Health ministry initiates Spain's regulatory approval of cannabis for medicinal and therapeutic use

The debate on the legalisation on medical cannabis has intensified around the world in recent years. Countries like Portugal, Norway, the United Kingdom and Canada have regulations that authorise cannabis for specified medical uses. Likewise, the World Health Organization (WHO) has recognised the therapeutic properties of the substance through an official recommendation issued on 14 December 2017.

Antecedents of the Draft Royal Decree

Cannabis is classified in the 1961 UN Single Convention as a narcotic drug, and its use is therefore restricted to medical and scientific purposes. Thus far, the Spanish Agency for Medicines and Health Products (AEMPS) has approved a limited number of drugs containing cannabinoids for marketing. These medicines are prescribed exclusively for the treatment of multiple sclerosis and some types of epileptic seizures.

In this context, the current regulatory framework poses two challenges: the difficult access to the drugs due to their high economic cost and the limitation of their distribution in hospitals, combined with the exclusion of pathologies that could potentially also profit from these treatments.

Proposal for regulation

In response to the demand of democratisation to access these pharmaceutical products, the regulation proposal has established main objectives that include the development of new medicines containing cannabinoids, the expansion of the clinical picture that can be treated, and distribution in pharmacies.

In particular, the subcommittee of the Congress of Deputies in charge of analysing experiences in regulating cannabis for medicinal use has issued the following recommendations to the legislator:

• Guaranteeing the availability of cannabis-derived medicines. It proposes exploring new ways of making available cannabis extracts or preparations that are not currently authorized in Spain and giving pharmacy establishments the competence to make these standardized preparations for direct use by the patient.
• Quality control. The aim is to establish a rigorous quality assessment procedure for standardised cannabis preparations that serve as the basis for the preparation of magistral formulas.
• Dispensing of magistral formulas or standardised preparations. It is intended that the distribution will be done through the network of pharmacies in the health system, preferably hospital pharmacies or, alternatively, community pharmacies that meet certain requirements.
• Preserving and strengthening the role of the AEMPS. The agency is urged to define mechanisms for prescribing and dispensing drugs and standardized preparations derived from cannabis.
• Consolidating the role of healthcare actors. It is indicated that prescriptions will be granted exclusively by medical professionals specialized in the area. For this reason, training in the therapeutic use of cannabis is envisaged for these professionals.
• Potential uses. It is suggested that the list of therapeutic indications that can be treated with medicines containing cannabinoids be extended. Only those pathologies with more solid evidence of a favourable response will be considered, such as inhibition of nausea, endometriosis, oncological pain, and chronic pain. Nonetheless, the proposed regulation is shaped with the necessary flexibility to evolve and integrate new therapeutic indications as more scientific evidence is gathered.

The proposal is characterized by its guaranteeing approach, as it establishes a legal framework designed to ensure the provision of higher quality and safer therapeutic cannabis-based compounds. Furthermore, it aims to expand the catalogue of available products and the pathologies for which their use can be prescribed.

Current status of the proposal for regulation and next steps

The Ministry of Health will approach the legislative proposal based on the conclusions of the subcommittee of the Congress of Deputies in charge of analysing experiences in regulating cannabis for medicinal use, which in turn requested the AEMPS to draw up a roadmap for the approval of said regulation.

During the twenty-day period, which ended on 4 March, public participation in the process of drafting regulations was enabled.

The legislative process will conclude with the approval of the draft regulation by the Council of Ministers. In pursuit of transparency and information, the Royal Decree may be sent to the Congress of Deputies, but the approval of the Lower Chamber is not required.

Osborne Clarke comment

Although the Draft Royal Decree to regulate medical cannabis is at an early stage and a final or preliminary draft is not yet available, the conclusions of the subcommittee of the Congress of Deputies indicate that the aim is to develop a more comprehensive and effective regulation that addresses the deficiencies present in the current legislation. With the approval of this regulation, Spain would align itself with WHO guidelines and would contribute to providing new data on the use of cannabinoids for therapeutic purposes.