TWN Info Service on Health Issues (Mar24/10)
21 March 2024
Third World Network

WHO: Revised pandemic negotiating text fails to deliver on equitable access; pushes towards production concentration

Geneva, 21 March (K M Gopakumar) – The revised negotiating text (negotiating text) of the pandemic instrument that is under discussion at the ongoing 9^th Meeting of the Intergovernmental Negotiating Body (INB) fails to deliver on equitable access.

The negotiating text also contains provisions which lead to further concertation of production and supply of pandemic-related products.

The 9^th INB is taking place at the WHO Headquarters in Geneva from 18 to 28 March in a hybrid mode.

According to the negotiating text “pandemic-related products” means products that are needed for pandemic prevention, preparedness and response, which may include, without limitation, diagnostics, therapeutics, vaccines and personal protective equipment.

The following articles directly deal with various aspects of equitable access:

Article 9:   Research and development
Article 10: Sustainable and geographically diversified production
Article 11: Transfer of technology and know-how
Article 12: Access and benefit sharing
Article 13: Supply chain and logistics
Article 14: Regulatory systems strengthening.

These proposed articles suffer from the following shortcomings:

• Lack of predictable and sustainable access to pandemic-related products and technology
• Absence of interlinkage among Articles 9, 10, 11, 13 and 14
• Silence on the international coordinating mechanism for implementation
• Risk of concentration of production and supply of pandemic-related products.

Lack of predictable access to pandemic-related products

Except Article 12 none of the articles offer guaranteed access to pandemic-related products to Parties who need these products. According to Article 12.6(b) manufacturers of pandemic-related products who conclude a pandemic access and benefit sharing contract (PABS contract) with WHO must provide 10% of the real-time production to WHO. Further, these manufacturers also have to provide another 10% at a not-for-profit price.  It states:

“…real-time contributions of relevant diagnostics, therapeutics or vaccines produced by the manufacturer, 10% free of charge and 10% at not-for-profit prices during public health emergencies of international concern or pandemics, to be made available through the Network established under Article 13 for use on the basis of public health risks, needs and demand”.

However, this clause is not applicable to manufacturers who have not signed the PABS contract. In any event, this 10% donation commitment is too low and would not address the need in the absence of diversified manufacturing. Article 10 deals with sustainable and geographically diversified production.

Article 13bis(2) attempts to offer equitable access through a best endeavour provision i.e. national procurement and distribution-related provisions. This provision states:

“Each Party, in accordance with national laws, shall include provisions in government-funded purchase agreements for pandemic-related products that promote timely and equitable global access to such products, such as provisions that:
(a) permit the donation of such products outside of its territories;
(b) facilitate potential modifications in order to address supply gaps around the world;
(c) incentivize or otherwise encourage licensing and other transfer of technology, in particular for the benefit of developing countries; and
(d) incentivize or otherwise encourage the formulation and sharing of global access plans for the products.”

Article 9 deals with R&D and proposes an obligation on Parties to “take steps to strengthen international coordination and collaboration to support well-designed and well-implemented clinical trials, by developing, strengthening and sustaining clinical trial capacities and research networks at the national, regional and international levels”, in accordance with national circumstances and taking into account international standards. However, there is no guaranteed access to pandemic-related products is guaranteed.

Various committees or panels appointed after the COVID-19 outbreak identified the concentration of research and manufacturing of health products required for pandemic response. The report of the Independent Panel for Pandemic Preparedness and Response cites the concentration of production and R&D as one of the reasons for inequitable access. The Report states:

“Concentration of manufacturing capacity, and of trials and knowledge generation, for vaccines, therapeutics, diagnostics and other essential supplies in a small number of countries has been a major contributor to inequity”.

Similarly, the GPMB report 2021 cites the concentration of production as a reason for the lack of access to health products during a pandemic. The report observes:
“Higher-income countries outbid their poorer counterparts for essential medicines resulting in severe shortages in countries that were already under resourced.  LMICs (Low and Middle Income Countries) have lacked access to quality-assured diagnostic tests while high-income countries (HICs) have enjoyed an array of options. A key contributing factor has been the geographic concentration of R&D and manufacturing, leaving large areas of the world vulnerable to export bans, transportation bottlenecks, and other distribution obstacles.”

