Pharmaceutical Group of the European Union

Members Area

Proportionality of Professional Regulation

The main goal of health professional regulation is to ensure the highest quality of healthcare and the protection of patients and public health in general.

European health systems are consistently ranked among the top performing in the world and are recognised for providing high quality and accessible healthcare services to citizens. Article 168 of the Treaty of functioning of the EU establishes the need for a high level of human health protection to be ensured in the definition and implementation of all Union policies and activities. In addition, this provision states that the organisation and delivery of health services to citizens is a responsibility of Member States. In general, and unless explicitly defined otherwise, Union action is therefore restricted to a complementary and coordinating function where added value can be achieved.

European health systems as well as the access to and the practice of health professions are highly regulated at national level. These provisions are characterised by a high number of obligations and restrictions on the healthcare professionals. The main goal of such provisions is to ensure the highest quality of healthcare and the protection of patients and public health in general.

For instance, in the pharmacy profession, the opening of pharmacies is subject to authorisation and/or registration requirements in all Member States. In addition, all EU countries have reserved certain activities for pharmacists (such as providing advice on use of medicines, dispensing, compounding, etc.). Many countries link the establishment of new pharmacies to the number of inhabitants in a given area or to the geographical or demographic characteristics of the territory with the aim of safeguarding a sufficient access to medicines. Pharmacists are subject to continuous professional development requirements and professional ethics and supervision, among other obligations. The application of such criteria has proven to be key in the organisation of national healthcare systems and guarantees high quality, safe and accessible pharmacy services throughout the national territory.

Furthermore, cost-containment for public health expenditure (either by the state budget or by Statutory Health Insurance) is an important goal of national regulation in the health sector. These economically specific circumstances of the health sector constitute an outstanding distinction from other economic sectors and call for a different approach.

We believe that Member States should remain fully responsible to define the conditions for access to and practice of healthcare professions, such as pharmacists, as well as to choose the most appropriate method to assess the proportionality and necessity of such requirements. When implementing new regulation for healthcare professions Member States are best placed to consider the country-specific issues and take into account the interest of patient safety and quality of healthcare. In addition, given that health and life of humans rank foremost among the assets and interests protected by the TFEU, PGEU would like to stress that the objectives of healthcare systems and the regulation of health professions (namely ensuring accessibility and quality) should always take priority.