Considerations on COM(2013)168 - Transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2013)168 - Transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of ... |
|---|---|
| document | COM(2013)168  |
| date | March 18, 2013 |
(2) In order to take into account the evolution of the pharmaceutical market and of national policies to control public expenditure on medicines medicinal products, substantive changes are necessary to all major provisions of Directive 89/105/EEC. Therefore, in the interest of clarity, Directive 89/105/EEC should be replaced.
(3) Union legislation provides a harmonised framework for the authorisation of medicinal products for human use. According to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use,[9] medicinal products may be placed on the market in the Union only after they have received a marketing authorisation based on the evaluation of their quality, safety and efficacy.
(4) Member States have been confronted to 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 medicinal products 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 medicinal products es, to regulate their prices or to establish the conditions of their public funding. Such measures mainly aim at promoting public health for all citizens by ensuring the availability of adequate supplies of medicinal products at reasonable costs, while ensuring the financial stability of public health insurance systems.
(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.
(6) In order to reduce the effects of the disparities on the internal market, national measures should comply with minimum procedural requirements enabling the parties concerned to verify that those measures do not constitute quantitative restrictions on imports or exports or measures having equivalent effect thereto. Those minimum procedural requirements should also ensure legal certainty and transparency for all the parties involved in the process of pricing of medicinal products and inclusion in the health insurance systems, while promoting the production of medicinal products, accelerating the entry into the market of generic medicinal products and encouraging research and development of new medicinal products. However, those requirements should not affect the policies of those Member States which rely primarily upon free competition to determine the price of medicinal products. They also should not affect national policies on price setting and on the determination of social security schemes, except as far as it is necessary to attain transparency within the meaning of this Directive and to ensure the functioning of the internal market.
(7) In order to ensure the effectiveness of the internal market in medicinal products, this Directive should apply to all medicinal products for human use within the meaning of Directive 2001/83/EC.
(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.
(9) Competent authorities and marketing authorisation holders increasingly engage in voluntary contractual agreements to provide patients with access to innovative treatments. In particular, those agreements allow the inclusion of a medicinal product in the scope of the health insurance systems while at the same time addressing the evidentiary uncertainties relating to the relative efficacy and/or effectiveness of a specific medicinal product by monitoring the elements agreed upfront and for a defined period of time. The delay in defining the terms and conditions of such voluntary contractual agreements often exceeds the time limits set in this Directive and justifies the exclusion of such agreements from its scope. Those agreements should effectively facilitate or enable patients' access to innovative medicinal products, should remain voluntary and should not affect the right of the marketing authorisation holder to submit an application for the inclusion of a medicinal product in the health insurance system pursuant to this Directive.
(10) Any measure taken by the Member State 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 transparent objective and verifiable criteria that are independent from the origin of the product and should provide adequate legal remedies, including judicial remedies, in accordance with national procedures, 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.
(11) The Union's support for cooperation on health technology assessment (hereinafter “HTA”) in accordance with Article 15 of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare[10] aims to optimise and coordinate HTA methodologies which should ultimately also reduce delays in pricing and reimbursement procedures of medicinal products for which Member States use HTA as part of their decision-making process. HTA includes, in particular, information on the relative efficacy as well as on the short-term and long-term effectiveness, where appropriate, of health technologies, also taking into account broader economic and social benefits or cost-effectiveness of the assessed medicinal product, in accordance with the methodology of the competent authorities. HTA is a multidisciplinary process that summarises information about the medical, social, economic and ethical aspects relating to the use of health technology in a systematic, transparent, unbiased and robust manner. Its aim is to contribute to the formulation of safe, effective, health policies that are patient-focused and that seek to achieve best value.
(12) Applications to approve the price of a medicinal product or to determine its coverage by the health insurance system should not delay the placing on the market of that product beyond what is necessary. It is therefore desirable that this Directive sets out mandatory time limits within which national decisions should be made. In order to be effective, the prescribed time periods should run from the receipt of an application until the entry into force of the corresponding decision. They should include all expert evaluations, including health technology assessments where applicable, and all administrative steps required for the decision to be adopted and take legal effect.
