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Feb 16 – Sativex Is Approved For Use In Gibraltar - Government Statement

The Drugs (Misuse) Regulations 2005 have been amended to allow for the cannabis-based medicine “Sativex” to be approved for use in healthcare. Henceforth, MS patients will have a medicine which can treat and alleviate their symptoms whilst clinicians will be reassured when prescribing this drug.

The Drugs Advisory Council, the statutory body that advises the Government on the misuse of drugs and is chaired by the Minister with responsibility for drug and alcohol awareness and rehabilitation, Samantha Sacramento, at its recent meeting discussed concerns as to the manner in which certain cannabis-based medicinal products are available for prescription in Gibraltar.

The Chair of the Advisory Council asked for advice as to the use of cannabis based medicinal products as well as for absolute clarity as to the prescription of cannabinols that were currently prescribed by the GHA. Minister Sacramento instructed the office of Parliamentary Council to liaise with the Director of Public Health to prepare any necessary legislative changes as may be required to remove any ambiguity that may arise from such prescription.

The Government’s advisory council met with the medical professionals to ascertain what changes, if any, could immediately be made to legislation to ensure that cannabis based medicinal products, which are licensed by the European Medicines Agency and appear in the British National Formulary, may be prescribed in Gibraltar.

Following representations from the medical professionals and legal advice, it was ascertained that the only relevant licensed medicine, which fell into this category is “Sativex”. This is a proprietary extract of cannabis licensed for treatment of severe spasticity in multiple sclerosis. The amendment published deals with that product.

The amendment to the legislation leaves no doubt that this licensed product, which is contained with the British National Formulary, may be prescribed in Gibraltar. Given the nature of this substance, and on the advice of the medical professionals, the use and prescription of this product will be limited by its licence to specialist use and placed within a class of medicine which may in effect only be dispensed via the GHA Hospital pharmacy.

Samantha Sacramento, Minister with responsibility for drug and alcohol awareness and rehabilitation said: “Having recently been appointed as Chair of the Drugs Advisory Council, one of the first matters on the agenda was to look at the potential use of medicinal cannabis and I asked the members, and in particular the medical professionals to advise the Government on the matter. I referred the legal issue of current prescription to Government’s legal team and I am very grateful for their advice on the matter and their preparation of the Regulations we have published. I have discussed the matter with my colleague Neil Costa, who as Minister for Justice has signed off on these Regulations and as Minister for Health will be responsible for its implementation at the GHA. We will of course be working together in this respect”.

The Minister with responsibility for Health, Care and Justice, Neil F. Costa, said:
“On having discussed this with both medical and legal professionals, I am assured that the change in legislation made today makes it crystal clear that Sativex may be prescribed by the appropriate specialist medical clinicians in Gibraltar for its licensed uses without undue difficulties. I believe that the change in the law, together with the restrictions regarding dispensing and use, balance the requirement for public safety with the need to ensure that our medical professionals are able to rely on the full range of cannabis based medicines currently contained the British National Formulary to treat members of the public.”


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