Proposed new International Health Regulations

Infectious diseases have never respected national boundaries, and ever increasing movement of people and goods means that no country or region, no matter how wealthy, can make itself invulnerable to infections emerging elsewhere.¹,² Equally neither can any country be confident that it will not be the source of a threat to the global community.² The International Health Regulations are legal instruments designed to provide the maximum security against the international spread of infectious disease with minimal interference with world traffic.³,⁴ Although the World Health Organization is responsible for the regulations, they are agreed collectively by its member states. Individual states may state a reservation, but great trouble is taken to come up with regulations that almost every country will sign up to. The current regulations (in place since 1969) have been recognised to be inadequate for today's global village and the acid tests that countries may face (box).⁵,⁶ WHO has been revising the regulations since 1995. Progress was initially slow, but the relative irrelevance of the regulations during the outbreaks of severe acute respiratory syndrome (SARS) gave added momentum to the process, which is now approaching its intended end—approval of new regulations by the World Health Assembly in May 2005.

The current regulations require notification only of cases of three diseases—yellow fever, plague, and cholera—and contribute little when faced with established foes such as pandemic influenza, let alone emerging infections such as SARS or new multidrug resistant organisms. Furthermore, they have no authority over the detection, prevention, and control of disease within individual member states.

Intrinsic to the current regulations is an optimistic philosophy that infections can be stopped at borders by regulation of travellers, aircraft, and cargoes. However, borders will always be permeable to infections with incubation periods longer than the duration of an air flight. When SARS occurred, what mattered was how the disease was controlled in exporting areas (Guangdong and Hong Kong) and how safely acute respiratory infections were managed in emergency departments and hospital wards in receiving countries. Exit screening played a part, but entry screening was of little value.⁷,⁸ In addition, entry or exit screening in major airports will need commitment of considerable human resources that will probably be better used elsewhere during an infectious disease crisis.⁷

The new regulations take a radical approach, requiring countries to apply a decision instrument (an algorithm) to any “event potentially constituting a public health emergency of international concern.”⁹ Countries would then have to report events (for example, avian influenza in humans) that might represent the start of the next influenza pandemic or a covert bioterrorist attack (box). Then they would have to satisfy WHO that their response is adequate to contain the threat. Countries facing difficulties could then receive assistance through WHO—for example, by using its global outbreak alert and response network (www.who.int/csr/outbreaknetwork/en/)—a mechanism that worked well during SARS and after the recent tsunami. WHO will officially be allowed to use information from informal sources such as the media. All countries will have to develop internal surveillance and response mechanisms that can detect issues within the country that threaten the global community.⁵

These revisions are responding to shifts in the political, economic, and technological climates that have brought about new collective ways of thinking about public health governance.³,⁴ During SARS all states (apart initially from China) openly reported outbreaks and cooperated with WHO without legal obligation.⁸ Most countries have also been open about avian influenza. The new regulations will provide the legal framework in which these modern public health systems can rest.

The draft regulations were recently considered by an intergovernmental working group meeting in Geneva.⁵,⁹ Progress was slow and the meeting will reconvene in February. Some countries have concerns over sovereignty and loss of control, others want extensive disease lists as well as or instead of the algorithm, and yet more question who will pay for the modernisation and strengthening of surveillance and response systems. Another issue is whether the regulations will apply in large economic groupings such as the European Union or whether current European mechanisms should apply.⁶ The interface of the regulations with pre-existing treaties is a complex area.¹⁰ However, some aspects of the European Union make it more, rather than less, vulnerable to infectious diseases. Its legislative base for public health, article 152 of the Consolidated Treaty, is weak—considerably weaker than the legal basis for the protection of animal health.¹¹ Furthermore, the laudable European policy of free internal movement of goods and people facilitates the easy spread of infections.⁶,¹² European citizens should receive the same levels of protection that the new regulations will provide in other well resourced regions.

The world faces many threats from infection. Most topical is the risk of pandemic influenza, which seems to be the highest in three decades. WHO is updating its pandemic plan and proposing that should avian influenza become a pandemic strain in one country the international community should combine to help the country stamp the strain out.¹³ However, this requires that affected countries report such events immediately to the world community, which is what the new regulations are about. People with national responsibilities must argue these issues to an acceptable compromise before May. Some national sovereignty will need to be ceded in return for collective protection from infection. The status quo is not compatible with any adequate response to the threats that all countries face from emerging and re-emerging infections.¹,⁹,¹⁰