It is 2018: Brexit negotiations are toxic, a ‘no-deal’ outcome appears inevitable, the European Medicines Agency (EMA) has announced it is leaving the UK for the Netherlands, and UK affiliate GMs are increasingly alarmed at the mood music about the UK emanating from their corporate HQs.
The UK Government continues to press the flesh in managed access deals while, at the same time, the Life Sciences Sector Deal is seen by many as a plaster to stop a haemorrhage. The 2014 Pharmaceutical Price Regulation Scheme has less than a year to run.
Against this backdrop, it was crucial to cut beneath the counterarguments on both sides of the turmoil and establish an evidence-based, rather than opinion-based, narrative. As such, in Q1 2018, IQVIA undertook a survey, in collaboration with Informa, targeted at global C-suite pharma and biotech HQs, with the question: ‘How attractive is the UK for inward investment in clinical trials and to launch new medicines now the UK has voted to leave the EU Bloc?’
A total of 123 global life sciences executives replied to the survey and, based on their responses, the outlook was grim. Brexit was seen to have had a net negative impact on the UK’s position as a priority launch country and destination for clinical trials.
- Nearly 50% of respondents stated that Brexit made the UK less attractive for medicines launches. Most of them saw the UK as a later launch market, anticipating at least a one-year delay for the UK
- Nearly 40% said the UK was less attractive to conduct clinical trials
- Few respondents were aware of the Government’s Life Sciences Industrial Strategy and the Life Sciences Sector Deal, which UK stakeholders had hoped would inject investor confidence into the UK market.
The qualitative findings were elaborated by the following comments from two C-suite executives, from global biotech and pharma, respectively:
“The UK has a very low priority as a stand-alone market. Therapeutics are developed globally and being outside of the major US/EU/Japan markets removes the UK as a relevant market of interest… Developing products with reference to the UK is not just irrelevant but potentially dangerous.”
“There will be inevitable delays if the Medicines and Healthcare Products Regulatory Agency (MHRA) has to review after the European Medicines Agency (EMA). There will be a knock-on effect to Health Technology Assessment (HTA) submissions to the National Institute for Health and Care Excellence (NICE). The cost of research in the UK is high and there is a great deal of uncertainty if high calibre UK institutions/KOLs/academics are able to participate in the high-profile, public-private partnerships that enable generations of evidence of differentiation of value of products versus competitors. The price of products will also be impacted.”
IQVIA shared these findings with UK Government departments and others in the space, who listened and worked collaboratively, focusing on recommendations that would address the challenges of bringing commercial research and real-world studies to the UK. This included recommendations on the changes that needed to happen for the UK clinical trials and real-world environment to remain competitive.
The Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Ethical Medicines Industry Group (EMIG) led industry engagement with the Government on the significant changes that would be needed to ensure that the UK remained a priority destination for medicine launches.
Policy developments
Over the last few years, the UK Government and government agencies have published a total of 114 policy documents designed to address and improve the attractiveness of the UK life sciences sector in a globally competitive market.
Following three years of dialogue with Government, the policies most welcomed and likely to have the greatest impact are the UK Clinical Research, Recovery, Resilience and Growth Programme (RRG), Data Saves Lives, the NICE Standards and Methods review and the Government’s Life Sciences Vision.
Now, the UK has finally left the EU bloc and started to evolve beyond the COVID-19 pandemic, and the negotiation process for the next Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), which becomes operational in 2024, is about to begin.
For fear that the UK might be caught in its own echo chamber, with global HQs being unaware of these positive market changes, the timing was right to repurpose the 2018 ‘Overall Attractiveness of the UK’ survey for a 2021 audience.
The same original question was posed for global C-suite executives. In addition, the Office for Life Sciences, the ABPI and the BIA were invited to contribute to the questions in the research, adding richness and individually different perspectives to the survey.
The survey was conducted online during July 2021. It received an overwhelming response from executives representing global life sciences organisations from the US to the Asia-Pacific region.
What a volte-face the 2021 survey revealed, compared to that of 2018, as demonstrated by the insights captured below:
* A total of 76% of 166 respondents reported that the UK was considered the same, or an even more attractive, clinical research destination since it had left the European Union
- Of note was the vote of confidence in the MHRA – with 34% of those aware of new MHRA processes indicating the MHRA as a priority regulator, based on new processes. Of those aware of new MHRA processes, 22% had plans to submit to the MHRA and EMA simultaneously
- Most (81% of 160 respondents) stated that they thought that leaving the EU had made the UK at least the same, or more attractive, for medicines launches
- In light of the NICE Standards and Methods Review, the proposed Innovative Medicines Fund, the NHS England Managed Access Framework, the Life Sciences Vision and recent therapeutic tendering policy changes, 79% of 156 respondents thought that the UK would remain a priority launch country for their organisation
- Considering recent life sciences policies (UK RRG, the Life Sciences Vision, MHRA Innovative Licensing and Access Pathway, Project Orbis, the NHS England Commercial Framework for Medicines and NICE 5-Year Strategy), 88% of respondents thought their organisation’s UK-based research and medicines launches would increase or remain the same over the next four years
- Among 105 respondents aware of the UK Government’s RRG and Life Sciences Vision, 94% thought it would have a somewhat positive, or very positive, impact on the overall attractiveness of the UK for research for their organisation
- The survey reported a healthy launch pipeline for NHS patients, with a strong focus by global pharma and biotech on specialty and orphan medicines.
- A total of 85% of respondents indicated that their organisation planned to launch at least one new medicine (including new indications) in the UK over the next three years
These are important and encouraging findings both for the UK and its life sciences sector. They demonstrate that the leadership of the global pharmaceutical and biotech industry continues to support the UK as an important centre for clinical research and new medicine launches. Additionally, this shows that the events of the past five years, and the UK’s research, COVID-19 vaccine and treatment achievements, have increased the attractiveness of the UK as a destination for life sciences.
The policy challenge is to build from this position of strength at pace if the UK is to realise the Government’s ambition to become a global life sciences superpower and further enhance its attractiveness in a highly competitive global sector.
The Government and the Life Sciences Council now need to put policy into practice and adopt the recommendations in Figure 2.
For further information on this primary market research investigating the ‘Overall Attractiveness of the UK for Clinical Research and Medicines Launches’, please contact Manesha Banwait: Manesha.banwait@iqvia.com.
References available on request.
