Cannabinoid drugs, medicinal cannabis and opioid drugs in Spain – a legal guide

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Cannabinoid Drugs

For the purposes of this topic shall mean any industrially produced medicinal product which contains cannabinoids.

 

1. Are Cannabinoid Drugs authorized in your country?

Cannabinoid Drugs may be authorized in Spain on the basis of scientific criteria on its quality, safety and efficacy. The foregoing is provided that applicable regulations on narcotics, such as Law 17/1967 on narcotics, and Royal Decree 2829/1977 on narcotics and its production, distribution, prescription and dispensation are observed.

 

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The main Spanish authorities with jurisdiction over Cannabinoid Drugs are the Spanish Ministry of Health and the AEMPS.

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

No. The general regulatory framework applicable for the authorization, pricing and reimbursement of medicinal products apply to Cannabinoid Drugs.

There are, however, specific regulations that may be applicable to other activities related to Cannabinoid Drugs such as manufacturing, distributing, prescribing, dispensing etc. (see, among others, Law 17/1967, Royal Decree 2829/1977 and Royal Decree 1675/2012 on prescribing and dispensing narcotics for both human and veterinary use).

 

4. Which are the cannabinoid drugs that have received market approval to date?

To date, only Sativex 2,7 mg / 2,5 mg Oromucosal spray solution (“Sativex®”) has received market approval in Spain. Sativex® is a Cannabinoid Drug which contains, per each single 100 microlitre spray, 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) from Cannabis sativa L. The marketing authorization holder of Sativex is GW Pharma Ltd.

Sativex® has been classified as a hospital diagnosis drug, which means that it shall only be used for the treatment of diseases diagnosed either in hospitals or centers which have appropriate diagnosis means, or by specialized doctors (see art. 24.3.b of Royal Decree 1345/2007 on the procedure for authorization of industrially produced medicinal products for human use).

Likewise, according to section 4.1 of the technical sheet of Sativex®, Sativex® must only be used “to improve symptoms of adult patients with moderated or serious spasticity due to multiple sclerosis” if “other anti-spasticity medicines have not worked” and “a significant clinical improvement has been observed regarding the symptoms of spasticity after an initial trial period of the treatment”.

 

5. Who can prescribe Cannabinoid Drugs?

Doctors, odontologists and veterinaries, each of them in the field of its competence, can prescribe narcotic drugs.

 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

There is not a list of doctors authorized to prescribe Cannabinoid Drugs. Doctors, provided that they comply with the applicable requirements and procedures (which include the need to use the appropriate prescription forms), can prescribe Cannabinoid Drugs without need to be previously registered in any official list. It is to be noted that doctors holding prescription forms for narcotic drugs may be controlled (and, therefore, somehow listed) but these are lists relating to the prescription forms (holders of such forms are listed) and not related to the doctors themselves.

 

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Provided that applicable regulations are complied with (including the use of the appropriate prescription forms), doctors themselves do not have to ask for any specific approval or make any specific notification each time they prescribe Cannabinoid Drugs.

 

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Cannabinoid Drugs can be dispensed to the public by authorized pharmacy offices/services.

Cannabinoid Drugs can be distributed (that is, sold to either other authorized distribution entities or pharmacy offices/services) by any of the following entities provided that they comply with all applicable regulations on medicinal products and narcotics (such as Law 17/1967, Royal Decree 2829/1977 -and its complementary regulations- and Royal Decree 1675/2012):

  • Pharmaceutical laboratories;
  • Distribution entities duly authorized to distribute medicines for human use (see Royal Decree 782/2013 on distribution of medicinal products for human use); and/or
  • Distribution entities duly authorized to distribute veterinary medicines (see Royal Decree 109/1995 on veterinary medicinal products).

 

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

  • Retailers. The AEMPS, with the cooperation of the regional authorities, publishes lists including all pharmacy offices opened to the public in Spain. Such pharmacy offices can dispense Cannabinoid Drugs if they comply with applicable regulations (please refer to Question 8).
  • Distributors. The AEMPS publishes lists including all entities authorized to distribute veterinary medicines and medicines for human use in Spain. All entities authorized to distribute Cannabinoid Drugs must be included in such lists.

 

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

We are not aware of any proposal to significantly reform the regulation of Cannabinoid Drugs in Spain. Please refer to Question 24 for further information regarding Medicinal Cannabis.

