Case 3015/2006

Appellant alleged that a resolution issued by the General Directorate of Pharmacy and Chemical Products (GDPCP) violated provisions in Spain’s Law of Medicines and General Law of Health by restricting the distribution of the pharmaceutical Rebetol for reasons other than objective reasons of health.

When new pharmaceutical drugs were developed in Spain, owners of the products requested funding from GDPCP and inclusion in the Social Security system. In exchange for funding, the GDPCP, under the auspices of the National System of Health, was authorized to create special conditions for the administration and distribution of these pharmaceuticals, but only for objective reasons of health. The GDPCP’s restriction on the distribution of Rebetol required that patients could acquire the drug only at National Health System hospitals and not from any other facilities licensed to distribute pharmaceuticals.

Appellant filed an administrative appeal due to the restrictions contained in the funding approval resolution issued by the GDPCP. The administrative appeal was denied by the Sub-secretariat of Health and Consumers and the Superior Court of Justice of Madrid upheld the denial. Appellant further appealed to the Supreme Court.

The Court held that the GDPCP’s actions were based on economic reasons and such restriction was unlawful under Article 22 of the Law of Medicine (which only allowed restrictions exclusively for objective reasons of health). The Court found that considerations involving insurance coverage for the drug by the Social Security system played a significant and inappropriate role in the GDPCP’s decision to place restrictions on the distribution of Rebetol.The Court based its holding largely on its previous decision regarding a drug called Temodel which faced nearly identical unlawful restrictions.

The Court also declined to make an exception or amendment to precedent based on policy reasons, noting that any expansion of the rule to allow for restrictions based on additional reasons besides health “would lead to misapplication of the will of the legislator.”

"Appealing to semantics, there is no doubt that health is a term that evokes a determined field that is related to health, and within which are included the means for the reestablishment of such health, both human and material means. Health is a fundamental right recognized by article 43 of the Constitution to all the Spanish people, assigning its organization and protection to the public authorities, concreting in article 3 of the Law 14/1996, that the means and undertaking of the health system shall be destine, with priority to the promotion of health and prevention of diseases, the extension of health care to all the Spanish people, and that the access and health services shall be done in conditions of effective equality, among other things.” Page 3

 “Recurriendo a la semántica no cabe duda de quesanitarias es palabra derivada de Sanidad, y este término evoca, indudablemente, un campo, determinadoque es el relacionado con la salud y dentro de este se encontrarían incluidos los medios con que se cuentapara el restablecimiento de aquella, ya sean medios humanos o materiales. La protección de la Salud es underecho fundamental que la Constitución Española reconoce a todos los españoles en su artículo 43 , para locual encarga su organización y tutela a los poderes públicos, concretando en el artículo 3° de la Ley 14/1996que los medios y actuaciones del sistema sanitario estarán orientados prioritariamente a la promoción de lasalud y prevención de enfermedades, la extensión de la asistencia sanitaria a toda la poblaciónespañola yque el acceso y prestaciones sanitarias se realizarán en condiciones de igualdad efectiva,entre otras cosas.” Page 2.

“…if we analyze the content of the preceding resolution, we will observe that it establishes exclusive distribution of the drug in hospital’s pharmacies, because of purely economic reasons, and this sort of restriction based on economic reasons would not be authorized or contemplated by…the Law of Medicines, Law 25/1990 of December 20…” Page. 8.

“…se observa que la misma establece la dispensación exclusiva en la farmacia de los Hospitales, porrazones prioritariamente económicas, y ese tipo de restricción por razones económicas no estaría autorizadoni contemplado por la norma que se trata de aplicar art. 22 de la Ley del Medicamento , Ley 25/1990 de 20 dediciembre…” Page 6