Regulation Multiple: Pharmaceutical Trajectories and Modes of Control in the ASEAN

Abstract

This article revisits the conceptualisation of pharmaceutical regulation. While States and multilateral organisations play a central part in devising rules, regulation as a social practice extends beyond their role. Domestic and international interests, geopolitics and spatial configurations, commercial and health considerations, governmental policies and individual behaviours and legal and illegal transactions all contribute to regulating the pharmaceutical milieu. This consideration expands the epistemological range of pharmaceutical regulation, which then appears as the assemblage of heterogeneous laws, rules and codes of conducts. The way in which these layers are connected forms what regulation actually is in practice. Regulation multiple thus appears as the product of tensions between harmonisation efforts and persistent diversity, as well as the result of interactions and overlaps between official regulation and unofficial regulatory practices. This article explores these tensions in the Southeast Asian pharmaceutical market along three themes: circuits and logistic regimes; control and attention to quality; bridges and harmonisations. The globalisaTion of pharmaceutical markets which has been taking place over the last 30 years is marked by deep transformations in the geographies of production

Therapeutic mobilities

“…Moreover, the great diversity of pharmaceutical regulations between border countries (Baxerres and Le Hesran 2011) and large regions of the world (Bourdier, Man, and Res 2014) is a major factor in the way health products disseminate between different points of the planet. The notion of 'regulation multiple' (Quet et al 2018) illustrates the manifold interactions and overlaps between official regulations and unofficial regulatory practices leading to official movements of essential medicines as well as smuggled pharmaceuticals. 'Domestic and international interests, geopolitics and spatial configurations, commercial and health considerations, governmental policies and individual behaviours and legal and illegal transactions all contribute to regulating the pharmaceutical milieu' (Quet et al 2018: 498), which influences the transnational distribution of health products.…”

Myanmar Traditional Medicine: The making of a national heritage

“…The standardization and modernization of, and disenchantment with, medicine brought about by the process of institutionalization is thus countered by healers and manufacturers who maintain the diversity of the techniques used, alongside the more spiritual and esoteric aspects of medical practice. Other forces also support this diversification, the most relevant of which is the market, as argued by Quet et al (2018, 5) elsewhere in Southeast Asia. In fact, the market's very existence relies on diversity and visibility.…”

“…While weak controls and corrupt agents facilitate the bypassing of regulations, the choice to do so is motivated by commercial and medical logics, tinged with defiance towards biomedical authorities. As stated by Quet et al (2018, 15): ‘alternative routes, corrupt practices and other forms of arrangements are rather pervasive, sometimes inescapable and deeply embedded in official regulatory processes’.…”

Empty stocks and loose paper: Governing access to medicines through informality in Northern India

“…The fee … was 3300 INR but obviously I can’t tell you how much I paid or he will be caught ( laughs ).’ 17 Given the extent of this practice, it would be inappropriate to point only at the corruption of individuals: the state itself participates in the legitimization of the human resources involved in the informal provision of medicines, thus promoting the informality of the system by facilitating access to informal working statuses. This can be seen as another way of institutionalizing informality (Quet et al, 2018), besides more socially legitimate practices of training which institutions such as the Red Cross or WHO dispense.…”