Tuula Rintala
Director, Quality of Care and Advocacy
EBMT, European Society for Blood and Marrow Transplantation
Barcelona, Spain
As we are approaching the EBMT Annual Meeting 2025, in Florence, we have been reflecting on the changes in the landscape that JACIE, as everyone else working within the field of HCT and Cellular Therapies are facing. Since JACIE joined FACT in co-publishing the 3rd edition of IEC Standards (due to be published later this year), we have taken the opportunity to think about the rationale for JACIE expanding the opportunity for certification beyond the ‘traditional’ HCT Centres.
Just as JACIE Office has received queries from Clinical Trials and Oncology units, for example, on how to achieve the JACIE Certification, we have also been challenged on what is the relevance of JACIE in relation to the non-transplant units delivering ATMP treatments. Therefore, addressing a few key points on why JACIE has a role to play in the field of ATMPs seems appropriate.
It has been suggested that there should be a ‘JACIE-light’ option for non-HCT Centres administering IECs and other ATMPs. However, this rather misses the point of what is the purpose of JACIE certification. At the heart of the Standards and JACIE’s approach to certification, is a commitment to patient and (cellular) product safety and continuous quality improvement. This is relevant in respect to JACIE certification process as well, and we are continuously looking ways to improving the process to ensure that Centres applying are supported throughout their certification process. JACIE continues to be a voluntary certification scheme (with a very few exceptions), and we want to continue to welcome into our fold everyone interested in quality improvement in our field.
We also appreciate the audit burden on the Centres who are often facing not just JACIE inspections, but audits by the different regulatory authorities as well as pharmaceutical companies in the form of site qualification visits, for example. To address this, JACIE already in 2022 working as part of the GoCART Coalition, developed an agreement with Bristol Myers Squibb (BMS), Janssen, Kite and Novartis to leverage JACIE certification as part of their site qualification process. We hope that in due course, many other, newer arrivals to this field, will also adopt this approach. Similarly, JACIE works closely with the Competent Authorities particularly in Spain and Italy, bringing together the implementation of international Standards and the national framework.
Lastly, after more than 25 years working in certification in HCT and the expansion of Cellular Therapies in the Haematology Context, JACIE wants to share the experience and knowledge it has developed in this rapidly evolving field. Rather than focussing on how easy or difficult complying with an individual Standard in a particular setting, JACIE is about the mindset of developing a programme that wants to meet the Standards developed by the global experts in the field; one that wants to learn and improve; and one that is patient and safety focussed with quality at the heart of all they do.