Rare Disease Day event looks at Transparency Directive revision to improve access to orphan medicines
In line with the 2013 Rare Disease Day campaign “Rare Disorders without Borders”, EURORDIS organises a multi-stakeholder Policy Discussion Meeting on 26 February co-hosted by Members of European Parliament Ms Antonyia Parvanova (Bulgaria) and Mr Cristian Silviu Buşoi (Romania) to discuss the revision of Transparency Directive 89/105/EEC on medicinal products ahead of the upcoming vote in plenary session of the Parliament. Improving transparency around pricing and reimbursement of medicinal products can improve equitable access to medicines for rare disease patients in the European Union (EU). The Transparency Directive revision presents a unique opportunity to work towards the overarching goal of improving access to medicinal products by introducing or revising specific measures.EURORDIS supports the proposed revision to the Transparency Directive that would reduce the time limit for pricing and reimbursement decisions from 90 days for pricing/90 days for reimbursement (or 180 days for combined pricing and reimbursement decisions) to 60/120 days, as well the proposal for enforcement measures when these time limits are exceeded.
EURORDIS propounds additional amendments to the revision, including an exchange of information between Member State competent authorities on pricing and related negotiations, as well as greater transparency around orphan medicinal product pricing. Marketing Authorisation Holders will be invited to provide a certain degree of information on the cost structure of the orphan medicinal product – a fair request with regards to the economic advantage of the Market Exclusivity period - in order to adjust price to the value of the product in question. This “value-based pricing” approach associated with improved transparency is being elaborated in related initiatives, including the Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) process launched in 2010.
Other provisions in the Directive revision proposal that EURORDIS is supporting are the guarantee that Member States will not re-assess previously determined information, including significant benefit, for orphan medicinal products.
In addition EURORDIS seeks the prevention of existing and inequitable “post-code lotteries,” particularly in countries with regionalised health systems.
Other issues include clarifying terminology to distinguish between “marketing” and “placing on the market”, and continuing compassionate use of medicinal products for patients responding to treatment.
The Policy Discussion Meeting in Brussels, being held in celebration of Rare Disease Day 2013, will take into consideration both the Public Health and the Internal Market/Industry perspectives on proposed revisions for the Transparency Directive and seeks above all to move forward equitable access to orphan medicinal products across Europe.
Author: Louise Taylor, Communications and Development Writer, EURORDIS
.png)
No hay comentarios:
Publicar un comentario