jueves, 16 de enero de 2020

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

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

Todo sobre GW Pharma en PHARMACOSERÍAS

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.

11. When are they likely to come into force?


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

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