Background: In 2013, the European Directorate for the Quality of Medicines and Healthcare (EDQM), an organisation part of the Council of Europe, promulgated several important recommendations on haemophilia through the Wildbad Kreuth III initiative. These were subsequently published in the scientific journal Haemophilia.

On 15 April 2015, in advance of World Haemophilia Day (17 April), the Council of Europe’s Committee of Ministers representing the States who are Parties to the Convention on the Elaboration of a European Pharmacopoeia [1] took the Wildbad Kreuth III recommendations into account and recommended that the governments of those State Parties “take appropriate measures to step up the promotion of [the following] principles:

  1. To optimise the organisation of haemophilia care, a system should be established in each member State to allow the implementation of a multidisciplinary approach for the treatment and care of patients (for example by setting up an advisory body including representatives of the relevant clinicians, national haemophilia bodies, patients’ organisations, the health ministry, the paying authority, blood establishments and the regulatory authorities or by setting up centres of excellence);
  2. In each member State, the coagulation factor VIII utilisation level should be at least 3 International Units (IU) per capita;
  3. Decisions on whether to use a new or an alternative product should be based on evidence of safety and effectiveness and not solely on cost;
  4. The evidence of the effectiveness of different treatment regimes should be strengthened. Prophylaxis is currently recognised as the optimum therapy for children with severe haemophilia. Ongoing prophylaxis for adults should be provided, when required based on a clinical decision by the clinician in consultation with the patient;
  5. Prophylactic treatment with bypassing agents should be offered to haemophiliac children who have developed inhibitors and in whom immune tolerance induction therapy has failed or was unsuitable;
  6. Single coagulation factor concentrates should be used as therapy wherever possible in patients with rare bleeding disorders.

We greatly welcome this timely and historic recognition by the Council of Europe of these important recommendations,” stated Mr Brian O’Mahony, President of the EHC. “These had already resulted in the establishment of a formal advisory body on haemophilia in Romania, increased emphasis on availability of minimum levels of treatment in Europe and increased awareness of the requirement for access to prophylaxis for adults – and we hope that this official recommendation will encourage all other European governments to implement them as well.”

This is the first Council of Europe Resolution directly on haemophilia and rare bleeding disorders since the Council’s 1980 ‘Recommendation No R (80) 5 of the Committee of Ministers to member States concerning blood products for the treatment of haemophiliacs.’

The Resolution broadly endorses the principles outlined in the recommendations of Wildbad Kreuth III prepared in 2013 and presented during the joint European Haemophilia Consortium (EHC) and Paul-Ehrlich-Institut (PEI) World Haemophilia Day event held on 16 April 2014 at the PEI premises in Langen, Germany.

You can watch the Wildbad Kreuth III principles here below:


[1] Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, “the former Yugoslav Republic of Macedonia”, Turkey, Ukraine and United Kingdom.