Podcast: Distinguished Guest Practitioner Gian Luca Burci Lectures on the New Field of International Health Law
On Wednesday, February 22, 2012, Distinguished Guest Practitioner Gian Luca Burci, the General Counsel to the World Health Organization (WHO) in Geneva, Switzerland, gave a fascinating talk at Seton Hall Law School on “Navigating the New Field of International Health Law.” The program was sponsored by the Seton Hall Law Center for Health & Pharmaceutical Law & Policy and the International Law program at Seton Hall Law.
Mr. Burci emphasized at the outset that if one defines international health law narrowly, to encompass only international law created “for public health purposes … within a public health environment,” the field is very small indeed. If one looks more broadly, though, health concerns impact many international law areas, including international environmental law, human rights law, intellectual property law, national security law, and trade law.
The WHO, which is the public health arm of the United Nations, is the source of much or all of what little “hard” international health law there is. Like other international bodies, the WHO can adopt treaties, but it can also promulgate regulations which do not need to be ratified by its member countries. Adopted by the WHO’s World Health Assembly, these regulations come into force for all member countries on a specified date. States that do not wish to be bound by them must affirmatively opt out.
As Mr. Burci put it, the expectation was that the WHO would be a “powerful, normative organization” but “the record is poor, at least in terms of hard law.” In its 65 years of existence, the WHO has adopted just one treaty, the 2003 Framework Convention on Tobacco Control, and two regulations, the Nomenclature Regulations, which address the classification of, and compilation and publication of statistics on, diseases and causes of death, and the International Health Regulations (IHRs), which aim to limit the international spread of disease.
On the other hand, Mr. Burci explained, the WHO has been “very successful” in introducing rules of a “recommendatory nature,” so-called “soft law.” The agency is a source of a plethora of technical standards, guidelines, and best practices, including, for example, its non-binding codes on Marketing of Breast-milk Substitutes and on International Recruitment of Health Personnel.
The interplay between soft and hard law is complex and the line between the two can be blurred. Mr. Burci offered as an example the case of the Codex Alimentarius, which is a collection of non-binding recommendations governing food safety. If the steps a country takes to protect its food supply conform to the Codex Alimentarius, the country benefits from a presumption that it is in compliance with the General Agreement on Tariffs and Trade (GATT) and the Agreement on the Application of Sanitary and Phytosanitary Measures, both binding treaties. Concomitantly, if a country takes measures that do not comply with the Codex Alimentarius, it exposes itself to the possibility of legal challenge on the grounds that the measures are too trade restrictive. The ostensibly soft Codex Alimentarius, then, is harder than it seems.
Might we see more hard law from the WHO? Mr. Burci noted that there has been a strong call for a convention on alcohol control, but opined that such a convention is unlikely to be adopted. Tobacco, he explained, is different from alcohol in that there is no level of use that is harmless. Mr. Burci suggested that the problems of illicit trade in medicines and of counterfeit medicines might be amenable to a hard law solution, as might the failure of the market to produce medicines for certain diseases. With regard to the latter, Seton Hall Law Professor Carl Coleman notes here that a WHO working group recently recommended “the adoption of a binding international convention to promote research and development related to diseases predominantly affecting developing countries. The proposal is expected to be on the agenda for the May 2012 meeting of the World Health Assembly…, where it is likely to generate significant discussion.”