Pharmaceuticals & Healthcare Law
The development and marketing of medical products is highly regulated throughout Europe. It is widely acknowledged that pharmaceutical and medical devices companies are faced with a complex legal environment, which is specific to this industry sector.
Operating a healthcare company requires in-depth knowledge of the applicable legal regime on both a national and European level, thus there is a significant market need for expert legal knowledge within this field.
Baker & McKenzie's European Pharmaceuticals and Healthcare Practice Group comprises over 50 lawyers from 17 offices within the European Region. The group have relevant legal and scientific qualifications, along with regulatory and industry experience. We are dedicated to providing advice on a wide range of legal issues to pharmaceutical and healthcare companies of all sizes and have well established contact lines with national regulatory authorities in many jurisdictions.
We work closely with a range of Baker & McKenzie Practice Groups within Europe and globally, particularly Intellectual Property, Information Technology, Commercial, Dispute Resolution and Tax, in order to provide unparalleled international expertise on a range of legal matters.
Our Services
- Advice on European regulatory procedures for new products, from the early research stage, through to submission for marketing approval;
- Handling commercial disputes between pharmaceutical and medical device manufacturers;
- Promotion and advertising of medical products;
- Defence of product liability claims and product recalls;
- Advice on documentation of clinical trial protocols, compensation guidelines and indemnities;
- Advice on latest developments in EU legislation;
- Provision of international tax planning services to pharmaceutical and healthcare industries;
- Patent litigation and advice.
To ensure continuous monitoring of issues relevant to the industry, the Group participates in Europe-wide meetings, which are scheduled annually.
Publications
The Group has collectively written and published the following books:
- Advertising Laws of Pharmaceuticals in Europe (Bilingual 1st Edition)
- Internet Advertising of Pharmaceuticals in Europe & North America (Bilingual 3rd edition)
- Promoting Medical Products in Europe & North America (Bilingual 2nd edition)
For more information about these books and the services the European Pharmaceuticals Group provides, please contact Geeta Hundalani.
You may also read the latest issue of our Pharmaceutical & Healthcare Newsletter.