Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
FERRERE / Uruguay
Important legal questions related to cannabinoid drugs, medicinal cannabis and opioid drugs in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
Yes. We understand Cannabinoid Drugs as psychoactive cannabis for recreational non-medical use, as opposed to Medicinal Cannabis (understood as cannabis used for pharmaceutical purposes), the regulatory framework of which is described in “Medicinal Cannabis” below.
Law 19,172 defines psychoactive cannabis as flowering tops (buds), with or without fruit, of the female cannabis plant, except for seeds and leaves when separated from the stem, which have a natural tetrahidrocannabinol (THC) content equal to or greater than 1% of its volume.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
The regulatory authorities with jurisdiction over Cannabinoid Drugs are the Institute for Cannabis Regulation and Control (IRCCA), the Ministry of Public Health (MSP), and the Ministry of Livestock, Agriculture and Fisheries (MGAP).
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
Yes. The regulatory framework related to Cannabinoid Drugs includes:
- Law 19,172 – “Marijuana and its derivates”. Passed on December 20, 2013, this Law establishes that “The State will assume the control and regulation of the activities of importing, exporting, planting, growing, harvesting, producing, acquiring under any title, storing, commercializing and distributing cannabis or its derivatives, or hemp, as applicable, through institutions to which it may grant legal mandates….”, with the IRCCA having the broadest powers of inspection and control.
Regarding advertising, Article 11 of the Law prohibits any kind of direct or indirect advertising, promotion or endorsement of Cannabinoid Drugs by any means of communications (print media, radio, television, cinema, magazines, filming in general, posters, billboards, brochures, banners, e-mail, Internet technologies, and any other pertinent type of media).
Article 13 of Law 19,172 provides that “The protection measures on social spaces established by art. 3 of Law 18,256 shall apply to psychoactive cannabis….” Article 3 of Law 18,256 prohibits smoking or keeping tobacco products lit in enclosed public places which are of public use or a workplace, also including “… enclosed spaces and unroofed interior spaces located within the built-up area.” Hence, the ban regarding smoking tobacco in public indoor places extends to cannabis.
Penalties (including criminal liability) for violations and offenses under the provisions of the Law include: warnings, monetary fines, confiscation and/or destruction of offending goods or items, suspension of licenses, closure of establishments, etc.
When passed, the Law was challenged by the United Nations as constituting a violation of existing international law under the argument that Uruguay would be adopting by law the 1988 “United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances” and several other international cooperation treaties that seek control, penalties, etc., for illegal transportation of drugs and substances, cannabis included.
- Law 14,294. This Law, which regulates narcotics use and commercialization, establishes in Article 3 (as amended by Law 19,172) that: “Plantation, cultivation, harvesting and marketing of any plant from which narcotic drugs or other substances causing physical or psychological dependence may be extracted shall be prohibited, with the following exceptions: a) When performed with the exclusive purpose of scientific research or for the development of therapeutic products of medicinal use. In such cases, plantation or cultivation must be authorized in advance by the Ministry of Public Health and shall remain under its direct control. Specifically, in the case of cannabis, plantation and cultivation must be authorized in advance by the IRCCA, and shall remain under its direct control….; b) Plantation, cultivation and harvesting, as well as industrialization and dispensing, of psychoactive cannabis for other purposes, provided that they are performed under the framework of current legislation and with prior authorization by the IRCCA, which shall remain under its direct control….; c) Plantation, cultivation and harvesting, as well as industrialization and commercialization, of cannabis for non-psychoactive use (hemp). Plantation or cultivation, in such cases, must be authorized in advance by the Ministry of Livestock, Agriculture and Fisheries and shall remain under its direct control….; d) Plantation, cultivation, harvesting, storage for research purposes as well as industrialization for pharmaceutical use, provided they are performed under the framework of current legislation and in accordance with regulations, which must have the prior authorization of IRCCA and shall remain under its direct control; e) Plantation, cultivation and harvesting of psychoactive cannabis plants by membership clubs, which shall be controlled by the IRCCA…”. Furthermore, Article 6 of this Law provides that both import and export of cannabis must have prior authorization from the MSP, which will issue the certificate allowing this activity.
The Ministry of the Interior shall have the task of “prevention, control and prosecution of all acts involving the import, export, production, manufacture, trading, marketing or illegal use of substances regulated by this law.”
