Pharma Bids for European Funding in New Research Program

The ink is not yet dry on the European Union's Horizon 2020 agreement to invest some €70 billion ($92 billion) in research over the next seven years, and already contenders for funding are jostling for attention as they prepare their bids. Some of the sharpest elbows are wielded by pharmaceutical organizations, because a large portion of the budget is reserved for life sciences, and the biggest share of that is likely to go to the fittest and fastest in the fray.

Europe's biggest drug industry association, the European Federation of Pharmaceutical Industries and Associations, scored something of a coup by having breakfast with the president of the European Commission on the very day that the program proposal was agreed in mid-July. EFPIA has won support from the commission (and possibly €1.5 billion) for a new and improved version of the Innovative Medicines Initiative (IMI), its public-private partnership with the European Union on early-stage collaborative research. At a special launch ceremony on the upper floors of the commission's headquarters in Brussels, Joe Jimenez, CEO of Novartis and vice-president of EFPIA, announced that industry would match this with €1.5 billion in cash and kind.

Others have moved almost as swiftly to press their case for funding. Before July was out, the European Alliance for Personalized Medicine had announced a major conference in the European Parliament in Strasbourg on "Horizon 2020 and the Future of European Research," amounting to a naked pitch for support for this coalition's ambitions to develop the right treatment for the right patient at the right time. Its members—industry, academics and patient groups—also favor public/private collaborations as "a necessary condition to succeed where individual stakeholders' efforts have failed or were delayed."

A markedly different approach to utilizing the life sciences budget is being advocated by civil society organizations that are less interested in industry success and, they claim, more interested in patients. Arguing for wider access to medicines, the European Public Health Alliance and its partners, who include Doctors of the World and Health Action International—Europe, are calling for research and innovation that is "needs-driven" and "based on social criteria." The objective, they say, should be "affordable access to R&D outcomes" that can "bring medicines prices down." This is central, they argue, to providing an adequate response to the "dreadful situation faced by millions in Europe regarding access to medicines and the dire health outcomes that result."

Reaching agreement on Horizon 2020 had been one of the priorities that the Irish government had set for its six-month stint in the chair of the European Union in the first half of this year. "It will boost innovation, jobs, and growth," said Ireland's research minister, Sean Sherlock, as he emerged triumphant from the round of talks that clinched the deal. Until the last minute, and through six months of laborious negotiations, questions remained over the size, scope, and emphasis of the program, caught in crossfire from national governments, political parties, and diverse lobbies from science, industry, and consumer and environmental organizations. At the end of 2012, the program looked as if it might be shredded as the austerity-hit European Union battled over cuts in its long-term budget. But the bulk of the funding was ring-fenced, after urgent pleas from Nobel prizewinners, and industry groupings across Europe representing everything from steelmakers to aviation.

The European Parliament also fought to maintain the integrity of the program against member state penny-pinching, and to champion the role of smaller researchers too. As the agreement was initialled, Christian Ehler, the center-right German politician who piloted many of the Parliament's debates on the plans, praised the deal, and congratulated himself on winning "a new bottom-up mechanism that will allow for small innovative projects to be funded at any time." His Portuguese colleague, Maria da Graça Carvalho, also closely involved in the Parliament's debates, claimed responsibility for "measures aimed at increasing participation by small research groups and smaller firms." But Swedish liberal Kent Johansson greeted the opportunities for innovative smaller firms as a victory for his political group. And so did the chair of the Parliament's research committee, Italian Amalia Sartori. Even then, not all the Parliament's aspirations were satisfied. Belgian Green politician Philippe Lamberts described it as "a timid agreement" that "lacks ambition."

In the program's final form, the funding will be split across three strands. More than a third will go to a segment termed "Excellent Science," which will finance pure research, vital infrastructures, and future and emerging technologies. A second component—"Societal challenges"—will receive a similar amount, and focus on what are billed as "areas of most concern to citizens and business." This segment also offers possibilities for funding research into health— particularly in healthy living and active aging— alongside support for research in climate, food, security, transport, and energy. A third strand—"Industrial Leadership," with about a quarter of the total funding—will back selected industrial technologies, notably nanotechnologies, biotechnologies, and ICT, and will offer particular support to smaller firms.

The research-based drug industry is particularly optimistic about the prospects of Horizon 2020. It believes it can use the program as a vehicle not only for advancing medicines research, but also for gaining broader recognition for the industrial imperatives that lie behind its research activities. IMI-2 will have a focus that goes wider than merely therapy-related categories, or related areas such as biomarker research, innovative clinical trial design, or patient-tailored adherence programs; one of its major ambitions is to bring academia and regulators more closely into the picture, too. EFPIA director general Richard Bergström underlines the attention that Horizon 2020 will devote to the interplay between markets and regulation. This could help ease "the real long-term threat" that innovative medicines face because of the "huge problem of member states and uptake," marked by "increasing reluctance to embrace new products," he says. The drug industry is rejoicing in the elements of the new program that are designed to take account of the need for engagement of authorities responsible for pricing and reimbursement.

The predecessor of Horizon 2020 won praise in many countries and many sectors. The IMI program, which received €1 billion over the seven years of the EU research program now on the verge of completion, is widely regarded as a big success for pharma and for health. And some countries have done well from the European Union's 2007-2013 program: the United Kingdom will have received around €7.5 billion in funding from it by the end of this year—around 15 percent of the total program allocation. Cambridge University estimates that 20 percent of the work undertaken by its researchers is funded by EU grants. Grants of up to €2 million in life sciences have funded promising projects ranging from high-tech radiotherapy for head-and-neck cancer to supramolecular chemistry.

But there have been frequent criticisms of undue complexity and bureaucracy in previous EU research programs, so this time the mechanisms for seeking support are simplified and the criteria eased, in order to widen access to a greater number of organizations and promote diversity in research. Even so, the final legislative text, covering the detail of the program's operation, will run to more than 1,000 pages. And who gets what will now depend on how effectively the candidates for funding present their proposals in each of the distinct categories of the program.

The program is scheduled to come into operation in January 2014, with the first calls for proposals due to emerge shortly afterwards. But—the Europe Union being the European Union —even a done deal is not a done deal until everyone has signed off on it. The €70 billion budget is still subject to final agreement on the European Union's overall spending plans for 2014-2020—and that process will not be completed until September, at the earliest.

Reflector is Pharm Exec's anonymous columnist, a commentator so close to the action in Europe his identity must be kept secret.