International Health Regulations: New Mandate for Scientific Cooperation
August 02, 2005
The newly revised International Health Regulations (IHR) of the World Health Organization (WHO), adopted on May 23, 2005, signal remarkably increased willingness by member states and the organization itself to assert WHO authority not only in coping with emergent, serious communicable disease threats and outbreaks, but also in establishing a firmer international legal basis for international scientific cooperation toward that end. These are substantial changes in the traditional IHR functions of transborder controls. The new IHR greatly expand the legal obligations of states parties in the area of public health operations and related science, and they spell changes for operations within the WHO as well.
The World Health Organization has been reluctant to regulate; the chief exception is its promulgation of the IHR, which until now have dealt almost entirely with deterring trans-border spread of certain known diseases (mainly cholera, plague, yellow fever, and smallpox) and rodent and insect vectors. As already analyzed extensively during the drafting and negotiation stages, the topical reach of the revised regulations extends to newly recognized potential as well as actual major public health threats. By the time the revisions were approved, the drafters had in mind some frightening history, current events, and worldwide conditions. Among these are major chemical spills, early Soviet secrecy concerning the Chernobyl nuclear reactor explosion, China's initial lack of candor concerning severe acute respiratory syndrome (SARS), the very recent interspecies crossover of a newly discovered avian influenza from birds to human beings, the advent of bioterrorism, and the globalization of trade, transportation, and movement of people and disease vectors.
International scientific investigation is essential to recognizing, understanding and coping with disease threats. In this regard, the old IHR, which remain in effect until the new regulations enter into force, require only that member states insofar as practicable have near their border crossings quarantine and diagnostic facilities suitable for diagnosis of the few diseases reportable under the old IHR. Except for interception, diagnosis, and reporting, international scientific cooperation is not required. This changes under the new IHR. State parties' development of requisite scientific capacity toward the goal of containing communicable diseases is obligatory under the revised IHR. International scientific cooperation to limit the spread of major disease becomes obligatory. States parties "shall undertake to collaborate with each other, to the extent possible," in detection, assessment, and response to" potential and actual major threats to international health and "provision or facilitation of technical and logistical support, particularly in the development, strengthening and maintenance of the public health capacities required...."
The scientific capacity required to fully comply, not only with the ability to diagnose, intercept, control, and maintain surveillance in regard to known disease entities and vectors, but also to detect emerging threats, exists in only a few countries. Consequently, the IHR oblige the have-nations to contribute capacity development to the have-nots. This is an unfunded mandate; the regulations contain no formula for contribution.
Under its constitution, the WHO is to "act as the directing and co-ordinating authority on international health work." Until now this has been done under ad hoc arrangements and without clear legal structure. The new IHR establish a formal system for convening of experts and for emergency action. The new IHR require states parties and the WHO itself to maintain clear points of contact (national and local "focal points"). And the new regulations bolster the WHO's legal authority to intervene where serious threats to international health are kept secret, as in the early cases of SARS.
Significant for public health science, too, is the admonition in the new IHR that implementation "shall be with full respect for the dignity, human rights and fundamental freedoms of persons." The implication is that no shortcuts may be taken in protections for human subjects of public health research.
The revised IHR will enter into force in May 2007 and will be binding under international law for those WHO member states that do not reject them, and that do not attempt to attach impermissible reservations, within that time frame. Member states may make reservations to provisions in the IHR, if the reservations are consistent with the object and purpose of the IHR. But if one-third of the WHO member states object to a reservation, the reserving state must either withdraw the reservation or submit it to a detailed procedure within the WHO. If the reservation does not pass muster, the revised IHR would not enter into force for that state unless the member state withdraws its reservation. This procedure resolves two issues that are unresolved under the customary international law of treaties: It provides a means of determining whether a reservation is consistent with the object and purpose of an international agreement and, if it is not, the procedure sets forth the consequences.
