Our EU and German healthcare practice advises on regulatory, public policy and legal strategy as well as on antitrust, public procurement, privacy, transactional and licensing matters both in Germany and in the rest of the European Union. We provide legal know-how, technology knowledge, industry insight and internationally oriented advice from a commercial perspective. We offer clients a “full service” approach which interfaces with the public sector, including in niche matters of public law. JUVE nominated WilmerHale as the “Law Firm of the Year for Regulated Industries” in Germany in particular as a result of our healthcare and pharmaceutical industry practice.

We have advised on the inclusion of innovative medical devices and future-orientated e-health solutions in public reimbursement schemes and have assisted in connection with tender procedures, negotiations and litigation concerning agreements between healthcare funds and pharmaceutical companies, associations of physicians and other healthcare providers.

We also regularly advise our clients on the reforms of the public healthcare system in Germany and other major EU Member States, assist them in overcoming regulatory and legislative obstacles when launching new products and enable them to benefit from initiatives such as the introduction of e-health systems. In addition, we have handled a broad range of complex regulatory and legislative issues and new directives and regulations on the EU level in the field of health, safety and product standards applied to life sciences companies. 

Our EU and German healthcare practice advises on regulatory, public policy and legal strategy as well as on antitrust, public procurement, privacy, transactional and licensing matters both in Germany and in the rest of the European Union. We provide legal know-how, technology knowledge, industry insight and internationally oriented advice from a commercial perspective. We offer clients a “full service” approach which interfaces with the public sector, including in niche matters of public law. JUVE nominated WilmerHale as the “Law Firm of the Year for Regulated Industries” in Germany in particular as a result of our healthcare and pharmaceutical industry practice.

We have advised on the inclusion of innovative medical devices and future-orientated e-health solutions in public reimbursement schemes and have assisted in connection with tender procedures, negotiations and litigation concerning agreements between healthcare funds and pharmaceutical companies, associations of physicians and other healthcare providers.

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Experience

In recent significant matters, our lawyers have:

  • Advised a Boston-based medical device producer on a contract with DSO, the German federal foundation for organ transplantation regarding the financing of a heart transplant device (Organ Care System)
  • Advised US companies in medical devices industries on market access and reimbursement in the EU as well as regulatory product approval and labeling and requirements
  • Advised in a landmark court proceeding regarding commissioned data processing of patient data
  • Advised a major US pharmaceutical client on the implications of the planned revision of the EU Transparency Directive on pricing and reimbursement for pharmaceuticals in national healthcare systems
  • Advised and represented associations of German physicians in negotiations for selective agreements on standards for primary medical care and doctor’s fees, including the ground-breaking first selective agreement affecting approximately 5,000 general practitioners, almost 4 million patients and a major public health insurance fund; according to the German Federal Minister of Health, the new arrangement now serves as a role model for similar agreements
  • Advised and represented associations of general practitioners in more than 350 arbitration proceedings with public health insurance funds and 155 litigation proceedings before the social courts in connection with various arbitral awards in Germany
  • Advised a leading German association of pharmaceutical companies in legislative proceedings on the application of antitrust law to public healthcare funds and in a complaint to the German antitrust authority against the collective tendering practice of major public healthcare funds
  • Advised major pharmaceutical companies in health technology assessment (HTA) procedures in Germany following the 2010 Act on the Restructuring on the Pharmaceutical Market (AMNOG) introducing value based pricing for new drugs 

Publications & News

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December 6, 2016

The Legal 500 Germany Recognizes WilmerHale Lawyers and Practices in 2017 Edition

The Legal 500 has released its 2017 edition of The Legal 500 Deutschland, Germany's guide to outstanding lawyers, recognizing WilmerHale in five categories.