United Kingdom: medical cannabis available from November 1

The British Home Office has finalized the draft regulations governing cannabis-based medicines. They were developed in collaboration with the Advisory Council on the Misuse of Drugs (ACMD), the Chief Medical Officer, and a panel of independent experts tasked with pressure from civil society. These regulations were recently presented to both houses of Parliament and will take effect on November 1.

«Special» medications»

We had already explained in detail in a previous article Details of these regulations: They include an official definition of cannabis-based medicines as well as specific channels for access. These products are considered «special» medicines and fall under the existing legal framework governing the supply of unlicensed medicines to patients with exceptional needs. They may only be produced or imported by a manufacturer or seller that has obtained a license from the national drug regulatory agency and has complied with the applicable production standards.

This specific procedure, governed by Regulation 2001, also stipulates that these drugs may only be made available under the following conditions:

• a prescription from a specialist physician listed in the General Medical Council’s registry.
• clinical trials designed to test an experimental product.
• a marketing authorization approved by the national drug regulatory agency.

In short, access to cannabis-based medications will be phased in gradually and will remain extremely restrictive. The reason is that cannabis itself remains classified under Schedule Schedule 1 and is therefore not prescribed as is. It will therefore not be approved as a pain reliever, as is sometimes the case in the United States. The products will be transferred from the Schedule 1 to Schedule 2 subject to the granting of licenses by the national regulatory agency and, therefore, as scientific research progresses. The drugs in the Schedule 1 are available upon special request to the Ministry of the Interior, but only in exceptional cases.

The official document specifies that these regulations are not an end in themselves, but that the ACMD will conduct a long-term review of medical cannabis in parallel. The National Institute for Health and Care will be responsible for advising and training practitioners on medical cannabis. Meanwhile, the government will study the impact of this policy and develop a database.