Supply chain issues, driven by the pandemic, continue to present problems – a situation that has been exacerbated during the winter, when demand has been at an all-time high. Even though the worst of the recent crisis appears to be over, there is now an extended mandate – certainly in Europe – to monitor and manage any shortages of medicinal products and medical devices. That’s both at an industry level and by EU member states.

‘In 2023, the real sign of commitment to a transformed future will be a passion not just to improve compliance and operational efficiency, but also to have an impact on the future of health’

The onus is on the industry now to capture and provide the right data during major events and public health emergencies. This may require formal data mapping – to identify where the relevant data sits within a company and who can provide it. Given that efficiency and accuracy of these insights are critical when public health is at stake, it is essential that the industry is prepared. Forward-thinking companies will see this as an opportunity to review existing data governance, determining where the relevant data sits within their organisations, for instance, and how it might be provided to the EMA most efficiently.

The increased speed of regulatory processes seen during the pandemic has set a precedent and the only way to maintain that pace over the longer term is to modernise. ISO IDMP standards remain pivotal to the expanding and transforming role of data – so that it becomes a lever for improvement.

But this requires more proactive data governance, if companies are to truly harvest the power of their data, and it’s something they’ll need to navigate this year alongside other internal and external pressures – alleviating the increasingly critical but hugely labour-intensive burden of data management. Overall, the pre-condition of setting up suitable data governance is becoming clearer all the time. Although, as they are, data and systems may facilitate an exchange, it is not a given that this would happen in a reliable way without the right controls.

With necessity being the mother of invention, much faster regulatory processes materialised during the pandemic – from rapid access to scientific advice and rolling reviews to accelerated assessments and other possibilities under compassionate-use programmes. Improvements were also seen in the drug development process itself.

Ultimately, the pandemic forced out-of-the-box thinking and helped identify weaknesses in existing systems. We’ve seen old norms being challenged in clinical trials, for instance, as the result of issues that peaked in the pandemic, including those linked to subject recruitment. These issues have helped inspire alternative approaches to trials and their design – including decentralised trials, faster data sharing and increased collaboration across parties.

It’s when the level of the conversation is really raised that we begin to see how far standardised data can take us as an industry. Having an agreed model for the data that multiple stakeholders and collaborators can work with is potentially transformational in a great many ways.

The European project on substances (the EU-SRS database), which went live on 24 January this year, illustrates what’s possible. Using the same data model, software and scientific standards per substance class enables increased exchange with the FDA, WHO and other regulators. In the event of another pandemic in the future, we would soon see the practical benefits of that improved exchange.

The overriding challenge for this industry now will be to hold onto some of the great lessons of the last two to three years and use them as a springboard to reduce the time it takes for the latest advances in life sciences to reach patients.

As escalating cost and resourcing pressures threaten safe access to healthcare for all, the drive for new care models is strong – and data lies at the heart of many of the proposed solutions. These include increasingly sophisticated patient self-care propositions (using devices for condition monitoring and management) and selective first-line care provision by high street pharmacies.

From operational efficiency, through more automated processes, to more convenient and affordable routine patient care, the unifying enabler is good quality, standards-based data that everyone can trust.

‘As escalating cost and resourcing pressures threaten safe access to healthcare for all, the drive for new care models is strong – and data lies at the heart of many of the proposed solutions’

In specific terms, we can expect clinical trial innovation to continue apace, along with defined next steps toward IDMP implementation in the EU and US (beyond the immediate DADI-based Marketing Authorization submissions process) and further clarifications on ePI and serialisation.