SPAIN’s ambitious plans to see the regulation and distribution of medical cannabis rolled out across the country by the end of 2022 appear to have been delayed.
December 27, 2022 marked the deadline for the Spanish Agency for Medicines and Health Products (AEMPS) to ensure proposals, passed in June, ‘fit into regulations’.
As this deadline has come and gone, the Spanish government has remained tight-lipped about the reasons behind the delay, and when this legislation could be enacted.
Just like Germany’s ‘traffic-light’ coalition, the current administration is now in a ‘race against the clock’ to deliver on its promise of cannabis reform before regional, municipal and general elections put the project under threat.
Doubts remain, however, over whether this rapid legislative turnaround will deliver a competent and efficient medical cannabis programme.
‘Medical cannabis by the end of the year’
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.
Later that month (June 2022), the Health and Consumption Commission of the Congress of Deputies voted to approve these proposals in a dramatic decision that came down to the wire, including last-minute amendments and threats to scupper the process entirely.
After the proposals were given the green light, the task fell to the AEMPS to prepare a document with recommendations of how to fit this framework into the country’s regulations and ensure they were legally viable.
However, the AEMPS was given just six months to complete this task amid government efforts to slash deadlines and push the medical cannabis project through as quickly as possible.
More than two weeks after the initial six-month deadline, this document is nowhere to be seen, stalling any further progress on bringing these proposals into law.
“We don’t have any clue what’s going on,” the Spanish Observatory of Medicinal Cannabis (OECM) president Carola Pérez told BusinessCann.
“We don’t have any answers from the Spanish government…We are afraid the Spanish government is playing with us.”
According to Ms Pérez, while the AEMPS has promised the OECM that it was due to meet its deadline, there is now radio silence on the situation.
She added that some press reports have suggested the report could be ready by January 20, but nothing has been confirmed.
In a statement to Spanish publication El Mundo on the day after the initial December 27 deadline, the AEMPs said it intended to publish the recommendations before the end of the year if not the first days of January.
“Everything indicated by the Subcommittee has been collected, and it has been compared with all the European Union guides and models from other countries. They are looking at the best way to guarantee the quality, safety and efficacy of the drug. Despite the fact that we know that not everyone is going to be happy, we have to act as a scientific-technical body.”
Furthermore, the government has given little indication as to what happens after the report is published.
She continued: “No one has replied to the question – when the agency releases the report, what’s going to happen next? Do we have to go to Congress again and vote? Do we go to the Minister of Health? Do we go to get interterritorial advice? We don’t know anything.
“There are so many questions that need to be answered, and no one is answering them.”
Race against the clock
With so much up in the air, the race is on for the current administration to make good on its promises of cannabis reform before the elections take place, which could scupper the project entirely.
Regional and municipal elections are due to take place across many regions of Spain on May 28, with a general election due to take place later this year.
The conservative People’s Party (PP) are now ahead in the polls, with speculation it may need the support of the far-right Vox party to form a government. Both parties voted against the medical cannabis bill in June 2022.
“If we have new elections and the conservatives win, this is going to be a problem. It’s a race against the clock.”
There are also concerns that even a delayed programme would be too restrictive for patients, forcing many to return to Spain’s prevalent illicit market.
One of the issues that the AEMPS has spoken about, according to the OECM, is its reluctance to include the use of flowers in vaporisers, a method approved in numerous EU countries.
Concerns also remain around whether prescriptions will be limited to specialist doctors, in which case Ms Pérez believes there is a risk patients will be forced to choose between waiting lists of up to a year or private prescriptions, likely to be out of budget for the majority.