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Abstract
This paper deals with the relation between regulatory crises and regulatory change. It considers the question of whether factors that explain how accidents or disasters escalate into a regulatory crisis also explain subsequent reforms. Looking at the evolution of post-marketing drug safety and at the crisis caused by the discovery of the fatal effects and market withdrawal of the drug cerivastatin in 2001, it investigates the conditions in which shared solutions to a regulatory crisis emerge. It argues that regulatory change is a process by which existing or emerging technologies come to be framed as a solution to the crisis. Framing means aligning the actors of the regulatory space around common schemes of interpretations of what is needed to improve the regulatory framework. The case study points at the power of scientific and medical experts to foster such cognitive alignment.
Notes
1 Thousands of cases of focamelia (foreshortening of the limbs) in new born babies, caused by the prescription of thalidomide to pregnant women.
2 Defined as ‘the science and activities relating to the detection, assessment, understanding and prevention of drug adverse effects or any other drug-related problem’ in official documents of the World Health Organization.
3 Ever since the thalidomide case, which made the blunt demonstration that medicines did have adverse effect, a concept which did not even exist at the time.
4 Included in cases where the benefits of this legislation are diffuse and costs concentrated on the regulated industry, leading to opposition by the latter.
5 The thalidomide tragedy caused the US Congress to pass a new bill for regulation of pharmaceutical product in 1959, literally just a few days after that very bill had been considered irrelevant and taken out of the agenda of the Congress. The bill introduced drug efficacy as a criteria for the licensing of new medicines, whereas the thalidomide tragedy highlighted the lack of safety of medicines (Temin Citation1985).
6 Reconstruction, restoration, disillusion or stagnation being the four options.
7 Alink et al. (Citation2001) stress general contextual variables such as constitutional rules, institutional features, in their case study of asylum policies: ‘the interpretation of the crisis and the subsequent decision-making on the future course of the sector take place in the very same institutional context which is under discussion’ (p. 303).
8 The causal link between an event and regulatory change tends to be contracted into a framework of analysis in which regulation is at the same time the independent variable (anomalies create the crisis) and the dependent variable (what needs to be changed).
9 The rapid breakdown of muscle tissue, causing the potentially fatal release of muscle cells in the plasma and kidneys.
10 The report established by Bayer after the withdrawal in September 2001 includes 59 cases of death between November 1998 and June 2001. A total of 40 of them had been signalled to the French medicines agency, most of which occurred in the USA. Eleven cases occurred in the European Union and were notified to the UK regulatory agency that was in charge of the product in the framework of the European regulatory system. Bayer failed to notify European regulatory agencies of eight cases of death which took place outside the EU.
11 In the European regulatory system, the licensing of certain categories of products is collegial: a scientific committee comprised of national experts collectively prepares decisions. The scientific evaluation of products is entrusted to one national expert, which acts as rapporteur for the rest of the scientific committee. This expert or, in practice, the agency of which he/she is the employee, remains in charge of the product after authorization.
12 Now the Medicines and Healthcare products Regulatory Agency.
13 Snow and Benford use the expression of ‘prognosis framing’ to refer to similar phenomenon of suggesting solutions, strategies, and tactics to a problem (Snow and Benford Citation1988).
14 The International Conference for Harmonization was launched at the beginning of the 1990s with the objective of harmonizing regulatory requirements of the three major pharmaceutical regulators, the FDA, the European Union and the Japanese Ministry of Health. Representatives of the FDA, the Japanese authorities, the European Union and of the major trade associations participate to its meetings.
15 The Council for the International Organization of Medical Sciences is a non governmental joint supported by the UNESCO and the WHO. It gathers representatives from professional and scientific bodies of the medical world to establish standards related to such topics as medical ethics, the use of medicines or medical terminologies.
16 The map represents the themes which are most frequently dealt with in the literature on post-marketing drug safety. The map features the 20% themes that are most dealt with in the field and their co-occurrence in publications. The length of the links measures the frequency with which themes are associated in the literature. The density of the cluster shows its centrality. A cluster that is both dense and made of short links is a research programme which researchers invest into to stay dominant in the field. The database which was used contains all articles published between 1980 and 2004 in three major journals of the field, excerpted from the medical literature database Medline.
17 On another note, the concentration of the pharmaceutical industry, its dissociation of big pharmaceutical companies from chemical and agro-chemical businesses and the circulation of experts between the private sector and other regulatory organizations, also contribute to this situation.