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Cannabis-based medicinal products - what do the changes mean?

St Marys/Hammersmith Hospitals 21-12-16
Hospital doctors looking at computer screen SMH2016

In July 2018, the Home Office announced plans to reschedule cannabis-based medicinal products in order to widen their availability within the NHS. The new regulations came into effect on 1 November 2018.

FAQs

  • What has led to this change in policy?

    In summer 2018, the Government announced a review of the medicinal benefits of cannabis following campaigning from families of young children suffering from conditions including epilepsy and multiple sclerosis.

    The review followed two stages: a review of the existing evidence by the UK chief medical officers and an assessment by the ACMD (Advisory Council on the Misuse of Drugs) on scheduling cannabis-derived medicinal products. The review concluded there was evidence to support therapeutic benefits of medicinal cannabis for some conditions, and advised that clinicians in the UK should have the option to prescribe these products when they meet the requirements and standards for certain conditions.

    Acting on this advice, the Home Office announced plans in July 2018 to reschedule cannabis-based medicinal products in order to widen their availability within the NHS. The new regulations came into effect on 1 November 2018.

     

  • What products are classed as cannabis-based products for medicinal use?

    As of 1 November 2018, the only cannabis-based medicine that had a marketing authorisation in the UK was Sativex (also known as nabiximols), an oral spray licenced for use by the MHRA (Medicines and Healthcare products Regulatory Agency) to treat spasticity in adults with Multiple Sclerosis. NICE (National Institute for Healthcare Excellence) do not consider Sativex to be a cost-effective treatment, and therefore its usage is limited in the NHS across the UK. However, the All Wales Medicine Strategy Group do recommend its use in Wales.

    The 2018 Regulations introduce a definition of cannabis-based products for medicinal use. Only products meeting this definition will be rescheduled to Schedule 2. 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 is or 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.

    Any product that satisfies these three criteria is considered to be a ‘cannabis-based product for medicinal use in humans’ and is now a Schedule 2 drug under the 2001 Misuse of Drugs Regulations. These Regulations include the need to keep a controlled drug register, and safe custody requirements.

     

  • How can patients access a cannabis-based product for medicinal use?

    From 1 November 2018 there are three ways for patients to access a cannabis-based medicinal products:

    1. Doctors on the GMC specialist register can prescribe a cannabis-based medicinal product as an unlicensed ‘special’ medicinal product (see below);
    2. Participants in clinical trials for investigational medicinal products can be given a cannabis-based product for medicinal use without a marketing authorisation;
    3. Doctors can prescribe a medicinal product that has MHRA marketing authorisation (currently only Sativex in the UK).

    Prescribing is only restricted to a doctor on the GMC specialist register where the cannabis-based product is an unlicensed ‘special’ medicinal product for use by a specific patient. Once a product receives a licence from the MHRA, it will be available for prescription in the same way as any other Schedule 2 drug.

     

  • What are specials?

    The new regulations will mean that doctors on the GMC specialist register can prescribe cannabis-based products for medicinal use as ‘specials’. These are unlicensed medicines that are manufactured or procured specifically to meet the special clinical needs of an individual patient.

    ‘Specials’ have not received marketing authorisation from the MHRA. However, the MHRA, does licence manufacturers and checks standards of good manufacturing practice.

    Further information about specials

  • Who can issue prescriptions?

    Due to the way the regulations have been drafted, only doctors on the specialist register will be able to sign prescriptions. NHS England will issue further guidance on this.

    NHS guidance on medicinal cannabis

  • What guidance is available to prescribers?