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Chapter I

Introduction of International Health Regulation

The International Health Regulations (IHR) is an international legal instrument that is binding on 194 countries across the globe, including all the Member States of WHO. Their aim is to help the international community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide.

In the globalized world, diseases can spread far and wide via international travel and trade. A health crisis in one country can impact livelihoods and economies in many parts of the world. Such crises can result from emerging infections like Severe Acute Respiratory Syndrome (SARS), or a new human influenza pandemic. The IHR can also apply to other public health emergencies such as chemical spills, leaks and dumping, or nuclear melt-downs. The IHR aims to limit interference with international traffic and trade while ensuring public health through the prevention of disease spread.

The IHR, which entered into force on 15 June 2007, require countries to report certain disease outbreaks and public health events to WHO. Building on the unique experience of WHO in global disease surveillance, alert and response, the IHR define the rights and obligations of countries to report public health events, and establish a number of procedures that WHO must follow in its work to uphold global public health security.

The IHR also require countries to strengthen their existing capacities for public health surveillance and response. WHO is working closely with countries and partners to provide technical guidance and support to mobilize the resources needed to implement the new rules in an effective and timely manner. Timely and open reporting of public health events will help make the world more secure.

The International Health Regulation (2005)

I. What is the International Health Regulations (2005) and why does the world community needs them to enhance global public health security?

The International Health Regulations (2005) or "IHR (2005)" are an international law which helps countries work together to save lives and livelihoods caused by the international spread of diseases and other health risks. They entered into force on 15 June 2007 and are binding on 194 countries across the globe, including all WHO Member States. The IHR (2005) aims to prevent, protect against, control and respond to the international spread of disease while avoiding unnecessary interference with international traffic and trade. The IHR (2005) are also designed to reduce the risk of disease spread at international airports, ports and ground crossings. Born of an extraordinary global consensus, the IHR (2005) strengthen the collective defenses against the multiple and varied public health risks that todays globalized world is facing and which have the potential to be rapidly spread through expanding travel and trade.

The IHR (2005) establish a set of rules to support the global outbreak alert and response system and to require countries to improve international surveillance and reporting mechanisms for

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public health events and to strengthen their national surveillance and response capacities. This makes the IHR (2005) central to ensuring global public health security.

II. What is the history of the IHR?

The cholera epidemics that overran Europe between 1830 and 1847 were catalysts for intensive infectious disease diplomacy and multilateral cooperation in public health. This led to the first International Sanitary Conference in Paris in 1851. In 1948, the WHO Constitution entered into force and in 1951 WHO Member States adopted the International Sanitary Regulations, which were replaced by and renamed the International Health Regulations in 1969. The 1969 Regulations were subject to minor modifications in 1973 and 1981. The 1969 IHR were primarily intended to monitor and control six serious infectious diseases: cholera, plague, yellow fever, smallpox, relapsing fever and typhus. Under the IHR (1969), only cholera, plague and yellow fever remain notify able, meaning that States are required to notify WHO if and when these diseases occur on their territory.

In the early 1990s, the resurgence of some well known epidemic diseases, such as cholera in parts of South America, plague in India and the emergence of new infectious agents such as Ebola hemorrhagic fever, resulted in a resolution at the 48th World Health Assembly in 1995 calling for the revision of the Regulations. In May 2001, the World Health Assembly adopted Resolution WHA 54.14, Global health security: epidemic alert and response, in which WHO was called upon to support its Member States in strengthening their capacity to detect and respond rapidly to communicable disease threats and emergencies.

In May 2003, resolution WHA56.28 on Revision of the International Health Regulations, established an intergovernmental working group (IGWG) open to all Member States to review and recommend a draft revision of the International Health Regulations for consideration by the World Health Assembly. The IGWG held two sessions in November 2004 and February/May 2005 with a view to endorsing a final text for consideration by the World Health Assembly at its 58th meeting. The World Health Assembly adopted the IHR (2005) on 23 May 2005 by way of resolution WHA58.3. The IHR (2005) entered into force on 15 June 2007.

III. Why was the IHR revised?

The limitations of the IHR (1969), which led to their revision, related to their narrow scope (three diseases), their dependence on official country notification, and their lack of a formal internationally coordinated mechanism to contain international disease spread. In recent decades, cross-border travel and trade have increased and communication technology has developed markedly. News now spreads rapidly via a multitude of formal and informal channels. New challenges have arisen in the public health control of emerging and re-emerging infectious diseases.

With its focus on just three diseases (cholera, plague and yellow fever), the IHR (1969) were not equipped to address the growing and varied public health risks that resulted from increased travel and trade in the last quarter of the 20th century. In addition, some countries were reluctant to promptly report outbreaks of these diseases for fear of unwarranted and damaging travel and trade restrictions. A way needed to be found to increase the confidence of countries in reporting significant and/or unusual disease events, by linking early disclosure to prompt

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support and accurate information dissemination about the nature of the event. The IHR (2005), which are firmly grounded in practical experience, broaden the scope of the 1969 Regulations to cover existing, new and re-emerging diseases, including emergencies caused by non-infectious disease agents. Through a new legal framework, the IHR (2005) ensure a rapid gathering of information, a common understanding of what may constitute a public health emergency of international concern and the availability of international assistance to countries.

The IHR (2005)s reporting procedures are aimed at expediting the flow of timely and accurate information to WHO about potential public health emergencies of international concern. Under these rules, WHO, as a neutral authority, with critical technical expertise and resources, and an extensive communications network can assess information, recommend actions and facilitate or help coordinate technical assistance, when needed that is tailored to events as they unfold.

IV. What are the main functions of the IHR (2005)?

Notification

The IHR (2005) require States to notify WHO of all events that may constitute a public health emergency of international concern and to respond to requests for verification of information regarding such events. This enables WHO to ensure appropriate technical collaboration for effective prevention of such emergencies or containment of outbreaks and, under certain defined circumstances, inform other States of the public health risks where action is necessary on their part.

These notification requirements, together with WHOs mandate to seek verification from countries with respect to unofficial reports of events with potential international implications is intended to promote and facilitate information sharing between WHO and States Parties to the IHR (2005).

Greater understanding of the event as it unfolds, plus the assurance of timely technical collaboration, leads to a climate of greater willingness on the part of countries to contact the WHO when a possible public health emergency of international concern is suspected.

National IHR Focal Points and WHO IHR Contact Points

Under the IHR (2005) countries are required to notify and report events and other information through their National IHR Focal Points to a regional WHO IHR Contact Points Focal points and Contact points must be available on a 24 hour-a-day basis, seven days a week. There are currently 193 National IHR Focal Points and six corresponding WHO IHR Contact Points.

Requirements for national core capacities

Under the IHR (2005), each State Party is required to develop, strengthen and maintain core public health capacities for surveillance and response by using existing national resources, such as the national plans for influenza pandemic preparedness. Key sanitary and health services and facilities are also to be developed at international airports, ports and ground crossings designated for this purpose by States Parties.

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Recommended measures

WHOs response to a public health emergency of international concern will include temporary recommendations concerning appropriate public health responses, and may include recommended measures for application by the State affected by such an emergency, as well as by other States and by operators of international transport. These temporary recommendations are made by WHO on a time-limited, risk-specific basis, as a result of a public health emergency of international concern.

Standing recommendations indicate the appropriate measures for routine application for specific ongoing public health risks, and are for routine or periodic application. Recommended measures could be directed towards persons, baggage, cargo, containers, ships, aircraft, road vehicles, goods or postal parcels.

External advice regarding the IHR (2005)

The IHR (2005) include procedures for obtaining independent technical advice concerning IHR implementation. One context is the process for the establishment of an Emergency Committee to advise the Director-General of WHO in determining whether a particular event is, in fact, a public health emergency of international concern and to provide advice on any appropriate temporary recommendations. An IHR Review Committee is tasked with advising the Director-General on technical matters relating to standing recommendations, the functioning of the Regulations and amendments there to.

V. What is meant by a "public health emergency of international concern" in the IHR (2005)?

According to the IHR (2005) a public health emergency of international concern refers to an extraordinary public health event which is determined, under specific procedures:

(a) to constitute a public health risk to other States through the international spread of disease; and

(b) to potentially require a coordinated international response.

To ensure adequate and early communications with WHO about potential international public health emergencies, the IHR (2005) include a decision instrument (Annex 2 of the Regulations) which sets the parameters for notification to WHO of all events which may constitute a public health emergency of international concern (PHEIC) based on the following criteria:

(a) seriousness of the public health impact of the event;

(b) unusual or unexpected nature of the event;

(c) potential for the event to spread internationally; and/or

(d) The risk that restrictions to travel or trade may result because of the event.

Timely and transparent notification of events combined with a collaborative assessment of the risks by the concerned State and WHO, along with effective risk communication will reduce the potential for international disease spread and the likelihood of unilateral imposition of trade or travel restrictions by other countries.

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THE LEGAL FRAMEWORK ESTABLISHED BY THE IHR (2005)

VI. What is the legal status of the IHR (2005) and how did they enter into force for States?

Under the WHO Constitution, all WHO Member States were automatically bound by the new IHR because they did not affirmatively opt out within a limited time period and only a very small number made reservations. According to the procedures established in the IHR (2005), reservations are evaluated by other WHO Member States within a defined time period. Because one third of the other States did not object to the reservation(s), the Regulations entered into force for the States that filed them subject to the reservation(s).

