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UK government announces “competitive approach” to regulating medicines and medical devices post Brex

The UK government today announced plans to develop a

“streamlined, internationally competitive approach to the licensing and regulation of innovative medicines and devices, to give patients access to the best possible treatments and support the UK’s life sciences industry.”

Currently, most of the UK regulatory framework for drugs and devices is set by Brussels.

Post Brexit, depending on the details of the deal, the UK government may have latitude to diverge from these European Union regulations should it wish to do so.

Today’s document, released in tandem with the Queen’s Speech, outlines the newly elected government’s plans across the board. It does not provide a great level of detail. In a same-day briefing, the group NHS Providers commented that:

"[T]he recent election has given the Conservative Government an 80 seat majority, so it is almost certain these bills will get through Parliament with relative ease... The bills will likely be introduced after Christmas, potentially in early February following the UK’s exit from the EU."

The document’s language, with its focus on speed of access, innovation and industry competitiveness is likely to raise concerns among groups campaigning for lower drug prices and higher evidence requirements for medicines and medical devices.

Key points below.

New legal framework for medicines and medical devices

The newly elected government’s plans include passing a new Medicines and Medical Devices Bill.

Its stated purpose is to:

“Ensure that our NHS and patients have faster access to the best innovative medicines while supporting the growth of the UK life sciences sector to ensure we remain at the forefront of the global life sciences industry. Allow the UK to take a leading role in global research to develop rapid diagnostics and advanced therapies and devices to provide transformational care for patients around the world after Brexit.”

The planned Medicines and Medical Devices Bill would also include:

  • Updating safety requirements relating to medical devices, medicines, veterinary medicines, new innovative practices and clinical trials, in response to new evidence or risks”

  • Removing unnecessary bureaucracy for the lowest risk clinical trials, to encourage rapid introduction of new medicines”

  • Enabling national regulators “to develop innovative regulatory approaches to respond quickly to developments such as artificial intelligence in treatments and ensure the UK can break new ground in complex clinical trials”

  • “Simplifying and strengthening the system of enforcement where medical devices regulations are breached.”

No action to tackle high drug prices?

The document estimates that the UK life sciences sector is worth over £74 billion per annum, and employs close to 250,000 people. Promoting growth of the sector has long been a key pillar of the government’s post Brexit industrial strategy.

Today's document contains no plans to lower the prices the UK currently pays for drugs. in marked contrast to a campaign promise by the opposition Labour party to use compulsory licensing and other mechanisms to force drug prices down.

During the election campaign, leaked documents showed that US trade negotiators had raised the issue of the prices the UK currently pays for medicines. The government explicitly states that during forthcoming trade negotiations with other countries, “[t]he price the NHS pays for drugs is not on the table”.

‘NHS not for sale’

During the recent election campaign, Labour alleged – without providing much evidence – that the Conservative government was planning to ‘sell the National Health Service’. The document reassures voters that:

“[T]he NHS is not, and never will be, for sale. The Government is committed to the guiding principles of the NHS – that it is universal and free at the point of need.”

Health Service Safety Investigations Body

The document also outlines plans for new legislation to establish a Health Service Safety Investigations Body to investigate patient safety concerns and share recommendations to prevent similar incidents from recurring.

The new body would have the “powers and independence to conduct investigations into incidents that occur during the provision of NHS services and have, or may have, implications for the safety of patients.” These investigations would be conducted by appointed Medical Examiners, and would be done “for the purpose of learning and not [to] attribute blame or find fault.”

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