The EU’s Pharmaceutical Strategy must do more to support nanomedicines and protect patient safety. Here’s why.
Mike Isles is the Executive Director of the European Alliance for Access to Safe Medicines (EAASM).
If Europe is to make its world-leading pharmaceutical sector fit for the future, a regulatory framework that supports innovative types of treatments and protects patient safety is imperative. The European Commission’s new Pharmaceutical Strategy, published in the midst of a pandemic consuming all our attention, could provide a great opportunity for a step in the right direction.
Here we focus on a highly significant innovative technology in the medical field: nanomedicine. Nanomedicine is an exciting and growing field, offering potential solutions to several treatment challenges, notably in key areas such as cancer, cardiovascular and neurodegenerative diseases.
Nanomedicines are medicinal products with at least one dimension in the nanoscale range – from 1nm to 100nm. They enhance the way that medicines target and reach areas of disease within the body, opening up new therapeutic options. However, nanomedicines and their follow-on products, nanosimilars, are complex molecules and so it is essential that their regulatory oversight is scientifically appropriate.
A risk to patient safety
Despite these opportunities, the current regulatory framework of nanomedicines within the EU-27 is not fit-for-purpose. As of now, nanomedicines can be approved through a decentralised procedure, allowing for different policies and interpretations in each member state and creating uncertainty, confusion and ambiguity. To better protect patient safety, EAASM is campaigning for the introduction of a single and specific regulatory framework at EU level.
We are particularly concerned about the potential implications for patient safety in three areas. There is no unambiguous, legal definition of nanomedicines, leading to problems in how to classify these products. In addition, due to their elaborate nature, the regulatory tools available to fully characterise them are not fully developed. Finally, nanomedicines are extremely difficult to copy given their highly complex manufacturing process and even the slightest variation from the original product can bring different levels of efficacy – this is why they would benefit from a tailored regulatory pathway for their approval similar to the one which has been developed for biosimilars. Patient safety must always be the most important criterion when approving a new product. This principle is of particular importance for nanomedicines.
A fresh approach?
The Pharmaceutical Strategy allows the Commission to introduce a fit-for-purpose regulatory framework and ensure that the full potential of nanomedicines and nanosimilars is realised. But there is, regrettably, no mention of nanomedicines within it, despite the pressing need for the Commission to address the topic – and that the EU already recognises it as a Key Enabling Technology. This is an oversight that must be remedied.
The Commission has stated that two key aims of the Pharmaceutical Strategy are to respond to unmet medical needs and ensure that the legislative framework for pharmaceuticals is future-proofed so it can adapt to cutting edge developments. Nanomedicine is a prime example of this. The pace of scientific change is moving at tremendous speed, and the new strategy can and must serve as the catalyst for adopting the proper regulatory framework on nanomedicines.
The overarching priority for the European Alliance for Access to Safe Medicines (EAASM) is to protect patient safety by ensuring access to safe and legitimate medicines. Our recent report, “Patient Safety and Nanomedicines: the need for a centralised regulatory procedure”, calls on DG SANTE, the EMA and member states to address unmet medical needs as well as tackle patient safety issues. We see the need for the EU to develop a scientific consensus on definitions of nanomedicines, adopt an EMA-centric procedure for all nanomedicines and nanosimilars and clarify the criteria for approving nanosimilars.
A pan-European consensus
On 30th November, we held a stakeholder event, Innovation in nanomedicines: enhancing patient safety through regulatory clarity. This included contributions from MEPs, the Commission and academic experts, with a strong focus on how nanomedicines can address unmet medical needs. The success of this event demonstrates that there is growing political appetite for regulatory solutions to be brought forward by the EU. What we need now, then, is a consensus on the way forward.
Nanomedicine has already proven its worth in the development of the new COVID-19 vaccines the world needs if it is to beat the pandemic and we know it can help treat diseases such as cancer in a more targeted manner. Patients stand to gain hugely in terms of quality of life and survival prospects – but only if we get the right regulatory framework and that must be pan-European.