BIO Deutschland participates in second round of the Pharma Dialogue
On 16 November 2018, the German government held for the first time in the current legislative period top-level discussions under its Pharma Dialogue. The dialogue is part of the government’s efforts to strengthen Germany’s position as a research, innovation and production location for the pharma and biotech industries. In the coalition agreement, the governing parties – the CDU/CSU and the SPD – promised to continue the inter-ministerial dialogue with the (bio)pharma industry and the trade union IG BCE and to also involve the scientific community.
The present round of dialogue is focusing on innovation topics such as digitalisation, personalised medicine and advanced therapy medicinal products.
With regard to trends in the research, development and approval of new drugs – e.g. personalised medicine and novel therapeutic approaches – there was a high degree of consensus among industry representatives, regulatory authorities and the scientific community. They were unanimous in their assessment that the convergence of IT-driven methods and new bio(techno)logical findings can lead to breakthrough innovations that bring about a complete paradigm shift. Giving many concrete examples, dialogue participants strongly pointed out to policymakers that those regulations regarding self-governance and stemming from social legislation need to be revised in way that allows such developments to evolve in the German industrial sector and produce benefits for medical patients.
They also saw the future holding great promise for Germany in terms of its position as a manufacturing location. According to participants, there is considerable potential in complex production processes, an area that is expected to play an increasingly large role. They also believe that the issue of reliability of supply offers opportunities for European manufacturing, provided that health insurance funds refrain from engaging in ruinous price competition.
Background
The German government launched the Pharma Dialogue in 2014. A new development in the current legislative period is the participation of the governing parties and the federal states in top-level discussions. The governing parties are represented by Bundestag members Martina Stamm-Fibich and Sabine Dittmar (SPD), Michael Hennrich (CDU) and Stephan Pilsinger (CSU), and the federal states by Hesse and Rhineland-Palatinate. Industry continues to be represented by the trade associations BIO Deutschland, BAH, BPI, Pro Generika and vfa, while the Fraunhofer-Gesellschaft, the Helmholtz Association, the Leibniz Association and the Association of Medical Faculties in Germany (MFT) are participating in the dialogue on behalf of the scientific community. The latter two scientific organisations are taking part for the first time. The heads of two German regulatory bodies – the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut - Federal Agency for Sera and Vaccines (PEI) – are also represented. State Secretaries Lutz Stroppe (Federal Ministry of Health), Christian Luft (Federal Ministry of Education and Research) and Director-General Winfried Horstmann (Federal Ministry for Economic Affairs and Energy) are moderating the dialogue for the government. A representative of the Federal Chancellery is attending as a guest.