Activities of Bernadette VERGNAUD related to 2012/0035(COD)
Plenary speeches (1)
Transparency of measures regulating the prices of medicinal products for human use (debate)
Amendments (60)
Amendment 25 #
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168 thereof,
Amendment 27 #
Proposal for a directive
Recital 5
Recital 5
(5) Disparities in national measures may hinder or distort intra-Union trade in medicinal products and distort competition, thereby directly affecting the functioning of the internal market in medicinal products.
Amendment 35 #
Proposal for a directive
Recital 14
Recital 14
(14) The quality, safety and efficacy of medicinal products, including the bioequivalence of generic medicinal products with the reference product and the similarity of biosimilar medicinal products, are ascertained in the framework of marketing authorisation procedures. I and may be re-assessed in the framework of pricing and reimbursement procedures, Member States should therefore not re- assess the elements on which the marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product.
Amendment 44 #
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168 thereof,
Amendment 44 #
Proposal for a directive
Article 2 – paragraph 1 – point 3 a (new)
Article 2 – paragraph 1 – point 3 a (new)
3a. “biosimilar medicinal product” means a similar biological medicinal product approved in accordance with Article 10(4) of Directive 2001/83/EC;
Amendment 45 #
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Member States shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in timeguarantee that the marketing authorisation holder has the possibility to introduce an application to approve the price of the product. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 49 #
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 690 days of the receipt of an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 1530 days, provided that the price of the reference medicinal product has been approved by the competent authorities.
Amendment 51 #
Proposal for a directive
Recital 5
Recital 5
(5) Disparities in national measures may hinder or distort intra-Union trade in medicinal products and distort competition, thereby directly affecting the functioning of the internal market in medicinal products.
Amendment 51 #
Proposal for a directive
Article 3 – paragraph 6
Article 3 – paragraph 6
Amendment 52 #
Proposal for a directive
Article 3 – paragraph 7
Article 3 – paragraph 7
7. If the competent authorities decide not to permit the marketing of the medicinal product concerned at the price proposed by the applicant, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 53 #
Proposal for a directive
Article 3 – paragraph 8
Article 3 – paragraph 8
Amendment 54 #
Proposal for a directive
Article 3 – paragraph 9
Article 3 – paragraph 9
9. If the competent authorities decide to reduce the price of a specific named medicinal product on their own initiative, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The decision shall be communicated to the holder of the marketing authorisation, who shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 55 #
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shall ensure that an application to increguarantee that the marketing authorisation holder hase the price of the product can be submitted by the marketing authorisation holder at any point in timeossibility to introduce an application to increase the price of a medicinal product. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 56 #
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
Member States shall ensure that a decision on an application submitted in accordance with the requirements laid down in the Member State concerned, by a marketing authorisation holder to increase the price of a medicinal product is adopted and communicated to the applicant within 690 days of its receipt.
Amendment 57 #
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 2
Article 4 – paragraph 3 – subparagraph 2
In case of an exceptional number of applications, the time limit set out in this paragraph may be extended once only for a further 690 days. The applicant shall be notified of such an extension before the expiry of the time limit set out in this paragraph.
Amendment 58 #
Proposal for a directive
Article 4 – paragraph 5
Article 4 – paragraph 5
Amendment 59 #
Proposal for a directive
Article 4 – paragraph 6
Article 4 – paragraph 6
6. If the competent authorities decide not to permit the whole or part of the price increase requested, the decision shall contain a statement of reasons based on objective and verifiable criteria and the applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 61 #
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. In the event of a price freeze or price reduction imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a Member State, that Member State shall publish a statement of reasons for its decision based on objective and verifiable criteria, including, if applicable, a justification of the categories of products subject to the price freeze or price reduction.
Amendment 62 #
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons. The application shall contain an adequate statement of reasons. Member States shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in timeguarantee that the marketing authorisation holder has the possibility to introduce an application for a derogation. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 63 #
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Member States shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 60 days of the receipt of the application. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. If the derogation is granted, the competent authorities shall forthwith publish an announcement of the price increase allowed.
