The Council of Europe’s decision-making body, the Committee of Ministers, adopted Resolution CM/Res(2017)43 on principles concerning haemophilia therapies at the end of 2017. Elaborated by the European Committee on Blood Transfusion (CD-P-TS) on the basis of the recommendations from the Wildbad Kreuth Initiative IV meeting « Optimal use of clotting factors and platelets » of 2016*, the new Resolution replaces Resolution CM/Res (2015)3 on the same subject and calls on governments to take into account specific principles for the treatment of haemophilia and care for haemophilia patients.
Problems of access to haemophilia treatments
Haemophilia and bleeding disorders impact the ability of blood to clot. Those affected can lead normal and fruitful lives when they are given access to adequate treatment. However, despite the rarity of these conditions, there are relevant challenges in ensuring access to adequate treatment, which is often expensive, or not available in sufficient quantities.
Haemophilia new Resolution content
The new Resolution foresees the creation of haemophilia care systems based on multidisciplinary approaches, as well as the creation of advisory bodies on haemophilia care composed of representatives of clinicians, national haemophilia bodies, patients’ organisations, Ministries of Health, paying authorities, blood establishments and regulatory authorities.
Haemophilia treatment choice
Decisions on whether to use new or alternative products should be based on evidence of safety and effectiveness and not solely on cost; stronger evidence and outcome data (such as health-related quality of life, annualised bleed rates, mortality and time off from education or employment) should also be collected to monitor the effectiveness of different treatments.
Prophylaxis for severe haemophilia
Prophylaxis is currently recognised as the optimum therapy for children with severe haemophilia and ongoing prophylaxis should also be provided to adults if a clinician, in consultation with the patient, recommends so. Treatment with extended half-life coagulation factors should be individualised and protection against bleeding should be improved by increasing trough levels.
Single coagulation factor concentrates
Single coagulation factor concentrates should be used as therapy wherever possible in patients with rare bleeding disorders. The Resolution sets the annual coagulation factor VIII utilisation in each member state at a new level of at least 4 International Units (I.U.) per capita of general population and recommends that data expressed as I.U. per severe haemophilia patient should also be collected in parallel in future. The minimum annual consumption of factor IX concentrate in a country should be at 0.5 I.U. per capita of general population.
The incidence of inhibitors in haemophilia therapy
Finally, the Resolution recommends better understanding and minimisation of the risks related to differences in the incidence of inhibitors between different products: people with inhibitors should have access to immune tolerance induction therapy and also to elective surgery at specialised centres, whereas prophylactic treatment with bypassing agents should be offered to haemophiliac children who have developed inhibitors and for whom immune tolerance induction therapy has failed or is unsuitable.
Role of Council of Europe
The work of the Council of Europe in the field of blood transfusion focuses on studying the ethical, legal and organisational aspects of blood transfusion and aims to ensuring quality, increasing availability, avoiding wastage, ensuring optimal use of blood supplies and assessing the ethical and organisational impact of new scientific developments.
More information on the new Resolution
- Access the full text of the “Resolution CM/Res(2017)43 on principles concerning haemophilia therapies”
- More information on the activities of the EDQM on blood transfusion
- More information on the Wildbad Kreuth Initiative
- More information about the work of the European Haemophilia Consortium (EHC) on haemophilia and other congenital bleeding disorders
*The Kreuth conferences provide a platform for discussing clinical practices, future developments and recommendations on the optimal use of components from human blood across the Council of Europe member states