Four areas of focus. One agile approach

Contracting and Negotiations

• Creation and maintenance of general template libraries

• Setting up contract management systems including standard operating procedures and training

• Complex negotiations with payors, purchasing groups, procurement organisations including innovative contracting models

• Advising on the full spectrum of commercial agreements (analysis, drafting, negotiating and execution) including collaboration, wholesale, distribution, promotion, logistics, procurement, contract manufacturing and supply and other (master) services agreements including supply chain (ESG) and trade compliance aspects, regulatory approvals, and licensing requirements

• Development of standard agreements with healthcare professionals (e.g., speaker, consulting, advisory board, sponsorship) and agreements with healthcare organisations and institutions (e.g. clinical trial agreements, non-interventional study agreements and other research agreements)
  standard-form data privacy, pharmacovigilance, and quality agreements

Healthcare Advertising and Promotion

• Review and assessment of promotional and scientific materials pursuant to EU and German laws (German Unfair Competition Act (UWG) and German Drug Advertising Act (HWG)), taking healthcare code practice into consideration

• Structuring of above-market (EU) marketing and promotional campaigns including product launch support, pre-launch considerations (including early access programs, disease-awareness campaigns) and risk-mitigation strategies

• Review and advice on digital projects, social media and omnichannel-marketing campaigns and strategies

• Development and implementation of European and German standard operating procedures governing marketing material review and competitor complaint processes, including above-market (EU) coordination, development and provision of training/training materials for marketing, medical and market access functions

Market Access, Pricing and Reimbursement in Germany

• Support on pricing and reimbursement negotiations in the context of the AMNOG (German Act on the Reform of the Market for Medicinal Products) process which sets out the rules for the benefit assessment of reimbursable medicinal products with new active ingredients (or newly authorised indications) based on evidence provided by the pharmaceutical company

• Review and drafting of pricing and rebate agreements, support of negotiations with payors and statutory sick funds

• Assessment and guidance on early access programs

• Anti-bribery and anti-corruption laws, European (e.g. EFPIA) and national code (German FSA, AKG Code) compliance

• Interactions with healthcare professionals (HCPs), healthcare organisations (HCOs), patient organizations and public officials

• Audit support, compliance gap-analysis and implementation of corrective and ­­­preventive actions

• Compliance program governance (e.g. policies and standard operating procedures, training documentation and provision of training)

• Internal investigations support

• Due diligence support and analysis in connection with M&A, finance/capital markets and private equity transactions focusing on the healthcare sector (e.g. licenses, regulatory approvals, key commercial contract landscape, supplier/customer structures, pricing commitments, etc.)

• Coordination of due diligence processes across EU jurisdictions and management of local counsel

• Drafting and negotiating of business development and licensing agreements (including supply, manufacturing, distribution and promotion arrangements)

• Drafting and negotiating of collaboration and partnership agreements

• Analysis and monitoring of healthcare-related EU and German legislative dossiers and proposals (including medical devices)

• Provision of summary reports and related guidance on implementation of processes in companies with respect to new laws and regulations

• Drafting of position papers and amendment proposals to EU and German laws and regulation

• Monitoring and advice on regulatory developments, guidelines and procedures