Basic concepts and issues: a primer on distribution and sales representative agreements in the medical device and durable medical equipment industries

Counsel for a manufacturer of medical devices or durable medical equipment must have working knowledge of various legal disciplines to draft contracts with intermediaries (sales representatives and distributors) for the marketing and sale of the manufacturer's products. If the manufacturer wishes to sell its products abroad, counsel must become familiar with the laws and business practices of the target country, and methods of gaining access to the foreign market. This Article gives readers an overview of the applicable legal principles, under U.S. and foreign laws, in the areas of agency, contracts, healthcare regulation, consumer protection, intellectual property protection, and dealer protection. To aid counsel in drafting intermediary agreements, specific contractual terms and issues are explored in depth, including: appointment clauses, performance provisions, provisions concerning pricing and payment, protective clauses (shielding the manufacturer from liability), term and termination provisions, independent contractor clauses, export control clauses, recordkeeping and audit provisions, choice of law clauses, and dispute resolution clauses.     

"No-hire" clauses in healthcare sector contracts: their use and enforceability

In today's healthcare industry, many hospitals utilize outside agencies for both business and clinical functions. This Article acknowledges the prevalence of outsourcing contract labor in the healthcare arena and focuses on the restrictive provisions included in these employment contracts, particularly "no-hire" clauses. No-hire clauses are often included in contracts between healthcare providers and professional groups that provide clinical service employees to the provider, such as a medical practice group providing physicians to a hospital or an agency providing nurses to a nursing home. These clauses usually provide that the healthcare provider may not directly hire an employee provided by the professional group, nor may it contract with another professional group that later hires the employee. The purpose of a no-hire clause is two-fold: to protect the professional group's investment of time and moneyfor recruiting, training, and establishing the employee's clinical practice, and to give the professional group leverage to retain its employees. While noncompete clauses in employment contracts have traditionally been the subject of litigation, no-hire clauses raise distinct legal issues. Case law provides conflicting views as to the enforceability of these provisions. Some courts find no-hire clauses to be per se illegal restrictions on trade, while others will permit them when they are reasonable within a specific context. The author proposes that a multifactor test be applied on a case-by-case basis to determine the reasonableness of the no-hire provision in a given employment contract and suggests drafting improvements to facilitate enforcement.     

Antitrust, health care quality, and the courts

Antitrust law represents the principal legal tool that the United States employs to police private markets, yet it often relegates quality and nonprice considerations to a secondary position. While antitrust law espouses the belief that vigorous competition will enhance quality as well as price, little evidence exists of the practical ability of courts to deliver on that promise. In this Article, Professors Hammer and Sage examine American health care as a vehicle for advancing understanding of the nexus among competition, quality, and antitrust law. The Article reports results of a comprehensive empirical review of judicial opinions in health care antitrust litigation between 1985 and 1999, with specific attention to courts' handling of quality and other nonprice concerns. Professors Hammer and Sage conclude that, although antitrust law cannot be expected to serve as the sole oversight mechanism for industries as complex and quality dependent as health care, courts have been successful incorporating some nonprice factors into antitrust analysis.     

Disintegration: Environmental Protection and Article 81 EC

This article addresses the question of whether the modernisation and decentralisation of EC competition law will affect the integration of environmental protection requirements into the framework of Article 81 EC. First, the interface between competition policy and environmental protection at both the constitutional level and operational level is investigated. Following this, the Commission's assessment of environmental benefits under Article 81(3) EC prior to decentralisation and modernisation is explored. It is submitted that the Commission's expansion of its interpretation of the first two positive criteria of Article 81(3) EC allowed environmental objectives and competition goals to be balanced within the framework of Article 81 EC. Finally, this article examines the extent to which the decentralisation and modernisation of Community competition law may impede the integration of environmental protection into the definition and implementation of Article 81 EC.     

Structural conditions for novelty: the introduction of new environmental clauses to the trade regime complex

When do parties introduce novel clauses to a system of contracts or treaties? While important research has investigated how clauses diffuse once introduced, few empirical studies address their initial introduction. Drawing on network theory, this paper argues that novel clauses are introduced when agreements are concluded in certain structures of earlier agreements and the clauses they include. This paper demonstrates this argument using the example of 282 different environmental clauses introduced into the trade regime complex through 630 trade agreements concluded between 1945 and 2016. We find that trade agreements are more likely to introduce novelties when they involve parties with a diversity of experience with prior environmental clauses and introduce more novelties when more parties are less constrained by prior trade agreements between them. Contrary to prevailing wisdom, power asymmetry between the negotiating parties is not statistically significant.

