Find Lawyers in Hamburg, Germany for Pharmaceuticals Law

Life Sciences is one of the most innovative, fast-changing, and complex market sectors. It is also one of the most regulated. Currently pharmaceutical and medical device companies face increased examination from regulators and increasing pricing pressure. The industry is undergoing a period of intense transformation, with companies facing an ever-increasing level of strict cost management in order to remain competitive and profitable. Whereas the rules and regulations with regard to pharmaceuticals, medical devices, other health care products, food, and food supplements are largely harmonised throughout the EU this is not the case for the full set of the legal framework relevant for the market access of these products

Law firms which are active in the life sciences sector have to provide a comprehensive legal service to multinational and local pharmaceutical, listed biotech and medical device companies. Furthermore, they support venture capital backed start-up companies as well as service providers. The advice of law firms specialised in this area usually extends to the full range of practice areas that are central to the business of life sciences companies throughout the clients’ whole product life cycle, from discovery and development of the drug through to end-of-life patent disputes. For instance, their services include legal consulting in regard to licensing and collaboration, product liability, intellectual property, trademarks, manufacturing and distribution agreements, corporate transactions (mergers and acquisitions, joint ventures, private equity, venture capital), regulatory issues, competition (anti-trust), as well as state-aid law and subsidies.

In regard to regulatory law, clients of legal services providers in the life sciences sector frequently demand support in regard to clinical trial regulation, data and market exclusivity, supplementary protection certificates (SPC), and paediatric regulation. In addition, lawyers help them with issues concerning orphan drug designation, marketing authorization procedures, promotion campaigns and compliance issues, as well as pricing, reimbursement, and market access. Furthermore, they also provide their services in regard to more complex products of the industry such as biosimilars and personalized medicines. As the legislative and regulatory framework differs from one jurisdiction to another both local and international specialist knowledge is required to provide comprehensive regulatory law services in the life sciences sector.