International Health Regulations
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Article by Article Compilation of Proposed Amendments to the International Health Regulations (2005)
From video 9th May
Article 1 Definitions
“standing recommendation” means non-binding advice issued by WHO
“temporary recommendation” means non-binding advice issued by WHO
Article 2 Scope and purpose
including through health systems readiness and resilience in ways that are commensurate with and restricted to public health risk all risks with a potential to impact public health,
Article 3 Principles
The implementation of these Regulations shall be with full respect for the dignity, human rights and fundamental freedoms of persons
Article 10 Verification
whilst encouraging the State Party to accept the offer of collaboration by WHO, taking into account the views of the State Party concerned.
Article 11 Exchange of information
WHO shall facilitate the exchange of information between States Parties and ensure that the Event Information Site For National IHR Focal Points offers a secure and reliable platform
Article 12 Determination of a public health emergency of international concern public health emergency of regional concern, or intermediate health alert
2. If the Director-General considers, that a potential or actual public health emergency of international concern is occurring,
If the Director-General determines that the event constitutes a public health emergency of international concern, and the State Party are in agreement regarding this determination,
5. If the Director-General, following consultations with the Emergency Committee and relevant States Parties the State Party within whose territory the public health emergency of international concern has occurred,
New para 6: Where an event has not been determined to meet the criteria for a public health emergency of international concern, but the Director-General has determined it requires heightened international awareness and a potential international public health response,
the Director-General, on the basis of information received, may determine at any time to issue an intermediate public health alert to States Parties
Article 13 Public health response
3. At the request of a State Party, WHO shall collaborate clearly defined assistance to a State Party offer assistance to a State Party in the response to public health risks and other events by providing technical guidance, health products, technologies, know-how, deployment of civil medical personals,
The State Party shall accept or reject such an offer of assistance within 48 hours and, in the case of rejection of such an offer, shall provide to WHO its rationale for the rejection, which WHO shall share with other States Parties.
4. If WHO, … determines that a public health emergency of international concern is occurring, it may shall offer, in addition to the support indicated in paragraph 3 of this Article,
5. When requested by WHO, States Parties should shall provide, to the extent possible, support to WHO- coordinated response activities,
including supply of health products and technologies, especially diagnostics and other devices, personal protective equipment, therapeutics, and vaccines, for effective response to PHEIC occurring in another State Party’s jurisdiction and/or territory,
NEW Article 13A WHO Led International Public Health Response
States Parties recognize WHO as the guidance and coordinating authority of international public health response during public health Emergency of International Concern and undertake to follow WHO’s recommendations in their international public health response.
New Article 13A: Access to Health Products, Technologies and Know-How for Public Health Response
Immediately after the determination of a public health emergency of international concern under Article 12, the Director General shall make an immediate assessment of availability and affordability of required health products and make recommendations, including an allocation mechanism,
3. States Parties shall provide, in their intellectual property laws and related laws and regulations, exemptions and limitations to the exclusive rights of intellectual property holders to facilitate the manufacture, export and import of the required health products, including their materials and components.
e) establish a repository for cell-lines to accelerate the production and regulatory of similar biotherapeutics products and vaccines
NEW Chapter IV (Article 53 bis-quater): The Compliance Committee 53 bis Terms of reference and composition
1. The State Parties shall establish a Compliance Committee that shall be responsible for:
New Article 54 bis – Implementation4]
The Health Assembly shall be responsible to oversee and promote the effective implementation of these Regulations.
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