lancet-header

Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.

Patient Access in Fourteen High-Income Countries to New Antibacterials Approved by the FDA, EMA, PMDA, or Health Canada, 2010-2020

16 Pages Posted: 14 Apr 2021

See all articles by Kevin Outterson

Kevin Outterson

Boston University School of Law

Ebiowei S.F Orubu

Boston University - Institute for Health System Innovation & Policy, Social Innovation on Drug Resistance Program

John H. Rex

F2G Limited

Christine Årdal

Norwegian Institute of Public Health - Antimicrobial Resistance Centre

Muhammad H. Zaman

Boston University - Department of Biomedical Engineering

More...

Abstract

Background: Inaccessibility of patented medicines in low- and middle-income countries (LMICs) is a frequent challenge. Yet it is typically assumed that high-income countries have complete access to the full arsenal of medicines. This study tests this assumption for patented antibacterials, a class widely acknowledged as having a broken business model. New antibiotics are saved as a last resort in order to prevent the development of resistance, resulting in insufficient revenues to offset costs.

Methods: We identified all antibacterials approved in Canada, Europe, Japan, and the USA for the decade beginning January 1, 2010 and evaluated differences in marketing authorizations and commercial launches in fourteen high-income countries. Delays in access were described as launch lags – the time in days between approvals and commercial launch. Associations between several factors including “innovativeness” were explored.

Findings: Eighteen new antibacterials were identified. The majority were accessible in the US (n=17, 94%), the United Kingdom (n=11, 61%), and Sweden (n=10, 56%), with the remaining eleven countries having access to less than half of them. European marketing authorization did not lead to widespread European access, as fourteen of the antibacterials were approved by EMA, but many fewer were commercially launched. Five antibacterials were deemed as “innovative”, but there was no significant difference in access between “innovative” and “non-innovative” antibacterials. Surprisingly, antibacterials not listed on the EML had shorter launch lags. Japan had the longest median launch lags. Canada had the fewest drugs commercially available (n=2, 11%).

Interpretation: Patient access to new antibacterials is limited not just in LMICs, as previously reported, but also in high-income countries such as Canada, Japan, France, Germany, Italy, and Spain. The major driver of delayed access appears to be poor commercial prospects for reimbursement, leading to company decisions to delay or forego commercialization in many high-income countries due to expectations of insufficient profitability.

Funding Information: No funding received.

Declaration of Interests: John H. Rex, MD is Chief Medical Officer & Director, F2G, Ltd., Editor-in-Chief, AMR.Solutions, Operating Partner & Consultant, Advent Life Sciences, and Adjunct Professor of Medicine, McGovern Medical School, Houston, TX; He has received grant support from Wellcome Trust; He sits on the scientific advisory boards of Bugworks Research, Inc., Basilea Pharmaceutica, Forge Therapeutics, Inc., Novo Holdings, and Roche Pharma Research & Early Development; He has received consulting fees from Phico Therapeutics, ABAC Therapeutics, Polyphor, Ltd., Heptares Therapeutics, Ltd., Gangagen, Ltd., Meiji Seika Pharma, Basilea Pharmaceutica International Ltd., Allecra Therapeutics GmbH, Forge Therapeutics, Inc., SinSa Labs, AtoxBio, Peptilogics, F. Hoffmann-LaRoche, Ltd., Novo Holdings, Innocoll, Vedanta, Progenity, Nosopharm SA, Roivant Sciences, Shionogi Inc., GlaxoSmithKline, and Pfizer Pharmaceuticals; He is a shareholder in AstraZeneca Pharmaceuticals, F2G, Ltd, Advent Life Sciences, Zikani Therapeutis, and Bugworks Research, Inc. The opinions expressed are his own and do not necessarily reflect the opinion of any of the groups with which he works. All others have nothing to disclose.

Suggested Citation

Outterson, Kevin and Orubu, Ebiowei S.F and Rex, John H. and Ardal, Christine and Zaman, Muhammad H., Patient Access in Fourteen High-Income Countries to New Antibacterials Approved by the FDA, EMA, PMDA, or Health Canada, 2010-2020. Available at SSRN: https://ssrn.com/abstract=3825520 or http://dx.doi.org/10.2139/ssrn.3825520

Kevin Outterson (Contact Author)

Boston University School of Law ( email )

765 Commonwealth Avenue
Boston, MA 02215
United States

Ebiowei S.F Orubu

Boston University - Institute for Health System Innovation & Policy, Social Innovation on Drug Resistance Program

595 Commonwealth Avenue
Boston, MA 02215
United States

John H. Rex

F2G Limited ( email )

Chesire
United Kingdom

Christine Ardal

Norwegian Institute of Public Health - Antimicrobial Resistance Centre ( email )

PO Box 4404
Nydalen, N-0403
Oslo
Norway

Muhammad H. Zaman

Boston University - Department of Biomedical Engineering