Creating the Conditions for Investment and Growth in UK Life Sciences

Entry to Regulatory
Sep 17
8 min read

Updated: Oct 1

The innovative pharmaceutical industry is a cornerstone of the UK’s health and economy, investing around £9 billion in R&D in 2022 alone. However, unlocking its full potential requires a supportive business and regulatory environment that attracts investment and accelerates growth. Recognizing this, the Association of the British Pharmaceutical Industry (ABPI) has outlined a vision for making the UK the best place in the world to research, develop, and use future medicines. By creating the right conditions - from faster regulatory pathways to sustainable NHS access and pro-innovation policies - the UK can generate a "virtuous cycle" where investment in new treatments drives further innovation and economic gains. Below, we explore the key areas that need attention and how they relate to regulatory affairs consulting.

Accelerating R&D and Regulatory Pathways

A top priority is strengthening the development, regulation, and adoption journey for new medicines and vaccines. This means ensuring the UK has a joined-up life sciences ecosystem with the capacity for rapid regulatory approvals followed by swift adoption in the NHS. In recent years, the UK’s clinical trial activity has declined significantly - the number of industry-sponsored trials started per year fell by 41% between 2017 and 2021. The drop was especially steep in late-stage trials, where the UK slipped from fourth to tenth in global rankings for Phase III trials during that period. This trend threatens the UK’s attractiveness for research investment and has reduced opportunities for patients to access cutting-edge trials.

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While 2022 brought some early signs of recovery - industry trial initiations ticked up 4.3% from 394 in 2021 to 411 in 2022 - this remains far below the peak of 690 trials seen in 2015. Annual recruitment of patients into trials, at about 42,000 in 2022/23, is still 16,000 fewer people than participated in 2017/18.

Reversing this decline is critical. The ABPI calls for setting bold targets to restore the UK’s clinical research leadership - for example, reversing the decline in trial activity and leveraging the UK’s rich health data infrastructure to enable world-leading patient recruitment. Harnessing the NHS’s vast health data (including genomic data and electronic health records) could make it much easier to identify eligible patients and run efficient trials, attracting global studies to UK sites.

The regulator’s capacity is another focal point: pharmaceutical companies report that a lack of MHRA resources and predictability is a major hurdle, with over 80% of drugmakers describing the UK regulatory environment as challenging in this regard. Post-Brexit adjustments and budget cuts have strained the MHRA’s staff and capabilities, even as it proved its agility by fast-tracking COVID-19 vaccine approvals. Both industry and government recognize the need to bolster the regulator - for instance, plans are underway to establish a new "Regulatory Innovation Office" to streamline processes and improve approval timelines. The goal is to make UK regulatory review not only scientifically rigorous but also faster and more predictable than rival markets.

For businesses, these developments underscore the importance of aligning product development with evolving regulatory pathways. By planning smart regulatory strategies, companies can take advantage of new expedited approval routes and data-driven trial recruitment initiatives. Expert regulatory affairs consulting can be invaluable here - helping sponsors design high-quality submissions that meet MHRA requirements on the first pass, and advising on how to integrate programs like rapid scientific advice or rolling reviews into the development plan. Faster approvals and well-run trials mean patients get access to innovative therapies sooner, and the NHS benefits too. In 2018/19, the NHS received an estimated £335 million in revenue for delivering industry-sponsored clinical research. Expanding clinical trial activity could greatly increase these benefits - in fact, analyses show that boosting patient recruitment into trials could generate up to £3.5 billion in additional income for the NHS over five years (including around £678 million saved on medicines provided free in trials). In short, a more investment-friendly R&D ecosystem creates a win-win: accelerating innovation for patients while reinforcing the UK’s status as a global R&D hub.

Partnering to Improve Patient Access and NHS Sustainability

Another vital area is ensuring rapid adoption of new medicines and vaccines in the healthcare system, in partnership between industry and the NHS. It is not enough to approve innovative drugs - patients need to actually receive them, and health services must see value from these innovations. The ABPI emphasizes that the long-term benefits of medicines should be properly valued and rewarded.

This speaks to the UK’s system of drug pricing and reimbursement, where recent policies have put the industry under pressure. Under the outgoing Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), pharmaceutical companies faced an unprecedented revenue clawback - returning 26.5% of their UK medicine sales revenue to the government in 2023. This steep rebate (amounting to almost £3.3 billion in 2023) is more than double the rate in any comparable country and was deemed "unsustainable" by the industry. ABPI warned that such extreme measures were actively harming the UK’s life sciences ecosystem, leading companies to scale back investment in R&D and manufacturing locally. Indeed, in one high-profile case, a major drug maker chose to cancel plans for a new UK manufacturing facility in favor of another country, explicitly citing the UK’s tax hikes and onerous sales rebate as factors in the decision.

A healthier way forward is a new pricing and access framework that controls NHS spending growth without deterring innovation. Negotiations for a revised scheme (the Voluntary Scheme for Pricing, Access and Growth, or VPAG) have aimed to reset the rebate to a more reasonable level and give companies confidence to launch products in the UK. Delivering on these commitments will be crucial to restore the UK’s reputation as a viable market for new therapies. For the NHS and patients, the payoff for improving access could be tremendous. Research by PwC found that simply increasing usage of certain recommended medicines (for conditions like atrial fibrillation, diabetes, severe asthma, and hyponatremia) to the levels recommended by NICE would yield 429,000 additional years of life in good health for patients and £17.9 billion in productivity gains for the UK economy. In other words, better uptake of effective medicines isn’t just a healthcare improvement - it boosts economic output by reducing illness.

