Business interests vs vaccine idealism at CEPI

Øyunn Holen has stood by a hospital bed many times, knowing that that there is a vaccine out there that could save the patient fighting for life right in front of her eyes. Yet, the Norwegian doctor continued to be a helpless witness to death.

“I ran from one dying child to another, but felt that I made no difference,” Holen says about her experience during a measles epidemic in Angola many years ago.

She was on a mission for Doctors Without Borders (also known as Médecins Sans Frontières, the humanitarian medical non-profit), and this was the first of her many encounters with a brutal reality: countries that can pay for vaccines protect their people. Countries that cannot, leave people to their own fate, at the mercy of charities and other philanthropic givers.

Sara Creata | MSF
Øyunn Holen at an MSF clinic in Bangladesh | Photo: Sara Creta/MSF

“I had to tell parents who had just seen their child die that ‘there is nothing more we can do’,” says Holen. “And when the mother and father prayed to God, I felt that they should have been angry instead. Because it didn’t have to be like this.”

Global battleground

Today, the battle for fair access to a vaccine is on again — on a larger scale than ever.

Everyone is waiting for the vaccine that can end the Covid-19 nightmare. But, if and when it comes, who will own it, who will get it, in what order and at what price? One young, Norway-based organisation is deeply enmeshed in these questions.

An anonymous concrete building along Ring 2 in Oslo is an important front line in the battle for the Covid-19 vaccine. CEPI — Coalition for Epidemic Preparedness Innovations — employs many people who are well-versed in the contradictions between securing life-saving vaccines for everyone, and the business model on which the pharmaceutical industry is based. Long before 7.8 billion people learned to say “corona”, CEPI had become an arena for a tug-of-war between the interests of the pharmaceutical giants and the call for fair and equitable vaccine distribution.

When idealism collided head-on with other considerations, idealism had to give way.

Doctors Without Borders (MSF), which found itself in the midst of this struggle, used harsh words to describe the situation. In March 2019, Joanne Liu, president of MSF International, wrote an open letter stating that a new set of CEPI rules “betrays the interests of everyone who invested in CEPI because they wanted to change the deadly status quo”.

CEPI, however, doesn’t see it that way.

“We have become more realistic,” argues Frederik Kristensen, deputy head of CEPI. “We have gained a lot of experience in having to negotiate based on reality.”

Paying with public money

The entrance to the Coalition for Epidemic Preparedness Innovations is easily overlooked. It is located between a bicycle shop and a hi-fi center, along a busy ring road in Oslo. But in the last six months, CEPI has been thrust on to centre stage in the drama surrounding the vaccine that the whole world is waiting for.

The coronavirus has killed more than 980,000 people and is holding all economies hostage. Governments are digging deep into public pockets to help the pharmaceutical industry develop a vaccine. Many heads of governments in low and middle income countries are demanding that this vaccine become a global common good — a “people’s vaccine”.

CEPI came into existence in Davos in 2017 | Photo: CEPI

But this demand runs contrary to the system that regulates access to vaccines. It is a system based on patent rights, market forces and the pharmaceutical industry’s consideration of its bottom lines.

An amount of 1.4 billion USD, which has been allocated internationally, goes through the organization in Oslo. CEPI distributes the money to research groups and biotechnology and pharmaceutical companies that are developing a Covid-19 vaccine. Currently, nine different vaccine candidates have received CEPI’s commitments for support — two of them with several hundred million USD each. The money is partly loans that must be repaid if the recipient makes profits on their vaccine in the future.

Together with the World Health Organization and the vaccine alliance, GAVI, CEPI plays a pivotal role in the historic attempt to establish a global procurement scheme for the Covid-19 vaccine. This initiative aims to ensure that all countries have fair access. It is an effort to prevent wealthier states from buying up a disproportionate share of the supply, which is what happened during the 2009 swine flu epidemic.

Many states channel public money through CEPI. But it was Norway, India, Germany, Japan, the British Wellcome Trust, the Bill & Melinda Gates Foundation and the World Economic Forum that provided the start-up capital when the organization was established in 2017.

Major biotechnology and pharmaceutical companies supported the initiative. The purpose was to enable state authorities, industry and non-profit organizations to work together and alleviate some of the brutal effects of market forces. CEPI would help ensure that there would be vaccines accessible to everyone during times of need, regardless of whether the recipients could afford them.

