22 Amendments of Phil PRENDERGAST related to 2012/0035(COD)
Amendment 34 #
Proposal for a directive
Recital 14
Recital 14
(14) The quality, safety and efficacy of medicinal products, including the bioequivalence of genericand the biosimilarity of medicinal products with the reference product, 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, safety, efficacy or, bioequivalence or biosimilarity of the medicinal product.
Amendment 38 #
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 generic or biosimilar medicinal product, should not request information concerning the patent status of the reference medicinal product and should not examine the validity of an alleged violation of intellectual property rights should the generic or biosimilar medicinal product be manufactured or placed on the market subsequently to their decision. Consequently, intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the Member States.
Amendment 47 #
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 price of the reference medicinal product has been approved by the competent authorities.
Amendment 50 #
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 68 #
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 reference medicinal product has already been included in the public health insurance system.
Amendment 71 #
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 guidelines.
Amendment 73 #
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 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 75 #
Proposal for a directive
Article 7 – paragraph 8
Article 7 – paragraph 8
8. Member States shall publish in an appropriate publication and communicate to the Commission the criteria which the competent authorities must take into account when deciding whether or not to include medicinal products within the scope of the public health insurance system. The identity and statements of interest of the experts involved in the decision-making process shall also be published.
Amendment 78 #
Proposal for a directive
Article 8 – paragraph 2 – subparagraph 1 – point b
Article 8 – paragraph 2 – subparagraph 1 – point b
Amendment 79 #
Proposal for a directive
Article 8 – paragraph 2 – subparagraph 1 – point b a (new)
Article 8 – paragraph 2 – subparagraph 1 – point b a (new)
(b a) refer any instances of non- compliance with time limits set in Article 7 to the relevant body, in accordance with national law, should the competent authority have been unable to prove that the delay is not imputable to it.
Amendment 80 #
Proposal for a directive
Article 8 – paragraph 2 – subparagraph 1 – point c
Article 8 – paragraph 2 – subparagraph 1 – point c
Amendment 81 #
Proposal for a directive
Article 8 – paragraph 2 – subparagraph 2
Article 8 – paragraph 2 – subparagraph 2
Amendment 82 #
Proposal for a directive
Article 8 – paragraph 2 – subparagraph 3
Article 8 – paragraph 2 – subparagraph 3
Amendment 83 #
Proposal for a directive
Article 8 – paragraph 6 – subparagraph 1
Article 8 – paragraph 6 – subparagraph 1
The body referred to in paragraph 2 shall state reasons for its decision. Furthermore, where that body idoes not have judicial in characterauthority, provision must be made to guarantee procedures whereby any allegedly illegal measure taken by the independent body or any alleged defect in the exercise of powers conferred on it can be subject to judicial review or review by another body which is a court or tribunal within the meaning of Article 267 of the Treaty on the Functioning of the European Union and independent of both the competent authority and the body referred to in paragraph 2.
Amendment 86 #
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 publicationmade publicly available.
Amendment 87 #
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Member States shall publish in an appropriate publicationmake publicly available and communicate to the Commission the objective and verifiable criteria according to which medicinal products are classified in view of their inclusion in the public health insurance system.
Amendment 88 #
Proposal for a directive
Article 10 – paragraph 3
Article 10 – paragraph 3
3. For the medicinal products subject to such grouping or classification, Member States shall publish in an appropriate publicationmake publicly available and communicate to the Commission the methodologies used to determine the extent or conditions of their inclusion in the public health insurance system.
Amendment 90 #
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 publicationmade publicly available.
Amendment 96 #
Proposal for a directive
Article 13 – title
Article 13 – title
Additional proof of quality, safety, efficacy or, bioequivalence or biosimilarity
Amendment 100 #
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
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 or biosimilarity of the medicinal product.
Amendment 102 #
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
Where a Member State intends to adopt or amend any measure falling within the scope of this Directive, it shall give interested parties, civil society organisations and stakeholders the opportunity to comment on the draft measure within a reasonable period. The competent authorities shall publish the rules applicable to consultations. The results of consultations shall be made publicly available, with the exception of confidential information in accordance with Union and national legislation regarding business confidentiality.
Amendment 116 #
Proposal for a directive
Article 17 a (new)
Article 17 a (new)
Article 17 a The Commission shall establish and maintain a publicly accessible online database containing comparative information on procurement prices for all medicines purchased by Member States.