cultivation and manufacturing, the country is poised to become one of the world’s principal producers of cannabis for medical use.
Medical cannabis has shown efficacy in a number of conditions, including palliative care for cancer, chronic pain and epilepsy. However, regulatory approaches across countries are far from harmonised and policies with respect to medicinal cannabis production and consumption vary greatly. In Europe alone certain countries provide for its cultivation and use while others strictly prohibit it.
Apart from its favourable climate, low production costs, and a strategic location within Europe, Portugal’s well-established medical cannabis legislation has made the country an attractive location for medicinal cannabis production and exportation. With a legal framework that was put in place in 2018 and practical requirements for the cultivation and manufacture of cannabis-based products created in 2021, Portugal is rapidly becoming a hotbed for medicinal cannabis.
Last year saw a 63 percent increase in the volume of exports and up until August of this year, as reported by Canna Reporter based on figures from Portugal’s National Authority of Medicines and Health Products (Infarmed), the country has exported more than 5.4 tons of cannabis, mainly to Germany, Poland and Australia.
Portugal appears to have found a balance between establishing the necessary rigor to ensure safety and quality while incentivising investments in the sector. “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,” asserted Ricardo Rocha from Portuguese legal firm PLMJ.
“It will be hard for countries such as Colombia or Lesotho to produce at the same standards and lower costs than what we foresee in Portugal,” Miguel Silva, CEO of Portugal-licenced grower Sabores Púrpura told MJBizDaily.
The Role of Infarmed
Infarmed, Portugal’s regulatory authority for medicinal products, preparations and substances, has been instrumental in creating and implementing a robust regulatory framework, as well as in licensing and inspection of the various entities operating in the medical cannabis market.
To create its regulatory structure, Infarmed looked to other countries’ experience in the areas of licensing, inspection, manufacturing, and research activities, particularly those with more mature regulatory regimes such as Canada and Israel. Infarmed also closely monitored companies looking to enter the medical cannabis market in Portugal, which provided the authority with an opportunity to accumulate experience and translate it into the design and improvement of the existing regulatory regime.
Infarmed’s criteria for evaluating medicinal cannabis operations are exhaustive and comprise compliance with Good Agricultural and Harvesting Practices (GACP) and Good Manufacturing Practices (GMP) as well as compliance with the United Nations order against illicit traffic in narcotic drugs and psychotropic substances. The regulatory body also assesses the implementation of security measures within production facilities; the traceability of products, as well as the economic feasibility and the health value proposition of each project.
“It’s a health agency that doesn’t take any unnecessary risks,” said Silva. “That’s why everything needs to be very well documented to get a license.”
The regulatory body has claimed that for international companies looking to establish operations in Portugal, the country’s regimented regulatory environment coupled with the fact that many other European countries do not have such specific regulations have made it an attractive investment destination.
Growing Number of Players
The number of companies looking to edge into the Portugal’s cannabinoid market is indeed on the rise. This year, the agency issued no less than 76 new authorisations to cultivate, manufacture, import, export and distribute medicinal cannabis in Portugal. Moreover, there are an additional 265 requests in the regulatory body’ post-decision or suitability for inspection phase.
24 companies currently hold licenses for cultivation, while 15 have licenses for the manufacture and preparation of substances and preparations, 12 for wholesale trade, and 32 for import and export. Among the authorised companies, 17 have already obtained EU Good Manufacturing Practices (GMP) certification.