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OPCM: “It is a historic landmark in Portugal and Europe”
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Approval of the first cannabis-based product or substance in Portugal, dried flowers with 18% THC, come to solve the problems of Portuguese patients who use medical cannabis? Cannareporter contacted Portuguese associations in the field of cannabis, the OPCM – Portuguese Observatory of Medicinal Cannabis and the Cannativa – Cannabis Studies Association. THEonly the OPCM responded, through a letter sent by its president, Carla Dias.
What does this new product on the market represent for the OPCM?
From the OPCM's point of view, the fact that the National Authority for Medicines and Health Products (Infarmed) has approved the first substance based on the cannabis plant for medicinal purposes is a historic milestone in Portugal and in Europe. It is the first of many important steps towards the implementation of law n.2 33/2018, of July 18, on Medicinal Cannabis.
What will be the selling price to the public which, from the perspective of the OPCM, is the most affordable and suitable for this type of product?
From the perspective of the OPCM, the price charged must comply with the law. The pricing regime for preparations or substances based on the cannabis plant for medicinal purposes is regulated in Ordinance No. practice, approved by Infarmed, available on the Infomed website (infarmed.pt)
What other products do you expect to see approved in Portugal?
The preparations and substances based on the cannabis plant that benefit the 7 indications
therapies listed by Infarmed should be the priority at the moment. The submissions of the ACMs are the sole responsibility and will of the companies already licensed. The licensed companies that are able to submit them have certainly carried out their market studies in order to understand the needs of patients in Portugal.
How many patients does the OPCM estimate could benefit from it?
The company that obtained the approval of the first ACM is certainly the holder of this information, which is the result of a market study, which is fundamental in this process. In any case, evaluating the therapeutic indications of this first product with approved ACM and the percentages of patients who do not have their pathology controlled by conventional medication, a number can be arrived at.
How many patients are currently benefiting from cannabis in Portugal and what main difficulties face?
Patients who benefit from cannabis??? Patients so far have not benefited from Medicinal Cannabis as provided for in law n.2 33/2018, of July 18, but they will be able to do so from this moment on, as the greatest difficulty was related to access. The OPCM management is aware that this is certainly the first ACM of others, which will be approved soon and will allow other patients with other pathologies to benefit from them.
What initiatives is the OPCM developing to disseminate these therapies among health professionals and what kind of support is it providing to patients in our country?
According to the statutes, the OPCM “may develop all the actions it deems necessary or convenient for the pursuit of its purpose, always in strict respect for the legislation in force.” In this way, access to therapy provided for by law by patients who need it, which now begins with the first ACM, is the result of a close collaboration between the OPCM and governmental, private and associative entities.
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[Disclaimer: Please note that this text was originally written in Portuguese and is translated into English and other languages using an automatic translator. Some words may differ from the original and typos or errors may occur in other languages.]____________________________________________________________________________________________________
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With a degree in Journalism from the University of Coimbra, Laura Ramos has a postgraduate degree in Photography and has been a Journalist since 1998. Winner of the Business of Cannabis Awards in the category "Journalist of the Year 2024", Laura was a correspondent for Jornal de Notícias in Rome, Italy, and Press Officer in the Office of the Minister of Education of the 21st Portuguese Government. She has an international certification in Permaculture (PDC) and created the street-art photography archive “Say What? Lisbon” @saywhatlisbon. Co-founder and Editor of CannaReporter® and coordinator of PTMC - Portugal Medical Cannabis, Laura directed the documentary “Pacientes” and was part of the steering group of the first Postgraduate Course in GxP's for Medicinal Cannabis in Portugal, in partnership with the Military Laboratory and the Faculty of Pharmacy of the University of Lisbon.
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