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Prosecuting Excessive Pricing of Pharmaceuticals under Competition Law: Evolutionary Development
Get PDFProsecution of pharmaceutical companies for excessive pricing of products under competition law is now a reality. As recently as a decade ago, such prosecutions were virtually nonexistent. That situation has changed dramatically as competition authorities in Europe and South Africa have pursued a significant number of such prosecutions and have levied substantial fines against the investigated parties. While the United States has traditionally led in policing the pharmaceutical market against anticompetitive misconduct, in this specific arena it has fallen behind, principally because federal courts so far have refused to acknowledge excessive pricing as a cause of action under Section 2 of the Sherman Act.
In a succession of cases European competition authorities have demonstrated concretely the way in which excessive pricing prosecutions may be pursued. This article examines those cases in some detail showing the challenges that competition authorities have faced, and how they have gone about addressing them. The successes in Europe should help put to rest arguments regarding the difficulties in ascertaining how pharmaceutical products are priced, particularly for products no longer covered by patents or regulatory market exclusivity. The South African competition authority is undertaking its second major prosecution of excessive pricing of originator products. The ongoing case involves an essential anticancer medicine the pricing of which has deprived individuals in South Africa of lifesaving treatment.
Methodologies for investigating and analyzing abusive pricing are being regularized. This is important because competition authorities around the world should be able to rely on generally accepted standards for pursuing misconduct. This article suggests doctrinal improvements in the form of per se baseline rules for establishing excess with respect to generics, and rule of reason balancing tests for assessing the fairness of pricing practices for originator products and generics not encompassed by per se rules. The continued evolution of excessive pricing doctrine does not depend on these improvements. More important is continuing legal, financial, and political support for the efforts of competition authorities in this area.
Patents, regulatory market exclusivity and other structural features insulate the pharmaceutical market from economic pressures that ordinarily create and recreate an equilibrium that protects consumers. For the pharmaceutical market, there must be a means to redress excessive prices in themselves. Competition law enforcement is an important tool for achieving that redress
Doctrinal Destruction and Chevron\u27s Extinction Debt
Get PDFChevron, the landmark Supreme Court case urging judicial deference to reasonable agency interpretations of vague or ambiguous statutes, has dominated federal administrative law since 1984. The sudden rise of the major questions doctrine, however, has destroyed Chevron’s jurisprudential habitat. Conservation biology suggests that habitat destruction is most devastating to dominant species, often imposing a biological “debt” that must be repaid through extinction. As with biology, so with law: “Major questions” having displaced agency deference, Chevron is doomed
FSU Law Focus - 01/13/2023
Get PDFFrom the Dean: Upcoming alumni receptions; FSU Law Car Races at New Smyrna Speedway; Alum Profile: Katherine E. Giddings (’92); Student Profile: 3L Gavin Sitkoff-Vuonghttps://ir.law.fsu.edu/fsu-law-focus/1282/thumbnail.jp
FSU Law Focus - 08/25/2023
Get PDFFrom the Dean: 1L Orientation; 2023 Alumni Awards Presentation; Alum Profile: Erin M. Carr (’10); Student Profile: 3L Shannon Kelleyhttps://ir.law.fsu.edu/fsu-law-focus/1089/thumbnail.jp
The Supreme Court\u27s Fragile Copyright Law
Get PDFFor a generation, copyright scholars have taken it as a given that copyright law is destined to be disrupted by technological change. The basic problem, they have explained, is that it is impossible for Congress to anticipate the ways that new technologies will affect the creation, distribution, adaptation, and consumption of creative work. While excusing Congress and the courts for copyright law\u27s uncertainties, this view also leads to a kind of resignation. Unless we are to halt the march of technological progress, we must accept the unpredictability of copyright law as an inexorable fact of life. This Article complicates the conventional account by identifying an independent cause of copyright uncertainty, one that is rooted not in technological change but in the judicial process itself. Copyright law is vulnerable to disruption due to an unappreciated interaction between the certiorari- and merits-stage practices of the Supreme Court. For a century, the choice to hear copyright cases has rested in the Court\u27s discretion, and it has typically used that discretion to avoid the field. Because intervention by the Court is infrequent and unpredictable, participants in the copyright system have no choice but to look to circuit law. Indeed, some of the most important precedents for copyright industries today are not precedents of the Supreme Court but of the circuit courts of appeals. But occasionally the Supreme Court decides to hear a copyright case. And when it does, the circuit law forming the bedrock of our copyright system suddenly becomes vulnerable. Although the Court has, at times, deferred to lower court decisions in other areas of law, it has not done so in any contemporary copyright case. Repeatedly, the Court decides copyright cases without deference to lower court decisions, even decade-old decisions that have been widely accepted by the relevant industry and engendered significant reliance interests. Identifying this mechanism reveals the prevailing technologyfocused account of copyright disruption to be incomplete. A surprisingly small share (less than fifteen percent) of recent Supreme Court copyright cases involve any post-enactment technological developments. But rather than discrediting the conventional view, this complication suggests that copyright uncertainty may be more pervasive than previously recognized. To the extent technological developments are raising new questions of copyright law, the Supreme Court-and hence, the judicial process-is not providing many final answers
FSU Law Focus - 06/09/2023
Get PDFFrom the Dean: Registering employers for Fall 2023 interview programs (OCI); Faculty Profile: Nadia Banteka; In Memoriam: Alum Jon Wheeler (\u2769); Profile: Celebrating 2023 Grad Kayla Nealhttps://ir.law.fsu.edu/fsu-law-focus/1156/thumbnail.jp
FSU Law Focus - 06/30/2023
Get PDFFrom the Dean: Claude Pepper Elder Law Clinic held event for World Elder Abuse Awareness Day; Faculty Profile: Jacob Eisler; Alum Profile: Logan K. McEwen (\u2712); Profile: Celebrating 2023 Grad Daley Pajcichttps://ir.law.fsu.edu/fsu-law-focus/1176/thumbnail.jp
FSU Law Focus - 04/14/2023
Get PDFFrom the Dean: Celebration for Shawn Bayern\u27s latest Book, Autonomous Organizations ; Student Compete in Legal Hackathon; In Memoriam: Alum Pamela Gayle Davis (\u2791); Student Profile: 3: Rachel Changhttps://ir.law.fsu.edu/fsu-law-focus/1242/thumbnail.jp