This section is meant to give readers an insight into the emerging field of nanotechnologies and risk regulation. It informs and updates readers on the latest European and international developments in nanotechnologies and risk regulation across different sectors (e.g., chemicals, food, cosmetics, pharmaceuticals) and policy areas (e.g., environmental protection, occupational health and consumer product, food and drug safety). The section analyzes how existing regulatory systems deal with new kinds of risks and reviews recent regulatory developments with a focus on how best to combine scientific freedom and technological progress with a responsible development and commercialization of nanotechnologies.
Nanomedicine, the application of nanotechnology to healthcare offers numerous improvements to medical diagnosis, drug delivery, therapy and implants. The potential impact of nanomedicine is foreseen radically to change health care; however it also challenges existing perceptions, dynamics and standards relating to ethics, safety and governance. This paper introduces the emerging field of nanomedicine and then proceeds to detail the current regulatory framework and regulatory bodies in the European Union relating to medicinal products, medical devices, biologics and therapies. This is followed by a detailed analysis of two nanomedical applications in the context of regulatory challenges. The paper concludes with a discussion of the adequacy of the current regulatory regime in Europe and where problems are likely to arise as nanomedicine evolves.
The potential benefits of nanotechnologies in healthcare are widely expected to be enormous and a considerable amount of investment is already pouring into public research in this area. These high expectations of benefits are coupled with uncertainty surrounding the potential risks of the prospective products containing nanomaterials, in addition to concerns about the adequacy of regulatory oversight. These challenges add another level of uncertainty for those deciding to invest in nanotechnology R&D and threaten to impede product development and commercialisation. Nanotechnology in healthcare (often labelled as nanomedicine) presents a situation where waiting games are a strong possibility; however, waiting games have been avoided (so far) through the unlocking of the dominant regulation regime. This paper describes how an innovation impasse in nanomedicine could have ensued if the traditional wait and watch strategies of legislators and regulators had been followed. We describe how waiting games were avoided through the opening up and distribution of regulatory approaches.
Attempts at suitable identification of a generally accepted definition of a ‘nanomaterial’ have been going on in Europe and worldwide for some time. Definitions are important from a regulatory perspective as “they assist in establishing the subject matter and scope of what is to be regulated”. However, considering the complexities associated with nanoscience and also the differing opinions on various definitions, this has not been an easy task. Reaching an agreement on fundamental terms and definitions such as ‘nanotechnology’, ‘nanoparticle’, ‘nanoscale’, and a ‘nanomaterial’ is both complex and contested. To date, there is no internationally recognised and accepted definition of a ‘nanomaterial’ even though several definitions have been discussed and proposed by national authorities, scientific committees, international organisations, and other bodies.
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