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Competences

Pharmaceuticals

Market participants in the area of pharmaceuticals and healthcare are confronted with time-consuming, costly approval procedures, restrictions on sales and marketing, and countless competitive disputes. Succeeding in a highly regulated, fiercely contested market requires efficient representation of interests that is tailored to the specific needs of the company and its products.

Medicinal-products law

More than any other, medicinal-products law is a legal area characterised by basic conditions and European requirements that are constantly changing. With our expertise, we can provide you with comprehensive support in the area of pharmaceuticals law:

  • Approvals and registrations of medicinal products
  • Licenses to manufacture, import, and export medicinal products, as well as for medicinal-products wholesale
  • Activity of the responsible individuals in the company
  • Effective sales channels for your products
  • Development, including clinical drug trials
  • Compliance with industry standards in the manufacture and sale of medicinal products, e.g. according to company rules, GMP, GDP
  • Delimitation of drugs from food, animal feed, cosmetics, and biocidal products
Law on the advertising of medicines and competition law

In a highly regulated environment, the proper marketing strategy plays an important role for successful positioning in the pharmaceuticals market. The degree of regulation in the pharmaceuticals industry is very high, including with respect to restrictions under competition law. We can provide you with support in gaining a decisive competitive advantage. We can devise creative leeway for you:

  • Structuring your advertising and promotional campaigns in way that conforms with competition law, always with a view to European requirements and European and national case-law
  • Legally sound “multi-channel marketing”, particularly when using the Internet and social media
  • Preventing and inhibiting unfair marketing practices by your competitors
  • Defending your marketing activities in and out of court when faced with competitive complaints
  • Developing effective litigation and defence strategies, using all procedural options and proper trial tactics
Compliance

Collaboration between the pharmaceutical industry and members of professional groups in compliance with national, international, and internal company requirements and taking into consideration court decisions and association codes is a special, constantly growing challenge. We can provide you with support in this regard:

  • Liability prevention from a civil- and criminal-law standpoint, taking into account aspects of social insurance law and accompanying referral and gratuity prohibitions in the professional law of the members of professional groups and in the law on the advertising of medicines  
  • Providing advice about anticorruption law when collaborating with members of professional groups, e.g. concerning industry-financed continuing education for physicians, advisory and speaking contracts, sponsoring measures
  • Codes of industry associations
  • Drafting and revising internal company guidelines and standard operating procedures
  • Training and continuing education for employees on site
Sales law

With a highly developed understanding of the sale of medicinal products from not just a legal but also a commercial standpoint, we can provide you with support:

  • Creating and developing a sales structure tailored to your company
  • Providing advice about direct sales channels and sales over the Internet
  • Sales strategy co-promotion, co-marketing, co-sales
  • Drafting and negotiating “customised” sales contracts, particularly liability and termination aspects, including contracts on delineating responsibilities
  • General business terms and conditions
Contract law

Put your company activities on a legally sound contractual footing – from research and development to manufacturing to sales and marketing:

  • R&D contracts
  • Manufacturing contracts
  • Sales contracts
  • Contracts on performing clinical trials and monitoring studies (AWBs)
  • Risk-share agreements
  • Contracts with CROs and CMOs
  • Collaboration and licensing agreements
  • Contracts on collaboration with members of professional groups
  • Non-disclosure agreements
  • General terms and conditions of purchasing and sales
Social law

The system of statutory health insurance is becoming more and more complex, with the material pressure increasing on those involved. We can help you in safeguarding your interests:

  • Negotiations with statutory health insurers and their associations
  • Proceedings before social courts
  • Review of the duty of statutory health insurance to pay for innovative medicinal products
  • Legal questions of the negative list, setting of fixed amounts, and prescription limitations under medicinal-products guidelines
Crisis management

Should the worst happen, we are there to help you with our industry experience and our expertise:

  • Product complaints by authorities
  • Product recall
  • Liability issues
  • Prevention through in-house training sessions, e.g. steps and response options when searches are conducted
  • Establishment of effective crisis management
  • Dealing with and notifying the public
Industrial Property Rights

Measures to ensure the protection of intellectual property and entrepreneurial performance are indispensable for company success:

  • Securing and defending industrial property rights and know-how
  • Trademarks, titles, and company identifiers
  • Designs and patents, as well as other technical property rights
  • For many years, we have collaborated with patent solicitors experienced in the industry in order to secure the optimal infrastructure.