Big pharma rejected EU plan to fast-track vaccines in 2017

The world’s largest pharmaceutical companies rejected an EU proposal three years ago to work on fast-tracking vaccines for pathogens like coronavirus to allow them to be developed before an outbreak, the Guardian can reveal.

The plan to speed up the development and approval of vaccines was put forward by European commission representatives sitting on the Innovative Medicines Initiative (IMI) – a public-private partnership whose function is to back cutting-edge research in Europe – but it was rejected by industry partners on the body.

The commission’s argument had been that the research could “facilitate the development and regulatory approval of vaccines against priority pathogens, to the extent possible before an actual outbreak occurs”. The pharmaceutical companies on the IMI, however, did not take up the idea.

The revelation is contained in a report published by the Corporate Observatory Europe (COE), a Brussels-based research centre, examining decisions made by the IMI, which has a budget of €5bn (£4.5bn), made up of EU funding and in-kind contributions from private and other bodies.

The IMI’s governing board is made up of commission officials and representatives of the European Federation of Pharmaceutical Industries (EFPIA), whose members include some of the biggest names in the sector, among them GlaxoSmithKline, Novartis, Pfizer, Lilly and Johnson & Johnson.

A global lack of preparedness for the coronavirus pandemic has already led to accusations in recent weeks that the pharmaceutical industry has failed to prioritise treatments for infectious diseases because they are less profitable than chronic medical conditions.

The world’s 20 largest pharmaceutical companies undertook around 400 new research projects in the past year, according to Bloomberg Intelligence. Around half were focused on treating cancer, compared with 65 on infectious diseases.

There are eight potential vaccines for coronavirus in clinical trials, but there is no guarantee of success. One of the most promising, being developed at Oxford University, is said to have only a 50% chance of being approved for use.

The COE report says that rather than “compensating for market failures” by speeding up the development of innovative medicines, as per its remit, the IMI has been “more about business-as-usual market priorities”.

The report’s authors cite a comment posted on the IMI’s website, since removed, selling the advantages of the initiative to big pharma as offering “tremendous cost savings, as the IMI projects replicate work that individual companies would have had to do anyway”.

The European commission’s “biopreparedness” funding proposal in 2017 would have involved refining computer simulations, known as in silico modelling, and improved analysis of animal testing models to give regulators greater confidence in approving vaccines.

The hunt for a coronavirus vaccine

Minutes of a meeting of the IMI’s governing board from December 2018 reveal that the proposal was not accepted. The IMI also decided against funding projects with the Coalition for Epidemic Preparedness Innovations, a foundation seeking to tackle so-called blueprint priority diseases such as Mers and Sars, both of them coronaviruses.

“While the scope of a regulatory topic as proposed by the commission was not supported by EFPIA industries, the theme of regulatory modernisation is considered very important by industries, and will be further discussed,” the minutes record. “Interaction with the Coalition for Epidemic Preparedness Innovations (CEPI) continues but no immediate co-investment is expected.”

In response to the report, a spokeswoman for the IMI said infectious diseases and vaccines had been a priority from the outset. She highlighted a €20m project known as Zapi launched in 2015 following the Ebola pandemic and which focuses on biopreparedness.

The IMI launched funding for “innovations to accelerate vaccine development and manufacture” in January.

The spokeswoman said the topic had been competing with other priorities at the time of the 2017 proposal, including research into tuberculosis, auto-immune diseases and digital health.

“The report seems to suggest the IMI has failed in its mission to protect the European citizen by letting pass an opportunity to prepare society for the current Covid pandemic,” she said.

“This is misleading in two ways: the research proposed by the EC in the biopreparedness topic was small in scope, and focused on revisiting animal models and developing in silico models to better define/anticipate the type and level of immune response elicited in animals and humans in order to increase regulators’ confidence in the evidence base for alternative licensing procedures.

“IMI’s projects have contributed, directly or indirectly, to better prepare the research community for the current crisis, eg the Ebola+ programme or the Zapi project.”

The COE report says the directing influence of big pharma on the IMI’s research agenda has led it to becoming dominated by industry priorities, and sidelining poverty-related and neglected diseases, including coronaviruses.

The thinktank points to official evaluations that found the IMI had enabled competing global companies to work together with small and medium-sized businesses and academia, but that it was difficult to identify positive socioeconomic outcomes.

The most recent evaluation in 2017 questioned whether the European pharmaceutical industry should continue to be the “main driver” on the future of medicine.

The COE also says that as a result of the industry’s domination of the IMI, there are significant gaps in funding for diseases pinpointed by the World Health Organization (WHO) Report on Priority Medicines for Europe and the World as of public health importance, for which pharmaceutical treatments either do not exist or are inadequate.

Seven of the 25 priority areas the WHO identified have no IMI projects, including neonatal conditions and postpartum haemorrhage, according to the report.

Seventeen IMI projects relate to Alzheimer’s disease, 12 to diabetes and 10 to cancer. As important as these diseases are, there is no lack of wider interest in providing treatments, leading the report to question whether EU money has been appropriately spent.

“Clearly, these disease areas are not suffering from a market failure, as the global pharmaceutical industry is investing heavily in them already, which is not surprising, given the large market potential for new treatments,” the CEO writes.

An IMI spokeswoman said that about a third of the IMI budget was spent on infectious diseases, including antimicrobial resistance, vaccines, Ebola and tuberculosis, and that other funds went on cross-cutting issues in drug development.