Source: European parliament register
Subject: Answer to written question on Reimbursement of medicines in Romania and the Transparency Directive
Date published: September 2 2011
Question for written answer E-006562/2011 to the Commission Rule 117 Cristian Silviu Buºoi (ALDE)
Subject: Reimbursement of medicines in Romania and the Transparency Directive
In response to the financial crisis facing Romania, the Romanian Government has undertaken drastic cost-cutting measures. Whilst this has helped to contain some healthcare costs, the reforms have also resulted in reduced access to healthcare for many Romanian patients.
One of the cost-containment measures used by the Romanian Government has been to block the reimbursement of new, innovative medicinal molecules. Accumulating since July 2008, there are now over 100 molecules, which have all necessary approvals in place, but which are still waiting for a final decision on reimbursement.
Among the products awaiting reimbursement decisions are medicines with life-saving potential. There are also innovative medicines with the potential to reduce costs to the healthcare system and thus public finances via, for example, enabling patients to return to active employment, reducing hospitalisation days and curbing adverse effects, etc.
The Transparency Directive (89/105/EEC) requires Member States to grant a decision on reimbursement within 180 days from regulatory approval. On this basis, will the Commission consider investigating this issue of arbitrary postponement of reimbursement decisions, and thereby help the Romanian authorities to find ways for Romanian patients to gain access to newly-approved drugs?
Answer given by Mr. Tajani on behalf of the Commission
The Honourable Member points out the excessive delays in Romania in taking decisions on pricing and reimbursement of new innovative medicinal molecules, as part of cost-containment measures in healthcare. It is claimed that the Romanian authorities do not respect the time-limits of 90/180 days provided under Directive 89/105/EEC for issuing pricing and reimbursement decisions.
To date, the Commission has not received any complaint highlighting repeated or systematic delays with respect to reimbursement decisions for medicinal products in Romania. The information available indicates that the time-limits laid down by Directive 89/105/EEC have been adequately transposed into Romanian legislation. If the Romanian authorities fail to comply with the obligations of the Directive as transposed in national law, the Commission draws attention to the fact that affected parties have the possibility to seek legal redress before the competent national courts. The Commission will, nevertheless, inquire about the situation with the Romanian authorities and examine potential issues with respect to the time-limits for issuing decisions regarding pricing and reimbursement of innovative medicines.
The Commission also informs the Honourable Member that it has announced a possible review of Directive 89/105/EEC.