Lawyer Joana Silveira Botelho provides regular legal assistance to pharmaceutical companies and other entities of the health sector. Here she examines Portugal’s new regulatory framework on cannabis for medicinal purposes.
What will actually change considering that in Portugal (and in the European Union) it is already possible to obtain a marketing authorization for a medical product containing components of cannabis?
The use of cannabis for medical purposes is about to become a reality in Portugal. At least, that’s what is expected by the year-end. After a national discussion, involving multiple payers, on July 18, 2018, the Portuguese Parliament approved the legalization of cannabis for medical purposes.
The new law establishes the legal framework for the medical use of medicinal products, preparations and substances extracted from the cannabis plant. According to the new law, these products are subject to marketing sanctions to be outlined by the national agency on medicinal products, Infarmed. It is also established in the new law that, the therapeutic indication of these products shall be approved by Infarmed.
The law was approved, but we are still waiting on further regulation necessary to implement the new rules. It should have been in force by September 18 and we are still waiting.
But, what will actually change considering that in Portugal (and in the European Union) it is already possible to obtain a marketing authorization for a medical product containing components of cannabis? And considering also, that it is already possible for a company in Portugal to obtain a license to cultivate, produce, extract, manufacture and distribute substances derived from the cannabis plant?
Although we believe that, from a legal perspective, it is not very clear from the new law what will, in fact, change with the legalization of cannabis for medical use, we are of the opinion that the regulation to implement the new law will clarify these doubts. We believe that the regulation will create a new framework for a new medical product. We know that the commercialization of the products shall be subject to marketing restrictions authorized by Infarmed, but most likely it will be a much simpler and faster procedure. It would not make sense otherwise, once it is already possible to submit a medical product containing cannabis to obtain a marketing authorization under the medical products framework.
Infarmed will also be responsible for defining the authorized therapeutic use of these products. Therefore it shall be ruled a new procedure to supervise the therapeutic indications approved and the respective prescription of the products by the physicians and pharmacies.
Regarding the cultivation, extraction, production and manufacturing, these activities are currently being authorized by Infarmed based on a law from 1993. There may be an update of the authorization procedures to undertake these activities, but no material change is expected.
Considering the above, we may conclude that Portugal has legalized the use of cannabis for medical purposes, but we still do not know how and when it will be implemented. We expect that 2019 will bring us the complete picture on this matter.
To read more from Joana Silveira Botelho on Portugal’s pharma legislation, download —