New Important Body of the Council of Europe

ČSH

In recent weeks, the Council of Europe recognised the European Directorate for the Quality of Medicines & HealthCare (EDQM) as its member body. EDQM issues recommendations in clinical fields, including the optimal use of blood and blood derivatives. As early as 1999 and 2009, EDQM issued recommendations on the optimal use of preparations that closely concern hemophilia. These recommendations carry great significance, as they take on the character of official Council of Europe regulations.

They therefore carry greater weight and significance than the widely known and frequently cited European principles of hemophilia care approved by the European Association for Haemophilia and Allied Disorders (EAHAD), the European Haemophilia Consortium (EHC), and the World Federation of Hemophilia (WFH).

The EDQM principles and recommendations provide justification for efforts to improve treatment and overall care. They are very specific and therefore very useful in pursuing concrete objectives. For example, in 2009, EDQM established 2 IU FVIII per capita as the minimum guaranteeing at least survival. This was particularly important for countries where consumption did not reach such quantities. Fortunately, such concerns do not apply to us.

This year's EDQM session in April 2013 also had hemophilia on its agenda; the community was represented by the EHC, which could draw on a survey of the state of care in 35 member countries. The EHC was represented by its top officials, as well as the WFH president, as a member of the EHC steering committee ex officio.

Some key recommendations can play a crucial role in improving care for people with hemophilia in many countries. They will be published in due course and may also serve as inspiration for the Czech National Hemophilia Programme. In its policy efforts in the areas of adult prophylaxis, centre certification and audit. The aim is also to prevent a possible supply monopoly by a single new long-acting FVIII or FIX preparation. The arrival of such products is expected very soon, and EU legislative regulations on market principles will also assist individual countries. The EHC recommends establishing National Hemophilia Committees in all member countries so they can help put specific recommendations into practice. They should also serve as intermediaries for disseminating information from European bodies in individual regions, in which the EHC will also provide significant assistance.