The Life Sciences multi-jurisdictional guide brings together information on current cross-border issues, country-specific Q&A guides, and details of recommended life sciences lawyers and law firms in jurisdictions worldwide.
In times when the terms austerity and financial crisis are common, the future of our leading global industries naturally comes under close scrutiny; the life sciences industry is no exception. However, despite declining markets and a unified tightening of budgets, healthcare continues to be a key issue for authorities, and as such the pharmaceutical and medical device industries continue to thrive. Despite this seemingly positive outlook, pressures continue to mount on industry players. The ever closer patent cliff combined with constantly decreasing pricing levels is impacting market trends and creating a new, potentially bleak, landscape.
In reaction to such fiscal demands, there are ever increasing steps towards the concept of e-Health which, as a product driven ideal, is essentially a leap towards improvement of current pharmacoeconomics. There has also been substantial consolidation in the industry, with notable M&A activity over the past 12 to 18 months. The acquisition of the branded manufacturer Cephalon, by the world leading generic producer Teva, marked a notable change in the landscape of pharmaceutical companies. The Israeli giant's acquisition of Cephalon shows the growing trend towards integration between originator and generic companies. It also represents tangible evidence of the blurring of the boundaries between these two strands of the industry. As a consequence, the need for external legal advice in the corporate sphere has increased rapidly, and opportunities have arisen for niche players to play a central role in this ever complex area of law.
The UK Bribery Act has had far reaching implications for both industry professionals and lawyers alike. In combination with the FCPA emanating from the US, life sciences companies of all levels are under scrutiny, and are increasingly seeking compliance and advisory aid on this issue. The effects of such legislation are heightened by the increasing globalisation of industry players and the entry of many into key emerging markets, most notably Asia and Latin America. In a world where markets are readily accessible to both the consumer and manufacturer, through advanced technologies and ever improving relations, it is essential to be at the forefront of key deals that can make or break a company’s reputation in a developing market.
The future of pharmaceuticals continues to remain uncertain. While technologies will continue to advance in many related fields, it is unclear whether pharmaceuticals as we know them will continue to play such a leading role in the lives of consumers. Personalised medicine is increasingly important in many sophisticated markets and marks a trend towards niche pharmaceuticals. Further, advances in companion diagnostics evidence a shift in the role of genomics in traditional drug manufacture, and highlights the increasingly complex regulation in today's regime.
With cutting edge developments in technology and continuing regulatory and social pressures surrounding the industry, legal professionals continue to specialise within the life sciences field. There is now a community of hybrid legal and technical experts to which industry leaders entrust their most complex mandates. Issues surrounding the categorisation of certain medical products, including software, are all too common in the current legal world. While cost pressures continue to mount on firms and legal practitioners, the complexity of matters will continue to increase.
2012 offers a blank canvas for many in the life sciences industry. While others will approach the year with caution, many will agree that change is imminent, with another year of further transactions, litigation and scientific breakthroughs. Although it is difficult to predict future trends, 2012 is going to be a notable year for industry professionals and legal practitioners alike.
Against this background, this guide includes our special feature Life Sciences Super Leagues, which identifies the leading industry and regulatory practices with notable geographical breadth and depth. In addition, the analysis chapters examine various life sciences topics relating to regulatory, IP and competition and corporate issues.
The country-specific Q&A chapters provide practical information on life sciences law in 31 jurisdictions. In particular, they examine the regulatory system, pricing and state funding, manufacturing authorisations, clinical trials, marketing authorisations, advertising, packaging and labelling, traditional medicines, patents, product liability, and reform proposals.
This guide is available online as part of PLC Cross-border. This is a unique online service that provides know-how and market intelligence for in-house counsel, as well as private practitioners operating across borders. The service includes practical guidance notes, standard form documents and checklists, as well as Practical Law Global, the new online magazine aiming to simplify global law through clear, practical and easy-to-read cross-border legal analysis. Visit www.practicallaw.com/aboutcrossborder for more information.
Other guides in the series include: Arbitration, Capital Markets, Competition, Construction and Projects, Corporate Governance and Directors' Duties, Corporate Real Estate, Data Protection, Dispute Resolution, Doing Business in…, Employee Share Plans, Environment, Insurance and Reinsurance, Investment Funds, IP in Business Transactions, Labour and Employee Benefits, Leniency, Media and Communications, Mergers and Acquisitions, Outsourcing, Private Client, Private Equity, Restructuring and Insolvency, Secured Lending, Structured Finance and Securitisation, Tax on Transactions, and Venture Capital.
This guide has been co-published with the contributors. We would like to thank all the firms involved for their excellent contributions and attention to deadlines. If you wish to contact any contributor, full details are set out at the end of the relevant chapter.