UK Government issues a further response to an ACMD report on potential research exemptions. Although they agree in principle to lowering barriers for research, the key proposal to define "research organisations" was seen as not practical, but they have asked for more input from the ACMD.
For a number of years now, the Advisory Council on the Misuse of Drugs, which advises the UK government has been consulting and proposing changes to legislation to allow some for or research exemption in the UK (see here for more on this).
The ACMD had proposed substance de-minimis limits for research organisations (e.g below a certain amount the law would not apply)
In January the government responded that it thought it would be ‘not practical’ to define a wide-ranging definition of a ‘research organisation’ and hence without a definition of a research organisation the possibility of de-minimis limits based exemption faltered.
The government has now issued a further response on this subject, where they say; ‘We have considered your recommendation to define a “research organisation” whose activities could be exempt from controlled drugs licensing. In my previous letter, I sought the ACMD’s views on options to extend Schedule 2 status for research purposes to all Schedule 1 drugs, which would benefit two types of research organisation, not-for-profit hospitals, and universities.
Beyond this, we have not found an appropriate definition of a research organisation that has sufficient legal certainty to prevent the risk of loopholes. We would welcome your views on how this could be defined with certainty. Our view is that there is nevertheless potential for wide-ranging exemptions for legitimate research with controlled drugs by exploring forms of approved research, including research with clinical trials approval, ethics approval and other equivalent approvals.
My officials will present these options in more detail to the ACMD. Given that these approvals would not apply to early-stage research, we would welcome your advice on expanding the concept to also cover early-stage research.’
The full correspondence chain can be found on the government website here
At Scitegrity this does sound like partial progress, however it is still far from clear if and how this would apply to early stage research (pre-clinical trials). It also doesn’t cover whether chemical vendors would be allowed to supply controlled drugs under such a provision. However, given this discussion has been ongoing since 2016 / 2017 with the first ACMD proposal in 2021, it is good to see some progress. That said, I wouldn’t hold my breath given the length of time it taken to get to this point.
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