Today, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Cancer Patient Coalition (ECPC) and Diaceutics have shared their concerns related to the lack of readiness of the healthcare sector ahead of the date of application of the in vitro diagnostic Regulation (IVDR) with European institutions calling for its phased implementation. While we agree that well-regulated diagnostics are critical for quality testing, we are concerned that the infrastructure supporting the transition to this new regulation will not be ready in time to ensure the continued availability of tests required for cancer patients whose therapeutic management relies on the delivery of appropriate in vitro diagnostics.
With exactly one year to go before the date of application of the IVDR, only four Notified Bodies (NBs) have been designated to date (22 under the previous legislation) whereas the workload to assess diagnostics for NBs is estimated to increase by 600-700% under the new regulation compared to the situation under the existing legislation. Additionally, current device certification capacity is so limited that product files are taking on average 9 to 12 months for review regardless of the device classification.
Should institutions not agree to a phased implementation, we believe that most diagnostics currently on the EU market will not be authorised for use in EU Member States healthcare systems as of 26 May 2022, severely impacting the management of cancer patients across Europe.
A case study developed by Diaceutics shows that in the year following IVDR implementation, 110,575 metastatic non-small cell lung cancer (NSCLC) and ovarian cancer patients will require testing for biomarkers in order to have access to the appropriate innovative and life-saving precision medicines. They estimate that the reduction in biomarker testing due to the implementation of the IVDR could impact the lives of as many as 65,000 NSCLC and ovarian cancer patients per year. These patients could miss out on the opportunity to identify an appropriate personalised treatment and could consequently be prescribed less effective medicines. This number could be greater if we were to consider all cancer types which require a biomarker test for access to a precision medicine.
“After careful assessment, we believe that European healthcare systems will be unable to assess diagnostics at the pace required to ensure continued life-saving care for patients should the IVDR be applicable as of 26 May 2022” said Ken Mastris, ECPC President.
“We believe there is still time for EU institutions to implement the following urgent measures, followed Nathalie Moll, EFPIA Director General:
- A one-year postponement of the IVDR date of application with immediate effect
- A phased IVDR rollout which prioritises NBs’ assessment of high-risk impact diagnostic tests (i.e. starting with class D devices)
- An accelerated designation of a sufficient number of NBs, prompt release of key guidance documents and full functionality of the Eudamed database to ensure that the critical regulatory infrastructure required is in place on the date of application of the IVDR”.
"We believe that every patient should receive the precision medicine they need. Patients’ access to the best possible treatment options will be significantly compromised should urgent measures to fix the current infrastructural issue not be taken. We urge the Commission to consider an immediate postponement of the date of application of the IVDR followed by a phased implementation, as the optimal solution to this challenge. " Peter Keeling, CEO Diaceutics
About the European Federation of Pharmaceutical Industries and Associations
EFPIA represents the biopharmaceutical industry operating in Europe. Through its direct membership of 36 national associations, 39 leading pharmaceutical companies and a growing number of small and medium-sized enterprises (SMEs), EFPIA’s mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy.
About the European Cancer Patient Coalition
European Cancer Patient Coalition (ECPC) is the voice of cancer patients in Europe. With over 450 members, ECPC is Europe’s largest umbrella cancer patients’ association, covering all 27 EU member states and many other European and non-European countries. ECPC represents patients aﬀected by all types of cancers, from the rarest to the most common.