52003SC1082

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the the common positions adopted by the Council on the adoption of a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency 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 a Directive of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products

2001/0252 (COD) 2001/0253 (COD) 2001/0254 (COD)

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT in accordance with Article 251(2), second indent, of the EC Treaty concerning the common positions adopted by the Council with a view to the adoption of a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency 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 Directive of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products

1. BACKGROUND

Proposal sent to the Council and the European Parliament

(COM(2001) 404 final) - 2001/0252 (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) - 2001/0251 (COD) // 10 December 2002

Amended proposal sent to the Council and the European Parliament

(COM(2003) 163 final) - 2001/0252 (COD) and 2001/0253 (COD) // 3 April 2003

Council common positions // 29 September 2003

2. OBJECTIVE OF THE COMMISSION PROPOSAL

The review of the pharmaceutical legislation, comprising proposals for the replacement of Regulation 2309/93 on the Community procedures for the authorisation and supervision of medicinal products and the amendment of Directives 2001/83/EC and 2001/82/EC on the Community codes relating to medicinal products for human use and veterinary medicinal products, respectively, pursues the following objectives:

- 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;

- 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;

- to meet the challenges of the future enlargement of the European Union;

- to rationalise and simplify the system, thus improving its overall consistency and visibility, and the transparency of procedures.

With regard to veterinary medicinal products, the proposal also intends to address the issue of availability of such medicinal products.

3. ANALYSIS OF THE COMMON POSITIONS

3.1. General observations

The Council common positions introduce a number of changes in the Commission's amended proposals. However, they are consistent with the objectives and main principles contained in the proposal.

3.2. Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

3.2.1. Amendments accepted fully, in part or in principle by the Commission and the Council

The Council has accepted amendments 12, 14, 28, 30, 32, 33, 36, 37, 40, 41, 60, 69, 72, 75, 77, 78, 90, 98, 99, 103, 106, 111, 112, 124, 126, 127, 135 and 146 adopted by the European Parliament, subject to minor drafting changes in a few cases. These amendments were also accepted by the Commission and incorporated in its modified proposal without changes. The Council has also accepted without changes amendments 13 and 60. These amendments were accepted in principle by the Commission.

In addition, the Council has accepted in part or in principle amendments 1, 4, 13, 15, 18, 20, 22, 23, 24, 25, 31, 34, 38, 39, 43, 44, 47, 49, 50, 51, 52, 53, 54, 62, 63, 64, 66, 68, 73, 76, 79, 80, 81, 82, 84, 86, 87, 88, 89, 91, 93, 95, 96, 100, 104, 105, 107, 108, 109, 110, 113, 118, 120, 121, 123, 125, 128, 129, 130, 131, 134, 140, 141, 153, 155, 157, 163, 165 and 166. These amendments have been accepted at least partially or in principle by the Commission in its amended proposal. Subject to specific comments, the Commission can support the Council changes, which refer namely to:

- Amendments 1, 13, 129 and 130 (partly) on the reduction of fees for small and medium sized companies and on the specific assistance to be provided to veterinary companies. The Commission takes note that the Council has considered that more detailed provisions are required for the reduction of fees to be defined via a Committee procedure and that in the case of veterinary specific assistance it does not need to be limited to small and medium sized companies;

- Amendments 4 and 100 on relative effectiveness;

- Amendments 18 and 22 on the name of generic medicinal products;

- Amendment 20 on benefit-risk analysis;

- Amendments 23 and 68 on opinions of the Scientific Committees in the context of the mutual recognition procedure;

- Amendments 24 and 25 (partly) on good clinical practice and clinical trials;

- Amendment 24 (partly) referring to the exceptions from the principle of single name;

- Amendments 15 and 47 dealing with Directive 89/105/EEC on national procedures for the pricing and reimbursement of medicinal products;

- Amendments 31 and 73 on conditions and restrictions in relation to the safe and effective use of medicinal products;

- Amendment 34 on the accelerated procedure for the evaluation of certain medicines;

- Amendments 38 and 76 on assessment reports;

- Amendment 39 on marketing authorisation holders' obligation to provide data on adverse reactions upon request to the European Medicines Agency (Agency);

- Amendments 43, 51, 53, 79, 81, part of 87, 109 and 131 concerning the reference to Regulation 1049/2001/EC on access to documents;

- Amendment 44 on authorisation of medicinal products under exceptional circumstances;

- Amendment 49 (partly) on the accuracy of the documents and data submitted by the applicant;

- Amendment 50 on the communication of pharmacovigilance information to health care professionals;

- Amendments 52, 80 and 121 concerning the funding of pharmacovigilance activities of the Agency. These amendments are only accepted as far as the Agency activities are concerned and not as far as national competent authorities are concerned;