 

11. When are they likely to come into force?

N/A

 

Medicinal Cannabis

For the purposes of this topic shall mean “the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted” (see art. 1 of the Single Convention on Narcotic Drugs of 1961); and Medicinal Cannabis shall mean Cannabis used/intended to be used for medicinal purposes. Cannabinoid Drugs (as defined above), products formulated by pharmacists containing cannabinoids which qualify as medicines under Spanish law (see art. 8.1.b and c of the Spanish Law on Medicinal Products) and cannabinoid products with very low concentrations of THC fall outside the concept of Medicinal Cannabis for the purposes of this Chapter.

 

12. Is Medicinal Cannabis authorized in the country?

The use of Cannabis for medicinal purposes is not specifically regulated in Spain; being a legal void in this field which generates significant legal uncertainty.

Notwithstanding the foregoing, we make the following comments:

  • Cannabis qualifies as a narcotic in accordance with art. 2.1 of Law 17/1967 and List I of the Single Convention on Narcotic Drugs of 1961. Likewise, Cannabis is considered as a “prohibited product” in accordance with art. 2.2 of Law 17/1967 and List IV of the Single Convention on Narcotic Drugs of 1961.
  • Art. 22 of Law 17/1967 (which states that the use of narcotic drugs for therapeutic uses may be allowed under certain circumstances), art. 51.3 of the Spanish Law on Medicinal Products (which states that plants traditionally used as medicines and offered without reference to therapeutic, diagnosis or preventive properties may be sold under certain circumstances) and other regulations have been used by certain authors to try to defend Medicinal Cannabis in Spain. Such interpretations, however, shall be read with extreme caution (and be considered as mere opinions) as long as in Spain there is not a clear regulatory framework regarding Medical Cannabis and, therefore, no clear and solid conclusions can be reached in this regard.
  • From a criminal point of view, self-consumption of Medicinal Cannabis (provided that the corresponding requisites established by case law are complied with) is not criminally punishable. Other activities connected somehow with Medicinal Cannabis shall be carefully analyzed as long as they may trigger legal risks, including criminal ones (see art. 348 of the Spanish Criminal Code which literally states that “those who execute acts of cultivation, processing or trafficking, or otherwise promote, favour or facilitate the illegal consumption of toxic drugs, narcotics or psychotropic substances, or possess them for those purposes, shall be punished…”).
  • Rules such as Law 17/1967, Royal Decree 2829/1977 (and its complementary regulations), Royal Decree 1675/2012 and criminal regulations should be considered when reviewing rules applicable to Medicinal Cannabis as long as certain activities connected somehow with Medicinal Cannabis may fall within their scope.

 

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

The main Spanish authorities with jurisdiction over Medicinal Cannabis are the Spanish Ministry of Health and the AEMPS.

 

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Please refer to Question 12.

 

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

Production/import of Cannabis is mainly regulated in Law 17/1967 and Royal Decree 2829/1977. General foreign trade regulations and international conventions, when applicable, shall also be observed.

In addition to the foregoing, it is also worth mentioning a ministerial order dated on 7 May 1963 on cultivation of medicinal plants related to narcotics and two informative notes published in the official website of the AEMPS in December 2018 which regulate the matter of the cultivation of Cannabis for medicinal purposes.

The Spanish Ministry of Health and the AEMPS have authority regarding the production/import of Cannabis.

 

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

The production/import of Cannabis is subject to the obtention of an authorization to be granted by Spanish regulatory authorities according to the regulations and the informative notes mentioned in Question 15.

 

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

There is no regulation specifically regulating the promotion of Medicinal Cannabis. However we make the following comments:

  • If a product (such as Cannabis) is presented for treating or preventing diseases, it may be considered as a medicinal product according to Spanish regulations (see art. 2.a of Spanish Law on Medicinal Products which refers to the definition of medicinal product by presentation);
  • In Spain, medicinal products cannot be promoted if they have not received a valid marketing authorization (see art. 2.1 Royal Decree 1416/1994 on marketing of medicinal products for human use).
  • Provided that Cannabis, to date, has not received a marketing authorization, the promotion of Medicinal Cannabis is not acceptable.
  • It is also worth mentioning the fact that plants that have been traditionally considered as medicinal plants (someone could try to argue that this is the case of cannabis) have a specific regime in Spain (see art. 51.3 of Spanish Law on Medicinal Products and related regulations). Without analyzing such regime (or analyzing if cannabis can be authorized through the same), we note that such “medicinal plants”, even if they are finally authorized, cannot be “offered to the public with reference to its therapeutic properties”.

