Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Corral Rosales / Ecuador
An intro to the legal situation for medical cannabis, cannabinoid drugs and opioids in Ecuador. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for USD 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
No. However, within the second discussion of the draft reform of the Health Law, the text of Volume II was approved in which, from Article 340 onwards, the therapeutic uses of cannabis and by-products are discussed. In this section it is established that the Ministry of Health destermines the illnesses or medical conditions that may be treated by medications and natural processed medicinal products that contain cannabis by-products.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
The Ministry of the Interior
The Ministry of Health
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
No
4. Which are the cannabinoid drugs that have received market approval to date?
None
5. Who can prescribe Cannabinoid Drugs?
N/A – their prescription is prohibited
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
N/A – their prescription is prohibited.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
N/A – their prescription is prohibited.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
None
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
No
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
Yes, within the draft reform of the Health Law.
11. When are they likely to come into force?
Second half of 2019, if approved.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
No. However, within the second discussion of the draft reform of the Health Law, the text of Volume II was approved in which, from Article 340 onwards, the therapeutic uses of cannabis and by-products are discussed. In this section it is established that the Ministry of Health determines the illnesses or medical conditions that may be treated by medications and natural processed medicinal products that contain cannabis by-products.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The Ministry of the Interior
The Ministry of Health
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
Once the reform of the Health Law is approved, the Health Commission must determine the process for the authorization of sale, pricing and reimbursement of medicinal cannabis.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
Currently it is prohibited. If the draft reform of the Health Law is approved, the responsible authority will be the Ministry of Health.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
There are currently no systems for the importing or production of medicinal cannabis.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
There are currently no regulatory frameworks for the marketing and distribution of medicinal cannabis.
18. How can patients obtain Medicinal Cannabis?
Currently not possible.
19. Who can prescribe Medicinal Cannabis?
Currenly, nobody.
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
No
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
It is currently not possible to prescribe medicinal cannabis.
22. Where is Medicinal Cannabis available?
Currently not available.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
No
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
Yes, the draft reform of the Health Law is under discussion.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
Yes
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
Ministry of Health
National Regulatory Agency (ARCSA)
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
Yes, for the registration of an opioid medication there are certain requirements, as follows:
- Register with ARCSA as an importer / vendor / distributor of medications that contain substances categorized as subject to control.
- Certificate of administration of substances categorized as subject to control, issued by the Technical Secretary of Drugs (SETED) – if registering with ARCSA as producer.
- Annual projections of consumption of imported medications that contain substances categorized as subject to control.
- List of possible clients (if registering as vendor).
The Ministry of Health will set the maximum price for the sale of these medications, through the Technical Secretary for Medication Price Control.
28. Which are the Opioid drugs that have received market approval to date?
There are various opioids registered in Ecuador, either as combination drugs or mono drugs. The main ones are as follows:
– Hydrocodone
– Oxycodone
– Morphine
– Codeine
– Methadone
– Fentanyl
29. Who can prescribe Opioid Drugs?
Health professionals authorized for the prescription of medications that contain substances categorized as subject to control (opioids).
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
Yes, the Minister of Health maintains an up-to-date register of authorized professionals.
31. What approvals or notifications are required to prescribe Opioid Drugs?
Be a health professional that treats illnesses which have shown effective therapeutic responses to the use of opioids. Such professional must be authorized by the Minister of Health
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
Authorities that are registered with ARCSA for the purpose of the administration of medications that contain substances categorized as subject to control (opioids).
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
The Minister of Health holds an up-to-date list of which distributors may sell these medications.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
Yes, through the reform of the Health Law which is currently under debate, in which opioid drugs are identified as controlled substances. However, the regulation is not expected to lead to significant changes in respect of these medications.
35. When are they likely to come into force?
Second half of 2019, if approved