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Competition rules maximise consumer welfare by promoting efficient use of scarce resource and thus high output, low prices, high quality, varied services, innovation, production and distribution. European courts consider doctors and hospital staff as undertakings (any entity that performs economic activities), so that if they enter into agreements then they have to comply with competition rules. This paper's objective is to determine whether competition law, which applies to undertakings, can in fact be applied to different healthcare‐sector players and whether specific rules are needed regarding competition between healthcare undertakings.

Data were selected from relevant European and national case law, European institution legal documents (such as regulations, guidelines and communications) and healthcare competition law literature, and then examined.

The paper finds that competition rules are applicable to healthcare players considering the consequences if competition rules are applied to the healthcare market. For market processes to result in the appropriate cost, quality and output, competition law must be proactive. In other words, quality must be fully factored into the competitive mix, allowing consumers to weigh healthcare price and non‐price characteristics.

Countries have different healthcare system and competition rules (although similar), competition rule impact is different for each country. Some healthcare systems are more regulated and there will be less opportunity for healthcare players to compete.

Efficiently applying competition law to healthcare players means that several challenges need facing, such as healthcare quality complexity and court scepticism.

This article points out the challenges when competition law is applied to the healthcare sector and how these challenges are faced in certain countries such as The Netherlands.

In 2009, the Third Circuit decided Hydrogen Peroxide, which announced a more rigorous standard under Federal Rule of Civil Procedure 23(b)(3) for assessing whether a putative class could establish antitrust injury. Earlier this year, the Supreme Court decided Comcast v. Behrend, a case that carries potentially broad implications for both antitrust cases and Rule 23(b)(3) class actions generally. A review of the case law starting with Hydrogen Peroxide and continuing through Comcast and its progeny reveals the new rigor in antitrust class action decisions and suggests what the future may hold, including the type of arguments that may provide defendants the most likely chance of defeating class certification. After Comcast, rigor under 23(b)(3) can no longer be avoided in assessing all class actions questions, and courts should now apply Daubert fully in the class setting concerning both impact and damages. Courts should also closely evaluate plaintiffs’ proposed methodologies for proving impact to determine if they apply to each class member. Finally, courts will inevitably have to determine how rigorously to scrutinize experts’ damages methodologies and whether Comcast requires or suggests more scrutiny in assessing common evidence for measuring damages.

The Federal Trade Commission (FTC) has initiated policies and legal challenges that have shaped the evolution of competition in healthcare. This chapter discusses not only discusses the current matters in healthcare competition, but it also gives a history of past issues faced by the FTC and the approaches used to resolve them. These FTC actions range from challenges to hospital mergers to preventing “reverse payments” from patent holders to generic entrants in pharmaceuticals. Ultimately the healthcare industry faces many unique regulatory and competitive aspects that, while challenging, do not require special rules.

The Bureau of Economics in the Federal Trade Commission has a three-part role in the Agency and the strength of its functions changed over time depending on the preferences and ideology of the FTC’s leaders, developments in the field of economics, and the tenor of the times. The over-riding current role is to provide well considered, unbiased economic advice regarding antitrust and consumer protection law enforcement cases to the legal staff and the Commission. The second role, which long ago was primary, is to provide reports on investigations of various industries to the public and public officials. This role was more recently called research or “policy R&D”. A third role is to advocate for competition and markets both domestically and internationally. As a practical matter, the provision of economic advice to the FTC and to the legal staff has required that the economists wear “two hats,” helping the legal staff investigate cases and provide evidence to support law enforcement cases while also providing advice to the legal bureaus and to the Commission on which cases to pursue (thus providing “a second set of eyes” to evaluate cases). There is sometimes a tension in those functions because building a case is not the same as evaluating a case. Economists and the Bureau of Economics have provided such services to the FTC for over 100 years proving that a sub-organization can survive while playing roles that sometimes conflict. Such a life is not, however, always easy or fun.

Brand-name pharmaceutical companies have engaged in a variety of business conduct that has increased price. One of these activities involves “product hopping,” or brand switches from one version of a drug to another. The antitrust analysis of product hopping implicates antitrust law, patent law, the Hatch–Waxman Act, and state drug product selection laws, as well as uniquely complicated markets characterized by buyers different from decision makers. As a result, courts have offered inconsistent approaches to product hopping.

In this chapter, we offer a framework that courts and government enforcers can employ to analyze product hopping. The framework is the first to incorporate the characteristics of the pharmaceutical industry. It defines a “product hop” to include instances in which the manufacturer (1) reformulates the product to make the generic nonsubstitutable and (2) encourages doctors to write prescriptions for the reformulated rather than the original product.

When the conduct meets both requirements, our framework offers two stages of analysis. First, we propose two safe harbors to ensure that the vast majority of reformulations will not face antitrust review. Second, the framework examines whether the hop passes the “no-economic-sense” test, determining if the behavior would make economic sense if the hop did not have the effect of impairing generic competition. Showing just how far the courts have veered from justified economic analysis, the test would recommend a different analysis than that used in each of the five product-hopping cases that have been litigated to date, and a different outcome in two of them.

This chapter assesses the doctrine of reasonable interchangeability through the lens of the US Department of Justice’s (DOJ’s) successful effort to enjoin the megamerger of two of the largest national insurance companies, Aetna and Humana. The DOJ focused its challenge on the companies’ Medicare Advantage business, arguing that it is a separate product market from original Medicare and the merger would substantially reduce competition in the market for Medicare Advantage in many geographic markets across the country. The case turned on whether there was reasonable interchangeability between original Medicare and Medicare Advantage in the eyes of consumers. The judge relied on both practical indicia of interchangeability, including evidence of how likely Medicare beneficiaries were to switch between Medicare Advantage and Original Medicare, along with econometric evidence. The decision provides a useful roadmap of how a knowledgeable judge reviewing a merger will consider both Brown Shoe factors and econometric evidence in assessing reasonable interchangeability.

The Supreme Court’s decision in Federal Trade Commission v. Actavis, Inc. is a challenge to conventional antitrust analysis. Conventional civil antitrust cases are decided by a preponderance of the evidence. This means that conduct challenged under the rule of reason is only condemned if the conduct resulted in more competitive harm in the actual world than a world without the alleged violation. Under conventional analysis, the intent of the parties also plays only a supporting role in determining whether the conduct was anticompetitive. A holder of a valid patent has a right to exclude others practicing the patented technology. And, the patent holder is not assumed to have market power because it expended resources in maintaining exclusionary rights. Actavis creates doubts about these propositions in circumstances beyond the “reverse” payment settlement of a patent suit that may have delayed an alleged infringer market entry. This chapter explores whether applying Actavis logic to antitrust litigation can result in condemnation of practices where there is little chance of an anticompetitive effect, where the patent holder likely has a valid and infringed patent, where there is little reason to believe that the patent holder has market power, and where only one party, or no parties, to an agreement have an anticompetitive intent. This chapter also investigates whether Actavis creates new problems with standing analysis, damages calculations, and the balancing of efficiencies against anticompetitive effects. Nevertheless, the lower courts have begun to extend the logic of Actavis. This is apparent in the condemnation of no-Authorized-generic settlements.

The health care industry has been influenced by changes in the market structure and new technological developments during the recent decades. With the new technological developments in medicine, some less complex care moved out of the hospitals that led to decrease in demand for inpatient services. This recent change in hospital care created excess capacity in hospital markets, and therefore hospitals started to explore potential financial gains through horizontal consolidations. This has resulted in a wave of mergers in 1990s, which transformed the US, Canadian and European hospital markets. This, in turn, created concerns among policy makers and researchers in terms of its welfare implications.