Activities of Ashley FOX related to 2012/0035(COD)
Shadow opinions (1)
OPINION 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
Amendments (9)
Amendment 29 #
Proposal for a directive
Recital 8
Recital 8
(8) Due to diversity of national measures managing the consumption of medicines, regulating their prices or establishing the conditions of their public funding it is necessary to clarify Directive 89/105/EEC. In particular this Directive should cover all types of measures devised by Member States and susceptible to impact the internal market. Since the adoption of Directive 89/105/EEC, the pricing and reimbursement procedures have evolved and have become more complex. While some Member States have interpreted the scope of Directive 89/105/EEC restrictively, the Court of Justice ruled that those pricing and reimbursement procedures fall within the scope of Directive 89/105/EEC given the objectives of that Directive and the need to ensure its effectiveness. Therefore, this Directive should reflect the developments in national pricing and reimbursement policies. Given that specific rules and procedures exist in the area of public procurement and voluntary contractual agreements, national measures involving public procurement and voluntary contractual agreements should be excluded from the scope of this Directive.
Amendment 31 #
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8 a) In addition to conventional measures laid down by law, regulation or administrative action to regulate the conditions of public funding of medicinal products, public authorities are increasingly engaging in agreements which aim at providing patient access to innovative treatments by including a medicinal product in the scope of the public health insurance system whilst monitoring elements agreed upfront with the marketing authorisation holder. Such monitoring aims at addressing evidentiary uncertainties related to the effectiveness and appropriate use of the medicinal product in clinical practice over time. The level of coverage of the medicinal product subject to such agreement is dependent on the output of monitoring and is unknown upfront. The terms and conditions of such agreements are governed by contracts concluded between the public authority and the holder of a marketing authorisation concerned. Where public authorities make the decision on including a medicinal product in the scope of the public health insurance system conditional upon the entry into such agreement, the agreement should not be considered to have been concluded at the request of the holder of the marketing authorisation.
Amendment 32 #
Proposal for a directive
Recital 14
Recital 14
(14) The quality, safety and efficacy of medicinal products, including the bioequivalence of generic medicinal products and the similarity of biosimilar 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. The marketing authorisation of an orphan medicinal product is also based on the evaluation of several criteria, including the significant benefit of the product over any available existing alternatives in the Union, in accordance with Regulation (EC) No 141/2000, which should not be re-assessed in the framework of pricing and reimbursement procedures.
Amendment 37 #
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 39 #
Proposal for a directive
Article 1 – paragraph 2 – subparagraph 1 – introductory part
Article 1 – paragraph 2 – subparagraph 1 – introductory part
This Directive shall apply to measures intended to determine which medicinal products may be included in contractual agreements or public procurement procedures. This Directive shall not apply to the following:
Amendment 41 #
Proposal for a directive
Article 1 – paragraph 2 – subparagraph 1 – point a
Article 1 – paragraph 2 – subparagraph 1 – point a
(a) voluntary contractual agreements 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 paagreements concluded at the written request of the holder of a marketing authorisation with public authorities which aim at including a medicinal product in the scope of the public health insurance system whilst monitoring elements agreed upfront with the holder of a marketing authorisation to address evidentiary uncertainties related to the effectiventess uander specific conditions appropriate use of the given medicinal product over time;
Amendment 42 #
Proposal for a directive
Article 1 – paragraph 2 – subparagraph 2
Article 1 – paragraph 2 – subparagraph 2
Amendment 93 #
Proposal for a directive
Article 13 – title
Article 13 – title
Additional proof of quality, safety, efficacy or, bioequivalence or biosimilarity
Amendment 97 #
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.