ABSTRACT
BACKGROUND AND OBJECTIVES:
The growing interest in the medical use of cannabis and phytocannabinoids has led European Union (EU) countries to regulate the production and access to cannabis products for their citizens. This regulation is based on international conventions, the European Medicines Agency (EMA) guidelines and legal loopholes that grant autonomy to EU member countries to authorize the production and marketing of cannabis-based drugs and foods. This summary aims to present the current status of medical cannabis legislation in the EU, highlighting the authorization of drugs, regulatory processes and the autonomy of member states in the production of magistral formulas.
CONTENTS:
Most EU countries allow, in some form, the legal use of cannabis and its derivatives as a drug. Since 2019, three drugs containing nabiximols, dronabinol or nabilone have been authorized on the markets of EU member states. In addition to the EMA centralized procedure for marketing authorization, cannabinoid-based products can also be authorized through regional or national processes in EU countries. This autonomy extends to the production of magistral formulas in compounding pharmacies, allowing pharmacists to prepare formulas containing cannabis for use according to a specific medical prescription and, in some situations, at scale.
CONCLUSION:
While it is not possible to conclude which is the ideal approach to the regulation of medical cannabis that all countries should adopt, the experience of the EU provides valuable lessons. The autonomy granted to the member states allows the expansion of the medical use of cannabis through the authorization of drugs and the production of magistral formulas. These experiences can be used as a basis for reformulations in Brazilian regulations, aiming to expand access and medical use of cannabis in the country.
Keywords
Drug and narcotic control; Europe; Medical marijuana; Pharmaceutical preparations.
HIGHLIGHTS
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Expansion of access to medical cannabis in recent years in several European states.
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Particularities of regulatory models in European Union countries.
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Challenges and counter-trends in regulatory frameworks for cannabis as a drug in Europe, and lessons for Brazil.