European Pharma Gears Up for Horizon 2020

  European Pharma Gears Up for Horizon 2020 The ink is not yet dry on the European Union’s Horizon 2020 agreement to invest some €70 billion ($92 bn) in research over the next seven years, and already contenders for funding are jostling for attention. Europe’s biggest drug industry association EFPIA 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 bn) for a new and improved version of the Innovative Medicines Initiative (IMI), its public-private partnership with the EU on early-stage collaborative research. Others organizations 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 to the right patient at the right time. A markedly different approach 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 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”. 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 roåund 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 organisations. At the end of 2012, the program looked as if it might be shredded as the austerity-hit EU 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 program’s 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 ageing - 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. 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. Horizon 2020’s predecessor won praise in many countries and many sectors. The IMI program, which received €1 bn over the seven years of the EU research programme 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 EU’s 2007-2013 programme: the UK will have received around €7.5bn in funding from it by the end of this year - around 15% of the total programme allocation. But there have been frequent criticisms of undue complexity and bureaucracy in previous EU research programs, so this time round 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 programme’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 programme. The programme 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 EU’s overall spending plans for 2014–2020 - and that process will not be completed until September, at the earliest.

The ink is not yet dry on the European Union’s Horizon 2020 agreement to invest some €70 billion ($92 bn) in research
over the next seven years, and already contenders for funding are jostling for attention.

Europe’s biggest drug industry association EFPIA 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 bn) for a new and improved version of the Innovative Medicines Initiative (IMI), its public-private partnership with the EU on early-stage collaborative research.

Others organizations 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 to the right patient at the right time.

A markedly different approach 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 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”.

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 roåund 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 organisations. At the end of 2012, the program looked as if it might be shredded as the austerity-hit EU 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 program’s 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 ageing - 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. 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.

Horizon 2020’s predecessor won praise in many countries and many sectors. The IMI program, which received €1 bn over the seven years of the EU research programme 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 EU’s 2007-2013 programme: the UK will have received around €7.5bn in funding from it by the end of this year - around 15% of the total programme allocation.

But there have been frequent criticisms of undue complexity and bureaucracy in previous EU research programs, so this time round 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 programme’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 programis 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 EU’s overall spending plans for 2014–2020 - and that process will not be completed until September, at the earliest.