San Marino aims at the legalization of the therapeutic use of cannabis

In March 2015, the relevant authorities of San Marino commenced the in-depth studies about the theurapetic use of cannabis, and were followed up in April and September with a series of meetings between doctors from the ISS, Istituto Superiore di Sanità[1], which produced a strong interest about the therapeutic use of cannabis.

In October 2015, at a meeting of the Istanza d’arengo[2] [1] (nº8 from October 4th, 2015), the legalisation of the phsicotropic substances with a therapeutic use was discussed and voted for by a majority and accepted by the Grand and General Council of San Marino in January 2016 (resolution nº 22). During the debate, it was assessed, among other topics, how to form a business from the possibility of producing medicines on-site and making the exploration and the monitored cultivation autonomous. According to the Director of the Health Authority in San Marino and considering the results of the discussion and the favourable answer by the Parliament about the cultivation for theraupetic purposes, the cultivation could start shortly.

During this occasion, the Council of State has initiated the procedure for putting the legalization into effect, carefully evaluating how to adapt the objective of the proposal to the present regulations.

In May, the government has established the “Commissione per lo studio dei provvedimenti per la produzione delle sostanze psicotrope per uso terapeutico”[3], which is coordinated and chaired by the Director of the Health Authority and also consists of other members such as: the General Director of ISS, the Director of the Department of Economic Affairs, the Director of the Foreign Affairs Department, the Director for Health and Social Health ISS Acitivities, the Director of the Department of Institutional Affairs and Justice, the Director of the Department of Education (or a delegate) and a representative of the Secretary of State for Health and Social Security. The Commission could also be composed of external members, experts and/or technicians of the socio-medical field.

The government has granted the Commission 90 days to indicate the operating methods, procedures and their order of priorities with the objective to “regulate the production of pharmaucetical drugs, specifically psychotropics and also their distribution and clinical use”. In addition, the Commission will have to determine the responsabilities of the health Authority regarding the control of psychotropics for theraupetic use and procedures for the use of the pharmaceutical drug derivatives. This is to be done by defining the diagnostic-therapeutic procedure for the patients that will use the pharmaceuticals, the importing modality of the seeds, the requirements on production and distribution, conservation and use of the pharmaceutical drugs derived from cannabis, through the preperation of a public notice for the selection of those products in compliance with already approved norms related to the therapeutic use of cannabis by other European countries.

Currently, Sativex is allowed to be administered free of charge to those patients with multiple sclerosis or some kind of spinal-cord injuries. The objective of the Istanza d´arengo is to spread the use of pharmaceuticals derived from cannabis, taking Tuscany and other regions where the costs are not enterely charged to the patient as a role model. We hope now that, by the end of August, the Commission will have reached a decision in response to the demands by the Government.

[1] The Istanza d‘arengo is an instrument of direct democracy instituted by the Republic of San Marino, which allows the citizens to present requests of public interest at the time of the election of the heads of state.

Translation: Paula Muñoz

[1] Translator´s Note: English translation as National Institute of Health

[2] Translator´s Note: The Istanza d´arengo is one of the three institutions of direct democracy in the Republic of San Marino.

[3] Translator’s Note: English translation as “Comission for the study of the measures in the production of psychotropic substances for theraupetic use”.