Life Sciences

A Q&A guide to life sciences in Austria. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in Austria and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For a full list of recommended life sciences law firms and lawyers in Austria, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in Brazil and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For a full list of recommended life sciences law firms and lawyers in Brazil, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in China. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in China and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For a full list of recommended life sciences law firms and lawyers in China, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in Finland. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in Finland and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For a full list of recommended life sciences law firms and lawyers in Finland, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in Germany. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in Germany and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability.   For a full list of recommended life sciences law firms and lawyers in Germany, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in India. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in India and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability.  For a full list of recommended life sciences law firms and lawyers in India, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in Italy. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in Italy and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For a full list of recommended life sciences law firms and lawyers in Italy, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in Mexico. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in Mexico and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For a full list of recommended life sciences law firms and lawyers in Mexico, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in the Poland. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in Poland and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For a full list of recommended life sciences law firms and lawyers in Poland, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in Romania. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in Romania and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in South Africa. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in South Africa and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in Spain. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in Spain and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For a full list of recommended life sciences law firms and lawyers in Spain, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in Switzerland. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in Switzerland and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For a full list of recommended life sciences law firms and lawyers in Switzerland, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in The Netherlands. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in The Netherlands and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For a full list of recommended life sciences law firms and lawyers in The Netherlands, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in the United States. It provides a high level overview of life sciences funds in the United States and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For a full list of recommended life sciences law firms and lawyers in the United States, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A drug or device recall can have enormous impact on a drug or medical device company, and on the future of the concerned product. Careful planning can help to mitigate the risks of a recall and contain liability, while allowing the company to respond quickly to a crisis. This article traces, from a drug and device company's perspective, the steps of a product recall through its various stages as they impact on potential liability and litigation. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

Traditionally, the market entry of a generic pharmaceutical brings about a 30% to 40% shift in market share from the innovative pharmaceutical company to the generic firm, along with a 20% (in the first year after generic entry) to 25% (in the second year after generic entry) reduction in the average medicine price. With patent term expiries fully underway, innovative market players increasingly have recourse to a toolbox of strategies.  This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This article sets out some of the main features of EU Regulation 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals) (REACH) and how it is likely to affect medical device companies. It also provides an overview of the most significant EU regulatory developments as they apply to the medical devices industry sector. This chapter is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

In the past 18 months, there have been significant anti-corruption developments for companies and individuals, particularly in the healthcare sector. Against this background, this chapter looks at recent developments in enforcement of anti-corruption laws. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

Pharmaceutical regulatory law and patent law are often seen as separate legal fields governed by distinct laws. However, these fields can be seen to interact in Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products (SPC Regulation). In recent years a number of cases have emerged under the framework of the SPC Regulation, in which the interpretation of certain provisions has led to a discussion of various concepts that have been introduced from patent law or regulatory law. Another, more recent regulatory development that has created an additional interaction between regulatory law and the SPC Regulation is Regulation (EC) 1901/2006 on medicinal products for paediatric use (Paediatric Regulation). The Paediatric Regulation couples the obligation to conduct paediatric clinical research with an extension of an SPC. This means that an additional regulatory factor has been introduced that influences SPCs. This article looks at the: • Legal framework. • Interaction between pharmaceutical regulatory law, patent law and the SPC and the Paediatric Regulation in case law in Europe. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.