Barbel R. Dorbeck-Jung

Is the European Medical Products Authorisation Regulation Equipped to Cope with the Challenges of Nanomedicines

This article analyses the emerging European regulatory activities in relation to nanopharmaceuticals. The central question is whether the regulatory responses are appropriate to cope with the regulatory problems nanomedicinal development is posing. The article explores whether the medical product regulations are robust enough, whether there are certain regulatory gaps, and whether the competent bodies have the expertise to evaluate nanomedicinal products when approval is applied for. Based on a social-constructive approach, the article identifies significant regulatory actors, their ideas on regulatory problems, and preliminary governance responses to them. It finds that the current dynamic regulatory structure appears robust enough to adapt to some of the technological challenges posed by nanomedicines. It concludes that regulators have not yet responded adequately to regulatory gaps related to definitions, classification and specific safety, quality, and efficacy standards that nanopharmaceutical development seems to require. As a consequence of these deficiencies legal certainty, a principle of high priority in European medical regulation policy, cannot be sufficiently provided.

Exposure limit values for nanomaterials-capacity and willingness of users to apply a precautionary approach

In the European Union, the legal obligation for employers to provide a safe workplace for processing manufactured nanomaterials is a challenge when there is a lack of hazard information. The attitude of key stakeholders in industry, trade unions, branch and employers’ organizations, and government policy advisors toward nano reference values (NRVs) has been investigated in a pilot study that was initiated by a coalition of Dutch employers’ organizations and Dutch trade unions. NRVs are developed as provisional substitutes for health-based occupational exposure limits or derived no-effect levels and are based on a precautionary approach. NRVs have been introduced as a voluntary risk management instrument for airborne nanomaterials at the workplace. A measurement strategy to deal with simultaneously emitting process-generated nanoparticles was developed, allowing employers to use the NRVs for risk assessment. The motivational posture of most companies involved in the pilot study appears to be pro-active regarding worker protection and acquiescent to NRVs. An important driver to use NRVs seems to be a temporary certainty employers experience with regard to their legal obligation to take preventive action. Many interviewees welcome the voluntary character of NRVs, though trade unions and a few companies advocate a more binding status.

Legitimate Governance within the State

The theory of the state is traditionally a theory of law in a social context. Since the state is a relatively recent phenomenon, theorizing about it only started at the beginning of this century. Georg Jellinek’s ‘Allgemeine Staatslehre’, published in 1900, is often seen as the official starting point. On the basis of neo-Kantian thought Jellinek distinguishes between the theory of the state as a social phenomenon and the theory of the state as a legal phenomenon (Jellinek, 1900: 50).1 Referring to the differences between facts and norms, he argues that both perspectives must be clearly separated.2 While the social theory of the state purports to use empirical methods, research on the state as a legal institution is purely based on normative methods. Jellinek’s approach has been criticized by Hans Kelsen, a distinguished follower of legal positivism. Like Jellinek Kelsen emphasizes the neo-Kantian point of view. He concludes, however, that a social theory of the state is not possible, because the state and the legal order are one and the same (Kelsen, 1984). In political science, an opposite but equally extreme position was taken by David Easton, who argued that the concept of the state should be abolished because of its legal connotation (Easton 1971).3 According to Easton, it is political behavior that really matters (behaviorism). From the point of view of the method used and subject of research, Easton’s perspective appears to be just as restrictive as that of Kelsen.While Kelsen maintains that a theory of the state can only be based on a normative method that focuses on legal judgments, Easton concentrates on the empirical study of political behavior, while denying the value of the concept of the state in scientific research.

Setting Priorities in Dutch Legislative Policy

Setting priorities in legislative policy is one of the most controversial issues of contemporary legislative policy. During the development of the welfare state, government regulation was regarded as the instrument for achieving wealth, equality and freedom. From the seventies onward, however, legislative policy was reversed in many countries. Increasingly, legislation was coming to be regarded as ineffective, a constraint to economic growth and an intrusion on personal freedom. As a result of this discussion the priorities of regulation policy tended to shift to the strategies of deregulation, privatization and self-regulation. These deregulation operations, however, reveal contradictory effects. In Europe they have not been very successful so far, and current developments seem to indicate an opposite trend in the direction of re-regulation (Majone, 1990; 1996).

Transcending the Myth of Law’s Stifling Technological Innovation

This chapter explores the lessons that can be drawn from how adaptive drug licensing processes cope with legitimacy issues of regulatory connections. The exploration assumes that a responsive approach to technology regulation offers opportunities to meet legitimacy requirements. Looking at existing and proposed adaptive drug licensing pathways through the lens of this theoretical frame we see a realistic responsive approach to regulation. By indicating that adaptive licensing can bring beneficial medicinal drugs earlier to patients this approach seems to be equipped to transcend the myth of law’s stifling technological innovation. The evaluation of the current stage of adaptive drug licensing leads to three tentative lessons. First, a shared interest, accompanied by strong drivers and enablers, is crucial; second, ongoing prudent coordination of a leading regulatory agency is essential; third, to ensure that new responsibilities and the norms of participation, transparency, integrity, and accountability are taken seriously a new social contract can be supportive.