In light of the global impact of the COVID pandemic, the World Health Organization (WHO) established a process to negotiate an agreement to better prevent, prepare for and respond to future pandemics (commonly known as the “pandemic accord”). Since February 2023, governments have been negotiating the text of the accord, and an outcome is expected to be presented in May 2024 at the World Health Assembly.
As an international medical humanitarian organisation that provides medical care to people during crises, Médecins Sans Frontières/Doctors Without Borders (MSF) has responded to many infectious disease outbreaks, epidemics and pandemics over the last 50 years. These experiences have shown that timely, equitable and affordable access to medical products such as medicines, vaccines and diagnostic tests is crucial for an effective response to health emergencies. Based on our experiences, we believe that governments must take the following steps to ensure that the global pandemic accord safeguards access to medical products.
1. Prioritise global equitable access and medical humanitarian needs in international stockpiling and allocation efforts
Building and maintaining stocks of medical products is an important strategy to help prepare for and respond to health emergencies. Stockpiles of medical products can be established by countries to get better prepared for an emergency in advance. They can also be established and managed at an international level for outbreak response, to ensure rapid activation and delivery to countries when an emergency occurs. International stockpiles are especially critical when there is an anticipated shortage of supply globally, and they have proven effective at ensuring equitable access during multiple outbreaks.
However, some national stockpiling efforts could compete with needs internationally. Stockpiled treatments for Ebola virus disease are a case in point. While there are now two approved treatments for Ebola virus disease, almost all of the global supply sits unused in the national biosecurity stockpile of the US. As a result, people most affected by Ebola in countries where the disease is endemic are left relying only on ad hoc donations in order to be treated. To date, no international stockpiling and allocation mechanism is available to secure supply for possible new outbreaks.
MSF teams also saw how people living in conflict zones and other humanitarian settings were often left behind when it came to access to COVID medical products. While a global mechanism was created during the COVID pandemic to provide vaccines to people in humanitarian settings, it proved excessively lengthy, complex, opaque, and ultimately not fit for purpose, when MSF tried using it.
The accord needs to specify clear rules to ensure supply for international stockpiling for the purpose of global equitable access, and to prevent national stockpiling efforts from competing against global access needs. Humanitarian and public health needs should be put at the centre of priority setting and decision making for stockpiling and allocation efforts.
2. Address intellectual property challenges for the protection of the right to health and access to medicines
MSF’s experience of responding to HIV, TB, Ebola, COVID and other infectious diseases has made it clear that market monopolies supported by intellectual property (IP) can obstruct timely and equitable access to lifesaving medical products by people in need. Major pharmaceutical corporations often use IP as a tool to exclude competitors and charge high prices.
While international trade law contains some flexibilities to allow governments to overcome IP barriers, not all states have these flexibilities incorporated into their national laws. Countries also often face challenges when trade and investment negotiations threaten to undermine their ability to use these flexibilities.
The accord needs to specify governments’ responsibility to incorporate and use all possible legal flexibilities for the broadest possible access to medical products, both to prepare for and respond to health emergencies. Attempts to introduce more stringent rules around IP in trade negotiations must be quashed. Governments must also agree on time-bound waivers on IP as an additional measure to support the rapid increase of global production and supply of medical products in an emergency.
3. Ensure medical products that benefit from public contributions are accessible to people who need them
Governmental and public support is vital to biomedical innovation. The public sector makes substantial contributions to research and development (R&D) through grants, subsidies and tax credits. However, access to publicly funded medical products that are needed globally is often restricted because the private sector is allowed to claim IP ownership for itself and determine pricing, production and supply of medical products. This is mostly because public investments into R&D do not come with clear conditions to ensure global access.
The example of the TB drug bedaquiline—the first new drug in half a century to treat the world’s leading infectious killer—is a case in point. Research estimated that public contribution to the development of bedaquiline was five times more than that by Johnson & Johnson (J&J), the corporation that received a patent for it. Yet, this public investment did not result in access to the medicine by people who needed it, particularly in low- and middle-income countries (LMICs), as J&J priced the medicine out of reach for a decade since it was launched in 2012.
Beyond countries that contribute financially to the R&D of medical products, communities in developing countries also often make vital contributions by hosting and joining clinical trials which generate crucial data that eventually allows a product to be developed and approved. Yet their contributions go totally unrecognised. While there are existing international medical and ethical guidelines on ensuring post-clinical trial benefit sharing with communities participating in the trials, and with developing countries with medical needs, these guidelines are poorly implemented.
The pandemic accord needs to include rules that introduce conditions to ensure access to medical products whose development has benefitted from public funding. These conditions can include pricing products affordably and transparently, licensing the product to multiple producers in different parts of the world to help ensure sufficient supply and overcome potential shortages, making the product available to global stockpiles, and corporations being transparent about pricing, costs, IP status, and supply capacity. We also need agreement on rules to incorporate international medical ethical guidelines to ensure post-clinical trial access to the end products, especially by communities in developing countries.
4. Safeguard transparency, accountability and the public’s right to information by restricting confidentiality and trade secrets
Access to information is an important determinant of timely, reliable and affordable access to medical products. But in MSF’s experience, obtaining relevant information has often proven challenging, both during and outside of pandemics.
For instance, while pharmaceutical corporations often claim that high prices for drugs and other medical products are based on the high costs of R&D, they do not typically disclose these costs. This makes it hard to estimate if and how R&D costs influence the price of products, and to negotiate fairer prices.
Information on pricing, IP and licensing, and production and supply of medical products in funding and purchase agreements is also essential to understanding access options and to holding pharmaceutical corporations and governments accountable, but this is also often unavailable due to confidentiality claims by corporations.
While the accord recognises transparency as a key principle, it should go further and introduce obligations for governments to increase access to information and prohibit the use of confidentiality clauses, especially in procurement and purchase agreements when access to medical products is at stake. At the very least, transparency commitments from World Health Assembly Resolution 72.8 on transparency should be introduced as mandatory requirements.
5. Introduce an international access and benefit-sharing mechanism to ensure fruits of R&D are shared fairly with all contributors
The timely sharing of biological materials such as pathogens is an essential component of international health cooperation, and it plays a crucial role in preparedness for and response to global health emergencies. The sharing of pathogens and related sequence data with scientists and laboratories enables the development of medical products such as diagnostic kits, medicines, and vaccines. However, as the COVID pandemic showed, there is no global mechanism to ensure that pharmaceutical corporations that access pathogens and related data for product development share the products adequately to enable equitable access of their products at the global level.
The principle of access and benefit sharing can remedy this injustice by placing obligations on entities to share benefits resulting from their access and use of genetic resources. It originated in the context of the 1992 Convention on Biological Diversity, and has been given shape in the field of global health through WHO’s Pandemic Influenza Preparedness Framework.
An international access and benefit-sharing mechanism has been proposed in the pandemic accord negotiations. Concrete benefit-sharing requirements that can result in fair and equitable access to medical products should include dedicating a portion of global production and supply to global stockpiling and equitable allocation mechanisms, and transfer of technology and know-how to manufacturers, particularly in resource-limited countries and regions.