Lord Mawson

Proportionate and balanced regulation of charities is key to helping the sector deliver the vital work that it does. The Charities Act 2022, which gained Royal Assent in February 2022, implemented Law Commission recommendations to reform a number of processes in charity law. No formal impact assessment has yet been undertaken into the level of regulatory burden on charities, but in line with Government practice DCMS intends to conduct a post-Implementation review of the Charities Act 2022 by February 2027.

The Charities Act 2022, which gained Royal Assent in February 2022, implemented Law Commission recommendations to reform a number of processes in charity law. These include how charities can change their governing documents, sell land, make better use of permanent endowment funds, and merge with other charities.

The Act should reduce unnecessary or burdensome regulation that increases the sector’s costs and discourages people from volunteering to become trustees, whilst preserving important safeguards. The Law Commission’s recommendations are estimated to deliver savings for charities of £28m over a ten year period.

DCMS officials continue to review the charities’ legislative framework to ensure that regulation is balanced and proportionate.

A post-implementation review will be conducted and published three to five years after Royal Assent, in line with usual Government practice. DCMS intends to conduct a post-Implementation review of the Charities Act 2022 by February 2027.

Proper safeguarding is a key governance priority for all charities and is core to the delivery of frontline services that charities provide. No formal impact assessment has been undertaken into the impacts of safeguarding regulation and guidance on charities.

The Charity Commission has published guidance for charities which helps charities understand their safeguarding responsibilities. The Government has also published an online safeguarding tool designed to help charities handle safeguarding allegations.

The Government is considering its response to the 2022 consultation and will make an announcement in due course.

The Department, through the National Institute for Health and Care Research (NIHR), funds a range of research to improve the health outcomes for people with depression. This includes research into the clinical and cost-effectiveness of non-drug related approaches to treatment of the condition.

For example, the NIHR has funded research that demonstrated that mindfulness cognitive therapy delivered by a practitioner is an effective alternative to, and more cost effective than, cognitive behavioural therapy for adults with mild to moderate depression, providing alternative treatment options.

In addition, the NIHR is currently funding a £1.5 million randomised controlled trial to test the clinical and cost effectiveness of artificial intelligence (AI) driven care for depression symptoms in comparison to current practice, stepped care, which starts with less intensive treatments, followed by more intensive treatments for patients for whom the initial treatment fails. AI driven stratified care, which involves targeting treatment towards groups of patients based on key characteristics, could improve the evidence on how to decide which non-drug related approaches, like psychological therapy, may be most effective for each individual, and help to plan and deliver more effective clinical services.

The NIHR welcomes funding applications for research into any aspect of mental health, including non-drug related approaches to treating depression. Applications are subject to peer review and judged in open competition, with awards being made based on the importance of the topic to patients and health and care services, value for money, and scientific quality.

A number of anti-depressant products have been licenced by the Medicines and Healthcare products Regulatory Agency (MHRA). These medicines are prescription only, and must only be prescribed by a healthcare professional.

Each individual product is assessed for its efficacy and safety in a specific indication prior to the issuing of a marketing authorisation. Only when the benefit-risk analyses have been shown to be positive in relation to quality, safety, and efficacy, will a product obtain an approval.

The Product Information for each product will include not only the details of the indication, but will also include posology, or the dose recommendations, contra-indications, a list of known side-effects, and a reference to the Yellow Card Scheme, for reporting new side-effects. Safety is regularly monitored in order to detect any safety signal not recorded during the clinical trials and once the drug is available to a wider population.

Details of products approved by the MHRA, including therapeutic indications, can be found by searching ‘antidepressant’ on the MHRA website, which is available in an online only format.

The effectiveness of the product, which is measured post-authorisation, is considered by the National Institute for Health and Care Excellence (NICE), and other learned bodies, for the development of clinical guidance.

It should be noted that non-pharmacological alternatives may also be recommended to a patient, however this a decision for the healthcare professional.

The NICE is the independent body responsible for translating evidence into authoritative guidance and best practice for the health and care system. NICE guidelines provide recommendations in terms of both the effectiveness and cost-effectiveness of interventions and services, and National Health Service organisations are expected to take them fully into account in designing services that meet the needs of their local populations.

The NICE has published guidance on the treatment and management of depression in adults which provides recommendations on the use of antidepressants and non-drug treatments for depression.

The Medicines Used in Mental Health statistical release includes information about prescribing in England for medicines classified within the British National Formulary section 0403, as antidepressant drugs. There were 6,873,381 total identified patients, aged 18 years old and over, in quarter two of 2024/25.

The Office of National Statistics (ONS) publishes population statistics for England on the ONS website. The estimated mid-year population for people aged 18 years old and over in England in 2023 was 45,691,677.

Based on the latest published data, the number of adults, those aged 18 years old and over, in England who received a prescription for antidepressant drugs in the quarterly period of July to September 2024 was 15% of the estimated 2023 mid-year population.

Unintended consequences, such as potential side effects, associated with taking antidepressants are outlined in the Product Information provided with each pack of medicine. The safety of all medicines is kept under continuous review by the Medicines and Healthcare products Regulatory Agency, and the product information is updated as needed to reflect what is known about the medicine. The product information is designed to support but not replace the clinical conversation between the prescriber and patient on the benefits and risks of pharmacological treatment.

The Prescription Cost Analysis (PCA) provides the total number of prescription items of each medicine dispensed in the community in England. The following table shows the total number of items prescribed, based on information within the PCA and using British National Formulary Section 0403 for antidepressant drugs that have been dispensed in England regardless of where prescribed, as well as their net ingredient cost (NIC), for each calendar year from 2014 to 2023, and from January to November 2024:

The NHS Business Services Authority does not hold a single cost to the National Health Service. Total NIC is the amount that would be paid using the basic price of the prescribed medicine and the quantity prescribed, before any discounts, dispensing costs, or fees. It also does not include other costs to the NHS, such as those associated with purchasing or storing these medicines. The basic price is given either in the Drug Tariff or is determined from prices published by manufacturers, wholesalers, or suppliers.