The lack of a fit-for-purpose regulatory framework on nanomedicines and their “generics” poses risks for the safety of EU patients and the European Commission should urgently look to address this, the director of the European Alliance for Access to Safer Medicines (EAASM) has said.
Nanomedicine uses state-of-the-art nanotechnology like nanoparticles, nanorobots or nanoelectronic biosensors for diagnosing or treating diseases.
“In order to harness the full potential of nanomedicines, we need a fit-for-purpose regulatory framework – which we believe that, right now, we do not have. This has implications for patient safety,” Mike Isles told EURACTIV.
Isles spoke on the occasion of the World Patient Safety Day today (17 September) and said the Commission’s forthcoming Pharmaceutical Strategy presents an opportunity to address this issue.
“The Commission could introduce a fit-for-purpose regulatory framework and ensure that the full potential of nanomedicines and nanosimilars [their “generics”] can be realised,” he emphasised.
Nanomedicines are emerging as an innovative technology in the scientific field that helps address unmet medical needs and offer alternatives for many therapeutic areas.
They offer potential solutions for a number of current treatment challenges such as cancer, cardiovascular, and neurodegenerative diseases.
Complexity and different approaches
Isles said there are problems in classifying these products, considering that there is currently a lack of legal definition of nanomedicines.
“Secondly, these medicines are highly complex, and we do not yet have the regulatory tools and procedures to fully characterise them and fully understand their critical quality attributes,” he said.
“This problem is further exacerbated by the fact that these products can still be approved through a decentralised procedure, hence different member states regulatory authorities in Europe can take slightly different approaches in assessing them,” he added.
The situation is equally critical when it comes to nanosimilars, he said.
“Because of their complexity, they are extremely difficult to copy and we do not yet have a dedicate regulatory pathway to ensure the quality, efficacy and safety of follow-on products.”
Asked how exactly patients are affected by this lack of a regulatory framework, he replied that this a cutting-edge area of science and we do not yet fully understand all the potential and implications of this new technology.
“So when the new meds are being assessed we must ensure the highest of standards. Why do we take this stance? Because we have noticed different regulatory approaches in Europe on how these complex products should be treated.”
He explained that the simple generic pathway used for conventional medicines is not sufficient in proving the therapeutic similarity of nanosimilars.
“More data, especially clinical data, should have been provided in order to ensure the follow-on product was as efficacious as the originator.”
The issue was addressed in the European Parliament in the past, but the EU executive did not take any action. EAASM released a new report on the safety of nanomedicines today asking the Commission to reconsider its approach.
“The upcoming Pharmaceutical Strategy provides a unique opportunity to look into our regulatory framework and see what needs to be changed in order to address this issue and be able to reap the full benefits of this highly innovative, but complex, technology,” Isles emphasised.
[Edited by Zoran Radosavljevic/Natasha Foote]