Joel D'Silva

Taking Temperature - A Review of European Union Regulation in Nanomedicine

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.

Defining Nanomaterials for the Purpose of Regulation within the European Union

Consumer desire for superior and/or new products has provided industry with the opportunity and market demand to incorporate and experiment with new technologies, including nanotechnologies. While these products and processes have fallen under the scope of existing regulatory frameworks, potential health and safety concerns has prompted some stakeholders to call for new, nano-specific regulations. Until now, governments have been hesitant to respond to such demands given the evolving state of the scientific art and limited international agreement as to what nanotechnologies or nanomaterials ‘are’. Despite these challenges, in November 2009 the European Union formally embraced the idea of specifically regulating the use of nanomaterials in cosmetic production. To achieve this objective, the Parliament and Council had to define what they meant by nanomaterials within the context of the adopted text in order to regulate them. It appears likely that other instruments will be similarly amended so as to include nano-specific provisions, including definitions. This article explores this policy shift within the European Union and the implications of the Parliament and Council’s stance at this stage due to the absence of a generally accepted definition within the international community.

To Label or Not to Label? - It’s More than a Nano-Sized Question

Nanotechnologies use techniques, processes and materials in the approximate range of 1-100 nanometres (nm) in order to create novel properties and to stimulate particular desired functionalities. Nanotechnologies and various nanomaterials are likely to profoundly affect a wide range of industrial sectors, including energy production and storage, health care, consumer products, textiles, and agriculture amongst others. Despite the perceived benefits of the technology, there has been an increasing number of calls for governments and other stakeholders to evaluate the adequacy of current health and safety regulatory regimes so as to ensure the effective regulation of current and anticipated applications. In response to these calls, governments in several jurisdictions have initiated in-house or commissioned independent regulatory reviews, each of which has been designed to determine the appropriateness of these regulatory regimes to manage the potential risks of the technology. At the same time, a number of commentators have expressed their concern over the perceived limitations and gaps in these frameworks. In light of the increasing international discourse in this field, there is increasing pressure from all sectors of society to determine how nanotechnologies are, and will be, regulated as they evolve.

For Me to Know and You to Find Out? Participatory Mechanisms, the Aarhus Convention and New Technologies

The Aarhus Convention lays down a legislative framework for participatory rights in environmental matters and potentially has wide-ranging application in and across the European Union and its Member States. This analysis identifies how these participation requirements can or may be imposed upon the European Commission as it sets about developing a regulatory framework for nanotechnologies. It then proceeds to identify a set of practical guidelines regarding public participation and nanotechnologies that could guide and assist the Commission in its current work on nanotechnology regulation. It is also suggested that these guidelines could provide an appropriate basis for assisting in the development of a suitable regulatory framework for new technologies in the future.

Government Regulation of Nanotechnologies

Regulation shapes decision making and human behavior. However its impact - as it has often been argued – can encourage or stifle innovation, especially in relation to emerging technologies such as nanotechnologies. It is therefore not surprising that the regulatory debate in relation to nanotechnologies is highly contested. As an increasing number of products incorporating nanomaterials and nanoparticles make their way onto the market in an environmental of imperfect information, such debates have only intensified. The aim of this chapter is to introduce readers to the notion of regulation and illustrate how regulation in its many guises is currently being employed to the regulation of nanotechnologies.