Addressing this concern, the UN Political Declaration on Pandemic Prevention, Preparedness and Response (PPPR) adopted by the UN General Assembly in September 2023 in paragraph 31 provides the following mandate to WHO: “Urge the sustainable, affordable, fair, equitable, effective, efficient and timely access to medical countermeasures, including vaccines, therapeutics, diagnostics and other health products and call on the World Health Organization to coordinate this with relevant partners, ensuring coherence with the ongoing discussions of the Intergovernmental Negotiating Body and the Working Group on Amendments to the International Health Regulations (2005) in Geneva”. (Emphasis added).

Further, paragraph 40 of the Political Declaration stresses the need for diversification of production and Member States agreed to: “Commit to remove trade barriers, strengthen supply chains, facilitate the movement of medical and public health goods, and diversify manufacturing capacities across regions, especially during pandemics and other health emergencies among and within countries”.

Article 10.1 of the pandemic instrument negotiation text recognises the need for geographically diversified production. It states: “The Parties commit to achieving a more equitable geographical distribution and scaling up of the global production of pandemic-related products, and increasing sustainable, timely, fair and equitable access to such products, as well as reducing the potential gap between supply and demand during pandemics“.

Towards this end, it obligates Parties to take the following six measures in collaboration with WHO and other relevant organisations:

1. Provide support, maintain and strengthen production facilities at national and/or regional levels, particularly in developing countries, and facilitate scaling up of production of pandemic-related products during emergencies;
2. Facilitate the continuous and sustainable operations of the facilities mentioned above;
3. Facilitate the transfer of relevant technology, know-how, and licences pooled in relevant mechanisms;
4. Take measures, and encourage international organizations, to establish long-term contracts and make investments, especially in developing countries;
5. Facilitate and support authorization of pandemic-related products produced by the facilities referred to in Article 10.2(a);
6. Support and/or facilitate skills development, capacity-building and other initiatives for production facilities.

Although these measures are to be carried out by Parties in collaboration with WHO there is no mention of the role of WHO in the implementation of the above measures.

Technology Transfer Rhetoric

The facilities established under Article 10 need technology to produce the required pandemic-related products. What is proposed is an obligation on Parties to facilitate technology transfer for the facilities established under Article 10 through a mechanism established under Article 11.2. However, the establishment of such a mechanism is at a future date. Article 11.2 states:

“The Parties shall develop and strengthen, as appropriate, mechanisms coordinated by WHO with the participation of other relevant technology transfer mechanisms as well as other relevant organizations, to promote and facilitate the transfer of technology and know-how for pandemic-related products to geographically diverse research and development institutes and manufacturers, particularly in developing countries, through the pooling of knowledge, intellectual property, know-how and data to all developing countries”.

Technology transfer provisions under Article 11 are heavily qualified. For instance, Article 11.1, which lists a set of measures qualifies those measures with the term “taking into account its national circumstances”. Further, out of four measures listed under Article 11.1 three are qualified with the terms “promote” or “within its capabilities”. Similarly, measures listed under Article 11.3 are also stated in “best endeavour” language.

Article 11.1(c) proposes worldwide licensing of government-owned pandemic-related products. It states: “… make available licences, on a non-exclusive, worldwide and transparent basis and for the benefit of developing countries, for government-owned pandemic-related products, and shall publish the terms of these licences at the earliest reasonable opportunity and in accordance with national laws”.

However, the phrase used is “for the benefit of developing countries”, therefore such licenses are not necessarily directed towards manufacturers in developing countries. Similarly, it is restricted to government-owned technologies and may not include government-funded technologies. The ownership of government technologies varies from country to country.

Though Article 11.4 obligates the WHO Secretariat to work towards improving access to medicine through technology transfer, there is no mention of the concrete measures to be taken in this regard. Article 11.4 reads:

“The WHO Secretariat shall work towards the improvement of access to pandemic-related products, especially during pandemic emergencies, through transfer of technology and know-how, including through cooperation with relevant international organizations”.

