Big Pharma rejected vaccine prep efforts, watchdogs say

NGOs say industry’s rejection of a Commission-funded effort to speed vaccine approvals represents broader problems with the Innovative Medicines Initiative.

In 2017, the European Commission proposed working with the pharmaceutical industry to research ways to get vaccines against dangerous bugs to the market quicker, before an outbreak actually occurs.

Industry declined to sign on, according to a new investigation published Monday by two NGOs focused on corporate accountability.

It’s a particularly timely critique within a broader attack on the Commission’s collaboration with Big Pharma, known as the Innovative Medicines Initiative, as the world races to find treatments and vaccines to help both humans and economies recover from the coronavirus.

With IMI’s survival up for debate as part of negotiations over the EU’s next seven-year budget, the NGOs Corporate Europe Observatory (CEO) and Global Health Advocates are urging member countries and MEPs to reject renewing the public-private partnership without major reforms.

The Brussels pharma lobby EFPIA counters that preparation for meeting urgent needs is at the soul of IMI, and that this particular project just wasn’t a good fit. But the watchdogs say it reflects how IMI is too hobbled by industry influence to serve the public good.

Behind the curve?

Three years ago, the Commission proposed a new research project on the decision-making process for vaccine approvals. The aim was to “facilitate the development and regulatory approval of vaccines against priority pathogens, to the extent possible still before an actual outbreak occurs,” according to a letter from DG Research Deputy Director General Signe Ratso to Martin Pigeon, a researcher for CEO.

The effort would also help regulators use alternative methods to confidently approve immunizations.

After discussions with industry partners, "the topic idea was eventually not taken up by the EFPIA companies,” Ratso said.

Marine Ejuryan, Global Health Advocates’ advocacy manager, said the industry’s refusal “to work on biopreparedness, even with public subsidies ... demonstrates many of the inherent problems with the current biomedical profit-driven R&D model.”

Its agenda, she added, is “overly dominated by industry priorities while sidelining poverty-related and neglected diseases, including coronaviruses, simply because these are not profitable for the industry.”

EFPIA spokesman Andrew Powrie-Smith disagreed, writing in an email that drugmakers did have “significant interest” in the idea.

Ultimately, however, the specifics seemed “better suited” to groups “focused on regulatory evolution rather than a public-private consortium focused on removing scientific bottlenecks," he contended.

For their part, IMI and the Commission noted in statements to POLITICO that the public-private partnership does have projects that can help fight the coronavirus, launched both before and during the current outbreak.

They include a 2015 biopreparedness initiative known as ZAPI, which resulted in antibodies for the MERS coronavirus that are now being studied to see if they could work against the COVID-19 bug.

Further, they said, some of the elements of the 2017 vaccines proposal have been incorporated into a fast-tracked IMI topic launched in the early days of the current coronavirus emergency, which is already funding eight projects.

As Ejuryan sees it, however, IMI’s coronavirus efforts have come too late.

“An effective response to epidemics requires timely and sustained investments,” she said. “Otherwise, when a pandemic emerges, the research and development simply hasn't been done in time to respond effectively.”

But Powrie-Smith rejected the watchdogs’ report as a “biased” salvo launched as part of an ongoing campaign against the industry. The emphasis on the 2017 vaccine discussion, he said, “shows an eye for a headline and fundamental lack of knowledge on the topic."

"IMI has, and continues to play a key role on biopreparedness, focused on its core purpose of accelerating the development of diagnostics and therapeutics,” he said.

Uneasy partnership

Since it started in 2008, IMI has been a bête noire of watchdog NGOs, like the Gates Foundation-backed Global Health Advocates and CEO, which gets funding from George Soros’ Open Society Foundation.

IMI2, the current iteration, has a €3.3 billion budget over seven years, with half coming from the Horizon 2020 research grant program and the other half from industry.

The idea is that the EU taxpayers offer funding to nonprofit researchers or small biotech firms, while EFPIA members match the euro figure with either grants or “in-kind” contributions. Projects are supposed to focus on areas where breakthroughs are desperately needed, or where the market doesn’t provide incentives for new investments, like antibiotics.

It’s meant to fight Europe’s “innovation paradox,” as a Commission spokesperson put it: “We have very good science but little innovation and market deployment.”

The problem, according to the NGOs, is that IMI isn’t fulfilling its mission to address unmet needs. Rather, investments heavily skew toward research in areas like cancer and Alzheimer’s, which are already key targets for the industry, while other conditions on the World Health Organization’s list of priorities, like AIDS, tobacco use and strokes — not to mention the so-called neglected tropical diseases that primarily affect low-income countries — get little attention.

There have also been some high-profile spats between industry and its nonprofit collaborators: A network of European specialists in antimicrobial resistance pulled out of an IMI project in 2017 citing “unresolved problems of conflict of interest in shaping policy recommendations” by its industry partners.

The Commission spokesperson rejected the suggestion that IMI is ignoring unmet needs: Alzheimer’s still has few treatment options, for example, and the Commission “massively” funds research into diseases of poverty in other ways, if not IMI.

An IMI spokesperson added that while the public-private partnership didn’t launch its Ebola vaccine initiative until 2014, when the West African outbreak started, it was not on the WHO's list of priorities in 2013, ruling it out as a strategic research topic.

Unused innovations

One project could have great implications for poor African countries trying to manage HIV, the report notes. But the findings aren’t being used.

The 60-year-old drug flucytosine is a key treatment for people living with HIV-weakened immune systems who are more vulnerable to fungal infections, a top cause of HIV-related death. But it’s not available in much of Africa and Asia because of its cost and lack of generic options.

A project to find a cheaper, more environmentally friendly way to produce the drug — involving the pharma giant Sanofi, the University of Durham and €10 million from the EU — achieved its goal by early 2017.

Yet neither Sanofi nor Durham appears to have given manufacturers in poor countries the rights to use this new production method. (Durham told the report authors it's working on it. Sanofi didn't respond to requests for comment by the NGOs nor to POLITICO’s request for comment Sunday.)

The new method also works for one of Sanofi’s other existing HIV drugs, leading the report to question whether IMI “has merely provided Sanofi with a handy — and publicly-funded — cheaper process in the production of two of its existing medicines.”

The IMI spokesperson acknowledged that there’s not much it can do if companies don’t follow through. Usually, IMI participants report that they’re using the results when the projects close out.

But ultimately, “projects are not obliged to report to us in the long term after the end of the project," the spokesperson said. "This makes it very hard to follow up on long-term impacts.”

The Commission is working on the next round of the public-private partnership, which would likely see the medical device industry added to the mix along with drugmakers.

Acknowledging the report, a Commission spokesman said that “all constructive criticism is welcome and will be factored into the impact assessments and proposals for the next generation” of public-private partnerships.

Cristina Gonzalez contributed reporting.