Spain’s long-awaited and hard-fought laws to launch a medical hashish market within the nation has been slammed by pharmacists, affected person advocacy teams and hashish companies.

The draft decree, which was printed earlier this 12 months, was instantly criticised for its restrictive nature, stopping the nation’s in depth community of native pharmacies from with the ability to prescribe, and dismissing hashish flower as an possibility for sufferers.

With the deadline for the second public session interval on the proposals now handed, the business has as soon as once more been left ready to know what form Spain’s medical hashish business may take.

What occurred?

Two weeks in the past, the general public remark interval on the draft decree, which was printed on September 30, got here to a detailed.

As per the draft decree, Spain’s plan for medical hashish use outlines 4 particular indications for its software: spasticity attributable to a number of sclerosis, extreme refractory epilepsy, nausea and vomiting brought on by chemotherapy, and continual refractory ache.

Notably, the checklist of authorised indications could also be expanded or modified primarily based on rising scientific proof, making certain the plan stays adaptable to new developments.

The plan additionally establishes a register of standardized hashish preparations, which shall be utilized in particular circumstances. Standardized magistral formulation will solely be employed when authorised medicines (like Sativex) are unavailable or unsuitable for a affected person’s wants. In such instances, docs should completely justify their resolution, documenting the rationale within the affected person’s medical historical past.

Moreover, sufferers shall be knowledgeable in regards to the accessible medical proof, anticipated advantages, and potential dangers related to medical hashish use.

The plan imposes sure restrictions on the prescription and dishing out of medical hashish. Solely specialist docs shall be authorised to prescribe medical hashish, excluding major care physicians from this course of. Moreover, medical hashish will solely be allotted in hospital pharmacies fairly than neighborhood pharmacies.

It’s price noting that Spain already has authorised and marketed cannabis-based medicines, akin to Sativex. Underneath the brand new plan, docs will solely be capable to prescribe medical hashish (within the type of magistral preparations) when these approved medicines are ineffective or inapplicable, that means flower at present is not going to be prescribed.

No flower

This improvement is critical, as Spain is one in every of Europe’s main medical hashish manufacturing hubs, with an estimated output of 23.4 tonnes in 2023.

Whereas the upcoming framework is predicted to drive development in Spain’s medical hashish cultivation market, with manufacturing output for export projected to extend by 50% in line with Prohibition Companions, the dearth of inclusion of flower within the home market presents an enormous missed alternative for one in every of Europe’s most prolific growers.

At present, the business is comparatively concentrated, with seven licensed corporations for medical and scientific functions.

Over a dozen corporations even have analysis licenses, utilising a big proportion of Spain’s cultivated hashish (4,365 kg in 2023) for analysis functions

At present, the few corporations with a business cultivation licence, akin to Linneo Well being and Medalchemy, export giant volumes of medical hashish overseas.

One other firm with a business cultivation licence is Canamedics, the one licenced grower in Spain’s most prolific cultivation area, Catalonia,  which additionally at present exports giant volumes of medical hashish throughout Europe.

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In a latest LinkedIn Publish, the corporate stated of the restrictions round prescribing flower within the draft decree: “It’s stunning that many of the medical hashish produced underneath authorization in Spain is for the manufacturing of medical hashish flower (not extract) for medical functions that’s prescribed to sufferers in lots of different international locations round us.”

They continued: “The draft says {that a} standardised hashish preparation can solely be a number of standardised extracts beforehand registered by the Aemps. The definition of a standardized hashish preparation appears very restrictive to us if we analyze the truth and high quality of the proof.

“We should proceed to combat for a regulated market the place sufferers have actual entry to the remedy that works for them.”

No dishing out in native pharmacies 

Moreover, the dishing out of those preparations is predicted to be restricted to hospital pharmacies fairly than Spain’s 22,000 native pharmacies. This was one of many key issues raised by activists when the suggestions had been initially mentioned in 2022.

The Ministry of Well being has justified this resolution, claiming that it takes under consideration the conclusions of the Subcommittee which analysed the regulation of medical hashish again on the beggining of the method, regardless of the ultimate opinion of the suggestions in 2022 requesting their inclusion. 

It additionally argues that the given situations for which medical hashish shall be prescribed require monitoring, which is carried out in a hospital setting.

A refrain of discontent has now erupted from Spanish pharmacists over the federal government’s omission.

The Common Council of Pharmaceutical Faculties has expressed remorse that the Ministry of Well being has not thought of the potential of neighborhood pharmacies in dishing out standardised hashish preparations.

“We imagine that there are not any well being, security or authorized causes that justify limiting the dishing out of standardized hashish preparations to hospital pharmacy companies,” a spokesperson advised Público.

This sentiment is echoed by the Council of Pharmaceutical Faculties of Catalonia, which has additionally spoken out in opposition to the exclusion of neighborhood pharmacies from dishing out hashish prescriptions.

The Spanish Society of Main Care Pharmacists (SEFAP) has been notably vocal in its objection, highlighting the absurdity of sufferers having to journey lengthy distances to hospitals to entry their medicine.

“It’s absurd… Evidently we’re going backwards with hashish, when pharmacies have already been coping with narcotics every day for a very long time. It’s too timid,” stated José Manuel Paredero, President of SEFAP.

The Spanish Observatory of Medicinal Hashish (OECM) has additionally weighed in, lamenting that sufferers’ wants haven’t been taken under consideration within the regulation. “Simply as these of us who want it now decide up fentanyl on the pharmacy subsequent to our home, we might decide up hashish oil… Sufferers have the suitable to the absolute best high quality of life. We will not be curable, however we will be cared for,” stated Carola Pérez, President of OECM.

Different organizations, together with the Spanish Society for Individualized Treatment (LASEMI) and the Impartial Skilled Affiliation of Pharmacists Formulators (APROFARM), have additionally joined the refrain of discontent.

LASEMI’s President, Concepción Chamorro, emphasised the advantages of accessibility and price financial savings, saying: “Pharmacies enhance entry for all sufferers who want it… The neighborhood pharmacy is a assure of the preparation, custody and dishing out of individualized medicines derived from hashish.”

What subsequent?

Following the remark interval, the Ministry of Well being will analyse the suggestions obtained and doubtlessly revise the draft Royal Decree, a course of anticipated to take round 2-4 weeks, relying on the amount of feedback and the extent of the revisions.

Potential Timeline:

• Evaluation and Revision (2-4 weeks): October 22, 2024 – November 18, 2024 (anticipated)
• Interministerial Session (1-2 weeks): November 19, 2024 – December 2, 2024 (if vital)
• Approval by the Council of Ministers (1-2 weeks): December 3, 2024 – December 16, 2024
• Publication within the Official State Gazette (BOE): December 17, 2024 – January 7, 2025 (estimated)
• Entry into Power: Estimated January or February 2025, relying on the publication date and any potential transitional durations.

Whereas the Ministry of Well being had promised to roll out the medical hashish framework this 12 months, contemplating the in depth delays to the method thus far, sufferers might nonetheless be ready months earlier than significant progress is made.