. The scope of this procedure still includes categories of medicinal products for which the procedure is obligatory and those for which it is optional. As regards substance, it is proposed to maintain the scope of the original Regulation subject to certain amendments resulting from the experience acquired over the past six years and scientific and technological progress.
This proposal lays down that the centralised procedure should remain compulsory for medicinal products resulting from biotechnical processes, in particular those using recombinant DNA technology. This definition covers gene therapy products, including the vectors used, and any medicinal product which contains a proteinaceous constituent obtained using recombinant DNA technology, whether or not the constituent is an active substance of the medicinal product. Products intended for cell therapy have to be considered as medicinal products requiring marketing authorisation if they are industrially manufactured. If cell therapy products are the result of any biotechnology process referred to in the Annex to this proposal, they will have to be authorised under the centralised procedure. The Commission refers in this respect to the interpretation of 'medicinal products developed by means of biotechnological processes' given in its two Communications 94/C 82/04 i and 98/C 229/03 i. The interpretation remains fully applicable to this proposal (Article3 i and point 1 of the Annex).
The main amendment proposed seeks to make this procedure also compulsory for any new active substance appearing on the Community market (Article 3 i and point 3 of the Annex).
There are various arguments in favour of this field of application. For one thing, the acceptance and broad dissemination of biotechnical medicinal products is to a large extent explained by the introduction in 1995 of a Community procedure guaranteeing a common approach and a high level of expertise. For another, the cost of developing most of the molecules with high innovative potential does not allow them, from the economic or sociological points of view, to be restricted to a few national markets and justifies a global, Community approach, giving them access from the outset to a continental market. In these circumstances and as regards the assessment costs, it should be remembered that the Agency had the possibility under Regulation (EC) No 297/95 i of reducing the fees linked to the authorisation or to maintaining the authorisation.
- This proposal provides for the centralised procedure to be optional for the other medicinal products which constitute therapeutic innovation. In addition, it is proposed to allow access to this procedure for medicinal products which, although 'innovative', may be of benefit to society or to patients if they are authorised from the outset at Community level. This may apply in particular to certain medicinal products which cannot be supplied without a medical prescription (Article 3(2)).
- Finally, provision is made for Member States to have the possibility of authorising at national level the generic form of medicinal products authorised by the Community, on the condition that the harmonisation achieved at Community level is maintained. The manufacturers of these generic forms would thus henceforth have the choice between the two existing procedures (centralised and decentralised) for obtaining marketing authorisations (Article 3(3)).
2. Apart from the change to its name to reflect the comprehensive nature of its competence regarding medicinal products, the composition of the Scientific Committee responsible for the centralised procedure (Article 5) is changed (one representative per competent authority) to take account of the future enlargement. In addition, in order to maintain the necessary scientific representation, the possibility of coopting additional members has been introduced (Article 54). The possibilities for the Committee to create working parties or groups of experts and to delegate certain tasks to these groups are included in the legislation (Article 50 i and (3)). Particular emphasis is placed on the creation of a standing working party attached to this Committee, responsible for the development and adoption of scientific opinions and providing advice to companies. The Commission considers the development of this service by the Agency of prime importance, particularly insofar as it may concern small and medium-sized businesses developing biotechnological medicinal products or firms working in the research and development of new therapies.
3. The centralised procedure itself is not changed substantially. One change is made to the appeal procedure for applicants who contest the scientific opinion of the Committee, in order to make the procedure more effective by better preserving the applicant's position (Article 9 i and Article 55 i, second subparagraph). The context of the Commission's decision-making is altered. The current procedure has been highly criticised, as has already been mentioned, particularly because of its length. At present, the decision-making procedure is subject to a comitology procedure of the type III b) i. It should first be noted that from the outset the Commission has always followed the Agency's opinion on highly scientific matters. Every time the Regulatory Committee has been consulted, a favourable opinion has been adopted on the Commission's draft Decision, either unanimously or by qualified majority in a very small number of cases i. Furthermore, the vast majority of these opinions i were given by written procedure without a formal meeting of the Regulatory Committee - a possibility provided for under Regulation (EEC) 2309/93. The rare cases that gave rise to a formal vote at a meeting occurred in the first few procedures, that is when the centralised Community system was at the running-in stage.
Given the industry's criticisms (see the abovementioned Commission report), in the light of the experience acquired over six years and, finally, with the adoption of a new 'Comitology' Decision by the Council on 28 June 1999 (1999/468/EC) i, it has proved necessary to reassess the decision-making procedure.
