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Media rebuke of Europe’s Innovative Medicines Initiative thrusts debate into the public arena.
This spring, the European Union (EU) will hold a high-level conference with a wide audience including public and patient representatives, with the aim of improving vaccination coverage rates and promoting general reflection on the value of vaccination. Alarming outbreaks of communicable and eminently preventable disease are jolting health authorities across Europe into the realization that public understanding is a vital part of any health policy.
The European Centre for Disease Prevention and Control says that "the root cause of the continued measles and rubella transmission in the EU is the sub-optimal uptake of MMR vaccine, leading to an accumulation of susceptible individuals." It estimates that 4.9 million children born between 1998 and 2008 missed the first dose of measles vaccine, and the number of children who did not receive a second dose is even higher.
John Ryan, a senior health official in the European Commission, recently acknowledged that "there is insufficient understanding of the value of immunization, both among healthcare workers and the general public. Inaccurate perception of the safety and effectiveness of vaccines, on the one hand, and underestimated risks of communicable diseases, on the other hand, result in vaccine hesitancy in the general public." And no less a figure that Guido Rasi, until recently the executive director of the European Medicines Agency (EMA), remarked at a recent meeting on the subject: "Important issues have been raised by civil society in terms of advocacy of vaccines; the voice of patients and civil society is the most powerful, and one of the few credible today."
The recognition of the importance of public opinion in Europe has implications that go far beyond the realm of vaccines. And one of the implications is that in other areas of health-and notably in terms of medicines development-the attention to public opinion also needs to be sharp. An intriguing test arose in March when three respected European news organizations-Der Spiegel in Germany, De Standaard in Belgium, and the Swiss public broadcaster SRG SSR-produced an extensive critique of the EU's biggest drug research program, the Innovative Medicines Initiative (IMI). The essence of the report was a suggestion that public money is subsidizing private-sector research, and that inadequate controls over the program were leaving the interests of patients, academics, and smaller companies sidelined in favor of big pharma.
The accusations were direct-and naturally attracted considerable public attention. With headlines such as "Europe pampers the drug industry," "No control over individual drug firms," "No real transparency," "IMI ignores WHO priorities," or "Patients are turned into drug industry lobbyists," the interest of readers and viewers was naturally provoked. But what proved as interesting as the accusations themselves was the way the discussion then evolved in Europe among the organizations involved. I take no sides in the debate-both because it is not my role as a journalist to take sides, and also because I declare a tenuous interest in the subject: I am an (unpaid and entirely independent) member of the advisory board of one of the IMI projects impugned, the European Patients Academy. I restrict myself here simply to summarizing the arguments and counter-arguments that ensued.
The critics asserted that the research agenda pursued by IMI (into which the EU put €2.6 billion-close to $300 billion over the last five years) has been dominated by private companies hungry to replace diminishing blockbuster profits by grabbing public money to pay for their development projects. As a result, the projects reflect industry interests in profitable product segments rather than the therapeutic areas listed as priorities by the World Health Organization (WHO). Academics and smaller companies have experienced difficulty in access grant money from the complex, secretive, and highly competitive tendering procedures. Intellectual property protection arrangements are opaque and biased towards industry interests, and subsidized trials are unethical and focus more on the profitable U.S. market than on European needs. In addition, there is insufficient access to details of just what industry is contributing, and lack of transparency leaves scope for conflicts of interest.
The accusations were substantiated by reference to named sources: a Dutch professor, one former and two current members of the European Parliament, some German biotech companies, some university associations, a renowned Italian investigator, a German advisory body, and a member of the advisory board of the patient academy.
The drug industry reacted swiftly, with a statement from the European Federation of Pharmaceutical Industries and Associations, issued the day after the accusations were published. It offered some general justifications for IMI as a "platform through which the pharmaceutical industry, academia, and regulators may collaborate to find suitable solutions" to "significant challenges" Europe faces of "providing effective and timely treatment to its citizens." It pointed out that pharmaceutical companies do not receive any direct financing for their input, and commit their own resources to IMI projects. (The principle of IMI is that contributions are made in kind by participating companies-for instance, in terms of their researchers' time-to match the EU grant money.) It claimed that the research agenda is "aligned with the 2013 update of the WHO's Priority Medicines for Europe and the World Report," and that the intellectual property rules "apply equally to all public and private partners." And it listed the mechanisms for certifying and verifying companies' reports of their contributions.
But it made no mention of complaints from academics and smaller companies about difficulties in access grant money, or about the alleged complexity and secrecy and competitive nature of the tendering procedures. Nor did it respond to accusations of unethical trial procedures, undue focus on the US market, or potential for conflicts of interest.
Three days later, IMI issued its own statement, which also offered some general justification for the program. It specified that "large pharmaceutical companies do not receive any IMI funding," that most grant recipients are academics, that smaller firms receive 17% of funding, and that "patient groups and regulators are also well represented." Through the intellectual property protection policy," project partners are sharing compounds, data, and knowledge with one another in an unprecedented way, in an open innovation ecosystem." IMI governance is shared between EFPIA and the European Commission, and input comes from its scientific committee and from EU member countries, and it is "scrutinized closely by other EU institutions including the European Parliament." Most project ideas come from EFPIA companies, but "other organizations can also put forward ideas."
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Again, it left some of the accusations unanswered-and the case for the defense immediately provoked further criticism from healthcare campaigners. Citing a (subsequently-deleted) passage from the EFPIA website, Helle Agaard of MSF said: "To use EFPIA's own words, the Innovative Medicines Initiative offers pharmaceutical companies 'tremendous costs savings' when taxpayer money is used to pay for research that companies would otherwise have to do themselves. That in itself is a dubious practice. What makes it worse is that these subsidies come with no strings attached to ensure that final medicines, vaccines, and diagnostics are affordable to the public afterwards, or that the research is driven by where the biggest public health need is."
Tessel Mellema, a policy advisor with Health Action International, said: "The intellectual property principles published on the IMI website are very general. Without more detailed information about the deals that the industry negotiates, it's impossible to tell whether taxpayers are getting a good deal. More importantly, these principles don't say anything about affordability of the end products developed using IMI money." It took another two days for more specific answers to be offered by IMI, EFPIA, and the European Commission to the detailed accusations.
Everyone will draw their own conclusions from this debate. One inescapable conclusion, however, is that the level of debate might be higher, and interventions might be faster and more specific. Since this type of debate is taking place in the public arena, its conduct as well as its content will influence public opinion. The logic therefore demands that anyone-or any organization-claiming to have the public interest at heart must be more attentive to the quality of public debate, and to their input to it.
Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.