VII. How is compliance with the IHR (2005) being achieved?

The IHR (2005) were agreed upon by consensus among WHO Member States as a balance between their sovereign rights and shared commitment to prevent the international spread of disease. Although the IHR (2005) do not include an enforcement mechanism per se for States which fail to comply with its provisions, the potential consequences of non-compliance are themselves a powerful compliance tool. Perhaps the best incentives for compliance are "Peer pressure" and public knowledge. With today's electronic media, nothing can be hidden for very long. States do not want to be isolated. The consequences of non-compliance may include a tarnished international image, increased morbidity/mortality of affected populations, unilateral travel and trade restrictions, economic and social disruption and public outrage. Working together with WHO to control a public health event and to accurately communicate how the problem is being addressed has helped to protect countries from unjustified measures being adopted unilaterally by other states.

VIII. How are questions or disputes on the interpretation or application of the IHR (2005) resolved?

The IHR (2005) contain a dispute settlement mechanism to resolve conflicts arising between States in respect of the application and/or the interpretation of the Regulations. The mechanism emphasizes the amicable settlement of differences. Several options are open to States under this mechanism, including negotiation, mediation and conciliation. Disputes may also be settled by referral to the Director-General of WHO or by arbitration, if agreed to by all the parties to the dispute. Since their entry into force on 15 June 2007, the dispute settlement provisions have not been invoked.

THE ROLES, RESPONSIBILITIES AND OBLIGATONS OF STATES PARTIES AND

WHO UNDER THE IHR (2005)

IX. Who is responsible for implementing the IHR (2005)?

The responsibility for implementing the IHR (2005) rests upon all States that are bound by the Regulations and WHO. The State is responsible, including all of its sectors, ministries, levels, officials and personnel for implementing the Regulations at the national level. WHO collaborates with and supports States in the implementation of the Regulations.

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X. How will States benefit from the IHR (2005)?

By agreeing to be bound by the IHR (2005), States: enjoy the benefits of a respected partner in the international effort to maintain global health security;

receive WHO guidance in building the core capacities necessary to quickly detect, report, assess and respond to public health emergencies and public health risks, including those of national and international concern;

are offered technical assistance and receive help in efforts to mobilize possible funding support to meet these new obligations;

receive WHO guidance during outbreak assessment and response; have access to specific information gathered by WHO about public health risks world-

wide which is necessary for them to protect themselves;

receive WHO advice and logistical support, when requested, to respond to disease outbreaks and other public health events;

Have access to the Global Outbreak Alert and Response Network (GOARN), a one-stop shop of global resources to help manage public health risks and emergencies of international concern.

XI. According to the IHR (2005), what are the key obligations for States?

States Parties to the IHR (2005) are required:

to designate a National IHR Focal Point (see Question 4 above); to assess events occurring in their territory and to notify WHO of all events that may

constitute a public health emergency of international concern using the decision instrument included in Annex 2 of the Regulations (see Question 5 above);

to respond to requests for verification of information regarding events that may constitute a public health emergency of international concern; to respond to public health risks which may spread internationally;

to develop, strengthen and maintain the capacity to detect, report and respond to public health events;

to provide routine facilities, services, inspections and control activities at designated international airports, ports and ground crossings to prevent the international spread of disease;

to report to WHO evidence of a public health risk identified outside their territory which may cause international disease spread, manifested by exported/imported human cases, vectors carrying infection or contamination, contaminated goods;

to respond appropriately to WHO-recommended measures; To collaborate with other States Parties and with WHO on IHR (2005) implementation.

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XII. According to the IHR (2005), what are the key obligations for WHO?

Laying down the rules for global public health security, the IHR (2005) confer on WHO new roles and responsibilities. WHO has strengthened its ability to fulfill these fresh obligations by:

designating WHO IHR Contact Points at the headquarters or the regional level (see Question 4 above);

conducting global public health surveillance and assessment of significant public health events, and disseminating public health information to States, as appropriate;

offering technical assistance to States in their response to public health risks and emergencies of international concern;

supporting States in their efforts to assess their existing national public health structures and resources, as well as to develop and strengthen the core public health capacities for surveillance and response, and at designated points of entry;

if required, determining whether or not a particular event notified by a State under the Regulations constitutes a public health emergency of international concern, with advice from external experts;

if a PHEIC is declared, developing and recommending the critical health measures for implementation by States Parties during such an emergency (with advice from external experts);

Monitoring the implementation of IHR (2005) and updating guidelines so that they remain scientifically valid and consistent with changing requirements.

XIII. When and how can WHO issue recommendations concerning public health emergencies of international concern?

Once WHO has determined that a particular event constitutes a public health emergency of international concern, the IHR (2005) require WHO, upon request, to give a real-time response to the emergency. Based on the details specific to each emergency, the Director-General of WHO will recommend measures for implementation by the affected State as well as by other States. These time-limited recommendations are made available to States and, subsequently, made public. Depending on the evidence, recommended measures could then later be modified or terminated. The Emergency Committee (see Question 4 above) will advise the Director-General on these recommendations.

TRAVEL AND TRADE UNDER IHR (2005)

XV. How does the IHR (2005) affect international travel and trade and individual travelers?

International travel and trade

The extent of international travel in the modern world presents an extraordinary opportunity for international disease transmission. Global trade has implications in terms of potential food borne disease or other contaminated goods. While health measures to control disease spread at borders remain one important element of the Regulations, evidence shows that rapid response

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at the source is the most effective way to secure maximum protection against international spread of diseases.

One of the objectives of the IHR (2005) is to minimize unnecessary restrictions to travel and trade by specifying, in real-time, the appropriate public health measures for the assessed risk. WHO's neutral expert guidance in assessing and controlling public health risks is key to limiting unnecessary restrictions on trade and travel. During a public health emergency of international concern, however, application of time-limited measures affecting international travel and trade may be recommended.

Individual travelers

The IHR (2005) aims at preventing the international spread of diseases while limiting unnecessary restrictions on the free movement of travelers. During public health emergencies of international concern or in connection with specific public health risks, measures affecting travel may be recommended to avoid the international spread of disease. Health information, basic examinations and vaccination documentation may be requested of a traveler by States. At the same time, under the IHR (2005), States are required to treat travelers with respect for their dignity, human rights and fundamental freedoms together with confidential treatment of their personal data.

XVI. How and why States Parties are required to designate international airports and ports and may designate certain ground crossings for capacity strengthening purposes under the IHR (2005)?

Large-scale growth of travel and trade in recent years has increased the potential and opportunities for international disease spread. Although rapid response at the source is the most effective way to prevent disease from crossing borders, routine public health measures applied to international conveyances and at airports, ports and ground crossings may further reduce the risk of spread. States Parties are, therefore, required to designate the key international airports and ports to develop and strengthen the capacities provided in Annex 1of the IHR (2005). Additionally, where justified for public health reasons, States Parties may designate ground crossings that shall develop these capacities. These designations should be made as soon as possible because the timelines established in the Regulations started running on 15 June 2007.

COLLABORATION UNDER IHR (2005)

XVII. How are the IHR (2005) interacting with other international agreements and bodies?

Under the IHR (2005), States recognize that the Regulations and other relevant agreements should be compatible. The IHR (2005) provide for cooperation between WHO and other competent intergovernmental organizations or international bodies in the implementation of the regulations. WHO therefore continues to foster its longstanding working relationships with a number of organizations such as the International Atomic Energy Agency, the International Air Transport Association, the International Civil Aviation Organization, the International Maritime Organization, the World Tourism Organization, Food and Agriculture Organization of the United Nations, the Office International d'Epizooties (World Organization for Animal Health) and the World Trade Organization. In addition to these specialized organizations,

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WHO works with regional economic integration organizations such as the European Union and the Mercado Comn del Sur (MERCOSUR) in implementing the Regulations in the countries of their respective regions.

XVIII. How have the IHR (2005) affected the Model Deratting and Deratting Exemption certificates, Maritime Declaration of Health, International Certificate of Vaccination or Revaccination against Yellow Fever and the Health Part of the Aircraft General Declaration?

Model Ship Sanitation/Ship Sanitation Exemption Certificate replaces the Deratting/ Deratting Exemption certificate

Ship Sanitation/Ship Sanitation Exemption Certificates in the IHR (2005) replaced the narrower Deratting/Deratting Exemption Certificates in the IHR (1969) on 15 June 2007.

Model Maritime Declaration of Health

The Maritime Declaration of Health was updated to reflect the broader scope of the IHR (2005) and currently accepted technical standards and terminology.

Model International Certificate of Vaccination or Prophylaxis replaces the International Certificate of Vaccination or Revaccination against Yellow Fever

Yellow fever remains the only disease specifically designated under the IHR (2005) for which proof of vaccination or prophylaxis may be required for travelers as a condition of entry to a State. The international certificate was revised as follows: on 15 June 2007, the International certificate of vaccination or revaccination against yellow fever was replaced by the International certificate of vaccination or prophylaxis. Clinicians issuing the certificate should note that the main difference from the old certificate is that they have to specify in writing in the space provided that the disease for which the certificate is issued is yellow fever. The current Certificate no longer contains references to a designated vaccination centre (See answer to Question 20) and its period of validity is limited to the date indicated on the certificate for the particular vaccine or prophylaxis.