Regarding the distribution of Medicinal Cannabis, please refer to Question 12.

 

18. How can patients obtain Medicinal Cannabis?

Please refer to Question 12.

 

19. Who can prescribe Medicinal Cannabis?

Please refer to Question 12.

 

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

Please refer to Question 12.

 

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

Please refer to Question 12.

 

22. Where is Medicinal Cannabis available?

Please refer to Question 12.

 

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

Please refer to Question 12.

 

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

There have been several proposals presented by different political parties, at both national and regional level, to reform or significantly change the regulation of Medicinal Cannabis in Spain. However, we are still far away for a consensus or an agreement between political parties in this field and, therefore, we do not expect any of such proposals to be approved and to entry into force in the near future.

 

Opioid Drugs

For the purposes of this topic shall mean any industrially produced medicinal product which contains opioids.

 

25. Are Opioid Drugs authorized in your country?

Opioid Drugs may be authorized in Spain on the basis of scientific criteria on its quality, safety and efficacy. The foregoing is provided that applicable regulations on narcotics, such as Law 17/1967 on narcotics, and Royal Decree 2829/1977 on narcotics and its production, distribution, prescription and dispensation, are observed.

 

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The main Spanish authorities with jurisdiction over Opioid Drugs are the Spanish Ministry of Health and the AEMPS.

 

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

No. The general regulatory framework applicable for the authorization, pricing and reimbursement of medicinal products apply to Opioid Drugs.

There are, however, specific regulations that may be applicable to other activities related to Opioid Drugs such as manufacturing, distributing, prescribing, dispensing etc. (see, among others, Law 17/1967, Royal Decree 2829/1977 and Royal Decree 1675/2012 on prescribing and dispensing narcotics for both human and veterinary use).

 

28. Which are the Opioid drugs that have received market approval to date?

There are many medicinal products containing opioids that have received market approval to date in Spain.

An updated and complete list of all medicinal products authorized in Spain classified by active ingredient (as well as by trademark, registration number, etc) can be found in CIMA, and online data base held by the AEMPS and available in the official website of the AEMPS. All medicinal products containing opioids that have received market approval in Spain are included in such list.

 

29. Who can prescribe Opioid Drugs?

Doctors, odontologists and veterinaries, each of them in the field of its competence, can prescribe Opioid Drugs.

 

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

There is not a list of doctors authorized to prescribe Opioid Drugs. Doctors, provided that they comply with the applicable requirements and procedures (which include the need to use the appropriate prescription forms), can prescribe Opioid Drugs without need to be previously registered in any official list. It is to be noted that doctors holding prescription forms for narcotic drugs may be controlled (and therefore somehow listed), but these are lists relating to the prescription forms (holders of such forms are listed) and not related to the doctors themselves.

 

31. What approvals or notifications are required to prescribe Opioid Drugs?

Provided that applicable regulations are complied with (including the use of the appropriate prescription forms), doctors themselves do not have to ask for any specific approval or make any specific notification each time they prescribe Opioid Drugs.

Treatments with Opioid Drugs for patients addicted to Opioid Drugs have their specific regulations (such as Royal Decree 75/1990 on treatments with opiates for people addicted to opioids, and the circular of the AEMPS 6/2003 regarding the conditions to distribute narcotics for the treatment of people addicted to opioids.

 

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

Opioid Drugs can be dispensed to the public by authorized pharmacy offices/services.

Opioid Drugs can be distributed (that is, sold to either other authorized distribution entities or pharmacy offices/services) by any of the following entities provided that they comply with all applicable regulations on medicinal products and narcotics (such as Law 17/1967, Royal Decree 2829/1977 -and its complementary regulations- and Royal Decree 1675/2012):

  • Pharmaceutical laboratories;
  • Distribution entities duly authorized to distribute medicines for human use (see Royal Decree 782/2013); and/or
  • Distribution entities duly authorized to distribute veterinary medicines (see Royal Decree 109/1995).

 

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

Retailers. The AEMPS, with the cooperation of the regional authorities, publishes lists including all pharmacy offices opened to the public in Spain. Such pharmacy offices can dispense Opioid Drugs if they comply with applicable regulations (please refer to Question 32).

Distributors. The AEMPS publishes lists including all entities authorized to distribute veterinary medicines and medicines for human use in Spain. All entities authorized to distribute Opioid Drugs must be included in such lists.

 

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

We are not aware of any proposal to significantly reform the regulation of Opioid Drugs in Spain.

 

35. When are they likely to come into force

N/A

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