Spain had set a goal to regulate and distribute medical cannabis nationwide by the end of 2022. With no announcement, these ambitious plans appear to have been delayed.
December 27, 2022 was the deadline for the Spanish Agency for Medicines and Health Products (AEMPS) to ensure that the proposals, adopted in June, “fit into the regulations”.
As this deadline has passed, the Spanish government has been very tight-lipped about the reasons for the delay and when the legislation could be enacted.
Like Germany’s “traffic light” coalition, the current administration is now engaged in a “race against time” to deliver on its promise of cannabis reform before regional, municipal and general elections set the stage. project in jeopardy.
Doubts remain, however, as to whether this rapid legislative reversal will result in a competent and effective medical cannabis program.
Medical cannabis by the end of the year
After more than a year of research, a subcommittee tasked with studying medical cannabis frameworks deployed around the world has presented its proposals for how a similar framework would look in Spain.
Later in June 2022, the Health and Consumer Affairs Commission of the Congress of Deputies voted to approve these proposals on the wire, with last-minute amendments and threats to scuttle the process entirely.
After the proposals were given the green light, the task fell to AEMPS to prepare a document with recommendations on how to integrate this framework into the country’s regulations and ensure that they are legally viable.
However, AEMPS has only had six months to complete this task, as the government strives to reduce delays and get the medical cannabis project through as quickly as possible.
More than two weeks after the initial six-month deadline, this document cannot be found, which blocks any progress in the adoption of these proposals.
“We have no idea what’s going on,” Carola Pérez, president of Spain’s Medicinal Cannabis Observatory (OECM), told BusinessCann. “We have no response from the Spanish government… We are afraid that the Spanish government is playing with us. »
According to Ms. Pérez, while the AEMPS promised the OECM that it had to meet its deadline, there is now radio silence on the situation.
She added that some news reports have suggested the report could be ready by January 20, but nothing has been confirmed.
In a statement to the Spanish publication El Mundo the day after the original December 27 deadline, the AEMP said it intended to publish the recommendations before the end of the year, if not in the first days of January.
“Everything indicated by the sub-commission has been collected, and has been compared with all the guides of the European Union and with the models of other countries. They are looking for the best way to guarantee the quality, safety and efficacy of the drug. Even though we know that not everyone will be satisfied, we must act as a scientific-technical body. »
Furthermore, the government has given little indication of what will happen after the report is released.
She continues: “No one has answered the question: when the agency publishes the report, what will happen next? Should we go back to Congress and vote? Should we go to the Minister of Health? Are we going to ask for an interjurisdictional opinion? We don’t know anything at all. »
“There are so many questions that need to be answered, and no one is answering them. »
A race against time
With so much up in the air, the race is on for the current administration to deliver on its cannabis reform promises before an election takes place, which could derail the project entirely.
Regional and municipal elections are due to take place in many parts of Spain on May 28, with general elections expected to take place later in the year.
The conservative People’s Party (PP) is currently leading the polls, and 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 a new election and the Conservatives win, that’s going to be a problem. It’s a race against time. »
Some also fear that even a delayed program will be too restrictive for patients, forcing many to return to Spain’s predominant illicit market.
According to the OECM, one of the issues AEMPS has spoken about is its reluctance to include the use of flowers in vaporizers, a method approved in many EU countries, including France as part of its experimentation.
Concerns also remain over whether prescriptions for medical cannabis will be limited to specialist doctors, in which case Ms Pérez believes there is a risk that patients will be forced to choose between waiting lists of up to one year or private prescriptions, which may be out of budget for the majority.