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An Overview of the International Health Regulations

An Overview of the International Health Regulations And the Pandemic Influenza Preparedness Framework Professor Allyn Taylor Georgetown Law. Learning Objectives. At the end of this session, you will:

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An Overview of the International Health Regulations

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  1. An Overview of the International Health Regulations And the Pandemic Influenza Preparedness Framework Professor Allyn Taylor Georgetown Law

  2. Learning Objectives At the end of this session, you will: • Have a broad understanding of the history of international efforts to control the global spread of infectious diseases; and • Have an understanding of the underlying rationale, structure and key provisions of IHR (2005), including: • Objective and scope • Significant obligations of States Parties • Major responsibilities of WHO • Have an understanding of the impact of the IHR on state practice and some of the major limitations of the IHR as a legal instrument. • Have a broad understanding of the 2011 Pandemic Influenza Preparedness (PIP) Framework and how this agreement may influence future implementation of IHR.

  3. Outline of the Lecture • Introduction • History of international cooperation to control the global spread of infectious diseases • The globalization of infectious diseases and the road to the IHR (2005) • Overview of IHR (2005) • Key obligations of States Parties under the IHR (2005) • Major responsibilities of WHO under the IHR (2005) • Conclusion of IHR and 2011 PIP Framework

  4. Introduction: History of International Efforts to Control the Global Spread of Infectious Diseases Trade in a Seaport of the Mediterranean About the Time of Marco Polo Source: Giclee Print, available at http://italophiles.com/marcopolo.htm (courtesy of allposters.com) (last visited Feb. 10, 2010). Venetian Trading Ships, 17th Century Source: Museo Correr, Venice / Erich Lessing / Art Resource, available at http://www.saudiaramcoworld.com/issue/200802/east.meets.west.in.venice.htm (last visited Feb. 10, 2010).

  5. History of International Efforts to Control the Global Spread of Infectious Diseases: Black Death Source: Decameron Web (a project of the Italian Studies Department’s Virtual Humanities Lab at Brown University), Trade Routes that Brought the Plague to Italy, available at http://www.brown.edu/Departments/Italian_Studies/dweb/images/plague/plague_routes.jpg (last visited Feb. 6, 2010) Etching by Paulus Furst of Nuremburg, Germany, 1956

  6. History of International Efforts: Smallpox spreads to the Americas in the 16th Century Aztec smallpox victims in the Sixteenth Century Source: Historia De Las Cosas de Nueva Espana, Volume 4, Book 12, Lam. cliii, plate 114. Peabody Museum of Archaeology and Ethnology, Harvard University. Mexican Emperor Montezuma II receiving Cortés and the Spanish in 1518. Source: Available at http://reformation.org/mexicans.html (last visited Feb. 10, 2010).

  7. History of International Efforts: 1918 Spanish Influenza

  8. History of International Organization for Infectious Disease Control In 1851, the first International Sanitary Conference is held in Paris to draft uniform quarantine measures for all Mediterranean ports In 1902, the International Sanitary Bureau of the Americas is formed In 1923, the Health Organization of the League of Nations is formed 1825 1850 1875 1900 1925 1950 In 1907, the Parisian L’Office International D’Hygiene Publique is established In 1838, the Conseil Supérieur de Santé (Superior Council of Health) of Constantinople is established to supervise the sanitary regulation of the Turkish port in order to prevent the spread of cholera between Asia to Europe In 1948, the World Health Organization is established

  9. History of International Organization for Infectious Disease Control: WHO and the International Health Regulations In 1969, WHO adopts the International Health Regulations In 2005, the new IHR are adopted In 1948, the World Health Organization (WHO) is established 1950 1960 1970 1980 1990 2000 In 1951, WHO adopts the International Sanitary Regulations In 1981, the IHR are amended to include only 3 diseases.

  10. The Road to the Adoption of the IHR (2005): The Globalization of Infectious Diseases

  11. The Road to the Adoption of the IHR (2005): Globalization of Infectious Diseases

  12. The Road to the Adoption of the New IHR (2005): Globalization Highlights Weaknesses of the Old IHR (1969) IHR (1969): • Applied directly to only 3 diseases (cholera, plague and yellow fever). • Emphasized sanitary conditions, services and procedures to be maintained at frontiers and borders. • Were routinely ignored by States Parties.

  13. The Road to the New IHR (2005): SARS and the Emergence of Global Health Security Concerns

  14. Overview of the IHR (2005): Legal Significance of WHO Regulations • IHR (2005) were adopted by World Health Assembly in May 2005 and entered into force in June 2007. • IHR (2005) were adopted pursuant WHO Constitution Article 21 regulatory authority. • Regulations automatically enter into force and are binding international law for all Member States, except those that notify the WHO Director-General. • National ratification is not required.

