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Royal Legislative Decree 1/2015, of 24 July 2015, approving the consolidated text of the act on guarantees and rational use of medicine and health products refers to a list of plants whose sale to the public will be restricted or prohibited. Although the list has not yet been made public, it seems clear that it will include cannabis, since it was already on the list included in the Ministerial Order of 2004, overturned by a sentence from the Spanish High Court (Audiencia Nacional).
The International Narcotics Control Board recalls that Article 28.2 of the 1961 Convention exempting cannabis crops intended for industrial purposes applies only to seeds and fibres and not to extracts. In the case of any cannabinoids contained in the plant and intended for medicinal purposes, the same controls on cultivation need to be applied as for opium.
In some countries, plants can be classified as food supplements and the Spanish authorities cannot oppose the marketing of products made with medicinal plants in the EU as food supplements. In this regard, the Court of Justice handed down a categorical ruling in its judgement of 5 March, 2009 on Case C‑88/07 (Commission of the European Communities v Kingdom of Spain) on the free movement of goods and products classified as medicinal products and products lawfully produced or marketed as food supplements or dietary products in other Member States.
The AEMPS has therefore authorised a number of companies in Spain to grow cannabis for research purposes and to produce derivatives from cannabis extraction. One such firm has been authorised by the AEMPS to undertake an experimental project for “Production of flowers and leaves for the extraction of cannabinoids”. The AEMPS lists a series of prerequisites for cultivation: inter alia, the company may only send the products to other AEMPS-authorised organisations and its inspection department must be able to perform controls on the plants when so required.
The AEMPS is aware of recent developments in the therapeutic use of cannabis, with the European Medicines Agency approving a number of applications for developing medicines with CBD for treating rare diseases, such as Dravet’s syndrome, perinatal asphyxia and glioma. Arising out of this approval, pharmaceutical companies can benefit from EU incentives for medicine development, such as reduced costs and protection from competition once the medicine has been marketed.