It is also important to note that though Article 11.2 is referred to in Article 10 there is no corresponding reference to manufacturing facilities mentioned under Article 10.1 in Article 11.

Apart from Articles 10 and 11, Articles 9 and 13 also contain certain measures on technology transfer in the context of publicly funded R&D.

Article 9.6 proposes the following:

“Each Party shall develop national policies to:

(a) include provisions in government-funded research and development agreements for the development of pandemic-related products that promote timely and equitable global access to such products during public health emergencies of international concern and pandemics. Such provisions may include (i) licensing and/or sublicensing, preferably on a non-exclusive basis; (ii) affordable pricing policies; (iii) technology transfer on voluntary terms; (iv) publication of relevant information on research inputs and outputs; and/or (v) adherence to product allocation frameworks adopted by WHO; and

(b) publish relevant terms of government-funded research and development agreements promoting equitable and timely access to such products during a pandemic emergency.”

This obligation to make national policies on government-funded technology licensing and even publication of terms and conditions for promoting equitable access do not guarantee access to pandemic technology or transfer of pandemic-related technology to developing country manufacturers.

The technology transfer provision under Article 12 as part of PABS is only voluntary, for example Article 12.6(c) includes technology licenses only as a voluntary non-monetary contribution. It lists the following: “voluntary non-monetary contributions, such as capacity-building activities, scientific and research collaborations, non-exclusive licensing agreements, arrangements for transfer of technology and know-how in line with Article 11, tiered pricing for relevant diagnostics, therapeutics or vaccines”.

Article 13bis (2) obligates Parties to include provisions in their national laws and government-funded procurement contracts to “incentivize or otherwise encourage licensing and other transfer of technology, in particular for the benefit of developing countries”. But it is a qualified provision, and it is also important to note that incentivising does not necessarily lead to technology transfer.

Concerns on Concentration

Article 13 proposes the establishment of a Global Supply Chain and Logistics Network (Network) under the coordination and convenorship of WHO but does not make it clear whether it would facilitate equitable access through global procurement, though Article 13.1 states that “the Network shall pay particular attention to the needs of developing countries, including those in fragile and humanitarian settings”. There are no details given to achieve this. Important functions of the Network include:

• identifying the types of pandemic-related products and estimating the quantities needed and anticipated demand for robust pandemic prevention, preparedness and response; 

• identifying the sources of safe, effective and quality assured pandemic-related products, including raw materials and potential surge capacities as well as developing and maintaining a tool for this purpose; 

• collaborating with relevant national authorities and organizations/institutions, as appropriate, and taking into account national and regional circumstances to establish, strengthen and maintain national, regional and/or international stockpiles of various pandemic-related products, including stockpiles earmarked for humanitarian settings, as well as to maintain related logistic capacities and assess them at regular intervals; 

• facilitating the equitable allocation of pandemic-related products, including those procured through the facilitation by the Network, acquired through the PABS or donated by countries as referred to in Article 13bis, paragraph 2, based on public health risks and needs, and taking into account factors, such as population size, demographic structure, epidemiological situation and health system capabilities of beneficiary countries and their readiness and capacity to utilize such products; 

• facilitating the most efficient delivery and distribution of pandemic-related products, including, as appropriate, through regional stockpiles, consolidation hubs and staging areas, while taking into account specific requirements for these pandemic-related products, including in humanitarian settings;

Interestingly there is no reference to Article 10.2(a) in Article 13. It effectively means that the Network, if engaging in global procurement, is not bound to procure from the manufacturing facilities mentioned under Article 10.2, which is to supply at national and regional levels during emergencies. In the absence of such reference the Network will follow the current practice of global procurement i.e. limiting the global procurement only to WHO prequalified products. This would exclude the procurement of pandemic-related products from facilities mentioned under Article 10.2(a) and lead to procurement from a very limited set of manufacturers who have WHO prequalification.

