‘The year that nobody wanted, but the one we might just have needed’. This sort of sentiment has echoed around the globe this year. Yes, it has been a horrible year. To underplay the pain experienced by humanity would be wrong and highly insensitive. But, time and time again we hear notions of the pandemic permitting us to take stock. For individuals, families, societies and national governments as well as businesses and entire sectors, 2020 has been not only a year of immense struggle, but also of reflection and realisation of what can be achieved.
The derailment of the Life Sciences and the broader health sector
The start of the decade was eagerly anticipated. In the Life Sciences sector, the industry was filled with excitement about the opportunities that the decade would behold. An article in the Life Sciences Leader spoke of ‘virtuous investment cycles’, ‘an enlarged universe of academic research’and ‘the convergence of tech and life sciences’, that all pointed towards a decade of growth. Boris Johnson’s 2019 General Election win saw manifesto commitments made to bolster the UK’s Life Sciences industry. We heard of an ambitious Innovative Medicines Fund and the ‘biggest ever cash boost’ for the NHS.
All of that optimism was dealt a sucker punch in the form of a sun-shaped microscopic virus, as proceedings ground to a halt. For the first time since its creation, the National Institute for Health and Care Excellence (NICE) scaled back on its activity. NICE prioritised its activities to focus only on therapeutically critical topics and guidance addressing COVID-19 diagnostic or therapeutic interventions. The Scottish Medicines Consortium (SMC) meanwhile ‘suspended all meetings with immediate effect’ and the All Wales Medicines Strategy Group (AWMSG) opted to ‘suspend normal business’.
More significantly perhaps in term of patients access to new medicines, was the immediate and massive setback to clinical trials. In May, just over a quarter of trials overseen by the National Institute for Health Research were progressing as usual, with nearly 6 in 10 being stopped entirely.
We have seen disruption to healthcare delivery across all disease areas. Macmillan estimates that up to 50,000 cancer diagnoses are ‘missing’ from 2020. The charity estimates that it would take 20 months to work through this diagnosis backlog, even if activity was increased to 10% higher than it was in 2019.
The Chancellor’s Autumn Spending Review also fell short of the wishes of some stakeholders. For example, the NHS Confederation has called the Spending Review a ‘Polyfilla budget’ that leaves cracks unfilled, and the King’s Fund believes it is unlikely to address health and care pressures.
Industry has consistently called for faster progress, whether it be in funding, medicines approval, or broader market access policy. Valuable contributions to the policy debate have been made by industry this year, such as an interesting piece in the rare disease space from the UK Bioindustry Association (BIA) ‘A Rare Chance to Reform’; and in the world of digital healthcare, Boehringer Ingelheim’s tool: An Innovator’s Guide to the NHS: Navigating the barriers to digital health. Many of these publications feature thoughtful recommendations that warrant serious consideration by policy-makers.
An unexpected perfect storm
What has played out this year means development is unlikely to surpass expectation. Yet, as a sector, the Life Sciences must look at the positives. The last year has seen improvements, just not in the way one might have predicted. What this tells us is that advances can happen, and they can happen quickly and at scale.
For instance, NICE exhibited its adeptness and agility, developing rapid COVID-19 guidelines. This RAPID-C19 initiative was conceptualised, set up and implemented within weeks. NICE also waived its normal licensing requirements for reuse and reproduction of its content for rapid guidelines and rapid evidence reviews internationally.
Private-public partnerships also flourished. Industry rallied in response to a call to arms, collaborating with academic research centres to develop a COVID-19 vaccine. In approving the Pfizer/BioNTech vaccine in record time, the Medicines and Healthcare products Regulatory Agency (MHRA) demonstrated a welcome ability to respond efficiently where clinical need demanded it.
In response to Brexit, the MHRA also broadened its horizons, joining regulatory collaboration initiatives, Project Orbis and the Access Consortium. It is expected that these programmes will lead to faster medicines approval and greater patient access.
Some of the projections made at the beginning of the year were met. We have witnessed the relationship between tech and the healthcare sector strengthen. Over the course of the pandemic’s first wave in the UK, there was a staggering move to virtually enabled GP appointments. It seems certain that telemedicine is here to stay, bringing with it potentially huge benefits in resource efficiency.
Further, governments across the world are grasping the potential of big data. For all of NHS Test and Trace’s difficulties, governments are realising that suitable, robust technology is needed. Any drive to ensure that the marrying of tech and healthcare is appropriate will be of fundamental importance to the MHRA. The Cumberlege review called for an improved post-marketing surveillance system to ensure the safety of medical devices– innovative digital solutions will be essential in realising this aim.
In June, the government, in collaboration with the NHS and industry, launched a pioneering scheme to discover new antibiotics for NHS patients. The new funding model will pay pharmaceutical companies upfront for access to their antibiotic product, based on a product’s value to the NHS, rather than how much is used. The model is essential in order to re-incentivise a much needed antibiotic development market – characterised by high cost and low returns, making antibiotic development commercially unattractive. This was the outcome of several years of work, rather than a direct result of COVID. However, as we experience the impact to society of one of the largest public health threats in generations, steps taken to protect us from another potential one are extremely welcome.
The year has seen other truly exciting advances, including DeepMind’s AI technology, which represents a gigantic leap forward in demystifying protein structures, as well the decision to pilot a potentially revolutionary blood test that detects more than 50 cancers in the NHS.
The Life Sciences industry has experienced setbacks and delays this year, with the ‘perfect storm of COVID’ doubtless responsible for many of these; whilst at the same time driving progress and accelerated innovation. We have experienced change in our ways of working above anything else. NICE, the NHS, Industry and the MHRA have all stepped up to the task at hand. The collective effort reaffirms how important the Life Sciences sector is to fostering science-based healthcare innovation in the UK and beyond. The ambition shown over the past year will be of paramount importance as we head into 2021, with COVID-19 still dominating, and the end of the Brexit transition period looming. Supporting the Life Sciences industry to do what it does best, has never felt like a more important, and more worthwhile, cause.
By Will Greenhill