- Decree 120/014. This Decree regulates Law 19,172 and consists of 104 articles, divided into five titles: “Psychoactive Cannabis for Non-medical Use,” “Cannabis Registry,” “Institute for Cannabis Regulation and Control (IRCCA)”, “Violations and Penalties”, and “Tax Provisions.”
Only three mechanisms are provided for use of Cannabinoid Drugs: purchase at pharmacies, membership in a cannabis club, or home-growing.
- Users purchasing Cannabinoid Drugs at pharmacies must register with the IRCCA, which guarantees personal data protection. Registration may be made by any legally competent person over 18 years of age with legal or natural Uruguayan citizenship or duly proved permanent residence in the country.
The maximum amount to be acquired may not exceed 40 grams per month per user, with a maximum of 10 grams per week. Cannabinoid Drugs are sold at pharmacies in 5-gram packages with warning messages concerning their health effects.
- Another way to acquire Cannabinoid Drugs is through “Cannabis membership clubs,” which also require registering, as civil associations with the Ministry of Education and Culture first, and then as grower clubs with the IRCCA. For this purpose, they must specify the growing location and appoint a technician in charge of the crop.
The aforementioned clubs shall have a minimum of 15 and a maximum of 45 members. If at any time a club has fewer members than the minimum required, it may be dissolved or, otherwise, a one-year term is given to reach the 15-member requirement.
- As a third option, consumers may also opt for home-growing, for which they must also register with the IRCCA. In this case, the regulations provide that household planting cannot exceed six plants, regardless of the number of persons living thereat or the family relationship among them. The maximum annual amount in this case is 480 grams.
Provisions are clear and establish that access to, and use of, Cannabinoid Drugs shall be exclusively as mentioned hereinabove, thus excluding all other types of businesses, such as sale at coffee shops, for instance.
Persons under 18 years of age will not have access to Cannabinoid Drugs (art. 14 of the Law).
- Decree 372/014. This Decree, in force since December 2014, allows “Plantation, cultivation and harvesting, as well as industrialization and commercialization, of cannabis for non-psychoactive use (hemp). Plantation or cultivation, in such cases, must be authorized in advance by the Ministry of Livestock, Agriculture and Fisheries and shall remain under its direct control.”
Hemp refers to plants or parts of plants of the Cannabis genus, leaves and flowering tops (buds), not containing more than 1% THC, including derivatives of such plants and parts of plants. The varieties of hemp seeds to be used may not contain more than 0.5% THC.
- Decree 128/016. This Decree prohibits the use at the workplace, allowing employers to establish preventive control measures and apply penalties, in coordination with the Ministry of Labor.
Pricing of Cannabinoid Drugs sold in pharmacies is made by the Uruguayan State through the IRCCA. The price is updated every six months based on parameters that take into account variations in exchange rates, salaries, and the Consumer Price Index. Currently, the retail price per 5-gram package of Cannabinoid Drugs amounts to $213 (two hundred and thirteen Uruguayan pesos, approximately USD 6.5). Pharmacies must sell the products to the customers at the established price.
Reimbursement is not regulated.
4. Which are the cannabinoid drugs that have received market approval to date?
Four products have received market approval to date (Alfa I, Alfa II, Beta I and Beta II). These products correspond to ICC and Simbiosys, the only authorized companies to produce and distribute Cannabinoid Drugs in Uruguay.
Alfa I and Alfa II are indica-dominant hybrids, while Beta I and Beta II are also hybrids but with sativa-dominant characteristics. These strains have a moderate THC content (THC: ≤ 9%) and high cannabidiol content (CBD ≥ 3%), which makes them moderately psychoactive.
5. Who can prescribe Cannabinoid Drugs?
Cannabinoid Drugs may be bought by any registered Uruguayan citizen. No prescription from a doctor is required.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
No prescription from a doctor is required.
7. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
Distribution and production of Cannabinoid Drugs is made through two private companies (ICC and Simbiosys), which were licensed by the IRCCA in 2015 through a bidding process. These are the only two companies authorized to produce and distribute Cannabinoid Drugs.
Products are distributed by ICC and Simbiosys from the production site straight to pharmacies (art. 13 of Decree 120/014). Pharmacies are the entities authorized to sell the products to registered citizens (please refer to answer #3 above).
8. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
A list of pharmacies adhered to the dispensing network of Cannabinoid Drugs, which act as retailers for product sale to registered citizens, can be found on the IRCCA’s website https://www.ircca.gub.uy/farmaciasadheridas/
9. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
A bill of law has been recently submitted to Congress to include some plant species, preparations and substances under the control regime corresponding to the preparations contained in Schedule III of the Single Convention on Narcotic Drugs of 1961: flowering or fruiting tops of the cannabis plant (non-extracted resin), and cannabis resin, extracts and tinctures of cannabis, separated resin, whether crude or purified, obtained from the cannabis plant. This means that the control measures for substances included in Schedules I and IV of the said Convention shall not be applicable to said plant species, preparations and substances.
In addition, it establishes that THC shall be subject to the control regime corresponding to substances contained in Schedule III of the Convention on Psychotropic Substances, 1971, with the control measures set forth for Schedule I not being applicable thereto.
For its part, Dronabinol shall be under the control regime corresponding to the substances contained in Schedule IV of the Convention of Psychotropic Substances, 1971, not being applicable to the said substance the control regime provided for Schedule II.
The proposed changes are based on removing the obstacles that hinder the handling of cannabis products. The lawmakers presenting the bill express that “this is a way to promote national scientific research on cannabis, as our country has laws potentially useful for these purposes, while fostering the development of the domestic industry, creating jobs related to knowledge and innovation in connection with an international market that increasingly demands cannabis-derived products.”
10. When are they likely to come into force?
It was recently submitted to Congress, so, it is difficult to anticipate the political boost and support it may receive, or when or if it may come into force.
Medicinal Cannabis
11. Is Medicinal Cannabis authorized in the country?
Yes.
12. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The regulatory authorities with jurisdiction over Medicinal Cannabis are the IRCCA and the MSP.
13. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
Decree 46/015, which regulates Law 19,172 in relation with medicinal cannabis, was published on February 10, 2015.
The decree regulates the use of cannabis for scientific research and for development of therapeutic products for medicinal use (plant specialties) and pharmaceutical purposes (pharmaceutical specialties).
The decree permits the use of cannabis for scientific and/or medicinal purposes, with the following scope:
- Plantation;
- Cultivation;
- Harvest;
- Gathering;
- Marketing
I. Scientific Research: The decree defines scientific research as an activity aimed at developing research projects that contribute to the production of knowledge and scientific evidence regarding the use of cannabis.
The authorization for use of cannabis for this purpose is subject to compliance with the requirements indicated in this rule, accompanied by a research project, with presentation of a detailed report on the progress and the corresponding results before the MSP at the end of the project.
II. Pharmaceutical specialties and plant specialties: Pharmaceutical specialties are defined as any single or compound cannabis-based drug, with its name registered with the MSP, having a qualitative and quantitative formula declared as industrially produced and verifiable therapeutic properties, sold in certain sales units. Regarding plant specialties, the decree merely defines them as herbal cannabis or cannabis herb blends used for medicinal purposes.
There is no regulation related to pricing or reimbursement of Medicinal Cannabis.
14. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
Production and import of Medicinal Cannabis is regulated under Law 14,294 and Decree 46/015, as well as by the IRCCA and the MSP. Authorizations by the IRCCA and the MSP must be obtained to plant, cultivate, harvest, import, etc. medicinal cannabis.
The first step to apply for authorizations would be to establish a company in Uruguay and to register the same before the Cannabis Operator Registry of the IRCCA. Then, depending on the scope of the project, documents and information are to be submitted to the IRCCA and the MSP, which may include the requirements indicated in answer #3 of “Regulatory, Pricing, and Reimbursement Overview”.
In addition, prior to the grant of any of authorization, an approval from the Uruguayan National Bureau for Prevention of Money Laundering and Financing of Terrorism (SENACLAFT) is also required. SENACLAFT will analyze the legal background of the shareholders, the ultimate beneficiaries and the legality of the origin of the funds to be invested in the project.
15. What approval or notifications are necessary to produce or import Medicinal Cannabis?
Article 6 of Law 14,294 provides that both import and export of cannabis must have prior authorization from the MSP, which will issue the certificate allowing this activity.
To produce Medicinal Cannabis, authorizations from the IRCCA and the MSP are necessary as mentioned in answer #4 in “Medicinal Cannabis” below.
For the purposes of selling Medicinal Cannabis, the product must be registered with the MSP following the same procedure described in Question 3 in “Regulatory, Pricing, and Reimbursement Overview” if the product is registered as a pharmaceutical specialty, or as indicated in Question 1 in “Traditional Medicines and Over-the-Counter Products” if registered as a plant specialty.
16. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
As per Decree 46/015, only pharmacies authorized by the MSP may sell plant and pharmaceutical specialties based on psychoactive cannabis to the public, upon presentation of an official prescription.
Regulation for marketing and distribution of drugs (pharmaceutical) and plant specialties also apply to Medicinal Cannabis. Please refer to “Regulatory, Pricing, and Reimbursement Overview” and to “Traditional Medicines and Over-the-Counter Products”.
No Medicinal Cannabis may be advertised or sold without prior registration with the MSP. Rules regarding this matter are of the strictest nature and non-compliance is subject to criminal law.
17. How can patients obtain Medicinal Cannabis?
Medicinal Cannabis is to be sold exclusively in first and second category pharmacies. That means, in commercial pharmacies and the ones located at healthcare institutions.
Medicinal Cannabis must be prescribed by doctors by means of official medical prescriptions (Law 14,294, Decree 454/976, Decree 537/978 and Decree 46/015)
According to the regulations, Medicinal Cannabis may be obtained by legally competent persons over 18 years of age by presenting at the pharmacy the corresponding official medical prescription issued by the attending physician.
The prescription must specify the type of product indicated, its amount, and route of administration, as well as information of the patient.
18. Who can prescribe Medicinal Cannabis?
Doctors.
Decree 298/017 classified pharmaceutical specialties with cannabidiol active ingredient as “Prescription drugs” to prevent them from being sold as over-the-counter products directly to consumers.
19. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
Any doctor (legally registered in Uruguay as a Doctor of Medicine) is authorized to prescribe Medicinal Cannabis.
20. What approvals or notifications are required to prescribe Medicinal Cannabis?
No approvals or notifications are required. Doctors can prescribe Medicinal Cannabis to their patients at their own discretion (art. 31 Decree 46/015).
21. Where is Medicinal Cannabis available?
Pharmacies.
22. Is there a list of retailers authorized to sell Medicinal Cannabis?
No. Any pharmacy is authorized to sell Medicinal Cannabis to patients.
23. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
Please refer to answers to Questions 10 and 11 above.
Opioid Drugs
24. Are Opioid Drugs authorized in your country?
Yes, but under strict controls in terms of use, marketing and production processes.
25. What are the regulatory authorities with jurisdiction over Opioid Drugs?
The MSP is the regulatory authority with jurisdiction over Opioid Drugs.
26. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
These substances are mainly regulated by Decree-Law 14,294 and its regulatory Decree 454/976.
Without prejudice to the above, subsequent rules regulate these types of substances and update the contents of the Lists of controlled substances and narcotic drugs, using the lists of New York Convention as reference.
For the purposes of obtaining narcotics marketing authorization, the interested party(ies) must fill certain forms as specified by the MSP to be attached to the application for authorization to market the said narcotics, which shall include a statement to comply with the regulations in force.
27. Which are the Opioid drugs that have received market approval to date?
Under Decree 209/018, the MSP established a list of substances considered to be narcotic drugs and psychotropics for which special authorizations must be obtained from the MSP.
To the extent an authorization is requested to manufacture or import products based on any of the substances included in the lists updated by Decree 209/018, the MSP must authorize the sale and use thereof pursuant to certain conditions set forth in Decree-Law 14,294 and its regulatory decree 454/976.
28. Who can prescribe Opioid Drugs?
According to the provisions of article 67 of Decree 454/976, doctors, dentists and veterinarians shall be entitled to make prescriptions, depending on the product and its intended use.
29. Is there a list of doctors authorized to prescribe Opioid Drugs?
There are no lists. However, each professional must request a special prescription pad to the MSP in order to prescribe. These pads are for exclusive use of the requesting professional.
30. What approvals or notifications are required to prescribe Opioid Drugs?
No approvals or notifications are required. Doctors can prescribe Medicinal Cannabis to their patients at their own discretion. Please also refer to Question 29 above.
31. Which organizations are authorized to sell/distribute Opioid Drugs available?
To import, sell and distribute Opioid Drugs, organizations must be authorized by the MSP as described in “Regulatory, Pricing, and Reimbursement Overview”. Pharmacies are the only organizations authorized to sell the products directly to patients upon presentation of an official medical prescription.
Other than sale to the public, laboratories may sell to pharmacies or drugstores, or deliver originals to health professionals.
32. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
No. Any pharmacy is authorized to sell Opioid Drugs to patients.
33. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
No.
34. When are they likely to come into force?
Please refer to Question 33 above.
