Disagreements in the transposition of European rules on medicines into Spanish national regulations

Abstract

The European Community is not a Federal organization, like United States for example, but a close community of independent Member States and this presents a problem in the application of any common law from the European Union (EU) over the Member States (MS) because there are not European Federal Laws. To solve this problem in order to have harmonized regulations in all countries, the EU regulatory bodies have developed some legal instruments to be applied by the MS. These main instruments are European Directives, and Guidelines. The European Directives are rules issued by the European Commission, the European Council or the European Parliament with supranational scope. These Directives are not addressed to the citizens but to the MS which are obliged to incorporate in their respective national regulations those aspects as stated in the Directives coming into force before the deadline. Therefore the European Directives have supranational force. The second legal instrument, the Guidelines, are recommendations related to any Directive but without a strict mandatory character. Guidelines are issued help to the MS to transpose and apply the European Directives in all countries in the same way. Therefore, applying both instruments Directives and Guidelines to the transposition of these EU rules into the national system of every MS, the aspects regulated by the European Community are regulated in the same way in all countries. As it is well known, medicinal products are widely regulated within the European Union because of their interest and significance from an economical, scientific and sanitary point of view. These detailed rules are developed by the different legal instruments foreseen in the EU, mainly by Directives, as commented above, to be incorporated into the National regulations of every country in order to be effectively implemented. Of course, this incorporation into regulations at national level has to be performed in the same way in all Member States to state the same prescriptions in all countries. However this correct incorporation into National regulations is not always strictly correct, at least in Spain.