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Theresa Trapp

Theresa Trapp is an associate in Covington’s Frankfurt office and a member of our Food, Drug and Device Practice. She advises clients on regulatory and compliance matters.

Theresa helps clients with all aspects of pharmaceutical and medical device regulation, clinical trials, advertising and other regulatory issues over the entire product lifecycle. She also counsels clients on contractual matters. Her practice includes advisory and she also represents clients before authorities and in court.

Before joining Covington, Theresa has worked as a professional support lawyer in another international law firm in Frankfurt. During her legal traineeship, she has, among other stations, worked at the State Prosecutor’s Office in Marburg and in the central legal department of an international pharmaceutical company.

Orphan drugs have a special position under EU pharma laws. Among other things, the EU orphan drug laws grant the marketing authorization holder (MAH) of an orphan drug a 10 year period of so-called “market exclusivity”. According to Article 8(1) of the Regulation (EC) No. 141/2000 on orphan medicinal products, the EU and the EU

At the end of June 2023, a draft Health Data Use Act (“GDNG”) and a draft Digital Act (“DigiG”) of the German Federal Ministry of Health have become public. These drafts are part of the German government’s digitalization strategy for the health sector. The Health Data Use Act plans to grant industry companies an access right to patient health data for research purposes. The Digital Act envisages significant restrictions for the pricing and reimbursement of Digital Health Apps. Below, we summarize key aspects of these two legislation proposals.

Continue Reading Germany plans Health Data Use Act and stricter pricing & reimbursement rules for Digital Health Apps

On 22 December 2022, the Court of Justice of the European Union (CJEU) — sitting in Grand Chamber — published its judgement in case C-530, Euroaptieka. The judgement adds further commentary to the meaning of “advertising medicinal products” in the EU and the competencies of EU Member States to restrict drug advertising activities. The judgement has particular implications for advertising “unspecified medicinal products”. No doubt, this judgement will be of interest to pharmaceutical companies and pharmacies looking at the communications activities they carry out in the EU and the risks entailed.

Continue Reading CJEU Rules on the Advertising of “Unspecified Medicinal Products” in the EU