Health Part of the Aircraft General Declaration

This is a document of the International Civil Aviation Organization (ICAO), a United Nations agency. The document is periodically reviewed by ICAO Member States, and has historically, for practical purposes, been reproduced in the annexes of the IHR. Consequently, the revised version of this Declaration submitted by ICAO to WHO has been reproduced in the second edition of the IHR (2005), published in 2008.

SPECIFIC DISEASES UNDER THE IHR (2005)

XIX. How do the IHR (2005) help to address the risk of an influenza pandemic in humans?

Under the IHR (2005), all cases of these four diseases must be automatically notified to WHO: smallpox, poliomyelitis due to wild-type poliovirus, SARS and cases of human influenza caused by a new subtype. Case definitions for each of these four diseases have been prepared by WHO and posted at on its website at www.who.int/ihr.

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XX. What kind of yellow fever vaccines are valid under the IHR (2005) and must they be administered at a vaccination centre designated by the State or at a listed WHO-approved vaccination centre?

Under IHR (2005), each State must designate at least one yellow fever vaccination centre, but, if it so wishes, no longer has to restrict the issuance of yellow fever vaccination certificates to such an officially-designated centre. The yellow fever vaccine used must be approved by WHO. The WHO no longer maintains a list of vaccinating centers designated for the administration of yellow fever vaccine and for the issue of International Certificates of Vaccination or Revaccination against yellow fever.

Ten things you need to do to implement the IHR

1. Know the IHR; purpose, scope, principles and concepts

The International Health Regulations (2005) (hereinafter "the IHR" or the Regulations) are an international agreement that is legally binding on 194 countries (States Parties), including all WHO Member States. The IHR define their "purpose and scope" as: "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade". Since their entry into force on 15 June 2007, the IHR directs and governs particular WHO and States Parties activities aiming that protect the global community from public health risks and emergencies that cross international borders. These activities are implemented in ways that are consistent with other international law and agreements; their implementation must "be with full respect for the dignity, human rights and fundamental freedom of persons" and "guided by the goal of their universal application for the protection of all people of the world from the international spread of disease".

The scope of the IHR is purposely broad and inclusive in respect of the public health event to which they have application in order to maximize the probability that all such events that could have serious international consequences are identified early and promptly reported by States Parties to WHO for assessment. The Regulations aim to provide a legal frame work for the prevention, detection and containment of public health risks at source, before they spread across borders, through the collaborative actions of States Parties and WHO.

Notification is required under IHR for all "events that may constitute a public health emergency of international concern". In this regard, the broad new definitions of "event", "disease" and "public health risk" in the IHR are the building blocks of the surveillance obligations for States Parties and WHO. "Disease" means "an illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans". The term "event" is broadly defined as "a manifestation of disease or an occurrence that creates a potential for disease". "Public health risk" refers to "a likelihood of an event that may affect adversely the health of human populations, with an emphasis on one which may spread internationally or may present a serious and direct danger". A public health emergency of international concern (PHEIC) is defined as "an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response". Consequently, events of potential international concern, which require States Parties to notify WHO, can extend beyond communicable diseases and arise from any origin or source.

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The IHR explicitly allow WHO to take into account information from sources other than official notifications and consultations, and, after assessment, to seek verification of specific events from the concerned States Parties. Notification to WHO marks the beginning of an exclusive dialogue between the notifying State Party and WHO on further event assessment, potential investigation and any appropriate local or global public health response.

The responsibility for implementing the IHR rests jointly with States Parties and WHO. In order to be able to notify events, or respond to public health risks and emergencies, States Parties must have the capacity to detect such events through a well established national surveillance and response infrastructure. States Parties are required to collaborate actively with each other, together with WHO, to mobilize the financial resources to facilitate the implementation of their obligations under the IHR. Upon request, WHO assists developing countries in mobilizing financial resources and provides technical support to build, strengthen and maintain the capacities set out in Annex 1 of the Regulations.

2. Update national legislation

An adequate legal framework to support and enable all of the varied IHR State Party activities is needed in each country. In some countries, giving effect to the IHR within domestic jurisdiction and national law requires that the relevant authorities adopt implementing legislation for some or all of the relevant rights and obligations for States Parties. However, even where new or revised legislation may not be explicitly required under a country's legal system for implementation of one or more provisions in the IHR, revision of some legislation, regulations or other instruments may still be considered by the country in order to facilitate performance of IHR activities in a more efficient, effective or otherwise beneficial manner. Additionally, from a policy perspective, implementing legislation may serve to institutionalize and strengthen the role of IHR capacities and operations within the State Party, as well as the ability to exercise certain rights contained in the Regulations. A further potential benefit from such legislation is that it can facilitate necessary coordination among the different entities involved in implementation and help to ensure continuity. For these reasons, States Parties to the IHR should consider assessing their relevant existing legislation to determine whether they may be appropriate for revision in order to facilitate full and efficient implementation of the Regulations.

3. Recognize shared realities and the need for collective defenses

The recognition that globalization brings with it new challenges and opportunities for preventing the international spread of disease was the starting point for the revision of the International Health Regulations (1969) or "IHR (1969)". In 2003, the outbreak and eventual control of SARS convinced the world's governments of the necessity for a collective and coordinated defense against emerging public health threats, providing the impetus needed to complete the revision process. The IHR were adopted by the Health Assembly on 23 May 2005, and entered into force on 15 June 2007.

The IHR legal framework supports existing and innovative approaches in the global detection of events and response to public health risks and emergencies. The current Regulations were built in part on the foundations of their predecessor, the IHR (1969), and were primarily based on the experiences of WHO and its Member States in national surveillance systems, epidemic intelligence, verification, risk assessment, outbreak alert, and coordination of international

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response, all of which are part of WHOs decade-long work to enhance global public health security.

In contrast to the IHR (1969), the current Regulations have a broad scope, provide for the use of a wide range of information and emphasize collaborative actions between States Parties and WHO in the identification and assessment of events and response to public health risks and emergencies. In WHO's coordination of the international response to public health emergencies of international concern, maximum measures are replaced by formally recommended and context-specific temporary health measures, tailored to the actual threat faced.

4. Monitor and report on IHR implementation progress

States Parties and WHO alike are required to report to the World Health Assembly on IHR implementation. To date, this requirement has been fulfilled through annual reporting by the WHO Secretariat to its governing bodies. Using information gathered through questionnaires, the WHO Secretariat has summarized the activities carried by countries to implement the IHR. It is anticipated that, in the future, this data will be collected using specific indicators currently under development. In addition to this, the IHR Coordination Department collaborates closely with WHO Regional Offices and other relevant departments and programs to report on WHOs work in support of IHR implementation.

5. Notify, report, consult and inform WHO

The IHR describe key elements of the procedures to be followed by States Parties and WHO in terms of information sharing with regard to notified events. Official event-related communications under the IHR are carried out between the National IHR Focal Point and their corresponding regional WHO IHR Contact Point, both of whom are officially designated and required to be available on a 24 hour basis, 7 days a week.

The IHR (2005) specify three ways in which States Parties can initiate event-related communications with WHO:

Notification Under the IHR, States Parties are required to notify WHO of all events that are assessed as possibly constituting a PHEIC, taking into account the context in which an event occurs. These notifications must occur within 24 hours of assessment by the country using the decision instrument provided in Annex 2 of the Regulations. This decision instrument identifies four criteria that States Parties must follow in their assessment of events within their territories and their decision as to whether an event is notifiable to WHO:

Is the public health impact of the event serious? Is the event unusual or unexpected? Is there a significant risk of international spread? Is there a significant risk of international restriction(s) to travel and trade?

Notifications must be followed by ongoing communication of detailed public health information on the event, including, where possible, case definition, laboratory results, source and type of the risk, number of cases and deaths, conditions affecting the spread of the disease and the health measures employed.

Consultation - In cases where the State Party is unable to complete a definitive assessment with the decision instrument in Annex 2, State Parties have an explicit option of initiating

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confidential consultations with WHO and seeking advice on evaluation, assessment and appropriate health measures to be taken.

Other Reports - State Parties must inform WHO through the National IHR Focal Point within 24 hours of receipt of evidence of a public health risk identified outside their territory that may cause international disease spread, as manifested by imported or exported human cases, vectors which carry infection or contamination, or by contaminated goods.

In addition to these three types of communications, States Parties are required under the IHR to respond to WHO Requests for Verification. WHO has an express mandate to obtain verification from States Parties concerning unofficial reports or communications, received from various sources, about events arising within their territories which may constitute a PHEIC; these reports are initially reviewed by WHO prior to the issuing of a verification request. States Parties must acknowledge verification requests by WHO within 24 hours and provide public health information on the status of the event, followed, in a timely manner, by continued communication of accurate and sufficiently detailed public health information available to the notifying State Party.

6. Understand WHOs role in international event detection, joint assessment and response

The IHR underpin WHOs mandate to manage the international response to acute public health events and risks, including public health emergencies of international concern. The Regulations also recognize WHO's general surveillance obligations, and set out specific procedures for concerned States Parties and WHO to collaborate in the assessment and control of public health events and risks, even before such events have been officially notified to WHO.