(13) In order to facilitate compliance with the time limits set in this Directive, it may be useful for applicants of a marketing authorisation to start informal negotiations for price approval or for inclusion of a medicinal product in the public health insurance systems already before the marketing authorisation is granted. To this end, Member States should have the possibility to allow such applicants to submit a request for informal negotiations for price approval of a medicinal product or for its inclusion in the health insurance systems after the scientific assessment is finalised by the Committee for Medicinal Products for Human Use or by the national competent authority in charge of the marketing authorisation procedure, as appropriate. In such cases the time limits for decisions on the price of a medicinal product or its inclusion in the health insurance system should run from the formal application for pricing or inclusion in the health insurance systems after the granting of the marketing authorisation.
(14) 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 procedure should be put in place.
(15) In its Communication 'Executive Summary of the Pharmaceutical Sector Inquiry Report'[11] the Commission demonstrated that pricing and reimbursement procedures often unnecessarily delay the launch of generic medicinal products medicines in Union markets. Approving the price of generic medicinal products and their coverage by the health insurance system should not require any new or detailed assessment when the reference product has already been priced and included in the health insurance system. It is therefore appropriate to lay down shorter time limits for generic medicinal products in those cases. Same conditions might apply where appropriate to biosimilar medicinal products.
(16) The judicial remedies available in the Member States have played a limited role in ensuring compliance with the time limits due to the often lengthy procedures in national jurisdictions, which deter affected companies from initiating legal action. Therefore, effective mechanisms are necessary to ensure swift infringement resolution besides the judicial proceedings if necessary so as to control and enforce compliance with the time limits for pricing and reimbursement decisions. To this end, Member States should have the possibility to designate an existing administrative body.
(17) The quality, safety and efficacy of medicinal products, including the bioequivalence of generic medicinal products or the biosimilarity of biosimilar medicinal products with the reference product, are ascertained in the framework of marketing authorisation procedures. In the framework of pricing and reimbursement procedures, the competent authorities 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 which have been already assessed during the marketing authorisation process. Similarly, in the case of orphan medicinal products, the competent authorities should not re-assess the criteria of the orphan designation. However, competent authorities should have full access to the data used by the authorities responsible for granting the marketing authorisation of a medicinal product as well as the possibility of using or generating additional relevant data for the purpose of assessing a medicinal product in the context of its inclusion in the scope of the public health insurance system.
(18) The non-reassessment of the elements on which the marketing authorisation is based within the framework of pricing and reimbursement procedures should not, however, prevent the competent authorities from requesting, accessing and using data generated during the marketing authorisation process for the purpose of HTA. Data sharing between the competent authorities responsible for marketing authorisation and for pricing and reimbursement should be possible at national level if such sharing exists. The competent authorities should also be able to use available data or generate additional relevant data for health technology assessment purpose.
(19) 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.
(20) The Commission and the Member States might investigate possibilities to co-operate in the view of setting up and maintaining price information database on medicinal products and relevant conditions so as to provide a Union-wide added value in terms of price transparency while respecting the Member States’ competences in this field.
(21) In order to ensure the transparency, integrity and independence of the decision-making process within the national competent authorities, the names of experts participating in the bodies responsible for pricing and reimbursement decisions, together with their declarations of interest and the procedural steps leading to pricing and reimbursement decisions should be disclosed to the public.
(22) Member States have frequently amended their health insurance schemes or adopted new measures falling within the scope of Directive 89/105/EEC. It is therefore necessary to establish an information mechanism mechanisms intended, on the one hand, to ensure the consultation of all interested stakeholders including civil society organisations, such as patient and consumer groups and, on the other hand, to facilitate preventive dialogue with the Commission as regards the application of this Directive. Since the objective of the action to be taken, namely providing minimal transparency rules to ensure the functioning of the internal market, cannot be sufficiently achieved by the Member States, as the notion of transparency of national measures is understood and applied differently in each Member State, and can therefore, by reason of the scale of the action be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.
(23) In accordance with the Joint Political Declaration of Member States and the Commission on explanatory documents of 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified.