Federal Trade Commission Actions on Prescription Drugs, 2000-2022.

Importance: The Federal Trade Commission's (FTC) oversight role in the pharmaceutical market is critical to the health of patients and the health care system. This study characterized the FTC's policy on the pharmaceutical market in recent decades, identifying the types of actions it has favored, barriers it has faced, and authorities that remain untested. Objective: To review FTC legal actions in the pharmaceutical market from 2000-2022. Evidence Review: Legal actions were determined through manual review of search results from the FTC's online Legal Library as well as a 2023 FTC report on pharmaceutical actions. The alleged misconduct, type of legal action taken, timing, and outcome were collected from press releases, complaints, orders, and other legal documents. Findings: From 2000-2022, the FTC challenged 62 mergers, brought 22 enforcement actions against allegedly unlawful business practices, and made 1 rule related to pharmaceuticals. Alleged misconduct in enforcement actions involved anticompetitive settlements in patent litigation (n = 11), unilateral actions by brand manufacturers to delay generic competition (n = 6), noncompete agreements (n = 4), and monopolization (n = 3), with 10 outcomes involving monetary payment, totaling $1.6 billion. Of the 62 mergers the FTC challenged, 61 were allowed to continue, 58 after divesting certain drugs to third-party competitors. The FTC's reliance on drug divestitures decreased from 18 drugs per year from 2000-2017 to 4.3 per year from 2017-2023. Conclusions and Relevance: The FTC brought about 1 enforcement action and 3 merger actions per year against pharmaceutical manufacturers from 2000-2022, pursuing a small fraction of the estimated misconduct and consolidation in the pharmaceutical marketplace. Although the FTC faces substantial legal and practical limitations, important tools remain untested, including a rule defining "unfair methods of competition," that may allow it to more effectively prevent repetitive patterns of anticompetitive behavior.

Patents and Regulatory Exclusivities on GLP-1 Receptor Agonists.

Importance: Glucagon-like peptide 1 (GLP-1) receptor agonists were first approved for the treatment of type 2 diabetes in 2005. Demand for these drugs has increased rapidly in recent years, as indications have expanded, but they remain expensive. Objective: To analyze how manufacturers of brand-name GLP-1 receptor agonists have used the patent and regulatory systems to extend periods of market exclusivity. Evidence Review: The annual US Food and Drug Administration's (FDA) Approved Drug Products With Therapeutic Equivalence Evaluations was used to identify GLP-1 receptor agonists approved from 2005 to 2021 and to record patents and nonpatent statutory exclusivities listed for each product. Google Patents was used to extract additional data on patents, including whether each was obtained on the delivery device or another aspect of the product. The primary outcome was the duration of expected protection from generic competition, defined as the time elapsed from FDA approval until expiration of the last-to-expire patent or regulatory exclusivity. Findings: On the 10 GLP-1 receptor agonists included in the cohort, drug manufacturers listed with the FDA a median of 19.5 patents (IQR, 9.0-25.8) per product, including a median of 17 patents (IQR, 8.3-22.8) filed before FDA approval and 1.5 (IQR, 0-2.8) filed after FDA approval. Fifty-four percent of all patents listed on GLP-1 receptor agonists were on the delivery devices rather than active ingredients. Manufacturers augmented patent protection with a median of 2 regulatory exclusivities (IQR, 0-3) obtained at approval and 1 (IQR, 0.3-4.3) added after approval. The median total duration of expected protection after FDA approval, when accounting for both preapproval and postapproval patents and regulatory exclusivities, was 18.3 years (IQR, 16.0-19.4). No generic firm has successfully challenged patents on GLP-1 receptor agonists to gain FDA approval. Conclusions and Relevance: Patent and regulatory reform is needed to ensure timely generic entry of GLP-1 receptor agonists to the market.

Hospital Consolidation: The Rise of Geographically Distant Mergers.

This Viewpoint discusses how and why cross-market hospital mergers are different than prototypical within-market mergers in their effects on patients and communities, why the trend may be accelerating, and future policy and research directions.

European Health Care Systems and the Emerging Influence of European Union Competition Policy.

CONTEXT: Since the 1990s, the EU's influence over national health care policy has been limited to European internal market law or social policy coordination mechanisms. The introduction of EU competition law into health care is more recent and underdeveloped; however, its introduction would potentially be much more far-reaching and disruptive. METHODS: Three EU competition law (state-aid) cases are used and comprise both Court of Justice and European Commission decisions. One is from Ireland, one is from the Netherlands, and the third is from Belgium. FINDINGS: The Belgian (Iris-H) case sees EU institutions scrutinize a clearly "social" (nonmarket) health care model with EU competition law for the first time. This is a highly significant development. It is clear, however, that the European Commission is more reluctant to use EU competition law to scrutinize health care systems than the European courts are. CONCLUSIONS: This intent on the part of EU institutions will have to be assessed in future cases, as considerable uncertainty about its shape and outer contours remains. However, EU competition law, and the EU's state-aid investigation apparatus, encroaching into the national health care systems for the first time is highly significant.

Excessive pricing in the pharmaceutical industry: adding another string to the bow of EU competition law.

The paper addresses the issue of excessive price abuse under Article 102(a) of the Treaty on the Functioning of the European Union (TFEU), by drawing inspiration from a recent stream of cases (developed first at the national and then at the EU level) involving pharmaceutical companies marketing off-patent drugs. In particular, the two 'most advanced' cases are analysed: Aspen in Italy and Pfizer/Flynn in the United Kingdom. This new-found attention towards exploitative practices in the form of excessive and unfair pricing by dominant undertakings that have traditionally been subject to a cautious antitrust scrutiny seems worth exploring for a number of reasons, as illustrated in the paper. Ultimately, it is argued that this further 'interference' of competition law into the realms of regulation may be actually justified, albeit subject to precise conditions for enforcement, and may pursue policy objectives in the wider context of EU health law.

The role of EU competition law in health care and the 'undertaking' concept.

Part of the controversy surrounding competition and health care stems from the complexity connected with delineating the applicability of competition law - encompassing both the provisions governing anticompetitive agreements and abuse of dominance and the state-aid rules. Cases determined at the European Union (EU) level within the past 30 years have developed a broad framework, and notable trends have emerged - for example, a distinction between health care providers and managing bodies (purchasers). The former have been subject to an 'abstract' test and the latter to a more sophisticated 'concrete' test. In this paper, we chart the development of the EU courts' approach to developing the 'undertaking' concept in health care and examine the current EU competition law framework with a view to identifying future directions. van de Gronden has recently identified a 'three-prong' test of exemption from competition law in connection with the recent CEPPB case: firstly, where the supply of services is predominantly dependent upon public financing; secondly, the public funding aims to achieve a public interest goal and thirdly, the activities concerned are closely related to this public interest goal. We examine this test in a health care context, drawing on our findings regarding Dutch competition reforms.

Applicability of European Union Competition Law to Health Care Providers: The Dividing Line between Economic and Noneconomic Activities.

Ever-increasing health spending, which, according to future projections, continues to outpace economic growth, will further endanger the financial sustainability of health systems. In a quest to improve the efficacy and efficiency of the health system and thus strengthen its financial sustainability, member states are employing market-based mechanisms to finance, manage, and provide health care. However, the introduction of elements of competition is constrained by the application of EU competition law, which raises significant concerns regarding the applicability of competition law and its limits in the field of health care. Due to the lack of a clear definition in EU legislation, the applicability and scope of competition law are determined on a case-by-case basis, which reveals an inconsistent approach by the European Commission and the CJEU regarding the application of competition law to health care providers and has created legal uncertainty. The aim of this article is to analyze relevant decisions by the commission and the CJEU case law in the pursuit of "boundaries" that may trigger the applicability of competition law with regard to health care providers. Based on the findings of the analysis, the article proposes a set of principles or guidelines for determining whether a health care provider should be considered as an undertaking and, as such, subject to EU competition law.

