This article is part of our special report The future of nanomedicines in Europe.
The European Parliament will put pressure on the Commission and the member states to provide the necessary regulatory framework for nanomedicines in order to better make use of their potential for patients, EU lawmaker Pietro Fiocchi told EURACTIV in an interview.
“We are currently discussing the need to give the necessary regulatory framework not only for nanomedicines but also for a wide range of incredible technologies in the health system. I expect some results by April 2021,” the Italian MEP said.
Nanomedicines are emerging as an innovative technology in the scientific field, as they help address unmet medical needs and offer alternatives for many therapeutic areas.
Nanomedicines use state-of-the-art nanotechnology, like nanoparticles, nanorobots or nanoelectronic biosensors, for diagnosing or treating cancer, cardiovascular, and neurodegenerative diseases.
Fiocchi, who also represents the European Conservatives and Reformists Group in the Special Committee on Beating Cancer, said nanomedicines provide huge advantages in both screening (detecting cancer earlier) and therapies (acting only on the cancerous cells and not on the healthy ones).
“The advantage for the quality of life of patients is huge; a lot of pathologies could be cured without surgery and chemotherapy. Strong support and a regulatory framework in this field is the desired outcome of the report of the Special Committee on Beating Cancer,” he said.
The lack of a fit-for-purpose EU regulatory framework on nanomedicines and their generics” poses risks for the safety of EU patients, the director of the European Alliance for Access to Safer Medicines (EAASM), Mike Isles, recently told EURACTIV in an interview.
Nanomedicines are complex by nature and their use is made even more complicated by the fact that EU member states’ regulatory authorities assess them differently.
Fiocchi defended a “centralised approach”, especially following the COVID-19 pandemic, which exposed Europe’s weaknesses and fragmented health systems.
“Even now, there are difficulties in collecting the data and coordinate the reactions. A centralised European approach could solve a lot of these problems, but it could also be a strategic move to make Europe the centre of excellence worldwide on the health sector, with huge benefits for the economy and all the EU citizens,” he said.
For the conservative MEP, a key challenge will be how the EU member states will approach the issue.
“They generally do not like a strong EU centralised approach and interference in their health system. This problem will take a lot of political mediation and a lot of patience,” he warned.
He added that the European Parliament is currently collecting the “success stories” on different pathologies from across member states. “Then the Commission has to analyse all this data and devise an action plan. With the support and the pressure from the Parliament, of course,” he said.
A recent study has found that of the 85 nanomedicines applications, just two products were approved through the centralised procedure.
Jon De Vlieger, director of business development at Lygature, a not-for-profit partnership management provider bringing together academia, industry and society, emphasised that a centralised process should be the best route for nanomedicines as it “guarantees consistency in the scientific evaluation of these products” and centralised safety monitoring.
[Edited by Zoran Radosavljevic]