Public Policy & Governmental Affairs
The understanding of public policy matters and governmental affairs is becoming increasingly important in any regulated industry. The business impact of legislative changes is usually significant and must be analyzed at an early stage before a product is launched, a company is acquired or a licensing deal is closed.
This is particularly true for the public health system and its stakeholders, both of which being subject of complex legal regulations on a European and national level which are continuously under reconstruction and modification. For one, the increasing cost pressure on public health insurances due to the demographic development on the one hand and the development of new treatment options and diagnostic methods on the other hand regularly leads to the ad-hoc introduction of new cost-containment measures typically with grave consequences for pharma and medtech companies. The imposition of stricter quality and safety regimes, politically motivated by product defects prominently featured in media, e.g. with breast implants, also have far-reaching implications for companies. The same holds true for legal bills tightening the business compliance requirements for the cooperation with other stakeholders in the healthcare sector.
Against this background, it is of utmost importance for the pharmaceutical and medtech industry to monitor such legislative procedures and sufficiently articulate their interests. We have significant experience in public policy matters and governmental affairs by legally advising and supporting pharma and medtech companies as well as industry associations in monitoring and accompanying legislative bills and procedures in the Life Sciences sector at various levels, covering subjects as diverse as the regulation on orphan drugs, AMNOG-legislation or business compliance.
Our services include in particular:
- Development of strategies and their implementation for the product launch in Germany
- Drafting of legal bills and legislative changes as proposals for companies and industry associations
- Drafting of legal statements and assessments on future and current legislative procedures for companies and industry associations
- Legal impact assessment regarding legislative bills
- Legal preparation of companies and industry associations for legislative hearings as well as meetings with Members of Parliament and government officials
- Development, implementation and monitoring of Compliance-Systems for communication with Members of Parliament and government officials
- Initiating litigation against legislative bills and certain cost-containment measures