Åpen konsultasjon om mulig revisjon av direktiv 89/105/EØS om innsyn i prisbestemmelsene for legemidler til mennesker og slike legemidlers opptak i de nasjonale syketrygdordninger
Åpen konsultasjon igangsatt av Kommisjonen 28.3.2011
Kommisjonen igangsatte 28. mars 2011 en åpen høring om et mulig behovet for revisjon av gjennomsiktighetsdirektivet fra 1989 om prisfastsettelse og refusjon av utgifter for legemidler. Direktivet skal sikre like konkurranseforhold for farmasøytiske produkter og fjerne hindringer for salg av legemidlerover landegrensene. Høringsfrist er satt til 25. mai 2011.
BAKGRUNN (fra Kommisjonens pressemelding 28.3.2011, dansk utgave)
Pricing and reimbursement of medicines: Commission consults on EU transparency rules
The European Commission has launched a public consultation in view of modernising rules on the transparency of Member States’ decisions regarding the pricing and reimbursement of medicines. The consultation invites all interested parties to share their views on the review of Council Directive 89/105/EEC, often referred to as the 'transparency directive'. This directive has not been amended since 1989 despite substantial changes in the pharmaceutical market. Although the prices of medicines and reimbursement are decided at national level, the Transparency Directive is aimed at facilitating the free movement of medicines in the EU. The deadline for submitting contributions is 25 May 2011.
European Commission Vice-President Antonio Tajani, Commissioner for Industry and Entrepreneurship, said: "Transparent in pricing and reimbursement procedures contribute to maintaining a dynamic pharmaceutical market and can help diminish the strain on public health budgets. The time has come to rejuvenate the existing framework: public authorities, companies and, above all, citizens will benefit from a more modern set of rules."
The consultation will help the Commission determine how to best update the existing rules to reduce pharmaceutical prices, guarantee transparent national procedures and facilitate a broader and timely access to medicines. Some of the issues covered in the consultation include:
• Delays in pricing and reimbursement procedures highlighted by the European Commission competition inquiry into the pharmaceutical sector (July 2009);
• Consistency between existing transparency rules and:
• the development of increasingly innovative products;
• the evolution of pharmaceutical cost-containment mechanisms in the Member States.
• The role of the case-law of the European Court of Justice, which has always provided an extensive interpretation of the existing rules in order to guarantee their effectiveness.
• The opportunity and feasibility of extending the scope of the Transparency Directive to include medical devices.
• Explore the possibility of a community-wide system of penalties in case of delays in pricing and reimbursement decisions.
In the EU, medicinal products can only be placed on the market after they have been authorised by the European Commission or the competent national authorities. Marketing authorisations are granted in accordance with common EU rules intended to ensure the quality, safety and efficacy of medicines. Member States are responsible for controlling the prices and reimbursement of medicines in view of promoting the health of their citizens and the financial sustainability of their social security systems.
Pricing and reimbursement measures affect the capacity of pharmaceutical companies to sell their products in national markets and are capable of creating barriers to trade within the EU. The Transparency Directive aims to mitigate the potential impact of national rules by ensuring that pricing and reimbursement decisions follow transparent procedures and do not discriminate between medicines produced nationally and those imported from other Member States. It ultimately benefits patients by facilitating trade in medicines in the EU.
Member States are responsible for the organisation of their own health insurance systems as well as the allocation of resources devoted to healthcare (Article 168(7) of the Treaty on the functioning of the European Union). Nevertheless, national decisions regarding the pricing and reimbursement of medicines are subject to the rules of the Treaty on the free movement of goods and to the procedural requirements defined in the Transparency Directive 89/105/EEC. The directive mainly defines procedural obligations on the Member States to ensure that pharmaceutical companies benefit from timely, motivated and appealable decisions as regards the pricing and reimbursement of their products. These rules are based on the principle of minimal interference in the organisation of social security policies by the Member States.