Background of the amendment: The delivery of letters enclosing Bacillus anthracis powder in October, 2001, just after the 9.11 attack, caused world-wide fear and actual health damage including fatal infections. Necessity of preventive measures against terrorism including bioterrorism was recognized internationally. The United States of America and other countries responded quickly to this situation by enacting necessary regulations. Under these circumstances, in December 2004, the Headquarters of Counter-International Organized Crimes and International Terrorism under the direction of the Japanese Chief Cabinet Secretary issued the "National Defense Program Guideline, FY 2005-" (the new NDPG) and the "Mid-Term Defense Program, FY 2005-FY 2009" (http://www.kantei.go.jp/foreign/tyokan/2004/1210statement_e.html). A bill for the revision of the Infectious Diseases Control Law aiming at legal framework of handling pathogens and like substances was submitted to the Diet of 2006.
The Infectious Diseases Control Law before the revision and the Tuberculosis Prevention Law had several drawbacks. United States and United Kingdom had already established standards for possession or use of pathogens and like substances and implemented obligatory registration of the institutions possessing such agents. The global scheme of controlling pathogens and like substances by creating a global network has been debated at various places, such as in OECD. Japan has had no legislation specific to the handling of pathogens and like substances so far.
It was claimed that the Tuberculosis Prevention Law might not protect the human rights sufficiently. For example, while tuberculosis patients living alone could not be ordered to be hospitalized (because such patients are considered not to transmit the pathogen to roommates), if they are with roommates, the patients were forced to be hospitalized against their will, because the law did not provide patients with a chance of receiving recommendation of hospitalization before such measures are taken (see below). Some people claimed that presence of legislation dealing with specific infections, such as leprosy and AIDS, resulted in people's discrimination of the patients and created prejudice against them.
Main topics of the amendments
1. New provisions for regulation concerning control of pathogens and like substances
Pathogens and like substances, if they are not handled properly, may cause accidental infections, which may spread among populations endangering their lives. So far, in Japan, handling of pathogens and like substances has been entirely entrusted to researchers. After the present revision, however, possession, importation, transportation, etc of pathogens and like substances became under the revised Infectious Diseases Control Law. It is recognized, meanwhile, that the research or laboratory diagnosis of infectious diseases should not be hindered by introduction of the new regulatory measures.
(1) Definition and classification of pathogens and like substances: "Pathogens and like substances" are defined as organisms and materials which cause infectious diseases (Infectious Diseases Control Law, Article 6, Clause 16). To assure measures proportionate to the infectivity and severity, pathogens and like substances were classified into groups 1-4. In principle, possession of the group 1 pathogens and like substances is prohibited. The possession of the group 2 pathogens and like substances is allowed if prior permission is obtained from the Government. The possession of the group 3 pathogens and like substances is allowed if notification is made to the Government after obtaining such agents. The possession of the group 4 pathogens and like substances is allowed if security standards are well observed [see Table 1 (pdf file & gif file)]. Any agents that will be later found to require restriction as to possession and use will be classified into either one of the four groups.
(2) Outlines of restrictions for each group
Group 1: Pathogens and like substances likely to cause serious unrecoverable life-threatening damages. This group includes agents not possessed anywhere in Japan even for research purposes, and those whose possession is not recommended internationally. Possession of and research on these agents is generally prohibited. As an exception, a national institute, an independent administrative agency, or a juridical person ordained by the government ordinance can possess the agents only if the institute is so designated by the Minister of Health, Labour and Welfare. Punitive clauses are provided for release or attempted release of these substances.
Group 2: Pathogens and like substances, whose use for developing therapy and laboratory tests is recognized as social benefit. They cause life-threatening damages as severe as the Group 1 agents do and potential use for bioterrorism has been raised. Possession of these agents requires special biosafety facilities and other measures. A special permission by the Minister of Health, Labour and Welfare is obligatory for its possession and use.
Group 3: No prior permission by the Minister of Health, Labour and Welfare is necessary. However, notification of the possession (for the purpose of tracing the group 3 agents) is mandatory. The biosafety laboratories complying with the applicable construction standards are requested.
Group 4: No prior or post notification is needed. Installation of facilities complying with the construction standards is required. Any offence against such standards will invite Government's order such as improvement of facilities or direct inspection by the Government.
