Activities of Zofija MAZEJ KUKOVIČ related to 2012/0035(COD)
Plenary speeches (1)
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 (24)
Amendment 48 #
Proposal for a directive
Recital 4
Recital 4
(4) Member States have been confronted towith a steady rise in pharmaceutical expenditure over the last decades, leading to the adoption of increasingly innovative and complex policies to manage the consumption of medicines in the framework of their public health insurance systems. In particular, Member States’ authorities have implemented a broad range of measures to control the prescription of medicines, to regulate their prices or to establish the conditions of their public funding. Such measures mainly aim at promoting public health by ensuring the availability of adequate supplies of medicinal products on equal terms to all EU citizens at reasonable costs, while ensuring the financial stability of public health insurance systems. Medicines classed as essential on the WHO list should be available to patients in all Member States, whatever the size of the market.
Amendment 66 #
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, are ascertained in the framework of marketing authorisation procedures. In the framework of pricing and reimbursement procedures, where legitimate reservations have arisen from knowledge newly obtained, Member States should therefore not re- reassess the elements on which the marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product.
Amendment 72 #
Proposal for a directive
Recital 15
Recital 15
(15) In accordance with Directive 2001/83/EC, intellectual property rights do not provide a valid ground to refuse, suspend or revoke a marketing authorisation. By the same token, applications, decision-making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which, as such, are independent from the enforcement of intellectual property rights. The national authorities in charge of those procedures, when examining an application with respect to a bioequivalent generic medicinal product, should not request information concerning the patent status of the reference medicinal product and should not, but they should be allowed to examine the validity of an alleged violation of intellectual property rights should the bioequivalent generic medicinal product be manufactured or placed on the market subsequently to their decision. ConsequentlyThat responsibility may not be removed from Member States. Without prejudice to the responsibility of Member States to examine information, intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the Member States.
Amendment 73 #
Proposal for a directive
Recital 15 a (new)
Recital 15 a (new)
Amendment 75 #
Proposal for a directive
Recital 15 b (new)
Recital 15 b (new)
(15b) The transparency, integrity, and independence of decision-making within national authorities should be ensured through publication of the names of the competent authorities and the procedural steps leading to pricing and reimbursement decisions.
Amendment 82 #
Proposal for a directive
Article 1 – paragraph 2 – subparagraph 1 – point a
Article 1 – paragraph 2 – subparagraph 1 – point a
(a) voluntary contractual agreements, subject to verification of elements concerning the efficacy and/or relative efficacy or the proper use of the given medicine, concluded between public authorities and the holder of a marketing authorisation for a medicinal product that have as their object to enable the effective provision of this medicine to patients under specific conditions for the agreed period;
Amendment 90 #
Proposal for a directive
Article 2 – point 5 a (new)
Article 2 – point 5 a (new)
(5a) "voluntary contractual agreement" as referred to in Article 1(2), point (a) means an agreement concluded between public authorities and the marketing authorisation holder for a medicinal product which is neither mandatory or required by law nor is the agreement the only alternative to be included in the national pricing and reimbursement scheme.
Amendment 99 #
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, wWith respect to medicinal products for which Member States use health technology assessment as part of their decision-making process, the time- limit shall likewise 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 113 #
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 690 days of receipt of this additional information. However, wWith respect to medicinal products for which Member States use health technology assessment as part of their decision-making process, the time- limit shall likewise 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 124 #
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. The decision and a summary justification shall be made available to public view.
Amendment 131 #
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
Member States shall ensure that a decision onto approve or reject 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 discussed, adopted, and communicated to the applicant within 690 days of its receipt of the application.
Amendment 137 #
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 147 #
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 690 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 160 #
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 690 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 690 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 167 #
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
If there is an exceptional number of applications, the relevant time limit set out in paragraph 3 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 paragraph 3
Amendment 173 #
Proposal for a directive
Article 5 a (new)
Article 5 a (new)
Article 5a Member States shall ensure that the patient or the insured person also genuinely has the benefit of the agreed reimbursement prices. Any possible lack of transparency at dispensaries which results in distortion because of failure to present prices transparently shall be avoided.
Amendment 185 #
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, wWith 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 reference medicinal product has already been included in the public health insurance system.
Amendment 196 #
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 690 days of receipt of this additional information. However, wWith respect to medicineal products for which Member States use health technology assessment as part of their decision-making process, the time- limit shall likewise 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 guidelines.
Amendment 205 #
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 1280 days. However, wWith respect to the medicinal products for which Member States use health technology assessment as part of their decision-making process, the time limit shall likewise not exceed 180 days. With respect to generic medicinal products, that time limit shall not exceed 360 days, provided 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 221 #
Proposal for a directive
Article 8
Article 8
Amendment 233 #
Proposal for a directive
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Measures referred to in paragraph 1, including any evaluation, expert opinion or recommendation on which they are based, shall be published in an appropriate publication and made available to public view.
Amendment 249 #
Proposal for a directive
Article 14 – paragraph 2
Article 14 – paragraph 2
2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend or revoke decisions relating to the price of a medicinal product or its inclusion within the public health insurance system. Member States may not, however, under any circumstances, be deprived of the power to verify intellectual property.
Amendment 269 #
Proposal for a directive
Article 16 – paragraph 4 – subparagraph 1
Article 16 – paragraph 4 – subparagraph 1
The Commission may send its observations to the Member State which has communicated the draft measure within threewo months.
Amendment 278 #
Proposal for a directive
Article 19 a (new)
Article 19 a (new)
Article 19a Monitoring and Reporting 1. Three years after entry into force of this Directive the Commission shall submit a report to the European Parliament and to the Council assessing the enforcement of this Directive. 2. The Commission shall be equipped with sufficient resources to monitor the enforcement of the Directive.