According to a recent report of the United States International Trade Commission: “These procurement agencies, however, rely on WHO prequalification (or emergency use listing) and guidance issuance for all tests and treatments, which were reported to have caused delays. In the case of some therapeutics, such as remdesivir, WHO recommendation and prequalification came a full two years after U.S. authorization and the first VLs (voluntary licences) were signed. This means that although treatments were available, many countries were not immediately able to access them. WHO prequalification, which is also required for certain MPP (Medicines Patent Pool) sublicensing agreements, requires significant effort by manufacturers in order to complete the application requirements and address data standards, which may be challenging for some manufacturers. It can also be costly. As noted in chapter 2, a one-time application fee of $25,000 is required in addition to a $20,000 annual fee for a full product assessment. Industry representatives have noted that these fees may be too expensive for smaller manufacturers in many LMICs”.

The promotion of prequalification is further pushed through Article 14, which deals with regulatory system strengthening. Article 14.4 nudges the Parties to provide incentives to manufactures to obtain WHO prequalification of their products.  This Article states: “Each Party shall, consistent with national laws, encourage manufacturers of pandemic-related products, as appropriate, to generate and submit in a timely manner, relevant data and diligently pursue regulatory authorizations, approvals and/or prequalification of pandemic-related products with WHO, WHO listed authorities and other authorities as appropriate”.

In addition, Article 14 uses the pandemic instrument to push the regulatory harmonisation agenda, which would enhance the compliance cost of producers in the developing countries, which operate on minimal capital investment. Article 14.6 states:

“Each Party shall endeavour to, subject to national laws: 

(a) adopt, where needed, regulatory reliance processes in its national regulatory frameworks for use during pandemic emergencies, taking into account relevant guidelines; 

(b) converge and/or align and, where possible, harmonize relevant technical and regulatory requirements, in accordance with applicable international standards and guidance;”

Similarly, Article 16.7 states: “Each Party may consider adopting, within the limits of its national legislation, policies and legal practices, guidance and technical documents concerning medical products from relevant international regulatory harmonization initiatives or organizations and other relevant global or regional regulatory forums”.

Thus, the scope of these provisions goes beyond pandemic-related products and covers the entire spectrum of health products regulation.

This is further clear from Article 16.8 which indirectly pushes standards of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The proposed Article 16.8 states:

“The Parties shall undertake to cooperate, to the extent possible, directly or indirectly and/or through relevant international bodies including WHO and other relevant partners, to support and improve regulatory capacity with the goal of enhancing the maturity level of the regulatory bodies, as assessed by WHO, and facilitating equitable geographical distribution and scaling up of the global production of medical products”.

Though there is no explicit reference to ICH the term “relevant international bodies” is a clear indication of ICH. Article 16.8 is a modified text and was presented and discussed during the 8^th meeting of the INB. That text reads:

“Each Party shall consider adopting and implementing, when practicable and consistent with national law and procedures, guidance and technical documents concerning medical products developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Medical Device Regulators Forum (IMDRF) or their successor organizations”.

The revised draft negotiating text replaced ICH and the International Medical Device Regulators Forum (IMDRF) with relevant international bodies.  Adoption of ICH and IMDRF standards involve higher compliance cost and is beyond the reach of most of the developing country producers where national regulatory laws already comply with established and recognised Good Manufacturing Practices.

A WHO meeting report on the impact of the implementation of ICH Guidelines in Non-ICH countries states:

“The public health implications of the application of guidelines of greater technical complexity in developing countries may be far-reaching.  In many countries, essential drugs required for the prevention and treatment of locally endemic conditions are not supplied by major multinationals, but by local industry or by generic manufacturers. If these suppliers are unable to meet what may unsubstantiated quality standards the adverse impact of withdrawal of these drugs on the health of the population might well be far more dramatic than that of any hypothetical risk posed by failing to achieve the ICH standards”.

Thus, the legitimisation of harmonisation of ICH and IMDRF standards through the pandemic instrument can lead to more concentration and dependency, the exact situation which the pandemic instrument was promised to change.+