The preamble to the new Council Decision (recital 7) lays down that the regulatory procedure should be applied for measures of general scope, which is clearly not the case when a particular economic operator is granted a marketing authorisation for a specific medicinal product. Furthermore, experience has shown that decision-making in this specific context does not necessarily give rise to a particular problem likely to suspend or delay the taking of a decision. The Commission therefore proposes applying a consultation procedure to the taking of a decision within the meaning of Decision 1999/468/EEC, when the draft submitted by the Commission follows the Agency's scientific opinion, or applying a management procedure within the meaning of this Decision in all the other cases. In both cases, the deadlines are adapted in order to shorten the consultation phase with the Member States (Articles 10 and 77).
4. To meet patients' legitimate wish to have the swiftest possible access to certain innovative therapies with a major impact on public health, the proposal introduces two new ways of obtaining marketing authorisation. On the one hand, the applicant may apply for an accelerated assessment and decision, which therefore has priority over other procedures. The applicant must justify the request from the point of view of public health and the Scientific Committee may agree or refuse to give it priority. In any event, the usual assessment criteria based on the quality, safety and efficacy of the medicinal products must be met. This refers in particular, but not exclusively, to medicinal products to treat cancer, HIV infection, etc. (Article 13(6)). The second procedure introduced concerns the specific case of certain medicinal products which are likely, according to the studies available, to be of considerable benefit to patients, since the risk/benefit balance is favourable given the pathology - often serious - for which they are recommended. This proposal provides for the granting of a provisional authorisation of one year, subject to strict conditions and annual reassessment. The framework for the implementation of this provision will have to be drawn up in detail, following the opinions of scientists based on the experience acquired in non-member countries and the Member States. It is proposed that the Commission should determine this framework in an implementing regulation adopted under the Regulatory Committee procedure (Article 13(4)).
5. As in the decentralised procedure and the proposals made in the general context of legislation on marketing authorisation, this proposal abolishes the five-yearly renewal of marketing authorisations. This is combined with the strengthening of pharmacovigilance procedures and an increase in the frequency at which updated safety reports must be submitted (Article 13 i and Articles 15 to 24). Two comments should be made in this respect. To reduce the administrative burden on the Agency, to ensure greater market transparency and to take into account the withdrawal of the obligation to renew authorisation on a five-yearly basis, this proposal lays down that any marketing authorisation which does not result in the actual marketing of the medicinal product concerned during two consecutive years ceases to be valid (Article 13 i and (3)). The strengthening of pharmacovigilance and market surveillance will bring with it greater efficiency and speed up the administration's decision-making and sanction processes (Article 18 i ff).
1. Most of the abovementioned points reappear in identical form in the part of the proposal concerning veterinary medicinal products. This is true for the provisions concerning generic medicinal products for veterinary use (Article 3(3)), the composition and procedures applicable to the Scientific Committee competent in the veterinary field ("Committee for Veterinary Medicinal Products") particularly as regards the creation of expert groups (Article 54 and Article 50 i and (3)), the procedure for appealing against the scientific opinion of the Scientific Committee (Article 31 i and Article 55 i, second subparagraph), and provisions concerning the Commission's Decisions (Article 32 and Article 77). The abolition of the five-yearly renewal of authorisation and the invalidity clauses concerning authorisation (Article 35 i to (3)) and the provisions to strengthen pharmacovigilance and market surveillance (Articles 37 to 46) are introduced in parallel to those proposed for the human sector.
Finally, provision is also made for applicants to propose an accelerated assessment of their case, whereby the Agency gives it priority. Applicants have to justify such a request from the point of view of therapeutic needs and animal health. The Scientific Committee will accept or reject the request on the basis of the details provided by the applicant. In any event, standard criteria linked to the quality, safety and efficacy of the medicinal products must be fulfilled (Article 35(5)).
2. Nevertheless, there are some provisions of a specific nature. Provision is made for the application of the centralised procedure to be adapted to the specific context in which certain veterinary medicinal products are used. For instance, given the 'regional' distribution of certain infectious diseases, it seems appropriate to provide for special administrative measures, such as the taking over of responsibility for the translations, by the agency, in order to facilitate the authorisation of medicinal products to treat these diseases (Article 69). On the other hand, it is useful to allow authorisation under the centralised procedure for immunological medicinal products used for diseases subject to Community prophylactic measures (Article 3(2)), whether or not the substances used are new.
1. The amendments to the provisions concerning the Agency concern on the one hand its responsibilities and on the other the adaptation of its administrative and scientific structures to its new tasks and the future enlargement of the Union. The principles governing the Agency, its administrative structure and its overall operating methods are not changed, since experience has shown that the choices made in 1993 were satisfactory.
