Today's post is written by John Ricketts, Director, European Government Affairs, Policy & Public Affairs at Eli Lilly.
With the European Union’s new five-year legislative cycle kicking off last year, there’s no better time to dive into the challenges facing the healthcare sector. AmCham EU’s new Life Sciences for Europe report argues for an integrated approach to life sciences that protects this strategic European sector, supporting high-value jobs and bringing faster access to medicines.
The report pinpoints some of the interconnected opportunities for medical innovation. The COVID-19 pandemic has already brought some to light, like the work needed to educate healthcare professionals (HCPs) and policymakers on emerging technologies up and down the value chain. But it also proposes an approach to tackle common challenges facing life sciences. Let’s dive deeper together…
Four core pillars
Today, emerging technologies and digital integration are driving a new era of innovation in the life sciences sector. Boundaries are being pushed further and further everywhere from personalised and biologic medicines, to digital health, to diagnostic technologies, to medical devices.
But there are significant linkages between each of these areas and new practices or restrictions in one soon ripple through to the others. As a result, there is a convergence of regulatory policy areas governing the delivery of 21st Century healthcare which needs to be both robust but flexible at the same time. So, what can be done at a European level to keep up?
Overlapping regulatory responses
An inconsistent European regulatory regime for integrated or combined technologies creates confusion and holds back long-term innovation. Added together with immature data and health infrastructure, the combined effect is an area ripe for regulatory change.
For a Commission aiming to establish a digitally robust Europe, this should be viewed as a welcome challenge and an opportunity. The European Medicines Agency (EMA) is a jewel in the EU crown, and it has a key role to play. There is much that can be gained, for example, by increasing the requirements for interoperability of new health technologies and cross-border health information and real-world evidence sharing amongst professionals across Europe. This should be underpinned by a consistent digital health strategy and the promotion of European Reference Networks (ERN).
Obtaining greater regulatory clarity around data would provide a boost for medical research and clinical development, providing an appropriate balance is struck between data security and HCP understanding of what can be shared. Either way, there is space for the European Commission to oversee the development of new certification mechanisms that can enhance citizens’ trust in digital health services. The EMA also has a key role to play in speeding up its own authorisation processes to accelerate patient access to innovation.
The ongoing COVID-19 pandemic has reemphasised as the strategic importance of the EU becoming a global leader in life sciences as well as the need for faster access to medicines. Going forward, an integrated approach to incentives and IP framework can reward innovation and protect high value jobs, while safeguarding improved access to modern healthcare.
Faster access to state-of-the-art healthcare also requires deeper understanding on the part of HCPs and policymakers of the strategic value of technologies in the innovation process, and how different elements are mobilised for better patient care. The need for an integrated approach to include a focus on education around emerging technologies is underscored here.
Interconnected challenges, interconnected opportunities
There is no doubt that a new approach to building policy solutions will be needed if we are to foster the life sciences sector in Europe. Given developments in the US and Asia, the time for Europe to act is now. Moving forward means embracing a bespoke life sciences strategy within the overall Industrial Strategy. This, in turn, means taking a collaborative approach to improving the policy environment. In order to truly live up to its ambition of global leadership and protecting high-value jobs, the European Commission needs to bring together each of the four pillars of innovation in personalised and biologic medicines, diagnostic technologies, digital capacities in health care and medical devices, into a single framework.