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Info Service on Health Issues (Aug23/01) Geneva, 14 August (TWN) – The 4th Meeting of the Working Group on Amendments to the International Health Regulations 2005 (WGIHR4) decided to hold informal meetings to discuss amendment proposals on Surveillance (Article 5) and the determination to public health emergency of international concern (PHEIC) (Article 12). Although Article 12 primarily deals with the determination of PHEIC, the proposals for amendments are mostly related to eliminating consultations between WHO and the concerned State Party and introducing intermediate alerts as well as emergencies of regional concern. The WGIHR4 meeting took place from 24 to 28 July at the WHO headquarters in Geneva. As reported earlier, the work of WGIHR4 substantially focussed on amendment proposals made by developed countries on issues including on national focal points (Article 4), surveillance (Article 5), notification and sharing of information (Article 6), sharing of genetic materials (Article 7), consultation, verification and information from WHO (Articles 8-11), regional and intermediate alerts (Article 12). Several of the proposals from the developing countries were discussed during the 3rd Meeting of WGIHR, including equitable access to health products, a financial mechanism and strengthening of health systems capacities. During WGIHR4 developing countries questioned how the above-mentioned proposals on Articles 4 to 12, essentially initiated by the U.S., improve the current functioning of IHR 2005 or the delivery of equity, which is an unequivocal mandate of the amendment process. They argued that several of the proposals substantially alter the obligations on information sharing between WHO and Member States, as well as with other entities, and such changes are inconsistent with the stated purpose and scope of IHR 2005. Following this, several of the proposals were pushed to informal consultations for further discussions and consensus building, with an understanding that no informal meetings will take place during the month of August. The report of WGIHR4 reads: “The Working Group agreed that efforts should continue during the intersessional period, including as follows: – Discussions between proponents of various proposed amendments, with a view to presentation of any outcomes for the consideration of the drafting group. – Intersessional briefings and facilitated informal consultations, in a hybrid format open to all drafting group members, as well as joint intersessional work with the INB at dates and times to be announced, covering Articles and Annexes discussed during the fourth meeting of the WGIHR, including those that have been the subject of intersessional work…” The report does not specifically identify the amendment proposals or provisions that would be dealt with in the informal intersessional work. However, according to a few developing country delegates “the Bureau Co-Chairs will intimate the proposals and provisions to be taken up during informals, however, Articles 5 and 12 will definitely be discussed during intersessional informals.” Under Article 5, the U.S. has proposed that the WHO shall develop an early warning criterion for assessing and progressively updating the national, regional, or global risk posed by an event of unknown causes or sources and shall convey this risk assessment to States Parties. Under Article 12, the U.S. proposal seeks to eliminate the obligation of WHO to seek consultation with States Parties on whose territories the emergency is occurring before the determination of PHEIC as well as notifying other States Parties. On the other hand, the U.S. also wants WHO to consult “relevant States Parties” to determine the termination of PHEIC, i.e. not just States Parties on whose territories events are occurring. Further the U.S. wants to enable WHO to declare public health emergencies of regional concern and an intermediate alert during the events which do not constitute a PHEIC, but needs a potential international health response. Some countries such as the Republic of Korea, New Zealand, Russia and India also had similar proposals on early warning and localization of health emergency concerns. The U.S. proposals on Article 12 need to be read along with other U.S. proposals related to Articles 6, 10 and 11, where States Parties and WHO will have to work within a very short span of time to make and communicate decisions. There again the U.S. has proposed to increase the scope of information to be shared and eliminate consultation. On the other hand, the U.S. proposal contains nothing on sharing of benefits derived from such sharing of information, or forging a better international public health response. For instance, under Article 12, after proposing intermediate alert and emergencies of regional concern, the U.S. fails to provide for “actions” or “international public health response” that will need to be followed thereafter. The U.S. proposals faced opposition not only from developing countries, but also from some other developed countries who were also of the opinion that regional alerts and intermediate alerts could affect the fabric of international health regulations, and can politicise the determination of PHEIC. No Informal Consultation on Article 4 and Co-chairs prepare text for negotiations Interestingly, with an intent to push forward a low-hanging fruit approach, the WGIHR Bureau initiated a more text-based approach when it came to the proposals on national authorities, surveillance and other related provisions on information sharing, determination of PHEIC and notification. Currently Article 4 provides for responsible authorities for the implementation of health measures under IHR 2005 though specifics are only provided for having National IHR Focal Points and their functions. Switzerland and Russia had proposed to establish a “National Competent Authority” for overall implementation of IHR 2005 and adoption of national legislation respectively. Although there were several conceptual issues relating to a variety of the institutions proposed under Article 4, the co-chairs produced a new text with the help of the secretariat that substantially alters the existing Article 4 of IHR 2005. The new text proposed for Article 4 seeks to establish 2 or more entities in States Parties to IHR, in addition to National Focal Points i.e., National IHR authority (National Authority) and other competent authorities. According to the new proposal, the major function of NFPs will be communication with WHO IHR focal points. The national authority will look after the overall implementation