Introduction
Regulation
Authorisation
Price setting
Current state of market
Cannabis for personal use
Comment
Three years have passed since the approval of the Portuguese medical cannabis law. In this period, many changes have taken place in this area, the main one being the fact that Portugal has now started to build a medical cannabis market.
Since the approval of Law No. 33/2018 on 18 July 2018, Portugal has become one of the most sought-after countries in Europe for the development of cannabis projects. Many leading worldwide players have turned their attention to Portugal and the country currently has a significant number of projects in the pipeline promoted or endorsed by such companies.
From a regulatory point of view, after the publication of Law No. 33/2018, the government issued Decree Law No. 8/2019 on 15 January 2019, which framed the following activities relating to the cannabis plant for medical purposes:
- cultivation;
- production;
- extraction and manufacturing;
- wholesale trade;
- import and export;
- transit;
- acquisition; and
- sale and delivery of medicines, preparations and substances.
The decree law also covers the placing on the market of medicines, preparations and substances based on the cannabis plant for medical purposes, and it establishes the terms and conditions under which such products can be marketed, prescribed and sold.
The decree law referred to a ministerial order that would establish the process for applying for an authorisation to work with medical cannabis, regardless of whether it is the cultivation, manufacture or marketing thereof. The resulting order, Ministerial Order No. 83/2021, was finally published on 15 April 2021.
The publication of this ministerial order had been long awaited given that it establishes the practicalities behind the applications to obtain an authorisation to engage in activities relating to medical cannabis. Although the competent authority (Infarmed) had adopted an internal procedure covering these applications, the ministerial order has clarified many practical aspects of the application requirements.
Before the publication of the ministerial order, Infarmed's approach had been very proactive and collaborative. It continued to insist on high standards and clarified that the restrictions and safety requirements applicable to working with controlled substances had to be followed. The concepts and mechanisms created by Infarmed enabled applicants to proceed with their application projects without being blocked by the absence of a regulatory ministerial order, allowing companies to make progress with such projects.
Despite the delay in publishing the regulation, the government was diligent in regulating the mechanism for setting the prices of preparations and substances. In fact, Ministerial Order No. 44-A/2019, issued on 31 January 2019, establishes the mechanisms under which the price of medicines, preparations and substances based on the cannabis plant intended for medical purposes should be set. In general, the framework establishes that the price should be proposed by the holder of the authorisation to place the substance on the market to Infarmed, with reference to the current price on the international market. The price will then be approved or refused by Infarmed. In case of refusal, the holder of the authorisation to place the substance on the market should propose a new price.
When it comes to setting the prices of medicines based on the cannabis plant, the pricing mechanisms are the same as those that apply to common medicines.
Furthermore, in January 2019, a resolution of Infarmed's board of directors established the first seven therapeutic indications for preparations and substances based on medical cannabis. These indications primarily relate to pain pathologies, such as multiple sclerosis, oncology and epilepsy.
Although the regulatory framework is established, the truth is that the use of medical cannabis products is still limited. On the one hand, the market does not have a significant number of alternatives. In the case of medicines, at the moment, only Sativex is sold on the Portuguese market at a relatively high price,(1) even though it is subject to co-payment by the state. As regards substances and preparations, there are some applications pending before Infarmed, but, for the moment, only one preparation is currently being marketed and it is not subject to co-payment by the state. Besides, the medical world has been expressing reservations, mainly due to the lack of evidence on the use of medical cannabis.
Even though the legal framework is sufficient to allow the use of medical cannabis products, there is still a lot to be done before medical cannabis products can be fully implemented and used in Portugal. Various issues relating to the development of the market must first be resolved.
Doubts about medical cannabis
The first issue relates to the need for medical professionals to resolve their doubts and fears about medical cannabis. The final decision on the use of a medical cannabis product is in the hands of doctors and they will only use such a product – either a medicine, a substance or a preparation – if they trust the product.
Price of medical cannabis
The second aspect is the price. As mentioned, there is currently only one medicine being marketed in Portugal with a price of €475.27. Even with co-payment at a rate of 37%, the patient still has to bear a significant part of the price, which makes access to therapy difficult for a significant proportion of patients. With regard to substances, there is also only one currently being marketed in Portugal,(2) for which the Portuguese state does not partake in co-payment.
The solution to the problem lies in rebalancing the margins of the different players in the value chain by reviewing the prices of these substances, particularly by considering increasing the co-payments granted to these medicines, preparations or substances. This rebalancing would:
- make such therapies more accessible to users – which is particularly relevant when these therapies are most often the last resort for the treatment or control of symptoms associated with serious pathologies; and
- make the market more attractive for the pharmaceutical industry, justifying investment in research and development and the launch of new products on the market.
Parliament has started discussing the liberalisation of cannabis for personal use. The bills were submitted by the parties Bloco de Esquerda ("Left Block") and Iniciativa Liberal ("Liberal Initiative") and intend to allow the consumption of recreational cannabis, without prescription, under certain circumstances. However, to date, there has been no vote on the bills.
The bill will certainly be up for discussion again in the near future; it is possible that a market for recreational cannabis will become a reality in Portugal by the end of 2022.
It is important to mention that the covid-19 pandemic has affected the Portuguese medical cannabis market by taking the industry by surprise. Players are now waiting to see the extent of the impact before working out how they will overcome the delays caused by it.
Nevertheless, Portugal continues to attract many global players, which are maintaining and even increasing their investments in Portugal. Considering that the recovery is already underway, there are good reasons to believe that prosperous times are on the horizon for this sector in Portugal.
For further information on this topic please contact Ricardo Rocha at PLMJ by telephone (+351 213 197 300) or email ([email protected]). The PLMJ website can be accessed at www.plmj.com.
Endnotes
(1) Sativex is co-funded by Portuguese state under the general regime at a rate of 37% of a selling price of €475.27.
(2) Dry flower for inhalation, with a selling price of €150.87.