Life sciences have been in the public eye more than ever before in 2020.
Politicians have given whole press conferences over to explaining statistical analyses, pointing to graphs explaining infection rates, and discussing the need for, among others:
- medical devices in the form of ventilators
- in-vitro diagnostics (IVDs) to test for infection and antibodies, and
- biotech solutions in the form of vaccines.
Scientists and health policy leaders have been profiled in extensive features in written, visual, and audio magazines. While the primary reason for this attention will, we very much hope, be brought to an end in 2021, we predict developments in the life sciences sector will continue to be intertwined with politics in 2021.
COVID-19: healthcare in the round – the silver lining?
2021 should be the year we put COVID-19 behind us with the aid of a vaccine. The pandemic monopolised our attention in 2020 (perhaps with a short break for the US election), but brought to view insights that have the potential to change the organisation and regulation of healthcare and life sciences products in 2021 and beyond.
The pandemic highlighted the importance of viewing healthcare in the round. Ventilators are of no use if you don't have enough ICU facilities and staffing for those facilities. Drive-through test centres don't help if there are not enough laboratories available to quickly process the samples.
Into 2021, we'll see that world-leading research for the super-fast development of vaccines is unable to reach an entire population without the rapid manufacture of delivery devices, manufacturing plant meeting GMP, a cold-chain infrastructure and finally a healthcare system able to deliver vaccines to the population at large.
Don't just take our word for it. The EU has already responded by creating the European Health Union initiative. The vision is for all EU Member States to prepare for and respond to health crises together, ensure continuity of affordable and innovative medical supplies, and improve prevention, treatment, and aftercare for diseases such as cancer. This marks a significant change in the division of competences, with an extension of the EU's powers into healthcare, previously reserved by treaty to the Member States.
The COVID-19 pandemic has shown there is value in the collective bargaining power and organisational prowess of the EU27 bloc, especially when compared to the responses of some individual Member States. Having said that, while a unified response in times of a pandemic is likely to command consensus, the broader aims of improving prevention and treatment of diseases may meet greater resistance once differences in cultural considerations and nationalistic tendencies surface.
Greater moves towards digital and telehealth provision
Governments and other stakeholders have directed vast sums into healthcare to address the health crisis of the pandemic, but this may not be sustainable in the long-term. Already stretched health budgets are going to come under even greater pressure due to the greater national debt once the population is vaccinated against COVID-19. While fiscal pressures might deter investment, those allocating budgets will also know that many digital health technologies have the potential to offer efficiencies in the provision of healthcare.
According to research by McKinsey & Company, the adoption of telehealth in the US has grown very significantly, from 11% of consumers using it in 2019 to 46% in April 2020. Although we have a very different system for healthcare provision in Europe, as a result of the need to change methods of healthcare provision because of COVID-19, we expect that telehealth provision is here to stay and will become even more widespread.
Physicians previously resistant to telemedicine rapidly changed their views as lockdowns became the norm. Avoiding infection or being an agent of infection has meant avoiding in-person patient interactions. It now feels like common sense that immunocompromised patients accessing oncology clinics, for example, benefit from not having to attend in person unless absolutely necessary.
COVID-19 has also seen the advent of the use of apps to monitor and track the health of the nation.
In the UK, King's College London quickly set-up the C-19 by Zoe app in March which continues to track infections allowing researchers to contribute to the understanding of the course of this disease in individual patients. To date this app has over 4.4 million users.
The UK government took longer to act, but since the summer it has made the NHS COVID-19 app available to track and trace individuals and to contact them if they have been in proximity with an infected individual.
The digital health industry has continued to innovate, including developing apps which monitor and track diseases and well-being. We predict that during 2021, apps will go even more mainstream and, as with all new technologies, a small handful will become the preferred option for specific diseases, for example in diabetes care.
All NHS patients will eventually be using one or more healthcare apps and to prevent patients with multiple diseases becoming overwhelmed, we expect to see a level of convergence, although that is unlikely to happen in 2021, but at some later date.
New life sciences products bring headaches for governments which must decide whether or not to pay for them and at what price. Digital health solutions are no different.
Without reimbursement from governments, this burgeoning industry may fail to reach its full potential in countries with universal healthcare that is free or heavily reimbursed. It would then be left to consumers, their employers and providers such as pharma and device companies to fund these products.
Without institutional customers, developers will feel less incentive to develop ambitious products that might be prescribed or used by hospital physicians. Happily, digital health solutions are being embraced in universal funding models by some governments, particularly the UK, Germany and Sweden. We see this trend continuing and expanding in these and other countries through 2021.