Amendment 64 #
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
Amendment 66 #
Proposal for a directive
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States shall ensure thatguarantee that the marketing authorisation holder has the possibility to introduce an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time. If the public health insurance system comprises several schemes or categories of coverage, the marketing authorisation holder shall be entitled to apply for the inclusion of its product in the scheme or category of its choice. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 68 #
Proposal for a directive
Recital 14
Recital 14
(14) The quality, safety and efficacy of medicinal products, including the bioequivalence of generic medicinal products with the reference product and the similarity of biosimilar medicinal products, are ascertained in the framework of marketing authorisation procedures. In the framework of pricing and reimbursement procedures, Member States should therefore not re-assess the elements on which the marketing authorisation is based, including the quality,, and Member States should have full access to the data used in the marketing authorisation procedure so that they can assess the relative safety, and efficacy or bioequivalence of the medicinal productf a medicinal product in the context of pricing and reimbursement procedures.
Amendment 69 #
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Member States shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system, submitted by the marketing authorisation holder in accordance with the requirements laid down in the Member State concerned, is adopted and communicated to the applicant within 690 days of its receipt. However, with respect to medicines for which Member States use health technology assessment as part of their decision- making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 15 days, provided that the reference medicinal product has already been included in the public health insurance system.
Amendment 74 #
Proposal for a directive
Article 7 – paragraph 8
Article 7 – paragraph 8
Amendment 84 #
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Any decision to exclude a medicinal product from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the product concerned, shall contain a statement of reasons based on objective and verifiable criteria. Such decisions shall include any evaluation, expert opinion or recommendation on which they are based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 85 #
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Any decision to exclude a category of medicinal products from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the category concerned, shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication.
Amendment 87 #
Proposal for a directive
Article 2 – point 3 a (new)
Article 2 – point 3 a (new)
3a) ‘biosimilar medicinal product’ means a similar biological medicinal product approved in accordance with Article 10(4) of Directive 2001/83/EC;
Amendment 89 #
Proposal for a directive
Article 11 – paragraph 3
Article 11 – paragraph 3
Amendment 91 #
Proposal for a directive
Article 11 – paragraph 4
Article 11 – paragraph 4
4. At the request of the holder of a marketing authorisation whose interests or legal position are affected by the measures referred to in paragraph 1, the competent authorities shall specify the objective data and criteria on the basis of which these measures have been taken with respect to its medicinal product. In such a case, the competent authorities shall also inform the marketing authorisation holder of all remedies available, including judicial, and of the time limits for applying for such remedies.
Amendment 94 #
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Member States shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in timeguarantee that the marketing authorisation holder has the possibility to introduce an application to approve the price of the product. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 94 #
Proposal for a directive
Article 13 – title
Article 13 – title
Additional proof of quality, safety, efficacy or, bioequivalence or biosimilarity
Amendment 98 #
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
In the framework of pricing and reimbursement decisions, Member States shall notmay re-assess the elements on which the marketing authorisation is based, including the quality, safety, or efficacy or bioequivalence of the medicinal product.
Amendment 102 #
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 690 days of the receipt of an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 1530 days, provided that the price of the reference medicinal product has been approved by the competent authorities.
Amendment 104 #
Proposal for a directive
Article 16
Article 16
Amendment 121 #
Proposal for a directive
Article 3 – paragraph 6
Article 3 – paragraph 6
Amendment 122 #
Proposal for a directive
Article 3 – paragraph 7
Article 3 – paragraph 7
7. If the competent authorities decide not to permit the marketing of the medicinal product concerned at the price proposed by the applicant, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 123 #
Proposal for a directive
Article 3 – paragraph 8
Article 3 – paragraph 8
Amendment 125 #
Proposal for a directive
Article 3 – paragraph 9
Article 3 – paragraph 9
9. If the competent authorities decide to reduce the price of a specific named medicinal product on their own initiative, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The decision shall be communicated to the holder of the marketing authorisation, who shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 127 #
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shall ensure that an application to increguarantee that the marketing authorisation holder hase the price of the product can be submitted by the marketing authorisation holder at any point in timeossibility to introduce an application to increase the price of a medicinal product. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 135 #
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
Member States shall ensure that a decision on an application submitted in accordance with the requirements laid down in the Member State concerned, by a marketing authorisation holder to increase the price of a medicinal product is adopted and communicated to the applicant within 690 days of its receipt.
