Government announces research changes
The Government has recently written to the ACMD about part 2 of their ‘barriers to research’ work, with some notable developments:
- General: “A new cross-government officials working group will focus on any new issues involving research with controlled drugs while also monitoring the changes following your recommendations.”
- Recommendation 1: Research using Schedule 1 Controlled Drugs in universities and hospitals be exempt from the need to apply for a Home Office domestic licence and instead to operate in accordance with the requirements of Schedule 2 Controlled Drugs. Government response: “The government agrees with this recommendation in principle subject to operational feasibility”.
- Recommendation 2: The ACMD recommends that clinical studies using Schedule 1 Controlled Drugs with relevant HRA and MHRA approvals be exempt from the need to apply for a HO domestic licence and instead to operate in accordance with the requirements of Schedule 2 Controlled Drugs. Government response: “The government agrees with this recommendation in principle”.
- Recommendation 3: The ACMD recommends that organisations that are already exempt from the need to apply for a Home Office domestic licence for the purpose of supplying a university or hospital with Schedule 2–5 Controlled Drugs, be exempt from the need to apply for a Home Office domestic licence for the purpose of supplying a university or hospital with a Schedule 1 Controlled Drug for research purposes. Government response: “The government cannot accept this recommendation as currently presented in the ACMD report…This will therefore be discussed within the cross-government working group, and the ACMD will be asked for further clarification regarding this recommendation if required.”
- Recommendation 4: The ACMD recommends the HO review the domestic and import/export licence application systems to consider if there are any further options to improve applicant understanding and experience, recognising some applicants are first-time applicants or use the system infrequently. Government response: “The government accepts this recommendation”.
- Recommendation 5: The ACMD recommends the HO design a framework for the assessment and evaluate the impact of any policy changes to reduce barriers to research associated with Schedule 1 Controlled Drugs. Government response: “The government accepts this recommendation”.
The letter can be viewed in full here.
