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Gleiss Lutz advises pharmaceutical companies and medical product manufacturers, as well as hospital operators and health insurers on all questions of pharmaceutical, medical product and health law. Advising in this area in particular places special demands on lawyers. In addition to understanding of the foundations of natural science and medicine, industry-specific know-how is indispensable.
We advise drug and medical product manufacturers from the early phase of product development in the formulation of contracts for R&D cooperation, on orphan-drug designation, on the acquisition and granting of licences and on the acquisition of marketing authorisation. We accompany further product development from the development of national and international patent strategies, to drug approval and the certification of medical products, to the conclusion of manufacturing agreements and plant approval procedures pursuant to the Genetic Engineering Act and the Immissions Protection Act.
Gleiss Lutz advises on market introductions, in particular in connection with the law on drug advertising and on the introduction of new sales models. Always present in such cases are the ever more significant questions of the law on statutory health insurance, of European health law and of competition law. We also have specific know-how regarding the regulatory framework for the cooperation of drug and medical product manufacturers with benefit payers.
With respect to hospital law, our practice focuses on privatisations. We also advise hospitals in disputes over their inclusion in the hospital planning of the German states, on the conclusion of supply contracts and on advising in regard to questions of hospital finance law (DRG system) and integrated care models.
In regard to food law, Gleiss Lutz advises clients in regard to the question of what ingredients are legally permitted and how products have to be specifically labelled. The identification of allergens, the labelling of quantity of ingredients and the use of novel food ingredients are current emphases of ours. The demarcation of foodstuffs, drugs and medial products, which is particularly relevant for functional foods, is an issue that Gleiss Lutz has dealt with extensively in advising and in litigation. In the event of undesired substances in food, Gleiss Lutz advises on the development of legally required and economically reasonable countermeasures including product recall and product liability.
Another essential area of our practice is advising complex corporate transactions in the pharmaceutical, medical product and health care branch.
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