After legalisation, what next for medical cannabis in Portugal?

Cannativa’s Maria Álvares reflects on the landmark decision of legalising medical cannabis in Portugal – Is this a game changer to the cannabis landscape?

In 2018, medical cannabis in Portugal is legal when prescribed by a doctor, dispensed in a pharmacy, and licensed by regulatory body INFARMED but – to the disappointment of many – stopped short of allowing patients to cultivate their own supply. The law – which saw overwhelming support from all parliamentary parties bar the centre-right Popular Party, who abstained – came close to 20 years after Portugal made the radical decision to decriminalise all drugs and has been welcomed by many in the country, who have noted Portugal’s ideal climate for growing cannabis.

Against this background, Cannativa – the Association of Cannabis Studies brings together a range of stakeholders, among them activists, health professionals, politicians, farmers, lawyers and patients – to study and disseminate important information on cannabis, with a view to inspiring a sustainable and informed paradigm shift in drug policy that enables the cultivation, transformation, distribution and consumption of cannabis and hemp – whether for medical or recreational purposes.

Here, Maria Álvares, a member of Cannativa’s scientific board, reflects on the impact of medical cannabis legislation, potential obstacles to access, and its own role in advancing the conversation.

What progress has been made since Parliament voted to approve the legalisation of cannabis-based medicines last year?

Progress has been slow, and regulation was approved only after the legal 60-day period, under pressure by the Parliament and Cannativa. The law was passed on 18 July and Decree No. 8 only published in the official gazette this year, on 15 January, four months after the deadline.

The regulatory entity INFARMED has been analysing dozens of applications, but few licences have been approved and all of them still according to previous rules, targeted at exportation. Even before the new regulation was in place, in what looks like a response to the growing interest in the Cannabis market, INFARMED aggravated the checklist of prerequisites for the granting of licences and licences granted are dominated by already established players, e.g. international pharma companies. Production is still in its first steps, and companies are now establishing their sites of production, with only Tilray hoping to produce in the immediate future.

Does the new legislation go far enough to ensure that patients who need medical cannabis will be able to access it?

INFARMED is not willing or able to implement the law. Holders of marketing authorisations need to supply the market with the medicines for which the licence was granted according to ‘Estatuto do Medicamento’. This is not happening with GW Pharmaceuticals, who holds a marketing authorisation for Sativex. Despite the medical need and the existence of a licence it is not commercially available in Portugal. Under the approved law no co-payments were defined; hence, cost could limit access to patients.

In addition to cost, the availability of medical cannabis in pharmacies is another key concern.

Does Cannativa support calls for licensed patients to be allowed to cultivate their own cannabis?

The freedom to cultivate is one of the main pillars of Cannativa’s view on cannabis policy. We believe in the right to grow your own.

What measures would you like to see put in place to support greater research and information sharing around medical cannabis?

Budget – a serious commitment from the state in areas where the market fails: agronomy, epidemiology and impartial scientific dissemination. Budget is also necessary to comply with the approved law, which states that the government should support/enable R&D in this area. The upcoming expected tax returns could be a source of funding, but since companies are only exporting, they aren’t.

In what ways does Cannativa contribute to the debate on medical cannabis regulation?

Cannativa was consulted in the drafting of the bill presented by the left-wing party that presented the law proposal and was heard by parties with parliamentary seats present in the specialised health commission when the proposal was discussed in specialty.

The process of drafting the bill, plenary discussion, specialty and final vote was accompanied by a significant increase in media attention on the subject. Through Cannapress, its media body, Cannativa produced and disseminated information that fuelled the debate and was present in radio and television programmes where the topic was discussed.

Cannativa also organised Lisbon Medical Cannabis, the first international medical cannabis conference in Portugal and workshop for professionals.

Cannativa was not consulted in the process of law regulation, and all requests for clarification and initiatives of contact with INFARMED to produce clarifications – namely regarding the status of CBD and other aspects – have been unsuccessful.

Maria Álvares
Member, Scientific Board
Cannativa
www.cannativa.pt

Please note, this article will appear in issue 9 of Health Europa Quarterly, which will be available to read in April 2019.