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TWN
Info Service on Health Issues (Oct23/06) Geneva, 19 October (TWN) – The draft negotiating text on the pandemic instrument released by the Bureau of the Intergovernmental Negotiating Body (INB) is unbalanced, essentially serving the interest of developed countries without any concrete deliverables on equity. This draft text is to be considered by the 7th meeting of the INB for conversion into a formal negotiating text. The 7th meeting of INB is to be held at the WHO Headquarters, Geneva from 6-10 November. The INB drafting group meeting held on 4 – 6 September decided that “The INB Bureau will develop and circulate to the INB for its consideration a proposal for negotiating text of the WHO CA+ (the pandemic instrument)”. TWN learned from sources that the draft negotiating text is essentially prepared by the Secretariat in discussion with the Bureau. The finalisation of the draft negotiating text involved negotiations among the members of the Bureau. This in a way reaffirms the concern that the draft negotiating text reflects the individual and collective negotiating strength of Bureau members rather than objectivity based on the discussions in the formal and informal meetings of the INB since the body’s 4th (27 February – 3 March 2023). Important issues of concern over the draft negotiating text are explained below. Unbalanced approach The approach of the draft negotiating text is unbalanced because it proposes concrete legal obligations on all Parties regarding surveillance (Article 4), One Health (Article 5), preparedness and readiness (Article 6). These obligations primarily serve the interest of developed countries and the draft text offers nothing in return to developing countries for providing information through enhanced surveillance. In other words, it ignores the demand of developing countries to have an equitable regime for pandemic prevention, preparedness and response (PPPR). Developing countries made several proposals to achieve equity in PPPR; however, the proposals on equity in the draft negotiating text are couched mostly in best endeavour language or future promises. This is in stark contrast to the proposed legal obligations in Articles 4 to 6. These obligations as shown below are concrete legal obligations on parties irrespective of their level of development and associated capacities. Implementation of these obligations goes beyond the conventional understanding of pandemic and even includes measures to check antimicrobial resistance (while an urgent health issue, its linkage here raises concerns). Interestingly the proposals in the draft negotiating text are silent on regulating the marketing practices of the pharmaceutical industry, which is one of the important cause of antibiotics resistance. One of the prime interests of developed countries to revamp the health emergency regime is to establish a system to fast-track information sharing to accelerate the early warnings on disease outbreak or emergence of dangerous pathogens with potential of pandemic or public health emergency of international concern (PHEIC). At the same time developed countries do not want to undertake any obligation either to assist developing countries to set up the infrastructure and systems for surveillance and response, or to share the benefits such as vaccines, therapeutics or diagnostics emerging from sharing the information obtained from surveillance systems in the developing countries. Some examples are highlighted below. Article 4.4: Each Party shall develop, strengthen, implement, periodically update and review comprehensive multisectoral national prevention and surveillance plans, that are consistent with and supportive of effective implementation of the International Health Regulations. To this end, each Party shall, in accordance with its capabilities: (a) develop, strengthen and maintain the capacity to: (i) detect, identify and characterize pathogens presenting significant risks; and (ii) conduct risk assessment of such pathogens and vector-borne diseases to prevent spill-over in human and animal populations and cause serious diseases leading to pandemic situations, (b) strengthen efforts to ensure access to safe water, sanitation and hygiene including in hard-to-reach settings in the Parties’ territory; (c) ensure the implementation of effective infection prevention and control measures applying as far as possible the applicable international standards and guidelines; (d) strengthen efforts to ensure the sound management of wastes from health facilities and require healthcare institutions to have in place a regularly updated infection prevention and control programme; (e) strengthen animal disease preventive measures and monitor and mitigate environmental factors associated with the risk of zoonotic disease spill-over and spill-back; (f) strengthen laboratory biosafety and biosecurity, including in research facilities, in order to prevent the accidental exposure, misuse or inadvertent laboratory release of pathogens through biosecurity training and practices, regulating access to sensitive locations, and strengthening transportation security and cross-border transfer, in accordance with applicable rules and standards; and (g) take actions to prevent outbreaks due to pathogens that are resistant to antimicrobial agents, and, in accordance with national context, develop and implement a national One Health action plan that includes an antimicrobial resistance component. Article 4.5: Each Party shall develop, strengthen and maintain the capacity to carry out integrated surveillance, including with respect to infectious diseases in humans, and animals that present significant risks for zoonotic diseases spill-over. Article 6.4: The Parties shall establish, building on existing arrangements as appropriate, genomics, risk assessment, and laboratory networks in order to conduct surveillance and sharing of emerging pathogens with pandemic potential, with such sharing pursuant to the terms and modalities established in Article 12. Article 7.3: The Parties shall invest in establishing, sustaining, coordinating and mobilizing a skilled and trained multidisciplinary global public health emergency workforce that is deployable to support Parties upon