- Amendment 54 on patients reporting of adverse reactions to health care professionals;

- Amendment 62 on guidance on adverse reactions;

- Amendments 63 and 88 on access to the database on pharmacovigilance;

- Amendment 64 providing for increased surveillance in the first years following a marketing authorisation through the collection of data from groups of patients;

- Amendment 66 ensuring that pharmacovigilance systems of the Member States and the Agency work in a coordinated way;

- Amendment 82 on the reference to residues of medicinal products in relation to the evaluation of the risk/benefit balance;

- Amendments 84, 104, 107 (partly) and 108 (partly) on the setting up of therapeutic advisory groups by the Scientific Committees;

- Amendment 86 on minority views in the opinions of the Scientific Committees;

- Amendment 87 (partly) on the wording of the labels and package leaflets;

- Amendments 89, 91 (partly) and 93 (partly) on the communication of pharmacovigilance information and on the information to the public of the Agency's database;

- Amendment 93 concerning the tasks of the Agency in relation to bio-terrorism;

- Amendments 95, 96 and 157 aimed at specifying the contents of the database of the Agency;

- Amendment 105 (partly) concerning the establishment of contacts by the Scientific Committees with interested parties;

- Amendment 109 (partly) on the declaration of conflicts of interest;

- Amendment 110 on the declaration of financial interests;

- Amendment 113 on the procedure for the nomination of the Executive Director;

- Amendment 118 on the participation of the chairman of the Scientific Committees to the meetings of the Management Board;

- Amendments 120 and 123 relating to the financial provisions of the Agency;

- Amendment 125 on the publication by the Court of Auditors of an annual report on the Agency;

- The first part of amendment 128 replacing "amount of fees" with "level of fees";

- Amendment 131 on the rules and procedures of the Agency and its bodies and on the European Public Assessment Reports;

- Amendment 134 on continuous supply of medicines for compassionate use;

- Amendment 140 relating to the responsibility for a medicinal product;

- Amendment 141 on notification of withdrawals;

- Amendments 153 and 155 on information on withdrawals of applications for marketing authorisations;

- Amendments 163, 165 and 166 concerning the provisions on renewal of marketing authorisation. The Council supports in principle the approach followed by the European Parliament and the Commission in its amended proposal that a marketing authorisation is to be renewed after five years, after which its validity is undetermined. The Council however introduces an additional renewal which is limited to important pharmacovigilance grounds. The Commission can agree to this addition.

3.2.2. Amendments accepted fully, in part or in principle by the Commission, but not by the Council

The Council has rejected certain amendments of the European Parliament that the Commission accepted fully, in part or in principle in its amended proposal. These amendments are: 59, 61, 101, 102, 114, 115, 116 and 117.

The Council has rejected amendment 59 aimed at clarifying the time-lines for the submission of the first updated periodic safety report as it considers that relating the period to the actual marketing of the product would entail unnecessary administrative burdens for the competent authority. The Commission notes however that the Council has agreed the establishment of a Committee procedure for the adoption of the detailed arrangements concerning these reports. On this basis, the Commission can accept the Council common position.

The Council has rejected amendment 61 aimed at preventing the marketing authorisation holder from providing pharmacovigilance information without the consent of the Agency. However, the Council has agreed with the objective of the amendment and has included in its common position a requirement from the marketing authorisation holder to notify the Agency of this information and thereby giving the Agency the possibility to counter any misleading information.

The Council has rejected amendments 101, 102 and 114 aimed at modifying the method of nominating the members of the Scientific Committees. The Council has reflected in its common position the fact that the members of these Committees have to be appointed directly by the Member States. In this regard, although the Commission would have preferred the change in the nomination procedure for the members, as the amendments of the European Parliament aimed at reinforcing both the scientific composition of the Committees as well as the areas of expertise available, it could accept the common position on this point in the light of the additional provisions agreed by the Council. In fact, the latter agreed to provide for co-opted members to complement the expertise of the members appointed by the Member States. The Council has also accepted the provisions aiming at reinforcing the expertise of the Committees by the setting up of scientific advisory groups from different scientific areas and disciplines.

The Council has rejected amendment 115 aimed at covering the activities of the future Committee on Herbal Medicinal Products in the context of the responsibilities of the Executive Director. It is acceptable as it concerns certain activities for which the relevant legislation has not yet been adopted.

The Council has rejected amendments 116 and 117 aimed at modifying the composition of the Management Board. The Council has however accepted to reduce the number of representatives from two to one, which means that the size of the Board after enlargement remains the same as the present one. The Commission has shown its flexibility on this point so as to facilitate rapid progress of this important file while reserving its position in relation to what the position of the European Parliament will be during its second reading. This accounts for the declaration the Commission has entered in the Council minutes (see under point 5, hereafter: declaration ad Article ... of the Regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency). The Commission notes as well as that the Council has deleted the provision on the setting up of an Advisory Board, as a consequence of the approach, followed by the Council, in defining the composition of the Management Board.

