Medical nanotechnology and Governance
Richard Moore examines the notion of "governance"
In our regular series on issues linked to medical nanotechnology, Richard Moore examines the notion of "governance", what it may mean to different stakeholders and how it may affect medical nanotechnology, especially on a European level. The term “governance” derives from the Latin suggesting a notion of “steering”. This sense of ”steering” a society can be contrasted with the traditional ”top-down” approach of a government ”driving” society or the distinction between ”power to” in contrast to a government’s ”power over”. However, the term “governance” may be taken to mean different things by different people and groups in society. It is therefore important to define a common understanding of the term “governance” in order to avoid considerable confusion. Taking the differing types of interpretation into account, the International Risk Governance Council (IRGC) decided to address the question of governance in relation to nanotechnology in a white paper in June 2006.
In relation to the governance of risks associated with nanotechnology, the IRGC suggests that governance includes the processes, conventions and institutions that determine:
- how power is exercised in view of managing resources and interests - how important decisions are made and conflicts resolved - how interactions among and between the key actors in the field are organised and structured - how resources, skills and capabilities are developed and mobilised for reaching desired outcomes; - and how various stakeholders are accorded participation in these processes.
Here, governance is seen as implying a move away from the previous governmental approach, which could be characterised as a top-down legislative approach attempting to regulate the behaviour of people and institutions in quite detailed and compartmentalised ways, towards a joint effort of industrial, public and civil society actors, usually within networks, with the goal of making best use of their respective resources, skills, and capabilities for reaching specific ends or purposes.
In such a system, permeable and flexible system boundaries facilitate communication and support the achievement of higher level goals, while the government role also continues. These assumptions underline the switch from government alone to governance in debates about the modernisation of policy systems, implying a transition from “constraining” to “enabling” types of policy or regulation (i.e. a move from “sticks” to “carrots”).
In relation to non-pharmaceutical medical nanotechnology, governance must also be viewed in the legislative context of the three medical device directives, i.e.
- Active Implantable Medical Device Directive (90/385/EEC) - Medical Device Directive (93/42/EEC) - In-vitro Diagnostic Medical Device Directive (98/79/EC)
All three of these directives are “new approach” and echo the move from “constraining” or prescriptive European legislation to a more flexible “enabling” and innovation-friendly form. All three are also firmly based on a principle of risk analysis and risk management and utilise a supporting voluntary harmonised European Standard, EN ISO 14971. The IRGC White Paper suggests a cyclical risk governance approach to nanotechnology incorporating pre-assessment, risk appraisal, risk tolerability and acceptability judgement (including the need for risk reduction measures) and risk management, supported at all stages by risk communication activities. This model closely follows the conceptual framework of EN ISO 14971 which also includes hazard identification, risk analysis, risk reduction, risk/benefit judgement, risk management and risk communication.
It can be concluded, therefore, that the medical technology industry and their regulators are already well-prepared for the challenges posed by nanotechnology-led innovation and this view appears to be currently supported by discussions within the new technologies working group of the European Commission’s Medical Device Expert Group.
While EN ISO 14971 does not currently address nanotechnologies, the basic conceptual framework is considered by many in the industry to be suitable with possible appropriate additional guidance required on hazards and associated risks particular to nanotechnology. In this respect, the IRGC White Paper proposes “four generations” of nanotechnology products:
Passive nanostructures (fixed functionality). An example in medical nanotechnology could be nanocontoured implant surfaces Active nanostructures, i.e. functionality will change in response to external stimuli. Medical technology examples could include sensors that can detect and respond to changes in physiological conditions in the body, and targeted cancer therapies based on paramagnetic nanoparticles Integrated nanosystems that combine active subsystems, for example artificial organs built from nanoscale and evolutionary nanobiosystems. Products based on heterogeneous molecular systems built from the bottom-up, rather than manufactured using top-down fabrication methods. These could include for example nanoscale gene therapies and molecules designed to self-assemble. For the purposes of risk governance the IRGC White Paper further divides these four generations into two “frames of reference” with generation one “passive nanostructures” in the first frame and generations two to four in the second frame. It has been considered that “frame one knowledge” is fairly complete for passive nanostructures whereas the knowledge associated with active nanostructures is less certain due to lack of risk-related know-how. For integrated nanosystems and molecular systems, knowledge is deemed ambiguous due to lack of clarity on scientific and technological development and on societal impacts.
Current medical technology innovation is certainly active at the first and second levels with products at levels three and four still in early stage research.
Perceptions by different stakeholders of the process of governance in relation to medical nanotechnology
To some extent, the way different actors perceive medical nanotechnology and the form of governance that should be applied to it can also be related to their type of involvement, their institutional culture and their perception of the risks of the technologies.
The medical technology industry for example has, since 1990, been used to an “enabling” non-prescriptive form of European legislation. It believes that it has the measures in place for self-control or, at least co-regulation, based on a risk management approach inherent in the current legislation. It therefore favours a continuation of that system, or at least the key fundamental principles enshrined within it.
The pharmaceutical industry, on the other hand, is governed by a more prescriptive form of European legislation and has formulated its systems to gather the information demanded by that regulatory regime. Here, we see a somewhat more “top down” system of governance, which is somewhat at variance to the IRGC model, where governmental representatives essentially set the limits and boundaries as to what is acceptable and what is not in terms of risk.
While many regulators involved with such prescriptive legislation themselves believe it to be “safer” it is highly arguable whether this is actually the reality. Such legislation is inherently innovation-unfriendly because it cannot evolve quickly enough to keep up with scientific advances and was originally designed to deal with a scenario, e.g. mass-produced pharmaceuticals, which is quite different to the increasingly individual patient-centred type of therapy which nanomedicine will facilitate. In addition, the timescales involved in regulatory approval of pharmaceutical products are a major disincentive to investment in novel nanomedicine-based therapies as there will be a long period before major R&D costs can be recouped through sales.
Two groups of stakeholders who are often left out of debates concerning governance are the medical professionals and the patients and much is decided which affects them by parties who are not directly affected by the technologies. It is this author’s view that novel technologies such as nanomedicine should be driven by user needs and that the system governance applied by way of regulation should reflect these needs, taking into account both safety of the technology and accessibility to the treatment as well as the needs of regulatory certainty, which will facilitate the R&D process and the commercial needs of the manufacturers of nanomedical products.
A lack of such an ongoing dialogue between these various parties, as recommended by the IRGC, will surely result in governance that is ultimately unsuitable, confusing and inadequate.
Richard Moore is Manager of Nanomedicine and Life Sciences at the Institute of Nanotechnology.
Source: NANO Magazine - Issue 4 /...
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