At the international level, WHOs real-time analysis of public health events uses technical knowledge, an understanding of the situational and operational context, and risk communication requirements to assess public health risks in accordance with WHOs mandate under the IHR. To further strengthen international alert and response capabilities, an enhanced event-management system and standard operating procedures have been developed by WHO. This web-based tool functions as the official repository of all information relevant to an event that may constitute a public health emergency of international concern. It facilitates communications within WHO, with National IHR Focal Points, with technical institutions and partners, and provides timely public health information for the management of these events and risks.

Information relating to public health risks notified or reported under the IHR (2005) to WHO is jointly assessed with the affected State Party to ascertain the nature and extent of the risk, the potential for international disease spread and interference with travel and trade, and appropriate response and containment strategies.

In order to meet its IHR obligations and to facilitate information sharing between the Organization and States Parties to the Regulations, WHO has established an IHR Event Information Site. This site is accessible to National IHR Focal Points and provides up-to-date information on ongoing public health events of international concern.

7. Participate in the PHEIC determination and WHO recommendations-making processes

PHEIC determinations and the issuing of corresponding WHO recommendations by the Director-General will be a rare occurrence. Indeed, since the entry into force of the IHR on 15 June 2007 only one such determination has been made and recommendations issued. It is

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important that States Parties to the IHR are aware of the processes that may affect them and of their right to be consulted and present their views.

If immediate global action is needed to provide a public health response to prevent or control the international spread of disease, the IHR give the Director-General of WHO the authority to determine that the event constitutes a PHEIC. On such occasions, an IHR Emergency Committee provides its views to the Director-General on temporary recommendations on the most appropriate and necessary public health measures to respond to the emergency. A State Party affected by a potential emergency needs to work closely with WHO to ensure that all relevant information and considerations are brought to bear prior such a determination and the adoption of any corresponding temporary recommendations. However, the right of a State to be consulted or prevent its views to an Emergency Committee shall be without prejudice to the need to act swiftly in the event of an emergency.

In cases where the State Party concerned may not agree that a PHEIC is occurring, the Emergency Committee will also provide advice. The temporary recommendations issued by the Director-General are for affected and non-affected States Parties in order to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic.

8. Strengthen national surveillance and response capacities

Another fundamental aspect of the IHR is the obligation for all States Parties to develop, strengthen and maintain core public health capacities for surveillance and response. In order to be able to detect, assess, notify and report events and respond to public health risks and emergencies of international concern, States Parties must meet the requirements described in Annex 1A of the IHR (2005). Annex 1A outlines these core capacities at the local (community), intermediate and national levels, including, at the national level, the assessment of all reports of urgent events within 48 hours and the immediate reporting to WHO through the National IHR Focal Point, when required.

The IHR require each State Party, with the support of WHO, to meet the core surveillance and response capacity requirements "as soon as possible", but not later than five years after the date of entry into force for that country. The IHR set out a two-phase process to assist States Parties to plan for the implementation of their public health capacity obligations. In the first phase, from 15 June 2007 to 15 June 2009, States Parties must assess the ability of their existing national structures and resources to meet the core surveillance and response capacity requirements. This assessment must lead to the development and implementation of national plans of action. As specified in the IHR, WHO must support these assessments and provide guidance on the national planning and implementation of these capacity strengthening plans.

In the second phase from 15 June 2009 to 15 June 2012, the national action plans are expected to be implemented by each State Party to ensure that core capacities are present and functioning throughout the country and/or its relevant territories. States Parties that experience difficulties in implementing their plans may request an additional two year period until 15 June 2014 to meet their Annex 1A obligations. On the basis of a justified need, an extension of two years may be obtained. In exceptional circumstances, and supported by a new implementation plan, the Director-General of WHO may grant an individual State Party a further extension not exceeding two years to meet its obligations.

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9. Increase public health security at ports airports and ground crossings

International points of entry, whether by land, sea or air, provide an opportunity to apply health measures to prevent international spread of disease. For this reason, many of the provisions addressing this aspect in the IHR (1969) have been updated in the IHR (2005). A number of new provisions have been included. When applying IHR-related health measures to international travelers, for example, it is required that they be treated with courtesy and respect, taking into consideration their gender, socio cultural, ethnic and religious concerns. They must be supplied with appropriate food, water, accommodation and medical treatment if quarantined, isolated or otherwise subject to medical or public health measures under the IHR (2005).

States Parties are required to designate the international airports and ports and any ground crossings which will develop specific capacities in the application of the public health measures required to manage a variety of public health risks. These capacities include access to appropriate medical services (with diagnostic facilities), services for the transport of ill persons, trained personnel to inspect ships, aircraft and other conveyances, maintenance of a healthy environment as well as ensuring plans and facilities to apply emergency measures such as quarantine.

10. Use and disseminate IHR health documents at points of entry

The IHR require the implementation of a range of health documents at ports, airports and ground crossings. Failure by States Parties to use and include these documents in their daily operations may result in unnecessary disruption to international traffic.

Model Ship Sanitation Control Exemption Certificate/Ship Sanitation Control Certificate

The Ship Sanitation Control Exemption Certificate/Ship Sanitation Control Certificate replaced the narrower in scope Deratting/Deratting Exemption Certificate on 15 June 2007.

Model Maritime Declaration of Health

The Maritime Declaration of Health reflects the broader scope of the IHR and currently accepted technical standards and terminology.

Model International Certificate of Vaccination or Prophylaxis replaces the International Certificate of Vaccination or Revaccination against Yellow Fever

Yellow fever is the only disease specifically designated under the IHR for which proof of vaccination or prophylaxis may be required for travelers as a condition of entry to a State. The International certificate of vaccination or revaccination against yellow fever was replaced by the International certificate of vaccination or prophylaxis (ICVP). Clinicians issuing the certificate should note that the main difference from the old certificate is that they have to specify in writing in the space provided that the disease for which the certificate is issued is yellow fever. The ICVP does not contain a reference to a designated vaccination centre.

Health Part of the Aircraft General Declaration

This is a document of the International Civil Aviation Organization (ICAO), a United Nations agency. The document is periodically reviewed by ICAO Member States, and has historically, for practical purposes, been reproduced in the annexes of the IHR. Consequently, the July 2007

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revision of the Declaration adopted by ICAO has been reproduced in the 2008 second edition of the IHR (2005).

Case definitions for the four diseases requiring notification to WHO in all circumstances under the IHR (2005)

Under the International Health Regulations 2005 (IHR 2005), the World Health Organization is to establish case definitions for the following four critical diseases which are deemed always to be unusual or unexpected and may have serious public health impact, and hence must be notified to WHO in all circumstances:

smallpox poliomyelitis due to wild type poliovirus human influenza caused by a new subtype, and severe acute respiratory syndrome (SARS).

Note, however, that these case definitions are specifically for purposes of notification under the IHR (2005), and may not apply to other surveillance or reporting systems, which may have their own definitions.

The IHR (2005) also require notification of all (public health) events which may constitute a public health emergency of international concern, in accordance with the Decision Instrument in Annex 2.

Monitoring and evaluation of IHR (2005) implementation

Monitoring and evaluation (M&E) of progress on IHR (2005) implementation is central to the proper follow up and continuous improvement of implementation activities at national, regional and global levels. M&E systems track what is being done (monitoring) and whether the implementation of IHR (2005) is making a difference (evaluation).

Objectives

To provide regular progress reports, including maps, to WHO, States Parties and WHO governing bodies.

To propose specific studies, modifications or changes to improve the implementation of the Regulations.

Activities and expected results

In partnership with WHOs partners:

to identify, test, collect and analyses indicators for all countries to monitor and evaluate the implementation of the IHR (2005), building on information and/or systems already available from existing programs, including WHO regional strategies for disease surveillance and response.

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Chapter II

Decentralization and Health System Reform

Issue in brief Decentralization is pursued for a variety of reasons: technical, political, and financial. On the technical side, it is frequently recommended as a means to improve dministrative and service delivery effectiveness. Politically, decentralization usually seeks to increase local participation and autonomy, redistribute power, and reduce ethnic and/or regional tensions. On the financial side, decentralization is invoked as a means of increasing cost efficiency, giving local units greater control over resources and revenues, and sharpening accountability. However, it can also be employed (overtly or covertly) to offload financial responsibility from resource-poor central governments to regional and/or local entities. In the health sector, when decentralization has been pursued for technical reasons, it has been a major component of performance improvement efforts. In many countries, decentralization, along with health financing reform, has figured in system reforms for at least twentyfive years. In countries where the political and financial purposes of decentralization have been primary, the health sector has had to develop coping strategies to maintain services and progress toward health objectives. In short, health sector reformers may in some cases choose decentralization, while in others decentralization may be thrust upon them.

Thus, assessing the results of decentralization experience has proven to be difficult for a number of reasons. First, as noted, a wide variety of objectives may be pursued through decentralization, and a range of functions can be decentralized. So the combinations and permutations embodied in individual country experience can be extensive. Second, as with many concepts in the international development field, decentralization is subject to ambiguous, confusing, and conflicting definitions. This ambiguity and confusion make comparison and drawing lessons difficult. Third, the process aspects of decentralization are often in completely captured or ignored, including the lag time between putting decentralized systems in place and signs of improvements.

