When signing contracts with Big Pharma, read the fine print first

As the World Health Assembly (WHA), WHO’s governing body, is gathered this week for its Seventy-fifth annual session—for the best coverage in town, follow our colleagues at Health Policy Watch—it may come as no surprise that when discussing health, conversations about its politics are more transparent and open than conversations about its business. And healthcare is big business: over the past twenty years, it is estimated that the global pharmaceutical market has experienced significant growth, jumping from $390 billion in 2001 to $1.27 trillion in 2021.

And so, in the end, talks about the future of the world’s health architecture will also be defined in large part by fiendishly complex and confidential agreements signed between governments, pharmaceutical companies, and an extended network of global actors, including health activists and civil society.

From the very first stage of the pandemic, even before they knew whether their vaccines would be effective or gain eventual approval, some manufacturers set draconian conditions and criteria in their contracts to sell doses to governments. When AstraZeneca signed a huge contract with Brazil, for instance, it contained the condition that should its vaccine fail to be effective against COVID-19, no reimbursement could be claimed. First revealed by the FT, an MoU also contained a clause that AstraZeneca, who had pledged “not to profit during the pandemic,” would be able to declare the end point of the pandemic, thus becoming free to raise its prices. AstraZeneca had set July 2021 as the date—a wildly off-target prediction.

A 2020 report by the British-based Bureau of Investigative Journalism revealed that Latin American countries accused Pfizer of “high-level bullying” during COVID-19 vaccine negotiations.

According to the report, the company demanded additional indemnity against any civil lawsuits citizens might file in relation to Pfizer’s vaccine. This would include cases brought due to Pfizer’s own negligence, fraud, or malice. Pfizer also reportedly asked governments to put up sovereign assets, including military bases and federal bank reserves, as collateral for potential future legal costs.

It is thus no surprise that negotiations in Geneva and beyond about the role of WHO and the future of the global health architecture will see some serious confrontations.

Many governments who feel they have been subjected to unacceptable commercial pressure from manufacturers will push for transparency when treaties and agreements are negotiated—whether deciding to set up a new outbreak alert system, a new cooperation mechanism for the exchange of medical samples, or regarding IP-related issues.

Governments of emerging countries also insist greater access to vaccines, treatments, and technology must be made mandatory whenever an emergency is declared by WHO under the provisions contained in the International Health Regulations. The proposal is supported by India, South Africa, China, Pakistan, Indonesia, Argentina, Brazil, and other developing nations.

The US and the EU are adamant in insisting that triggering such a mechanism should only occur when a pandemic is declared, not in cases of more limited outbreaks. For the supporters of the proposal, however, activating flexibilities every fifty years or so would effectively render such an agreement useless, and would lead to the same dramatic inequalities in vaccine access and treatment that marked the early stages of the COVID-19 pandemic.

The discussion will extend long after the conclusion of the WHA. Some diplomats predict that tensions will arise later this year when the negotiations start in earnest. They will include an attempt to define the legal status of a pandemic.

But despite these profound divergences, real progress has been made to address the inequity in access to COVID-19 vaccines. The most important and successful initiative to remedy this structural inequity is undoubtedly the mRNA Technology Transfer Hub Program launched by WHO with the aim of establishing sustainable, locally-owned mRNA manufacturing capabilities in and for low-and middle-income countries (LMICs). South Africa’s Afrigen was selected in June 2021 as the main hub for the program. In August of 2022, after barely two months, Afrigen developed a copy of the Moderna vaccine using a recipe formulated from publicly available information about existing shots. As the program hub, Afrigen provides technology and training to a network of so-called “spokes” around the world, which, after passing the pilot phase, will produce the mRNA vaccines locally.

The initiative constitutes a major step towards empowering LMICs to not only make their own mRNA vaccines, but ultimately to have the choice of which vaccines they want to make. It could take as long as two years, however, for WHO’s partners to fully develop and get approval for their own mRNA COVID-19 jabs.

"The technology transfer center goes beyond the fight against inequalities of access: today, it is a fight … against COVID, and tomorrow it will ensure the full health sovereignty of countries and equitable access to vaccines,” French Global Health Ambassador Stéphanie Seydoux said last Monday (May 23) during an event at the French Mission.

The consensus among the panelists was that for the program to be impactful, it will need first to deliver on all the milestones for the development of this first COVID-19 vaccine, including its approval. The mRNA platform should be suitable for learning, and for technology development and innovation in LMICs, and the initiative must be able to create the capacity not only to design vaccines but also to ensure their end-to-end production and delivery over the so-called “last mile”, so people can be vaccinated.

But there are potentially severe hurdles that could impede the effort, and one of them is of an economic and commercial nature. In essence, the mRNA vaccine hub program bypasses major pharmaceutical producers. COVID-19 vaccines were developed with public funds. Yet, the manufacturers may hold the key to the success of the venture, and it is far from clear if they are willing to compromise and cease operating on a strictly profit-led logic. Moderna’s patents in South Africa, for instance, give the company the right to stop anyone from producing or selling an mRNA vaccine in the country—such as the one developed by the Hub.