While much attention has been focused on negotiations at the World Health Organization (WHO) on a pandemic treaty, there has been less scrutiny on WHO deliberations on proposed amendments to the International Health Regulations (2005). The reasons are two-fold: 1) The Working Group on Amendments to the International Health Regulations (2005) has only met once in November 2022 and 2) the proceedings of the Working Group on Amendments to the International Health Regulations (WGIHR) are currently closed to non-State actors in official relations with WHO, media, and the public at large. However, at the first meeting of the WGIHR in November 2022, it is expected that future meetings of the WGIHR will open up to various stakeholders; member states are still considering the option of web-streaming of the the Working Group meetings.
In terms of access to future meetings, the first meeting of the WGIHR noted:
(a) With respect to proposed modalities of engagement for relevant stakeholders, the working basis will be the modalities adopted by the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (document A/WGPR/1/6). At the second meeting of the Working Group on Amendments to the International Health Regulations (2005), Member States will populate the various annexes to that document in accordance with the mandate of the
Working Group and provide their approval, with it being understood that the document will be considered a living document, open to further consideration by the Working Group as appropriate. Prior to the second meeting of the Working Group, modalities for this work will be set out by the Bureau, noting the importance of advancing work during the intersessional period and noting that relevant documentation will be provided at least three weeks prior to the second session of the Working Group.
(b) With respect to web-streaming of Working Group meetings (or parts thereof), the Bureau will provide Member States with a proposal in this regard, to be considered by the Working Group through a written silence procedure in advance of the Working Group’s second meeting.
In December 2022, WHO published the list of proposed targeted amendments to the IHR by the following countries: Armenia, Bangladesh, Brazil, Czech Republic (on behalf of the Member States of the European Union), Eswatini (on behalf of the Member States of the WHO African Region), India, Indonesia, Malaysia, Namibia, New Zealand, Republic of Korea, Russian Federation (on behalf of the Member States of the Eurasian Economic Union (EAEU), Switzerland, United States of America, and Uruguay (on behalf of the Member States of the Southern Common Market (MERCOSUR). On 11 January 2023, Third World Network (TWN) provided an analysis of all sixteen proposals with a focus on the developing country proposals on equity.
This piece will zero in on key amendments proposed by Eswatini on behalf of the Member States of the WHO African Region, including a far-reaching proposal for a new Article 13A on Access to Health Products, Technologies and Know-How. The Africa Group proposed that after a declaration of public health emergency of international (PHEIC):
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.
With respect to publicly funded inventions, the Africa Group proposed that :
4. States Parties shall use or assign to potential manufacturers, especially from developing countries, on a non-exclusive basis, the rights over health product(s) or technology(ies), when the same is/are obtained in the course of research wholly or partially funded by public sources, and is/are identified as required health product(s) or technology(ies) to respond to a PHEIC, with a view to ensure equitable, timely availability and affordability through diversification of production.”
In terms of facilitating local production, the Africa Group proposed that the WHO secretariat undertake a number of measures including establishing a “repository for cell-lines to accelerate the production and regulatory of similar biotherapeutics products and vaccines”.
In terms of regulating the behavior of manufacturers, and “those claiming associated intellectual property rights”, the Africa Group called on State Parties to undertake the following measures to ensure that the activities of the pharmaceutical industry and rights holders “do not conflict with the right to the highest attainable standard of health”. These measures include requirements on pricing transparency, and obligations to “to share the technologies, know-how for the diversification of production” and “to deposit cell-lines or share other details required by WHO repositories or database established pursuant to paragraph 5.
7. The States Parties shall take measures to ensure that the activities of non-state actors, especially the manufacturers and those claiming associated intellectual property rights, do not conflict with the right to the highest attainable standard of health and these Regulations and are in compliance with measures taken by the WHO and the States Parties under this provision, which includes:
a) to comply with WHO recommended measures including allocation mechanism made pursuant to paragraph 1.
b) to donate a certain percentage of their production at the request of WHO.
c) to publish the pricing policy transparently.
d) to share the technologies, know-how for the diversification of production.
e) to deposit cell-lines or share other details required by WHO repositories or database established pursuant to paragraph 5
.
f) to submit regulatory dossiers concerning safety and efficacy, and manufacturing and quality control processes, when called for by the States Parties or WHO.
With respect to Article 1 on definitions of the International Health Regulations (2005), the Member States of the African Region proposed:
“health products” include therapeutics, vaccines, medical devices, personal protective equipment, diagnostics, assistive products, cell- and gene-based therapies, and their components, materials, or parts.
“health technologies and know-how” includes organized set or combination of knowledge, skills, health products, procedures, databases and systems developed to solve a health problem and improve quality of life, including those relating to development or manufacture of health products or their combination, its application or usage. “Health technologies” are interchangeably used as “health care technologies”.
The Africa Group provided the following rationale:
Africa Group proposes to include the definition for “health products” and “health technologies and know-how” in Article 1 on Definitions, since the phrases will be repeatedly used in the provisions intending to improve equity in international public health response to Health Emergencies. The use of the above phrase “health products” is consistent with the use of language in various WHO Resolutions and UN Documents as well as public health approaches to health emergency response.
Article 2 of the IHR (2005) details the purpose and scope; the Africa Group sought to amend Article 2 to embed equity and a human rights dimension into the purpose and scope (changes in bold).
