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Nano in Health Care: Fostering Innovation in Nanomedicines and Enhancing Patient Safety

Posted: Apr 16, 2019 by Instinctif Partners

By Laura Cigolot 

 

Patient safety is acknowledged as a priority at EU level. As highlighted during the 21st meeting of the Working Party on Public Health at Senior Level of the Council of the EU which took place on 10 April, key preconditions for developing patient safety at national level include a regulatory framework, clinical and political leadership, competent professionals, learning from medical errors by means of a transparent notification system and blame-free analysis, and empowerment of patients as advocates for healthcare safety.[1]

 

The use of nanotechnology in medicine

Science and technology have never moved as fast. Specifically, nanotechnology is booming worldwide in the areas of scientific research and technological development. With personalised medicines and the advent of gene therapy the standard rule book is coming under pressure. Nanotechnology is the creation and utilization of materials and devices at nanometer scale and its application in medicine is especially promising, with the direct impact it could have on the quality of health in future societies. The emerging discipline of nanomedicine brings nanotechnology and medicine together in order to develop novel therapies and improve existing treatments for all patients across Europe and beyond[2].

 

What is a nanomedicine?

Nanomedicines are medicinal products that have nanoscale size. They have unique properties which allow them move through the body in a way that was previously impossible. This is one of the reasons why nanomedicines have gained increasing attention in academia and research; they have the potential to improve medical diagnosis and therapy as well as regenerate tissues and organs.

Nanomedicines are as fascinating as they are complex. The complexity and number of this class of medicines is rapidly increasing and so are the questions around assessing their quality, biological properties and therapeutic profiles. They are used to treat a variety of serious medical conditions including cancer, auto-immune diseases, infectious diseases, anaemia and more. The absence of a legal definition on nanomedicines does not facilitate the safety and efficacy assessments of nanomedicines and follow-on products (nanosimilars).

Following up on the high-level breakfast meeting co-hosted by the European Alliance for Access to Safe Medicines (EAASM) and MEP Jose Inacio Faria (PT, EPP) in the European Parliament in March 2019[3], terminology harmonisation is the heart of the matter. Current regulatory approvals for nanomedicines and nanosimilars are decided on an ad-hoc basis by product category. With the accelerating progress in the development of clinically significant nanosimilars and in the absence of a specific regulatory approval process for these medicinal products, it is the right time to act, calling upon policymakers, regulators, physicians, healthcare professionals and patients to build consensus and align expertise so that this regulatory weakness can be tackled.

Translating science into health care practice is not an easy task. Appropriate science-based approval and post approval standards need to be introduced for nanomedicines and nanosimilars globally in order to ensure patient safety and benefits to all. “Europe has successfully pioneered and implemented a solid regulatory framework for biosimilars that ideally should serve as model for the approval of nanosimilars. Such framework avoids potential confusion and ambiguity of having a different policy or interpretation per country. Through a centralized procedure, the collective intelligence and experience of European Regulators will best serve the European citizens”, stated Jon de Vlieger, Coordinator of the Working Group on Non-Biological Complex Drugs (NBCD) at Lygature [4].

 

Challenges and opportunities at EU level for nanomedicines and their follow-on products

The European Commission does not intend to update existing regulations. It stresses that nanomedicines and nanosimilars should be treated as any other medicinal product, thus in accordance with the EU pharmaceutical legislation. As recently stated in a response from EU Commissioner Andriukaitis to a Written Question posed by a Portuguese Member of the European Parliament, “efforts are being made to better understand their specific properties and to continuously improve the available scientific guidance. For example, the European Medicines Agency has published specific guidance for nanomedicines[5].

Hence the need for a robust and fit for purpose regulatory framework in this exciting field of medicine. Training a new generation of experts and assembling knowledge and expertise through working groups will be critical to tackle the lack of consistent standards, address side effects issues and develop appropriate analytical methods for pharmacovigilance.

I am personally fascinated by innovative treatments and driven by an attempt to bring important solutions to areas of unmet medical needs. A consensus dialogue as well as an alignment between all concerned stakeholders in Europe is very much needed to further explore the field of nanomedicines at EU and national level, given its great potential for the wellbeing and health of our families, friends and communities.

More scientific, policy and practice knowledge on the quality, safety, and efficacy of nanomedicines and nanosimilars must be acquired to further raise awareness and achieve what should be the global direction of travel: improving the general level of safety for patients receiving healthcare in all EU member states.

I very much hope the upcoming legislators will take these considerations on board.