Battle over CEPI's access to vaccines policy deepens

MANILA — The board of the Coalition for Epidemic Preparedness Innovations has stood by its revised equal access policy after questions were raised about maintaining access to vaccines.

But Médecins Sans Frontières, which led the criticisms, said its concerns about the policy had deepened since its initial objections last year, and that the board’s response had failed to address those issues.

Ahead of CEPI’s board meeting last week, MSF published an open letter calling on it not to renege on its commitments to ensure affordable and equitable access to its funded vaccines. It came after the board decided to make changes to CEPI’s equal access policy. While the original version contained details on what CEPI expects from recipients of its grants — from price setting to intellectual property — many of those details were taken out of the newly adopted policy.

At the conclusion of CEPI’s meeting Friday, Jane Halton, chair of the board, told Devex the board had considered the issues raised by MSF in “great detail” and maintained they “share a common purpose” with partners like MSF in tackling the “devastating impacts of epidemics, particularly in already vulnerable communities.”

“The board is united in delivering those shared objectives and is confident that the implementation of CEPI’s access policy will safeguard equitable access to the products developed through CEPI. This includes issues of affordability and data, and extends through development to licensure,” she said, adding that CEPI will “honor” its commitment to publish details of how signed agreements will achieve equitable access on a regular basis.

But global health advocates remain unconvinced. “Stated commitments to access that are not backed up by solid and transparent policies and processes are meaningless,” said Ellen ’t Hoen, a lawyer and public health advocate who has published widely on medical law and policy.

“When you work in the public interest, you need to be publicly accountable and that comes with disclosure of the terms and conditions that govern the collaboration with others,” she said.

A ‘weaker’ policy

Katy Athersuch, senior policy adviser with MSF’s Access Campaign, explained that the policy in question was “an even weaker” version of the one MSF had opposed in October 2018, at the time of the last meeting MSF International President Joanne Liu attended before her term on the CEPI board ended.

“We were very surprised because we assumed that Joanne's criticisms [had] been listened to in October,” Athersuch told Devex. “If you look at this two-pager that they've published, there's basically nothing in it … There's zero detail pretty much in the whole policy.”

One of MSF’s key concerns was around transparency. The original policy stated that “a summary of the provisions in agreements which CEPI enters into with awardees will be made publicly available unless there is an exceptional reason not to, which would require board approval. It is anticipated that the summary will focus on equitable access obligations, shared risks/shared benefits arrangements and management of IP [intellectual property].”

The revised draft presented to the board in October removed the requirement for board approval, which MSF opposed. But the policy subsequently adopted in December includes even fewer assurances — mentioning only that the CEPI secretariat will summarize the partnerships agreements “to facilitate the board’s oversight.”

“This isn’t an oversight process, since it will come after the signing of the agreements. Further, the board itself is only to see ‘summaries’ rather than the full agreements themselves,” Athersuch said.

In addition, Athersuch said that when the board voted on the revised equal access policy in December, there were only seven voting members present. Members including Peter Piot, director of the London School of Hygiene & Tropical Medicine, and Gagandeep Kang, head of the Wellcome Trust Research Laboratory at the Christian Medical College in Vellore, India, were absent from the meeting.

“These voices that you would expect to be speaking up in the interest of developing countries were not present at the board meeting where the policy was adopted,” she said.

Kang told Devex in writing: "The access documents were discussed with the CEPI Board extensively at in person meetings ... on email and on the phone ... I believe that the abbreviated policy is an overarching statement that clearly states CEPI's complete commitment to access."

She added: "I think we need to trust the CEPI management's due diligence to select the best approaches and to negotiate the contracts to ensure that access is considered at every step of the negotiation. It is the responsibility of the Board to ensure that there is never any question of CEPI deviating from its founding principle of access."

Governance issues

MSF also questioned CEPI’s current governance, pointing out there are no civil society representatives on the board. Athersuch said MSF suggested several people who could take over Liu’s place but, to date, no civil society representative has been appointed.

Els Torreele, executive director of MSF's Access Campaign, currently serves as member of the CEPI Joint Coordination Group, an advisory team that CEPI convenes to discuss how the vaccines it finances will be rolled out. But it is not the board, and the position does not entail decision-making powers, an MSF spokesperson said.

Athersuch is also worried that the task of finding Liu’s replacement has been given to a pharmaceutical executive.

A public summary of the CEPI board meeting in December states that Rajeev Venkayya, president of the Global Vaccine Business Unit at Takeda Pharmaceutical Company Limited and chair of the Nominations & Compensation Committee at CEPI, “will work with the CEO and Board Chair on the process for appointing shortlisted candidates before the March Board.”

“Would you ask MSF to appoint the industry representative? Probably not. Should you ask industry to appoint the civil society representative or to be in charge of the selection? I find that in itself a quite worrying development,” she said.

However, a CEPI spokesperson said that while Venkayya is chair of the committee, he works with four other committee members in selecting shortlisted candidates for the board, including Trevor Mundel from the Bill & Melinda Gates Foundation and Joachim Klein from Germany's Federal Ministry of Education and Research.

The board has appointed two voting members since Liu stepped down alongside two others — Awa Coll-Seck, minister of state and former minister of health and social welfare of Senegal; and Tore Godal, special adviser on global health at the Norwegian Ministry of Foreign Affairs. 

The two new members are Nadine Gbossa, representative of the International Fund for Agricultural Development in Nigeria; and Charlotte Watts, chief scientific adviser of the United Kingdom Department for International Development. Their arrival leaves just one more seat on the board, which requires a total of 12 voting members.

“I think the state of their board in terms of the lack of civil society representation is something that you can clearly see reflected in the policy decisions they are taking,” said Athersuch.

Rachel Grant, spokesperson for CEPI, acknowledged that three board members were unable to attend the meeting in December when the new equal access policy was adopted. But she explained the policy was shared with all board members in writing in November, including a request for feedback.

She did not specify if and when the board plans to appoint a member of civil society, only saying: “We continually strive to ensure that our board is fully representative of all our stakeholders.”

CEPI was created in 2017 to speed up vaccine development for often neglected, epidemic diseases after the Ebola crisis in West Africa in 2014. Its arrival was seen by many as a game changer in the area of vaccine development, where lack of market incentives has led to an absence of life-saving vaccines, particularly for the world’s poorest.

It has so far raised $750 million of its $1 billion target, with multiyear funding from Norway, Germany, Japan, Canada, Australia, the Bill & Melinda Gates Foundation, and the Wellcome Trust, some of whom have voting representatives on the board.

Chair of the board Halton was formerly head of Australia’s departments of health and finance.

Update, March 14, 2019: This story was updated to include additional comment from CEPI on the process of making appointments to the board, as well as additional comments from Gagandeep Kang.