Parallel Trade in Prescription Medicines in the European Union: The Age of Reason?

In light of the economic reality, which is increasingly confirmed by relevant judicial authorities, we submit that hindering parallel trade in prescription medicines does not damage patients and national health budgets. It is therefore to be welcomed that both Community and national case law has confirmed that pharmaceutical companies are entitled to adopt measures responding to – but not prohibiting or eliminating – parallel trade, and such measures are not contrary to the EC competition rules. Parallel traders had previously been free-riding on case law which referred to sectors and cases that bore no relation to the special features of the European prescription medicines sector. To the extent there is an assumption that parallel trade in Europe safeguards intra-brand competition, the recent case law does not call this assumption into question: on the contrary, it confirms it, while noting that this assumption is inapplicable to the prescription medicines sector in Europe precisely because of that sector’s very specific features. It is therefore to be hoped that the long-running obsession of European competition law with parallel trade in prescription medicines may (at last) be coming to an end.prescription medicines, european union, competition law, market integration

Advancing the Right to Health: The Vital Role of Law

Effective laws and an enabling legal environment are essential to a healthy society. Most public health challenges – from infectious and non-communicable diseases to injuries, from mental illness to universal health coverage – have a legal component. At global, national and local levels, law is a powerful tool for advancing the right to health. This tool is, however, often underutilized. This report aims to raise awareness about the role that public health laws can play in advancing the right to health and in creating the conditions for all people to live healthy lives. The report provides guidance about issues and requirements to be addressed during the process of developing or reforming public health laws, with case studies drawn from countries around the world to illustrate effective practices and critical features of effective public health legislation. Advancing the right to health: the vital role of law is the result of a collaboration between the World Health Organisation, the International Development Law Organisation (IDLO), the O’Neill Institute for National and Global Health Law, Washington D.C., USA, and Sydney Law School, University of Sydney. The Project Directors were: Professor Lawrence O. Gostin, Linda D. and Timothy J. O’Neill Professor of Global Health Law and University Professor, Georgetown University; Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University; Mr David Patterson, Senior Legal Expert – Health; Department of Research & Learning, International Development Law Organization; Professor Roger Magnusson, Professor of Health Law & Governance, Sydney Law School, University of Sydney; Mr Oscar Cabrera, Executive Director, O’Neill Institute for National and Global Health Law, Georgetown University Law Center; Ms Helena Nygren-Krug (2011–2013), Senior Advisor, Human Rights & Law, UNAIDS. The content and structure of the report reflect the consensus reached at the second of two international consultations in public health law that preceded the preparation of the report, hosted by WHO and IDLO in Cairo, Egypt, 26-28 April 2010. Part 1 introduces the human right to health and its role in guiding and evaluating law reform efforts, including efforts to achieve the goal of universal health coverage. Part 2 discusses the process of public health law reform. The law reform process refers to the practical steps involved in advancing the political goal of law reform, and the kinds of issues and obstacles that may be encountered along the way. Part 2 identifies some of the actors who may initiate or lead the public health law reform process, discusses principles of good governance during that process, and ways of building a consensus around the need for public health law reform. Part 3 turns from the process of reforming public health laws to the substance or content of those laws. It identifies a number of core areas of public health practice where regulation is essential in order to ensure that governments (at different levels) discharge their basic public health functions. Traditionally, these core areas of public health practice have included: the provision of clean water and sanitation, monitoring and surveillance of public health threats, the management of communicable diseases, and emergency powers. Building on these core public health functions, Part 3 goes on to consider a range of other public health priorities where law has a critical role to play. These priorities include tobacco control, access to essential medicines, the migration of health care workers, nutrition, maternal, reproductive and child health, and the role of law in advancing universal access to quality health services for all members of the population. The report includes many examples that illustrate the ways in which different countries have used law to protect the health of their populations in ways that are consistent with their human rights obligations. Countries vary widely in terms of their constitutional structure, size, history and political culture. For these reasons, the examples given are not intended to be prescriptive, but to provide useful comparisons for countries involved in the process of legislative review

Corporate Social Responsibility in the Diamond Mining Industry on the West Coast of South Africa

the study was aimed at seeing how communities benefit from minin

The Global Risks Report 2016, 11th Edition

Now in its 11th edition, The Global Risks Report 2016 draws attention to ways that global risks could evolve and interact in the next decade. The year 2016 marks a forceful departure from past findings, as the risks about which the Report has been warning over the past decade are starting to manifest themselves in new, sometimes unexpected ways and harm people, institutions and economies. Warming climate is likely to raise this year's temperature to 1° Celsius above the pre-industrial era, 60 million people, equivalent to the world's 24th largest country and largest number in recent history, are forcibly displaced, and crimes in cyberspace cost the global economy an estimated US$445 billion, higher than many economies' national incomes. In this context, the Reportcalls for action to build resilience – the "resilience imperative" – and identifies practical examples of how it could be done.The Report also steps back and explores how emerging global risks and major trends, such as climate change, the rise of cyber dependence and income and wealth disparity are impacting already-strained societies by highlighting three clusters of risks as Risks in Focus. As resilience building is helped by the ability to analyse global risks from the perspective of specific stakeholders, the Report also analyses the significance of global risks to the business community at a regional and country-level

Comparing generic drug markets in Europe and the United States: prices, volumes, and spending

Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. Context: Rising drug prices are putting pressure on health care budgets. Policymakers are assessing how they can save money through generic drugs. Methods: We compared generic drug prices and market shares in 13 European countries, using data from 2013, to assess the amount of variation that exists between countries. To place these results in context, we reviewed evidence from recent studies on the prices and use of generics in Europe and the United States. We also surveyed peer‐reviewed studies, gray literature, and books published since 2000 to (1) outline existing generic drug policies in European countries and the United States; (2) identify ways to increase generic drug use and to promote price competition among generic drug companies; and (3) explore barriers to implementing reform of generic drug policies, using a historical example from the United States as a case study. Findings: The prices and market shares of generics vary widely across Europe. For example, prices charged by manufacturers in Switzerland are, on average, more than 2.5 times those in Germany and more than 6 times those in the United Kingdom, based on the results of a commonly used price index. The proportion of prescriptions filled with generics ranges from 17% in Switzerland to 83% in the United Kingdom. By comparison, the United States has historically had low generic drug prices and high rates of generic drug use (84% in 2013), but has in recent years experienced sharp price increases for some off‐patent products. There are policy solutions to address issues in Europe and the United States, such as streamlining the generic drug approval process and requiring generic prescribing and substitution where such policies are not yet in place. The history of substitution laws in the United States provides insights into the economic, political, and cultural issues influencing the adoption of generic drug policies. Conclusions: Governments should apply coherent supply‐ and demand‐side policies in generic drug markets. An immediate priority is to convince more physicians, pharmacists, and patients that generic drugs are bioequivalent to branded products. Special‐interest groups continue to obstruct reform in Europe and the United States