The resulting complexity makes it hard to develop simple guidance for decision makers interested in decentralizing health systems. This document offers some help in addressing decentralization for health sector actors interested in designing decentralization policies and strategies, implementing them, and/or operating within decentralized health systems.

Definitions

Decentralization deals with the allocation between center and periphery of power, authority, and responsibility for political, economic, fiscal, and administrative systems. The focus here is on administrative decentralization for health policy, health systems management, health financing, and service delivery. The most common definitions of administrative decentralization distinguish variants along a continuum where at one end the center maintains strong control with limited power and discretion at lower levels to progressively decreasing central control and increasing local discretion at the other. This continuum can also be thought of in terms of degrees of decision space, where decentralization is assessed in terms of the range of choices available to local-level decision makers, with wider ranges being associated with higher degrees of decentralization.

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Decentralization has a spatial aspect in that authority and responsibility are moved to organizations in different physical locations, from the center to the local level. And it has an institutional aspect in that these transfers involve expanding roles and functions from one central agency to multiple agencies (from monopoly to pluralism). The different types of decentralization are deconcentration, delegation, and devolution, which are defined as follows:

Deconcentration: transfer of authority and responsibility from central agencies in a country.s capital city to field offices of those agencies at a variety of levels (regional, provincial, state, and/or local).

Delegation: transfer of authority and responsibility from central agencies to organizations not directly under the control of those agencies, for example, semi-autonomous entities, non-governmental organizations, and regional or local governments.

Devolution: transfer of authority and responsibility from central government agencies to lower- level, autonomous units of government through statutory or constitutional provisions that allocate formal powers and functions.

Decentralization is not an either/or proposition. Administrative systems combine centralized and decentralized components, often in complex ways. For example, in Zambia, the central Ministry of Health delegated operational authority to a Central Board of Health (CBoH) while retaining policy and regulatory authority for itself. Operational responsibility is further deconcentrated in regional and district boards of health and hospital boards that can make some decisions independently of the CboH. While Ghana also delegated operational authority to a Ghana Health Service (GHS) and established deconcentrated local-level budget management centers, the GHS is vested with more central authority than the Zambian CboH. In the Philippines, a wide range of responsibilities was devolved to local government authorities, while the Medical Care Commission manages a national Medicare program and the Department of Health maintains national public health policy functions. The appropriate mix of central control and local management depends upon political, technical, and institutional factors. Real-world cases of this mix are not easy to untangle, specify, or categorize in neat typologies.

Objectives

Health reformers pursue decentralization largely to increase health sector performance, but in many cases governance and political objectives also figure importantly. The following list enumerates frequently cited objectives:

Increase service delivery effectiveness through adaptation to local conditions and targeting to local needs.

Improve efficiency of resource utilization by incorporating local preferences into determination of service mix and expenditures.

Increase cost-consciousness and efficiency of service production through closer links between resource allocation and utilization.

Increase health worker motivation through local supervision and involvement of service users in oversight, performance assessment, etc.

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Improve accountability, transparency, and legitimacy by embedding health service delivery in local administrative systems.

Increase citizen participation in health service delivery by creating systems and procedures for involvement in planning, allocation, oversight, and evaluation.

Increase equity of service delivery by enabling marginalized and poor groups to access health care providers and to influence decisions on service mix and expenditures.

Increase the role of the private sector in health service delivery by separating financing of health care from service provision.

Almost all decentralization strategies include several of these objectives, and in fact many of them are complementary. However, there can also be trade-offs, tensions, and conflicts. For example, deconcentrating units of a health ministry may increase the efficiency of resource allocation by allowing health facility managers to make decisions about purchasing supplies or replenishing medicine stocks, but may not empower service users and beneficiaries to have a say in allocation decisions, such as when staff are present to provide services to the most users at convenient hours or whether physicians are available in addition to nurses. Local staff of the ministry may resist community input on the grounds that such participation is costly and that health professionals know best what services and medications should be provided, when, and by what level of health manpower.

Another example of the tensions that can be introduced is when decentralization reforms compromise the quality of services. Analysis of immunization programs, for example, has shown that when EPI (Expanded Program on Immunization) is delegated to the local level there can be increased risk of problems such as improper cold chain maintenance, purchase and use of unsuitable equipment, reduced clinical supervision, and diminished outreach (see, for example, Fielden and Nielsen 2001).

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Chapter III

DESENTRALISASI KESEHATAN:

DEFINISI DAN TINJAUAN SEJARAH DI INDONESIA

Desentralisasi merupakan isu utama dalam reformasi kesehatan di negara-negara berkembang selama dua dekade terakhir ini. Konsep ini sebenarnya telah banyak diajukan oleh para pengamat dan praktisi sebagai salah satu bentuk dari reformasi untuk mencapai kesetaraan serta peningkatan kinerja dalam sektor pelayanan publik, termasuk juga sektor kesehatan (World Bank, 1995). Desentralisasi kesehatan sebenarnya merupakan bagian dari desentralisasi politis dan ekonomi yang lebih luas, dan jarang berdiri sendiri.

DEFINISI

Desentralisasi merupakan fenomena yang kompleks dan sulit didefinisikan. Definisinya bersifat kontekstual karena tergantung pada konteks historis, institusional, serta politis di masing-masing negara. Namun, secara umum desentralisasi dapat didefinisikan sebagai pemindahan tanggung jawab dalam perencanaan, pengambilan keputusan, pembangkitan serta pemanfaatan sumber daya serta kewenangan administratif dari pemerintah pusat ke:

1) unit-unit teritorial dari pemerintah pusat atau kementerian;

2) tingkat pemerintahan yang lebih rendah;

3) organisasi semi otonom;

4) badan otoritas regional;

5) organisasi non pemerintah atau organisasi yang bersifat sukarela

Rondinelli, Omar, Mills; menyebutkan bahwa secara umum desentralisasi merupakan transfer kewenangan dan kekuasaan dari tingkat pemerintahan yang tinggi ke tingkat yang lebih rendah dalam satu hierarki politisadministratif atau teritorial.

Definisi di atas banyak digunakan dalam literatur dan sebenarnya merupakan definisi dari desentralisasi demokratis atau desentralisasi politis dalam ilmu administrasi publik, dengan pihak yang menerima pelimpahan kekuasaan atau kewenangan merupakan representasi dari masyarakat lokal dan bertanggung jawab terhadap mereka. Desentralisasi ini dimaksudkan untuk meningkatkan partisipasi publik dalam pengambilan keputusan, sehingga dapat menyediakan pelayanan yang sesuai dengan kebutuhan dan aspirasi setempat, mengakomodasi perbedaan sosial, ekonomi dan lingkungan, serta meningkatkan pemerataan dalam penggunaan sumber daya publik.

Para ahli menyebutkan bahwa terdapat juga bentuk lain dari desentralisasi yaitu desentralisasi fiskal dan desentralisasi manajemen. Desentralisasi fiskal adalah pemindahan kekuasaan untuk mengumpulkan dan mengelola sumber daya finansial dan fiskal. Meskipun demikian, desentralisasi fiskal ini sering menjadi elemen yang tak terpisahkan dari desentralisasi demokratis. Desentralisasi manajemen digunakan pada saat situasi tanggung jawab manajerial

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di dalam suatu organisasi diserahkan kepada manajer unit sebagai agen desentralisasi yang terkecil. Model seperti ini telah diaplikasikan dalam sektor publik, dengan tanggung jawab untuk pelayanan dalam bidang tertentu diserahkan kepada manajer unit, misalnya untuk pelayanan kebersihan, katering, dan sebagainya. Hal ini bertujuan untuk meningkatkan efisiensi.

Penjabaran bentuk-bentuk desentralisasi yang sering digunakan dalam literatur dilakukan melalui pendekatan administrasi publik yang dikemukakan pertama kali oleh Dennis Rondinelli dan G. Shabbir Cheema (1983 cit Bossert, 1998) untuk mengevaluasi proses desentralisasi di Negara berkembang. Fokusnya pada distribusi kewenangan dan tanggung jawab untuk pelayanan kesehatan di dalam struktur politik dan administratif nasional. Pendekatan ini diaplikasikan ke bidang desentralisasi kesehatan oleh Mills dkk (1990). Menurut teori ini terdapat empat bentuk desentralisasi yaitu:

1. Dekonsentrasi

Pemindahan sebagian kewenangan dari pemerintah pusat ke kantor-kantor daerah secara administratif. Kantor-kantor daerah tersebut mempunyai tugas-tugas administrative yang jelas dan derajat kewenangan tersendiri, tetapi mereka mempunyai tanggung jawab utama ke pemerintah pusat.

2. Devolusi

Pemindahan kekuasaan secara legal ke badan politis lokal (pemerintah daerah) yang dalam beberapa fungsi benar-benar independen dari pemerintah pusat. Pemerintah lokal ini jarang benar-benar mempunyai otonomi total, namun mereka independen dari pemerintah nasional dalam beberapa area tanggung jawab misalnya pencarian sumber daya.

3. Delegasi

Pemindahan tanggung jawab manajerial untuk tugas-tugas tertentu ke organisasiorganisasi yang berada di luar struktur pemerintah pusat dan hanya secara tidak langsung dikontrol oleh pemerintah pusat (organisasi-organisasi ini sering disebut organisasi parastatal). Sistem pendanaan atau manajerial bervariasi, tetapi keputusan eksekutif tetap berada di tangan organisasi.