3.2.3. Amendments rejected by the Commission but accepted, in part or in principle by the Council

The Commission takes note that the Council has accepted, partly, the European Parliament amendment 46, which aimed at establishing the data protection period automatically linked with the one applicable in the context of the medicinal products authorised through the national procedures. However, the Commission takes also note that the Council has limited the application of this amendment to the products to be authorised, on an optional basis, through the centralised procedure. For these products, the same data protection scheme as the one foreseen for the nationally authorised products is applicable. For the medicinal products to be authorised, on a mandatory basis, through the centralised procedure, the Council has agreed with the Commission proposal to keep the 10 years period as it is currently applied on the basis of the existing Regulation with the possibility to extend this period with one extra year when a new indication bringing a significant clinical benefit in comparison with existing therapies is approved.

3.2.4. Amendments rejected by the Commission and by the Council

Certain amendments have not been integrated into the Commission's amended proposal nor into the Council common position. These amendments are: 2, 3, 5, 6, 7, 8, 10, 21, 25 (partly), 26, 27, 29, 42, 45, 48, 49 (partly), 56, 57, 58, 65, 67, 70, 71, 83, 85, 91 (partly), 92, 93 (partly), 94, 97, 107 (partly), 108 (partly), 119, 122, 128 (partly), 132, 133, 145, 147, 148, 152, 162, 173, 174 and 175.

3.2.5. Amendments introduced by the Council in its common position

The common position incorporates a number of changes in order to clarify the provisions of the text, to update terminology and to align the human and veterinary provisions, to which the Commission can agree.

The Council has also introduced certain substantial changes, which do not respond directly to an amendment of the European Parliament or a provision of the Commission's proposal.

The Council has defined the compulsory use of the centralised procedure to medicinal products for human use containing a new active substance for the treatment of 4 key diseases areas, i.e. HIV/AIDS, cancer, neuro-degenerative disorders and diabetes (Article 3 and Annex of the Regulation). This will apply in addition to the current mandatory scope of this procedure which is to be applied to biotechnological products. Even if the Commission agrees with the fact that these 4 diseases represent today the areas where industry is currently developing its research and therefore where new products will be developed, it regrets that the Council has applied a limited approach to the centralised procedure. The Commission considers, nonetheless that this proposal represents an improvement, even if limited, compared with the existing situation, and will permit in these particular areas the application of an European expertise and, finally, of a Community marketing authorisation, which will give access to all patients in the Community under the same conditions.

For veterinary medicinal products, the Council has chosen to apply the full optionality between the national and the Community procedures for medicinal products containing new active substances (Article 3 and Annex of the Regulation). The Commission can agree with this proposal taking into consideration in particular regional differences in Member States and in disease patterns.

The Council has decided to choose the same Committee procedure in relation to decisions on granting marketing authorisation (Articles 10 and 35). The Council has adopted the management procedure as the appropriate procedure to apply for these decisions. The Commission can agree to it.

The Council has amended the provision concerning the principle of one single authorisation for a medicinal product (Article 82). The Commission agreed with this amendment as it clarifies the exemptions to this principle and explicitly includes the co-marketing reasons for accepting more than one authorisation.

The Council has changed the provision concerning compassionate use (Article 83). The Commission agrees with the explicit reference to the provisions concerning the availability of medicines to individual patients under the responsibility of a health care professional. Indeed, these provisions do not have to be affected by the adoption of a new provision on compassionate use. In relation to the non-payment by the patients of compassionate use products, although the Commission would have preferred to keep the provision as proposed originally and as accepted by the European Parliament, it could accept the common position on this point, in view of the fact that, as stated in the declaration made by both the Commission and the Council, Member States will not be prevented by the new legislation to provide in their national legislation for a non-payment by the patients.

Other minor changes concern the possibility for Member States to ask an opinion of the Scientific Committee, subject to the discretion of the relevant Committee, the modification of some time limits concerning the evaluation procedure, the provision of the possibility to the competent authorities to request data from the marketing authorisation holder, and the duty of the marketing authorisation holder to report adverse reactions occurring in the territory of a third country. The Commission can agree to these changes.

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

3.3.1. Amendments accepted fully, in part or in principle by the Commission and the Council

The Council's common position incorporates 20 amendments adopted by the European Parliament, which had been taken up unchanged in the Commission's amended proposal. These amendments are: 2, 13, 25, 43, 47, 50, 57, 58, 61, 67, 68, 70, 83, 88, 93, 97, 110, 125, 130 and 158.

