Meeting of the Working Group on Diagnostics

The most recent meeting of BIO Deutschland’s Working Group on Diagnostics took a different form to previous meetings. At the beginning of October, the working group organised a joint meeting with the Working Group on Regulatory Matters at BIOTECHNICA to discuss the topic of companion diagnostics in detail from various perspectives. In the run-up to the meeting, both working groups had been working on the topic, so it made sense for BIO Deutschland’s future work for the two groups to hold a joint meeting. The aim of this coordinated collaboration is to produce a white paper on the topic to present the current challenges from the point of view of small and medium-sized enterprises in the pharmaceutical and diagnostics sectors. The intense discussion at the meeting in October generated a large number of ideas for topics to be discussed further in specific sub-groups.

After the joint meeting, the members of the working groups heard a presentation about the status of the implementation of a recommendation for an EU regulation on in-vitro diagnostics. The responsible rapporteur, Dr Peter Liese, a member of the German Bundestag, made clear that the draft directive is at the final stage.  However, it will only be adopted along with the recommendation for an EU directive on medical products. Some procedural issues still need to be coordinated between the two proposals. BIO Deutschland members are welcome to request a copy of the minutes of the meeting from the association’s office (e-mail: info@biodeutschland.org).