Last year, on 18 July 2018, Law no. 33/2018 was published in Portugal, legalising the use of cannabis for medicinal purposes. Within this new legislation, it was estimated that regulation would be issued 60 days following the law’s publication. However, it was almost 6 months later – on 15 January 2019 – that the Decree-Law no. 8/2019 was released. This goes to show how intricate and incredibly diverse this subject can be. Even with such detailed regulations in place, qualifying patients in Portugal are still struggling tremendously to access medicinal cannabis. In this article, I will dive into understanding Portugal’s regulations and how these may be affecting patient accessibility.
As allowed in the new legislation, Infarmed – the Portuguese Government agency ‘accountable to the Health Ministry, that evaluates, authorises, regulates and controls human medicines as well as health products’ – will oversee the supervision and regulation of medicinal cannabis. As the approving body of the industry’s licensing, it will oversee pharmacovigilance, approve and conduct studies into the industry, and determine the list of approved conditions and medical cannabis therapies. Infarmed have dedicated a page of their website to medical cannabis, providing information to patients, health professionals and trading entities. They have even provided an ‘adverse reactions’ form online to incentivise patients and health professionals to work together in the reporting of side effects of approved and prescribed cannabis-based medicines. Reporting of adverse effects will be a legal requirement.
Licensing to supply
When the law first came out in 2018, it was initially envisaged that The Military Laboratory of Chemical and Pharmaceutical products (LMPQ) would be the manufacturer of cannabis-based medicines in Portugal. However, the Decree-Law no. 8/2019 now states external bodies will also be able to apply for licenses for production, transportation, exportation, and cultivation. Infarmed will approve/reject applications within 90 days from the information, paperwork and payment provided. LMPQ will contribute to cannabis production, and must follow protocol in place for product testing and approval, but they will be exempt from any fees. Any products introduced to the market must comply with The Good Agricultural and Collection Practice Guidelines, as well as the following Portuguese laws:
- Law no. 33/2018, 18th July – Regulates the use of cannabis-derived products, preparations and substances for medicinal purposes.
- Decree-Law no. 8/2019, 15th January – Further regulates the use of cannabis-derived products, preparations and substances for medicinal purposes.
- Decree-Law no. 15/93, 22nd January – Legal regime surrounding the traffic and consumption of narcotic and psychotropic drugs.
- Regulatory-Decree no. 61/94, 12th October – Further regulates the Decree-Law no. 15/93, 22nd January.
- Ordinance no. 44-A/2019, 31st January – Governs the price regime for cannabis-derived products, preparations and substances for medicinal purposes.
Who will benefit?
Cannabis-derived medicines must be prescribed under the narcotics and psychotropic substances rules via a specific medical prescription and then dispensed strictly at pharmacies only. No medical license will be required for the patient but they will need a new medical prescription every time they require the medication. Infarmed have provided a list of conditions qualifying for medical cannabis, given that all conventional treatment methods have been unsuccessful:
- Spasticity associated with multiple sclerosis or spinal cord injuries
- Nausea and vomiting resulting from chemotherapy, radiotherapy and combined HIV therapy and hepatitis C medication
- Appetite stimulation in palliative care of the patient undergoing oncological or AIDS treatment
- Chronic pain associated with oncological or nervous system conditions such as neuropathic pain caused by nerve damage, phantom limb pain, trigeminal neuralgia, or after herpes zoster infection
- Gilles de la Tourette syndrome
- Epilepsy and treatment of severe seizure disorders in childhood such as the Dravet and Lennox-Gastaut syndromes
- Therapeutically resistant glaucoma
Cost of supply
Although all the conditions above are considered to qualify for cannabis-derived medication, so far Sativex has been the only cannabis-derived medication to be accepted. Not only is Sativex cost restrictive, at roughly €500 per month, but it has been patented only for the treatment of Multiple Sclerosis (MS) – meaning that only patients with MS that are financially well off currently have access to medicinal cannabis in Portugal. All other qualifying patients remain without access.
After Portugal’s drug decriminalisation law in November 2000 (Law no. 30/2000), and the rejected proposal for full legalisation in 2013, medical cannabis has now been successfully legalised. However, the legislation fails to separate medicinal use without a medical prescription and recreational use, associated with illicit acts such as drug trafficking or drug abuse. Personal possession or cultivation will, in fact, remain a violation under the decriminalisation law. Possession and cultivation for distribution purposes without the necessary licenses will be treated as a criminal violation.
However, although medicinal cannabis is legal, as long as a patient qualifies for a medical prescription, most qualifying patients remain with no access. So, if such
When will legislation benefit?
It is great that Portugal has joined
Jess Simoes is co-owner of Cannabinoid Soul