German government holds second Pharma Dialogue meeting
On 20 May 2019, the German government held for the second time in the current legislative period top-level discussions as part of its Pharma Dialogue. The meeting took place under the heading of “Quality of care and supply security”.
It was led by officials from the ministerial departments involved, namely Parliamentary State Secretary Sabine Weiss (BMG), State Secretary Christian Luft (BMBF) and Director-General Winfried Horstmann (BMWi). BIO Deutschland was represented at the dialogue meeting by Board Chairman Peter Heinrich and Managing Director Viola Bronsema.
After hearing a report on the work of the expert team on gene and cell therapies – a team that BIO Deutschland co-initiated – dialogue participants discussed issues concerning research, studies, production and access. Among other things, BIO Deutschland pointed out that there had been improvements in approvals of the GMP process and that there was a lack of clarity regarding the heavily delayed reimbursements for inpatient care.
Under the heading of “From research all the way to the provision of novel medicines”, participants examined and discussed the entire value chain of new gene and cell therapies, from research to development to transfer to supply. It was said that Germany was strong in research, but as soon as medicines reached the development stage and needed to undergo cost-intensive clinical trials, they regularly foundered in Germany because of the high financing needs.
Under the heading of “Framework conditions for a high quality and reliable provision of medicines”, those attending debated the question of whether and how the diversity in active substance manufacturing can be maintained and improved upon. It was also stressed that one should not repeat the mistakes made in the past with regard to the regulation of biologicals.
The final item on the agenda dealt with the “Opportunities for maintaining and developing active substance production in Europe”. Here, topics discussed were the framework conditions for the development and maintenance of (bio)pharmaceutical production in Germany. The prerequisite for a good investment location includes a whole set of conditions, from a sufficient supply of skilled workers, through a favourable tax environment, a good infrastructure and close proximity to mechanical engineering support, to research incentives and sound administrative practices. Another issue mentioned was the different administrative policies that exist across Germany’s federal system.