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Healthcare is a major component of the contemporary welfare state, and thus ensuring public health through product safety is a substantive public concern.

In this chapter, the fundamentals of pharmacovigilance are outlined with a particular emphasis on the role of healthcare professionals in reporting adverse drug reactions (ADRs). It also explains why pharmacovigilance is specifically important regarding biological medicinal products (biologicals).

This chapter introduces pharmacovigilance in the European Union (EU); due to the multi-level nature of the EU, pharmacovigilance is described both at the European and the national level. Both levels are linked through multiple inter-institutional relations and, in combination, the European and national levels make up the EU’s pharmacovigilance system.

There has long been a vague supposition that the European Union (EU) has a transposition problem (Groenleer et al. 2010; Kaeding 2006, 2007a, b, 2008a, b, c, 2012; Kaeding and Versluis 2014; Klika 2015a, 2015b; Mastenbroek and Kaeding 2006, 2007; Schmälter 2017; Steunenberg et al. 2006; Steunenberg and Kaeding 2009). This chapter offers a first assessment of the timeliness of national transposition processes for all EU Member States and their respective national pharmacovigilance systems.

This chapter represents the core of this study and presents the main findings. The aim of this chapter is threefold. First, it offers in-depth explanations of the adverse drug reaction (ADR) reporting systems, and it describes relevant tasks and actors involved in all six countries under consideration (the United Kingdom, Finland, Poland, France, Portugal and Germany).

In this chapter, we compare the challenges and best practices identified in the country chapters so that the in-depth analysis of selected Member States is complemented with a broader overview. In doing so, we aim to provide a better understanding of the practical implementation of the new European Union (EU) pharmacovigilance legislation across Member States.

Pharmacovigilance is vital for public health and patient safety and includes all activities relating to the detection, assessment and prevention of adverse effects due to medicinal products (see WHO 2004). Despite risk assessment before marketing authorisation, all medicines might produce adverse drug reactions (ADRs) during therapeutic use after marketing (Belton and the European Pharmacovigilance Research Group 1997).