Halloween 2018

Halloween 2018, the night before Medicinal Cannabis becomes generally legal and available in the UK.

Tis was the night before Cannabis Based Medicinal Products (CBMP) became legal in the UK, and nobody knew what to do. Well apart from Active Pharma Supplies Ltd, that is!

A great many things will change on 01 NOV 2018. Cannabis based products will be allowed to prescribed and supplied in the UK, for the first time in many years.

Cannabis as medicine in the UK is not new though, there are monographs for Cannabis Tannate Tincture for example in the BPC 1911 and there have been several licensed cannabis derived medicines in the UK for many years including Nabilone and Sativex.

Nabilone is a synthetic version of Dronabinol (delta-9-tetrahydracannabinol/ THC), and is available and has been available for over 20 years in the UK. Currently its marketed by MEDA. Nabilone, sold under the brand name Cesamet in the US and an essentially similar product in the UK , it is a synthetic cannabinoid with therapeutic use as an antiemetic and as an adjunct analgesic for neuropathic pain. It mimics tetrahydrocannabinol, the primary psychoactive compound found naturally occurring in Cannabis species.

The BNF includes several cannabis monographs and there are two cannabis based medicines with UK PLs.

Cannabis Extract: https://bnf.nice.org.uk/drug/cannabis-extract.html

Nabilone:https://bnf.nice.org.uk/drug/nabilone.html

https://bnf.nice.org.uk/drug/nabilone.html

Sativex SmPC:

https://www.medicines.org.uk/emc/product/602/smpc

Nabilone (MEDA/ Kinedexe UK Ltd) SmPC:

https://www.medicines.org.uk/emc/product/6176/smpc

So what is actually happening?

On the 11th of October the government announced (UK Parliment, 2018)via the home office that changes were to made to facilitate the use of cannabis as a medicine. Although this was seen as an exceptionally progressive undertaking by a Conservative parliament, the actual effect was simply to correct legislation that for many years had grouped cannabis which has been used for many years as as medicine together with substances that were quite rightly restricted as they were psychotropic and deemed to have no medical benefit. The change in regulation simply removes the need for a specialist home office license to be required to possess, handle and prepare Cannabis-Based Products for Medicinal Use In Humans’. From the 1st of November 2018. Cannabis-Based Products  for Medicinal Use In Humans’ will be classed as schedule 2 controlled drug medicines. As the medicines will be classed as controlled drugs UK Home Office controlled drugs licenses will still be needed for importation, storage, distribution and manufacturing of Cannabis-Based Products  for Medicinal Use In Humans’.

The 2018 Regulations introduces a definition of ‘cannabis-based product for medicinal use in humans’. Only products meeting this definition will be rescheduled to Schedule 2 to the 2001 Regulations and de-designated from the 2015 Designation Order

Any product which does not satisfy this definition will remain a Schedule 1 drug and only be available under a Home Office licence.

To constitute a ‘cannabis-based product for medicinal use in humans’, a product must satisfy three requirements:

1.    It needs to be a preparation or product which contains cannabis, cannabis resin, cannabinol or a cannabinol derivative;

2.    It is produced for medicinal use in humans and;

3.    Is a medicinal product, or a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product.

A medicinal product can be as follows only

A special medicinal product for use in accordance with a prescription or direction of a doctor (who has made the decision to prescribe) on the Specialist Register of the General Medical Council;

  1. An investigational medicinal product without marketing authorisation for use in a clinical trial or;
  2. A medicinal product with a marketing authorisation.

“Special Medicine”

There are well-established mechanisms for the supply of unlicensed medicines to patients with exceptional needs. Unlicensed medicines of this sort are known as “specials” and can only be manufactured in or imported into the UK by a manufacturer or wholesale dealer that has a licence from the MHRA to do so and are expected to meet standards of good manufacturing practice (GMP).

Specialist Prescriber

The decision to prescribe is only restricted to a doctor on the Specialist Register of the General Medical Council where the cannabis-based product is an unlicensed ‘special’ medicinal product for use by a specific patient. Once a product is licensed by the MHRA, it will be available for prescription in the same way as any other Schedule 2 drug.

Confused?

A lot of people are but we can help. Active Pharma Supplies have been researching the topic for a while now and we are on hand to advise.

The MHRA has thankfully produced a document to explain in more detail how the use of Cannabis-Based Products  for Medicinal Use In Humans’ will be within the law.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/752796/Cannabis_Guidance__unlicensed_CBPMs__-_Final_311018.pdf

And the NHS has published guidance.

https://www.england.nhs.uk/wp-content/uploads/2018/10/letter-guidance-on-cannabis-based-products-for-medicinal-use..pdf

So this is the beginning of a new therapeutic substance being widely available.

Copyright of Marc Saul Borson, material in this post is only reproducible with specific permission of the copyright holder.

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