In addition, the Council has accepted in part or in principle 42 amendments adopted by the European Parliament, which have been endorsed at least partially or in principle in the Commission's amended proposal. These amendments are: 3, 5, 12, 14, 15, 24, 27, 30, 31, 32, 33, 36, 42, 51, 52, 53 (part), 55, 60, 63, 66, 69, 71 (part), 82, 84, 85, 86, 92, 94, 95, 106, 108, 116 (part), 121, 122, 156, 157, 159, 167, 168, 185, 186 and 191. Subject to specific comments, the Commission can support these changes, which refer namely to:

- Amendment 3 concerning the objective to realise a high level of health protection;

- Amendments 5 and 32 on the application of the ethical requirements of Directive 2001/20/EC to all clinical trials in support of an application in the EU;

- Amendment 12 on the definition of a homeopathic medicinal product;

- Amendment 14 on the definition of a local representative;

- Amendment 15 on the definitions of risks and the risk-benefit balance;.

- Amendment 24 on the distribution of medicinal products in the case of biological threats or warfare;

- Amendments 27, 30, 31 and 33 on particulars and documents to be submitted with an application;

- Amendment 36 on the authorisation of a generic product in a Member State where the reference product has not been authorised;

- Amendment 42 on the summary of the product characteristics;

- Amendments 51, 52 and 53 on the public's access to information on the marketing authorisation, the assessment report and the scientific reasons;

- Amendment 55 on conditional marketing authorisations;

- Amendment 60 on the responsibility of the applicant or the marketing authorisation holder for accuracy of data submitted;

- Amendment 63 on guidelines to be adopted by the Commission to define a serious potential risk to public health;

- Amendment 66 on the arbitration procedures in case of Community interest;

- Amendment 69 on the deadline for forwarding the final scientific opinion after a referral procedure;

- Amendment 71 as far as it calls for a report on the functioning of the procedures of Title III, Chapter 3 of the Directive;

- Amendment 82 on a specific invitation in the package leaflet to consult the doctor or the pharmacist for the use of the product; it should be noted that the Council changed the order of certain parts of the package leaflet;

- Amendments 84, 85 and 86 on the clarity and legibility of package leaflets and on involving target patient groups in assessing the outer packaging, the immediate packaging and the package leaflet of a medicinal product;

- Amendment 92 as far as it provides for protection of data submitted with regard to a change of classification;

- Amendment 94 on the obligation of a parallel importer to inform the competent authority and the marketing authorisation holder of intended parallel imports;

- Amendment 95 on an uninterrupted supply of medicinal products;

- Amendments 106, 108 and 191 on the use of the international non-proprietary name of the trademark in advertising to the general public and to health-care professionals;

- Part of amendment 116 on collecting pharmacovigilance information and making it accessible to Member States, to the EMEA and to the public;

- Amendment 121 on the obligation of a marketing authorisation holder to inform the competent authority before or simultaneously with any communication of information on pharmacovigilance to the general public;

- Amendments 122 and 159 on the obligation of a marketing authorisation holder to inform the competent authority of any cessation of sales;

- Amendment 156 on the definition of a generic medicinal product;

- Amendment 157 on exceptions from the general rule that a marketing authorisation ceases to be valid if not used during three years;

- Amendments 167 and 168 on the so-called bio-similar medicinal products. The Council introduces certain acceptable clarifications regarding differences in the manufacturing processes;

- Amendments 185 and 186 on the renewal of marketing authorisations. In principle, the Council supports the approach taken by the European Parliament and the Commission in its amended proposal that a marketing authorisation is to be renewed after five years, after which its validity is undetermined. However, the Council provides for an additional renewal, which the Commission can support, as it is limited to certain circumstances justified by pharmacovigilance grounds.

3.3.2. Amendments accepted fully, in part or in principle by the Commission, but not by the Council

The Council has rejected 19 of the European Parliament amendments that the Commission had accepted fully, in part or in principle in its amended proposal. These amendments are: 11, 18, 20, 21, 22, 23, 35, 44, 46 (first part), 48, 80, 89, 91, 98, 104, 114, 140, 151 and 120 (first part).

The Council has rejected amendment 11 adding in the definition of a medicinal product the words "or by modifying a pharmacological action". The Commission could support to maintain the current definition, which generally has proven workable.

The Commission can support the approach taken by the Council on amendments 18, 20, 21, 22 and 23 on the delineation of medicinal products and other products. In line with the Commission's modified proposal, the Council maintains both the general provision of Article 2(2) and the corresponding recital 7, while rejecting a list of products excluded from the Directive. The Council's linguistic changes are acceptable clarifications.

The Council has rejected amendment 35, which concerns a clarification on the protection granted to innovative medicinal products. The Commission can accept this for the reasons set out with regard to amendment 34 below.

