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Europe trade and lobby group says implementation issues related to the legislation could impact 420 trials—and 42,200 patients—over the next three years.
As many as 160 clinical trials are currently being delayed in Europe because of new legislation designed, paradoxically, to deliver access to innovative medical technologies, alleges the pharmaceutical industry's major European lobby group, the European Federation of Pharmaceutical Industries and Associations (EFPIA). The European Union's In Vitro Diagnostic Regulation (IVDR) came into effect almost a year ago, but is proving to be a barrier as much as a prompt to patient care, say its critics.
The opening statement of the official text of the regulation describes it as providing "a robust, transparent, predictable, and sustainable regulatory framework for in vitro diagnostic medical devices which ensures a high level of safety and health while supporting innovation." It has set out to reinforce the supervision of notified bodies, risk classification, conformity assessment procedures, performance evaluation and performance studies, vigilance, and market surveillance. It has also introduced provisions aimed at improving transparency and traceability for in vitro diagnostic medical devices (IVDs).
EFPIA says problems with putting the new rules into operation has unforeseen implementation "that are delaying clinical trials and blocking access to new treatments for conditions like cancer and rare diseases." The system has been hit by "a lack of infrastructure, guidance, and coordination."
Companies in the sector expect up to 42,200 patients to be affected by the delays over the next three years, EFPIA reports, highlighting the predictable knock-on effects on the speed of nearly 100 therapies reaching patients in Europe. A survey of its member companies suggests that over the next three years the delays could impact 420 trials, impeding 42,200 patients in accessing investigative products—half of them in cancer medicine. The result will be patients waiting longer to participate in clinical trials, or even not participating at all.
The industry is linking its concerns over IVDs to its current campaign to halt the slide in Europe's global competitiveness, which it blames on excessively slow and onerous regulation driving research-based companies to move their operations to the US and Asia. It says two-thirds of the companies in its survey would consider reducing the number of EU trial sites if IVDR requirements remain the same, noting these trials would move to the US, Canada, UK, and Asia, among other locations. "This is a real-time example of how a lack of forward thinking in Europe could penalize patients and drive research out of the region," said EFPIA director general Nathalie Moll. "We have to act now to keep clinical trials in Europe and the benefits that they bring to European patients."
Compliance with the new legislation requires IVDs used in clinical trials to go through an assessment process when the diagnostic test result influences patient medical management. However, says EFPIA, this process is currently complex and uncoordinated. The industry grouping is urging all partners to start talks to overcome the problems. It wants to see deferral of the deadline for compliance with IVDR for clinical trials using an IVD, and voluntary coordination processes at the national level to improve the assessment procedure, as well as the development of new guidance clarifying the assessment process. The EU should consider a risk-based approach to avoid assessing IVDs that are low risk for patients, accepting on a case-by case basis, and with agreement of member states involved, to not conform with IVDR requirements if certain conditions are fulfilled.
The European medtech industry last week won a deferral of the deadlines for a parallel regulation on medical devices, also on grounds of inadequate infrastructure for implementation of the new rules.