4. Privatisasi

Pemindahan tugas-tugas pengelolaan atau fungsi kepemerintahan ke organisasiorganisasi sukarela atau perusahaan swasta for profit maupun nonprofit. Dalam praktiknya, tidak ada negara yang hanya menerapkan satu macam desentralisasi secara murni karena biasanya beberapa elemen dari bentuk-bentuk desentralisasi tersebut diimplementasikan pada saat yang sama. Misalnya, devolusi ke pemerintah lokal digabung dengan delegasi ke dewan rumah sakit disertai dengan peningkatan peran swasta.

Dekonsentrasi merupakan bentuk desentralisasi yang paling ringan. Bentuk desentralisasi ini sering disebut desentralisasi administratif. Beberapa ahli menyebutkan bahwa privatisasi bukanlah bentuk desentralisasi, sebab pihak yang menerima transfer kekuasaan bukanlah pihak yang secara formal berada pada tingkat yang lebih rendah dari pihak yang melimpahkan kekuasaan.

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Dalam perkembangannya, analisis desentralisasi kesehatan dengan hanya menggunakan pendekatan administrasi publik seperti di atas ternyata tidaklah cukup untuk menjabarkan proses implementasi desentralisasi serta implikasinya. Hal ini karena teori ini hanya menjelaskan tingkat dan bentuk kepemerintahan yang melimpahkan kewenangan dan pihak yang menerima transfer tersebut. Teori ini tidak memadai untuk menganalisis fungsi-fungsi dan tugas yang dilimpahkan dari tingkat yang lebih tinggi ke tingkat yang lebih rendah. Beberapa teori lain sempat muncul ke permukaan, misalnya pendekatan local fiscal choice dan teori social capital.

Teori local fiscal choice digunakan oleh ahli ekonomi untuk menganalisis keputusan dan pilihan yang dibuat oleh pemerintah daerah dalam penggunaan sumber daya lokal serta transfer dana dari tingkat kepemerintahan yang lain (intergovernmental transfer). Teori ini banyak digunakan di negara federal. Pemerintah Negara bagian mempunyai otoritas secara konstitusional dan sangat mandiri dalam hal pembangkitan sumber daya lokal (misalnya pajak). Penggunaan sumber daya lokal secara efisien oleh pemerintah merupakan isu penting dalam sistem Negara federal karena sangat berperan dalam pemilihan umum untuk memenangkan suara dari para pemilih dan pembayar pajak. Untuk menganalisis desentralisasi kesehatan terlebih lagi di Negara berkembang, teori ini kurang sesuai. Di samping karena pengelolaan sumber daya lokal masih belum sepenuhnya ditangani oleh pemerintah daerah, isu kesehatan juga belum merupakan hal yang dianggap penting dalam pemilihan umum.

Teori social capital digunakan oleh Putnam dkk. (1993 cit Bossert, 1998) yang meneliti mengapa pemerintah daerah di beberapa area mempunyai kinerja institusional yang lebih baik dibanding pemerintah di area yang lain. Putnam mengemukakan bahwa kuncinya adalah pada keberadaan organisasi sipil (organisasi sukarela seperti kelompok paduan suara, klub sepakbola) yang memperkaya pengalaman sosial pada populasi setempat, yang disebut social capital. Pengalaman sosial ini akan mempererat kerjasama dan kepercayaan antarpenduduk, sehingga proses desentralisasi tidak banyak menemui hambatan. Secara formal, teori ini sulit diaplikasikan untuk menganalisis desentralisasi kesehatan karena mengabaikan faktor-faktor lain seperti bentuk dan sistem organisasi pelayanan kesehatan serta kebijakan kesehatan yang berlaku.

TINJAUAN SEJARAH

Dalam dua dekade terakhir, telah banyak negara yang melaksanakan desentralisasi dengan latar belakang yang berbeda. Hampir semua negara maju yang tergabung dalam Organization for Economic Cooperation and Development (OECD) telah menjadi lebih terdesentralisir, dengan perkecualian Inggris12. Penerapan konsep desentralisasi ini sebagian besar terjadi sebagai respon terhadap tekanan politik dan perubahan situasi ekonomi. Di negara-negara Eropa Timur dan Tengah yang sebagian dikuasai oleh paham komunisme beberapa dekade yang lalu, otonomi lokal menjadi tuntutan yang mendasar dalam reformasi politik. Sementara itu di negara-negara Amerika Latin yang sebelumnya diperintah oleh rezim politik, desentralisasi menjadi elemen mendasar dalam proses demokrasi dan melibatkan masyarakat secara aktif dalam pembangunan.

Daerah juga menuntut akan adanya otonomi local yang lebih besar. Sebagian negara berkembang melaksanakan desentralisasi dengan tujuan untuk meningkatkan pelayanan

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publik yang lebih merata dan berkualitas atau sebagai cara untuk mengurangi beban ekonomi dan administrasi di pusat sehingga akan lebih efisien. Tidak jarang hal ini terjadi atas dorongan dari pihak donor asing. Akibatnya desentralisasi hanya menjadi reformasi administratif yang bersifat top-down. Di Afrika, sejarah kolonialisme sangat mempengaruhi proses desentralisasi. Pemerintah kolonial tidak menghendaki desentralisasi, namun pengaruh sistem pemerintahan di negara asal tetap berpengaruh di dalam negara yang mereka jajah.

Sebagai contoh, negara-negara anglophone seperti Uganda dan Zambia mempunyai sistem dekonsentrasi yang lebih baik dibanding negaranegara francophone, karena pada saat itu Inggris lebih terdesentralisir dibanding Perancis.

Para ahli menyebutkan bahwa ada dua fase utama dalam penerapan konsep desentralisasi di negara berkembang. Pada dekade 1950-an dan awal 1960-an, desentralisasi dalam bentuk pemerintahan daerah dicetuskan oleh pemerintah kolonial sebagai salah satu elemen dalam struktur negara demokrasi yang independen. Tujuan lainnya, sebagai sarana pendidikan politik bagi masyarakat dan sebagai mekanisme untuk memberikan tanggung jawab kepada daerah dalam sektor pelayanan. Struktur yang dibentuk pada saat itu didasarkan pada model pemerintahan daerah di Inggris atau Perancis, walaupun masih terbatas dalam hal kekuasaan dan fungsi pemerintah daerah. Pemerintah daerah hanya berfungsi sebagai agen pemerintah pusat. Namun demikian, proklamasi kemerdekaan di berbagai negara berkembang menyebabkan semakin pentingnya rasa persatuan nasional sehingga untuk sementara usaha menerapkan desentralisasi menjadi berkurang16. Pemerintah yang berkuasa setelah masa kolonial berakhir cenderung tidak menyukai konsep desentralisasi.

Pada dekade 1970-an dan 1980-an, minat terhadap kebijakan desentralisasi muncul kembali. Desentralisasi telah dicoba diterapkan di akhir era 1970-an dan berlanjut selama dekade selanjutnya, yaitu era 1980-an18. Alasan yang mendorong diterapkannya desentralisasi ini berbeda-beda di tiap negara. Di beberapa negara berkembang seperti di Afrika, pemerintah membagi sebagian kontrol kekuasaan dan pengambilan keputusan kepada organisasi di daerah. Dengan demikian, desentralisasi digalakkan dari pusat dan bukan berasal dari perifer. Namun, di beberapa Negara khususnya di daerah Pasifik, desentralisasi terjadi karena tekanan berbagai kelompok lokal atau regional agar memperoleh otonomi yang lebih besar.

Sejarah desentralisasi kesehatan juga mengikuti perkembangan desentralisasi dalam kepemerintahan. Secara global, selama tahun 1950-an dan 1960-an, negara mempunyai peranan sentral yang kuat dalam pembangunan. Di berbagai negara berkembang terutama di Afrika dan Asia Tenggara, pelayanan kesehatan masyarakat tumbuh sebagai respon terhadap gagasan pemerintah pusat untuk menyediakan pelayanan kesehatan di area pedesaan dan perkotaan. Pemerintah daerah tidak banyak berperan dalam hal ini. Pengambilan keputusan dalam hal pelayanan kesehatan pada saat itu sangat bersifat sentralistik, sehingga daerah mempunyai kemampuan administratif serta manajerial yang rendah. Namun demikian, pemerintah tidak memonopoli dalam kepemilikan pelayanan kesehatan. Banyak terdapat pelayanan kesehatan swasta atau pelayanan kesehatan yang bersifat sukarela, terutama yang dirintis oleh lembaga swadaya masyarakat dan keagamaan.

Pada masa itu, perumusan kebijakan kesehatan banyak dipengaruhi oleh kalangan elit medis. Namun kemudian dominasi paradigm medis (misalnya kebijakan yang terlalu terfokus pada obat dan pelayanan kesehatan kuratif) dalam kebijakan kesehatan mulai dipertanyakan dari segi epidemiologi dan ekonomis. Kemudian, deklarasi Alma Ata tahun 1978 yang berfokus pada peningkatan peran pelayanan kesehatan primer ternyata mampu memicu proses

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reformasi, sehingga arena kebijakan kesehatan bertambah dengan melibatkan kelompok selain profesi medis.

