The address for healthcare-law
If you are looking for a partner with excellent expertise in all areas of Healthcare and Food Law then we are the right firm for you. We provide the combination of legal know-how, fundamental knowledge of market and regulatory requirements and years of experience.
We master all queries of Pharmaceutical law: questions regarding clinical research, registration and approval as well as marketing of medicinal products at national and European level. This is our daily business.
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Consulting and legal representation of proceedings in drug advertising law and competition law are our core business.
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Concerning the SGB V the main aspect of our work is the eligibility of reimbursement of pharmaceutical drugs and medical devices associated with discount agreements, benefit assessments and price negotiations. We have represented our clients on these issues both before the Federal Constitutional Court and the European Court of Justice.
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In the area of Compliance we advise our clients and comprehensively train their employees in order to avoid violations of law and corruption allegations.
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Food law is another area of focus in our work: we provide support on all issues of food products, in particular on health-related products (i.e. food supplements, dietary foods/ foods for special purposes, supplementary and balanced diets, functional foods as well as novel foods) from product conception up to market maturity and beyond. Furthermore, we have special expertise in the demarcation of drugs on the one hand and foods, medical devices and cosmetics on the other hand.
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We have particular expertise in the borderline of pharmaceutical drugs, medical devices and cosmetics.
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Health claims i.e. their development, authorization, appropriate use and defense have become integral in our daily work.
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Medical device law accounts for an ever greater role in our daily consulting and litigation practice.
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We provide advice for physicians and pharmacists on professional law issues and represent them in recourse proceedings.
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Not all players of the healthcare sector can handle the extensive tasks of product development, regulatory requirements and marketing themselves. We support our clients with the division of labor with their partner companies including
Research and development agreements at the beginning of a product-life-cycle
Agreements for contract manufacturing and distribution and also
License agreements and purchase contracts of health products, in particular for market authorizations, complete portfolios or businesses.
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Co-operations
Staying with the motto: "Stay with what you know" we concentrate on legal issues related to health care and food law and co-operate with experts on other fields of law beyond that.
In patent cases we rely on Hamm & Wittkopp patent law office and their expertise in this field of law.
For cases related to corporate and tax law we maintain a reliable and trusting co-operation with the law firm Diestel & Partner Rechtsanwälte, tax consultants in Hamburg.
For transnational cases we have the valuable support of a large network of selected attorneys in Europe and world-wide.
Memberships
Our expertise in the field of health law and food law as well as on intellectual property protection is highly recognized. We are consultant for committees of the German Pharmaceutical Industry Association Bundesverband der Pharmazeutischen Industrie e.V. (BPI), the Bundesverband der Arzneimittel-Hersteller e.V. (.B.A.H.) as well as consultant for the working party for food supplements of the Bund für Lebensmittelrecht und Lebensmittelkunde e.V. (BLL).
In the media
The sector report JUVE
In the sector report of JUVE for many years our law firm has been ranked among the leading law firms in the field of pharmaceutical and medical devices law and has been highly recommended in the field of food law.
Wolfgang Kozianka ("extensive experience in the field of intellectual and industrial property rights and quick processing of inquiries", client) JUVE sector report 2016/2017
Michael Weidner ("highly competent litigation lawyer, with comprehensive knowledge of the HWG and who familiarizes himself quickly with our products”, client) JUVE sector report 2016/2017
LIFE SCIENCES
Wolfgang Kozianka ("gives great advice across the whole gamut of life sciences law“), WHO’S WHO LEGAL Germany 2017, Practice area LIFE SCIENCES
"Simone Winnands is recognised for her long-standing experience in the practice. She has notable expertise in healthcare advertising matters.“, WHO’S WHO LEGAL Germany 2017, Practice area LIFE SCIENCES