Policies like the new Innovative Medicines Fund are intended to help NHS patients get early access to cutting-edge treatments in areas of high unmet need; making sure this works as intended is another ABPI priority. Similarly, preparing for the next generation of vaccines (such as mRNA vaccines or personalized cancer vaccines) and supporting high vaccination uptake will improve public health resilience. The industry also urges sustained focus on antimicrobial resistance (AMR), calling for dedicated funding of the national AMR action plan to incentivize development of new antibiotics.

From a regulatory affairs perspective, this focus on access and sustaining the NHS means that companies must navigate not only regulatory approvals, but also the interface with health technology assessments and reimbursement processes. Evidence generation plans should demonstrate the real-world value of new therapies to payers and policymakers. A seasoned regulatory consultant can help sponsors anticipate what data will satisfy regulators and support a compelling value proposition for NICE and other health authorities. By aligning clinical trial endpoints and post-approval studies with the outcomes that matter to patients and health systems, companies can speed up uptake once a drug is approved. In essence, regulatory strategy and market access strategy are increasingly intertwined. Firms that proactively address questions of cost-effectiveness, patient benefit, and health equity will be better positioned in an environment where the government expects partnership with industry to improve both health outcomes and healthcare sustainability.

Building a Competitive Ecosystem for Investment and Growth

Finally, creating the conditions for investment and growth means equipping the life sciences industry with the tools to drive economic growth. This includes maintaining a favorable environment for advanced manufacturing, trade, talent, and intellectual property. The UK already has strengths to build on - pharmaceutical manufacturing contributes around £16.4 billion in gross value added (GVA) to the economy each year and provides roughly 26,000 high-value jobs. With the right support, this could grow dramatically. Analysis indicates that a supportive medicines manufacturing policy environment could attract £15 billion in new investment and double the number of UK medicines manufacturing jobs over the next decade. To achieve this, the ABPI recommends a long-term program of incentives, such as capital grants and innovation funding, to make the UK a world leader in advanced and sustainable medicine production.

Notably, the UK is competing globally to host facilities for emerging technologies like cell and gene therapies, mRNA vaccine production, and other biotech manufacturing - areas where a stable policy environment and targeted support will sway where companies build their factories. Ensuring the tax and fiscal regime is internationally competitive is another piece of the puzzle. Recent increases in taxes and reductions in R&D tax credits have drawn criticism for undercutting the government’s own Life Sciences Vision. Going forward, offering attractive R&D tax reliefs, patent incentives, and consistent capital allowances will be key to drawing investment. The impact of policy on business decisions is clear: when the UK raised its corporation tax and sustained high revenue clawbacks, some investors voted with their feet - as seen with AstraZeneca’s decision to invest in Ireland rather than expand in Britain. A reversal of that narrative will likely require rebuilding confidence through more predictable and innovation-friendly policies.

Protecting intellectual property (IP) and easing trade barriers are also vital for a competitive life sciences sector. Pharmaceutical innovation relies on strong IP rights, so the UK’s stance in international arenas like the World Trade Organization should continue to defend robust patent protections. During the COVID-19 pandemic, there were global debates on patent waivers; looking ahead, industry leaders stress that confidence in IP security is fundamental to risk-intensive R&D investments (especially for fields like advanced biologics). At the same time, as the UK strikes new trade agreements post-Brexit, it has an opportunity to champion life science exports and streamline regulatory cooperation with other markets. Aligning standards and eliminating duplicative requirements can help UK-based companies reach global markets more easily. Trade policy tools - from mutual recognition of Good Manufacturing Practice (GMP) inspections to tariff reductions on pharma supply chain materials - can all contribute to a more favorable operating environment for biotech and pharma firms.

Importantly, none of these ambitions can be realized without a skilled workforce. The rapidly evolving nature of biomedical research and manufacturing means the demand for talent is high - ranging from regulatory scientists and clinical trial specialists to bioprocess engineers and data analysts. The ABPI has called for a cross-government approach to education and skills, working closely with industry to address current gaps and future needs. This could mean expanding specialized training programs, supporting STEM education, and making the UK an attractive destination for global scientific talent. For example, if the UK is to add on the order of 26,000+ new biopharma manufacturing jobs in the coming years, it must ensure a pipeline of qualified graduates and upskill the existing workforce accordingly. Business-friendly immigration policies for skilled workers may also be part of the solution in the near term. For companies, engaging with these skill-building initiatives and investing in employee development will pay off in productivity and innovation capacity.

All told, the UK’s life sciences landscape is at a critical juncture. The potential rewards for getting the policy environment right are enormous - from unlocking billions in investment and thousands of jobs, to delivering faster cures and improved health for society. Achieving this will require true partnership between government and industry, characterized by collaboration, transparency, and a unified vision for health and growth. It will also require strategic navigation of an increasingly complex global regulatory climate. Companies that stay ahead of these changes - by leveraging expert regulatory affairs support and adapting to new regulatory science and policy initiatives - will be best positioned to thrive.