Law Commons^™

Patient Access In Fourteen High-Income Countries To New Antibacterials Approved By The Fda, Ema, Pmda, Or Health Canada, 2010-2020, Kevin Outterson, Ebiowei S F Orubu, Muhammad H. Zaman, John Rex, Christine Årdal

Faculty Scholarship

In 2010, the Infectious Diseases Society of America called for 10 new antibiotics by 2020 [1]. This goal was achieved in terms of the number of drug approvals, but actual patient access requires commercial launches in many countries, which itself requires sustainable commercial markets. Prior work has described limited access to new antibacterials in low- and middle-income countries (LMICs), in part due to the inability of many to afford these drugs [2]. This study examines patient access for new antibacterials in the G7 and 7 other high-income countries in Europe, to better understand other barriers to …

Antibiotic Development & Economic, Regulatory And Societal Challenges, Kevin Outterson, Christine Årdal, Manica Balasegaram, Ramanan Laxminarayan, David Mcadams, John Rex, Nithima Sumpradit

Faculty Scholarship

Antibiotic resistance is undoubtedly one of the greatest challenges to global health, and the emergence of resistance has outpaced the development of new antibiotics. However, investments by the pharmaceutical industry and biotechnology companies for research into and development of new antibiotics are diminishing. The public health implications of a drying antibiotic pipeline are recognized by policymakers, regulators and many companies. In this Viewpoint article, seven experts discuss the challenges that are contributing to the decline in antibiotic drug discovery and development, and the national and international initiatives aimed at incentivizing research and the development of new antibiotics to improve the …

An International Legal Framework To Address Antimicrobial Resistance, Kevin Outterson, Steven J. Hoffman, John-Arne Rottingen, Otto Cars, Charles Clift, Fiona Rotberg, Göran Tomson, Anna Zorzet, Zain Rizvi

Faculty Scholarship

Antimicrobial resistance is a growing threat to global health. Currently it accounts for approximately 700,000 deaths annually, but is predicted to cause as many as 10,000,000 deaths by 2050 if nothing is done to address it. To effectively deal with this problem three areas must be addressed simultaneously: access, conservation, and innovation. However, solving issues of access, conservation and innovation at the same time requires new coordination and financing mechanisms, some of which must be organized globally. This bulletin outlines the possible role that a binding international legal framework can play in the fight against antimicrobial resistance.

Cancer And The Constitution: Choice At Life's End, George J. Annas

Faculty Scholarship

J. M. Coetzee's violent, anti-apartheid Age of Iron, a novel the Wall Street Journal termed “a fierce pageant of modern South Africa,” is written as a letter by a retired classics professor, Mrs. Curren, to her daughter, who lives in the United States. Mrs. Curren is dying of cancer, and her daughter advises her to come to the United States for treatment. She replies, “I can't afford to die in America. . . . No one can, except Americans.” Dying of cancer has been considered a “hard death” for at least a century, unproven and even quack remedies have been …

Fair Followers: Expanding Access To Generic Pharmaceuticals For Low- And Medium-Income Populations, Kevin Outterson

Faculty Scholarship

U.S. trade offi cials frequently employ the rhetoric of free riding and piracy when discussing intellectual property (IP) rights for medicines (Drahos with Braithwaite 2002; Benson 2005). The gentler term free rider is applied when developed country governments (OECD) use monopsony power to negotiate price discounts on patented pharmaceuticals (Outterson 2004, 2005b; U.S. Department of Commerce 2004; PhRMA 2005). Poorer governments usually lack suffi cient market power as a purchaser to negotiate discounts for their low- and middle-income populations. In these cases, governments and patients may resort to unlicensed generic drugs and compulsory licensing. In response, U.S. trade offi cials …

Pharmaceutical Arbitrage: Balancing Access And Innovation In International Prescription Drug Markets, Kevin Outterson

Faculty Scholarship

While neoclassical economic theory suggests that arbitrage will undermine global differential pricing of pharmaceuticals, the empirical results are more complex. Pharmaceutical regulation, IP laws, global trade agreements, and company policies support differential pricing despite the pressure of arbitrage. For essential access programs in particular, the theoretical threat of pharmaceutical arbitrage is shown to be rarely observed empirically. Counterfeiting is demonstrated to be the more serious threat. These conclusions call for changes in the U.S. PEPFAR program for AIDS and in the implementation of the WTO TRIPS Agreement.

A more fundamental question, however, is whether pharmaceutical differential pricing is appropriate for …

Hipaa Regulations: A New Era Of Medical-Record Privacy?, George J. Annas

Faculty Scholarship

The new privacy regulations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) become effective April 14, 2003. This article outlines the implications of the new policy for practicing physicians. The regulations will affect virtually every physician, because they apply to any health care provider who conducts any business electronically, including billing. The regulations require health care providers to provide patients with a privacy notice that informs them who will have access to their records without their explicit consent and about patients' rights to inspect and amend their own records.