Life Sciences and Healthcare in Europe

European Union Regulatory Group

Key Contacts

Experience

  • Advised Becton Dickinson, a leading medtech/diagnostics producer, on fraud and abuse issues in relation to its sponsorship of a diagnostics research project supported by the German government and on various parallel import issues in the EU. 
  • Advised the Deutscher Hausärzteverband, the German Association of General Practitioners that represents approximately 50,000 doctors in Germany, and its subsidiary, the Hausärztliche Vertragsgemeinschaft e.G., in the negotiations of a ground-breaking agreement on standards for general medical care and doctors’ fees, affecting about 5,000 general practitioners, almost 4 million patients, and a major health insurer (AOK Baden-Württemberg). The agreement, which is the first of its kind, serves as a model for similar agreements currently being negotiated with all German statutory health insurers.
  • Advised and represented the Deutscher Hausärzteverband and its regional entities in numerous arbitration proceedings concerning the obligation of German health insurers to enter into agreements concerning standards for general medical care and doctors’ fees.
  • Represented several major pharmaceutical companies in a series of landmark public procurement litigation matters regarding the application of the procurement rules to German public health insurers and insurance funds (discount agreements for drugs).
  • Advised Schering Plough in relation to the transfer of multiple European and national marketing authorizations in the context of a large scale EC-forced divestiture.
  • Advised a supplier of vaccines on regulatory issues concerning the distribution of veterinary drugs and on new legal requirements regarding the importation of pharmaceuticals.
  • Advised and represented an agro-chemical company in litigation on plant protection, parallel import, counterfeiting and product liability in Germany.
  • Advised a seed producer on various EU and German regulatory issues relating to GMOs and represented the company in litigation in Germany relating to allegedly dangerous GMO maize and information requests brought by an NGO concerning disclosure of certain confidential data submitted in a GMO authorization procedure.
  • Advised US pharma companies on initiation of a test case to defend against illegal use of trademarks by a parallel importer as well as on EU and national proceedings concerning compliance with the Dangerous Preparations Directive.
  • Advised a US producer of implantable medical devices on the use of electronic labeling and instructions for use in the EU.
  • Provided guidance for a leading US medical device manufacturer in proceedings before the European Commission and Member States agencies with potential worldwide impact on standards for natural rubber latex used in surgical gloves.
  • Advised a US medical device manufacturer on obtaining funding from the public health care system for an innovative medtech device.
  • Counseled the inventor of a breakthrough method for generating radioactive isotopes for use in cancer treatment on a Euratom patent licensing strategy.
  • Advised a major diversified consumer products company on a strategy to bring tooth whitening products to market and helped the company to navigate the requirements of the EU’s Cosmetics, Medical Devices and Medicinal Products Directives.
  • Advised various clients from the pharma industry on the European Commission’s recent pharma sector review and its implications under EU competition law.
  • Advised the German branch of a US-based IT company on the implementation and financing rules concerning several e-Health solutions, including on the regulatory framework for the Electronic Health Card in Germany.