The regulators and policy makers

As a service provider to the healthcare industry, I am now established in a different mode of expectation – which is wanting greater “Clarity” into what lies ahead.

post covid

Whilst “Clarity” itself is a challenge, predicting which roads we will need to travel down due to trends throwing up multiple outcomes, innovations and policies that impact our days either directly or indirectly makes “Clarity” ever more insurmountable. Covid-19 has been an Armageddon, and re-calibrates the future. Such an important event is worth reviewing to see which course has changed or will change further and therefore is a lead indicator of our business futures.

On December 2nd 2020, Prof Derek Hill elegantly described with his comments in the ‘Science Media Centre,’ how the MHRA led the way in approving the Pfizer/BioNTech mRNA vaccine, the first of its kind against Covid-19 and the international acclaim that it brought. The approval of the vaccine was a fine example of international collaboration. Governments and regulators like the MHRA, EMA, US-FDA, industry, healthcare professionals and the WHO, working in tandem to develop new ways of working through modifications to existing regulatory and development pathways or creating new ones, offering us an insight to what the future might hold.

Unfortunately, although not unexpectedly, this was interrupted when national and regional political posturing risked undermining the speed of vaccine rollouts, threatening to unravel the international collaboration that had got us this far.  To their credit, regulators have been quick to respond when safety concerns had been raised about a vaccine, rapidly reviewing data and providing clear advice to the public to reassure them and confirm the importance of vaccination.

So, what is next for the regulatory agencies post Covid 19’?  For sure they should be seen as the go-to trusted resource, folks who are driven by data and science, who strive to remain apolitical, supporting policy.  The potential for a revised or invigorated alliance of all stakeholders, including government, can only lead to better outcomes, learning from the challenges, missed opportunities and successes that the Covid-19 pandemic brought us.   International collaboration and partnerships, knowledge sharing, coordinated procurement and supply chains should always be the front, middle and center, disregarding nationalism and short term political advantage.  Imagine what could be achieved in preventing and treating Cancer, Malaria, Alzheimer’s, and many other diseases and chronic conditions if political leaders worked together and supported the greater good of serving mankind, which was so evident in the development of the Covid 19 vaccine.

Covid 19 has also brought us back to recognizing the value of medicine re-purposing,  and as part of a panel discussion ‘Why Patent Protection is key to Commercialising Re-purposed Drugs’ at  LSPN Connect, the relationship between, investor, research and regulatory pathway was also discussed by John Liddicoat, Senior Research Associate at the University of Cambridge, Duane Marks, Assistant General Patent Counsel at Eli Lilly, John Conour Partner at MBHB, Pankaj Agarwal, Principal Computational Biologist at BioInfi and MaryAnne Armstrong, partner at BSKB also referencing that increased government cooperation is vital in driving research. So back to the question ‘what next for regulators and policy makers? Hopefully we will avoid looking at the Covid 19 crisis as an isolated incident and consider more that Covid 19 is an event shaped through current global pressures, raising the profile of support through direct and indirect partnerships. If we are looking for a road map ahead, we should maintain the level of cooperation seen during Covid 19 and governments should continue to invest heavily and systematically into research…regulatory authorities, industry and academia expanding capabilities in setting up policy and supporting industry in their endeavours, acting as enablers of development and growth. Hopefully, our collective memories will not wane post-Covid 19 and the collaborations that were built are retained and supported.

Seeing some glimpse from Covid 19 in what might be deemed as clarity for tomorrow’s healthcare business landscape, we saw the need to be more flexible in how we innovate bespoke service provisions to meet new policy demands as well as increasing our flexibility in service ramp-up. Launching our new division, Norak Pharma, goes a long way in meeting these demands in flexibility.  Norak and Norak Pharma, like our healthcare partners will continuously work hard on reading and understanding the rapidly changing landscape ahead, in our own ways contributing to the post Covid 19 future.