EAHP Position on Advanced Therapy Medicinal Products

Advanced therapy medicinal products (ATMPs) are innovative and complex medicines used to treat a variety of human health issues. Areas of application include, but are not limited to, cancers, neurodegenerative diseases, inherited diseases and autoimmune diseases. In particular, patients suffering from severe, rare or chronic diseases might benefit in the future from the growing use of ATMPs. Hospital pharmacists are responsible for ensuring the safe and effective use of medicines. This expertise of the pharmacy workforce should be a central component to adequate delivery of ATMPs within hospitals. Their participation is not only invaluable in clinical trials for ATMPs where they are responsible for the correct receipt, storage, distribution and control of the clinical trial drug, but also for routine clinical practice. 

Since the use of ATMPs for the treatment of disease and injury is growing, EAHP adopted a position paper on this topic that outlines the roles and responsibilities of hospital pharmacists in the handling of ATMPs, addresses their education and training in relation to these products and provides insights on the assessment of ATMPs and pharmacoeconomics.

In its position paper, EAHP

• states that the management of ATMPs, as licensed medications, is the responsibility of the hospital pharmacist.
• urges competent authorities across Europe to utilise the best practices and outcomes gathered by the Special Interest Group focused on hospital pharmacist’s preparedness for in-vivo gene therapy medicinal products.
• recommends the rapid development of European education and training materials in collaboration with scientific societies for healthcare professionals covering the entire ATMP spectrum.
• calls on pharmacy schools and professional bodies offering continuing education to integrate training of pharmacists on ATMPs into their curricula and training programmes.
• recognises the importance of further promoting the information sharing and communication on ATMPs towards patients and patient organisations.
• reminds national competent authorities to recognise the invaluable role of hospital pharmacists in regard to the assessment of ATMPs and pharmacoeconomics. 

EAHP’s Position Paper on Advanced Therapy Medicinal Products is available HERE 

Collaborations

In July 2023, EAHP co-signed a joint statement on the ATMPs development within the Revision of the EU general pharmaceutical legislation with the European Alliance for Vision Research and Ophthalmology and the European Paediatric Translational Research Infrastructure. 

The statement underlines that hospital pharmacists play a pivotal role as the handling of ATMPs as licensed medicines, falls under their responsibility and their knowledge of pharmacoeconomics and clinical evaluations are essential in assessing the added value of these products.

It is also highlighted that harmonised education and training of healthcare professionals are pivotal for coordinated practices of the hospital exemption including the development of European education and training materials with the integration of ATMP training in pharmacy and medicine schools. The collaboration of scientific societies involved across the entire ATMP spectrum is essential as well as of professional bodies offering continuing education programmes.

Have a look at the joint statement HERE