  15. Overview of IHR (2005): Basic Legal Characteristics • Global scope of IHR (2005): Today the Regulations are legally binding upon 194 states worldwide. • More countries are States Parties to the IHR (2005) than there are Members of the United Nations. • IHR (2005) are legally binding upon the entire national government: • The IHR (2005) are legal obligation of the entire national government, not just one ministry or sub-division. • States Parties to IHR (2005) have a legal obligation to implement all commitments contained in the Regulations: • IHR commitments are subject to immediate implementation. • One exception: there is a five year phase-in until 2012 for technical core capacities development. (Annex 1)

  16. Overview of IHR (2005): Underlying Purpose and Paradigm Shift The purpose and scope of these Regulations is to prevent, protect against, control, and provide public health responses to the international spread of disease in ways commensurate with and restricted to public health risks, while avoiding unnecessary interference with international traffic and trade. (Article 2)

  17. Overview of the IHR (2005): Revolutionary Approach to Global Infectious Disease Control

  18. Overview of the IHR (2005): Broad Scope Event: “a manifestation of disease or an occurrence that creates the potential for disease.” Disease: “an Illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans.” Event may be: • Biological/infectious, chemical, radio-nuclear; • Known or unknown, emerging or re-emerging; or • Transmissible by vectors, persons, goods, environment, etc.

  19. Overview of the IHR (2005): State Parties’ Obligations The IHR (2005) establish 6 main tasks that States Parties must undertake: • Establish a National IHR focal point which is available all of the time for official information exchange with WHO; • Provide a range of information to WHO, including the occurrence of events which may constitute a Public Health Emergency of International Concern (PHEIC); • Develop and ensure certain minimum core national surveillance and response capacities; • Implement point of entry provisions; • Limit the imposition of excessive measures on international trade and protect human rights; and • Comply with duties of international cooperation.

  20. (1) National Obligations under IHR (2005): National IHR Focal Points • States Parties must designate or establish a National IHR Focal Point that is available at all times for communication with WHO IHR Contact Points. (Article 4.1 and 4.2) • The National IHR Focal Point is also responsible for disseminating information nationally. (Article 4.2) The Focal Point must ensure coordination among all relevant ministries and sectors of the State Party government. • The National IHR Focal Point is designed to facilitate rapid sharing of surveillance information. By linking national IHR focal points through WHO, IHR (2005) establishes a global network that improves the real-time flow of surveillance information and responses from the local to the global level and also among States Parties.

  21. States Parties have a duty to notify potential PHEIC to WHO in a timely manner. (2) National Obligations Under IHR (2005): Notification and Public Health Emergencies of International Concern (PHEIC)

  22. Is an Event Notifiable as a Potential Public Health Emergency of International Concern? Decision Instrument Criteria for potentially notifiable events: (1) Is the public health impact of the event serious? (2) Is the event unusual or unexpected? (3) Is there a significant risk of international spread? (4) Is there a significant risk of international travel or trade restrictions? If the answer is "yes" to any two of these questions, States Parties are required to notify the event within 24 hours to WHO. WHO makes the final determination if a PHEIC exists.

  23. IHR (2005) Reporting Duties: Timeliness and Scope • National-level assessments of events, to determine if they are potential PHEICs, with the decision instrument must be completed within 48 hours. States Parties must report potential PHEIC to WHO within 24 hours of assessment and respond to requests for verification from WHO within 24 hours. (Annex 1, Articles 6.1 and 10.2) • Following reporting of an event that may constitute a PHEIC, States Parties must continue to communicate to WHO timely and detailed information on the event and health measures (e.g., quarantine) that are implemented in response. WHO must also be informed within 48 hours of the implementation of additional health measures that interfere with international trade and travel, unless the WHO Director-General has recommended such measures. (Articles 6.1, 43.3) • States Parties should consult with WHO on appropriate health measures for events that do not meet the criteria for formal notification, but may still be of public health relevance. (Article 8) • States Parties, as far as is practicable, must inform WHO within 24 hours of receipt of evidence of any public health risk identified outside their territories that may cause international disease spread, as manifested by exported or imported human cases, through vectors that may carry infection or contamination, or contaminated goods. (Article 9.2) Image Source: http://www.libforall.org/photos/Global%20Network%20Web%20Image.02.JPG

  24. (3) National Obligations under IHR (2005): Surveillance and Response Capacities (Annex 1) States Parties must strengthen and maintain the capacity to rapidly detect, report and respond to public health risks and PHEIC. Source: M. Baker & D. Fidler, Global Public Health Surveilliance under New International Health Regulations 12 (7) Emerging Infectious Diseases (2006)

  25. (4) National Obligations Under IHR (2005): Provisions Related to Points of Entry • Routine and emergency public health measures and required health documents at points of entry are necessary to: (i) ensure that conveyances and facilities at airports, ports and ground crossings are kept free from sources of infection; and (ii) mitigate the potential for international spread of disease. • States Parties are required to designate airports and ports and may designate certain ground crossings to develop the capacities provided for in Annex 1 of the IHR (2005). • States Parties are required to identify the competent authorities to carry out: (i) development of core capacities at designated points of entry; and (ii) implementation at points of entry of appropriate levels of hygiene and sanitation, including effective vector, rodent and environment control measures and procedures. • WHO has developed an assessment tool to assist countries in assessing core capacities at designated airports, ports and ground crossings.

