A Just Distribution of Health Care in the Case of Orphan Medicinal Products: Aligning the Interests of European Economic Integration and National Welfare Policy

Abstract

Since market integration measures touch upon issues that are the sole responsibility of the Member States, the efforts of the European Union (EU) to achieve a harmonised internal market clash, in some areas, with national welfare policy. Such a conflict exists where the allocation of health resources is concerned. The EU is very proactive in fostering research and development of medicinal products aimed at treating patients who suffer from rare diseases. The European incentive scheme (Regulation (EC) No. 141/2000) has been a considerable success but, although products are developed, they are not necessarily available to the patient. This is due to the fact that decisions about the price and the reimbursement of these (very expensive) products are made at the national level.

This article draws up a framework for distributing limited health resources where medicinal products for rare diseases (orphan medicine) are concerned. The provision in the Patients' Rights Directive (Dir. 2011/27/EU) on cooperation in health care among the Member States is discussed through the lens of ‘solidarity’ (understood as mutual cooperation) in order to align and remedy the deficits in the system and guarantee the patient access to the product in a timely and equitable manner.