Demand for effective medicines is rising. As the population ages and increases, new medical needs emerge and the disease burden of the developing world increasingly resembles that of the developed world. The main emerging countries (that is, Brazil, China, India, Indonesia, Mexico, Russia and Turkey) are also becoming increasingly prosperous, with projections suggesting that these countries could account for as much as one-fifth of global pharmaceutical sales by 2020.

At the same time, commercialisation of pharmaceutical products has become more complex as the competitive and regulatory environment has evolved. Today, regulatory regimes not only aim to protect public health and to ensure that there is robust data to support the safety and efficacy of pharmaceutical products, but also to limit expenditure on pharmaceutical products by countries (for example, market access, pricing and reimbursement and distribution channels, among others). One recent development is the implementation of transparency regulations in the US, Europe and some other countries. These regulations require manufacturers of medicines, medical devices and medical supplies to collect and track all financial relationships with healthcare professionals and healthcare organisations, and to report this information to either the local regulators or to publish it on their own website.

This book focuses on the legal environment surrounding the distribution and marketing of medicines. As explained above, the legal framework has been tightened and the standards for compliance have been raised by the regulators. This has led to an increasing need for legal support (whether in-house or external). Jurisdictions differ significantly around the world and, as a consequence, this book has become an important reference guide for the industry.

As in the first edition, the topics addressed in this book cover all relevant aspects of the sale, distribution and marketing of drugs for human use. These range from substantive issues such as the existence of compassionate use programs; admissibility of direct mailing; provision of free samples and discounts and the ability to communicate directly with consumers, to more procedural aspects such as identifying the competent authorities and legal remedies available to parties. As professional and other industry organisations have set up their own codes of conduct in many countries, individual chapters also refer to such codes and describe their implementation.

In conclusion, this book provides everything in-house or external counsel need to understand the distribution and marketing of medicines in the jurisdictions covered. This will assist readers in evaluating legal risks and in providing sound legal and compliance advice to the organisations which they support.