Activities of Nessa CHILDERS related to 2012/0035(COD)
Plenary speeches (2)
Transparency of measures regulating the prices of medicinal products for human use (debate)
Transparency of measures regulating the prices of medicinal products for human use (debate)
Shadow reports (1)
REPORT on the proposal for a directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems PDF (517 KB) DOC (660 KB)
Amendments (21)
Amendment 55 #
Proposal for a directive
Recital 9
Recital 9
(9) Any measure to regulate, either directly or indirectly, the prices of medicinal products, as well as any measure to determine their coverage by public health insurance systems should be based on objective and verifiable criteria that are independent from the origin of the product and should provide adequate legal remedies, including judicial remedies, to affected companies. These requirements should equally apply to national, regional or local measures to control or promote the prescription of specific medicinal products as such measures also determine their effective coverage by health insurance systems.
Amendment 58 #
Proposal for a directive
Recital 11
Recital 11
(11) The time-limits for the inclusion of medicinal products in the health insurance systems set out in Directive 89/105/EEC are mandatory as clarified by the case-law of the Court of Justice. Experience has shown that those time limits are not always respected and that there is need to ensure legal certainty and improve the procedural rules related to the inclusion of medicinal products in the scope of health insurance system. Therefore, an effective and rapid remedies procedures should be put in placeencouraged.
Amendment 64 #
Proposal for a directive
Recital 13
Recital 13
Amendment 95 #
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 time. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 107 #
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 60 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 medicinal products 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 generic product is essentially similar to the reference medicinal product, according to Directive 2001/83/EC and that the price of the reference medicinal product has been approved by the competent authorities.
Amendment 109 #
Proposal for a directive
Article 3 – paragraph 4
Article 3 – paragraph 4
4. Member States shall establish in detail the particulars and the main documents to be submitted by the applicant.
Amendment 120 #
Proposal for a directive
Article 3 – paragraph 5
Article 3 – paragraph 5
5. 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. 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 in all events 1530 days, provided that the price of the reference medicinal product has been approved by the competent authorities. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
Amendment 128 #
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shall ensure that an application to increase the price of the product can be submitted by the marketing authorisation holder at any point in time. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 144 #
Proposal for a directive
Article 4 – paragraph 4 – subparagraph 1
Article 4 – paragraph 4 – subparagraph 1
Member States shall establish in detail the particulars and the main documents to be submitted by the applicant.
Amendment 151 #
Proposal for a directive
Article 4 – paragraph 4 – subparagraph 2
Article 4 – paragraph 4 – subparagraph 2
The applicant shall furnish the competent authorities with adequate information, including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested. 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. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
Amendment 159 #
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. These reasons must be drawn from a pre-defined list determined and published in an appropriate publication by the Member State. 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 time. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 179 #
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 choice. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 182 #
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Member States shall establish in detail the particulars and the main documents to be submitted by the applicant.
Amendment 192 #
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 60 days of its receipt. However, with respect to medicinal products 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 generic product is essentially similar to the reference medicinal product, according to Directive 2001/83/EC and that the reference medicinal product has already been included in the public health insurance system.
Amendment 202 #
Proposal for a directive
Article 7 – paragraph 5
Article 7 – paragraph 5
5. 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. However, with respect to medicinal products 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 reference medicinal product has already been included in the public health insurance system. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelinesgeneric product is essentially similar to the reference medicinal product, according to Directive 2001/83/EC and that the reference medicinal product has already been included in the public health insurance system.
Amendment 211 #
Proposal for a directive
Article 7 – paragraph 6
Article 7 – paragraph 6
6. Irrespective of the organisation of their internal procedures, Member States shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this Article and the price approval procedure set out in Article 3 does not exceed 120 days. However, with respect to the medicinal products for which Member States use health technology assessment as part of their decision-making process, the time limit shall not exceed 180 days. With respect to generic medicinal products, that time limit shall not exceed 360 days, provided that the generic product is essentially similar to the reference medicinal product, according to Directive 2001/83/EC and that the reference medicinal product has already been included in the public health insurance system. Those time-limits may be extended in accordance with paragraph 5 of this Article or Article 3(5).
Amendment 213 #
Proposal for a directive
Article 7 – paragraph 7 – subparagraph 2
Article 7 – paragraph 7 – subparagraph 2
The decisions referred to in this paragraph shall also 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 the remedies procedure set out Article 8, of the time limits for applying for such remedies.
Amendment 220 #
Proposal for a directive
Article 8
Article 8
Amendment 244 #
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, safety, efficacy or bioequivalence of the medicinal product. However, Member States shall have full access to the data used by the marketing authorisation authority in assessing these elements for the purpose of evaluation. Competent authorities should also have the right to request additional data for the purpose of evaluation.
Amendment 259 #
Proposal for a directive
Article 15 a (new)
Article 15 a (new)
Article 15a Price transparency 1. At least once a year, the competent authorities shall publish in an appropriate publication and communicate to the Commission, a complete list of the medicinal products covered by their health insurance systems, the prices of which have been fixed during the relevant period, together with the prices which may be charged for such products. 2. The Commission and the Member States shall examine how to continue to co-operate on the functioning of the EURIPID price information database, which provides EU-wide added value in terms of price transparency.
Amendment 263 #
Proposal for a directive
Article 16
Article 16