Paul-Ehrlich-Institut

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Di­a­logue – Per­for­mance Pro­file of the Paul-Ehrlich-In­sti­tut ad­vanced dur­ing the Pandemic

Experts from the Paul-Ehrlich-Institut and representatives of the Federal Association of the Pharmaceutical Industry (Bundesverband der pharmazeutischen Industrie, BPI) met on 3 February 2021 for a virtual exchange of ideas. The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, positions itself as efficient and oriented toward the future in the frontline of containing the pandemic. "Our competencies make us a reliable, competent, and internationally networked player representing progress in biomedicine," said Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut, "a lively dialogue with the Federal Association of the Pharmaceutical Industry is a prerequisite for productive regulatory support on the part of the Paul-Ehrlich-Institut." Subjects of this year’s meeting included digital interfaces, the regulations of advanced therapy medicines (ATMPs) and allergen products, as well as vaccine supplies.

Microphone (Source: Fill/Pixabay.com)

Topics on the agenda included the increasing digitalisation of processes and information. Extensive measures taken to preserve the business continuity in times of the pandemic have resulted in digital advancement, which is a great step toward future-oriented technology. Important aspects, in this context, include the digitalisation of processes in internal and external interfaces. Thus, reports pursuant to the German Transplantation Act (Transplantationsgesetz, TPG) can now be performed only electronically using an online reporting portal at the Paul-Ehrlich-Institut. An important success is the inclusion of data from the health insurances for the supervision of the safety of COVID-19 vaccines. The Paul-Ehrlich-Institut will use its experience with innovative vaccine platforms and the marketing authorisation of COVID-19 vaccines to establish a centre for combating pandemics with vaccines on site.

One focus of discussion was the complex regulation of advanced therapy medicinal products (ATMP). These include gene therapies or cell therapies such as treatments with genetically modified stem cells. Another point of discussion was advancements in the implementation of the Therapy Allergen Regulation (Therapieallergenverordnung, TAV) the aim of which is the availability of allergen products with a tested efficacy and safety profile. 61 allergen products are currently undergoing a marketing authorisation procedure, however, they can still be marketed until a decision on the marketing authorisation has been made.

The BPI asked the Paul-Ehrlich-Institut a question concerning the improvement of vaccine supplies. In 2020, the Paul-Ehrlich-Institut received a new statutory mandate for the supervision of the supply with medicines. (SGB V, Sozialgesetzbuch V, 5th Social Security Statute Book). The Paul-Ehrlich-Institut was able to use this mandate to an increased extent during the pandemic to improve supplies with vaccines. For the availability of vaccines present an important precondition for maintaining vaccination rates, or even to increase them. In 2020, the Paul-Ehrlich-Institut supported measures for the provision and distribution (reallocation) of vaccine doses. In doing so, it benefited from established and new tools for analysing the supply situation: Besides reports on supply shortages from the marketing authorisation holders, the Paul-Ehrlich-Institut also receives reports of bottlenecks from doctors, pharmacies, and private individuals. A survey at doctor’s practices could clarify the causes of distribution problems in the supply of influenza vaccines.

Talks with the BPI and other associations have been held ever since 2010. These regular meetings are designed to create a platform for the discussion of fundamental and concrete questions regarding clinical trials and marketing authorisations and to exchange experiences – an essential basis for good cooperation.

Updated: 03.02.2021