Spain’s Ministry of Health has launched a public consultation on a proposal for a national medical cannabis framework.
Organizations and individuals now have until March 4 to submit comments on the proposal, in order to keep Spain’s new government committed to moving forward with the long-delayed rollout.
While stakeholders and patients welcome the opportunity to participate in shaping the industry, many complain about the limited range of products available and the indications they cover.
Most notably, under the current iteration, any form of medical cannabis flower will be completely 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 of developing a Royal Decree” that would approve the regulation of medical cannabis.
The draft Royal Decree has now been published and the government is inviting all interested parties to provide feedback on the proposal.
A meeting was held on Tuesday between the Ministry of Health and representatives from all of Spain’s patient communities to explain the proposals, and “all these organizations have approved the regulations.”
Discussions between the Department of Health and various patient organizations will continue throughout the consultation period, during which both organizations and individuals will be able to submit donations until 4 March.
Submissions can be sent to – Normative.aemps@aemps.es
it will come in a few weeks cannabis business Spain’s newly appointed Health Minister Mónica García Gómez appears in parliament for the first time, more than a year after the initial planned rollout, reaffirming her determination to establish a national medical cannabis framework. It was reported that.
Draft Royal Decree
In June 2022, after more than a year of research, a subcommittee tasked with examining medical cannabis frameworks being rolled out around the world issued recommendations on what a similar framework in Spain might look like. submitted.
In his speech to Congress in January, Garcia made it clear that these proposals would play a key role in the legislation the department is putting together.
The draft Decree appears to closely follow these recommendations and presents a framework that appears to be relatively prudent.
According to the text, the subcommittee’s report ordered the Spanish Agency for Medicines and Health Products (AEMPS) to give patients greater access to cannabis medicines “in the form of master formulas made from extracts and standardized preparations.” recommended that they do so.
“In this sense, the use of standardized preparations, in accordance with the recommendations of the subcommittee, is the most guaranteed procedure in terms of dosage, correct processing and stability.
“For this purpose, it is planned to create a monograph that will establish, among other things, the methods of preparation and administration of the master formula, the technical specifications, the conditions for display or storage, the quality control and the information provided for health. ” To professionals and patients. ”
In a nutshell, it is understood that only cannabis oil will be approved and then used in the production of the “master formula”.
These require specialist approval from Spain’s National Health System (SNS), meaning that private industry (as in the UK) is unlikely to be allowed to operate.
Furthermore, it is expected that the dispensing of these preparations will be limited to hospital pharmacies rather than Spain’s 22,000 local pharmacies. This was one of the main concerns raised by activists when the recommendation was first discussed 18 months before his.
Importantly, both THC and CBD cannabis flower are absent from the available products, which is one of the key demands among the Spanish patient community.
In a social media post about the news, the IAMC Patient Council denounced the omission of the item, which is “far from ideal for patients who find oil less effective” and urges these patients to continue to rely on the illicit market. He suggested that there was a possibility that the government would no longer be able to obtain
Although there are no specific details regarding the indications for which medical cannabis may be prescribed, the legislation does state that prescriptions will only be authorized for conditions for which there is the most evidence of its effectiveness. It is understood that the purpose is
These include chemotherapy-induced nausea and vomiting, intractable pain, rare forms of epilepsy, multiple sclerosis, and endometriosis.
However, the draft regulations state that “the regulations are designed to evolve dynamically, allowing new elements to be incorporated as more information and experience becomes available.” Therapeutic cannabis programs will be available. ”
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