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Life sciences law, the entire range of legal practice for the life sciences industry, has become increasingly important in recent years. This can be said since the number of additional legal provisions and regulations regarding drug safety, pharmacovigilance, quality management, distribution, reimbursement and collaboration with healthcare professionals or patient organisations has increased significantly. However, this is not the only reason. Heeding Warren Buffett’s famous warning, ‘It takes 20 years to build a reputation and five minutes to ruin it,’ pharmaceutical manufacturers and manufacturers of medical devices are increasingly willing to comply with these additional legal requirements and rules, in particular regarding collaboration with healthcare professionals and patient organisations. After the breast implant scandal in late 2011, pharmaceutical and medical device companies are now, more than ever, under public pressure to observe the respective requirements set out by legal provisions, directives and industry guidelines.

Further, the market for medicines and medicinal devices is highly competitive, and rule breaking is often pointed out and pursued by competitors. This is amplified by digitisation, which is becoming increasingly widespread and complex. Conditions are complicated even further since the activities of manufacturers of medicines and medical devices are rarely limited to one country, therefore, compliance with several rules and pieces of legislation must be ensured. Nevertheless, it is not only the broad range of applicable rules and the competitive environment for manufacturers that have made life sciences law one of the most important legal areas in the recent past. Because of tightening public finance constraints, the reimbursement of medicines and medical devices has become subject to strict requirements in several countries, consequently, greater demand for legal advice with respect to reimbursement has arisen.

With this in mind, the following legal outline should serve as a guide for manufacturers of medicines and medical devices. It provides a helpful overview of the applicable rules for a variety of activities, with particular attention given to recent legal or political reforms. Furthermore, since the chapters cover several different jurisdictions, this edition of Lexology Getting the Deal Through: Life Sciences is also a comparative legal guide for cross-border activities or activities in a number of countries. I am honoured by the great success of seven previous editions of Life Sciences and am very pleased to once again be contributing editor of the 11th edition.

This legal outline is no substitute for case-related legal advice. I, and the other lawyers who have contributed to this edition, would be pleased to provide readers with further insight based upon our experience in this important and challenging legal area.


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