EFPIA supports a "kick-start" process to revitalise antibiotic research
Brussels, 17 November 2011: EFPIA, the voice of the research-based pharmaceutical industry in Europe, welcomes the publication today of the European Commission's "Strategy and Action Plan to Tackle the Threat of Antibiotic Resistance".
The threat to public health from antibiotic resistance requires bold thinking followed by bold action. Building on the initiative of the Swedish EU Presidency of 2009 in putting this issue on the table, today's announcement follows a series of discussions over the course of this year and illustrates the strong will to address this issue in partnership.
Urging renewed commitment, EFPIA President Andrew Witty commented: "Antibiotic resistance is a major challenge throughout the world and one that we need to take seriously. It is a challenge that the pharmaceutical industry wants to be part of solving. What we are committed to, is to work with other stakeholders to find a new approach which allows this research to be restimulated, restarted, and allows us to be successful in re-equipping our medicines chests with effective antibiotics which will be available on the day we need them. So that when we do have a fundamental bacterial challenge we are able to protect ourselves."
The Innovative Medicines Initiative (IMI) Europe's largest public-private initiative, jointly-funded by EFPIA and the European Commission, which operates to speed up the development of better and safer medicines for patients, presents a strong mechanism to "kick-start" the process of revitalising antibiotic research. EFPIA welcomes the news that IMI is considering a new large-scale programme to progress the discovery and development of novel antibiotic drugs to treat the most urgent infections and the complementary measures being taken by the Commission to step up research efforts and stimulate the coordination of research activities within EU Member States.
Richard Bergström, Director-General of EFPIA said: "This programme of collaborative research needs to facilitate the involvement of large and small pharmaceutical companies and the antimicrobial research community at large. This is very new ground for the industry and over the course of the next few months we will be finalising the details, but the shape we hope to create for the initiative is clear."
This collaborative platform, which will also enhance efficiency and competition between companies, sharing their expertise in research and development, has the potential to extend to an unprecedented sharing amongst companies of learnings, including successes, failures and information on older products. That way efficiency will be enhanced. This collaboration should support activities across the whole research and development process, including the very-challenging process of drug development, which is recognised as a major stumbling in bringing new antibiotics to patients. In all of this, we believe that it is important to retain a competitive dynamic which will ensure that innovative approaches are developed. We face not just a lack of new antibiotics, but also a lack of novelty in those that are coming forward.
Mr Bergström said: "In the short -term we emphasise the need to identify improved regulatory pathways which will enhance the feasibility of clinical trials in this area. Currently, there are too many situations in which it is no longer feasible to conduct trials. We welcome the transatlantic dialogue that has already taken place on these issues and urge that it continue."
He added: "For the longer-term, we will build on what we are learning through IMI and integrate that learning with the Commission's vision for Horizon 2020, the next research programme of the EU. I hope that we will see more companies participating in this collaborative structure. Above all we need to ensure that investment in antibiotic R&D is strengthened. Our shared goal is more investment and more targeted investment in both public and private sector. EFPIA and its member companies look forward to building on today's announcement to make that vision a reality".
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Notes to the editor
As well as responding decisively in the short-term, the Commission's action plan provides a platform for working together over the medium and long-term on other important issues.
Three further crucial developments lie in the medium to long-term:
The development of rapid diagnostics to permit better selection of therapy is an area in which IMI has already been active.1 The availability of such diagnostics will enhance ultimately both the use and the development of antibiotics, but there are opportunities for progress that exist today and should be explored.
To find a sustainable model for commercialisation. New, effective antibiotics should be adequately-rewarded and that is not the case today. EFPIA and its members today call for a dialogue about how the commercialisation and use of new antibiotics should be carried out in future. We recognise the contradictions in relying on volume sales to earn revenue when authorities are seeking to conserve use. The industry seeks an alternative in which it is engaged with public authorities in monitoring use, incentivised to conserve the value of antibiotics and there are adequate rewards for developing new antibiotics. This is a complex area, requiring collaborative design and implementation involving regulation, medical practice, commercial perspectives and education.
An effective framework for global management and surveillance of antibiotic use. Given that infectious diseases cross borders, we need also to take steps to ensure that the effectiveness of future antibiotics is conserved not just in Europe, but globally. This is the most challenging area, but we cannot avoid the global dimension of this problem. EFPIA and its members are ready to play their part in putting these structures in place, including addressing access issues, recognising that our contribution needs to be matched by the actions of others.
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 31 national associations and 38 leading pharmaceutical companies, EFPIA provides the voice of 2,000 companies committed to researching, developing and bringing new medicines to improve health and quality of life around the world.
EFPIA member are committed to delivering innovative medicines to address unmet needs of patients and reducing the burden of chronic diseases for Europe's ageing population. EFPIA believes in close cooperation with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health threats in Europe.
The pharmaceutical sector directly employs some 640,000 people in Europe including 115,000 working in research and development. The industry also generates around three to four times more employment both upstream and downstream.
Europe's research-based pharmaceutical industry generates a substantial trade surplus, estimated at about €58,800 million in 2009, and has contributed significantly to reducing the European Union's trade deficit in high-tech products. More than a quarter of the EU's high-tech exports are pharmaceutical products.