The purpose and scope of these Regulations are to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with
andrestricted to public health risks, and which avoid unnecessary interference with international traffic, and trade, livelihoods, human rights, and equitable access to health products and health care technologies and know how.
Currently, the text of Article 6 of the IHR on notification reads as follows:
Article 6 Notification
1. Each State Party shall assess events occurring within its territory by using the decision instrument in Annex 2. Each State Party shall notify WHO, by the most efficient means of communication available, by way of the National IHR Focal Point, and within 24 hours of assessment of public health information, of all events which may constitute a public health emergency of international concern within its territory in accordance with the decision instrument, as well as any health measure implemented in response to those events. If the notification received by WHO involves the competency of the International Atomic Energy Agency (IAEA), WHO shall immediately notify the IAEA.
2. Following a notification, a State Party shall continue to communicate to WHO timely, accurate and sufficiently detailed public health information available to it on the notified event, where possible including case definitions, 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; and report, when necessary, the difficulties faced and support needed in responding to the potential public health emergency of international concern.
Under Article 6 on notification, the Africa Group proposed new language (sub-paragraph 2) on access and benefit sharing which is dissonant to Article 6.2 of IHR.
New 3. No sharing of genetic sequence data or information shall be required under these Regulations. The sharing of genetic sequence data or information shall only be considered after an effective and transparent access and benefit sharing mechanism with standard material transfer agreements governing access to and use of biological material including genetic sequence data or information relating to such materials as well as fair and equitable sharing of benefits arising from their utilization is agreed to by WHO Member States, is operational and effective in delivering fair and equitable benefit sharing.
With respect to Article 12 Determination of a public health emergency of international concern of the International Health Regulations (2005), the Member States of the WHO African Region proposed new text, including a reference to WHO’s Framework for Engagement of Non-State Actors (FENSA).
New 6. Immediately after the determination of PHEIC, the activities of the WHO in relation to such PHEIC, including through partnerships or collaborations, shall be in accordance with the provisions of these Regulations. The Director General shall report all the activities carried out by WHO, including references to the corresponding provisions of these Regulations in pursuance to Article 54./ul>
New 7. In case of any engagement with non-State actors in WHO’s public health response to PHEIC situation, WHO shall follow the provisions of Framework for Engagement of Non-State Actors (FENSA). Any departure from FENSA provisions shall be consistent with paragraph 73 of FENSA.
Article 13 of the IHR (2005) covers the public health response. The Africa Group proposed a lengthy new article (Article 13A) on Access to Health Products, Technologies and Know-How for Public Health Response. The entire article is reproduced below.
New Article 13A: Access to Health Products, Technologies and Know-How for Public Health Response
1. 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, to avoid any potential shortages of health products and technologies pursuant to Article 15 or 16 as appropriate.
2. States Parties shall co-operate with each other and WHO to comply with such recommendations pursuant to paragraph 1 and shall take measures to ensure timely availability and affordability of required health products such as diagnostics, therapeutics, vaccines, and other medical devices required for the effective response to a public health emergency of international concern.
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.
4. States Parties shall use or assign to potential manufacturers, especially from developing countries, on a non-exclusive basis, the rights over health product(s) or technology(ies),when the same is/are obtained in the course of research wholly or partially funded by public sources, and is/are identified as required health product(s) or technology(ies) to respond to a PHEIC, with a view to ensure equitable, timely availability and affordability
through diversification of production.
5. Upon request of a State Party, other States Parties or WHO shall rapidly cooperate and share relevant regulatory dossiers submitted by manufacturers concerning safety and efficacy, and manufacturing and quality control processes, within 30 days. The dossiers received by a requesting State Party shall be solely used by their regulatory authorities and manufacturers designated by the requesting State Party for the purposes of accelerating the manufacture and supply of product(s) or technology(ies) as well as expediting their regulatory approval. Requesting State Party shall take measures to prevent designated manufacturer(s) from disclosing such information to a third party(ies) except for the purposes of producing and supplying any materials or components to the manufacturer(s) under a contract with non-disclosure provisions.
6. WHO shall take measures to ensure availability and accessibility through the local production of required health products including:
a) develop and publish a list of required health products,
b) develop and publish specifications for the production of required health products,
c) develop appropriate regulatory guidelines for the rapid approval of health products of quality including development of immunogenicity co-relative protection (ICP) for vaccines,
d) establish a database of raw materials and their potential suppliers,
e) establish a repository for cell-lines to accelerate the production and regulatory of similar biotherapeutics products and vaccines,
f) review and regularly update WHO Listed Authorities so as to facilitate appropriate regulatory approvals,
g) any other measures required for the purposes of this provision.
7. The States Parties shall take measures to ensure that the activities of non-state actors, especially the manufacturers and those claiming associated intellectual property rights, do not conflict with the right to the highest attainable standard of health and these Regulations and are in compliance with measures taken by the WHO and the States Parties under this provision, which includes:
a) to comply with WHO recommended measures including allocation mechanism made pursuant to paragraph 1.
b) to donate a certain percentage of their production at the request of WHO.
c) to publish the pricing policy transparently.
d) to share the technologies, know-how for the diversification of production.
e) to deposit cell-lines or share other details required by WHO repositories or database established pursuant to paragraph 5.
f) to submit regulatory dossiers concerning safety and efficacy, and manufacturing and quality control processes, when called for by the States Parties or WHO.