  26. (5) National Obligations Under IHR (2005): Limitation of Excessive Measures on Trade, Travelers and Persons • Discouraging States Parties from implementing "excessive” measures is a crucial aspect of the IHR (2005). Unjustified health measures have important economic and human rights implications, and undermine national implementation of the IHR (2005). • The IHR (2005) recognizes that states have, in accordance with international law , the sovereign right to legislate and implement legislation in pursuance of their health policies. However, the IHR incorporate a variety of mechanisms to discourage unjustified imposition of excessive measures on trade, travel and persons. • In general, the Regulations do not preclude states from implementing health measures, in accordance with international law, in response to public health risks that achieve the same or greater protection of WHO recommendations as long as the measures meet requirements of principle (i.e., based on scientific principles, not more restrictive of international traffic and nor more intrusive or persons than reasonably available alternatives) and process (notifications to WHO) (Article 43).

  27. Limitations on Imposition of Excessive Measures: Protection of Human Rights under IHR (2005) • The first principle of the IHR (2005) requires full respect for dignity, human rights and fundamental freedoms of persons. (Article 3.1) • The IHR (2005) include multiple provisions that are protective of the interests of individuals who may be subject to public health measures. Such provisions include: • Health measures relating to entry of travelers within the territory of state (e.g., medical exams, vaccination or other prophylaxis) (Article 31); • Treatment of travelers (respect for gender, socio-cultural, ethnic and religious concerns as well as provision of basic conditions, including: adequate food, water and accommodation) (Article 32); and • Treatment of personal data. (Article 45) Source: denvergov.org

  28. (6) National Obligations Under IHR (2005): International Cooperation and Assistance States Parties are required to collaborate with each other, to the extent possible, in: • Detecting, assessing and responding to events under the IHR (2005); • Providing or facilitating technical cooperation and logistical support; • Mobilizing financial resources to facilitate implementation of IHR (2005); and • Formulating proposed laws and other legal and administrative provisions for the implementation of the IHR (2005). (Article 44)

  29. WHO’s Major Responsibilities Under IHR (2005) • Coordinate global surveillance and assessment of significant public health risks and disseminate public health information to States Parties. • Determine whether particular events constitute a PHEIC (with advice from external experts). • Develop and recommend measures for use by States Parties during a PHEIC (after consultation with external experts). • Provide direct support to States Parties by: • supporting states in assessing and strengthening their core public health capacities for surveillance and response and at designated ports of entry; • mobilizing financial resources to support developing countries in strengthening such core public health capacities; and • providing technical assistance to states in their responses to PHEIC. • Monitor and evaluate implementation of IHR (2005) and adopt technical guidelines to address evolving needs.

  30. WHO to help countries managing events • WHO Temporary and Standing Recommendations • WHO Regional Alert and Response teams • Train countries’ NFPs and WHO contact points for event management • New WHO Global Event Management System • Expand Global Outbreak and Alert Response Network GOARN and other specialized and regional support networks • Develop new tools and standard operating procedures

  31. Event Intelligence Official, State sources Verification Risk Assessment WHO HQ, Regional & Country Offices, Collaborators and experts Response Global Outbreak Alert and Response Network WHO system of Global Outbreak Alert and Response Network GOARN Operations

  32. IHR (2005) – A Triumph of Global Health Governance Over State Sovereignty? Lessons from H1N1 (2009)

  33. May 2011 Report of the Review Committee on the Functioning of the IHR in Relation to Pandemic (H1N1) 2009: The Limitations of Global Governance • The IHR helped make the world better prepared to cope with public – health emergencies. • The core national and local capacities called for in the IHR are not yet fully operational and are not now on a path to timely implementation worldwide. • The world is ill-prepared to respond to a severe influenza pandemic or to any similarly global, sustained and threatening public-health emergency. [Source, Report of the Review Committee on the Functioning of the IHR (2005) and on Pandemic Influenza A (H1N1) 2009, WHA A64/10 (May 2011)]

  34. IHR (2005) and the Underdevelopment of Core Surveillance Capacities: The Limitations of Global Health Governance • 66% (128) State Parties responded to a recent questionnaire on their progress: • Only 58% of respondents have developed national plans to meet core capacity requirements; and • Only 10% of respondents have fully established capacities as envisaged by the IHR. • Anecdotally, WHO officials report that WHO does not receive timely notifications of potential PHEIC: • On average, WHO receives 2-3 reports of potential PHEIC per month.