request, based on public health need, in order to contain outbreaks and prevent the escalation of small‑scale spread to global proportions. Article 7.4: The Parties shall develop a network of training institutions, national and regional facilities, and centres of expertise to strengthen and sustain a skilled and competent public health, health and care workforce at the subnational, national and regional levels. Removal of Common but Differentiated Responsibilities (CBDR) The draft negotiating text removed CBDR as a principle. Further, it also replaced Article 17 of the earlier Bureau’s text (Implementation), acknowledging differences in levels of development with Article 19. Article 19 in the draft negotiating text deals with implementation capacities and support. It creates a generic obligation on all Parties to cooperate with international bodies to strengthen capacities to fulfil the obligations arising from the agreement and also provide resources within their means for effective implementation. These efforts are to consider the needs of developing countries, which is a dilution from CBDR. Article 19 reads: 1. The Parties shall cooperate directly or through competent international bodies to strengthen their capacity to fulfill the obligations arising from this Agreement, taking into account especially the needs of developing country Parties. Such cooperation shall promote the transfer of technical, scientific and legal expertise and technology, as mutually agreed, to establish and strengthen sustainable pandemic prevention, preparedness and response capacities of all Parties. 2. Each Party shall, within the means and resources at their disposal, cooperate to raise financial resources for the effective implementation of the WHO Pandemic Agreement through bilateral and multilateral funding mechanisms. 3. The Parties shall give particular consideration to the specific needs and special circumstances of developing country Parties for financial and technical assistance to support the implementation of this Agreement. 4. The Parties shall, where a Party lacks the necessary capacity to implement specific provision(s) of this Agreement, work together to identify the most relevant partner(s) that can support the development of such capacities and shall cooperate to ensure that the mechanism(s) identified in Article 20 provides the necessary financial resources. Apart from this, Articles 5.7, 6.3 and 7.2 also has the generic obligation to cooperate while emphasising the need to assist developing countries. For instance, Article 6.3 states: “The Parties shall cooperate, within available means and resources, to provide financial, technical and technological support, assistance, capacity-strengthening and cooperation, in particular with respect to developing countries, in order to strengthen health emergency prevention, preparedness, response and health systems recovery, consistent with the goal of universal health coverage.” Similarly, the provisions on financial mechanism under Article 20 of the draft negotiating text do not contain any specific obligation on developed countries to provide financial resources for the implementation of the pandemic instrument. This Article treats all Parties on an equal footing without taking into account difference in financial capacity. The problem with this approach is that it is a general obligation on all Parties and not obligating developed country Parties, who have the financial and technological resources, to assist developing country Parties in the effective implementation of the provisions. In the absence of specific obligations on developed countries, it gives a good excuse to these countries to escape from their responsibilities to build a PPPR regime based on equity, solidarity and cooperation. It is also important to note that most of the obligations under Articles 4, 5, 6 and 7 are proposed without taking into account the development divide existing between the developed and developing countries. Certain proposed obligations do provide qualifications. For instance, Article 5.4 states “Each Party shall, in accordance with the national context and to the extent necessary, protect human, animal or plant health …” However, the term “national context” is too broad and does not specifically address the capacity constraints emanating from the level of development. Similarly, the obligation under Article 6.2 states: “Each Party shall, in accordance with applicable laws, including, where appropriate, the International Health Regulations, adopt policies, strategies and/or measures, as appropriate, and shall strengthen and reinforce public health functions for: …” This provision also treats both developed and developing countries on an equal footing and ignores the special needs of developing countries. In the absence of CBDR developing countries are required to invest massively to provide information to developed countries without legal guarantee to obtain assistance to respond to an outbreak of a pandemic. Non-committal on Equitable Access Articles 9 (Research and Development), 10 (Sustainable production), 11 (Transfer of technology and know-how), 13 (Global Supply Chain and Logistics) and 14 (Regulatory Strengthening) are primarily aimed at addressing the equitable access to pandemic-related products. Article 10 on sustainable production is a new addition, which was not there in the zero draft or earlier Bureau text. Articles dealing with R&D and transfer of technology do not propose any predictable arrangement for accessing R&D outcomes or transfer of technology from developed countries or entities based there. In other words, such provisions are either qualified or best endeavour clauses without any enforceable provisions. For instance: Article 9.2: “To this end, the Parties shall promote: …” Article 9.3: “The Parties shall, in accordance with national laws and regulatory frameworks and contexts, take steps to develop and sustain, strong, resilient, and appropriately resourced, national, regional and international research capabilities.” Article 9.4: “Each Party shall, in accordance with its national laws and considering the extent of public funding provided, publish the terms of government-funded research and development agreements for pandemic-related products, including