Tag Archives: government affairs

The government and mental health – what has happened so far?

Around two million adults and children are currently stuck on NHS waiting lists seeking mental health support. NHS England estimates the cost of untreated mental health to the UK economy to be £117.9 billion every year, taking into account those who are unfit to work because of their condition. Previous administrations have attempted to address this issue, in particular former Prime Minister Theresa May’s commissioning of the Wessely Review, but seemingly little substantive progress has taken place.

In opposition, Labour’s journey to office set off to a questionable start on mental health. The Party’s dedicated shadow mental health minister Rosena Allin-Khan resigned in September 2023 citing Starmer’s decision to remove the mental health portfolio from the shadow cabinet.

Since then, the Party has made no secret of its intention to overhaul what has been described as a mental health system in crisis. Labour leader Sir Keir Starmer vowed in his Party’s manifesto to reform and modernise the outdated Mental Health Act 1983, recruit 8,500 new mental health staff, and place mental health professionals in schools. Seven months on from Labour’s landslide general election victory, how can progress be described?

In the King’s Speech, the government brought forward the Mental Health Bill which seeks to address unnecessary detentions for people with a learning disability or autism and end the use of criminal justice cells to detain those who need care under the Mental Health Act. Ministers have said that the Bill, which is currently being scrutinised in the House of Lords, will ensure that all patients have a care and treatment plan tailored to their needs.

In addition, the autumn budget committed £26 million of investment in new mental health crisis centres to help ease pressure on A&E departments. This is due to the increase in patients presenting in hospitals because of a lack of accessible mental health services.

While these initial measures are targeted at the most severe and urgent cases of poor mental health, the government’s wider ambition for mental health looks to incorporate its overarching focus on health prevention. The government’s 10-year health plan, due to be published in spring 2025, will be underpinned by “treatment to prevention” as a core pillar. It is also likely to contain further details on how mental health prevention will be included within this shift towards preventative care.

There is evident cross-party support for improving mental health services, and parties of all colours recognise the devastating impact that maintaining the status quo will have, both on individuals and wider society.

The Liberal Democrat-chaired Health and Social Care Select Committee announced in December 2024 the launch of a new inquiry into community mental health services.  This is likely to reveal further improvements required in the system which will help shape the government’s approach to reform.

It is vital that providers and businesses engage with the committee’s inquiry which will be vital in shaping the development of policy in this area. The government must get mental health care right if it hopes to see any pressure on the NHS reduced or make a dent in the ever-growing list of workers signed off due to long-term sickness.

gk - The Medicines and Medical Devices Bill- the impact and opportunity

The Medicines and Medical Devices Bill: the impact and opportunity

On the 2nd March 2020, the Medicines and Medical Devices Bill 2019-20 went through its second reading in parliament. It has been one of the first pieces of domestic legislation to be introduced since the Queen’s Speech in December 2019 and represents a critical area of post-Brexit regulatory change.

The Bill is politically uncontroversial. It passed first and second readings unopposed by the Labour Party and is more about the need for legislation to return regulatory powers to central government rather than a Brexit-fuelled political move.

Nevertheless, the legislation can define the medicines and medical devices regulatory environment for years to come.

Specifically, the legislation could have a significant impact on contract research organisations (CROs) whose interest is in stymying excessive divergence from US and EU clinical trial regulation. The following are just a few areas the bill might interfere:

  1. The speed of approval processes for clinical trial applications

The UK has a reputation for world-leading standards in clinical research. It has several world-leading universities, research organisations, institutes and scientists operating around the ‘Golden Triangle’ (London, Cambridge and Oxford) and beyond. These hubs ensure pharmaceutical companies get the most out of phase I-III research, while also having applications approved quickly by the renowned Medicines and Healthcare products Regulatory Agency (MHRA). The combination of an effective and accessible regulator in the MHRA and its close relationship with NICE must be protected.

  1. Alignment to the EU Clinical Trial Regulations (CTR)

The UK and, specifically, the Clinical Trials Unit of the MHRA played an active and leading role in the development of the EU Clinical Trial Regulations over the past five years – due for implementation during 2020. The regulations aim to create a single set of standards across the EU, establish a single method for submissions to assessment processes and increase transparency, collaboration and information sharing across EU Member States.

While the UK’s departure from the EU means that it won’t be implementing the regulations it helped to develop, CROs across the country will want to ensure that the future of the UK’s clinical research regulation is as closely aligned to the EU as possible. This will ensure its ability to deliver competitive, expeditious and high-quality research. The Medicines and Medical Devices Bill should facilitate this alignment.

  1. The introduction of bureaucratic processes and regulatory burden for CROs

There is some anxiety in the CRO sector that the new regulatory environment will cause a significant bureaucratic burden when it comes to clinical trial applications. If the legislation oversees a divergence in regulatory standards and processes from other markets, applications to the MHRA could require more and different information to the U.S. Food and Drug Administration and the European Medicines Agency. CROs will be eager to mitigate this risk.

These are just a handful of areas where the Bill might affect CROs and the life sciences industry. Others include patient safety, pharmacies and medicine supply chains, as well as manufacturing, labelling and packaging.

GK Strategy are experts in political and government engagement, with long-standing experience and understanding of the life sciences and clinical research sectors. To discuss further with our team, please do get in touch via ian@gkstrategy.com