  35. Global Influenza Surveillance Network (GISN) • WHO's Global Influenza Surveillance and Response System • 136 National Influenza Centers (NICs) • 6 WHO Collaborating Centers (CCs) and 4 Essential Regulatory Laboratories (ERLs) • 12 WHO H5 Reference Laboratories (ad hoc internal network) Source: WHO Global Health Observatory Map Gallery

  36. Indonesia, GISN and Virus Sharing • In December 2006 Indonesia announces that it will no longer share virus samples of H5N1 in an effort to force a fundamental restructuring of GISN Source: WHO Global Health Observatory Map Gallery

  37. Market-Based Structural Challenges to Equitable Access to Vaccines • Lack of demand for seasonal influenza vaccine limits overall vaccine production capacity • For decades the only major purchasers of seasonal influenza vaccines have generally been high-income countries led by the United States, the United Kingdom, Australia, Japan, France and Canada • Consequence is that bulk of manufacturing capacity is in 9 countries. • Many high-income nations have secured advanced purchase agreements with vaccine producers • Consequence: LMICS do not have access until needs of high-income countries met and well after pandemic has commenced • Overcoming this hurdle requires rescinding and renegotiating agreements contrary to interests of high-income countries • Existing vaccine production relies upon a diverse array of pubic and private actors with considerably different interests and priorities: • 34 companies in 19 countries control the world’s entire influenza production capacity (2009) • As of 2011 total annual capacity is 876 million doses with 7 largest companies controlling 64% of the stock • WHO has launched a new plan to increase supply in developing countries, but progress to expand capacity and production slow.

  38. WHO Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits (2011) • Objective (Art. 2) to improve pandemic preparedness and response by strengthening the WHO global influenza and response systems (GISR) “with the objective of a fair, transparent, equitable, efficient, effective system for, on an equal footing: • (i) the sharing of H5N1 and other influenza viruses with human pandemic potential: and • (ii) access to vaccines and sharing of other benefits.“ Source: denvergov.org

  39. WHO Pandemic Influenza Preparedness Framework: Key Features • Member States should share samples with WHO in a rapid, systematic and timely manner • By doing so, they agree to onwards transfer and use, subject to provisions of the ‘Standard Material Transfer Agreements’ • Directs WHO Director-General to put in place a traceability mechanism in order to track in real time and report movements of samples into, within and outside of WHO system.

  40. WHO Pandemic Influenza Preparedness Framework: Key Features of PIP Benefit Sharing System • The Framework establishes a benefit sharing system that aims to: • Provide pandemic surveillance and risk assessment and early warning information to all countries. • Provide benefits, including capacity building in pandemic influenza surveillance and prioritize benefits such as access to antiviral medications and vaccines to developing countries and particularly affected countries. • Capacity building through technical assistance and transfer of technology, skills, know-how and expanded vaccine production capacity. • Concrete provisions: • DG to establish an a stockpile of 150 million doses of H5N1 vaccines and other influenza virus vaccines and antiviral medications. • Influenza vaccine, diagnostic and pharmaceutical manufacturers using the WHO GISRS will make an annual partnership contribution to WHO for improving global pandemic influenza response equivalent to 50% of the operating costs of the network.

  41. WHO Pandemic Influenza Preparedness Framework: Equitable benefit sharing? • States should urge pharmaceutical companies to set aside a portion of each production cycle to developing countries • States should urge manufacturers to implement tiered pricing, taking into account the economic situation of each country to increase affordability • States should urge pharmaceutical companies to transfer technologies to the benefit of developing countries • States and other stakeholders are encouragedto consider making donations and in kind contributions for improving global preparedness and response • States are urged to continue and increase their support to strengthen laboratory and surveillance capacity particularly in developing countries by providing adequate financial and technical support

  42. WHO Pandemic Influenza Preparedness Framework: Standard Material Transfer Agreements (SMTA) • Two types: • SMTA 1: used to govern transfers within the WHO GISRS. • SMTA 2: used to govern onwards transfers from WHO to entities outside the system (i.e. pharmaceutical industry).

  43. Standard Material Transfer Agreement II (SMTA II) How much remains to be negotiated? Articles on: liability and indemnity, warranties, duration, termination, governing law and dispute resolution all remain simply ‘to be agreed by the parties,’

  44. WHO Pandemic Influenza Preparedness Framework and Global Infectious Disease Surveillance: Final Remarks

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