The legal arguments
The appeals are challenging the order on multiple grounds. They place a greater emphasis on equity and patient access than on business interests.
CEOFA’s December appeal argues the decree ‘incurs in a regulatory excess, violating the principle of normative hierarchy and directly contradicting the provisions of the Law on Guarantees and Rational Use of Medicines and Health Products.’
According to the confederation, current legislation recognizes that community pharmacies are legally able to produce compounded medication according to National Formulary when equipped with sufficient resources.
The appeal argues that Article 8 ‘unduly limits an activity that the law does not restrict’ while ‘invading regional powers in matters of pharmaceutical regulation, such as the authorisation of facilities and formulation laboratories.’
CEOFA also contends the decree ‘usurps functions that belong to the AEMPS, an independent technical body to whom the law attributes the classification of medicines and the determination of its prescription and dispensing conditions.’
Both appeals are centered around the issue of access for patients. CEOFA said in its appeal that the network of local pharmacies ensures accessibility, equity in territorial distribution, and professional care for patients, particularly in areas with low healthcare resources or in rural regions.Â
Excluding these drugs without legal or technological basis is a barrier to access for serious illness patients to treatment that has been recognised by the Royal Decree as beneficial.
Cgcof focuses its January 2019 appeal on the inadequacy of the restrictions. The Cgcof stated that there is “no health, legal or safety reasons whatsoever” to limit the dispensing of the compounded medication to Hospital Pharmacy Services, and to prevent patients from accessing them via the community pharmacy network.
Cgcof President Jesús Aguilar has emphasised that community pharmacies already routinely handle controlled medications, including opioids like fentanyl, under strict regulatory oversight, making the exclusion of cannabis preparations appear arbitrary.
These appeals both point out internal contradictions that exist within the original decree. While Article 8 explicitly reserves cannabis preparation and dispensing for hospital pharmacies, Additional Provision Two and Article 9.3 acknowledge that autonomous communities may establish ‘non-face-to-face dispensing measures’ in cases of ‘vulnerability, dependency, or geographical remoteness.’
Next?
It is unclear when the Supreme Court will make a ruling on both appeals. Spanish administrative law can be a complex area that takes months, or sometimes years, to solve.
This weekend the nine-day window to add additional parties will close. However, it is still unclear whether patient advocacy groups or industry stakeholders as well as other pharmacy organizations would join.
The implementation of medical cannabis continues. AEMPS must publish monographs that detail authorised use, dosage parameters and prescription conditions. The deadline for this is today (January 9, 2026). It remains to be determined whether the AEMPS will continue publishing the monographs as long as the legal challenges remain pending, or if it will wait until the Supreme Court makes a decision.
These appeals may have a significant impact on the medical marijuana landscape in Spain. The Ministry of Health could be forced to change the law to allow community pharmacies to participate, potentially allowing thousands of patients to gain access, especially in rural areas, if the appeals are successful. A revision of the decree would most likely prolong implementation, which could be a problem for patients that have been pushing for legal access in rural areas since 2022.
Legal Arguments
In both appeals, the decret is challenged on many different grounds. However, the emphasis in each case has been on access to patients and on fairness rather than commercial interests.
CEOFA’s December appeal argues the decree ‘incurs in a regulatory excess, violating the principle of normative hierarchy and directly contradicting the provisions of the Law on Guarantees and Rational Use of Medicines and Health Products.’
According to the confederation, current legislation recognizes community pharmacists as having the ability to produce compounded medication according to National Formulary provided they are able to provide the resources.
The appeal argues that Article 8 ‘unduly limits an activity that the law does not restrict’ while ‘invading regional powers in matters of pharmaceutical regulation, such as the authorisation of facilities and formulation laboratories.’
CEOFA also contends the decree ‘usurps functions that belong to the AEMPS, an independent technical body to whom the law attributes the classification of medicines and the determination of its prescription and dispensing conditions.’
Both appeals are centered around the issue of access for patients. CEOFA said in its appeal that the network of local pharmacies ensures accessibility, equity in territorial distribution, and professional care for patients, particularly in areas with low healthcare resources or in rural regions.Â
Excluding these drugs without legal or technological basis is an unnecessarily restrictive measure for the patients, as they are unable to access treatments which even Royal Decree acknowledges could be beneficial in serious illness.
Cgcof’s January appeal is focused on the inadequacy of the restrictions. The Cgcof stated that there is “no health, legal or safety reasons whatsoever” to limit the dispensing of the compounded medication to Hospital Pharmacy Services, and to prevent patients from accessing them via the community pharmacy network.
Cgcof President Jesús Aguilar has emphasised that community pharmacies already routinely handle controlled medications, including opioids like fentanyl, under strict regulatory oversight, making the exclusion of cannabis preparations appear arbitrary.
These appeals both point out internal contradictions that exist within the original decree. While Article 8 explicitly reserves cannabis preparation and dispensing for hospital pharmacies, Additional Provision Two and Article 9.3 acknowledge that autonomous communities may establish ‘non-face-to-face dispensing measures’ in cases of ‘vulnerability, dependency, or geographical remoteness.’
Next?
It is unclear when the Supreme Court will make a ruling on both appeals. Spanish administrative law can be a complex area that takes months, or sometimes years, to solve.
This weekend the nine-day window to add additional parties will close. However, it is still unclear whether patient advocacy groups or industry stakeholders as well as other pharmacy organizations would join.
Meanwhile, the implementation of the framework for medical cannabis is continuing. AEMPS must publish clinical monographs that detail authorised use, dosage parameters and prescription conditions. The deadline for this is today (January 9, 2026). It remains to be determined whether the AEMPS will continue publishing the monographs as long as the legal challenges remain pending, or if it will wait until the Supreme Court makes a decision.
These appeals may have a significant impact on the medical marijuana landscape in Spain. The Ministry of Health could be forced to change the law to allow community pharmacies to participate, which would increase access for thousands of patients in rural areas. A revision of the decree would most likely prolong implementation, making it harder for patients to get legal access.
Cannabis Law Resources in Poland
Browse essential legal pages on cannabis sales and cultivation in Poland. You can use these resources to learn about the requirements for certification, permission, and compliance.
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Polish News Registration and Interests of Cannabis Businesses
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Permissions for Cannabis Sales in Poland
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Authorization for Importing or Manufacturing Medical Products
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Permission for Manufacturing or Importing Medical Products
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Certificate of Good Manufacturing Practices (GMP)
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Registration of Medical Products in Poland