TY - JOUR
T1 - A critical analysis of the review on antimicrobial resistance report and the infectious disease financing facility
AU - Brogan, David M.
AU - Mossialos, Elias
N1 - Funding Information:
While we commend the IDFF proposal for its attempt to enhance early financing, it lacks a comprehensive strategy for stimulation of antibiotic development and relies in large part on the co-funding of projects by third parties to supplement IDFF funds. The proposal appears to require this funding and loan repayments to generate the 5-10x multiplier effect. The validity of this approach is unclear, particularly if it is dependent on repayments from projects that are generally considered to be nonviable from a commercial standpoint. Essentially, this financing facility provides cheap money to pharmaceutical corporations in an effort to lower their cost of capital and promote investment in research and development. Unfortunately, the mechanism has no clawback provision to regain additional funds or discount the costs of the drugs if they are profitable. At best, the facility recoups the cost of the loan; at worst, the loan becomes a grant to the failed enterprise. This structure’s effects on the sustainability of the financing facility and on its ability to promote true innovation are unclear. The IDFF is demand driven, in that it funds proposals put forth by industry, with no clear agenda of its own, other than a generalized mandate. Without a clear framework to identify and set priorities, there is a risk that the facility will fund priorities of corporations instead of public health objectives. The European Innovative Medicines Initiative (IMI) provides a cautionary tale of how corporate incentives may diverge from public goals. The IMI is a jointly funded initiative by the European Union and the European pharmaceutical industry. The most recent program, funded in 2014, has a budget of €3.276 billion [14], with almost half of this coming from in-kind contributions from the pharmaceutical industry. While the focus of the program is to provide early stage development funding for a variety of medicines, including antibiotics, it has come under criticism recently for lack of transparency and diversion of resources to projects felt to be lucrative by the industry, but not aligned with major European public health objectives [15, 16].
Funding Information:
The IDFF proposal anticipates allocating money to small and medium sized enterprises, approximately €25 million to each of 8–10 companies. These companies would be expected to fund up to 25 % of the project, with a maximum of 50 % of funds coming from IDFF money. The remaining funds could then be contributed by a third party. This could prove sufficient to allow initial testing of products. However, recent data suggests that pre-clinical testing costs on average may be as high as US$1.1 billion [11]. Therefore, the funding from IDFF would likely not be sufficient to fund development through pre-clinical testing – substantial additional support would be required. The IDFF report also suggests that the project should have completed pre-clinical testing, thus €25 million could only be applied to clinical testing.
Publisher Copyright:
© 2016 Brogan and Mossialos.
PY - 2016/3/22
Y1 - 2016/3/22
N2 - Over the past year, two major policy initiatives have been introduced focusing on stimulating antibiotic development for human consumption. The European Investment Bank has announced the development of the Infectious Disease Financing Facility (IDFF) and the British government commissioned the Review on Antimicrobial Resistance, led by Jim O'Neill. Each constitutes a major effort by the European community to address the evolving crisis of antimicrobial resistance. Though both have similar goals, the approaches are unique and worthy of consideration. This manuscript utilizes a previously published framework for evaluation of antibiotic incentive plans to clearly identify the strengths and weaknesses of each proposal. The merits of each proposal are evaluated in how they satisfy four key objectives: 1) Improve the overall net present value (NPV) for new antibiotic projects; 2) Enable greater participation of Small to Medium Sized Enterprises (SME); 3) Encourage participation by large pharmaceutical companies; 4) Facilitate cooperation and synergy across the antibiotic market. The IDFF seeks to make forgivable loans to corporations with promising compounds, while the O'Neill group proposes a more comprehensive framework of early stage funding, along with the creation of a stable global market. Ultimately, the proposals may prove complementary and if implemented together may form a more comprehensive plan to address an impending global crisis. Substantial progress will only be made on these efforts if action is taken at an international level, therefore we recommend consideration of these efforts at the upcoming G20 summit.
AB - Over the past year, two major policy initiatives have been introduced focusing on stimulating antibiotic development for human consumption. The European Investment Bank has announced the development of the Infectious Disease Financing Facility (IDFF) and the British government commissioned the Review on Antimicrobial Resistance, led by Jim O'Neill. Each constitutes a major effort by the European community to address the evolving crisis of antimicrobial resistance. Though both have similar goals, the approaches are unique and worthy of consideration. This manuscript utilizes a previously published framework for evaluation of antibiotic incentive plans to clearly identify the strengths and weaknesses of each proposal. The merits of each proposal are evaluated in how they satisfy four key objectives: 1) Improve the overall net present value (NPV) for new antibiotic projects; 2) Enable greater participation of Small to Medium Sized Enterprises (SME); 3) Encourage participation by large pharmaceutical companies; 4) Facilitate cooperation and synergy across the antibiotic market. The IDFF seeks to make forgivable loans to corporations with promising compounds, while the O'Neill group proposes a more comprehensive framework of early stage funding, along with the creation of a stable global market. Ultimately, the proposals may prove complementary and if implemented together may form a more comprehensive plan to address an impending global crisis. Substantial progress will only be made on these efforts if action is taken at an international level, therefore we recommend consideration of these efforts at the upcoming G20 summit.
KW - Antibiotic development
KW - International Disease Financing Facility
KW - Review on Antimicrobial Resistance
UR - http://www.scopus.com/inward/record.url?scp=84962532585&partnerID=8YFLogxK
U2 - 10.1186/s12992-016-0147-y
DO - 10.1186/s12992-016-0147-y
M3 - Comment/debate
C2 - 27000847
AN - SCOPUS:84962532585
SN - 1744-8603
VL - 12
JO - Globalization and Health
JF - Globalization and Health
IS - 1
M1 - 8
ER -