Pierre Van Weperen of Grow Pharma on the post-Brexit issue surrounding the import of epilepsy cannabis medicines into the UK.
MAINTAINING existing quality standards was one of the key themes of the Brexit argument and for finished medicines this still comes with a European Union Good Manufacturing Practice (EU-GMP) certification.
And the continued application of these EU-GMP standards in the Netherlands and post-Brexit Britain is one of the reasons 40 children in the UK are now unable to access supplies of the epilepsy medicines they use.
The two main medicines at the centre of this debate – Bedrolite, a CBD oil, and Bedica, a THC oil – are produced from flowers cultivated by Dutch producer Bedrocan and made by the Transvaal Pharmacy in the Hague.
Whilst the Bedrocan flowers meet EU-GMP standards, the Transvaal Pharmacy does not have EU-GMP accreditation for its manufacturing processes and this has two consequences.
Brexit and EU-GMP
Firstly, Dutch law doesn’t allow non-EU-GMP products to be exported and secondly, UK law doesn’t allow non-EU-GMP products to be imported.
This hasn’t changed because of Brexit, this has always been the case. The practice worked pre-Brexit as a UK prescription could be filled by a pharmacy in any one of the member states.
The UK is no longer part of the EU, therefore one cannot go to another EU country to fulfil a prescription if, for example, the medicine that has been prescribed is not available in the UK.
Secondly, the reason for the law prohibiting non-EU-GMP imports is simple. A product is not guaranteed, as the manufacturer is not approved to the recognised production protocols.
‘Everyone Would Do The Same For Their Child’
The UK’s ill-conceived and poorly-functioning medical cannabis regime is one of the reasons these families have sought succour overseas.
That is entirely understandable. Every parent, I’m sure, would do the same for their child.
But, are there no cannabis epilepsy medicines that can be produced in the UK that meet EU-GMP standards with similar or identical specifications?
There are estimated to be around half-a-million children with epilepsy in the world and 26,000 children suffering with refractory childhood epilepsy in the UK.
UK epilepsy standards and pathways include EU-GMP compliant CBD isolates – GW’s Epidyolex for example is licensed for severe refractory epilepsy. There are also several unlicensed alternatives available.
However, children can develop a tolerance to purely CBD-based medicines and many clinicians and parents have found that adding THC to a CBD or moving to a full spectrum oil helps fight seizures.
‘We Can Import The Bedrocan Flowers’
Here in the UK, we can import the actual flowers from Bedrocan to be used by EU-GMP accredited facilities – including our JV partners at IPS Pharma – to manufacture oils with exactly the same CBD and THC-ratios and carrier oils.
All from the same plants, and if we were to use the same or better processes surely the end product should fit specifications and, if not, we can work together with the patients and Transvaal to make changes to get it right.
The reality is that no two crops are the same; for example the terpene profiles between two batches of Transvaal oil will also be slightly different.
To conclude, in no way am I suggesting that the children who use the Bedrocan oils should be switched and we hope they can continue to secure supplies.
However, if this is not the case, we hope this article will shed some further light on this issue and highlight how a sustainable, post-Brexit, UK solution is available.
Other cannabis medicines, which conform to European standards, are already widely available and frequently used to treat children with epilepsy across Europe and in the UK.
They are already being made in post-Brexit Britain and are available in many different CBD/THC ratios.
Pierre Van Weperen, CEO Grow Pharma
Prof Mike Barnes, who believes these are the only viable medicines for the children, will explain why he holds that view in BusinessCann tomorrow.