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Month: November 2018

Money laundering and the re-scheduling of cannabis based medicinal products

Money laundering and the re-scheduling of cannabis based medicinal products

BCL Solicitors, David Hardstaff and Daniel Jackson, have raised an important issue in relation to the Proceeds of Crime Act 2002 (POCA), anti-money laundering (AML), and the re-scheduling of cannabis based medicinal products for human use (http://www.bcl.com/a-green-light-for-business/).  Others have also done so.
The problem arises in relation to the definition of “criminal conduct” in s.340(2) POCA, namely, conduct which “(a) constitutes an offence in any part of the United Kingdom, or (b) would constitute an offence in any part of the United Kingdom if it occurred there” [emphasis added].
A money laundering offence under ss.327-329 POCA is not committed if a person “(a) …knows, or believes on reasonable grounds, that the relevant criminal conduct occurred in a particular country or territory outside the United Kingdom, and (b) the relevant criminal conduct (i) was not, at the time it occurred, unlawful under the criminal law then applying in that country or territory, and (ii) is not of a description prescribed by an order made by the Secretary of State”.  However, the Proceeds of Crime Act 2002 (Money Laundering: Exceptions to Overseas Conduct Defence) Order 2006, provides limited protection.
It would be a harsh result if a person fell foul of the money laundering provisions when handling, in the UK, money obtained by a reputable pharmaceutical company from the manufacture overseas (and under licence there) of a drug which, in the UK, is a “controlled drug” (MDA 1971) and not licenced for production in the UK.  Can this result be avoided?  It may not be tenable to say that because the company had acted under licence overseas, the same “conduct”, “if it occurred [in the UK]” (i.e., licensed production), would therefore not constitute an offence.  This would be to treat the grant or absence of a licence as a circumstance of the “conduct”.  If this were held to be sufficient to escape liability, then the outcome would (arguably) be more generous than the limited exception granted by the 2006 Order.  In any event, as the writers point out, a “‘like for like’ comparison of the UK’s controlled drug licensing regime with that of another country is unlikely to be straightforward”.  Perhaps the most satisfactory answer is to amend the 2006 Order and provide a wider exception or range of exceptions.

See also my post re the regulations in respect of CBMPs [Link]

Prescribing Cannabis-based Medicinal Products: Moving Forward from the Landmark

Prescribing Cannabis-based Medicinal Products: Moving Forward from the Landmark

Today is undoubtedly a landmark moment but – as foreshadowed in earlier posts – the regime will be more restrictive than many persons in the media, and certain commentators, had claimed a few months ago.   The reason is that the medicines legislation (and not just the Misuse of Drugs Act 1971) was/is bound to set the ‘pace’ in relation to Cannabis-based medicinal products (CBMPs).

The relevant legislation is The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (E.W.&S) Regulations 2018 (SI 2018 No.1055), which came into force today.

A useful and comprehensive statement of the current position has been published by the MHRA [link] “The supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans ‘specials’
A letter dated 31st Oct 2018 from the DHSC and NHS England is informative [link] but there are two statements within it that need to be treated with discretion:

Moving cannabis based products for medicinal use to schedule 2 will mean those [products] can be prescribed medicinally where there is an unmet clinical need” [p.1]
and that –
the Government has chosen to restrict the decision to prescribe cannabis-based products for medicinal use to only those clinicians listed on the Specialist Register of the General Medical Council. This restriction has been set out in regulations.” [p.2]

The latter statement is true if the CBMP is unlicensed: in which event, the product must be treated as a “special”.  However, IF a CBMP has a “marketing authorisation”, the MHRA state that this prescribing restriction “will no longer apply” [p.6]:

The Misuse of Drugs Regulations 2001, as amended by [SI 2018 No.1055], provide that the prescriber must be a Specialist doctor registered on the General Medical Council (GMC) Specialist Register to be able to issue prescriptions for unlicensed CBPMs.  Once a substance receives Marketing Authorisation this prescribing restriction will no longer apply, and the product is available for patient use as other Schedule 2 drugs. See Regulation 16A of the 2001 Regulations.

Regardless of whether the CBMP is unlicensed or has a “marketing authorisation”, professional and regulatory guidelines, and ethical considerations, will be relevant.  But, how long will it take for a CBMP to acquire a full “marketing authorisation”?

Note that a CBMP (as defined in the Regulations) can be “cannabis” or “cannabis resin” – but, it must be “produced for medicinal use in humans” (and meet the remaining parts of the definition).  The MHRA document makes clear that a CBMP that is unlicensed must meet the specifications of a Specialist Medical Practitioner.  A CBMP will only acquire a “marketing authorisation” if it satisfies the stringent requirements for doing so.  It remains to be seen which products are considered by the regulatory bodies to be eligible for prescribing.

A CBMP remains a “controlled drug” for the purposes of the MDA 1971.