Pharmaceutical antitrust—European Union—Q&A guide

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

  • Pharmaceutical antitrust—European Union—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—European Union—Q&A guide

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

Authors: Dechert LLP—Mélanie Thill-Tayara; Marion Provost

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

European legislation only covers the authorisation and marketing of pharmaceutical products. Pricing of pharmaceutical products falls within the exclusive jurisdiction of member states. European Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use sets forth the regulatory framework for the authorisation and marketing of pharmaceutical products in the European Union (EU). A pharmaceutical product cannot be placed on the European market without having obtained a marketing authorisation (MA), which can be granted through various procedures:

  1. the mutual recognition procedure;

  2. the decentralised procedure; or

  3. the centralised procedure, the latter being mandatory for certain categories of medicines, including, but not limited to, biological medicinal products.

The rules applicable to the centralised procedure are specifically set forth in Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004. Both sets of rules also provide for abridged procedures, in particular for the authorisation and marketing of generic drugs, according to which applicant companies do not need to provide

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