16/09/2019 - Corporate News

Narcotic drugs in Spain

Autor: Carlos Curto Martí

At the end of August, pharmaceutical giant Johnson & Johnson hit the headlines as result of a $572 million civil judgment for the opioid trial in the US. In particular, a judge of the Cleveland County District Court in the State of Oklahoma ruled that Johnson & Johnson pursued an intentional strategy by which it promoted the benefits and minimized the risks of opioids, ordering Johnson & Johnson to pay $572 million to the State of Oklahoma.

The reasons Johnson & Johnson was convicted were basically as follows:

  • Development and dissemination of “false, misleading and dangerous” marketing campaigns.
  • “Aggressive” marketing of opioids to doctors and patients claiming that they were totally safe and effective.
  • In the opinion of the ruling, due to Johnson & Johnson malpractice, there was an exponential increase in the rates of addiction, overdose deaths and newborn babies exposed to opioids.
  • Violation of the state’s public nuisance law, by causing a serious breakdown in the health of part of the population as a result of this opioid crisis.

In view of the above, it seems appropriate to describe briefly the Spanish legal landscape on psychoactive substances.

Psychoactive substances are regulated at a double level: at the international level, they are regulated by the United Nations Single Convention on Narcotic Drugs of 1961 (signed by Spain on 27 July 1961 and ratified by Instrument of 3 February 1966) and by the Convention on Psychotropic Substances of 21 February 1971 (signed by Spain through Instrument of Accession on 2 February 1973); At the national level, the legislation consists mainly of Law 17/1967 of 8 April 1967 on narcotic drugs, Royal Decree 2829/1977 of 6 October and Order of 14 January 1981 on psychotropic substances, Royal Decree 1675/2012 of 14 December, regulating official prescriptions and special requirements for prescribing and dispensing narcotic drugs and, at a general level, by Royal Legislative Decree 1/2015, of 24 July, approving the consolidated text of the Law on Guarantees and Rational Use of Medicines and Health Products.

Narcotic drugs mean those substances, natural or synthetic, included in Schedules I and II of the Single Convention of 1961 and those other substances that acquire such status at the international level, in accordance with the referred Convention and at the national level by such procedure as may be established by regulation. Among those substances, mention can be made to Cannabis, Morphine, Opium, Thebaine or Codeine (3-methylmorphine).

Psychotropic substances are those substances, natural or synthetic, or any natural material, included in Schedules I, II, III and IV of Convention on Psychotropic Substances of 21 February 1971. A psychotropic substance is Diazepam.

Given the nature of these substances and the risk of diversion of narcotic drugs into the illicit traffic, they can only be dispensed when prescribed by a doctor.

Narcotic drugs listed in Schedule I of the 1961 Convention (such as morphine or cannabis extract, for example) require, for their prescription and dispensing, an official prescription for narcotic drugs (regulated by Royal Decree 1675/2012 of 14 December), while drugs included in Schedule II (such as codeine) and Schedule III require only an ordinary prescription. On the other hand, substances listed in Schedule IV (such as Cannabis flowering and their resin) are considered prohibited articles and therefore they cannot be dispensed.

Given the increasing interest in the business around the Cannabis, a special mention must be made.

The 1961 Convention defines Cannabis as “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, by whatever name they may be designated”.

Cannabis -in particular, its extracts and tinctures- is included in Schedule I of the aforementioned Convention, and is therefore considered a narcotic drug, and its production, manufacture, export, import, distribution, trade, use and possession must be limited to medical and scientific purposes and is subject to the strict control and supervision of the Spanish Agency for Medicines and Health Products (Sativex is an example of a medicine containing extracts of Cannabis). At the same time, Cannabis flowering and its resin are included in Schedule IV, so it cannot be produced, manufactured, trafficked, possessed or used, with the exception of quantities necessary for medical and scientific research, including clinical experiments carried out under the supervision and control of health authorities.

Moreover, in accordance with Articles 7 and 8 of Law 17/1967 and Article 28 of the Convention of 1961, the cultivation of cannabis plants in Spain requires prior authorization from the Spanish Agency for Medicines and Health Products.

In view of the foregoing, the Spanish Agency for Medicines and Health Products currently grants two types of authorizations related to Cannabis: (i) authorization for the cultivation of cannabis plants for research purposes; and (ii) authorization for the cultivation of cannabis plants for medical and scientific purposes.

At present, there are 6 corporations in Spain authorized to cultivate Cannabis for research purposes and 4 corporations authorized to cultivate Cannabis for production and manufacture for medical and scientific purposes.

Finally, it should be noted that it seems that the World Health Organization is going to officially recommend that Cannabis (the flowering and the resin) should disappear from List IV. If that is the outcome the Cannabis will no longer be considered a prohibited substance and will only be included in List I, which means that it could be formulated as a medicine, which will undoubtedly open a horizon of new opportunities for many companies.