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LEGAL MEDICAL CANNABIS: WHY IN COLOMBIA?

In Colombia there are several regulations in terms of law for medical cannabis, Law 1787 of 2016 is one of the main ones on this subject,
The law regulated access to cannabis for medicinal and scientific purposes in Colombia, allowing the cultivation of cannabis plants, the manufacture of cannabis products, and the use of cannabis seeds as long as its purpose is medicinal or scientific. Activities related to the latter, such as marketing, export and storage, are also permitted and regulated by law, so it is necessary to have a lawyer who knows how to read and interpret these regulations correctly.

What is medical cannabis used for?

There is a large body of scientific evidence demonstrating the effectiveness of using cannabis to treat various symptoms or discomforts that cause chronic diseases or pain; the side effects of chemotherapy, for example, or advanced epilepsies that are resistant to traditional medications, have a high rate of improvement with the use of medical cannabis. This cannabis is subjected to strict analysis to prove that it is free of impurities and thus know exactly how many milligrams of active ingredient are present in each milliliter of extract.
Thus, people who use cannabis as a treatment for diseases or unfavorable health conditions have a specific amount that helps them to control their symptoms and improve their quality of life. Its use does not increase over time, as is the case with recreational cannabis, but rather, in conjunction with the physician, a specific amount is assigned to each person, taking into account his or her particularities.

Requirements for cannabis-related activity in Colombia:

The different persons, whether natural or legal, national or foreign domiciled in the country, who are interested in cannabis projects for medicinal or scientific purposes must request and obtain -prior to the start of these activities- the corresponding license; for the manufacture of cannabis products, a license is processed at the Ministry of Health and Social Protection; for the cultivation of cannabis and the use of the seed, licenses are processed at the Ministry of Justice and Law. These licenses are not transferable and are granted for a term of five years, subject to renewal as many times as necessary, a knowledgeable attorney can perform the process more efficiently.
There are also additional requirements for license holders, since for the use of seeds it is necessary to have a registration before the Colombian Agricultural Institute – ICA and for the manufacture of cannabis derivatives it is necessary to have a certification issued by the National Institute for the Surveillance of Medicines and Food – INVIMA.
Entrepreneurs interested in obtaining a quota for the development of this activity must submit an application and support it with market and demand studies; subsequently, the Government evaluates them through technical groups and approves them in whole or in part.

What is plant breeder registration?

The plant breeder’s registration is a system of protection granted to the creator of a new plant variety, which is morphologically different from its species and with which there is no other with which it shares its particular characteristics.
Being considered the breeder of a plant variety allows you to exercise rights such as, for example, to prevent:

  1. Production, reproduction, multiplication or propagation.
  2. Preparation for the purpose of reproduction, multiplication or propagation.
  3. Offer for sale.
  4. The sale or any other act involving the introduction into the market of propagating material for commercial purposes.
  5. Export.
  6. Importation.
  7. Possession for any of the purposes mentioned in the preceding paragraphs.
  8. The commercial use of ornamental plants or parts of plants as propagating material for the purpose of producing ornamental and fruit plants or parts of ornamental plants, fruit plants or cut flowers.[1]

Is it possible to protect a phyto-improved Cannabis plant by means of a plant breeder’s certificate?

In theory, it is possible to be the breeder of the registration of new plant varieties. This situation is evidenced by the following registration filed with the INTERNATIONAL UNION FOR THE PROTECTION OF PLANT VARIETY PROPERTY (UPOV): https://www.upov.int/edocs/tgdocs/es/tg276.pdf

 
In any case, even though the answer is initially positive, it should be noted that in Colombia Decree 780 of 2016 established a restrictive rule regarding the use of cannabis seeds, since it established that only those who register their seeds with the CNE and are authorized by the same entity to be considered “Supplier of seeds for planting” may put seeds into circulation for planting. Specifically, the decree defines the Supplier of seeds for sowing as follows:

Supplier of seeds for sowing:
person duly authorized by the FNE by means of a seed possession license, for the transfer of Seeds in any title for sowing cannabis plants for medical and scientific purposes.
Likewise, article 2.8.11.1.1.1 of the same decree establishes in its paragraph that:

Paragraph 1.
Without prejudice to the provisions of this regulation, the cultivation of cannabis plants, the possession of seeds for planting cannabis plants, as well as the processes of production and manufacture, export, import, use, distribution and trade of cannabis derivatives, shall be subject to the regulations in force or those issued by the respective authority for that purpose.
Thus, despite the fact that in Colombia there are rules for obtaining plant varieties, the possession of these may be subject to Decree 780 of 2016 and the corresponding rules, making it necessary to comply with both requirements and not only one of them in order to make effective the use of them, because if the seed variety registered with the CNE was previously protected as a plant variety, the breeder could prohibit the marketing and reproduction of the protected genetic material.
It is necessary to mention that what is established in this decree 780 of 2016 does not exempt the registration of seeds before the ICA (Different from the registration of plant variety breeder):
That the aforementioned article 2.8.11.11.1 is of a transitory nature and has made it possible to initiate the process intended exclusively for the production of seeds for sowing cannabis plant, which entails, in any case, the need to advance the registration before the Colombian Agricultural Institute – ICA as producer, importer, marketer or exporter of seeds for sowing, in accordance with the provisions of resolution 3168 of 2015 of that entity.

Could a breeder of a plant variety enforce the provisions of Article 12, Resolution 1893 of 1995 mentioned above against the resolution issued by the CNE and the ICA?

It is possible. Therefore, we suggest to all our customers not to submit to the ICA and CNE any seed that may be protected as a new plant variety. This would imply a conflict over eventual rights.

Could a plant variety be registered with the ICA as a plant variety and not registered as a supplier of seeds for sowing with the CNE?

Initially, it is possible. In any case, it should be noted that, if the provisions of Decree 780 of 2016 are not complied with, the possession of the plant material will not be entirely legal in the Colombian territory.

Must all seeds be registered with the ICA as a plant variety in order to be registered with the CNE?

Not necessarily, since Decree 780 of 2016 makes it clear that they are talking about seeds that are already in Colombia, whose tenure must be legalized and formalized. In any case, it is possible to mention that the breeder of the plant variety could eventually assert his prerogatives by requesting the person using his plant variety to cease using it despite having registered it with the CNE.

Why Cuadro Legal Abogados is a strategic ally in obtaining cannabis licenses?

Cuadro Legal Abogados has professionals who are immersed in the issue of obtaining the necessary licenses and permits for activities related to medical cannabis in Colombia, and more specifically have the right tools to expedite the processes from Medellin.
In the same way it knows the laboratories in the city of Medellin, which provide the proper handling of cannabis seeds based on the elements required by Colombian law.

Why invest in cannabis in Colombia?

Colombia obtained for the second consecutive year, in 2018, a quota of 40.5 tons to legally plant cannabis, this is equivalent to 44% of that year’s production authorized by the International Narcotics Control Board – INCB. This shows that Colombia could become the largest producer of medical cannabis in the world. This product has great economic benefits; the opportunity to export the extract helps to secure investments from which all those involved in the production chain would benefit.
In addition, Colombia and Medellín have a unique attraction for cannabis cultivation thanks to its optimal climatic conditions. As a result, countries such as Canada have shown strong interest in producing Cannabinol in Colombia, since the existing seasons in that country imply high production costs. This warns us that medical cannabis production costs are lower in Colombia.

Authors: Erik Andrés Ramirez and Juan Esteban Vallejo
Editing: Nestor Arturo Bedooya and Santiago Pinzon Sosa
[1] Article 12, Resolution 1893 of 1995.

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