OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2001/83/EC on the Community code relating to medicinal products for human use AMENDING THE PROPOSAL OF THE COMMISSION pursuant to Article 250 (2) of the EC Treaty

2001/0253 (COD) OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2001/83/EC on the Community code relating to medicinal products for human use

1. Introduction

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is to deliver an opinion on the amendments proposed by the European Parliament at second reading. The Commission sets out below its opinion on the 34 amendments proposed by Parliament.

2. Background

Proposal sent to the Council and the European Parliament COM(2001) 404 final - 2001/0252 (COD) - 2001/0253 (COD) - 2001/0254 (COD) // 26 November 2001

Opinion of the European Economic and Social Committee // 18 September 2002

Opinion of the European Parliament - first reading // 23 October 2002

Amended proposal sent to the Council and the European Parliament COM(2002) 735 final - 2001/0252 (COD) // 12 December 2002

Amended proposal sent to the Council and the European Parliament COM(2003) 163 final - 2001/0253 (COD) and 2001/0254 (COD) // 24 April 2003

Council common positions // 29 September 2003

Commission Communication on the common position // 7 October 2003

Opinion of the European Parliament - second reading // 17 December 2003

3. Objective of the proposal

Regulation 2309/93 makes provision for the evaluation of the Community procedures for the authorisation and supervision of medicinal products which entered into force in 1995. In the light of the experience acquired from 1995 to 2000, and the Commission's analysis in its report "on the operation of the procedures for granting marketing authorisations for medicinal products" (COM(2001) 606 final, 23.10.2001), it appeared necessary to adapt Regulation 2309/93 and Directives 2001/83/EC and 2001/82/EC on the Community codes relating to medicinal products for human use and for veterinary use.

Generally speaking, four main objectives are particularly relevant:

(1) to guarantee a high level of public health protection, particularly by providing patients, as swiftly as possible, with innovative and reliable products and by increasing market surveillance by reinforcing monitoring and pharmacovigilance procedures;

(2) to complete the internal market in pharmaceutical products while taking account of the implications of globalisation, and to establish a regulatory and legislative framework that favours the competitiveness of the European pharmaceuticals sector;

(3) to meet the challenges of the future enlargement of the European Union;

(4) to rationalise and simplify the system, thus improving its overall consistency and visibility, and the transparency of procedures

Lastly, with regard to veterinary medicinal products, the proposals intend to specifically address the problem of availability of such medicinal products.

4. Commission's opinion on the european parliament's amendments

4.1 General assessment

The Commission can accept in full the 32 amendments to the Council's common position adopted by Parliament on the proposal for a regulation, the 30 amendments to the Council's common position adopted by Parliament on the proposal for a directive on medicinal products for human use and the 22 amendments to the Council's common position adopted by Parliament on the proposal for a directive on veterinary medicinal products.

The Commission notes the convergence of views between the three institutions on the general approach and on the most important issues regarding the compulsory field of application of the centralised procedure, the administrative structure of the agency, the period of data protection, definitions, information for patients and the assessment of the environmental impact. Parliament's amendments make certain changes and clarifications to the Council's common position, which are nevertheless consistent with the objectives and general principles on which the Commission's proposals are based.

4.2 Analysis of the second reading

The amendments adopted by Parliament mainly concern the issues of the compulsory field of application of the centralised procedure, the period of data protection and the administrative structure of the agency as far as the regulation is concerned, and the definitions, period of data protection, information for patients and assessment of the environmental impact as regards the two directives on medicinal products for human use and veterinary use.

4.2.1 Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use

- Definitions (amendments 60, 61, 63, 65, 58 and 67 of the human code and 37, 39, 40, 35 and 44 of the veterinary code):

Parliament wished to amend the definitions of medicinal product, generic medicinal product and biosimilar medicinal product and to specify the conditions in which the definitions were applicable. It also specified the clause applicable in the case of borderline products, for which it is not possible precisely to determine which set of rules applies.

In the Commission's view these amendments clarify the provisions concerned and are therefore acceptable.

- Period of data protection (amendments 14, 68 and 62 of the human code and 38 of the veterinary code) :

Parliament adopted amendments to bring the period of data protection into line with the period applicable to products authorised under the centralised procedure (see above, point 4.2.1).

- Information for patients (amendment 77):

Parliament inserts a provision obliging the Commission to adopt a report on the situation in the Community regarding the information provided for patients on medicinal products available on prescription only. On the basis of that report, the Commission would state whether it considers it appropriate to make changes to the current rules applicable to those products.

The Commission accepts this amendment; future proposals on this subject will thus be based on facts and patients' real needs regarding information.

- Environmental impact of the authorisation of medicinal products (amendments 56, 64, 57, 75 and 84 of the human code and 34, 5, 43, 49 and 53 of the veterinary code) :

Parliament adopted amendments to strengthen obligations regarding the assessment of the effects on the environment that the authorisation of medicinal products may have and the measures to be taken to offset these effects. It also introduced a distinction between medicinal products for human use, for which the assessment of these effects cannot be included in the final assessment of the risk/benefit balance, and veterinary medicinal products, for which the assessment of these effects must be taken into account when the risk/benefit balance of the product is assessed.

The Commission accepts these amendments, particularly because they respect the difference between the two types of medicinal product - those for human use and those for veterinary use.

- Other amendments making the text clearer and more specific and strengthening its provisions:

* as regards the human code, the Commission accepts amendment 66 on clinical trials, amendment 69 on the application of the mutual recognition procedure to homeopathic medicinal products, amendment 70 on assessment deadlines, amendment 25 on the justification for approved indications, amendment 72 on conditional marketing authorisations, amendment 73 on international non-proprietary names, amendment 74 on the space to be provided on the packaging to indicate the prescribed dose, amendment 76 on information in Braille, amendment 83 on the provision regarding continued supplies, amendment 59 on the funds earmarked for pharmacovigilance, amendment 78 on the frequency of PSURs (periodic safety update reports), amendments 79 and 80 bringing the text into line with the regulation concerning tests carried out by an Official Medicines Control Laboratory and amendments 81 and 82 on transparency and public accessibility;

* as regards the veterinary code, the Commission accepts amendment 45 on the application of the mutual recognition procedure to homeopathic medicinal products, amendment 46 on assessment deadlines, amendment 48 on the space to be provided on the packaging to indicate the prescribed dose, amendment 36 on the funds earmarked for pharmacovigilance, amendment 54 on the frequency of PSURs (periodic safety update reports), amendments 52 and 51 bringing the text into line with the regulation concerning tests carried out by an Official Medicines Control Laboratory, amendments 41 and 42 adding the full reference of Commission Decision 2000/68/EC establishing the identification of equidae for breeding and production, amendment 11 concerning the withdrawal period for homeopathic medicinal products intended for food-producing animals the active substance of which is listed in Annex II to Council Regulation (EC) No 2377/90 and amendment 47 concerning the documents to be submitted for the five-year renewal of marketing authorisations.

The Commission accepts these amendments, which do not alter the objective of the proposal but strengthen some of the existing provisions.

5. Conclusion

Pursuant to Article 250(2) of the EC Treaty, the Commission amends its proposal as set out above.