Compulsory licensing of patents for COVID-19 vaccines
Once COVID-19 vaccines start to be authorised by competent authorities, governments will want to have them manufactured and administered as quickly as possible. This might be done either with the agreement of the patent owners, via a commercial deal, or some governments of a more authoritarian persuasion or who can't achieve the commercial deal they expect, might require a compulsory licence to those patents.
Governments will need to balance the value gained from coercion with the need for cooperation from the patent owners for access to know-how in manufacturing these complex biotech products. We'll no doubt see some governments try to use the information publicly available to go it alone in manufacturing vaccines and without the patent owners' consent.
Fast-track authorisations and virtual inspections
The EMA and national competent authorities and notified bodies have stepped up to grant authorisations for COVID-19 diagnostic tools and medical devices such as ventilators on an expedited basis. Competent authorities are gearing up to do the same for the various vaccines in the final stages of their clinical phase.
Necessary site audits have been and will continue to be undertaken largely virtually, something previously considered impossible. While in-person audits might be considered gold standard for GMP inspections, reducing some of the necessity for site visits has the benefit of reducing costs as well as the time of regulatory authorities and notified bodies and of manufacturers. In 2021, we expect all parties to analyse precisely which audits and which parts of audits might be undertaken virtually while still maintaining standards.
Diagnostics to the fore: heading-off diseases at the pass
The IVD industry has been the second, possibly third, child in the life sciences industry after drugs and general medical devices.
Getting reimbursement for and allocating severely limited budgets to IVDs is hard and making space for IVD machines and employing technicians and physicians to operate them and interpret their output can feel like a less justifiable expense than patient-facing activities and direct patient treatments. The pandemic has, however, shown that diagnostics should be at the front of the queue: they enable treatments to be properly directed and can be used to stop infectious diseases in their tracks.
(Another) year of devices - MDR crunch time and IVDR scramble in the EU
Notified body certification
The severe lack of notified body capacity for the incoming Medical Device Regulation (MDR) and the In-vitro Diagnostic Regulation (IVDR) has been well publicised. If manufacturers want new or updated certificates under any of the current Directives, they are already unlikely to be successful.
This is a situation that is only going to worsen as increasing numbers of general medical device manufacturers start to bump up against the end of their transitional periods for their current certificates and as a large number of IVD manufacturers gear up to make their first-ever application to a notified body for certificates of conformity in preparation for the IVDR.
Pleas for delays to the full applicability of MDR and/or IVDR made to the EU Commission have, to date, been strongly resisted and the MDR delay of one year would have been unlikely to have been agreed, had COVID-19 not struck early in 2020. We anticipate that cries for help with notified body applications will become amplified as we head towards the end of 2021. Furthermore, the Commission is likely to have to exercise its derogation discretion under Article 59 MDR and, after 26 May 2022, Article 54 IVDR.
Arrangements with economic operators
Economic operators dealing in general medical devices will continue their scramble to put in place agreements up and down supply chains before the deadline of 25 May 2021. Manufactures will also need to include obligations to address their own for post market surveillance (PMS) obligations as part of their PMS which must be in place by the same deadline.
Brexit: facing reality - a brave new UK?
Neither the MDR nor IVDR will automatically apply in the UK as they each (mostly) come into application after the end of the Brexit transition period. The MHRA has stated that new UK legislation for medical devices will be published for consultation very shortly. The new UK regime is supposed to be "robust" and "world-leading" and prioritise patient safety. The MHRA has given itself until 2023 to develop it fully (CE marked devices will be recognised in the UK until then). Will the UK government take this opportunity to offer 'MDR/IVDR lite' to induce companies to use the UK market as a testbed for their products in a post-Brexit landgrab?
Equally, for medicinal products, the UK will cease to participate in any EU-wide MA schemes and will instead rely solely on national (UK) authorisations, albeit that some will have been grandfathered in from EU centralised authorisations. This will give the MHRA scope to change the UK approach to authorisations and other incentive schemes such as for orphan products, paediatric products and data and market exclusivity rights.
Of course, all changes of approach to medical device and medicines legislation following completion of the Brexit transition period will only be feasible if there is no 'secret plan' to achieve mutual recognition with the EU in relation to these products in the longer term. Mutual recognition would require the UK to follow EU legislation very closely and not to take advantage of its independence from the EU to drive companies to the UK rather than the EU. 2021 might be the year of the big policy reveal on the regulation of medicines and medical devices in post-Brexit UK.
Find out more
If you'd like to discuss any of the issues raised in this article in more detail, please reach out to a member of our Life Sciences & Healthcare team.
