TWN Info Service on Health Issues
18 October 2021
Third World Network
www.twn.my

WHO: US ‘non-paper’ on equity reinforces its pharmaceutical industry dominance

Kochi/New Delhi, 18 October (Nithin Ramakrishnan and K M Gopakumar) – The United States’ non-paper on equity submitted to the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR) reinforces and maintains the status quo of its dominance in the global pharmaceutical industry.

An intersessional meeting of the WGPR, working under a World Health Assembly mandate, will discuss equity today (18 October). The non-paper was submitted during the third meeting of the WGPR, which took place on 4 to 6 October.

Apart from the US there were three other non-papers dealing with various elements of the proposed pandemic treaty or strengthening International Health Regulations (IHR) 2005. The IHR 2005 is the international law providing for internationally collaboration for public health response to a “public health emergency of international concern” (PHEIC) under the aegis of WHO and its Member States.

[The term “pandemic” is not found in international health law; the IHR 2005 term is “public health emergency of international concern”.]

Switzerland’s non-paper is on certain targeted amendments to the IHR 2005, while New Zealand submitted a list of identified legal principles and approaches to international pandemic prevention, preparedness and response. The Group of Friends of a Pandemic Treaty also submitted a non-paper which explains the benefits of developing a new legally binding instrument on pandemic preparedness and response. New Zealand and the Friends of a Pandemic Treaty also address the issue of equity, although in a limited fashion.

The US non-paper identifies the following 6 areas for further discussions:

• Research and development for public health emergency response
•  Promoting rapid access to public health emergency response products
•  Strengthening regulatory systems for public health emergency response
•  Expanding manufacturing capacity for public health emergency response products, including necessary input materials
•  Improving purchasing and procurement mechanisms
• Improving liability protection and compensation mechanisms.

Each of these elements contains further supplements.

Research and Development (R&D) for public health emergency: The non-paper proposes discussions on the following four sub elements of R&D: (i) approaches to information sharing, (ii) approaches to facilitate linkage between stakeholders and the appropriate role of WHO, (iii) options for global R&D collaboration, building from efforts of CEPI (Coalition for Epidemic Preparedness Innovations), the WHO R&D Blueprint, and ACT-A [Access to COVID19 Tools (ACT) Accelerator ( ACT-A)], and (iv) options for rapid, transparent, and open sharing of information and samples, including pathogens, clinical samples, genetic sequence data. However, the proposal on R&D does not offer a framework to carry out R&D or to share of R&D outcomes. It is even silent on the current mechanisms to share information such as WHO’s Global Observatory on Health R&D.

Access to pathogens and related information without benefit sharing: The non-paper pitches for the rapid and open sharing of information on pathogens including genetic sequence data under two proposals viz. R&D for public health and promoting rapid access to public health emergency products. In both these contexts, the non-paper is silent on benefit sharing. This is inconsistent with the provisions of the Convention on Biological Diversity and its Nagoya Protocol, which make benefit sharing part of the obligation when there is access to genetic materials. The US proposal is thus aimed at facilitating free access to genetic materials for the pharmaceutical industry to produce diagnostics, vaccines and therapeutics. The pharma industry uses free access to develop various health products and then uses intellectual property (IP) to exercise monopoly over these products. The use of IP results in the remote possibility of benefit sharing by preventing others in the industry from developing the generic or follow-on products.

Strengthening Regulatory Systems: The US proposal on strengthening regulatory systems is further pushing for regulatory harmonisation and regulatory reliance in the name of equity. One of the sub-elements states: “National and regional regulatory capacity building, harmonization, reliance, etc., including efforts at International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Medical Device Regulators Forum (IMDRF), and International Coalition of Medicines Regulatory Authorities (ICMRA), to facilitate harmonization of regulatory
requirements, submission review processes, inspections, and regulatory reliance mechanisms/work-sharing, etc., among countries”.

Regulatory harmonisation with standards of the International Council on Harmonisation (ICH) and the International Medical Device Regulators Forum (IMDRF) results in ‘upgrading’ of regulatory standards almost to the level of developed country requirements. This would increase the compliance cost of the local industry of developing countries and adversely impact the local production of medicines, vaccines, and devices. Many of the so-called ‘stringent standards’ are often regulatory barriers to entry of generic competition without adding to safety, efficacy and quality.

According to the WHO Report of an Experts Meeting examining the impact of the implementation of ICH Guidelines in Non-ICH countries, “In many countries, essential drugs required for the prevention and treatment of locally endemic conditions are not supplied by the major multinationals, but by local industry or by generic manufacturers. If these suppliers are unable to meet what may be unsubstantiated quality standards, the adverse impact of the 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.”

