Global pharma surveys in 2018 and 2021 show an impressive shift in opinion on the attractiveness of the UK for research and drug launches over the past three years. Angela McFarlane interprets the results
We are in 2018: Brexit negotiations are toxic, a ‘no deal’ outcome seems inevitable, the European Medicines Agency (EMA) has announced it is leaving the UK for the Netherlands, and UK affiliate chief executives UK are increasingly alarmed by the mood music about the UK emanating from their corporate headquarters.
The UK government continues to press the flesh on managed access agreements while, at the same time, the life sciences sector agreement is seen by many as a band-aid to stop a bleeding. The 2014 pharmaceutical price regulation system has less than a year to run.
In this context, it was crucial to cut under counter-arguments from both sides of the turmoil and establish a narrative based on evidence rather than opinion. As such, in Q1 2018, IQVIA undertook a survey, in conjunction with Informa, targeting C-suite global pharma and biotech headquarters, with the question: “To what extent does the UK Is Uni attractive for foreign investment in clinical trials and launching new drugs now? the UK voted to leave the European bloc? »
A total of 123 global life science leaders responded to the survey, and based on their responses, the outlook was bleak. Brexit was seen as having had a net negative impact on the UK’s position as a priority launch country and destination for clinical trials.
- Almost 50% of respondents said Brexit made the UK less attractive for drug launches. Most of them considered the UK as a later launch market, anticipating at least a year’s delay for the UK.
- Almost 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 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 global pharma respectively:
“The UK has a very low priority as a standalone market. Therapeutic products are developed globally and being outside the main markets of the US, EU and Japan eliminates the UK as a relevant market of interest…Developing products referring to the UK is not only irrelevant, but potentially dangerous.
“There will be inevitable delays if the Medicines and Healthcare products Regulatory Agency (MHRA) has to carry out a review after the European Medicines Agency (EMA). There will be a ripple effect on submissions Health Technology Assessment (HTA) at the National Institute for Health and Care Excellence (NICE) The cost of research in the UK is high and there is great uncertainty as to whether institutions/KOLs/academics High caliber British companies are able to participate in the high profile public-private partnerships that enable generations of evidence of product value differentiation from 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 studies of the real world in the UK. This included recommendations on what changes needed to happen to keep UK clinical trials and the real world environment competitive.
The Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Ethical Medicines Industry Group (EMIG) led industry engagement with government on the significant changes that would be required to ensure that the UK remains a priority destination for medical launches.
Over the past few years, the UK government and government agencies have issued a total of 114 policy documents designed to address and improve the attractiveness of the UK life sciences sector in a globally competitive market.
After three years of dialogue with the government, the policies most appreciated and likely to have the greatest impact are the UK’s Clinical Research, Recovery, Resilience and Growth (RRG) programme, Data Saves Lives, the Review NICE Standards and Methods and Government Life Sciences. Vision.
Now the UK has finally left the EU bloc and started moving beyond the COVID-19 pandemic, and the process of negotiating the next voluntary scheme for pricing and access to medicines from brand (VPAS), which will become operational in 2024, is about to start. .
Lest the UK be caught in its own echo chamber, with global headquarters ignoring these positive market changes, the time had come to reorient the 2018 ‘Overall UK Attractiveness’ survey for an audience of 2021.
The same initial question was posed to the C-suite global leaders. Additionally, the Office of Life Sciences, ABPI and BIA were invited to contribute to the research questions, adding richness and individually different perspectives to the survey.
The survey was conducted online in July 2021. It received an overwhelming response from leaders representing global life science organizations from the United States to the Asia-Pacific region.
What an about-face the 2021 survey revealed, compared to that of 2018, as evidenced by the information captured below:
* In total, 76% of the 166 respondents said the UK was seen as the same or even more attractive clinical research destination since leaving the European Union.
- Of note is the vote of confidence in the MHRA – with 34% of those aware of the new MHRA processes indicating that the MHRA is a priority regulator, based on new processes. Of those aware of the new MHRA processes, 22% planned to submit to the MHRA and EMA simultaneously
- Most (81% of 160 respondents) said they thought leaving the EU had made the UK at least as attractive, if not more so, for drug launches.
- In light of the review of NICE standards and methods, the proposed Innovative Medicines Fund, the NHS England managed access framework, the life sciences vision and recent policy changes tender, 79% of 156 respondents believed the UK would remain a priority launch country for their organization
- Considering recent life sciences policies (UK RRG, Life Sciences Vision, MHRA Innovative Licensing and Access Pathway, Project Orbis, NHS England Commercial Framework for Medicines and NICE 5-Year Strategy), 88% of respondents believed that their organization’s UK-based research and drug launches would increase or stay the same over the next four years
- Of the 105 respondents aware of RRG and the UK Government’s vision for life sciences, 94% thought it would have a somewhat positive, or very positive, impact on the UK’s overall attractiveness for research for their organization.
- The survey pointed to a healthy launch pipeline for NHS patients, with a strong focus from global pharmaceutical and biotech companies on specialty and orphan drugs.
- A total of 85% of respondents indicated that their organization planned to launch at least one new medicine (including new indications) in the UK in the next three years.
These are important and encouraging results for both the UK and its life sciences industry. They demonstrate that the leadership of the global pharmaceutical and biotechnology industry continues to support the UK as an important center for clinical research and the launch of new medicines. Furthermore, it shows that the events of the last five years and the results of UK research, COVID-19 vaccine and treatment, have increased the attractiveness of the UK as a destination for life sciences.
The political challenge is to build rapidly from this position of strength if the UK is to realize the government’s ambition to become a global life sciences superpower and further improve its attractiveness in a highly competitive global sector.
The government and the Life Sciences Council must now put the policy into practice and adopt the recommendations in Figure 2.
For further information on this primary market study on “the overall attractiveness of the UK for clinical research and drug launches”, please contact Manesha Banwait: [email protected]
References available upon request.