España: Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Spain (II)

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España: Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Spain (I)


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.

Cannabinoid drugs, medicinal cannabis and opioid drugs in Spain – a legal guide. 
Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from 
The Pharma Legal Handbook: Spain