Eyebrows could be raised about tackling a subject as specific as the history of an antimicrobial molecule. An analysis of the different stages of this molecule’s classification and uses at the international, European and national levels, in a narrow timeframe (between 2012 and 2017), may seem simplistic. One also may legitimately wonder about the lessons that could be drawn in terms of public policy analysis through the prism of such a narrowly defined sociological object! However, as an aspiring political sociologist, I was reassured. Numerous lessons may be drawn from this investigation which illustrate both the exemplary and unique nature of the colistin "case".

From a medical perspective, human health actors see colistin as an excellent example of the “antimicrobials of last resort" issue in hospital medicine. International (WHO AWaRE Tool) and national (ANSM, 2015) definitions of "last resort antimicrobials" are moreover instructive. Although this concept is essential to physicians, it remains rather vague, broad and without specific recommendations to guide prescriptions. The message understood is that doctors must remain free in the way they practice medicine.

In contrast, for animal health actors, colistin is a singular antimicrobial. Unlike doctors, veterinarians often express dissatisfaction with the constraints imposed on them regarding drug prescriptions. They fear that they may no longer have the means to treat diseases for which they are consulted. In this regard, they consider colistin to be a unique antimicrobial whose pharmacokinetic properties limit the development of resistance because the antimicrobial does not cross the intestinal barrier, which is demonstrated by the fact that it is well controlled in veterinary medicine.

If we step away from the medical dimensions of the subject, could we consider that colistin is representative of issues related to the classification of antimicrobials? From the perspective of the different procedures that have been applied to it, the answer is "yes". As discussed in previous posts, the risk analysis procedure (Boudia & Demortain, 2014) lies at the heart of all of the decisions that have been made in this case. Moreover, the social history that we reconstructed during the investigation illustrates the strong institutionalization of the use of scientific data, as well as policymakers’ systematic reliance on this data. It is important for them that this data be as up-to-date as possible.

Studying this case allows one to acquire a sound understanding of antimicrobial classification procedures, which are generally consistent, homogeneous and intended to be operational. These are real instruments of public action. While they oscillate between "conventional and incentive" forms and "legislative and regulatory" ones (Lascoumes & Le Galès, 2005), they consistently express an intention to control antimicrobial use in veterinary medicine.

Finally, this investigation also revealed that the case of colistin provided an opportunity to test different modes of governance. As we saw in the second post, the issue of critical antimicrobials is considered in the regulatory and administrative arena. By choosing to include the reduced use of colistin in the Ecoantibio 2 plan, and not to add the molecule to the decree of 18 March 2016 establishing the list of critically important antimicrobial substances, DGAL officials decided to encourage self-regulation by animal health professionals. This was, moreover, a characteristic distinguishing the Ecoantibio 2 from its predecessor.

For this reason, it is particularly valuable to consider the case of colistin in the light of the modes of regulation proposed by Gaudillière and Hess in relation to the drug market (Gaudillière & Hess, 2013). In their book, these authors identify four governance models that have emerged from the 19th century to the present day. Their typology is essentially based on identifying the social group that, at different points in time, manages to define regulation rules and the resulting instruments. They were thus able to distinguish between "professional regulation", "industrial regulation", "administrative regulation" and finally "public regulation".

Ways of Regulating Drug in the 19th and 20th Centuries (Gaudillière & Hess, 2012)

The "professional regulation" of drugs corresponds to the organisation set up by pharmacists when this market first emerged at the end of the 19th century. The purpose of these rules was to ensure that licensed pharmacists would hold a monopoly over drug sales.

As the consumption and sale of drugs increased, their manufacture gradually was industrialized. This was a period in which the pharmaceutical industries, heirs to the pharmacists' shops, competed with the burgeoning chemical industries. Against this backdrop, industrial manufacturers began putting in place a series of measures to standardize production, guarantee the quality of the drugs manufactured and limit customer complaints. This is referred to as "industrial regulation".

The third form of regulation is "administrative regulation". When government intervention became necessary to safeguard public health and the environment from the relentless pursuit of profit by industry, marketing authorizations were introduced in the mid-20th century. In their modern form, they are based on risk assessments conducted by independent health agencies.

In the case of colistin, within a mainly “administrative” governance of antimicrobials, there appears to be an official thread of “professional regulation”. It is no longer tacit, but officially established through the adoption of instruments encouraging self-regulation of colistin use by the professional group in charge of prescribing and selling it, namely veterinarians. While all regulatory regimes tend to articulate the various modes identified by Gaudillière and Hess, the regulation of antimicrobials in livestock production seems to emphasize the two modes mentioned above. This probably is due to both the "style" of public policy that is developing in this sector (that of veterinary drug regulation), and the influence exercised by the veterinarian professional group, particularly its administrative section in charge of animal health policies, in governance bodies.

The general idea that we take away from this investigation is that the classification of critical antimicrobials places scientific and medical issues and actors in a central and enduring position. Surveillance of the evolution of resistance is the main rule of the game that structures relations between social groups and guides public policies. For these policies to be feasible, accepted and as effective as possible, it must be possible to adapt the way that the molecule’s use is managed to the actual state of the development of resistance.

Although fine-tuning management in real-time would be difficult, there is a clear advantage to strengthening and designing surveillance in a partnership between human and animal health. By harmonizing measurement indicators, it would be possible to measure the impact of the reduction in antimicrobial use on the overall level of antimicrobial resistance in both human and animal health. Giving all social groups the means to speak the same language could help create cohesion around the objective that all ultimately share, namely the protection of human, animal and ecosystem health, or in other words, "One Health".

 

References:

ANSM (2015). Liste des antibiotiques critiques. Actualisation 2015.

BOUDIA, S., DEMORTAIN, D. (2014). La production d’un instrument générique de gouvernement. Le « livre rouge » de l’analyse des risques. Gouvernement et action publique. 2014/3 (3), pp 33-53.

LASCOUMES, P., LE GALES, P. (2005). Gouverner par les instruments. Presses de Sciences Po.

GAUDILLIERE, J.P., HESS, V. (2013). Introduction. “Ways of Regulating”. In : GAUDILLIERE, J.P., HESS, V. Ways of Regulating Drugs in the 19th and 20th Centuries. Palgrave Macmillan. pp. 5-16.