In Europe, a disease is classified as rare if it affects fewer than five in every 10,000 (or one in every 2,000) members of the population of the European Union. There are over 7,000 known rare diseases in total. Between 6% and 8% of the population live with a rare disease. This is equivalent to approximately one million people in the Netherlands and between 27 and 36 million people across Europe.
The Dutch government launched a National Rare Diseases Plan on 10 October 2013. One of the first steps that needs to be taken to put the plan into effect is to recognise certain centres of expertise for rare diseases. These centres must meet certain EU standards in order to be compatible with European networks for rare diseases. The Dutch Ministry of Health, Welfare, and Sport has asked the Dutch Federation of University Medical Centers to develop and adopt a procedure for designating nationally recognised centres of expertise in the Netherlands.
Procedure for designating centres of expertise
The designation procedure was developed in close collaboration with Orphanet Nederland and the Dutch Patient Alliance for Rare and Genetic Diseases. This guarantees that the procedure takes close account not just of the needs of medical researchers, but also of European law and the wishes and needs of patients. The goal of the Dutch Federation of University Medical Centres is to build up a comprehensive list of recognised centres of expertise for rare diseases in the Netherlands.
Recognition in accordance with European standards
Prospective centres of expertise are assessed both by subject experts and by patient organisations. The assessments are based on 17 criteria defined by the EU, covering seven main areas of reference. The findings of both assessments are submitted as recommendations to an independent committee, which then decides whether or not the centre in question should be recognised by the Ministry of Health, Welfare, and Sport. The candidates are informed of the assessment committee’s final decision, which is also submitted as a recommendation to the Minister of Health, Welfare, and Sport.
List of centres of expertise
The aim of the Ministry of Health, Welfare, and Sport is for patients suffering from rare diseases to know which centres of expertise in Europe they can go to for diagnosis, multi-specialist and multidisciplinary care, paramedical support and treatment. Both patients and professionals need to know where specific expertise is available. The list of centres of expertise is also a big step towards the provision of better, all-round care for patients with rare diseases.