A response to the Innovative Medicines Initiative’s open letter
On May 25th, Corporate Europe Observatory and Global Health Advocates published two investigative reports on two EU Joint Undertakings, the Bio Based Industries (BBI) and the Innovative Medicines Initiative (IMI). These two structures are public-private partnerships (PPPs) between the European Commission and two industry lobby groups, whose role is to stimulate research & innovation in these sectors through a combination of public research funds coming from the EU, and mostly in-kind contributions from the industry partners.
The Innovative Medicines Initiative (IMI) published a critique of a few points of our report, in the form of an open letter on its website. We thank IMI for having taken the time to engage with some of the points made in the report, although the letter misrepresents our report’s content and aims. This is our response.
To whom it may concern:
Thank you for your letter, and the time you took to respond to some of the points made in our report.
First of all, we would like to clarify one point: we do not question the dedication and competence of the IMI office staff. We see that our report was not well received by some on your end, and we understand why, given the main conclusion of our report is that IMI, as a structure, serves more the interests of the pharmaceutical industry, than the public. It is therefore understandable that this might have caused frustration or disappointment among professionals who believe they are doing their best to bring new medicines to the public. In fact, we would like the IMI office to have more power to drive the partnership towards the public interest.
We believe that among the issues we documented, the most serious is IMI’s set-up. We already knew that through lobbying, business groups had secured rules giving them the responsibility to develop the strategic research agendas of Joint Undertakings. IMI is no exception. In addition, IMI’s annual work plans are drafted by the pharmaceutical industry, which was also granted veto powers within IMI’s decision-making (half the voting rights on the Governing Board). As a result, although IMI is meant to address some of the health challenges the EU faces, and in particular market failures in medicines development, we found that the IMI funds mostly research projects in areas that are already commercially profitable, acting, as EFPIA itself once stated, as a mechanism funding “work that individual companies would have had to do anyway.”
We also found that some of these projects enable industry to influence regulation and have easier access to regulators, in addition to numerous issues related to the lack of transparency, inadequate accountability mechanisms, conflicts of interest and ethics documented in our report.
Your letter did not address these essential points. Rather, you criticised our report for some of its omissions, arguing that “the report targets isolated challenges that IMI has faced and turns them into generalities in order to dismantle the integrity of the programme”. This description of our report as a mere inferring exercise from a few isolated cases is not correct.
Our report did examine some projects funded by the partnership in its first part, among which the ones you are quoting, but the report did not claim this exploration to be exhaustive. Our report proposes a comprehensive assessment of the health priorities followed, and not followed by IMI, compared to what it was originally meant to prioritise, ie market failures. It also takes an in-depth examination of the partnership’s governance weaknesses, explaining the possible reasons for the failure to achieve IMI’s initial purpose: fund research to develop medicines that the private sector is unable or unwilling to develop.
Let us address the specific points of criticism raised in your letter:
– Coronaviruses and biopreparedness: your letter starts by focussing on these issues because our report showed how a European Commission proposal to “increase regulators’ confidence in the evidence base for alternative licensing procedures” to current vaccine testing standards in late 2017 was refused by EFPIA in the IMI Governing Board discussions. Your letter explains that our report failed to grasp how this topic was addressed in other calls. These are useful additional elements, but they are missing the point: we were aware of IMI-funded projects directly or indirectly related to coronaviruses, such as ZAPI (started in 2015, seven years after IMI was launched), as well as the new research funds mobilised for COVID-19 after the outbreak this year (and mentioned these in the report). We also knew – thanks to the European Commission’s reply to our questions – that “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)” but the said call was still ongoing when we were finalising the report. However, from our perspective, the point of focus here was EFPIA’s rejection of the Commission’s proposal: a strong example of how EFPIA companies were able to block a proposal from the Commission simply because the IMI’s set-up allows it. That is also what the press focused on mostly.
– HIV/AIDS research: Your letter explains again the reasons the IMI office gave us during the research as to why the partnership is not funding HIV research: the European Commission funds HIV/AIDS research through EDCTP and Horizon 2020 and wants to avoid duplication. We had read and evaluated these responses carefully. The report was still critical about the partnership for not investing in HIV/AIDS research because we were not convinced by these explanations.
The amount of money committed by the EU on HIV/AIDS research via EDCTP and Horizon 2020 – €220 million by April 2020 – is substantial, but the European Commission’s investments for HIV/AIDS, and in general for poverty related and neglected diseases, make up only about 5% of the global investments. According to the NGO DSW, EU institutions spend “less on neglected disease R&D in a year than the US government does in a month”. At the same time, the current level of R&D investment for these diseases that affect more than one billion people worldwide is not enough to develop the tools needed to fight them. There is clearly a need for increased investments in these areas, so this raises the question on why does the European Commission not use IMI, to which it is giving €2.6 billion of public research funding, to fund research in HIV/AIDS and poverty and neglected diseases, instead of funding research areas that the industry would invest in anyway? Could it be because the pharmaceutical industry actually can refuse this, given their voting power on the IMI’s Governing Board?
Moreover, let us bring your attention to the problems we found in one particular case study on a flucytosine manufacturing project, which IMI advertised as being helpful to make the drug more affordable for people living with HIV/AIDS in low-income countries. We published it as a separate case study: in fact, so far, while Sanofi seems to control key parts of the intellectual property for the process resulting from this IMI project – a process that enables the cheaper production of other, more profitable drugs Sanofi sells – flucytosine is not being manufactured with it and remains out of reach for millions of people living with HIV/AIDS. IMI “acknowledged that there’s not much it can do if companies don’t follow through”, as Politico reported. Indeed, if this how IMI projects mean to help people living with HIV/AIDS, without public interest safeguards to ensure the IMI funded projects deliver the positive societal impact they are supposed to deliver, perhaps we have to think twice on whether we want billions of public money to be channeled through such structures.
– Your letter also reproaches us for ignoring important projects it funded on Ebola. We understand your disappointment that the report hasn’t covered the breadth of what IMI has funded for Ebola and related diseases, and welcome the additional details you provided on this, as well as the updates with the latest developments on the J&J Ebola vaccine regimen. But we need to repeat that analysing in detail all the projects funded by IMI, including those for Ebola, was not the objective of our research. We chose only one Ebola project funded by IMI as an example – which is clearly stated in the report – because we could track the developments around this vaccine candidate before and after the IMI’s investment. This case study showed that IMI’s intervention was not done in time to respond effectively. We acknowledge that the “very little very late” subtitle of that section is not accurate and we modified it accordingly.
We are aware that the European Commission might have set up IMI 12 years ago with the genuine belief that letting the pharmaceutical industry drive a research agenda on issues identified by the EU as societal challenges would be beneficial both for addressing these and helping boost EU-based industries’ competitiveness. The evidence shows, however, that IMI funds a disproportionately high number of projects where the private sector is already invested. This raises doubts about the added value of the EU funding.
It is high time for the European Commission to seriously change its approach to research funding when it comes to public-private partnerships such as IMI, especially in the current COVID-19 and climate crises. There is a great deal of competence and expertise in Europe on these issues; but it needs to be used in the right direction.
In order to do this, the European Commission should lead much more participatory processes in designing these partnerships’ strategic agendas and annual work plans, end industry’s de facto veto power at the Governing Board level, and fix the numerous governance, transparency and accountability problems of their predecessors. Otherwise, industry will continue to divert public research funds for its immediate commercial interests, at the expense of all EU taxpayers.
Marine Ejuryan, EU Advocacy Manager, Global Health Advocates
Martin Pigeon, Researcher & Campaigner, Corporate Europe Observatory