Pharmaceutical antitrust—Germany—Q&A guide

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Pharmaceutical antitrust—Germany—Q&A guide
  • 1. What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?
  • 2. Which authorities are entrusted with enforcing these rules?
  • 3. Are drug prices subject to regulatory control?
  • 4. Is the distribution of pharmaceutical products subject to a specific framework or legislation? Do the rules differ depending on the distribution channel?
  • 5. Which aspects of the regulatory framework are most directly relevant to the application of competition law to the pharmaceutical sector?
  • 6. What are the main competition law provisions and which authorities are responsible for enforcing them?
  • 7. What actions can competition authorities take to tackle anticompetitive conduct or agreements in the pharmaceutical sector and what remedies can they impose?
  • 8. Can remedies be sought through private enforcement by a party that claims to have suffered harm from anticompetitive conduct or agreements implemented by pharmaceutical companies? What form would such remedies typically take and how can they be obtained?
  • 9. Can the antitrust authority conduct sector-wide inquiries? If so, have such inquiries ever been conducted into the pharmaceutical sector and, if so, what was the main outcome?
  • More...

Pharmaceutical antitrust—Germany—Q&A guide

This Practice Note contains a jurisdiction-specific Q&A guide to pharmaceutical antitrust in Germany published as part of the Lexology Getting the Deal Through series by Law Business Research (published: May 2020).

Authors: Dechert LLP—Clemens Graf York von Wartenburg; Marjolein De Backer; Thirith von Döhren

1. What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?

The most relevant Germany-wide laws with respect to pharmaceutical products, including generic drugs, are as follows:

  1. the Medicinal Products Act (AMG); and

  2. the Ordinance on the Manufacturing of Pharmaceuticals and Active Ingredients (AMWHV). German laws also implement the EU Directives and Regulations, in particular Directive 2001/83/EC and Regulation 726/2004.

The AMG covers all pharmaceutical products, including generic drugs. The AMG’s main focus is on the authorisation of marketing, manufacturing, sale or distribution, exports and imports of pharmaceutical products. It also provides a framework for pharmacovigilance systems and contains provisions on pricing. The AMWHV sets out specific rules and obligations with regard to the manufacturing of pharmaceutical products or ingredients (eg, regarding manufacturing premises, hygienic measures and personnel).

Other relevant laws include:

  1. the Fifth Social Security Act (SGB V);

  2. the Ordinance on the pricing of medicinal products; and

  3. the Act on advertising in the health sector.

2. Which authorities are entrusted with enforcing these rules?

Three federal agencies are responsible for enforcing the applicable rules:

  1. the Federal

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