Regulatory frameworks relevant to cannabis for medicinal use

Abstract

Medicinal products in the European Union (EU) fall under EU legislation and Marketing Authorisation (MA) procedures, with set specific requirements. As opposed to medicines with a MA, a number of cannabis products intended for medicinal use are not regulated under an EU Directive and do not form part of a common European or international regulatory framework. These products must satisfy the International Narcotics Control Board Regulations and are regulated through national legislation. The regulatory requirements differ from one country to another resulting in an uneven access. A harmonised approach in the European Union with respect to regulatory requirements for medicinal cannabis-based products without a MA would promote an even access in Member states. A review of the local requirements and legislations was carried out and compared to Portugal, Germany and The Netherlands. The information sought includes: The legislative implementation for cannabis for medicinal use; the competent authorities involved and regulatory requirements in relation to quality control, cultivation, production, manufacture, import and export activities. Information also comprises patient access. The differences of such regulatory requirements are discerned, and recommendations are put forward in an effort to promote even access for medicinal cannabis-based products in member states. A validated questionnaire is designed for medical practitioners that prescribed at least one cannabis-based product since 2018. The questionnaire includes aspects such as attitudes on prescribing cannabis products, the number of cannabis products prescribed, indications and treatment outcomes. An interview was carried out with medical practitioners that have the highest prescribing trends. Aspects such as opinions on prescribing cannabis-based products; age-criteria; indications, treatment outcomes, and point of view on local legislation are covered. The data obtained from this research provides an insight on local prescribing trends and reflect the differences between practices in European countries. The outcome highlights the need for a centralised laboratory for cannabis testing, database detailing cannabis prescribing patterns, price regulation, accredited courses, enhanced practice guidelines and recommendations for improving the use for cannabis-based products.