[Ip-health] New Report : “More Private Than Public: The Ways Big Pharma Dominates The Innovative Medicines Initiative”

Dimitri Eynikel Dimitri.Eynikel at msf.org
Mon May 25 01:34:21 PDT 2020


A timely critical report by Global Health Advocates and Corporate Europe Observatory on the European Commission Innovative Medicines Initiative, the Commissions flagship health R&D partnership with the pharma industry

A Politico article on the report further below in this email
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Dimitri
Dimitri Eynikel | Access Campaign EU Policy & Advocacy Advisor
Médecins Sans Frontières | Doctors Without Borders
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New Report : “More Private Than Public: The Ways Big Pharma Dominates The Innovative Medicines Initiative”
report "More private than public: the way Big Pharma dominates the Innovative Medicines Initiative" is part of an in-depth work dedicated to EU’s health and climate Public-Private Partnerships, in collaboration with the NGO "Corporate Europe Observatory".
The European Union’s Research and Innovation policy (R&I) is one of the key areas that can help us deliver both a better future for EU citizens and meet our international commitments, especially the UN’s Sustainable Development Goals. R&I is integral to addressing the many challenges faced by society, whether in health and wellbeing, food and farming systems, climate change, energy, or democracy and digitalization.
The European Commission sees the R&I policy as a core tool to “help create growth and jobs and tackle our biggest societal challenges”. To help achieve these policy objectives, the Commission, among others, has established partnerships with the private sector to pool “Europe’s resources to tackle the biggest challenges, support competitiveness, deliver high quality jobs, and encourage greater private investment in research and innovation.”

One of those partnerships, the Innovative Medicines Initiative (IMI), is a large-scale public-private partnership between the European Commission and pharmaceutical trade association and lobby group EFPIA (European Federation of Pharmaceutical Industries and Associations). The first partnership, IMI, ran from 2008-2013, and was renewed as IMI2 to run from 2014-2020. IMI is up for renewal again in 2020, with plans to shift its focus to digital health.
While its stated aim is to drive innovation in pharmaceutical research in the EU and improve health, IMI has been criticised as embodying a model by which the public sector foots a large part of the bill for research, while the private sector is able to set the research agenda in its own interests, and reap the rewards.

The EU’s policies ought to be shaped to achieve direct and tangible benefits for citizens and society, including equitable access to healthcare both within Europe and globally. In the case of the IMI, this means ensuring the agenda is needs-driven, rather than set by commercial interests.
As such, this report critically examines any structural weighting of IMI towards private sector interests. For example, we examine whether the IMI is setting research priorities for pharmaceutical innovation that may be more about business-as-usual market priorities, than about compensating for ‘market failures’ (the latter is a key rationale for such a public private partnership). We investigate, in particular, what value IMI adds, and whether its set priorities are really addressing public health needs such as HIV/AIDS and poverty-related and neglected tropical diseases.

We examine whether the IMI delivers – on its own stated terms – of increasing competitiveness in the European’s pharmaceutical sector, given some of the misgivings of project partners such as small and medium enterprises. The report looks at concerns over whether public, non-profit, and smaller partners have equal access to data produced in IMI projects, or whether the influence of the private pharmaceutical sector is placing undue limits on intellectual property.
The question of whether the IMI awards the private industry unwarranted influence in the formation of regulations for the health sector – such as medicines safety, or privacy of patients’ data – is also crucial. And it is equally important to assess whether an imbalance towards industry is reflected in the IMI’s governance, finance, and accountability structures.

Overall, this report asks whether the IMI’s health research truly delivers tangible benefits for citizens, such as better access to health innovations, or whether it is rather focused on enhancing the competitiveness of the largest pharmaceutical corporations?

Both Horizon 2020, the current R&I framework programme, as well as IMI2, end in 2020. At the time of writing, the European institutions are in the process of designing Horizon Europe to succeed Horizon 2020, as well as the successor of IMI2 to be called “Innovative Health Initiative”. It is an important moment, then, to investigate the societal impact of IMI, particularly in terms of public health goals, in order to meaningfully feed into the discussions and the processes around the future of the programme. The future shape of IMI’s successor is of interest to all European citizens, and especially given the large sums of taxpayers’ money to be spent on such a research framework, we believe this should be a topic of wider public discussion.

The methodology of the report has included desk and literature review and interviews, and Freedom of Information requests to the European Commission. We have compared the IMI’s research areas to those identified by the World Health Organisation as priority areas for medicine and interviewed former participants in IMI projects. We have examined the governance structure, accountability, and evaluation processes of IMI. This was an attempt to assess both whether IMI delivers positive societal impacts, and to understand whether its stated claims of enhancing EU competitiveness stand up to scrutiny.

Furthermore, we made a critical assessment of what governance and accountability mechanisms were in place to ensure that public money spent through IMI focuses in areas where there was a clear and real need for public funding. Billions have been spent on IMI to date, and it is likely that billions will be invested in the next partnership. It is therefore critical to analyse whether IMI is truly equipped to achieve its own stated aims and deliver benefits for society.
The report aims to answer to these and other questions that arose as we carried out our investigation into IMI.

Read the full investigation here. http://www.ghadvocates.eu/en/new-report-more-private-than-public-the-ways-big-pharma-dominates-the-innovative-medicines-initiative/

For further information or interview requests, please contact:
Hélène Gombert
Campaign & Media Officer
hgombert at ghadvocates.org
+336.27.63.42.13

Marine Ejuryan
Advocacy Manager
mejuryan at ghadvocates.org

POLITICO Pro Article -- Watchdogs hit Big Pharma on biopreparedness priorities --

-- By Sarah Wheaton

5/25/20, 5:00 AM CET | View in your browser
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 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 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 need. 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 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: 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.

Related stories on these topics: Cancer, Clinical trials, Coronavirus (in EU Budget), Coronavirus (in Health Care), Drug and device safety, EU Budget/MFF, Global health, Health care, Horizon 2020 (in EU Budget), Horizon 2020 (in Health Care), Major and chronic diseases, Medical devices, Medicines, Pharma, Regulation, Research and Development (in EU Budget), Research and Development (in Health Care), Tobacco and Nicotine, Vaccines, European Commission (in EU Budget), European Commission (in Health Care), European Federation of Pharmaceutical Industries and Associations (EFPIA), World Health Organization (WHO)





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