Product Liability and Labelling

US specific information concerning product regulation, safety and recall issues.

Italy specific issues raised by product liability claims.

France specific issues raised by product liability claims.

Germany specific issues raised by product liability claims.

US specific issues raised by product liability claims.

The patent system in Europe is set to undergo its biggest overhaul since the 1970s, with the introduction of the Unitary Patent and the Unified Patent Court. After more than 40 years of negotiations, and numerous false starts, the building blocks are in place for a patent with multi-jurisdictional European coverage and a new centralised court system. This article examines the current system, the Unitary Patent, the Unified Patent Court and practical points for life sciences businesses to start considering now. 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/lifesciences-mjg.

This article analyses the recent developments in enforcement of competition law in the South Korean pharmaceutical industry. It reviews the enforcement issues involving unreasonable inducement of customers (rebates), collaborative acts (cartels), resale price maintenance, unfair trade practices in the supply of pharmaceutical products and abuse of patent rights. 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/lifesciences-mjg.

This article examines obtaining and enforcing patents in Ukraine, in particular the legal landscape and recent developments in patent protection at the customs border, obtaining patent protection, patent enforcement including patent licensing strategies, enforcement and defence in the courts and evidence collection for patent enforcement, including general issues and peculiarities for patent infringement proceedings. 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/lifesciences-mjg.

A Q&A guide to life sciences law in Brazil. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in France. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Hungary. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. 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/lifesciences-mjg.

A Q&A guide to life sciences law in Ireland. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Japan. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in South Africa. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Spain. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Switzerland. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in the UK (England and Wales). The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in the United States. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. 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/lifesciences-mjg.

This article examines notification of research, development and innovation (R&D&I) aid and exemptions, examination of notified state aid and research, technology transfer and prohibited state aid. 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/lifesciences-mjg.

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/lifesciences-mjg.

A Q&A guide to life sciences law in Singapore. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. 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/lifesciences-mjg.

The table summarises patent protection and data and marketing exclusivity in the jurisdictions covered in the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Vietnam. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

The emergence of integrated health information systems, mobile apps and software-based medical devices presents significant opportunities in managing healthcare costs and achieving better outcomes. This article analyses the developing EU and US approaches to health information technology (health IT) and mobile medical applications (MMAs), and the emerging rules and compliance issues for companies developing and marketing these products. 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/lifesciences-mjg.

This chapter analyses the provisions of the South Korea-US Free Trade Agreement (FTA), which was signed by South Korea and the US on 30 June 2007 and will take effect on 15 March 2012. It looks at the FTA in terms of the adoption of the independent review process in the pharmaceutical sector, the introduction of the approval-patent linkage system, data exclusivity, customs duties and non-tariff barriers and competition law. 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/lifesciences-mjg.

A Q&A guide to life sciences law in Argentina. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. 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/lifesciences-mjg.

A Q&A guide to life sciences law in Belgium. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences in China. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. 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/lifesciences-mjg.

A Q&A guide to life sciences in Norway. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. 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/lifesciences-mjg.

A Q&A guide to life sciences in The Netherlands. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. 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/lifesciences-mjg.

A Q&A guide to life sciences law in the Russian Federation. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

Parallel trade in the European pharmaceutical sector is widespread. To deal with parallel trade, pharmaceutical companies operating in the EU usually respond by adopting dual pricing schemes and allocation systems. To a certain extent, such schemes and systems are supported by European pharmaceuticals regulation. Behaviour such as dual pricing schemes and supply allocation systems have been the subject of legal dispute for some years. Another issue that continues to be the subject of legal dispute concerns the repackaging of pharmaceuticals that have been parallel imported. This chapter considers recent case law on these issues and summarises any conclusions that can be drawn. 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/lifesciences-mjg.

This article looks at patent regulation in Ukraine, focusing on: The regulatory framework. Patent protection and enforcement. Enforcement and defence of patent rights in Ukrainian courts. Patent infringement on the internet. 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/lifesciences-mjg.

Various reforms have been proposed to the litigation funding regime in England and Wales. This article examines the nature of the reforms and other proposals, conditional fee agreements, after the event insurance, damages based agreements, third party funding/litigation funding, qualified one-way cost shifting, liberalisation of the legal market and the impact on pharmaceutical claims. 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/lifesciences-mjg.

This chapter looks at recent developments in Canadian public policy and case law that directly or indirectly affect biotechnology. It summarises the 2009 Canadian federal budget and a number of recommendations for improving government programmes, including the 2010 report, "An Action Plan For Prosperity", published by the Coalition for Action on Innovation in Canada. It then outlines the key issues and challenges for the Canadian government to improve business R&D spending, rates of commercialisation and productivity growth. Finally, this chapter looks at the functions of the Patented Medicine Prices Review Board (PMPRB) and recent litigation trends (including class actions). 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/lifesciences-mjg.

This article looks at important considerations and global developments in biosimilar regulation, including scientific and regulatory challenges, patent considerations in the US and considerations for the industry as a whole. 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.

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.

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.

A Q&A guide to life sciences in Israel. 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 article examines UK regulation of individual patient supply, importing unlicensed products, and the current status of the UK Medicines and Healthcare product Regulatory Agency (MHRA) consultation. 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.

The life sciences industry has experienced major changes over the last few years, and will continue to be affected by a number of technological, commercial and legal developments in the coming years. This article examines the changes that have occurred in the key life sciences jurisdictions of Europe, the US and China, and considers lawyers' predictions for the future of these local and international markets. 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.

Stakeholders in the life sciences industry are witnessing an increasing number of initiatives in the UK and across Europe to facilitate collective legal actions. There are a growing number of private sector entrants to the collective actions and third-party funding marketplace. The impact may increase the litigation risk in Europe, although it is important that this risk is not overstated. This article surveys key developments in collective actions and third-party funding at a European level and in a number of key European jurisdictions. It also discusses specific risks for the life sciences industry.