WAYS OF REGULATING: THERAPEUTIC AGENTS BETWEEN PLANTS, SHOPS AND CONSULTING ROOMS.
Call for papers International workshop
Organized by Jean-Paul Gaudilliere (CERMES, Paris), Volker Hess (Humboldt Universitaet Berlin), and Hans-Joerg Rheinberger (MPIWG, Berlin)
Berlin, December 1st-2nd, 2006.
The history of drugs is far from being an uncharted territory in the history of science and medicine. A vast corpus of literature including histories of firms, biographies of great pharmacists, legal studies of drug regulation, as well as economic surveys have expanded in the past two decades. This literature has provided information on the industrialization of drug making, or on the use of chemical knowledge in order to synthesize molecules with interesting therapeutic properties. Our understanding of “drug as chemicals” however means that other important aspects in the history of drugs have been less discussed. Drugs are medical tools used for the management of diseases. They are at the same time industrial products, commercial goods, and research objects.
Workshops in the series Drug Trajectories aim at a better understanding of this multifaceted nature of drugs by focusing on the “trajectories” of specific compounds, thus cutting through the various drug-making worlds, combining the commercial, the medical, the legal, and the experimental. Seeking for more thorough exchanges between the history of science, the history of medicine and the history of technology, the series favors papers addressing the impact of industrial practices, meaning production, intellectual property management as well as commercialization or clinical research, on the definition of what we know about drugs. Ways of regulating is the fifth workshop in the series. It will concentrate on the different ways in which medical experts, state officials, pharmaceutical entrepreneurs, and users (physicians and patients) have interacted in the “regulation” of drug production, drug sales, and drug uses.
The words “drug regulation” are usually employed with a narrow understanding, which focuses on the actions taken by the government or any form of administrative body in order to control the marketing of drugs. It is however worth considering a broader definition. Regulation may be viewed as a series of dispositifs, which do not only aim at the control of marketing, but also at the management of production and medical use. Regulation is therefore not exclusively a problem of state marching rights and marketing authorizations, but also a problem of norms of action within the laboratory, the production plant, or the doctor’s office. The targets and tools of such enlarged regulation in a given time and place are diverse, including pharmacological indexes, textbooks, recommendations from medical societies, package inserts, protocols for clinical assays or quality control procedures.
A reasonable hypothesis based on the current historiography of therapeutic agents is that a long 20th century beginning around 1880 has seen the emergence and interplay of three ways of regulating. The dynamics of a peculiar form of regulation has to be discussed at different levels, taking into account the following questions: which values guide the regulation process? Which problems or adverse practices are targeted? Who are the most important actors? What are the forms of evidence accepted in decision-making? Which regulatory tools are mobilized to survey and control the fate of drugs? Given these criteria one may for instance trace a professional form of regulation back to the early 19th century. Within this system, the definition of both what drug could be prepared and sold, and what count as a “good” medication was left to the expertise of professional (corporate) bodies of pharmacists and physicians, who were granted a licensing system ensuring sale and prescription monopoly. The diverse national pharmacopeias designed by committee’s of pharmacists mandated by state or public health authorities testify of this regulation. An alternative way of regulating emerged by the turn of the 20th century as an increasing number of drugs were produced in industrial plants rather than pharmaceutical shops. Regulation within the industrial context focuses on the entrepreneurial construction of markets, on the need for self-designed and self-accepted norms, which assure of the continuity of production and of the confidence of the consumers, physicians in the first place. Brand names of “ethical” drugs as well as standardized procedures of quality control belong to this way of regulation. A third and even more recent configuration has been extensively discussed in the historiography. It is the state regulation, which grew in importance with public health and the development of (national) health insurance systems. Within this framework, the delegation of expertise to the professions is attenuated by institutionalized reviews conducted by state bodies disposing of their own experts and defining conditions of production, sales, and/or use. During the second half of the 20th century, this state regulation has become the dominant mode of management of the tensions between drug consumption, public health and commercialization.
In order to address these ways of regulating, their nature and transformation the workshop will focus on studies of regulatory practices. Case studies may investigate various objects: for instance, drugs whose trajectories reveal the interplay between different forms of surveillance, public controversies which resulted in significant changes of the general approach of drug regulation, institutions, which have had a pivotal role in the development of regulatory networks. Contributions including comparison across national and time borders are especially welcomed.