Särläkemedelsbehandling inom EU och Sverige - En rättighet?

Sammanfattning: Within the European Union there is approximately between 5000 to 8000 different rare diseases that affect five to eight percent of the EU population sometime during their lifetime. During the 1990’s the awareness of the problem with lack of medicine production for unusual diseases increased. In 1999 the regulation (EG) no 141/2000 of Oprhan drugs was created with the purpose of increasing the production of medicine targeted to patients with rare diagnosis in the EU. Today, more than 15 years after its creation, only one percent of the EU citizens diagnosed with a rare disease have a proper drug treatment. The lack of drug treatment for these patients often involves medical suffering and availability of orphan drugs varies between EU member states. In Sweden, prescription medicines are not automatically included in the drug benefit but are judged by the Dental and Pharmaceutical Benefits Agency. The Agency has the task of contributing to an efficient and cost-effective use of medicines. In conjunction with the new drugs developed and marketed by Regulation (EC) 141/200, the discussion of orphan drugs high pricing in relation to health resources have been noted. As discussed above, a very small percentage of the patients diagnosed with a rare diagnosis have a drug treatment in the EU. This despite the efforts by EU to increase the availability of orphan drugs and that a number of international and regional conventions statutes the right to health as a fundamental right. Lack of orphan drugs raises questions regarding how the availability to medicines is regulated and what the right to health means. This paper therefore seeks to examine how the Swedish national law, EU law and international law defines people's right to health and if the right to health also includes access to orphan drugs.