Medicines regulation and law

Why it is too soon to celebrate the Alzheimer’s ‘wonder drug’

The US approval of aducanumab — the first disease-modifying drug for Alzheimer’s disease — based on a trial with a surrogate endpoint, has caused quite a stir. Here we look at the controversy and what the approval might mean for Alzheimer’s research.…

The man and his ‘illegal’ van trying to fix Glasgow’s drug problem

A van providing a safe space for drug users to inject is being piloted in Glasgow but, despite backing for the idea of such a facility from the Scottish government, Westminster says that it is illegal.…

Falsified Medicines Directive will close in Great Britain at the end of 2020

Pharmacies in Great Britain should ensure that their systems are no longer connected to the UK Medicines Verification System at the end of 2020, the UK FMD Working Group for Community Pharmacy has said.…

Just out of reach: why the UK must rethink its barriers to novel medicines

The early access to medicines scheme has been running for six years, but has it had the desired impact of ensuring the sickest patients are spared the wait for the most promising treatments, or is it failing to live up to expectations?…

Proposed legislation could see government ‘broaden’ use of data collected through the Falsified Medicines Directive

Members of the House of Lords have warned that proposed legislation for a UK version of the Falsified Medicines Directive “considerably broadens” how medicines data collected through the system would be used.…

Down, but not out: hydroxychloroquine could still have a role against COVID-19

Ongoing research may yet prove that the 4-aminoquinolones are an effective prophylactic medication in those at risk of developing COVID-19.…

The COVID-19 pandemic has forced the government to allow medicines reuse: we must not waste this opportunity to counter our throwaway culture

Fears over drug shortages during the COVID-19 pandemic mean that, in care homes and hospices, costly medicines prescribed but unused by one patient can now be given to another, rather than destroyed. This formerly illegal practice should stay long after we recover from the pandemic, and be extended …

Requesting a retrospective prescription from a GP

A locum pharmacist’s decision to substitute one medicine for another may be in the best interest of the patient, but what are the legal and ethical implications?…

Government allows bulk import and storage of medical cannabis

The government has announced that licensed medicines wholesalers will be able to hold reserve stocks of medical cannabis, effective immediately.…

Wider hub-and-spoke dispensing expected in 2021

The UK government is expected to allow hub-and-spoke dispensing between different legal entities from “early next year”, the Pharmaceutical Services Negotiating Committee has said.…