Drug Reimbursement Regulation in 6 Peer Countries.

The US has nearly 4.5% of the world's population but accounts for more than 40% of global drug spending. With the upcoming 2020 election, a top priority of many voters is to better control drug prices and reform the pharmaceutical market. In this Special Communication, the drug price mechanisms and government regulations used in 6 representative peer countries are evaluated: Australia, France, Germany, Norway, Switzerland, and the United Kingdom. Drug price regulation is compared with that currently used in the US. Eight key lessons from the regulations used in these countries and which elements are incorporated into the bills currently making their way through the US Congress are evaluated (2 from the US House of Representatives and 1 from the US Senate). None of these bills is as systemic or comprehensive in its drug pricing mechanisms and regulations as the schemes in the other countries.

The regulation of competition and procurement in the National Health Service 2015-2018: enduring hierarchical control and the limits of juridification.

Since 1990, market mechanisms have occurred in the predominantly hierarchical National Health Service (NHS). The Health and Social Care Act 2012 led to concerns that market principles had been irrevocably embedded in the NHS and that the regulators would acquire unwarranted power compared with politicians (known as 'juridification'). To assess this concern, we analysed regulatory activity in the period from 2015 to 2018. We explored how economic regulation of the NHS had changed in light of the policy turn back to hierarchy in 2014 and the changes in the legislative framework under Public Contracts Regulations 2015. We found the continuing dominance of hierarchical modes of control was reflected in the relative dominance and behaviour of the sector economic regulator. But there had also been a limited degree of juridification involving the courts. Generally, the regulatory decisions were consistent with the 2014 policy shift away from market principles and with the enduring role of hierarchy in the NHS, but the existing legislative regime did allow the incursion of pro market regulatory decision making, and instances of such decisions were identified.

How will recent trade agreements that extend market protections for brand-name prescription pharmaceuticals impact expenditures and generic access in Canada?

Canada recently entered into two multinational trade agreements (i.e., the Canada, United States, and Mexico Trade Agreement; and the Comprehensive Economic and Trade Agreement with the European Union). The resulting federal policy changes will prolong periods of market protection afforded to eligible brand-name prescription drugs by extending competition-blocking patent and data exclusivity terms. While previous studies have analysed these two policy changes in isolation, it remains unknown what the total combined impact will be in a typical year. Our objective was to design an analytic approach that can assess more than one change to a country's market protections and then to apply this methodology to the Canadian context. We find that the collective impact of these policy changes will be to extend the regulatory protection period for new drugs from an average of 10.0 years to 11.1 years. Depending upon the model's assumptions and all contingencies considered, an 11% increase equated to an average of $410 million annually (with a minimum estimate of $40 million and a maximum of $1.4 billion). Despite this uncertainty reflected in the range of possible financial impacts, we conclude that such methodological approaches could be useful for rapidly evaluating potential policy changes prior to adoption, which may further assist in budget planning to mitigate increased cost to the downstream health authorities most impacted by these trade concessions.

Should a Law Governing the Pharmaceutical Market Be Ethically Examined Based on Its Intent or Its Practical Applications?

Prescription drug prices are a top health care concern among US consumers. Although this issue is at the forefront of current policy discussions, it is not new. In 1984, the Drug Pricing Competition and Patent Term Restoration Act (colloquially, the Hatch-Waxman Act) addressed drug pricing concerns. This article argues that Hatch-Waxman properly applies utilitarian principles to complex issues of biopharmaceutical development by balancing innovation and availability. However, the statute's efficacy has been marred by so-called pay-for-delay arrangements, which disrupted that carefully constructed equilibrium. This article also argues that the 2013 US Supreme Court holding in Federal Trade Commission v Actavis, Inc appropriately restored the utilitarian balance initially achieved by Hatch-Waxman.