Pharmaceutical legislation

The development, approval, manufacture, distribution and distribution of medicinal products are characterized by a multitude of regulations. The European Union and the German legislature contribute to an ever-increasing regulatory density through continuous innovations. Safety and quality requirements for the consumer are increasing immensely.

In the interests of patients, national and European regulatory authorities pay particular attention to pharmaceutical legislation.

AMNOG stands for the “Arzneimittelmarktneuordnungsgesetz” and refers to the price regulation of innovative medicines in Germany. This method has been used since January 2011 to determine the prices of new patent-protected medicines on the basis of an additional benefit assessment.

This means that health insurance companies only pay as much as it corresponds to the identified added benefit of the medicines. The aim of the process is to strike a balance between innovation and affordability.

Our task is to bring projects and plans into line with the legal framework and to identify and support existing opportunities for the development, authorisation and distribution of medicines.

We focus on the following areas:

  • Classification of products and their delimitation (food, pharmaceuticals, medical devices, cosmetics)
  • Research and development contracts
  • Authorisation of finished medicinal products and homeopathic medicinal products – European Authorisation, Mutual Recognition, German Authorisation, Off-Label Use, Unlicensed and Compassionate Use
  • Registration of homeopathic medicinal products
  • Manufacturing permit – including the need for an expert, their personal requirements and their liability
  • AMWHV, GMP, WHO, GLP, contract manufacturing and contract auditing
  • Labelling of containers and outer packaging
  • Product information texts
  • Pack sizes
  • Sales practice, distribution channels (wholesale, hospitals, pharmacies, retail, mail order), licensing co-promotion, co-marketing and co-distribution, medicinal product advertising, cooperation with specialist circles
  • Reimbursement of medicinal products
  • Corporate law aspects – joint ventures
  • Pharmacovigilance
  • Liability
  • Medicinal Products Advertising (HWG)
  • General Competition Law (UWG)
  • Cooperation with expert bodies
  • Intellectual property rights – trademarks, utility models and designs

Our consulting services also include:

  • Assistance in all phases of the AMNOG procedure, both in relation to the preparation of the dossier, the G-BA benefit assessment procedure, in the price negotiations with the GKV umbrella association, in arbitration proceedings and in court proceedings
  • Comprehensive out-of-court and judicial advice on regulatory measures, such as fixed amounts, therapeutic advice, regulatory restrictions and exclusions or the autidem regime
  • Legal advice on the management of contracted physician profitability targets, key substance and other quotas, premium models, physician information and other regulatory instruments at the KV level
  • Legal advice on the management of contracted physician profitability targets, key substance and other quotas, premium models, physician information and other regulatory instruments at the KV level
  • Comprehensive legal advice on the legal framework of tenders, negotiation of contracts for innovative medicines with health insurance funds and initiation of procurement review procedures with the award chambers
  • Legal support and assistance with the reimbursement of medical equipment and aids, in particular with the listing of aids in the list of aids as well as with questions related to joining framework contracts pursuant to § 127 para. 2 SGB V
  • Legal review and development of strategies for dealing with audits of health insurance funds vis-à-vis hospitals in relation to new methods of examination and treatment
  • Comprehensive legal advice on new examination and treatment methods in all phases for early benefit assessment in accordance with § 137h SGB V and for testing regulations in accordance with § 137e SGB V

Ehlers, Ehlers & Partner has extensive experience in consulting in all areas of healthcare, both at our Munich location and in Berlin, Brussels and Düsseldorf. Another legal field in the sector-specific area is M&A issues of all kinds, such as:

  • Planning and execution of due diligence in relation to sector-specific issues such as approvals, certifications, permits, regulatory and commercial contracts
  • Planning and implementation of due diligence in the area of HealthCare and Business Compliance, including the conduct of management interviews
  • Preparation of due diligence reports in German and English based on international standards
  • Advising on the structuring of the transaction taking into account regulatory peculiarities
  • Comprehensive coordination of due diligence or supply of sector-specific content, e.g. for financial investors or other law firms without corresponding sector expertise or a German branch
  • Planning, execution and implementation of M&A projects in the healthcare sector, e.g. company acquisitions or licensing deals
  • Preparation and negotiation of comprehensive contractual documentation, from the purchase contract to important ancillary contracts such as contract manufacturing, sales or research and development contracts
  • Coordination with other jurisdictions and countries
  • Comprehensive support for clients or ad hoc support, e.g. for sector-specific contracts
  • Advising on and taking into account regulatory specificities in the context of corporate restructuring, e.g. in relation to permits and labelling requirements
  • Planning and implementation of appropriate corporate restructurings