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.
Its a particularly timely critique within a broader attack on the Commissions 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 IMIs survival up for debate as part of negotiations over the EUs 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 wasnt 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 industrys 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, IMIs 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 hasnt 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.
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 non-profit 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 doesnt provide incentives for new investments, like antibiotics.
Its meant to fight Europes “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 isnt fulfilling its mission to address unmet need. Rather, investments heavily skew toward research in areas like cancer and Alzheimers, which are already key targets for the industry, while other conditions on the World Health Organizations 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 non-profit 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: Alzheimers still has few treatment options, for example, and the Commission “massively” funds research into diseasRead More – Source