2. The proposal gives the Agency additional tasks, most of them going beyond the assessment of medicinal products. For instance, provision is made for it to increase and systematically develop the scientific advice it provides for companies at the research and development phases of new medicinal products, well before the authorisation procedures for placing them on the market (Article 51(l) . This aspect, already mentioned above, is of prime importance to the Commission, particularly in the context of new therapies and medicinal products resulting from biotechnological processes. The purpose is to help and stimulate pharmaceutical research in Europe and thus allow European patients to benefit earlier from more effective medicinal products. The emergence of new fields of research (pharmacogenomics, gene therapy and cell therapy, including xenogenic somatic therapy, etc.) together with the burgeoning of small and medium-sized businesses in these fields makes it essential to create a genuine partnership between the industry and the authority responsible for assessing future medicinal products, respecting the areas of competence of each party.
The Agency has already developed this type of service and the results are encouraging. This proposal aims to strengthen the Agency's expertise in this field (Article 50(3)) by creating a standing working party in order to allow greater use of this type of service.
3. It is also proposed that the Agency should participate in implementing, at Community level, the programmes set up by certain pharmaceutical firms for the compassionate use of human medicinal products covered by this Regulation (Article 73). Compassionate use is defined in this context as a firm making a medicinal product available, on its own responsibility, to certain groups of patients prior to authorisation but subject to specific conditions. Clearly such availability must reflect - at least potentially - major benefits as regards survival, quality of life or improving the prognosis for the patient concerned. Such compassionate use is therefore reserved for medicinal products intended for the treatment of serious, often fatal, pathologies, for which the treatment available is non-existent, rare or involves serious side-effects. By definition, compassionate use takes place before or during the assessment procedure for the granting of market authorisation. It ends with the result of this procedure. Finally, although some patients have access to medicinal products which are being developed through their participation in clinical trials, compassionate use as referred to here concerns the availability of a medicinal product outside such trials.
The proposal does not provide for replacing or harmonising either the Member States' legislation on this subject or any of the criteria that would determine which medicinal products should or may be covered by an early availability programme for certain patients. Its aim is simply to ensure greater equity between European patients as regards access to these programmes. It is therefore proposed that the scientific and material conditions under which the medicinal product would be made available to patients be established at Community level. Thus, when compassionate use is considered for a particular medicinal product, the Agency must be notified (Article 73(2)) and the Committee for Human Medicinal Products may adopt recommendations concerning the conditions for use, distribution and the choice of patients targeted (Article 73(3)). These recommendations must then be implemented in accordance with the national legislation of the Member States.
4. As regards international scientific cooperation, this proposal aims to allow the Agency to increase and develop its technical and scientific support for the Member States and the Commission, particularly through multilateral discussions on technical harmonisation (Article 51(h)). In this context, to meet a need expressed by the World Health Organisation and following repeated requests by pharmaceutical companies exporting medicinal products not intended for the Community markets to non-member countries, the proposal gives the Agency the task of carrying out a scientific assessment of these medicinal products on the basis of the criteria applied in the Community concerning quality, safety and efficacy. However, this assessment will be carried out only on the recommendation of the World Health Organisation confirming the needs expressed by certain non-member countries or international organisations (Article 52).
5. Finally, this proposal inserts an article in Regulation (EEC) No 2309/93 aimed at preventing or solving potential conflicts between the scientific opinions of the Agency and scientific opinions given by other scientific bodies, Community or otherwise (Article 53). This Article is similar to Article 29 of the Commission proposal establishing the European Food Authority i. It should be noted that this provision in no way seeks to resolve differences between the scientific opinions of the Agency and those of the national authorities competent in the field of medicinal products. Such divergences of opinion should be settled under the procedures drawn up for this purpose under Community pharmaceutical law. However, Article 53 should be applied each time there is a potential conflict between the opinion given by the Agency in connection with its responsibilities regarding medicinal products and the opinions of other competent bodies outside the field of medicinal product evaluation.
6. The second category of changes made to the Agency concerns its administrative and scientific structures. Most of these changes are made with a view to the next enlargement and aim to adapt the composition of the Committees accordingly. As a result, it is proposed that the Scientific Committees should henceforth consist of one representative from each competent national authority (Article 54(1)). In order to preserve the expertise necessary for the proper functioning of these Committees and to maintain a broad spectrum of knowledge in highly specialised fields, it is proposed, on the one hand, to introduce the possibility of coopting additional members to the afore-mentioned committees, and on the other hand, to make more systematic use of experts - either through their direct nomination by the Committee members (Article 54(1)) or by including them on the list of the Agency's accredited experts (Article 55 i. In this context, in order to rationalise and increase the potential expertise of the Committees, greater use of specialised working parties by the Committees is provided for (Article 50(2)) with the possibility of delegating certain tasks to these groups (Article 54(5)) The proposal incorporates in the Agency's administrative and legal structure the Committee on Orphan Medicinal Products created by Regulation (EC) 141/2000 and anticipates the establishment of a Committee on Herbal Medicinal Products, whose activities are described in the proposal for a specific directive which the European Parliament and the Council will be called upon to discuss alongside this proposal (Article 50 points c and d).