     

商标法第十五条的价值定位与适用规则研究

作为保护未注册商标、打击恶意抢注的重要条款,我国《商标法》第15条规制的是具有代理、代表等特定关系的商标抢注行为。从价值定位来看,其是商标法调整不同情形的抢注行为的重要一环,该定位决定了其适用范围应与其他条款相协调,从体系化的角度防止适用边界的重叠。从规范设计来看,第15条第1款和第2款分别调整不同的特定关系,分别具有着不同的适用要求与法律效力。从具体适用来看,争议较大的是对特定关系的认定、对在先使用的判断,一方面,实践中的特定关系往往牵连着复杂的关系链条,这需要对所涉及的关系进行实质性把握,另一方面,面对第15条可能沦为一些竞争者打击竞争对手的工具的现象,这需要审慎地对在先使用与在先权利的归属进行实质性判断。面对第15条在理解和适用上的模糊与争议,有必要回归其规范目的和价值定位予以体系化考虑,以正确界定其适用边界,合理把握其适用要件,恰当发挥其应有作用。     

Noncompetition Clauses: Unreasonable or Efficient?

Generally, legislators and courts look upon noncompetition agreements unfavourably. This paper questions the assumptions underlying the traditional theories on noncompetition clauses and advances two theories that have previously not been found in the legal literature. It is argued that noncompetition clauses are used as a device to self-select employees who desire a long-term contract with the firm. Furthermore, employees agree to these clauses to guarantee that the employer will make specific investments in the employment relationship. The noncompetition agreement protects the creation and distribution of the surplus of the employment relationship. Legal restrictions on noncompetition clauses have the danger of decreasing the ex ante value of the employment relationship. The result will be lower investments and lower wages.     

《刑法修正案(十一)》中竞合条款的理解与适用

随着刑事立法的日趋活跃,采“分则立法模式”的竞合条款日益呈现“立法肥大症”,可考虑将竞合条款(尤其是想象竞合从一重处断条款)进行总则化改造。就新增竞合条款的理解与适用而言,作为想象竞合表征的从一重处断条款,其适用关键是“一行为”与“数法益”的判断;新修正的我国《刑法》第229条第2款,标志着立法者对牵连犯现象的进一步肯认,其适用以客观上存在牵连关系、主观上具备牵连意图为限;新增的数罪并罚条款(第280条之二第3款),则存在修正程序与实体内容两方面的瑕疵,应将其视为想象竞合数罪并罚的“拟制规定”加以适用。     

To What Extent are Cost Savings Passed on to Consumers? An Oligopoly Approach

Competition policy often asks whether a “fair share” of the benefits from cost savings obtained through mergers or agreements is passed on to the consumers. We assess the factorsthat determine cost pass-on in some partial-equilibrium oligopoly models, and show that, although the strength of the pass-on varies from one situation to another, there are some rules of thumb that give a first approximation of the pass-on rate. We also show that, contrary to common belief and to what is written about the subject in the European Commission's guidelines on the application of Article 81(3), in most circumstances cost pass-on does not depend on the price elasticity of demand nor on the market share of the cost saver, and that with competition the pass-on of firm-specific cost savings is weaker than without. JEL Classification: C72 (non-cooperative games), D43 (oligopoly), L40 (antitrust policy)     

An economic and antitrust analysis of the distribution of medical products

The techniques used to distribute medical products are designed to maximize the manufacturers' profits by charging a relatively low price to hospitals and a relatively high price to other purchasers, such as doctors and nursing homes. This pricing scheme raises complex antitrust problems, including vertical price fixing between the manufacturer and its distributors, price discrimination by the manufacturer, and agreements between the manufacturer and the hospitals restricting the hospitals' ability to resell. This Article examines these antitrust issues.     

Unwanted cohabitation agreements

Given the predominant role in American law of cohabitation agreements in protecting cohabitants, this Article presents an informal study that measured attitudes toward such agreements. The results confirm the literature findings that people generally are not inclined to want cohabitation agreements upon cohabitation. Further studies might explore the reasons for the unpopularity of cohabitation agreements and the ways to improve the protection of cohabitants, and this Article offers potential considerations.     

