Life Sciences and Health Care REGULATORY AND GOVERNMENT AFFAIRS

Life sciences—including pharma, biotech, and medtech—is a core sector for WilmerHale. Globally, more than 100 of our lawyers provide legal advice specifically to life sciences clients. About 30 of our life sciences lawyers are located in our European offices. More information about our global Life Sciences practice can be found here.

Our European track record for the pharmaceutical, biotech, medtech and life sciences industries spans M&A, general corporate and contract advice, assistance with general and industry-specific intellectual property (including licensing) and support with all types of industry-specific regulatory issues. Our clients include large, midsized, and small pharma and biotech companies, including clinical research organizations, corporations, and companies from the medtech industry as well as strategic and financial investors. We provide legal know-how, technology expertise, industry insight and internationally oriented advice from an entrepreneurial perspective. Members of the Frankfurt team were recognized in 2006 by the German legal journal JUVE as belonging to the "Law Firm of the Year for Pharma and Medical Device Law.”

Our European life sciences regulatory specialists advise on clinical trial and marketing approval procedures and pharmacovigilance issues. We assist our clients in product launches as well as on advertising strategies. We also feature experts on compliance issues, including promotional compliance and anti-kickback safeguards, on GMO approval procedures and on product liability. Our lawyers have expertise in social security/public health care matters (including reimbursement questions). We have advised on issues such as the inclusion of innovative medical devices and future-orientated e-Health solutions in public reimbursement schemes and have assisted with bid processes, negotiations and litigation concerning agreements between health insurers and pharma companies, doctors' associations and other health care providers.

Putting the specific needs of our life sciences clients first, our teams are staffed across legal disciplines to ensure that excellent legal know-how is combined with a thorough understanding of the industry. Thus, our life sciences regulatory specialists work hand-in-hand with our Corporate and Transactional, Intellectual Property and Antitrust and Competition lawyers to tailor the teams to the specific issues at stake. Our public policy and legal strategy experts add insight into the policy and legislative processes in Brussels and in the Member States, particularly in Germany. For example, we regularly advise our clients on the reforms of the public health care system in Germany, help them to overcome regulatory and legislative obstacles when introducing new products and assist them in benefiting from initiatives such as the introduction of e-Health systems. In addition, we have handled a broad range of complex regulatory and legislative issues raised by EU initiatives in the field of health, safety and product standards applied to life sciences.

In recent and more significant matters, our life sciences experts have:

  • 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.

Life sciences—including pharma, biotech, and medtech—is a core sector for WilmerHale. Globally, more than 100 of our lawyers provide legal advice specifically to life sciences clients. About 30 of our life sciences lawyers are located in our European offices. More information about our global Life Sciences practice can be found here.

Our European track record for the pharmaceutical, biotech, medtech and life sciences industries spans M&A, general corporate and contract advice, assistance with general and industry-specific intellectual property (including licensing) and support with all types of industry-specific regulatory issues. Our clients include large, midsized, and small pharma and biotech companies, including clinical research organizations, corporations, and companies from the medtech industry as well as strategic and financial investors. We provide legal know-how, technology expertise, industry insight and internationally oriented advice from an entrepreneurial perspective. Members of the Frankfurt team were recognized in 2006 by the German legal journal JUVE as belonging to the "Law Firm of the Year for Pharma and Medical Device Law.”

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Louis, Frédéric

Frédéric Louis

Partner

+32 2 285 49 53 (t)

frederic.louis@wilmerhale.com

Gey LL.M., Peter

Dr. Peter Gey, LL.M.

Special Counsel

+49 69 27 10 78 204 (t)

peter.gey@wilmerhale.com

Henn, Tobias

Tobias Henn

Counsel

+49 69 27 10 78 227 (t)

tobias.henn@wilmerhale.com