We have an exceptional chance to make innovation thrive in Europe
Leading life scientists and healthcare stakeholders will be gathering in Basel next week for DIA Europe’s 35th-anniversary edition at an exceptional time for innovating medicines and treatments in the region. The confluence of information and biotechnology, such as health data and AI, and largescale regulatory reforms in the European Union promise to transform the way medicines are developed.
That’s why it’s important for thought leaders, practitioners, and policymakers in the healthcare sector to gather and exchange on how we can seize the opportunity to actualise Europe’s innovative potential and deliver the medicines that patients need.
The revision of the EU’s General Pharmaceutical Legislation is a once-in-a-generation opportunity to transform Europe’s regulatory framework and deliver rules that can drive innovation. A lot has changed since the current rules were put in place two decades ago: progress in science, medicine and health has been massive and the regulatory framework needs to be up to speed if Europe is to be at the cutting edge.
With the imperatives of ensuring innovation, safety and accessibility of medicines, overhauling a major economy’s pharmaceutical rules is always going to be a delicate exercise. A draft version of the new legislation that made it into the press gave us some idea of what’s to come: unsurprisingly, given that the text runs on for hundreds of pages, there are both improvements and causes for concern in the new proposed rules.
On the plus side, there would be numerous improvements made to the European Medicines Agency’s (EMA) setup with a simplification of its committee structure, optimisation of scientific advice and the creation of a ‘regulatory sandbox’ to adapt evidence requirements for certain novel medicines where standard data may not be available.
We can heartily welcome these kinds of changes as they will help future-proof the EU’s regulatory framework and facilitate the development of the next generation of biotherapeutics.
We should also ensure that other proposed measures are implemented quickly and in ways that patients can experience their full potential. A clear example here is the informational e-leaflet – which has the advantage of being adaptable to patients’ language or disabilities, such as being available in audio format – and would be allowed to accompany medicine by QR codes or other digital labelling technologies. This measure can have a meaningful impact on patients’ everyday lives and should not be delayed; the draft legislation foresees a long phase-out period of paper leaflets. Why wait?
At the same time, we strongly believe that other proposed measures such as the reduction of regulatory data protection for new medicines, and greater regulatory interference in R&D, can have negative consequences on Europe’s ambitious role of becoming a global leader in pharmaceutical research and development.
Let’s use the opportunity to make the EU an engine of innovation and events like DIA Europe are key to shaping the conversation.
So join us at DIA Europe 2023! I look forward to exchanging with you and being part of the conversation shaping healthcare innovation in Europe for the years to come.
#DIAEurope2023
Author: Alan Morrison,Vice-President, Regulatory Affairs, MSD