Tacking anti-microbial resistance
16.05.15
The report confirms the need to break with the past and create a new business model for antibiotic R&D, where revenues are dissociated from volume sales, but which remains attractive to drug developers. To do this, it must address both the uncertainty of antibiotic development and the level of available returns. We also support the clear statement that we need a global solution to this problem, addressing both over-use and lack of access.
Two specific funds are proposed in the report - a global reimbursement fund and an innovation fund. The Reimbursement fund will succeed or fail based on the level of global endorsement that it receives from governments and the extent to which it is able to design lump-sum reimbursment packages that provide the right incentives for antibiotic development. Both of these are surmountable, but not simple, challenges and the industry is keen to play its part in the review's follow-on work, including reflection on the industry's role in the stewardship of new antibiotics.
The report suggests the innovation would be a short-term initiative, funded by the industry on a one-off basis. However, we believe that the benefits identified in the report in improved coordination of research and early-stage development could equally be viewed as enduring elements of the new model. EFPIA's own experience of the Innovative Medicines Initiative (IMI) is that collaboration is generating benefits, but that these will be fully realised over the long-term. Hence we would encourage the review team to remain open to further evaluation of this proposal.
EFPIA and its member companies are already engaged in collaborative approaches to fighting antimicrobial resistance through the New Drugs for Bad Drugs (ND4BB), Innovative Medicines Initiative, programme. ND4BB aims to combat antibiotic resistance in Europe by tackling the scientific, regulatory, and business challenges that are hampering the development of new antibiotics. With an estimated budget of €600 million over 7 years, the funding for New Drugs for Bad Bugs includes around €300 million of in-kind contributions from participating member companies.
We welcome the focus the report has given on to these critical issues and EFPIA is committed to continuing to work with stakeholders across Europe and globally to find solutions to the scientific, regulatory and economic challenges caused by anti-microbial resistance.