Konsep desentralisasi mulai disadari sebagai elemen kunci dari pelayanan kesehatan primer. Di tahun 1980-an, gagasan neoliberal mulai mendominasi. Negara yang terlalu tersentralisasi dianggap mengalami kegagalan. Bank Dunia dan IMF pun memulai structural adjustment program. Dalam program ini, pihak donor bersedia mengucurkan bantuan dengan persyaratan khusus untuk meningkatkan efisiensi dan kualitas pelayanan publik termasuk di bidang kesehatan, misalnya seperti mengurangi pegawai pemerintah pusat, penerapan keharusan bagi pasien untuk membayar (user fee) dan dilonggarkannya peraturan bagi swasta. Kebijakan-kebijakan ini diterapkan untuk mengurangi kontrol oleh pemerintah pusat, memberikan keleluasaan bagi manajemen lokal, dan memperkuat akuntabilitas pemerintah terhadap masyarakat. Dibandingkan dengan dekade-dekade sebelumnya, kebijakan kesehatan menjadi agenda penting dalam perbincangan politis. Pada era 1990-an, lebih dari 25 negara di Afrika telah berada dalam proses implementasi desentralisasi, meskipun belum sepenuhnya. Desentralisasi yang diterapkan di Negara berkembang pada era sebelum 1990-an lebih merupakan bentuk dekonsentrasi, sebab tidak ada pemerintah daerah yang independen yang bertanggung jawab terhadap masyarakat dan lembaga lokal dan kantor perwakilan pemerintah pusat seperti kantor wilayah kementerian di daerah lebih merupakan sarana untuk mempermudah administrasi pelayanan dan tidak dapat mengambil keputusan sendiri. Hal ini banyak terjadi di negara-negara Asia Timur dan Tenggara, dan sampai saat ini masih dilaksanakan di negaranegara Eropa Timur24. Setelah era 1990-an, bentuk reformasi yang dipilih oleh sebagian besar negara berkembang adalah desentralisasi demokratis. Bentuk ini dianggap yang paling ideal. Pada awalnya, desentralisasi dikembangkan hanya sebagai reformasi administratif yang akan meningkatkan efisiensi dan kualitas pelayanan. Namun dalam perkembangannya dikemukakan bahwa keuntungan lain dari desentralisasi adalah: 1) perhatian terfokus pada masyarakat dan partisipasi masyarakat meningkat sehingga kebutuhan masyarakat akan terpenuhi secara lebih baik, 2) meningkatkan kemerataan dalam pelayanan kesehatan serta kebebasan individu, 3) meningkatkan program pembangunan dan cakupan pelayanan kesehatan nasional, 4) mempererat kerjasama intersektoral, 5) manajemen menjadi lebih fleksibel, mudah beradaptasi dan responsif, 6) meningkatkan akuntabilitas, transparansi, dan memperkuat otonomi lokal.

Namun demikian, ada beberapa hal yang dapat menyebabkan desentralisasi tidak berjalan dengan baik dan membawa implikasi negatif. Pertama, kurangnya kontrol dan koordinasi antara tingkat kepemerintahan dan di dalam kepemerintahan itu. Kedua, kompetensi personal mungkin mengalami penurunan atau tidak mampu mencapai tujuan akibat kurangnya supervisi dan pembangunan kapasitas. Ketiga, kemampuan pemerintah daerah untuk berkreativitas mungkin terbatas. Jika kemampuan pemerintah daerah sangat berbeda antardaerah, maka dapat terjadi kesenjangan antardaerah (dalam konteks kesehatan, mungkin adanya kesenjangan status kesehatan atau usia harapan hidup antar daerah). Keempat, dapat terjadi konflik akibat kurang jelasnya pembagian kewenangan dan ambisi pribadi. Di negara maju, ada perbedaan konteks dengan negara berkembang dalam masalah desentralisasi. Secara historis, pemerintah daerah di negara-negara maju telah berkembang. Sebagian besar pemerintah daerah mampu menyediakan pelayanan masyarakat dengan biaya swadana. Namun demikian, ada kecenderungan dari pemerintah pusat untuk membatasi pemerintah daerah. Hal ini untuk meningkatkan pemerataan dalam pelayanan masyarakat ke seluruh lapisan masyarakat dan area geografis serta mengatasi resesi ekonomi. Oleh karena itu,

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pengalaman negara maju dalam desentralisasi mungkin kurang sesuai untuk diaplikasikan pada negara berkembang. Relevansinya sangat tergantung pada masalah struktural pada masing-masing negara. Selain itu juga terdapat pengaruh masalah demografi dan epidemiologi, efisiensi dan efektivitas institusi sektor kesehatan, ketersediaan sumber daya, akses ke pelayanan kesehatan, skenario politik, kondisi ekonomi, tekanan internasional serta kebebasan dalam negeri.

SEJARAH DESENTRALISASI DI INDONESIA

Di Indonesia, desentralisasi telah menjadi tema utama selama dua dekade terakhir. Namun latar belakang desentralisasi di Indonesia sedikit berbeda dengan negara berkembang yang lain. Indonesia merupakan suatu negara dengan keberagaman etnis, kultur, geografis, dan sebagainya. Jika tidak diakomodasi dengan baik dapat menimbulkan ketidak puasan dan perpecahan. Hal ini merupakan suatu tuntutan tersendiri akan desentralisasi28. Pelaksanaan desentralisasi juga diakselerasi dengan timbulnya krisis politik dan ekonomi yang pada akhirnya menumbangkan presiden yang berkuasa pada saat itu dan mengangkat kembali masalah desentralisasi yang sebenarnya telah diajukan oleh para pengamat sejak tahun 1990-an.

Namun, desentralisasi yang baru dimulai pada tahun 2001 ini sebenarnya bukanlah usaha pertama untuk menerapkan desentralisasi. Sejak zaman kolonial, telah dilakukan berbagai usaha untuk melakukan desentralisasi, namun tidak ada yang berhasil. Pada tahun 1905 terbentuklah kotamadia yang pertama, diikuti dengan terbentuknya kabupaten yang pertama pada tahun 1910. Selanjutnya, provinsi yang pertama terbentuk di Pulau Jawa pada tahun 1920-an.

Setelah proklamasi kemerdekaan, dikeluarkanlah UU pertama yaitu UU No. 1 Tahun 1945 yang mengatur tentang Otonomi Regional. Otonomi regional dan hak-hak daerah ini juga disebut di dalam Pasal 18 UUD. 1945. Namun demikian, pihak Belanda masih tidak ingin melepaskan Indonesia sebagai negara jajahannya dan berusaha membentuk beberapa republik boneka di pulaupulau luar Jawa di bawah payung Kerajaan Belanda. Republik Indonesia dianggap merupakan bagian dari negara Republik Kesatuan Indonesia yang menjadi sebuah negara federal.

Republik Kesatuan ini tidak berumur panjang, hanya sekitar satu tahun dan pada tahun 1950 Indonesia kembali pada bentuk Negara kesatuan. Selanjutnya otonomi regional kembali dicetuskan kembali melalui UU No. 1 Tahun 1957. Dalam UU ini, disebutkan bahwa dewan lokal berhak untuk menunjuk pimpinan pemerintah daerah, yang sebelumnya ditunjuk oleh pemerintah pusat. Namun, setelah pecahnya pemberontakan di Sumatera, Sulawesi, dan Jawa Barat, pelaksanaan UU ini kembali tertunda. UU ini akhirnya diabolisi melalui Keputusan Presiden No. 6 Tahun 1959 yang menyebutkan bahwa pimpinan pemerintah daerah ditunjuk oleh pemerintah pusat. Beberapa aspek desentralisasi kembali disebutkan dalam UUNo. 18 Tahun 1965 walaupun tidak secara tegas.

Pada masa kekuasaan presiden kedua RI, Soeharto yang berlangsung dari tahun 1965 sampai 1999 (orde baru), sistem kepemerintahan di Indonesia sangatlah tersentralisir, meskipun desentralisasi telah tercetus dalam beberapa UU yang dikeluarkan pada masa itu. Masalah otonomi regional dipertegas melalui UUNo.5 Tahun 1974, yang beberapa aspeknya baru mulai dilaksanakan pada tahun 1992. Dalam UU ini disebutkan bahwa pemerintah pusat dapat melimpahkan semua tugas dan fungsi kepada pemerintah daerah yang otonom kecuali

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dalam bidang pertahanan dan keamanan, hukum, urusan luar negeri, keuangan, kewajiban-kewajiban yang dilaksanakan oleh pimpinan pemerintah daerah serta beberapa fungsi yang lebih baik jika dilaksanakan oleh pemerintah pusat. Di samping itu, aktivitas kementerian akan didekonsentrasikan kepada kantor regional kementerian pusat yang ada di daerah. Namun demikian, UU ini tidak pernah diterapkan secara penuh. Disebutkan juga bahwa daerah harus membuktikan bahwa mereka siap untuk melaksanakan fungsi mereka yang baru, dan hal ini akan dinilai oleh pusat.

