Itsy Bitsy Robots: Despite the positive impact nanomedicine has had on the innovation of healthcare and health research, its potential remains hindered as EU still struggles with nanotechnology regulation. How can the EU foster the development of nanomedicine while ensuring the safety of patients?

Submitted by: Alice Bould, Nout Faber, Yara van Hoek, Fenne Huizer, Evy Jiang, Lisa Lubberman, Beth Marriott, Natasha Martinez Challapa, Julia van der Schaar, Moon Wennink, Arthur Westerman, Teodor-Cristian Borcan (Chairperson, RO)

The European Youth Parliament aims to increase the quantity, and efficiency of research conducted in the field of nanomedicine. Furthermore, it seeks to reform the current regulatory system surrounding nanomedicine, while striving to improve stakeholders’ access to knowledge about nanomedicine. It also aims to maximise the potential of nanomedicine in a safe, efficient and cohesive way, leading to accessible, and high-quality treatments.

The European Youth Parliament,

  1. Acknowledging with gratitude the revolutionary achievements and profits gained with the help of nanomedicine,
  2. Recognising the lack of public awareness and trust in nanomedicine and its treatments,
  3. Noting with concern the lack of consistency in the classification of nanomedicine as a medical device or a medicinal drug,
  4. Deeply regretting the inefficiency of the current nanomedicine authorisation procedures that lead to:
    1. obstructed research and development of nanomedicine,
    2. a decrease of field interest, 
  5. Noting with concern the lack of communication, and cooperation between agencies, Member States and other stakeholders in the field of nanomedicine, both in- and outside of the EU,
  6. Alarmed by the differences in the safety standards required to authorise nanomedicine use in Member States,
  7. Deeply concerned about the decentralised authorisation procedures of the divergence of nanomedicine legislation in Member States,
  8. Noting with regret the possible exploitation of the decentralised authorisation procedure’s lack of uniformity in Member States by pharmaceutical companies,
  9. Deeply alarmed by the premature abandonment of application procedures due to the fear of undesired outcomes;
  1. Calls upon the European Medicines Agency (EMA) in cooperation with Member States to conduct workshops, seminars, and Massive Online Open Courses on nanotechnology;
  2. Advises Member States to broaden the scope of the science education curriculum in faculties of medical sciences by incorporating information on the applications of nanotechnology;
  3. Instructs EMA to put forward a separate classification system for nanomaterials and nanosimilar products;
  4. Encourages the EMA to foster transparency and efficient knowledge and progress sharing within the international community by reaching out to other drug-approving agencies such as the Medicines and Healthcare products Regulatory Agency in the United Kingdom;
  5. Asks the REFINE Nanomed Project to organise events focused on knowledge sharing and cooperation between international stakeholders in the field of nanomedicine;
  6. Further calls upon the European Commission to help allocate Horizon Europe grants to companies that choose to apply through the centralised procedure of authorisation;
  7. Requests the EMA to develop a guidebook detailing the application for authorisation of nanomedicine procedure to prevent the premature abandonment thereof;
  8. Strongly encourages the European Commission to introduce a Directive for a minimum safety requirement for nanomedicine authorisation to create a universal standard for the quality of nanomedicine.