As regards homeopathic medicinal products, the Commission regrets that the Council could not support amendment 44, reintroducing the obligation of Member States to take due account of registrations granted by other Member States before 1994. It is acceptable not to incorporate the concept of "potentisation" as it lacks sufficient clarity and to refuse, in line with the Council, amendments 46, 48 and 89. The Commission agrees with the Council that amendment 91 proposing to reword the disclaimer on the labelling into "without specific therapeutical indication" is not acceptable, as it could be misunderstood to imply that homeopathic medicinal products bear "general" therapeutic indications.

The Council could not support amendment 80, inviting patients to report suspected adverse reactions to a health-care professional and to the competent authority for pharmacovigilance. Similarly, the Council could not support amendment 114, as reworded by the Commission in its amended proposal, requiring Member States to oblige health-care professionals to notify of suspected adverse reactions. The Commission would have preferred to keep these requirements, as the amendments of the European Parliament aimed at increasing the information related to pharmacovigilance and at including the competent authorities as contact points to collect this type of information.

The Council has rejected amendments 98, 104 and 140 regarding information to patients. The Commission has shown its flexibility on this point so as to facilitate rapid progress in reaching a common position on this important file. In this sense, it has declared that in view of information technology developments, the deletion of the provision regarding information to patients, might leave patients exposed anyway to unchecked and unverified information (see under point 5, declaration ad Article 88 of the Directive modifying directive 2001/83/EC on the Community code relating to medicinal products for human use).

The Council has rejected amendment 120 counting the intervals for periodic safety update reports from the time of first marketing instead of marketing authorisation. This is acceptable, in particular as the Council has agreed on a new Article 104(6a) whereby amendments to the arrangements concerning the periodic safety update reports can be adopted through a Committee procedure in the light of experience gained.

The Council has rejected amendment 151 regarding the classification of a medicinal product in the context of a mutual recognition procedure. The Commission would have preferred to keep the classification of a medicine within the context of a mutual recognition procedure as the proposed exclusion reflected in the common position will maintain current problems for the free circulation of medicinal products.

3.3.3. Amendments rejected by the Commission, but accepted fully, in part or in principle by the Council

The Council has accepted in full, in part or in principle 10 amendments proposed by the European Parliament, which the Commission had not accepted in its amended proposal. These amendments are: 34, 38, 54, 101, 107, 134, 173, 181, 198 and 202.

The Commission takes note that the Council supports the European Parliament amendments 34, 134 and 202 on the data protection period for medicinal products other than those for which the centralised procedure is obligatory and on the so-called Bolar clause. A sufficient level of data protection is essential to guarantee the necessary incentives to invest in innovative products, irrespective of the procedure to be followed. The line taken by the European Parliament and the Council deviates slightly from the Commission's position. For medicinal products other than those that have to be authorised via the mandatory centralised procedure, an abridged application can be filed after eight years and no additional year may be obtained. However, the Commission considers that as a balance this compromise is in line with the underlying objectives of protecting innovation while reinforcing generic competition and can hence be accepted.

The Council has accepted amendment 38 rewording Article 10(3) on certain changes in a generic medicinal product and the tests to be submitted in case of such change. Though the Commission considers that a rewording is unnecessary, it can support this clarification.

Formally, the Council has accepted amendment 54 on making available marketing authorisations as well as other information on the Agency's web site. On the substance however, the Council agrees with the Commission that this does not require a specific provision in Article 21 as it is covered already by other provisions and in particular by Article 51(2) of the Regulation.

The Commission regrets that the Council has accepted amendments 101, 173 and 198 deleting the proposed test case on improving information to patients on prescription-only medicines and corresponding parts of the recitals (Article 88(2)). The Council considers that the issue of information to patients merits further consideration, so that it would be premature to resolve the issue in the context of the present revision of the Directive. The Commission considers that this would delay the adaptation of the current legislation to the developments and in particular to the widespread use of the Internet to obtain health-related information.

Formally, the Council has accepted amendment 107 on certain general conditions of advertising to the general public. This is acceptable to the Commission.

The Council has accepted in part amendment 181 referring to hospitality at sales promotions (Article 94(2)), whereas the Commission has rejected it. However, the wording proposed by the Council in its common position is very close to the Commission's position and can hence be accepted.

3.3.4. Amendments rejected by the Commission and by the Council

Certain amendments have not been integrated into the Commission's amended proposal nor into the Council common position. These amendments are: 1, 4, 6, 8, 9, 10, 16, 19, 26, 28, 29, 40, 45, 46 (part), 49, 53 (part), 56, 59, 62, 64, 65, 71, 72, 73, 74, 75, 76, 77, 78, 79, 81, 87, 92 (part), 96, 99, 100, 102, 103, 104, 105, 111, 113, 115, 116 (part), 117, 118, 119, 120 (part), 123, 124, 126, 127, 129, 131, 132, 135, 136, 141, 153, 154, 155, 172, 176, 179, 182, 189, 190 and 196.