The composition of the Agency's Management Board is changed to take account of the structure proposed by the Commission when the latest agencies and authorities on foodstuffs, maritime safety and air safety were set up. The Management Board consists of four representatives appointed by the Council of Ministers, four appointed by the Commission, four appointed by the European Parliament and four representatives of patients and the industry appointed by the Commission (Article 58).
To increase the technical consistency of the overall Community system of evaluating medicinal products and market surveillance and to optimise the way the Agency performs its duties, it is proposed that an Advisory Board should be set up under the Executive Director, comprising all the national authorities or agencies competent in the field of human and veterinary medicinal products (Article 59).
7. Finally, it is proposed to amend certain general provisions of the 1993 Regulation and to introduce new ones in order to solve some problems which appeared in its implementation and to restore the legal certainty essential for the proper functioning of the procedures. This involves in particular specifying the responsibilities of the Management Board regarding the definition of the transparency rule (Article 69), laying down certain marketing conditions for medicinal products authorised by the Community (Article 72), specifying the Agency's role as the authority responsible for checking that such medicinal products are distributed in a parallel fashion (Article 51 (m)) and specifying the procedures for the Agency's use of service providers (Article 55(4)).
This proposal is based on Article 95 and Article 152.4(b)of the EC Treaty. Article 95, which prescribes use of the co-decision procedure described in Article 251, is the legal basis for achieving the aims set out in Article 14 of the Treaty, which include the free movement of goods (Article 14(2)), in this case human and veterinary medicinal products. While taking account of the fact that any regulations on the manufacture and distribution of medicinal products, including veterinary medicinal products, must be fundamentally aimed at safeguarding public health, this aim must be achieved by means that do not impede the manufacture and free movement of medicinal products within Community. Since the Amsterdam Treaty came into force, all legislative provisions adopted by the European Parliament and the Council - except for directives adopted on the basis of executive powers vested in the Commission - and aimed at aligning the provisions on medicinal products have been adopted on the basis of that Article, since the differences between the national legislative, regulatory and administrative provisions on medicinal products tend to hinder intra-Community trade and therefore directly affect the operation of the internal market. The intervention of the Community legislator is therefore justified with a view to preventing or eliminating these obstacles.
The proposal contains all the provisions of Regulation (EEC) No 2309/93, which established the Agency and created a centralised authorisation procedure for medicinal products. The Regulation had already authorised the necessary transfer of responsibilities to Community level and legally and technically set up the Agency.
The Regulation which is the subject of this proposal and is a recasting of the previous regulation, pursues the objectives of adapting certain procedures and reforming the composition of the component bodies of the Agency, without altering the basic principles contained in the original Regulation, as well as maintaining consistency between the two consolidated directives. Certain new responsibilities for the Agency have also been introduced which can be inferred or derive from the powers already attributed to the Agency in 1993.
This proposal will increase cohesion and improve the functioning of the Community medicinal product market in the light of the six years of experience.
Furthermore, Article 152.4 b) mentions henceforth explicitly the measures having as their direct objective public heath protection in the veterinary and phytosanitary sectors. The present proposal contains a number of measures in the veterinary field having as an objective public heath protection. Before the adoption of the Treaty of Amsterdam, which institutionalised a new public health policy by granting legislative responsibilities to Community institutions, legislative instruments in this field were adopted on the basis of ex Articles 100 and 235 of the EC Treaty (for want of specific responsibilities at the time of their introduction) - which is no longer necessary in this area, given the existence of an ad hoc legal basis.
This proposal takes due account of the immense amount of work carried out on consolidating the directives in the field of Community legislation on medicinal products for human use (31 consolidated texts) and veterinary medicinal products (11 consolidated texts). It also introduces provisions to speed up and rationalise the decision-making procedures relating to marketing authorisations for medicinal products.
The Commission commissioned an external consultant to carry out an audit, as stated at the start of this explanatory memorandum. Many consultations, meetings and hearings were held with all the interested parties. The Commission also received many reports and working documents from these parties, particularly from patients' associations and European federations of the pharmaceutical industry, pharmacists and distributors. All of these documents and the analyses of them are included in the Commission's report to the European Parliament and the Council on the operating of the marketing authorisation procedures in the Community, mentioned earlier.