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AESGP Annual Meeting, Day 2 (Part 2): Can Regulation Be A Catalyst For Innovation?

Executive Summary

Regulation should be seen as a spur to creativity rather than a burden, suggest panellists during the second session of the AESGP's 58th Annual Meeting in Madrid, Spain. Sanofi Consumer Healthcare boss Julie van Ongevalle also makes the case for electronic patient information leaflets as a way to learn from the pandemic, which she describes as the greatest constraint the world has experienced in recent history.

“What is creativity?” asked Morten Friis-Olivarius, CEO of the Copenhagen Institute of NeuroCreativity (CINC), at the beginning of the second session of the Association of the European Self-Care Industry’s 58th Annual Meeting in Madrid, Spain.

From a neuroscience point of view, creativity is about novelty and usefulness, he said. Innovations have to have some kind of value.

However, novelty is not actually possible, he pointed out. The human brain does not create something completely new. What we do is take knowledge and recombine it.

We also mistakenly think that creativity is about open skies, no limits, he continued. But actually constraints boost creativity.

All of this was by way of introduction to the question of the session, which asked whether regulation, traditionally a bugbear of industry, could be a spur to innovation, rather than merely a constraint.

Sanofi Consumer Healthcare head Julie van Ongevalle seemed to think so, pointing to the pandemic as the biggest constraint the world has experienced in recent history, and how both industry and regulators had to adapt to ensure continuity of healthcare for consumers and patients.

“We had no choice but to evolve, innovate and be creative. I’m still impressed at how we did this,” she reflected.

Electronic Labelling

The question now, for van Ongevalle, is how companies and regulators can learn from the pandemic to help consumers take better care of themselves.

Electronic labelling is a good example, van Ongevalle suggested. Paper-based information could be replaced by QR codes, which have been used extensively during COVID-19.  (Also see "EU Regulatory News Round Up: NSAIDs During Pregnancy, Estragole Excipients, ePIs" - HBW Insight, 4 May, 2022.)

Electronic product information leaflets provide a number of benefits for stakeholders, she explained.

For consumers, e-PILs provide a more engaging way to present important information, making responsible use more likely.

For companies, they make it much easier to update and share information about products, as well as drastically reducing their environmental impact.

For regulators, e-PILs mean greater collaboration across EU member states, and the ability to present the same information simultaneously in different languages.

New Blood Needed

Speaking from a regulator’s point of view, Cesar Hernandez, head of department of medicines for human use at the Spanish medicines agency AEMPS, was very enthusiastic about ePILs’ potential.

Spain has been on its own digitalization journey in recent years, he explained, and offer patient information in the form of html code, enabling this data to be used in a variety of ways by different stakeholders.

This could provide a prototype for other countries, he suggested, but was only the beginning of a general move towards data-driven regulation that is becoming increasingly necessary.

In future, Hernandez predicted that we may use chatbots instead of ePILS, enabling consumers to ask directly questions like “can I take this medicine with x” or “what medicines are approved for x condition?”

To realize this possibility, however, he insisted that we need a new generation of data-savvy regulators, which will mean being able to compete with more glamorous and better paid sectors like finance.

Four Pillars

The final presentation of the session came from economist Miguel Amaral, who shared the Organisation for Economic Co-operation and Development’s (OECD’s) work on regulation after COVID.

The OECD’s work, which is aimed at helping regulators learn from the pandemic to improve their policies and practices, is based on four pillars, he explained.

Firstly, regulatory practices should be iterative, learning via evaluation what has worked and what has not worked, and adapting frameworks accordingly.

Secondly, regulators should be collaborative, recognizing that much innovation operates across existing boundaries.

Thirdly, regulation should be experimental, and governments should invest in horizon planning and engage early with industry stakeholders.

And finally, regulations should be as much as possible focused on outcomes, not on rules, with policy makers thinking more about what is trying to be achieved with enforcement.


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