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Boston University School of Law

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Health Law and Policy

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Full-Text Articles in Law

Evidence Supporting The Value Of Surgical Procedures: Can We Do Better?, Christopher Robertson, Jonathan Darrow, Willard S. Kasoff Dec 2020

Evidence Supporting The Value Of Surgical Procedures: Can We Do Better?, Christopher Robertson, Jonathan Darrow, Willard S. Kasoff

Faculty Scholarship

There is an acknowledged need for higher-quality evidence to quantify the benefit of surgical procedures, yet not enough has been done to improve the evidence base. This lack of evidence can prevent fully informed decision-making, lead to unnecessary or even harmful treatment, and contribute to wasteful expenditures of scare health care resources. Barriers to evidence generation include not only the long-recognized technical difficulties and ethical challenges of conducting randomized surgical trials, but also legal challenges that limit incentives to conduct surgical research as well as market-based challenges that make it difficult for those funding surgical research to recoup investment costs. …


Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy, Kevin Outterson, Anthony Mcdonnell May 2016

Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy, Kevin Outterson, Anthony Mcdonnell

Faculty Scholarship

A serious need to spur antibiotic innovation has arisen because of the lack of antibiotics to combat certain conditions and the overuse of other antibiotics leading to greater antibiotic resistance. In response to this need, proposals have been made to Congress to fund antibiotic research through a voucher program for new antibiotics, which would delay generic entry for any drug, even potential blockbuster lifesaving generics. We find this proposal to be inefficient, in part because of the mismatch between the private value of the voucher and the public value of the antibiotic innovation. However, vouchers have the political advantage in …


Antibiotic Reimbursement In A Model Delinked From Sales: A Benchmark-Based Worldwide Approach, Kevin Outterson, John Rex Apr 2016

Antibiotic Reimbursement In A Model Delinked From Sales: A Benchmark-Based Worldwide Approach, Kevin Outterson, John Rex

Faculty Scholarship

Despite the life-saving ability of antibiotics and their importance as a key enabler of all of modern health care, their effectiveness is now threatened by a rising tide of resistance. Unfortunately, the antibiotic pipeline does not match health needs because of challenges in discovery and development, as well as the poor economics of antibiotics. Discovery and development are being addressed by a range of public-private partnerships; however, correcting the poor economics of antibiotics will need an overhaul of the present business model on a worldwide scale. Discussions are now converging on delinking reward from antibiotic sales through prizes, milestone payments, …


International Cooperation To Improve Access To And Sustain Effectiveness Of Antimicrobials, Kevin Outterson, Christine Årdal, Steven Hoffman, Abdul Ghafur, Mike Sharland, Nisha Ranganathan, Richard Smith, Anna Zorzet, Jennifer Cohn, Didier Pittet, Nils Daulaire, Chantal Morel, Zain Rizvi, Manica Balasegaram, Osman Dar, David Heymann, Alison Holmes, Luke Moore, Ramanan Laxminarayan, Marc Mendelson, John-Arne Røttingen Jan 2016

International Cooperation To Improve Access To And Sustain Effectiveness Of Antimicrobials, Kevin Outterson, Christine Årdal, Steven Hoffman, Abdul Ghafur, Mike Sharland, Nisha Ranganathan, Richard Smith, Anna Zorzet, Jennifer Cohn, Didier Pittet, Nils Daulaire, Chantal Morel, Zain Rizvi, Manica Balasegaram, Osman Dar, David Heymann, Alison Holmes, Luke Moore, Ramanan Laxminarayan, Marc Mendelson, John-Arne Røttingen

Faculty Scholarship

Securing access to effective antimicrobials is one of the greatest challenges today. Until now, efforts to address this issue have been isolated and uncoordinated, with little focus on sustainable and international solutions. Global collective action is necessary to improve access to life-saving antimicrobials, conserving them, and ensuring continued innovation. Access, conservation, and innovation are beneficial when achieved independently, but much more effective and sustainable if implemented in concert within and across countries. WHO alone will not be able to drive these actions. It will require a multisector response (including the health, agriculture, and veterinary sectors), global coordination, and financing mechanisms …