3.3.5. Amendments introduced by the Council in its common position

The common position incorporates a number of technical and editorial changes, which the Commission accepts.

In addition, the Council has introduced certain substantial changes to the text of the Directive, which do not respond to an amendment adopted by the European Parliament or a provision of the Commission's proposals.

The Council has added a new paragraph 2a in Article 2, according to which the provisions on manufacturing apply to medicinal products intended only for export and to intermediate products.

The Council introduced a second subparagraph in Article 46, point f) extending the obligation to comply with good manufacturing practice to certain excipients, the list of which shall be established by a Directive to be adopted by the Commission through a Committee procedure.

These changes are acceptable to the Commission as they intend to ensure the best possible quality of medicinal products, while leaving the necessary flexibility.

In Article 5, the Council added a new paragraph 4 explaining that the liability for defective products according to Council Directive 85/374/EEC is not limited by the provisions of that Article. Such clarification is acceptable to the Commission.

In Article 23, the Council has included several paragraphs to make more explicit certain post-marketing obligations of the marketing authorisation holder, in particular to supply to the competent authority any relevant new information and on request all data justifying that the risk-benefit balance remains favourable. These changes do not modify substantially the current state of law and can be supported by the Commission.

The Council proposes a new Article 23a. It would oblige the marketing authorisation holder to inform the competent authority of the date of actual marketing, of any cessation of the marketing and of all data relating to the volume of sales as well as any data in its possession relating to the volume of prescriptions. Such obligations are acceptable as they correspond to the new provisions according to which a marketing authorisation ceases to be valid if not used during three consecutive years.

In Article 34(2)(a), the Council has introduced a minimum time of 5 days for Member States to comment on the draft Commission decision. Bearing in mind that in exceptional circumstances a shorter deadline may be fixed, this is acceptable to the Commission.

The Council proposes a new Article 126a, which permits a Member State to authorise, for justified public health reasons, the placing on the market of a medicinal product, which is authorised only in another Member State. The provision sets out in more detail the conditions and procedures to follow in such case. This provision could take account of problems of availability of medicinal products in the new Member States, whose small markets do not attract pharmaceutical companies, and hence can be supported.

Finally, the Council introduces a new Article 127a to take account of Community authorisations granted under conditions or restrictions to ensure the safe and effective use of the medicinal product as provided for in Article 9(4)(c) of the Regulation. In such case, a Commission decision to be adopted through a Committee procedure shall be addressed to Member States for the implementation of those conditions or restrictions. The Commission can agree with this mechanism, as it provides guarantees for a correct follow-up to such Community authorisations.

3.4. Directive of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products

3.4.1. Amendments proposed by the European Parliament accepted by the Commission in its amended proposal and by the Council in its common position

The Council has accepted amendments 19, 20, 29, 31, 33, 34, 35, 39, 46, 48 (as for its second part) and 49, adopted by the European Parliament, subject to minor drafting changes in a few cases. These amendments were also accepted by the Commission and incorporated in its modified proposal without changes. The Council has also accepted in full, with minor drafting changes, amendments 26, 36 and 42, which the Commission has accepted in principle.

In addition, the Council has accepted in part or in principle amendments 4, 5, 8, 9, 11, 14, 15, 18, 28, 41, 52, 53, 57, 58, 65 and 68. These amendments have been accepted at least partially or in principle by the Commission in its amended proposal. Subject to specific comments, the Commission can support the Council changes, which refer namely to:

- Amendment 4 on the definition of homeopathic medicinal product;

- Amendment 5 on the definitions of risk related to use of the veterinary medicinal product and risk/benefit balance;

- Amendments 8, 9 and 11 on the cascade procedure;

- Amendments 14 and 15 on the pharmacovigilance information to be included in an application for a marketing authorisation;

- Amendment 18 on data protection for certain veterinary medicinal products;

- Amendment 28 on "sunset clauses" for authorised veterinary medicinal products that are not placed on the market or that cease to be placed on the market;

- Amendment 41 on the labelling of homeopathic medicinal products;

- Amendments 52 and 53 on the simplified procedures for the administration of homeopathic medicinal products;

- Amendments 57 and 58 on the renewal of marketing authorisations. In principle, the Council supports the approach taken by the European Parliament and the Commission in its amended proposal that a marketing authorisation is to be renewed after five years, after which its validity is undetermined. However, the Council provides for an additional renewal, which the Commission can support as it is limited to certain circumstances justified by pharmacovigilance grounds;

- Amendment 65 on the derogation from the requirement to establish maximum residue limits for animals of the equidae family not intended for human consumption;

- Amendment 68 on the information relating to potential risks to the environment to be included in an application for a marketing authorisation.