of IHR 2005 and the competent authorities will take up their respective functions as listed in Article 22 such as monitoring persons, cargo and conveyances so that they remain uninfected and free from sources of infection or contamination. Another function is supervising service providers concerning travellers, cargo and conveyances including through conduct of inspections and medical examination. As with the current text, National Focal Points are specifically obligated to send out communications to WHO under various provisions from Article 6 to 12 under the co-chairs’ proposal. They also are required to collect information as well as send information to various administrative departments including points of entry health departments. Further, chair’s proposal in addition assigns all obligations not specifically assigned to NFPs or other competent authorities to National IHR Authority’s portfolio. States Parties are further required to provide adequate financial and human resources to these entities as well as to consider enacting or adapting legislation providing for the functioning of these entities. It is also provided that States Parties will share with WHO the contact information of NFPs and National IHR Authority and WHO will in turn share with all State Parties the contact information thus collected. The co-chairs’ proposal also stipulates obligations on WHO IHR Focal Points to send out urgent communications to NFPs under Articles 6 to 12. It was decided that the co-chairs’ text proposal would be taken up for discussion in the morning session of the last day of WGIHR4, along with text on Article 13A on equitable access to health products and technologies developed by the co-facilitators of the informal meetings, i.e., Bangladesh and Botswana. Article 4 was extensively discussed during the last day, but delegations were refrained from making textual suggestions. The discussions took up most of the scheduled time resulting in no negotiation engagement on Article 13A. The implication of this new Article 4 proposal is that States Parties to IHR would be obligated to establish National IHR Authority and share the contact details with WHO. Currently certain States Parties have National IHR Focal Points in a department or a section office and are free to choose where they want to establish, terminate or restructure these points as needed. If this new proposal goes through, a substantial amount of resources must be set aside in the national health budgets to maintain such an office, diverting limited resources available for broader health systems strengthening. There are concerns that donor countries through WHO and other institutions like the World Bank will place such conditionalities while providing financial resources. Furthermore, while National IHR Focal points are explicitly obligated to share information and provide response to communications sent by the WHO IHR Focal Points, no corresponding obligations are placed on WHO IHR focal points to provide responses to the requests for assistance from Member States under Article 13 on public health response. For all these reasons, co-chairs’ proposal invited criticism. U.S. calls for consideration of Joint Meeting of WGIHR and INB on Governance Amongst various other developments during that week, the U.S. had called for joint work of WGIHR and INB (the Intergovernmental Negotiating Body developing a new pandemic instrument) on governance mechanisms. According to a developing country diplomat the U.S. stated that it believes there are many co-benefits to be realised by having “a governing body” that could provide guidance to both IHR and the new pandemic instrument. The U.S. further suggested that issues relating to Articles 53 and 54 of IHR 2005 could be discussed in conjunction with Chapter III on governance being discussed in INB. Other co-facilitators who engaged in the informal consultations regarding the subject matter, i.e. the E.U., Malaysia, Africa Group, also seemed to have agreed to this call. “There was no objection to the proposal,” said the delegate. WGIHR’s Informal meetings in stark contrast with INB While it is a concern that Member States are constantly pushed to discuss proposals informally, WGIHR does it in a more transparent way by placing Member State’ text proposals on the negotiating draft and then inviting proponents of proposals to facilitate informal consultations and discussions. The informal consultations at WGIHR after the launch of formal negotiations are mostly led by proponents of text themselves, although one of the informals on Article 44A (WHO Financial Mechanism) was facilitated by Saudi Arabia, who is not a proponent of the text in question. At the INB, on the other hand, Member States are pressured into informals without the adoption of the formal negotiating text. These informals are facilitated by volunteer delegations rather than the proponents of the text. It is of concern that the INB mandates these delegations who co-facilitate informal meetings to develop text based on the discussions to be formally incorporated in the Bureau’s text for the new pandemic instrument. This essentially makes States compromise on their text proposals even before the launch of formal negotiations. Regulation of Information Sharing gets attention Malaysia had proposed to obligate WHO to ensure that information shared with them are not transferred to the entities engaging in conflict settings or performing violent activities as well as to take precautions such that they are not reaching such entities otherwise. Although this was initially opposed, later during the discussions, several countries expressed second thoughts on the need for disciplined sharing of information under WHO. It must be noted that the new proposals from developed countries make information sharing under IHR 2005 a broad mechanism whereby not only the scope of information shared is increased but also the number of actors with which information is shared. Much of health information, including the genetic sequence information of pathogens, are very sensitive information and could be misused by actors that perpetrate illegality. It could cause several national security concerns. Therefore, Malaysia submitted this proposal that the information shared with WHO should be handled with due diligence so that WHO should know who is using their data and for what purposes. Some of the developing country delegates indicated that they are waiting for a revised text proposal from Malaysia, as they find it critical and useful for a trustworthy environment for sharing of information.+
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