The original and successful business model of return on investment being sufficiently attractive to the pharmaceutical industry to encourage development of new antibacterial molecules and related diagnostics has been compromised by increasing development costs and regulatory hurdles, resulting in a decreasing chance of success and financial return. The supply of new effective agents is diminishing along with the number of companies engaged in antibacterial research and development. The BSAC Working Party on The Urgent Need:Regenerating Antibacterial Drug Discovery and Development identified the need to establish, communicate and apply the true health and economic value of antibacterials, along with the adoption of meaningful incentives, as part of the future model for antibacterial development. Robust data are needed on the cost of resistance and ineffective treatment of bacterial infection, along with national and local holistic analyses of the cost-benefit of antibacterials. An understanding of the true health and economic value of antibacterials and the cost of resistance across healthcare systems needs to be generated, communicated and used in order to set a pricing and reimbursement structure that is commensurate with value. The development and economic model of antibacterial use needs to be rebuilt based on this value through dialogue with the various stakeholders, including the pharmaceutical industry, and alternative incentives from 'push' to 'pull' and funding models, such as public/private partnerships, agreed. A research and development model that succeeds in developing and delivering new antibacterial agents that address the health needs of society from start to finish, 'from cradle to grave', must be established.
Bibliographical noteFunding Information:
A. R. W. is an independent consultant, a retired employee and shareholder of GlaxoSmithKline, and in the past 5 years has received financial remuneration for consultancy or presentations from GSK and Chiron/ Novartis. D. L. has received conference, speaking and research support from numerous pharmaceutical companies. He holds shares in AstraZe-neca, Merck, Pfizer, Dechra, and GlaxoSmithKline, and, as executor, manages further holdings in GlaxoSmithKline and Eco Animal Health. He is an employee of the UK HPA and is a UK taxpayer. R. B. is currently a senior partner at Transcrip Partners LLP and works with several large and small pharmaceutical companies in the area of antibiotic development. He is also a non-executive director of Helperby Therapeutics Ltd. R. F. has provided consultative advice Destiny Pharma, GlaxoSmith-Kline, Menarini Recherche and Novartis. F. B. is an employee of Eli Lilly and Company Ltd. I. C. is a member of the Scientific Advisory Board of Destiny Pharma Ltd, and has recently received research funding from Cubist, Destiny, Galapagos, Leo, Pfizer, Novartis and Novacta. The remaining Members of the Working Party have none to declare.
- Drug development
- Estimated net present values
- Return on investment