Life Sciences & Health Care

Seit Jahrzehnten sind wir im Bereich Life Sciences & Health Care tätig. Unter diesem Begriff fassen wir das Arzneimittelrecht, das Lebensmittelrecht inklusive Nahrungsergänzungsmittelrecht, das Kosmetikrecht, das Medizinprodukterecht und das Speziallebensmittelrecht zusammen. Diese Gebiete greifen ineinander und sind einem ständigen Wandel unterworfen, der zum einen durch die EU Gesetzgebung und zum anderen durch nationale und europäische Judikatur bedingt ist. Auch Deutschland hat hier einen wesentlichen Einfluss, weshalb wir in Kooperation sowohl mit deutschen Anwaltskanzleien als auch Gutachtern stehen.


    Pharmaceutical law is a field of law characterized by numerous special provisions. Both advertising and labeling require specialist knowledge and many years of experience in this matter. But topics such as approval, reimbursement, parallel imports or mail order also play an important role in our daily work.


    Food law is a legal matter that can hardly be surpassed in terms of scope. The EU legislation causes a constantly changing requirement (keyword: food information) and the national legal provisions such as ordinances or the food book bring a wealth of provisions to be observed. We consider this part of the classic food law. In addition, food law has an economically very important subgroup, namely food supplements.


    Anyone who has followed the development of food supplements in history as we have (keyword: consumption products) knows which changing legal provisions this product group is subject to. Most recently, due to the “endless history” of the Health Claims Regulation, no stone was left unturned in this area of ​​law. If you don't want to get lost in the mass of colorless health claims, you need sharp, but legally justifiable statements. We support you in this!

    Legal expertise is also required for plant substances in food supplements, so-called botanicals, in order to use the fragmented European legal situation to your advantage. Finally, more than with other product groups, the question of differentiation, especially from pharmaceuticals, has been one of our hobbyhorses for years.


    The EU Cosmetics Regulation brought about a largely harmonized area of ​​law for cosmetics. The regulation can be difficult to interpret. Issues related to the differentiation from other product groups also play a role.


    Due to the flood of regulations in other life science areas, the medical products has become a popular alternative. Here, too, questions of demarcation and advertising play an important role. The harmonized legal situation also makes it possible to choose declarations of conformity from any EU institute, which makes the application of the law even more complicated. This area is also subject to constant change. The new medical products regulation has brought a completely new legal framework in which not all questions have been clarified for many years.


    Due to the restriction in advertising for food supplements in particular, many products have been "switched" into so-called foods for special medical purposes. This area is also subject to change, not least due to Regulation EU 609/2013 and the delegated Regulation (EU) 128/2016, which is intensely occupying the industry.


    Food and feed law do share some of the essential fundamentals of European law, but in view of the diversity of the animal kingdom, feed law is characterized by numerous different requirements, starting with the broadest division into livestock and pets. Last but not least, the increasing demand from consumers for transparency poses new challenges for the labeling and advertising sector.

Mag. Jakob Hütthaler-Brandauer metaphorically grew up in the field of life sciences through his mother and founder of the law firm, Dr. Ruth Hütthaler-Brandauer. He regularly gives lectures in this area and advises national and international companies and associations. Since 2021 he has been a member of the commission for the publication of the Austrian Food Book (Codex Commission) and publishes regularly in national and international papers.