Further, while the regulatory reliance on a Stringent Regulatory Authority (SRA), predominantly in developed countries, has the potential to expediate regulatory approval at the national level and thus expediate access, it bears the danger of putting the burden of protecting the trade secrets related to the manufacturing process of vaccines, bio-therapeutics etc. on the regulatory agency which is relying on the SRA or WHO. This is because the full dossier is submitted to a SRA and there is no guarantee that the SRA shares the same with the relying regulatory authority. Further, even if shared, it imposes conditions to maintain confidentiality. As a result, in the case of regulatory reliance, the regulatory authorities in developing countries would not be able to make use of public health exceptions against trade secret protection, which may in turn make compulsory license ineffective in the case medical products such as vaccines and biotherapeutics.

[Regulatory reliance is an act whereby a National Regulatory Authority (NRA) in one jurisdiction may take into account and give significant weight to assessments performed by another NRA or trusted institution, or to any other authoritative information in reaching its own decision. The relying authority remains independent, responsible and accountable regarding the decisions taken, even when it relies on the decisions and information of others.]

Promotion of Voluntary License: The US non-paper openly promotes voluntary licensing (VL) for the diversification of manufacturing and undermines the need for suspension of IP or the use of public interest measures such as compulsory license to promote local production. Proposal 4 in the non-paper on expanding manufacturing capacity for public health emergency response products, including necessary input materials, contains three references to VL. These are:

• Approaches for expansion and strategic geographic distribution of public health response product manufacturing capacity to address needs across all regions and promote equitable access to these products, including through voluntary technology transfer hubs and voluntary licensing of public health response products and technologies on mutually agreed terms.
• Promotion of more timely and equitable access to public health response technologies originally developed by government entities, such as through the use of non-exclusive voluntary licensing of these technologies on mutually agreed terms to developing countries.
• Promotion and facilitation of voluntary licensing of critical public health response products by manufacturers on mutually agreed terms, including the voluntary transfer of technology and know-how on such terms.

It is interesting to note that VL is the preferred mode of technology transfer even on technologies developed by government entities. So far, the experiences of VL show that it divides the market and excludes many low middle income developing countries like Brazil, Malaysia etc. from the scope of VL. Further, VL functions like a private ordaining and undermines the State’s ability to ensure access to affordable medical products. In the COVID-19 context, Gilead Sciences issued several VL on the questionable patents on remdesivir, a drug thought to be of therapeutic value in the first months of the pandemic.

Institutionalisation of failed mechanisms such as ACT-A and COVAX: Another example of reinforcing the status quo is the institutionalisation of failed mechanisms like ACT-A and COVAX (COVID-19 Vaccines Global Access). The proposal on promoting rapid access to public health emergency products states: “Approaches to facilitate and coordinate equitable, timely access to critical public health emergency response products during emergencies, building on the lessons learned from ACT-A and COVAX.”

Another proposal on R&D also proposes the building on R&D efforts like the WHO R&D Blueprint and ACT-A. One of the primary objectives of ACT-A is equitable access to medical products required for COVID-19 response. ACT-A, having 4 pillars viz, therapeutics, diagnostics, vaccines, and health systems, has failed to deliver on its promise. Similarly, COVAX has failed to deliver the vaccine doses to cover even 20% of the population of low income countries that signed up for the free doses. Both these mechanisms did not take effective measures to challenge the monopoly on COVID-19 medical products and never promoted the idea diversification of manufacturing beyond VL.

A review carried out by the consulting firm Dalberg on ACT-A states: “Donor country voices and perspectives tend to dominate L/MICs’ contributions, posing risks of developing solutions that are not truly responsive to recipient countries’ needs.” On representation and participation, it highlights the “Insufficient inclusion and meaningful engagement of LMICs, regional bodies, CSOs, and community representatives.”

Further, both ACT-A and COVAX lack accountability to, and effective participation of, the WHO Member States.

Though the proposed topics for discussion focus entirely on the various aspects of equity access to medical products required for health emergency preparedness and response, the non-paper ignores other elements of equity such as resources for the maintenance of health systems, transparency in the technical assistance, and economic stress resulting from a health emergency. In an indirect justification for its narrow focus the non-paper states: “Recognizing that many of the issues covered by the broad concept of equity involve other international organizations and entities, engagement on these issues with them is essential and they need to be at the table to help address these issues”.

The other non-papers submitted by New Zealand and Friends of the Pandemic Treaty also lack concrete proposals on equity.

New Zealand aspires to strengthen several aspects of equity at two levels, one at the international level and second at the national level. It also provides its basis for equity in the public health emergency law, i.e. equity is founded on the fundamental human right to enjoy the highest attainable standard of health without distinction of race, religion, political belief, economic or social condition, based on the WHO Constitution, UN Charter and other international instruments on human rights. Equity also lies in the recognition that an inequitable approach is ineffective to responding to risks of pandemics.

