28 July 2010

THC and CBD to be Rescheduled - Home Office confirms

In June 2010 the cannabis-derived medicine Sativex received its licence in the UK. This meant that it had received approval to be used as a medicine. The active compounds in Sativex are THC and CBD.

This is problematic from a legal point of view. Cannabinol and its derivatives are currently Schedule 1 drugs under the Misuse of Drugs Regulations 2001. Drugs under Schedule 1 are generally cannot be prescribed and their possession, supply or administration is not permitted without a licence being granted by the Secretary of State.

This put THC and CBD in a somewhat invidious position. Licensed as a medicine but still in the most restrictive category of the Misuse of Drugs Regulations.

At present the Home Office has adopted a work-around. The Secretary of State has granted an open general licence to allow this specific medicine to be prescribed. This an interesting work-around, of dubious legality. It probably doesn't extend to all the other parties who need to be able to handle the drug - such as pharmacists for example. This would require more substantial revision of the legislation.

And indeed the Home Office has confirmed to us that it intends to undertake just such a revision - to move THC and CBD from Schedule 1 to a lower schedule which would allow it to be lawfully prescribed at a POM (prescription only medicine) and CD (controlled drug). This would probably mean it moving to Schedule 2 (same Schedule as Methadone) or Schedule 3 (the same as Buprenorphine).

But the really interesting part of this is that the legislation will not be able to specify the brand "Sativex." It would have to specify the specific compounds THC and CBD. Which means that the key active ingredients of cannabis will be recognised as having a legitimate medical use.

This doesn't mean a huge cause for celebration. It doesn't mean that herbal cannabis or cannabis resin will also change schedule. It will be very easy to specify that herbal cannabis and resin stay in Schedule 1 while certain cannabinoids drop down to Schedule 2.

But why it is so interesting is the issues of patent and trademark this throws up.
GW Pharmaceuticals coined the terms Tetranabinex and Nabidiolex and registered these as Trademarks. So these names, along with Sativex are protected. Similarly, the specific strains of cannabis hybridised by GW Pharmaceuticals are also Patented in some countries. So growing these specific strains without licence would be illegal.

But the underlying compounds - THC and CBD are not patented. And so while GW and Bayer now have a patent, license and trademark for Sativex, this is not in itself an obstacle to other producers developing their own products which are based around finding an effective balance of THC and CBD in an effective delivery mechanism.

It is to be hoped that, when THC and CBD are rescheduled, as they inevitably will be, this will open up the scope for more groups to explore the medical uses of cannabinoids, rather than them being consolidated in the hands of a big pharmaceutical giant like Bayer.

1 comment:

Derek Williams said...

The problem is SATIVEX isn't THC and CBD, it's also everything else produced in the cannabis oils; it is cannabis (albeit a blend of two strains).

SATIVEX is the same stuff as is sometimes sold on the street as "oil", thinned out a bit with alcohol. Interestingly this was originally a class A version of cannabis if memory serves which was downgraded to C and then up to B.

Another blend of cannabis could contain the same ratio of THC/CBD, undergo the exact same extraction process and yet have subtly difference effects due to the presence of other minor chemicals in the oil.

Therefore allowing SATIVEX use is allowing cannabis use, it isn't just allowing THC and CBD.

My feeling this hasn't happened yet because it simply isn't possible to legalise the use of this product but not legalise the medical use of cannabis.

Add to this the apparent legal right to import herbal cannabis medicine prescribed in Holland and it's clear the HO has a huge problem that it doesn't know how to resolve.