Welcome to the ten-year anniversary edition of the PLC Cross-border Life Sciences Handbook which 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.
It has been a turbulent year for the pharmaceutical market. The European Sector Inquiry has created disquiet among industry professionals and highlighted that the pipeline for innovative pharmaceutical companies is slowly drying up. Alongside the imminent patent expiry of a number of the biggest selling drugs in the market, questions have arisen as to the future of the innovative pharmaceutical industry. Naturally, a litigious culture has been borne of the uncertainty that surrounds the pharmaceutical industry and consequently, there has been a dramatic increase in patent litigation worldwide.
As an alternative to the costly and often unsuccessful pursuit into creating the next "blockbuster", the market is recognising a shift from the traditional vertical pipeline approach to a horizontal growth by expanding into emerging markets, and with the acquisition of and investment into small biotech companies. It is now common for traditionally innovative pharmaceutical manufacturers to branch out into generics. There has also been a distinct slimming down of personnel within a number of the big pharma organisations in a cost cutting exercise.
Due to technological advances, the distinction between pharma and biotech is becoming increasingly blurred. There has been a surge in the investment and creation of diagnostic drugs which combine traditional pharmaceutical practices with innovative and cutting edge technology. This may well mark the future for the pharmaceutical industry.
It is against this background that we publish the Handbook, which includes our special feature Life Sciences Super Leagues, which identifies the leading industry and regulatory practices with notable geographical breadth and depth. The cross-border chapters, discuss biosimilar regulation, drug and device product recalls, the financing of UK life sciences, the challenge of generic entry to traditional EU competition law, healthcare and reimbursement of medicines in Germany, legal aspects of REACH and the medical device sector, recent changes concerning regulatory protections for pharmaceutical companies in Japan, recent changes in the anti-corruption landscape, risk management of pharmaceuticals in the EU and US and supplementary protection certificates for medicinal products.
The country-specific Q&A chapters provide practical information on life sciences law in 30 jurisdictions. In particular, they examine the regulatory system, pricing and state funding, manufacturing authorisations, clinical trials, marketing authorisations, advertising, packaging and labelling, traditional medicines, intellectual property, product liability, and reform proposals.
The PLC Which lawyer? section of the Handbook identifies recommended life sciences lawyers and law firms worldwide. This should be read in conjunction with the Lawyer profiles section, which contains more detailed biographies of life sciences lawyers.
This Handbook 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 and private practitioners operating across borders. The service includes practice guidance notes, standard documents and checklists, as well as the online archive of PLC Cross-border Quarterly, featuring comparative regulatory and transaction guides, and law firm management reviews. Visit www.practicallaw.com/aboutcrossborder for more information.
Other Handbooks 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 Handbook 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.