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We examine the capital-market effects of changes in securities regulation in the European Union aimed at reducing market abuse and increasing transparency. To estimate causal effects for the population of E.U. firms, we exploit that for plausibly exogenous reasons, such as national legislative procedures, E.U. countries adopted these directives at different times. We find significant increases in market liquidity, but the effects are stronger in countries with stricter implementation and traditionally more stringent securities regulation. The findings suggest that countries with initially weaker regulation do not catch up with stronger countries, and that countries diverge more upon harmonizing regulation.

During the past two generations, democratic forms have coexisted with massive increases in economic inequality in the United States and many other advanced democracies. Moreover, these new inequalities have primarily benefited the top 1 percent and even the top .01 percent. These groups seem sufficiently small that economic inequality could be held in check by political equality in the form of “one person, one vote.” In this paper, we explore five possible reasons why the US political system has failed to counterbalance rising inequality. First, both Republicans and many Democrats have experienced an ideological shift toward acceptance of a form of free market capitalism that offers less support for government provision of transfers, lower marginal tax rates for those with high incomes, and deregulation of a number of industries. Second, immigration and low turnout of the poor have combined to make the distribution of voters more weighted to high incomes than is the distribution of households. Third, rising real income and wealth has made a larger fraction of the population less attracted to turning to government for social insurance. Fourth, the rich have been able to use their resources to influence electoral, legislative, and regulatory processes through campaign contributions, lobbying, and revolving door employment of politicians and bureaucrats. Fifth, the political process is distorted by institutions that reduce the accountability of elected officials to the majority and hampered by institutions that combine with political polarization to create policy gridlock.

New data on the extent of biological invasions pose major regulatory and political challenges to European institutions.

BackgroundThe 2014 European Union (EU) Tobacco Products Directive (TPD) was negotiated in a changed policy context, following adoption of the EU's ‘Smart Regulation’ agenda, which transnational tobacco companies (TTCs) anticipated would increase their influence on health policy, and the WHO Framework Convention on Tobacco Control (FCTC), which sought to reduce it. This study aims to explore the scale and nature of the TTCs' lobby against the EU TPD and evaluate how these developments have affected their ability to exert influence.MethodsAnalysis of 581 documents obtained through freedom of information requests, 28 leaked Philip Morris International (PMI) documents, 17 TTC documents from the Legacy Library, web content via Google alerts and searches of the EU institutions' websites, plus four stakeholder interviews.ResultsThe lobby was massive. PMI alone employed over 160 lobbyists. Strategies mainly used third parties. Efforts to 'Push' (amend) or 'Delay' the proposal and block 'extreme policy options' were partially successful, with plain packaging and point of sales display ban removed during the 3-year delay in the Commission. The Smart Regulation mechanism contributed to changes and delays, facilitating meetings between TTC representatives (including ex-Commission employees) and senior Commission staff. Contrary to Article 5.3, these meetings were not disclosed.ConclusionsDuring the legislative process, Article 5.3 was not consistently applied by non-health Directorates of the European Commission, while the tools of the Smart Regulation appear to have facilitated TTC access to, and influence on, the 2014 TPD. The use of third parties undermines Article 5.3.

\"This paper analyses the development of public-private partnership in Kazakhstan, where for many years the authorities have been trying to establish relations with private entrepreneurs. Thus, the purpose of the study is to characterise the current state of public-private partnership in Kazakhstan, to describe the trends of its development and existing problems, based on international experience. The main method in writing the study is the analysis, based on a significant amount of processed statistical and theoretical data. The study found that the development of public-private partnership in the Republic of Kazakhstan is at the initial level. Nevertheless, there are positive trends in the introduction of new projects and their effectiveness. The most urgent problems for Kazakhstan were identified: the low level of qualified personnel involved in the development of public-private partnership in the country; too extensive regulatory framework for regulating the public-private partnership process and frequent lack of funding for projects already started. Based on observations and the experience of different countries, councils were formed to solve the problems described in the paper, which should help in the development of a subsequent policy for the development of public-private partnership. The paper gives an opportunity to take a different look at the current state of public-private partnership in Kazakhstan, and also brings new knowledge to improve the principles of public-private partnership development in developing countries.\"