The Friends of the Pandemic Treaty’s non-paper speaks about equity in the context of equitable access to quality medical measures. Although it recognizes the importance of increasing the need for local production, strengthening regulatory systems and putting in place long-term mechanisms to improve equitable access, the non-paper calls only for “a framework for concrete measures to develop, manufacture and scale up new countermeasures, and improve equitable access to existing countermeasures.”

Secretariat’s Deep Dive Session on Equity and the Guiding Questions

Meanwhile, the WHO Secretariat has circulated a list of guiding questions to facilitate discussions during the 18 October deep dive on equity and medical countermeasures and sample sharing (benefits derived there-of). The questions are as follows:

“1. Do the existing mechanisms including the IHR (2005), suffice to address sample sharing and the equitable access to the medical countermeasures derived?

2. Based on the lessons learnt from the COVID-19 pandemic, and the various initiatives aimed at increasing equitable access to COVID-19 vaccines including through voluntary licensing and technology transfer arrangements and a call by the IPPPR as well as the WHO DG to increase access, what immediate actions or measures are available to address inequitable access to vaccine and countermeasures?

3. What are innovative ways to address inequitable access to vaccines and countermeasures during the pandemic, and how will these work with existing mechanisms and tools

4. How will the following be addressed/considered in order to assure equitable access to countermeasures for vaccines, diagnostics, therapeutics, PPE and other medical tools in the context of a global pandemic?

• Sample sharing
• Research and Development
• Intellectual Property
• Transparency
• National, Regional, Global Supply Chains and Regulatory systems

5. What role does Member States that host manufacturers and developers of vaccines and countermeasures play in facilitating equitable access to these products?

6. How can the private sector in all countries be brought productively into these discussions so that they can be a meaningful part of the solutions we are developing”

It is evident from the above quote that the deep dive guiding questions are only on medical countermeasures and sample sharing. They do not cover other aspects of equity such as the requirements in the building of health systems.

The Secretariat’s document also adapts the words from the non-paper of New Zealand in its attempt to define the context of equity as “the fundamental human right to enjoy the highest attainable standard of health without distinction of race, religion, political belief, economic or social condition, and ensure that these rights are upheld during response to a pandemic”. This definition does not make any reference to the duty to cooperate of Member States as a foundational legal obligation to ensure equity in international health response. It is more about national level obligations of States. Further, it limits the idea to of equity to “pandemic response”, though the WGPR mandate is the strengthening WHO preparedness and response to health emergencies.

Similar to the 3 non-papers mentioned above, the Secretariat’s document is also making attempts to reinforce the status quo and institutionalize mechanisms like ACT-A in addressing equitable access to health care products and services. It states: “Building on the current ACT-A framework, this (addressing equitable access) might include several areas of focus: timely and equitable distribution of countermeasures including vaccines, therapeutics, diagnostics, and health systems strengthening and the health systems connector; rapid sample sharing; advancing and speeding research and development; strengthening regulatory systems; sharing of technology and know-how for broadening manufacturing capacity across all regions through voluntary licenses and technology transfer and capacity-building; and social protection, health systems strengthening and universal health coverage (UHC)”.

Though social protection, health systems strengthening and UHC is mentioned in the document, not a single guiding question is raised in this regard for the deep dive discussion.

Therefore, it is doubtful whether there is any concrete proposal to enhance equitable access so far under the consideration of WGPR. Most of the recommendations seem to promote market options rather than a legal commitment to enhance equity, unlike IHR 2005. IHR 2005 establishes the duty to cooperate in numerous provisions and also recognizes the special needs and circumstances of the developing countries in building core capacities of preparedness and response to health emergencies. These provisions together form the basis for equity in health emergency preparedness and response.

IHR 2005 provides for three types of duty to cooperate for the States: (1) direct inter-state collaboration and assistance, (2) collaboration and assistance through WHO, and (3) interorganizational collaboration. Under the first type, providing for equitable access is a primary obligation, while under the other two, it is a subsidiary obligation. On one hand, IHR in this sense represents a break from the colonial form of international health response to epidemics that is fully based on sanitary and quarantine measures.

On the other hand, there are no mechanisms or guidelines available to implement the duty to cooperate in IHR especially under Articles 5, 13 and 44. In the absence of effective implementation of the legal obligations of IHR containing equity, the regulations continue to function as a colonial instrument. i.e. it imposes legal obligations on the developing countries to inform on the outbreak of diseases to the international community and allows the developed countries to take steps to protect its population without a corresponding legal obligation to provide the necessary assistance to the informing countries to effectively respond to the outbreak.+