UK’s pharma regulatory scene reckons with changes in 2023

A sense of urgency swirls in the UK regulatory landscape, and Natasha Spencer-Jolliffe lists the biggest events of the past year.

Credit: Getty Images/SimpleImages

More than seven years after Brexit and almost three years since the Covid-19 pandemic, this year has seen the UK government adopt a series of updates to pharmaceutical laws, governing the medication landscape for patients, pharmacists and manufacturers.

From patient safety and better access to clinical trials to fostering an innovative environment and managing medication costs, in 2023, the pharmaceutical industry has seen the emergence of various new regulatory plans, updates and overhauls. 

The after-effects of Brexit and Covid-19 prompted considerable concerns within the extensive pharma space and how this would impact patients and practitioners. This along with the ongoing Russia-Ukraine war and fears for future pressures on the pharma sector ever-present, there has been a sense of urgency in 2023, spurring regulators to act now.

1. New corporate plan

In July, the Medicines and Healthcare products Regulatory Agency (MHRA) revealed a new corporate plan to create a quicker and more predictable legal landscape. Describing the new three-year plan as “visionary”, the MHRA states the strategy is designed to expand access to safe, effective and innovative medical products to ensure patient safety.

Over the proposed three-year timescale, the plan seeks to address several key strategic areas, spanning public trust, better access to safe and effective products and developing new strategic partnerships to further enhance the UK’s pharma sector.

In addition, with the industry’s focus on using innovative technology to support pharma treatment, the new plan seeks to deliver more efficient and risk-appropriate regulatory pathways to aid innovation in areas including artificial intelligence (AI), cell therapy and vaccines. 

2. Clinical trial regulation update

The MHRA announced its updated clinical trial regulation aimed at recovering the UK's clinical research sphere in March. Following a public consultation with the Healthcare Research Authority, the regulatory body revealed its overhaul of the current regulation would speed up research timelines at several stages of the trial process. 

After receiving 2,000 responses from its public consultation, professor Sir John Bell and Sir Jonathan Symonds set out their plans for progressing the updated regulatory framework. The new clinical trials legislation aims to ensure patients and their safety are the focus of all clinical trials as well as democratising clinical trial access to all.

The updated regulation also seeks to create a proportionate and flexible regulatory environment, establish the UK as a destination for international trials, and develop an agile and responsive framework that meets interests and calls for innovation. 

3. Controlling costs of branded products

In March, news of a statutory scheme designed by the UK government to implement a drug tariff to manage the price of branded health service medicines emerged.

The UK government announced a proposed update to the payment percentage for the statutory scheme, as put forward in The Branded Health Service Medicines (Costs) Regulations 2018 regulation. The 2019 voluntary scheme for branded medicines pricing and access (VPAS) also exists to control the pricing of branded medicines to the NHS.

The proposal set out an increase to the statutory scheme payment percentage from 24.4% to 27.5%, to come into effect from 1st April 2023. The recommendation was based on higher than initially forecast growth in measured sales in 2022 and, therefore, a higher VPAS amount in 2023.

In July, the government announced that, if no further changes are made to the regulations, the statutory scheme payment percentage of 27.5% for 2023 will continue each year.

4. Amendments to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations

In May and September 2023, NHS England released guidance on The NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013. Ten years after its first publication, the latest updates establish the legal framework for commissioning pharmaceutical services in England, giving staff and service providers more protection and clarity.

The legislative updates include a new provision to enable staff to change their core hours to ensure they can take rest breaks, allow temporary coordinated closures through local hours plans, limit core hours of work for contractors who entered the pharmaceutical industry and list under the 100-hour exemption, and put in place business continuity measures if the pharmacy is unable to open.

The 100-hour exemption limit refers to the amended law enabling pharmacy contractors to apply to the relevant integrative care board (ICB) to remove the inclusion on the pharmaceutical list. The list specifies that the applicant agreed to provide pharmaceutical services for at least 100 hours per week, as stipulated in regulation 13 (1) (b).

5. Medical device registration

The MHRA, responsible for regulating medical devices in the UK, published guidance in July on the medical device market. It set out information on how manufacturers could get medical devices certified, recommendations surrounding conformity marking on medical devices, and how to register medical devices with the MHRA.

Updates to secondary legislation such as The Medical Devices (Amendment, etc.) (EU Exit) Regulation 2020, which came into effect on the 1st January 2021, is cited as responsible for changing how medical devices enter the UK market.

Medical device innovators and manufacturers now have a new route to market and product marketing of the UKCA marking. All medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, must be registered with the MHRA before they enter the UK marketplace, following the updates.