AUTHORED BY: João Taborda da Gama | Joana Albernaz Delgado

July 3, 2018

Five hundred years after showing medical cannabis to the West, and one hundred years after approving legislation that allowed the prescription of medical cannabis, Portugal passed last month the bill that will allow Portuguese patients to effectively access medical cannabis – we hope.

The bill was approved by the Parliament without a single vote against, although one right wing political party abstained. The bill still needs to be approved by the President (the President has the power to veto and/or suggest amendments) and once in force it must be regulated by Infarmed, the pharmaceutical and narcotics regulator.

The bill covers the use of cannabis-based medicines, preparations and substances: medical cannabis will be prescribed to Portuguese patients with a special medical prescription, but only when other medicines are not proven useful (a very broad concept left to the doctors discretion); cannabis-based medicines, preparations and substances can only be placed on the market after a market authorization is issued by Infarmed; and the Government, the law prescribes, should invest in clinical research in this area. Also, Infarmed can create a special office for medical cannabis and the military lab from the Ministry of Defense can be a player in the production of cannabis-based medicines, preparations and substances.

Five hundred years ago, Garcia de Orta, a Portuguese Jewish physician and naturalist, published in India a work on drugs, spices and other natural products used for several purposes, including medicinal purposes, in which he detailed the use and effects of bangue, a traditional drink made with cannabis leaves and seeds (1563). This was the first-time cannabis was described by an European as a medicinal herb, and soon the work of Garcia de Orta became an indispensable scientific catalogue all across Europe.

Ironically, the detailed bill passed in Parliament last month comes also almost one hundred years after the first regulation on medical cannabis was approved in Portugal. In line with the treatment of medical cannabis in the international treaties on drug control, Portugal regulates the production and prescription of medical cannabis since 1926. Cultivation, however, was only allowed in the law in 1970 and the first license was not awarded until 2014 when a GW affiliated company was granted an authorization to cultivate, import and export cannabis for medicinal purposes. Since then, another license was issued to Tilray in 2017 and, according to the media, several more are pending.

Although the prescription of medical cannabis was set out in the Portuguese legislation for almost a century, and although medical cannabis can be cultivated and manufactured in Portugal, the access to medical cannabis was not fully regulated and therefore was not possible until the law now approved.

Portugal has also one of the most innovative narcotic legal framework since drug possession and consumption were decriminalized in 2001, which is a case study all over the world. Under the Portuguese narcotics law, drug users are considered patients first, not criminals, and adequate measures are taken to make sure they have the necessary medical follow-up instead of being sentenced to prison. It was this ground-breaking public policy Portuguese approach to narcotics, as well as the steady and long-standing legal framework for medical cannabis, the two major reasons that made Portugal a potential target for medical cannabis investors. Furthermore, the climate conditions associated with economic and political stability, liberal public opinion views in what concerns cannabis and top-level clinical research makes Portugal a much sought-after market.

The law approved by the Parliament comes from the proposals submitted by a radical left-wing party (Bloco de Esquerda) and PAN, the green party (no pun intended). The original proposals suffered setbacks as the provisions on self-cultivation raised concerns that this would be a trojan horse for adult-use. The original wording was also criticized by members of the Portuguese pharmaceutical community who still see cannabis as a substance that is yet to be proven safe and effective for medical use, arguing it should be regulated as a standard medicine. This criticism led to changes in the draft bill before the final approval. Due to the last minute political compromises and amendments, the final text has inconsistencies that can prove detrimental to patients (even when compared to the sparsely regulated existing framework). For instance, the new law sets out that placing cannabis-based medicines, preparations and substances on the market needs a marketing authorization from Infarmed. This is a new provision, since the law in force does not require a marketing authorization for medical cannabis. And a difficult one, because no other detail is provided, which means for now it is not possible to know if the Parliament wants medical cannabis to have a specific marketing authorization, with specific requirements, and which will these requirements be.

All the inconsistencies in the bill, added to the fact that all countries implementing medical cannabis programs are still learning in the process, demand that clear and flexible regulation is approved by the Government and technical guidelines are issued by Infarmed, which must be in line with the Parliament’s will to grant access to medical cannabis to Portuguese patients in a quick and reliable way.

Only if the law just passed is reasonably regulated and applied we can say that Portugal is again leading public policies on drug control and pharmaceutical regulations like it did in 2001 or if we are taking a step backwards. Whatever the answer will be, the broader debate was launched and surely is changing the way in which the medical and pharmaceutical communities approach medical cannabis.

João Taborda da Gama (joao.gama@gamagloria.com) is a founding Partner and Joana Albernaz Delgado (joana.delgado@gamagloria.com) an Associate at Gama Glória (www.gamagloria.com), a Lisbon based law firm that provides strategic advice to businesses and governments and helps clients facing regulatory and public policy challenges.