Opioid-related deaths are 9 times higher in the US compared to the EU. This raises the question of why the effect was so much less intense in EU member states, and what regulatory measures and actions of European regulatory agencies (if any) stopped the EU opioid epidemic from happening at the same intensity as in the US.

The main regulatory framework for evaluating, researching, and monitoring the safety and efficacy of drugs and their use is the field of pharmacovigilance. As a body, the EU has a limited pharmacovigilance competence, defined in Article 168 of the Treaty on the Functioning of the European Union. What is interesting to know is to what extent this competence, and its implementation and promotion within European agencies tasked with pharmacovigilance oversight, are to thank for the lower impact of the opioid related deaths.

To evaluate the efficacy of EU agencies tasked with pharmacovigilance, we evaluate their regulatory interventions, limiting the analysis to a specific area. The efficacy of regulations is described in jurisprudence as the ability of measures to achieve the intended objectives as envisioned by legislators and is measured by the outputs with a causal link to the inputs.

The choice of opioid pharmacovigilance as a focus is based on the stark differences in societal impacts and prescribed numbers in the US and the EU. If it is in fact the EU regulations that were proposed, promoted or implemented by designated agencies that have influenced the death toll due to opioid misuse, how can we protect and expand them? Could these regulations, imposed to protect us from illicit usage, be putting us at risk of not receiving the licit palliative care we might need one day? If it is not due to the legal framework of the EU and the interventions of designated agencies, it is crucial to understand how the crisis was still avoided with ineffective regulations.