- Update of 3 December 2020: IMI has produced a document, IMI - the full story: IMI responses to the GHA / CEO report "In the name of innovation'', which responds in greater detail to the GHA / CEO report.
At IMI we are always open to justified, balanced, and constructive criticism of the model of public-private partnerships (PPPs) that is exemplified by IMI. We are the first to realise, as in any cutting edge collaborative model for biomedical research, that ongoing improvement, corrective measures, and new ideas are imperative in ensuring that PPPs serve the interests of EU citizens.
We therefore read the recent report of Corporate Europe Observatory (CEO) and Global Health Advocates (GHA) with great interest. There are some valid points in the report, for example, the relatively low levels of participation among SMEs and partners in the EU-13 countries, or the need to open up IMI’s advisory bodies to a wider spectrum of stakeholders. These were also mentioned as part of the most recent evaluations of IMI and will require design changes in the potential next programme.
However, overall we are disappointed that the authors have missed the opportunity to contribute to a constructive debate on IMI and health PPPs. We regret the fact that the report targets isolated challenges that IMI has faced and turns them into generalities in order to dismantle the integrity of the programme. We will not go into the details of all of them here, but would like to highlight three.
1. Is IMI doing enough on coronaviruses and emergency preparedness?
Infectious diseases and vaccines have been a priority for IMI since the beginning, and we launched a project specifically on biopreparedness (ZAPI) in 2015. It includes the coronavirus MERS as a case study and its findings are now feeding into research on COVID-19. In addition, many other IMI projects’ results are also contributing to efforts to tackle the current and future outbreaks. (see here for some examples)
More broadly, other IMI projects that are relevant to biopreparedness and vaccines include BioVacSafe, that aims at developing tools to speed up and improve the testing and monitoring of vaccine safety; ADVANCE that focusses at facilitating the rapid delivery of clinical data on vaccines to help public health authorities make decisions on vaccination strategies; and VAC2VAC on the development of alternative in-vitro, non-animal tests for vaccines.
The report highlights the case of a topic on biopreparedness that was discussed in 2017-2018. Here, the report shows a lack of understanding of how IMI Call topics are developed. Many topic ideas are put forward by EFPIA companies, the European Commission, and other stakeholders. These are discussed extensively within the industry, with the European Commission, with stakeholders and IMI´s advisory bodies. Topic ideas that are taken on board take time to mature and often evolve significantly during this process. At the same time, many topic ideas are not adopted because the IMI governance bodies decide that they would be better addressed through other mechanisms.
The topic on biopreparedness was relatively 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.
On reflection, it was felt that some elements of the topic would be better addressed through other channels. Meanwhile, aspects of the topic that were suited to an IMI project were included in the IMI2 - Call 20 topic 2 (Innovations to accelerate vaccine development and manufacture) including mathematical/in silico modelling of infectious diseases and designs of clinical studies based on human challenge models.
Finally, in relation to COVID-19 research, IMI launched a Call ‘Development of therapeutics and diagnostics combatting coronavirus infections’, whose evaluation recently took place. Eight large-scale research projects were selected in a fast-track call for proposals representing a total investment of €117 million.
2. Should IMI focus on HIV / AIDS?
The report repeatedly criticises IMI for not investing in HIV / AIDS research. As we have explained to CEO and GHA, the reasons for this are simple and have remained unchanged for over a decade.
- The European Commission was criticised in the past for having multiple funding mechanisms for the same topics, and in response, decided to focus action to HIV/AIDS through EDCTP and the H2020 collaborative research programmes.
- In alignment with this, the private sector has chosen not to use the IMI model for investments in HIV/AIDS R&D, but rather, to use other dedicated international instruments such as IAVI.
In this way, both public and private sectors have contributed to the huge global research effort to tackle HIV/AIDS.
3. IMI’s Ebola projects: too little, too late?
The report claims that IMI has done ‘too little’ on Ebola. Again the overall context and understanding is totally absent. IMI has funded 12 projects on Ebola and related diseases with a total combined budget of over EUR 300 million.
The impact that these projects have had is enormous. As we speak, late stage clinical assessments are ongoing with the J&J Ebola vaccine regimen. The projects advancing the development of this vaccine regimen are ignored in the report. Furthermore, it is incomprehensible that the report does not mention that IMI’s Ebola programme has delivered crucial and innovative assets including 2 rapid diagnostic tests that are being field trialled in the DRC at this moment, together with an iris scanning technology now being adapted for use in the COVID-19 context. J&J have invested hundreds of millions of euro in the vaccine project through IMI, and with many other partners (NIH, WHO, Wellcome Trust, BMGF etc) without any visibility of profit, so we fail to understand the underlying unjustified insinuation, i.e. the industry will only co-invest when there is a clear profitable interest.
The report cites just one project, VSV-EBOVAC, and here they seem to lay blame on IMI for a licencing agreement that took place between a Canadian biotech company and MSD before the IMI project even started. The goal of VSV-EBOVAC was to understand the human immune response to the MSD vaccine, to share these data with other vaccine developers and to understand more about the immune correlates of protection. On this, they have succeeded.
The report also claims that IMI’s actions on Ebola came ‘too late’. Firstly, Ebola was not in our Strategic Research Agenda or indeed the WHO document because no one knew that there would be an epidemic in 2014. Nevertheless, IMI launched a fast-track Call for proposals mobilising resources within 3 months and the resulting projects succeeded in getting the trials up and running rapidly. As the situation improved and the number of new Ebola cases began to fall, the original plan of testing the vaccine in Ebola-infected communities became more and more difficult.
The projects responded to this development by creating alternative ways of assessing the vaccine regimen’s efficacy by using a much larger population of healthy volunteers, which required designing a new clinical trial, seeking approval and extending the timelines for this much larger study.
More recently, the Ebola outbreak in the Democratic Republic of the Congo prompted the projects to restart trials of the vaccine regimen in an outbreak situation. This meant restarting the approval process for clinical trials (e.g. ethical approvals) and providing capacity building in a new country, with different languages and culture. Throughout all of this, the goal of the projects has remained constant: to evaluate the safety and efficacy of the vaccine regimen.
We are disappointed the report is not more rigorous and balanced in its assessment of IMI, especially as a number of the criticisms were explained thoroughly in writing and in a 2 hour long interview between the authors and the Executive Director of IMI several months ago.
We would welcome further dialogue with the authors on any points made here or elsewhere for clarification purposes.