Authors: João Taborda da Gama & Joana Albernaz Delgado
July 18 marks the first anniversary of the Portuguese medical cannabis law. Law 33/2018 set the framework for the regulation of the use of cannabis-based medicinal products, preparations and substances that would effectively allow Portuguese patients to access medical cannabis What really has changed during the last year? Very little happened in practice, but a lot changed in the regulatory setting – or, at least, that setting is now much clearer.
As we wrote one year ago, this law showed some inconsistencies due to political setbacks and last minute amendments, which could harm its success. General provisions on marketing authorizations for medical cannabis, for instance, raise significant doubts on whether the Parliament wanted to bring medical cannabis closer to classical medicinal products, which in the end could delay significantly the implementation of a medical cannabis system. Fortunately, the way the medical cannabis law was regulated by the Government provided more clarity and certainty on the regulatory framework: in January 2019, the Government published Decree Law 8/2019, detailing the requirements under which medical cannabis could be marketed, prescribed and sold.
The major merit of Decree Law 8/2019 was to provide a clear distinction between cannabis-based medicinal products, cannabis-based preparations and cannabis-based substances (dried flower and oils). In fact, after Decree Law 8/2019 it is now undeniable that cannabis-based preparations and substances have a different framework:
Cannabis-based medicinal products (such as Sativex®) are typical medicines, regulated under the medicinal products legal framework and subject to marketing authorizations (in fact, a change in the law was not necessary to accommodate such products);
Cannabis-based preparations and substances (e.g. dried flower and oils) are now clearly considered as a separate and distinct class od products. This does not mean they do not share some of the provisions applicable to conventional medicinal products when relevant, but they are now clearly recognized and have their own regulatory requirements.
That is precisely the case of the marketing authorization for cannabis-based preparations and substances. While Law 33/2018 only mentioned vaguely the marketing authorization as a requirement for preparations and substances, Decree Law 8/2019 clarified that cannabis-based preparations and substances will have a different marketing authorization, called authorization for placing on the market, or ACM (autorização de colocação no mercado). ACM takes in consideration the characteristics of medical cannabis preparations and substances, and is a simplified version of the marketing authorization required for medicinal products to some extent (for instance, no clinical trials are required).
Additional regulations were also approved this year, both coming from the Government and the narcotics and pharma regulator, Infarmed. The Government approved regulations on the medical cannabis pricing, and Infarmed, following the provisions of Decree Law 8/2019, approved a very strict list of therapeutic indications appropriate for medical cannabis preparations and substances (spasticity associated with multiple sclerosis; nausea and vomiting caused by chemotherapy, radiotherapy; appetite stimulant for cancer or HIV patients in palliative care; chronic pain associated to oncologic disease or to the nervous system; Tourette’s syndrome; refractory epilepsy in children; and drug resistant glaucoma). Although this list can (and should) be periodically reviewed, Portugal lost an opportunity to expand the access to more patients and give more flexibility to the medical community on the prescription on medical cannabis. At the same time, a closed list of therapeutic indications will also hinder scientific knowledge and research.
Infarmed was also proactive on the implementation of the medical cannabis law, making sure information on the new legal framework was available online to patients, health professionals, companies and the wider public since the entry in force of Decree Law 8/2019.
Regardless all these regulatory developments, what did change, in fact? Is there any marketed cannabis-based preparation or substance available in Portugal? Is the medical and the patient communities more aware of what medical cannabis is and how it can be used? Do pharmacies know how to deal with medical cannabis? The answer to all those questions is no. For now, at least.
It is true that one year is still a short period of time to implement a brand new market, especially in a such sensitive area (health and therapeutic products) and with a such sensitive product (cannabis is still a controlled substance both at the national and international level after all, although some changes are expected on that too). Companies applying for ACM are still navigating the new regulatory framework, and the same happens with the regulator. But there is a lot to be done on the Government side, especially at the educational and informational levels to doctors and patients. The law approved last year set out that the Government should make information available to doctors and other health professionals, on cannabis based medicinal products, preparations and substances. That is yet to be done, and there is no real access without a well-informed medical and pharmaceutical community.
Although Portugal has now a regulatory framework that allows the access of Portuguese patients to medical cannabis, we are still some steps away from providing patients medical cannabis treatments. The hardest part has already been done. Let us hope this last mile is completed soon, so that the Portuguese medical cannabis law can effectively get off the ground and patients can have full and affordable access to the products.