Even for the United States, the expanded IHR requirements imply a need for increased surveillance capacity and strengthened public health programs. Surveillance for a few known diseases is one thing; a national capacity for monitoring, surveillance, notification, and control measures for emerging, especially dangerous threats to international health, is quite another. Under international law, the IHR have the effect of treaty obligations for member states that have not rejected them and have not attached unacceptable reservations; consequently they would impose an obligation on the United States to act more proactively in the health field than the old regulations required.
In addition, under domestic law in the United States, the new IHR could affect federal-state relations in the health field. In 1920 the U.S. Supreme Court upheld a federal statute that implemented a treaty, without regard to whether the statute would have violated states' rights under the Tenth Amendment had there been no treaty. It could be argued that the 1920 case applies to federal health regulation under the new IHR, but the treaty in that case was submitted to the U.S. Senate, which gave its consent. Consequently the treaty was clearly the supreme law of the land under Article VI, Section 2 of the U.S. Constitution. If the new IHR are not submitted to the Senate for its advice and consent, the 1920 case would be distinguishable from the current situation and would not necessarily serve to expand federal powers in the health field at the expense of the states.
Apart from federal-state issues, the obligation to comply with these new treaty-derived regulations could be viewed as expanding federal authority (beyond discretionary use of the commerce and spending powers) for research and for scientific cooperation as well as for regulatory actions against potential and actual international public health hazards.
About the author
Gerald S. Schatz, an ASIL member, is assistant professor, Center for Ethics and Humanities in the Life Sciences, College of Human Medicine, and adjunct professor, College of Law, Michigan State University. He developed and teaches the joint seminar in International Law and Ethics of Human Subjects Research, for the Michigan State University Colleges of Law and Human Medicine. He is a former visiting scholar of the Georgetown University Center for Clinical Bioethics.
 Revision of the International Health Regulations, 58th World Health Assembly, WHA58.3, Agenda item 13.1 (23 May 2005), available at http://www.who.int/csr/ihr/en/ [hereinafter IHR (2005)].
 International Health Regulations, with Appendices. Adopted at Boston July 25, 1969; entered into force January 1, 1971. 21 UST 3003; TIAS 7026; 764 UNTS 3. Additional regulations amending articles 1, 21, 63 to 71, 92, and appendix 2 of the international health regulations. Adopted at Geneva May 23, 1973; entered into force January 1, 1974. 25 UST 197; TIAS 7786. Additional amendments to the international health regulations. Adopted at Geneva May 20, 1981; entered into force January 1, 1982. 33 UST 4436; TIAS 10314; World Health Organization, International Health Regulations (1969) (3d annot. ed., updated 1995), available at http://www.who.int/csr/ihr/current/en/print.html [hereinafter IHR (1969)].
 See David P. Fidler, Revision of the World Health Organization's International Health Regulations, April 2004, at http://www.asil.org/insights/insigh132.htm.
 IHR (2005) Annex 2.
 IHR (1969) arts. 14, 15.
 IHR (2005) Annex 1.
 IHR (2005) art. 44 & Annex 1.
 IHR (2005) art. 44.
 WHO const. art. 2(a).
 IHR (2005) art. 13 Â¶ 3, arts, 47-53.
 IHR (2005) arts. 4, 6(b).
 "When WHO receives information of an event that may constitute a public health emergency of international concern, it shall offer to collaborate with the State Party concerned in assessing the potential for international disease spread, possible interference with international traffic and the adequacy of control measures....If the State Party does not accept the offer of collaboration, WHO may, when justified by the magnitude of the public health risk, share with other States Parties the information available to it, whilst encouraging the State Party to accept the offer of collaboration by WHO, taking into account the views of the State Party concerned." IHR (2005) art. 10(3)-(4).
 Revision of the International Health Regulations, art. 3 Â¶ 1.
 IHR (2005) art. 62.
 Missouri v. Holland, 252 U.S. 416 (1920).