Amendment 141 #
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 2
Article 4 – paragraph 3 – subparagraph 2
In case of an exceptional number of applications, the time limit set out in this paragraph may be extended once only for a further 690 days. The applicant shall be notified of such an extension before the expiry of the time limit set out in this paragraph.
Amendment 152 #
Proposal for a directive
Article 4 – paragraph 5
Article 4 – paragraph 5
Amendment 153 #
Proposal for a directive
Article 4 – paragraph 6
Article 4 – paragraph 6
6. If the competent authorities decide not to permit the whole or part of the price increase requested, the decision shall contain a statement of reasons based on objective and verifiable criteria and the applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 154 #
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. In the event of a price freeze or price reduction imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a Member State, that Member State shall publish a statement of reasons for its decision based on objective and verifiable criteria, including, if applicable, a justification of the categories of products subject to the price freeze or price reduction.
Amendment 157 #
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons. The application shall contain an adequate statement of reasons. Member States shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in timeguarantee the marketing authorisation holder the right to submit an application for a derogation. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 164 #
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Member States shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 60 days of the receipt of the application. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. If the derogation is granted, the competent authorities shall forthwith publish an announcement of the price increase allowed.
Amendment 166 #
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
Amendment 178 #
Proposal for a directive
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States shall ensure that an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time. If the public health insurance system comprises several schemes or categories of coverage, the marketing authorisation holder shall be entitled to apply for the inclusion of its product in the scheme or category of its choicguarantee the marketing authorisation holder the right to submit an application to include a medicinal product in the scope of the public health insurance scheme. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 188 #
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Member States shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system, submitted by the marketing authorisation holder in accordance with the requirements laid down in the Member State concerned, is adopted and communicated to the applicant within 690 days of its receipt. However, with respect to medicines for which Member States use health technology assessment as part of their decision- making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 15 days, provided that the reference medicinal product has already been included in the public health insurance system.
Amendment 216 #
Proposal for a directive
Article 7 – paragraph 8
Article 7 – paragraph 8
Amendment 223 #
Proposal for a directive
Article 8
Article 8
Amendment 225 #
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Any decision to exclude a medicinal product from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the product concerned, shall contain a statement of reasons based on objective and verifiable criteria. Such decisions shall include any evaluation, expert opinion or recommendation on which they are based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 227 #
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Any decision to exclude a category of medicinal products from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the productcategory concerned, shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication.
Amendment 232 #
Proposal for a directive
Article 11 – paragraph 3
Article 11 – paragraph 3
Amendment 235 #
Proposal for a directive
Article 11 – paragraph 4
Article 11 – paragraph 4
4. At the request of the holder of a marketing authorisation whose interests or legal position are affected by the measures referred to in paragraph 1, the competent authorities shall specify the objective data and criteria on the basis of which these measures have been taken with respect to its medicinal product. In such a case, the competent authorities shall also inform the marketing authorisation holder of all remedies available, including judicial, and of the time limits for applying for such remedies.
Amendment 240 #
Proposal for a directive
Article 13 – title
Article 13 – title
Additional proof of quality, safety, efficacy or, bioequivalence or biosimilarity
Amendment 243 #
Proposal for a directive
Article 13
Article 13
In the framework of pricing and reimbursement decisions, Member States shall not re-assess the elements on which the marketing authorisation is based, including the quality,ssential elements (quality, safety, efficacy or biosimilarity) on which the marketing authorisation is based. Nevertheless, Member States shall have access to all the data used by the authority which granted the marketing authorisation so that they can assess the relative safety, and efficacy or bioequivalence of the medicinal productf a medicinal product in the context of the health insurance system.
Amendment 264 #
Proposal for a directive
Article 16
Article 16
Amendment 272 #
Proposal for a directive
Article 17 – paragraph 1 – subparagraph 1 – introductory part
Article 17 – paragraph 1 – subparagraph 1 – introductory part
1. By 31 January of […] [insert a date - the year following the date referred to in the first subparagraph of Article 18(1)], and by 31 January and 1 July of every year thereafter, Member States shall communicate to the Commission and publish in an appropriate publication a detailed report providing the following information: