Current situation
Ongoing challenges
Comment


After the publication of Law No. 33/2018 of 18 July 2018, much has happened within the cannabis market in Portugal. After the law's publication, Portugal started to attract interest from international players wishing to establish operations in Portugal and national companies intending to initiate activity in this field. This was inevitable: the legal framework was innovative and, as an EU member, Portugal could give a stamp of quality and credibility to products manufactured in Portugal.

Current situation

So far, the Portuguese competent authority for medicines and health products (Infarmed) has issued 20 authorisations for cultivation of the cannabis plant for medicinal purposes and eight authorisations for the manufacture of such products. In September 2022, there were 90 pending applications to obtain authorisation for activities relating to medical cannabis in Portugal, including the cultivation, manufacture, import, export and wholesale thereof.

The interest raised by the Portuguese legal framework was justified: it is investment friendly but does not jeopardise the control and supervision of the market by the authorities. This enables the industry to make long-term business plans and provides predictability to their operations. The full regulation of this activity was only concluded on 15 April 2021 with the publication of Ordinance 83/2021, which defined the requirements and procedures regarding the granting of authorisations for the exercise of these activities. Despite this, Infarmed was proactive – it created solutions and mechanisms to keep applications moving even before the publication of the ordinance.

Ongoing challenges

However, several companies have experienced difficulties. Some have gone through insolvency or creditor protection procedures, while others have adopted collective dismissal procedures to adapt their productive structure to the market conditions. Others still have left Portugal, concentrating their operations elsewhere. It makes sense to look at why these circumstances have arisen and, above all, what can be done to overcome the difficulties faced to explore the potential of the market and meet the initial expectations.

Organisation
First, there is a lack of organisation between companies. Companies operating in Portugal are adopting standalone strategies to their businesses, putting aside associations and entities that could be useful in defending their collective interests. As happened with the conventional pharmaceutical industry, sectorial self-organisation enables companies to benefit from their activities. This is even more true when products are highly controlled and cannot be sold in the free market as common products. It is therefore essential that companies join forces and have an interlocutor empowered to represent their interests. This will enable synergy that will benefit all companies and the industry as a sector of activity.

The organisation of the industry will also enable the growth of Portugal as a key player in the sector, even more so considering the legislative evolution in this field across Europe. As Portugal has several state-of-the-art good manufacturing practice processing facilities, beyond processing the raw materials produced within the country, the provision of processing services to foreigner raw materials producers should also be seen as a business field in which to invest.

Promotion
Another aspect on which the industry should focus is the promotion and investigation of applications with respect to products. Despite there being products in the market – both medicines and preparations – the promotion of such products with doctors is technically non-existent. It is essential to invest in the promotion of the products to give comfort and confidence to doctors to prescribe these medicines and substances to their patients.

It is only reasonable to prescribe medicines and substances to patients who can afford them. In fact, the only medicine currently being commercialised in Portugal is reimbursed at 37% by the Portuguese state; the patient is responsible for paying €300. In a country such as Portugal, this value is not affordable for the majority of the patients who need the medicine.

The solution to this problem is to increase the co-payments of products by the Portuguese state. Despite the law already allowing the co-payment of medical cannabis-based products, it seems that no such applications have yet been made. Considering that co-payment requests need to be submitted by the interested company, it is essential to move forward in this field to turn medical cannabis treatments into a real alternative for doctors and patients.

Comment

The sector has a lot of non-exploited potential. Companies, the government and patients need to be more active and diligent in defending their interests to create a real medical cannabis market in Portugal. Otherwise, the medical cannabis market will fail to come to fruition for the industry, the government and, above all, the patients who need such products to treat or mitigate their diseases.

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.