Here, the Malta Medicines Authority (MMA) shares a vision which integrates regulatory sciences, innovation, and academic initiatives
Cannabis, used for thousands of years for multiple purposes, is today discussed as a medical innovation. Legal provisions in force over the past times have rendered medicinal cannabis an essentially uncharted territory. The evolving legislative frameworks support the implementation of sensible regulation and spearhead advanced research in this dynamic field. The prospective therapeutic properties attributed to cannabis portend enhanced interest from patients with unmet needs, healthcare professionals and society at large, while presenting regulatory bodies with an amalgam of challenges and opportunities to get the policy decisions right.
The history of medicinal cannabis in Malta
The 2018 amendments to the Drug Dependence (Treatment Not Imprisonment) Act of the Laws of Malta enable licensed medical practitioners to prescribe cannabis-based products, manufactured under GMP, on a named-patient basis according to the procedures laid down by the Superintendence of Public Health.
Following review by the Medicines Authority, four such products were issued with a notification of approval and became accessible through local pharmacies as individual unit packs serialised with tamper-evident labels for traceability. The subsequent enactment of the Production of Cannabis for Medicinal and Research Purposes Act, Chapter 578 of the Laws of Malta, laid the legislative measures for local manufacture. Applications are evaluated by the Medicines Authority, in line with international obligations and the national regulatory framework, including comprehensive requirements related to established standards, Good Agricultural and Collection Practice (GACP), GMP certification, security measures, and reporting responsibilities.
Cognizant of the limited harmonisation on medicinal cannabis, the Medicines Authority published general guidance documents intended to provide the groundwork for production activities, which embrace safety and quality as principal healthcare safeguards. Quality and stability are essential components to ascertain that products made accessible to patients are true to the contents on their labelling. Addressing standardisation concerns in relation to cannabis extracts, which are marked by difficulty to obtain consistent results from batches of plant material whose composition goes beyond one or two compounds, should assist in progressing towards satisfying the requirements necessary for regulatory approval by adopting an approach appertaining to that of the pharmaceutical industry.
What does the Medicines Authority suggest?
Investigational medicinal products produced under GMP shall enable clinical research to proceed in a scientific manner and advance a comprehensive evidence-base. Publications from pertinent bodies around the globe indisputably call for more and more research. Malta’s stance on cannabis for medicinal and research purposes has put forward a vision which integrates regulatory sciences, innovation, and academic initiatives. The holistic strategy embraced by the Medicines Authority encompasses an upfront commitment towards research and education, identified as the key prerequisites to translate the creditable value of cannabis into tangible outcomes for the benefit of patients.
Extended dialogue with stakeholders, widespread collaborations, and the sharing of expertise are marking the Medicines Authority’s efforts towards making cannabis for medicinal and research purposes a working reality. Besides active contributions in local and international fora, the Authority, through its recently established Academy for Patient-Centred Excellence and Innovation in Regulatory Sciences, is tailoring advanced initiatives which bring together healthcare professionals, industry representatives, and regulators, to exchange views while appreciating the intricate regulatory, pharmaceutical and clinical context related to cannabis for medicinal use.
The empirical, theoretical and practical implications of having cannabis accessible for medicinal purposes undoubtedly necessitate further assessment. The Medicines Authority welcomes proposals for collaborative endeavours in sustainable research and development, to effectively strengthen a pragmatic knowledgebase and foster scientific excellence.