WTO中的公共道德例外条款分析

多边贸易协定一个重要目的就是消除贸易壁垒,实现贸易自由化。但是有时过度地追求贸易自由可能会给一国的公共道德造成威胁。因此,在多边贸易协定中往往内含了一些可以豁免缔约方缔约义务的例外条款。缔约方为了保护本国的公共道德,可以援引这些例外条款来对抗其他缔约方的指控。在WTO中,公共道德例外主要体现在GATT第20条﹙a﹚和GATS第14条﹙a﹚。另外,在《与贸易有关的知识产权协定》第27条第2款和《政府采购协定》第23条第2款中也规定了这种例外。     

PUNITIVE DAMAGES,CHINESE TORT LAW,AND THE AMERICAN EXPERIENCE

In a country such as China, with abundant consumer products and the inevitability of product defects, claims for punitive damages are sure to arise under Article 47 of the new Chinese Tort Law. Article 47 provides that “(w)hereany producer or seller knowingly produces or sells defective products, causing death or serious damage to the health of others, the injured party may request appropriate punitive damages.” As Chinese jurists and scholars interpret Article 47, they may wish to consider whether lessons can be drawn from the American experience. During the past two decades, few areas of American law have changed more radically than the law on punitive damages. While there were once few restraints on the ability of a judge or jury to impose punitive damages in a case involving egregious conduct, today there are a host of limitations embodied in American state and federal law. In many American states, statutes or judicial decisions restrict the ability of a court to award punitive damages by narrowly defining the types of conduct that will justify a punitive award, raising the standard of proof, capping the amount of punitive damages, requiring a portion of a punitive award to be forfeited to the state, or limiting vicarious liability for punitive damages. In addition, under federal constitutional law, the principle of due process limits the imposition of punitive damages by scrutinizing the ratio between compensatory and punitive damages and prohibiting an award to be based on harm to persons other than the plaintiff. An examination of these developments from a comparative law perspective may prove useful to the implementation of Article 47.     

海牙《选择法院协议公约》之防御性机制研究

作为目标宏大的《民商事管辖权与判决公约》难产的情况下达成的最大共识的产物,《选择法院协议公约》包含了大量的排除公约适用的防御性条款,对此深入研究可以为我国批准和加入公约后更好地解决国际民事诉讼中管辖权的冲突,以及更好的保护我国的司法主权提供理论基础。     

Internet gambling: Community flop or the Texas Hold'em poker rules1

Transformed by technology, the virtualisation of gambling has prompted administrations around the world to respond swiftly to the challenges posed by the new way of carrying out an age-old practice. However, approaches to regulation differ. Within the USA online gambling is prohibited by the Unlawful Internet Gambling Enforcement Act 31 U.S.C. 5361-5367 (enacted in the USA in October 2006). This has been played out by the threats of extradition and arrests of senior executives in Texas and ultimately imprisonment for criminal infringements in among other places Las Vegas. By contrast the UK has implemented a regulatory regime through the Gambling Act 2005. The European Community has provided a regime somewhere between the two following recent European Court of Justice decisions (Plancanica 2 CMLR 25) finding against Member States operating state monopolies preventing the establishment of private providers in this specific sphere of commercial activity, contrary to Article 43TEC (right of establishment) and Article 49TEC (the right to provide services, this will of course also have the corollary of the right to receive services). The appropriateness of these responses leads the commentators back towards embryonic Internet governance discussions on cyber-paternalism and cyber-liberalism with online gambling as the case study.     

RECOGNITION AND ENFORCEMENT OF JUDGMENTS BETWEEN CHINA,JAPAN AND SOUTH KOREA IN THE NEW ERA: SOUTH KOREAN LAW PERSPECTIVE

This article discusses the rules for recognition and enforcement of foreign judgments in the Republic of Korea (hereinafter referred to as “South Korea” or “Korea”). Articles 217 and 217-2 of the Civil Procedure Act of Korea and Articles 26 and 27 of the Civil Enforcement Act of Korea provide for the recognition and enforcement of foreign judgments respectively. Korea has not entered into any bilateral or multilateral treaties regarding the recognition and enforcement of foreign judgments and is not a party to the Convention on Choice of Court Agreements. The article also considers the current undesirable status of recognition and enforcement of judgments in the region consisting of China, Japan and South Korea (hereinafter referred to as “Region”) and suggests a course of action to be taken to improve the situation. The author believes that the experts of the Region should embark upon a project to improve the current situation and that the first step should be to exchange and gather information on the current legal regime of the countries in the Region on the recognition and enforcement of judgments. The author looks forward to future cooperation among the experts in the Region on this topic and is confident that the reciprocity requirement, which currently is a major obstacle to the mutual recognition and enforcement of foreign judgments in the Region, will be overcome in the near future.     

PRICE DISCRIMINATION UNDER EC COMPETITION LAW: ANOTHER ANTITRUST DOCTRINE IN SEARCH OF LIMITING PRINCIPLES?