information on: …” Similarly, technology transfer provisions under Article 11 are qualified with “on mutually agreed terms as appropriate,”. Further, it also states that countries shall “encourage” patent holders to waive royalty during pandemic or manufacturers to share the undisclosed information protected under Article 39.2 of the TRIPS Agreement. This will not change anything on the ground. The following obligations under Article 11 are without any qualifications, but essentially a statement of the existing situation. Article 11.2: (a) make use of the flexibilities provided in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), including those recognized in the Doha Declaration on the TRIPS Agreement and Public Health of 2001 and in Articles 27, 30 (including the research exception and the “Bolar” provision), 31 and 31bis of the TRIPS Agreement, and fully respect the use thereof by others; (b) collaborate to ensure equitable and affordable access to health technologies that promote the strengthening of national health systems and mitigate social inequalities; (c) develop a database that provides the details of pandemic-related products for all known pandemic potential diseases, including the technological specifications and manufacturing process documents for each product; and… Article 11.4(1): The Parties shall, with a view to effective pandemic response, when engaged in bilateral or regional trade or investment negotiations, take steps so that negotiated provisions do not interfere with the full use of the flexibilities provided in the TRIPS Agreement, including those recognized in the Doha Declaration on the TRIPS Agreement and Public Health of 2001. Though Article 10 deals with sustainable production, it leaves responsibilities entirely for Parties to identify and maintain production facilities unilaterally and there is no mechanism or obligation regarding international coordination. Without such coordination among Parties, it is extremely difficult to achieve “more geographically and equitably distributed global production of pandemic-related products,” and to increase “timely, fair and equitable access to safe, effective, quality and affordable pandemic-related products”. On the other hand, Article 13 shows the bias of WHO and developed countries by proposing a WHO Global Supply Chain and Logistic Network, which is the original proposal since the zero daft. This WHO idea is effectively disconnected with sustainable production in Article 10 and will result in more concentration and dependency on the pandemic-related products, when decentralised and scaled-up production and distribution is needed. The drafters did not pay any attention to the existing legal obligation to transfer technology under the Article X.1 of the Biological Weapons Convention that contains this obligation: “Parties to the Convention in a position to do so shall also co-operate in contributing individually or together with other States or international organisations to the further development and application of scientific discoveries in the field of bacteriology (biology) for the prevention of disease, or for other peaceful purposes”. Article 12 Access and benefit sharing Though the draft negotiating text brings more clarity to the Pathogen Access and Benefit System (PABS system) including the attempt to link it with sharing of samples and data under Articles 5 and 6, it leaves a big hole by postponing the finalisation of the Standard Material Transfer Agreement (SMTA). Instead of negotiating alongside the pandemic instrument, the draft negotiating text proposes a different timeline in Article 12.7 which states: “The Parties shall ensure that all components of the WHO PABS System are operational no later than 31 May 2025. The Parties shall review the operation and functioning of the WHO PABS System every five years.”. The review of the system will not be possible until the finalisation of the SMTA. Such deadlines are often not respected and may create pressure on developing countries to agree to a sub-optimal outcome. The recent example is the WTO Ministerial Decision on Vaccines adopted during the Ministerial Conference in June 2022, which clarifies and smoothen certain conditions for granting compulsory license. That decision states: “No later than six months from the date of this Decision, Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics.” Even after almost 10 months past the deadline there is no sign of the extension to the decision to diagnostics and therapeutics due to the relentless lobby of the pharmaceutical industry. Furthermore, assuming that the pandemic instrument is adopted in May 2024, there is no guarantee that the instrument will enter into force by May 2025. In order to initiate a negotiation on the PABS System among Parties to the pandemic instrument, the treaty has to first enter into force. This requires enough ratifications by States. Then the Parties must meet as a Conference of Parties, devise rules of procedure, and set up a working committee on PABS negotiation etc. This is not a realistic aim. Another contradictory proposal on the PABS is in Article 12. 4 (a) which requires each Party to “upload the genetic sequence of such WHO PABS Material to one or more publicly accessible database(s) of its choice, provided that the database has put in place an appropriate arrangement concerning WHO PABS material”. Most of these publicly available databases do not have a good track record of respecting access and benefit sharing norms. Furthermore, these databases are not accountable to the WHO and its Member States. They neither report their usage of information to WHO nor disclose information on their usage to WHO upon request. This makes it difficult to ensure compliance with benefit sharing requirements under the PABS system Moreover, any mechanism to respect the WHO PABS can be negotiated with a database only after the conclusion of the SMTA. Thus, it is clear from the above discussion that starting negotiations on this draft negotiating text without amending the same by incorporating text proposals from Member States will be detrimental to an equity-based pandemic PPRR regime. (A detailed analysis of the proposed text will follow.)
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