3.4.2. Amendments proposed by the European Parliament accepted by the Commission in its amended proposal but not by the Council in its common position

The common position has rejected three amendments which the Commission had accepted in full in its modified proposal.

The Council has not incorporated amendment 21 concerning the obligation for Member States to take account of the registrations and authorisations by other Member States of homeopathic medicinal products (Article 16(1)). Instead, the Council has aligned this provision which the equivalent provision in the human directive, excluding from its application products nationally authorised before 31 December 1993. The Commission does not object to this change.

As regards the terminology employed to designate the strength of homeopathic medicinal products (Articles 17 and 18), the common position has rejected Parliament's amendments 22 and 24 and has reintroduced the wording of the initial Commission's proposal. The Commission does not object to this change.

3.4.3. Amendments proposed by the European Parliament, not accepted by the Commission in its amended proposal, but accepted by the Council

The Council has accepted (in full, in part or in principle) several amendments proposed by the European Parliament, which the Commission had not accepted in its amended proposal.

The Council has accepted in full Parliament's amendment 16 concerning data protection of veterinary medicinal products (Article 13(1)) and aligning the human and veterinary directives. Thus, manufacturers of generic veterinary medicinal products will be able to submit an application eight years after the granting of the marketing authorisation to the reference product. The subsequent placing on the market will not take place until ten years have elapsed from the granting of the marketing authorisation to the reference product. The line taken by the European Parliament and the Council deviates slightly from the Commission's position. However, the Commission considers that as a balance this compromise is still in line with the underlying objectives of protecting innovation while reinforcing generic competence and hence is ready to accept it.

The common position has also accepted the principle underlying amendment 17, aimed at the extension of the data protection period in the case of smaller species and laying hens, by providing for the possible extension of the data protection period to others species through the comitology procedure (Article 13(1)). The Commission supports the change introduced by the common position.

The Commission notes that the Council has agreed with amendment 48 (as for its first part) of the European Parliament, accepted in full by the common position, which prohibits advertising to the public of veterinary medicinal products available on veterinary prescription only (Article 85(3)). Such a provision however does not take into consideration that there is at present no harmonisation at Community level concerning prescription. As a result of the different national regimes in this regard, the Commission considers that the enforcement of this provision would be difficult if it is not supplemented by further measures.

Finally, the Council has retained the principle of amendment 62, concerning minimum withdrawal periods (Article 11(2)), by providing for their possible modification through comitology procedures. The Commission supports the common position on this point.

3.4.4. Amendments proposed by the European Parliament, not accepted by the Commission in its amended proposal nor by the Council

The following amendments, which the Commission rejected for the reasons set out in its modified proposal, have also been rejected by the Council: 2, 3, 7, 10, 13, 23, 25, 27, 30, 37, 38, 40, 44, 45, 47, 56, 59, 60, 63, 64, 66, 67 and 69.

As regards amendment 43, the Parliament had proposed to introduce an exception in the rule that veterinary medicinal products for food-producing animals should be available only on prescription, when they are dispensed under the responsibility of a registered person (Article 67, first paragraph, indent (a*)). Following the Parliament's opinion, the Commission provided in Article 66(3) for the possibility that Member States permit on their territory the dispensing of veterinary medicinal products for food producing animals by or under the supervision of a registered person, which would however not entail an exemption from the requirement of a prescription. The common position does not accept either the exception to the requirement of prescription for food-producing animals proposed by the Parliament. However, it adds a provision for the adoption by 31 December 2006, through comitology procedures, of harmonised rules for exemptions from this general principle. The Commission supports this addition and undertakes to make a proposal concerning exemptions no later than 12 months after entry into force of the directive (see Declarations below).

3.4.5. Other amendments introduced by the Council

The common position incorporates a number of technical and editorial changes, which the Commission accepts.

In addition, the Council has introduced a number of changes of substance, which depart from the Commission's proposal. Some of the changes have been introduced to align the text of the veterinary directive to that of the political agreement concerning the Regulation and the Directive relating to medicinal products for human use. In particular, this concerns the changes -discussed above- in the following provisions:

- Alignment with both the Regulation and the Directive relating to medicinal products for human use: Articles 26(3), 28 and 36(5).

- Alignment with the Directive relating to medicinal products for human use: Articles 3(1)(e), 13, 13a, 13b, 14, 27a, 32(2), 34, 38, 61(1), 75 and 95a.

Other substantial changes are commented below.

The Council does not purport to amend the legal basis of the modified Directive, i.e. Directive 2001/82/EC. The Commission agrees with the common position.

