by Peter O'Donnell
BRUSSELS, 15 Feb (APM) - A concerted campaign to fine-tune Europe's drug regulatory environment is being launched by the companies that have long complained of conditions that hinder and delay innovation.
The industry's main European lobby group, EFPIA, has created what it calls its '4E strategy for 2023' with the ambitious aim "to advance regulatory science and to enhance improved regulatory decision making in Europe".
The scope is wide, with the four 'e's of its title alluding to "ensuring a world-class regulatory framework in Europe, evolving a framework for innovation, engaging with stakeholders and expanding the global convergence", explained EFPIA director general Nathalie Moll.
Companies have committed investment to developing evidence that can drive regulatory change, with reviews of evidentiary standards and acceptance for regulatory decision-making.
Challenges and opportunities
Moll told APM that the aim is to address both "the challenges and opportunities resulting from the current EU regulatory system".
The impact of Brexit is a very immediate challenge, she says.
So too is "the ever increasing burden of unmet patient need".
Her list of what matters also includes "the state of today's pharmaceutical legislation" and "the sequences between the regulatory and access processes", in which health technology assessment plays, she indicates, a crucial role.
But among the opportunities is "the continued rapid evolution of science and technology".
Moll says EFPIA has been analysing areas that industry perceives as bottlenecks in terms of regulatory procedures, pharmacovigilance and quality.
Now it is moving on to explore in detail "the acceptance of novel ways of gathering and analysing evidence for regulatory decision-making".
A particular focus will be on identifying policy options to address gaps, such as in the acceptance of real world evidence, or the feasibility of complex clinical trial designs for developing innovative medicines.
The central feature of the campaign is that Europe's regulatory system should be ready to "embrace advances in science, technology and medicines".
She says that the analyses so far suggest that most of the potential solutions could be dealt with by relatively minor changes, such as tweaking the current guidelines.
They could also take the form of "looking into amending European regulatory network's readiness, flexibility, capacity and competence to maximise opportunities of new technologies, data and science."
But some changes "might entail a legislative response, and further study is to take place of these possibilities."
The concept is to create "a shared vision for regulatory innovation" - shared, Moll explains, with regulators, health technology assessment bodies, patients and healthcare professionals.
The recent release by the European Medicines Agency of its Regulatory Science Strategy to 2025 is one obvious opportunity.
"Identifying the elements where we share a common vision will be instrumental in moving the needle in these areas, improving the current environment," she says.
Telematics "is an important element which needs to be part of the broader regulatory strategy", Moll adds.
"In many cases, building the right IT infrastructure and introducing interoperability of various systems and databases is crucial."
She says the current situation "is far from optimal".
Among other things, EFPIA wants to see a telematics roadmap that will ensure that projects being conducted by EMA and national authorities are synchronised with stakeholders.
There is a need to consider interdependencies among projects, so as to avoid operating multiple independent solutions over extended periods.
And a pragmatic approach should be followed that suits all regulators, types of businesses and ranges of products.
So an integral part of the EFPIA vision is pushing for changes "in handling ever more complex and high volumes of data that can support the evaluation of safety, efficacy and quality of medicines, pre and post-approval".