Context: Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. Methods: We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. Findings: The two regulatory systems differ in their mandate and orientation, organization, pre- and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Conclusions: Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium- and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and existing data collection tools, such as electronic health records; and fostering increased and more effective use of registries to ensure safe postmarket use of new and existing devices.

The Schoolhouse Rock! cartoon version of the conventional legislative process is dead, if it was ever an accurate description in the first place. Major policy today is often the product of \"unorthodox lawmaking\" and \"unorthodox rulemaking\" — deviations from traditional process marked by frequent use of omnibus bills and multiple agency implementation; emergency statutes and régulions issued without prior comment; outsourcing to lawmaking commissions and unconventional delegates; process shortcuts outside of emergencies; presidential policymaking; and outside drafters, some nonpartisan and others hyperpartisan. These unorthodoxies are everywhere, and they have shifted the balance in the elected branches and beyond, often centralizing power in actors — like party leadership and the White House — not traditionally part of the core lawmaking and rulemaking processes. These unorthodoxies are the new textbook process. The theories and doctrines of legislation and administrative law, however, have paid little attention to these evolutions. The limited commentary that does exist tends to lump all unorthodox policymaking together or to preserve an artificial divide between their legislative and administrative manifestations. But omnibus policymaking is different from emergency policymaking — not only in process and product, but in the challenges that each poses for courts. And both forms of policymaking are different from presidential policymaking, and so on. Unorthodoxies in one branch are also closely linked to unorthodoxies in the other. The \"law crowd\"—a group in which the value of process is deeply instilled—tends to look upon these modern changes with suspicion. But some unorthodoxies may in fact be beneficial to democracy, and any assessment requires a much clearer understanding of what legislative and administrative doctrines are for than we currently have. Unorthodox policymaking may make the job of courts more difficult by, for instance, making law messier or less transparent, but is the role of courts to reflect how policy is made? Improve how policy is made? Or advance different values altogether? This Essay develops an account of today's unorthodox lawmaking and unorthodox rulemaking and substantiates the link between them. It utilizes a new typology of unorthodoxies to explore the causes, costs and benefits, and winners and losers associated with each different kind of policymaking, and plays out the ways that the theories and doctrines of legislation and administrative law might respond to the modern context in which they now unquestionably operate.

Background Since 2006, when Poland ratified the WHO Framework Convention on Tobacco Control (FCTC), there have been efforts to improve tobacco control regulation in the country. At the same time, at the European Union level, Poland took part in discussion over revision of the Tobacco Tax Directive and the Tobacco Products Directive. This study aims to explore the tobacco industry's tactics to interfere with the creation of those policies. Methods Analysis of 257 documents obtained through freedom of information request. Results We identified three means that the tobacco industry used to interfere with tobacco control policies: creating a positive attitude, expressing a will to be a part of the policymaking process, and exerting pressure. We found that those tactics have often been used unethically, with the industry providing the government with ready legislation proposals, overstating its contribution to the economy and the government revenues, misrepresenting the illicit cigarette problem and misusing scientific evidence. The industry also used legal threats, including use of bilateral trade agreements, against implementation of tobacco control measures. The companies lobbied together directly and through third parties, with the cigarette excise tax structure being the only area of disagreement among the companies. The industry also pushed the Polish government to challenge tobacco control policies in countries with stronger public policy standards, including UK display bans and the Australian plain-packaging law. Conclusions From an object of regulation, the tobacco industry in Poland became a partner with the government in legislative work. Implementation of provisions of Article 5.3 of the WHO FCTC could prevent further industry interference.