Namun, implementasi desentralisasi pada saat itu tidak efektif. Secara formal, terdapat tiga tingkat kepemerintahan yaitu pemerintah pusat, 27 provinsi, serta 333 kabupaten. Dalam praktiiknya, pemerintah pusat mendominasi di semua tingkat, terutama dalam hal perekrutan sumber daya manusia serta penggunaan anggaran. Mekanisme alokasi anggaran dari pusat ke daerah melalui Instruksi Presiden (Inpres) yang bertele-tele telah membuat daerah lambat berkembang dan cenderung tergantung pada bantuan oleh pusat.

Disebutkan bahwa desentralisasi yang dilaksanakan pada era Soeharto lebih merupakan bentuk dekonsentrasi dibandingkan desentralisasi. UU No. 5 Tahun 1974 diujicobakan tahun 1996 pada 26 kabupaten sebagai daerah percontohan, namun banyak kesulitan yang ditemui karena pusat tidak memberikan dukungan dan fasilitas kepada daerah untuk melaksanakan fungsi yang baru. Tahun 1997, uji coba ini terhenti oleh adanya krisis moneter. Tujuan desentralisasi sebenarnya disebutkan kembali secara jelas dalam Rencana Pembangunan Lima Tahun V (Repelita V, 1989- 1994) dan dinyatakan kembali dalam Repelita VI. Akan tetapi hal ini hanya merupakan retorika karena tidak pernah diwujudkan dalam konsep yang nyata.

Pada medio tahun 1997, Asia dilanda oleh krisis ekonomi termasuk Indonesia yang mengalami dampak paling parah dibanding Negara Asia Tenggara lainnya. Krisis ini menimbulkan ketidakstabilan politis dan ekonomi, yang pada akhirnya menumbangkan kekuasaan Soeharto pada bulan Mei 1998. BJ Habibie, wakil presiden pada saat itu kemudian naik menjadi presiden. Untuk merengkuh simpati masyarakat, dia menjadikan reformasi menjadi isu utama dalam masa kepresidenannya. Salah satunya dengan penerapan desentralisasi secara penuh. Selain untuk meningkatkan efisiensi dan kinerja pemerintah daerah, hal ini juga bertujuan untuk mencegah pemisahan beberapa provinsi dari negara. Beberapa provinsi telah lama menuntut kebebasan dalam hal politis dan ekonomi, terutama provinsi-provinsi yang rawan konflik seperti Daerah Istimewa Aceh dan Timor Timur serta provinsi-provinsi yang kaya akan sumber daya seperti Kalimantan Timur dan Irian Jaya (sekarang Papua). Dikhawatirkan ketidakpuasan ini dapat menimbulkan tuntutan untuk membentuk negara federal. Oleh karena itu, desentralisasi dianggap sebagai bentuk reformasi yang terbaik.

Desentralisasi menjadi kebijakan nasional hanya dalam waktu 5 bulan setelah Habibie diangkat menjadi presiden. Pada bulan November 1998, sidang khusus MPR menetapkan tentang implementasi desentralisasi di Indonesia (Tap MPR No. 15). UU mengenai desentrali-sasi kemudian mulai dirumuskan antara bulan Desember 1998 s.d. Januari 1999. Lima bulan sesudahnya, UU No. 22 Tahun 1999 dan UU No. 25 Tahun 1999 disetujui oleh parlemen, masingmasing pada tanggal 7 dan 9 Mei 1999. UU No. 22 Tahun 1999 mengatur tentang pemerintah daerah, sedangkan UU No. 25 Tahun 1999 adalah mengenai keseimbangan Fiskal antara Pemerintah Pusat dan Pemerintah Daerah. Kedua UU ini merupakan dasar untuk menerapkan otonomi regional dan diikuti oleh keluarnya beberapa peraturan pemerintah untuk secara lebih jelas menjabarkan tentang proses pelaksanaan desentralisasi.

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Selanjutnya, dalam sidang tahunan MPR bulan Agustus 2000 dikeluarkanlah amandemen UU Dasar 45, dengan revisi dan dua tambahan pada Pasal 18 UUD 1945 sebagai dasar konstitusi untuk pelaksanaan otonomi regional dan desentralisasi secara luas. Sebelum amandemen tersebut diajukan, pasal ini hanya secara singkat menyebutkan tentang pemerintah daerah dan otonomi. Pada masa kepresidenan Abdurrachman Wahid, proses desentralisasi semakin dipercepat dengan dibentuknya posisi Menteri Negara Urusan Otonomi Daerah. Pemerintah pusat juga bermaksud untuk menyelesaikan pengaturan legislatif ini pada akhir tahun 2000 sehingga proses desentralisasi dapat dimulai pada bulan Januari 2001. Namun sampai bulan Maret 2001 pengaturan legislatif tersebut masih belum selesai.

Dengan pemberlakuan dua UU tersebut di atas, maka ada tiga bentuk desentralisasi yang berlaku di Indonesia yaitu: 1) devolusi, yaitu dalam bentuk penyerahan otonomi dan kewenangan dari pemerintah pusat kepada pemerintah daerah yaitu kabupaten termasuk pengaturan anggaran dalam semua bidang kecuali dalam bidang kebijakan internasional, pertahanan dan keamanan, hukum, fiskal dan moneter, serta keagamaan, 2) dekonsentrasi, yaitu pelimpahan kewenangan dari pemerintah pusat kepada pemerintah provinsi atau pembantu pemerintah pusat yang lain, 3) tugas pembantuan. Dengan demikian, hubungan antara kabupaten dan provinsi pada masa orde baru bersifat vertikal, pada masa desentralisasi bersifat horizontal. Keduanya berada pada posisi yang setara. Namun demikian, ada beberapa bidang yang otoritasnya masih dipegang oleh pemerintah provinsi. Di samping itu, kebijakan dekonsentrasi masih diperdebatkan dan ada kemungkinan akan diajukan suatu amandemen mengenai peranan provinsi.

Kantor wilayah dan kantor departemen yang merupakan agen lokal kementerian di daerah selanjutnya dihilangkan dan diganti dengan dinas provinsi yang bertanggung jawab terhadap pemerintah provinsi serta dinas kabupaten yang bertanggung jawab terhadap pemerintah daerah. Dengan demikian dalam bidang kesehatan saat ini terdapat tiga macam kesatuan administrative yaitu Depkes yang ada di pusat, dinas kesehatan provinsi yang ada di provinsi serta dinas kesehatan kabupaten atau kotamadia yang ada di kabupaten atau kotamadia. Personal yang ada di kantorkantor tersebut dialihkan posisinya menjadi pegawai pemerintah daerah.

Secara bertahap, proses desentralisasi di Indonesia dibagi menjadi tiga fase yaitu: 1) fase pengenalan (introductory phase, tahun 2001-2003). Pada fase ini, semua kabupaten diharapkan telah mulai menerapkan semua aspek desentralisasi seperti yang telah dijabarkan. Pemerintah pusat dan pemerintah lokal merencanakan dan melaksanakan program pembangunan kapasitas tanpa meninggalkan kesinambungan pemberian pelayanan pada masyarakat; 2) fase konsolidasi (2004-2007), proses desentralisasi sudah tidak bisa dikembalikan lagi ke sentralisasi. Dalam fase ini, reformasi dalam kepemerintahan dan fiscal tetap berlanjut, dan bantuan intensif pada pemerintah daerah yang masih membutuhkan akan terus berlanjut. Pada akhir fase ini, diharapkan telah terbentuk organisasi atau dewan lokal; serta 3) fase stabilisasi (dimulai tahun 2007). Selama fase ini, pemerintah pusat serta pemerintah daerah atau organisasi lokal telah mencapai kematangan. Namun demikian pembangunan kapasitas untuk memperkuat pemerintah daerah akan tetap terus dilangsungkan.

Segall (2003) mengungkapkan bahwa kebijakan desentralisasi tampaknya akan membawa dampak positif terhadap sebagian besar sistem kesehatan. Meskipun demikian, bentuk desentralisasi harus dipilih dengan hati-hati dan implementasinya harus bertahap dengan persiapan yang terencana. Wang dkk (2002) serta Martineau & Buchan (2001) menyebutkan

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bahwa salah satu elemen kunci dalam kesuksesan desentralisasi terletak pada para aktor pelaksana, terutama pada kemampuan mereka untuk menghadapi perubahan (managing change).

Desentralisasi dapat menimbulkan konflik di antara tenaga kesehatan, manajer maupun pengambil keputusan karena adanya perubahan dalam hal wewenang, tanggung jawab, serta tugas-tugas yang harus dilaksanakan. Hal ini terutama terjadi di negara-negara yang melaksanakan desentralisasi dalam waktu yang relatif cepat, tidak terkecuali di Indonesia.

BATASAN SENTRALISASI DAN DESENTRALISASI

a. Sentralisasi dalam lintas definisi

Tak kenal maka tak tahu mungkin ini lah sebuah ungkapan yang mendorong berbagai kalangan mengapa belajar dan menggali berbagai definisi yang muncul dari berbagai istilah yang dilahirkan dari berbagai Disiplin ilmu sebagai konsekuensi dari perkembangan sebuah peradaban kehidupan manusia

Ketika kita berbicara Sentralisasi sebuah pertanyaan yang akan muncul adalah Apa yang dimaksud dengan Sentralisasi ?

Ketika kita berbicara tentang definisi kita kan beranjak dari aspek etimologi dan terminology

Sentralisasi Secara etimologi

Sentralisasi berasal dari bahasa inggris yang