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1 1 (June 24, 2024)

handle is hein.crs/govepoz0001 and id is 1 raw text is: Con re &on I flesedrch Service horujig Aecjiiave le a~m 'e1914 Updated June 24, 2024 International Health Regulations Amendments Background Since 1980, outbreaks of new and long-standing infectious diseases have been occurring with increasing frequency and intensity. In response, the World Health Assembly (WHA), the governing body of the World Health Organization (WHO), has been amending the International Health Regulations (IHR)-a set of rules on global responses to public health emergencies. The IHR was most recently amended in June 2024. In January 2022, the United States and several other States Parties proposed amendments to the regulations. The 75th WHA agreed to establish a working group that would consolidate the proposals into a revised IHR. The working group presented the proposals to the 77th WHA, which debated and adopted agreed-upon amendments on June 1, 2024, as summarized below. Several Members of Congress expressed concern that some of the proposed amendments might encroach upon U.S. sovereignty. The State Department issued a press release in June 2024 asserting that the amendments would make the global health security architecture stronger overall while maintaining full respect for sovereignty of individual states. This In Focus addresses common questions regarding the IHR, including the role of Congress. Internationa Hea th Regu at ons In 1969, WHA adopted the IHR to stop the spread of six diseases (cholera, plague, yellow fever, smallpox, relapsing fever, and typhus) through quarantine and other infectious disease control measures. The WHA has since amended the IHR several times. The 2005 edition, known as IHR (2005), expanded methods for controlling infectious disease outbreaks beyond quarantine and broadened the type of public health events that would require international coordination. The regulations provide an overarching legal framework that defines the rights and obligations of States Parties, including the United States, in handling public health events and emergencies that have the potential to cross borders. They also outline criteria for declaring a public health emergency of international concern (PHEIC, described below) and requirements for States Parties to * report public health events, * designate National IHR Focal Points for communication with WHO, and * establish and maintain core capacities for surveillance and response. 2024 Amendments to IHR (2005) In the first year of the COVID-19 pandemic, States Parties debated whether WHO had sufficient authority to investigate the origins of a potential PHEIC, particularly when a State Party slowed the process (as China had). The United States and several other countries proposed amendments to the IHR to address this and several other related concerns. The proposal prompted broader discussions regarding IHR implementation, including the absence of financing mechanisms and distribution networks for procuring and disseminating countermeasures in low- and middle-income countries (LMIC) and ensuring sovereign rights of States Parties. These and other issues were addressed in the amendments, as summarized below. Sovereignty. While IHR amendments were being deliberated, several Members expressed concern that broadening the IHR might threaten U.S. sovereignty while numerous observers challenged that idea. Per Article 3, States Parties have the sovereign right to legislate and to implement legislation in pursuance of their health policies. As such, a PHEIC declaration would not automatically restrict travel or impose specific quarantine requirements, for example. Article 4, as amended, instructed States Parties to designate or establish a National IHR Authority, in accordance with its national law and context, to coordinate the implementation of the regulations. Equity. Early in the COVID-19 pandemic, LMIC struggled to gain access to novel therapeutics and vaccines to combat the disease. This phenomenon prompted intense debate about the equitable distribution of pandemic countermeasures. Article 3, as amended, added the promotion of equity and solidarity among the IHR (2005) principles. Article 13, as amended, authorized WHO to facilitate, and work to remove barriers to, timely and equitable access by States Parties to relevant health products. The article also directed the DG to support States Parties in expanding and diversifying production of relevant health products, including by promoting research and development and strengthening local production of relevant health products. Per Article 13, the DG is permitted to share with a State Party, upon its request, the product dossier related to a specific relevant health product, as provided to WHO by the manufacturer for approval and where the manufacturer has consented. Financing. For many years, IHR proponents argued that a funding mechanism was needed to support IHR implementation in LMICs. (For more information on this issue, see CRS In Focus IF10022, The Global Health Security Agenda (2014-2019) and International Health Regulations (2005)). The Global Health Security and International Pandemic Prevention, Preparedness and Response Act of 2022 authorized U.S. participation in a Financial Intermediary Fund-later called the Pandemic Fund-to support countries in IHR implementation, among other things. Article 44, as amended, established a Coordinating Financial Mechanism (CFM) to, inter alia, use or conduct needs and funding gap analyses, and promote sustainable financing for IHR implementation, including harmonizing existing funding streams and mobilizing new ones.

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