The Council has also added a new paragraph 3 to Article 2 in order to include certain substances under the scope of the directive for the purposes of the application of certain provisions on manufacturing and on the possessions and dispensing of medicinal products. This addition is acceptable to the Commission as they intend to ensure the best possible quality of medicinal products.

The common position has widened the scope of the cascade procedure (Articles 10(1)(b)(ii) and 11(1)(b)(ii)). The Commission can agree to this change inasmuch as the procedure has at the same time been assorted with additional safeguards in the case of food-producing animals.

A new paragraph 5 in Article 65 has been introduced by the Council concerning the obligation of a parallel importer to inform the competent authority and the marketing authorisation holder of intended parallel imports. The Commission does not object to this provision.

The Council has reduced the period during which all medicinal products containing new active substances must be available only on prescription from seven to five years (Article 67, third paragraph). The Commission supports this change which is consistent with the renewal of the marketing authorisation once and for a five-year period.

The provision on the choice of Committee procedure in relation to decisions to be taken by the Commission within the mutual recognition procedure following an opinion from the scientific committee (Article 89) have been changed. The management procedure will apply for these decisions. The Commission accepts the change introduced by the common position.

In Article 95, concerning withdrawal periods in test animals for human consumption, in addition to the use of withdrawal periods of Article 11(2), the common position provides for the alternative use of maximum residue limits, where they have been established. The Commission supports this addition.

Other minor changes of substance, which the Commission accepts, have been included by the Council in Articles 1(9), 3(2)(a), 5(1), 27(3), 69, 72(2), 73, 76(1) and concern the definitions of withdrawal period and magistral formula, the consideration of line extensions to a marketing authorisation as part of that authorisation, the evaluation of the benefit/risk balance, the possibility for member States to impose specific requirements for the reporting of adverse reactions, the records to be maintained by the owners of keepers of food-producing animals, and the access to and the exchange of pharmacovigilance information.

4. CONCLUSION

The Commission supports the texts of the common positions, adopted by qualified majority, for a regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and for a Directive amending Directive 2001/83/EC on the Community code relating to human medicinal products.

The Commission agrees with the text of common position, adopted by unanimity, for a Directive amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.

5. DECLARATIONS

The Commission made the following declarations:

Ad: Article 65 of the Regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency:

"The Commission would point out that its proposal for the composition of the Management Board is consistent with the Agency's specific needs and with the general ground rules for agencies. As an early decision would be desirable, however, the Commission is not opposing the adoption of a Council common position based on the Presidency compromise. The Commission nevertheless leaves open its option of reverting to this aspect of the proposal in the second reading, particularly if the European Parliament were to pass an amendment reinstating the Commission's original proposal."

Ad: Article 70 of the Regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency:

"When adopting the fees Regulation in accordance with Article 70(1), the Council and the Commission will ensure proportionality between the fees and the assessment related costs of each application, in particular in the case of applications submitted in accordance with Articles 10 and 10c of Directive 2001/83/EC."

Ad: Article 83 of the Regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency:

"The Council and Commission note that the wording of Article 83 does not prevent Member States from introducing or retaining national provisions for supply at no cost to patients".

Ad: Article 5 of the Directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use:

"The Council and Commission note that this Directive does not preclude Member States from taking action in accordance with Article 297 of the Treaty."

Ad: Article 10(5) of the Directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use:

"The Council and the Commission consider that the submission and subsequent evaluation of an application for a marketing authorisation as well as the granting of an authorisation are to be considered as administrative acts and as such do not infringe patent protection".

Ad: Article 16(3) of the Directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use:

"The Council and the Commission state that the future inclusion of registered homeopathic medicinal products in Title IX of the Directive must be considered within 3 years after the date of implementation referred to in Article 2 of this amending Directive. If modifications of Title IX are considered as necessary they shall be adopted in accordance with the procedure referred to in Article 108 of the Directive."

Ad: Article 88 of the Directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use:

"The Commission regrets the deletion by the Council of the provision designed to provide patients with information which has been checked and verified. The Commission considers that, in view of information technology developments, the omission of that provision might leave patients exposed to information not affording such assurances."

Ad: Article 67(aa) of the Directive amending Directive 2001/82/EC on the Community code relating to medicinal products for veterinary use:

"The Commission undertakes to make a proposal concerning exemptions from Article 67(aa) no later than 12 months after entry into force of the Directive. The proposal will cover all cases in which the Commission considers that exemptions from the general rule of Article 67(aa) would be appropriate and would not create an undue risk to consumer safety. In preparing its proposal, the Commission will take into consideration, in particular, the substances classified in Annex II to Regulation (EEC) 2377/90."