Harmonization of Quality Control and Product Licencing in Europe

D. Poggiolini, General Director of Pharmaceutical Service, Ministry of Health, Rome (Italy) In the last decade haemophilia treatment has made important progress through orthopedic surgery of locomotor disabilities, rehabilitation by means of suitable physical therapy, etc. Undoubtedly, however, the basic aspect of haemophilia care always remains haematologic treatment with factor VIII concentrates, i.e., treatment with drugs. It was the development and production of these drugs, achieved in the last decade, which brought about a real change in the haemophiliacs’ life and made it possible to undertake surgical treatment, unimaginable in the past. Progress in the production of anti-haemophilic concentrates was characterized not only by an increase in the production of these drugs, and therefore by their greater availability which allowed suitably intensive care of haemophilia, but also by an ever greater purification of the drugs themselves, achieving a higher concentration and biological activity, a lower risk of side effects, and easier handling and use. These are the achievements which enabled haemophiliacs, and the physicians who treat them, to avail themselves of modern methods of therapy, such as self-treatment, which freed haemophiliacs from the need to go to hospitals, clinics, or first aid stations for simple intravenous injections, and restored them to a normal social life. I believe that we can state that the availability of modern and suitable factor VIII and factor IX concentrates and the most recent concentrates for the treatment of haemophilia with inhibitor, used according to modern methods of clinical treatment, has allowed haemophiliacs to achieve a good quality of life which not many years ago would have appeared as a dream. Unfortunately, these conditions are not at present a reality in all countries, even in comparatively developed areas such as the European Economic Community (EEC). Haemophiliacs rightly wish that these health barriers might be broken down, so that they might enjoy the same quality of life wherever they live. The EEC Committee for Proprietary Medicinal Products, of which I am honored to be Deputy President, has for a long time made all possible efforts to reach the harmonization of drug registration procedures Harmonization of Quality Control and Product Licencing in Europe 63