The main objective of this article is to shed light on the compatibilityof price discrimination with EC competition law. We offer ananalytical framework which distinguishes between different categoriesof price discrimination depending on their effects on competition.Our framework suggests that different tests are needed to assessthe lawfulness of price discrimination practices under EC competitionlaw. A related objective of the article is to show that Article82(c), the main Treaty provision dealing with price discrimination,should only be applied to the limited circumstances where anon-vertically integrated dominant firm price discriminatesbetween customers with the effect of placing one or severalof them at a competitive disadvantage vis-a-vis other customers(secondary line injury price discrimination). In contrast, Article82(c) should not be applied to pricing measures designed toharm the dominant firm's competitors (first line-injury pricediscrimination) or to partition the single market across nationallines.     

Social Insurance Monopolies in Community Competition Law and the Italian Constitution: 'Practical' Convergences and 'Theoretical' Conflicts

An Italian judge, following earlier suggestions of the national antitrust Authority, has referred to the Court of Justice for a preliminary ruling under Article 234 EC Treaty two questions on the interpretation of Articles 81 and 86 of the EC Treaty. With those questions, raised in an action brought by a self‐employee against the Istituto Nazionale per l'Assicurazione contro gli Infortuni sul Lavoro (INAIL) concerning the actor's refusal to pay for social insurance contributions, the Tribunale di Vicenza has in summary asked the Court of Justice whether the public entity concerned, managing a general scheme for the social insurance of accidents at work and professional diseases, can be qualified as an enterprise under Article 81 EC Treaty and, if so, whether its dominant position can be considered in contrast with EC competition rules. This article takes this preliminary reference as a starting point to consider in more general terms the complex constitutional issues raised by what Ge´rard Lyon‐Caen has evocatively called the progressive ‘infiltration’ of EC competition rules into the national systems of labour and social security law. The analysis is particularly focused on the significant risks of ‘constitutional collision’, between the ‘solidaristic’ principles enshrined in the Italian constitution and the fundamental market freedoms protected by the EC competition rules, which are implied by the questions raised in the preliminary reference. It considers first the evolution of ECJ case law—from Poucet and Pistre to Albany International BV—about the limits Member States have in granting exclusive rights to social security institutions under EC competition rules. It then considers specularly, from the Italian constitutional law perspective, the most recent case law of the Italian Constitutional Court on the same issues. The ‘contextual’ reading of the ECJ's and the Italian Constitutional Court's case law with specific regard to the case referred to by the Tribunale di Vicenza leads to the conclusion that there will probably be a ‘practical convergence’in casu between the ‘European’ and the ‘national’ approach. Following the arguments put forward by the Court of Justice in Albany, the INAIL should not be considered as an enterprise, in line also with a recent decision of the Italian Constitutional Court. And even when it was to be qualified as an enterprise, the INAIL should in any case be able to escape the ‘accuse’ of abuse of dominant position and be allowed to retain its exclusive rights, pursuant to Article 86 of the EC Treaty. This ‘practical convergence’in casu does not, however, remove the latent ‘theoretical conflict’ between the two approaches and the risk of ‘constitutional collision’ that it implies. A risk of a ‘conflict’ of that kind could be obviously detrimental for the European integration process. The Italian Constitutional Court claims for herself the control over the fundamental principles of the national constitutional order, assigning them the role of ‘counter‐limits’ to the supremacy of European law and to European integration. At the same time, and more generally, the pervasive spill over of the EC market and competition law virtually into every area of national regulation runs the risk of undermining the social and democratic values enshrined in the national labour law traditions without compensating the potential de‐regulatory effects through measures of positive integration at the supranational level. This also may contribute to undermine and threaten, in the long run, the (already weak) democratic legitimacy of the European integration process. The search for a more suitable and less elusive and unilateral balance between social rights and economic freedoms at the supranational level should therefore become one of the most relevant tasks of what Joseph Weiler has called the ‘European neo‐constitutionalism’. In this perspective, the article, always looking at the specific questions referred to the Court of Justice by the Tribunale di Vicenza, deals with the issue of the ‘rebalance’ between social rights and economic and market freedoms along three distinct but connected lines of reasoning. The first has to do with the need of a more open and respectful dialogue between the ECJ and the national constitutional courts. The second is linked to the ongoing discussion about the ‘constitutionalization’ of the fundamental social rights at the EC level. The third finally considers the same issues from the specific point of view of the division of competences between the European Community and the Member States in the area of social (protection) policies.     

论世界贸易组织规则中的环境保护条款

世界贸易组织在许多协定、协议中都规定了环境保护的条款。但是这些规定不具体,没有统一的环境标准,缺乏可操作性,存在对发展中国家不公平,违背世界贸易组织的基本原则等问题。完善世界贸易组织的环境立法,要在世界贸易组织的框架下达成多边环境协议,重新考虑对相同产品的非歧视待遇原则,规定环境法律实施的透明度原则及其具体要求。