(3) Regulatory rules of pathogens and like substances (see p. 189 of this issue): Regulatory rules include general provisions for prohibition, permission or notification of the possession or importation of the pathogens and like substances and rules more specific to pathogens and like substances, such as facility standards, storage standards, rules for infection prevention, nomination of a laboratory biosafety manager, education and training of those entering the laboratories, record keeping of use and disinfection, destruction and disposal of agents that will not be used any more, report of accidents, emergency response plan, reports of keeping rules, inspection, order of improvements of facilities or practices, etc (see p. 192 of this issue).
2. Re-categorization of the infectious diseases under the Infectious Diseases Control Law [see Table 2 (pdf file & gif file)]
(1) New infectious diseases addedFSouth American hemorrhagic fever (including the Argentinean, Brazilian, Venezuelan, and Bolivian hemorrhagic fevers) was added and categorized as Category I. Tuberculosis is now categorized as Category II, because, it may necessitates isolation by hospitalization depending upon the symptoms and the severity, while it does not require containment of building as Category I infectious diseases. Monkeys infected with tuberculosis bacilli now have to be notified by veterinarians on account of high risk of transmission to humans.
(2) Re-categorized infectious diseases: Severe acute respiratory syndrome (SARS) has been transferred from Category I to Category II and enteric infectious diseases (cholera, shigellosis, typhoid fever and paratyphoid fever) in Category II were transferred to Category III. SARS is categorized as Category II, because while its infectivity is lower than that of Category I infectious diseases, hospitalization measures may be called for at the moment of epidemic. The enteric infectious diseases are categorized as Category III, because restricting certain occupational works, such as food handling (applicable to the Category III infectious diseases) is sufficient and in view of the hygienic level of this country hospitalization measures are not necessary for preventing its spread.
3. Integration of the Tuberculosis Prevention Law into the Infectious Diseases Control Law (see p. 190 of this issue)
Under the Tuberculosis Prevention Law, hospitalization could be ordered only when a patient had his/her roommate(s). As a consequence, hospitalization of a patient could not be ordered if the patient lived alone even when he/she definitely required it as public health measures. As the law did not provide a recommending step (see below) before forced hospitalization, infringement of human rights was often observed. These shortcomings of the law were solved through the process of its integration to the Infectious Diseases Control Law. Important provisions in the Tuberculosis Prevention Law, such as those for regular medical check, therapy and medical care services based on the tuberculosis registration cards, home visit, availability of doctor's advice etc, are transferred to the Infectious Diseases Control Law. The BCG vaccination is grouped as that of Category I disease in the Preventive Vaccination Law.
Guidance on prevention of tuberculosis is found in the special "Guidelines of Prevention of Specified Infectious Disease" for tuberculosis. After present revision, physicians now need not notify asymptomatic tuberculosis carriers not requiring any medical treatment.
4. Amendment of rules that affect human rights
(1) Amendment to enhance human rights: With the background of rising people's consciousness toward human rights and concerns on possible violation of human rights in the past infection control measures, a phrase "taking human rights into account" in Article 2, Basic Concept, is now changed to "respecting human rights" so as to clearly address the respect of human rights. When working restriction or hospitalization that may infringe the human rights is considered, "principles of minimizing (such) measures" are the rules. The principles of minimizing measures have already been applied to animals and goods, but now the principle is applied when the hospitalization of the patients with infectious diseases is considered.
(2) Amendments made to the procedures concerning hospitalization: Generally no patients should be ordered to be hospitalized without a prior step of recommendation. The recommendation step consists of appropriate explanation given to the patients and obtaining patients' consent of voluntary hospitalization. The patients should be given an opportunity to express their wishes and/or complaints concerning hospitalization. Patients' claims should be handled and responded in good faith and the measures taken should be communicated back to the patients.
5. Other amendments
There is a change in the Quarantine Law that is made in line with amendment of the International Health Regulations (IHR). The revised IHR was adopted in 2005 and came into effect in June 2007. The amended IHR requires no legally binding measures for cholera and yellow fever. Therefore, cholera and yellow fever which were quarantine diseases are now deleted from the list of the target diseases of the Quarantine Law (cholera which was classified as a Category II infectious disease is now classified as a Category III infectious disease after revision of the Infectious Diseases Control Law).