Spain publishes draft medical cannabis framework, but omits flower

Via Business of Cannabis 

Spain’s Ministry of Health has launched a public consultation on its proposals for a medical cannabis framework in the country.

Organisations and individual citizens will now have until 4 March  to submit their comments on the proposals, as Spain’s new government makes good on its promise to push ahead with the long delayed rollout.

While stakeholders and patients have welcomed the opportunity to participate in the shaping of the industry, many have also voiced their frustration at the limited scope of available products and which indications will be covered.

Most notably, under the current iteration, any form of medical cannabis flower will be entirely absent from Spain’s medical cannabis framework.

What happened?

Last week (February 14), Spain’s Ministry of Health announced via a press release that it had ‘started the process to develop a Royal Decree’ with which it plans to approve the regulation of medical cannabis.

This draft Royal Decree has now been made public, and the government has called on all interested parties to offer their feedback on the proposals.

It is understood that a meeting was held between the Ministry of Health and a swathe of representatives from across Spain’s patient community on Tuesday, in which the proposals were explained and ‘all these organisations approved the regulation’.

Meetings are set to continue between the Ministry of Health and various patient organisations throughout a consultation period, which will enable both organisations and individuals to submit their contributions until March 4.

Submissions can be sent to – normative.aemps@aemps.es

It comes just weeks after Spain’s newly appointed health minister, Mónica García Gómez, used her first appearance in Congress to reaffirm her commitment to establishing a medical cannabis framework in the country, more than a year after it was initially scheduled to be rolled out

The draft Royal Decree

In June 2022, following over a year of research, a subcommittee tasked with investigating medical cannabis frameworks deployed throughout the world put forward its proposals for how a similar framework would look in Spain.

In her January address to Congress, Ms García made it clear that these proposals will play a key role in legislation being put together by her department.

The draft decree appears to follow these recommendations closely, putting forward what appears to be a relatively cautious framework.

According to the text, the report from the subcommittee recommended that the Spanish Agency for Medicines and Health Products (AEMPS) enable greater access to cannabis medicines for patients ‘in the form of master formulas, made from extracts or standardised preparations’.

“In this sense, and following the recommendations of the Subcommittee, the use of standardised preparations is the procedure that offers the most guarantees in terms of dosage, correct processing, and stability.

“To this end, the preparation of monographs is planned that establish, among other aspects, the methods of preparation and control of the master formulas, the technical specifications and the conditions of labeling or conservation, quality control and information that is provided to the health professional and to the patient.”

In a nutshell, it is understood that only cannabis oils will be authorised, which will subsequently be used to make ‘master formulas’.

These must be authorised by specialist doctors in Spain’s National Health System (SNS), meaning it is unlikely that a private industry (such as the UK’s) would be allowed to operate.

Furthermore, the dispensing of these preparations is expected to be limited to hospital pharmacies rather than Spain’s 22,000 local pharmacies. This was one of the key concerns raised by activists when the recommendations were initially discussed 18 months ago.

Crucially, both THC and CBD cannabis flower will be absent from the available products, which is one of the key demands among Spain’s patient community.

In a social media post regarding the news, The IACM Patient Council called the omission of ‘far from ideal for patients who find oil less effective’, suggesting these patients could remain with no choice but to turn to the illicit market.

While no concrete detail was given on which indications medical cannabis will be prescribed for, it is understood that the decree will aim to approve prescriptions for only the conditions for which there is the most evidence of its efficacy.

These include nausea and vomiting caused by chemotherapy, refractory pain, rare forms of epilepsy, multiple sclerosis, and endometriosis.

However, the draft makes it clear that ‘the regulation is designed to evolve dynamically, allowing new elements to be incorporated as more information and the experience of the