New EU legislation designed to improve public health is delaying clinical trials and blocking access to new treatments for cancer and rare diseases, says the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The number of clinical trials delayed is expected to run into the hundreds, affecting up to 42,200 patients over the next three years, according to a survey run by EFPIA.
The EFPIA is urging all partners to enter talks to find solutions and mitigate the negative unintended impact of the legislation.
The In Vitro Diagnostic Regulation (IVDR) came into effect in May 2022. The regulation aims to ensure patients’ safety, provide a more transparent framework for IVDs and deliver access to innovative medical technologies.
However, the EFPIA claims, the implementation of the regulation has been challenged by a lack of infrastructure, guidance, and coordination, triggering a series of unintended consequences.
Nathalie Moll, Director General of EFPIA, said: “These figures are extremely worrying for patients with rare and life-threatening conditions. These patients should be at the front of the queue, getting fast access to care, not having to wait due to complicated bureaucracy and a lack of coordination across Europe.
“This is real time example of how a lack of forward thinking in Europe could penalise patients and drive research out of the region. There is a serious risk that a number of companies could have to omit European sites from trials and divert the research to the US and Asia while these challenges are being resolved – meaning much later access to treatments for Europeans. Our members are telling us that this is already happening. We have to act now to keep clinical trials in Europe and the benefits that they bring to European patients.”
Huge delays to clinical trials
The EFPIA member survey showed:
- Between 82 and 160 trials are currently being delayed in Europe, with an expected 238 to 420 trials to be delayed over the next three years.
- These delays mean that between 33,815 to 42,200 patients in Europe are expected to have delayed access to clinical trials over the next three years, around half of them (up to 27,400) being cancer patients.
- The launch of 89 therapies could be delayed because of this legislation, in innovative therapeutic areas such as oncology and rare diseases.
- Up to 400 trials are expected to enrol fewer patients, meaning some people missing out on innovative new treatments. These include trials for cancer, rare disease, neuroscience, inflammation, cell and gene therapies, paediatrics and cardiovascular diseases.
- 43% of companies surveyed said they expect delays of six to12 months to current clinical trials, with 48% expecting six to 12 month delays over the next three years.
- 67% of companies 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.
- Compliance with the IVDR means IVDs used in clinical trials go through an assessment process when the diagnostic test result influences patient medical management. However, this process is currently complex and uncoordinated. It results in patients waiting longer to participate in clinical trials, or even not participating at all.
Recommendations for improvement
EFPIA is currently working on complementary policy recommendations that would alleviate some of the barriers created by the implementation of the IVDR and improve access to clinical trials for European patients.
These recommendations potentially include:
- delaying the application of the IVDR for clinical trials using an IVD
- organising voluntary coordination processes at Member States level to improve the assessment procedure
- developing new guidance clarifying the assessment process
- considering 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
- clarifying the scope of in-house testing to broaden it