Ebola: An unnecessary epidemic

CEPI was born in the wake of another scary virus; the Ebola epidemic. Most Europeans watched on from a safe distance, while the epidemic caused rapid death in West Africa. 11,000 people lost their lives, and economies were shattered. Healthcare professionals protected themselves in what looked like spacesuits.

The world’s response to Ebola was weak. A vaccine had been under development for over ten years, but it was not distributed until the epidemic had lasted for over a year. “That vaccine was shown to be 100 per cent effective, suggesting that much of the epidemic could have been prevented,” says CEPI.

Franck Ngonga/MSF
MSF staff at an Ebola treatment centre in the Democratic Republic of Congo | Photo: MSF

MSF doctors and nurses remember feeling helpless during the Ebola epidemic. One health worker described the work as an attempt to “extinguish a fire with a spray bottle”. It was in the backdrop of this context that MSF president Joanne Liu joined the CEPI board to “change the deadly status quo.”

Pioneering policy

However, at CEPI, Liu soon found herself in a fierce battle over the design of the policy for fair access to vaccines. Among the parties were two major drug companies: Takeda from Japan and British GSK, according to Katy Athersuch, who was a senior adviser in the MSF Access Campaign until recently.

“We were shocked that these companies were invited to the table to discuss how the policy would be. This told us that the direction was business as usual. But we wanted to give our best to influence the result. We were not prepared to let GSK or Takeda define the policy,” says Athersuch.

A set of rules was ready after six months. It was a compromise, but MSF believed that it was quite clear and binding in outlining how CEPI would protect public health interests.

Companies that received money to develop vaccines would have to agree in advance how the price would be determined. In this way, it would be at a level that would be affordable for those who needed the vaccine. At the same time, it should be sustainable for the manufacturer.

This was something new.

The manufacturer would own the patent, as per standard practice However, CEPI demanded the right to take over all knowledge and all materials from developers who might not be able to — or want to — continue the work they had begun. CEPI also wanted a share of profits from the sale of vaccines that had been developed with its help. This money would be invested in new projects.

Forced to retreat

Richard Hatchett, who has been CEO of CEPI since 2017, believes that the pharmaceutical industry did not like this model. Hatchett — who left his job as deputy director of BARDA (the agency of the US Department of Health that helps develop and buys vaccines) — describes what happened to CEPI’s policy in this article.

CEPI’s policy mirrored the idealism that inspired its creation. However, several multinational vaccine companies said it did not “reflect the business realities confronted by vaccine developers”, according to Hatchett. They were also concerned that it might set a precedent “if an outside entity, in this case CEPI” would be allowed to set the price of a product unilaterally.

For the industry, the provisions were not “consistent with a competitive business model”, wrote the CEO.

Some companies were ready to use force to get CEPI to toe their line. The disagreement led “several capable vaccine manufacturers with demonstrated track records of bringing vaccines to licensure to declare that they could not work with CEPI under the provisions of the policy,” writes Hatchett.

Richard Hatchett does not mention the names of these companies, but journalist Gerald Posner does. In an article in the New York Times, the author of the book, Pharma. Greed, lies and the poisoning of America, names the American companies Johnson & Johnson and Pfizer, as well as the Japanese Takeda, among those who “pushed back”.

Investigate Europe has asked these three companies, as well as Merck (USA) and European GSK and Sanofi, what they thought of CEPI’s initial policy. Only Pfizer and Takeda responded. In an email, Pfizer says that CEPI remains an important public-private partnership that facilitates new vaccine research and development:

“The private sector, including Pfizer, plays a critical role in ensuring access to life-saving vaccines, along with policy makers, governments and delivery partners who make the decisions that determine whether, and how quickly, individuals will have access to immunizations.”

Spokesperson at Pfizer

Takeda, who is represented on the board of CEPI, advised us to pose the questions to CEPI.

“Alarming step backwards”

After a year of discussion with the pharmaceutical industry and MSF, CEPI changed its rules. The original policy filled 13 pages. The new rules took up less than three.

CEPI says the first policy was always intended to be temporary. The management believes it carried out a “broad and inclusive” process to revise it.

“It was a fait accompli. We participated in the consultation process for a revised policy. But they did not listen to us at all; none of our comments were taken on board,” says ex-MSF employee Katy Athersuch. The aid organization was disappointed. MSF president and CEPI board member Joanne Liu thought the new rules were “vague” and “toothless”.

This is “an alarming step backwards for the organisation because it no longer guarantees that the vaccines CEPI funds will be made available at an affordable price,” she wrote in a letter to the board.

MSF no longer sits on CEPI’s board, which has been reduced from 20 to 12 members. Nor do any other NGOs.

Influential Americans

Investigate Europe is aware that American companies were the most critical of CEPI’s first policy. This does not surprise journalist Gerald Posner.

“It goes against their DNA to agree to anything that requires a sharing of intellectual property and that in the remotest instance talks about price limitations,” he says.

Posner does not believe that European companies are less interested in maximising profits.

A young girl receives a vaccination in Kinshasa | Photo: MSF

“But they work inside a system where they understand there are restrictions. American pharma, however, has unfettered power to set prices. There are no negotiations. So they feel powerful, and they view the European model as something they have to put up with; they have to negotiate with governments, but they don’t like it. They always try to squeeze profits until the last dollar. Why would they change just because CEPI asked them to?”

However, CEPI states that vaccine companies have never defined its rules for fair access. “But the process taught CEPI to relate to realpolitik and real market mechanisms,” concedes CEPI’s deputy director, Frederik Kristensen, adding, “When we drew the first map, many gave more thought to how we wanted the world to be. Some of the elements of the first policy are not real alternatives. We could have slapped ourselves on the chest and said this is the way to go. But then we would have no vaccines. And the first commandment for a fair distribution of vaccines is that there actually are vaccines.”

Fear of losing out

Why did American companies in particular opposite CEPI’s first policy?

Norwegian social scientist Kristin Ingstad Sandberg, senior researcher on global health at Fridtjof Nansen’s Institute, has an answer. She interviewed representatives from many of the large companies with which CEPI works closely. The Americans were particularly concerned that it would not be possible to “fence in” CEPI’s policy on price, so that it would only apply to low-income countries, she says.

“What is the big difference in ability to pay between people in rural Kenya and in a poor southern state of the US? They feared there would be demands that CEPI’s principles should also apply in the USA,” explains Sandberg.

Devil is in the details

According to Frederik Kristensen, CEPI’s goals are not incompatible with MSF: both organisations want fair access to vaccines. “They had ambitions to change the interaction between industry, state authorities and others,” he says. “But we are not big enough for that. Nor is it our role to do so. We believe that we are reaching agreements that are revolutionary enough. We ensure low-income countries access to vaccines that they would not have received without us.”

But exactly how this happens, the public does not know. Details that were previously in the publicly-accessible policy document are now only found in contracts that few have access to.

This is not good enough, believes Katy Athersuch. “Transparency and accountability are key here — these are the values CEPI was supposed to be built on. How do we know that CEPI makes good agreements with the public money they get? The devil is always in the details, and the details are not available for the public. We are just told to trust the secretariat”.

The governments that have provided the money have access to the contracts on behalf of the public. CEPI has also published a summary of the contracts on its website, according to Kristensen. “I think we are far ahead in terms of transparency. But I note that some want us to go further. Unfortunately, I think that is unrealistic,” he says.

Norway’s Minister of International Development, Dag-Inge Ulstein, writes in an e-mail that he is happy that the guidelines from CEPI on fair distribution are so clear.

“Norway has allocated two billion NOK (approximately €190 million) this year, which CEPI will pass on to companies that may be able to develop the vaccine everyone is waiting for. For the government, CEPI’s policy on fair access is absolutely central to Norwegian support for the organization,” he states.

Unbalanced power

Such a huge amount should trigger more discussion, according to Katerini T. Storeng and Antoine de Bengy Puyvallée. The two social scientists at the University of Oslo are about to begin a large study of private-public initiatives for pandemic preparedness.

They will study how CEPI and the vaccine alliance GAVI finance access to a Covid-19 vaccine. They believe that the lack of transparency in the agreements is a democratic challenge. “How can one have insight when private interests are so strong?” asks Storeng.

The two scholars have previously studied the composition of boards in a number of similar health initiatives. In their research, they found an “extremely uneven distribution of power”. It is the representatives of rich countries and the private sector that dominate. Those who are to benefit from the measure, along with civil society members, are poorly represented.

CEPI and MSF have kept in touch. CEPI states that they have invited the aid organization to participate in evaluation rounds of each project in different phases. MSF representatives says that they are cautiously optimistic after CEPI’s established a separate committee for fair access. The minutes from that committee’s January meeting shows that MSF believes CEPI must more clearly demonstrate how it practices the access policy and how it is done “in a way that has teeth”.

This article was originally published in Norwegian in NRK

Read more about our investigation on the search for a Covid-19 vaccine and the attendant ‘vaccine nationalism’.