Pharmaceutical antitrust—Bulgaria—Q&A guide

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

  • Pharmaceutical antitrust—Bulgaria—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—Bulgaria—Q&A guide

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

Authors: Georgiev Todorov & Co—Tsvetelina Dimitrova

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

The applicable regulatory framework of the marketing, authorisation and pricing of pharmaceutical products in Bulgaria comprises the Medicinal Products in Human Medicine Act, as well as several secondary legislative acts that elaborate upon specific aspects of those areas.

2. Which authorities are entrusted with enforcing these rules?

The regulatory rules in relation to the marketing and authorisation of medicinal products are enforced by the Executive Drug Agency, while the pricing of medicinal products is regulated and enforced by the National Council for Pricing and Reimbursement.

3. Are drug prices subject to regulatory control?

Drug prices are heavily regulated at all levels of the supply chain, and at no point do they stop being regulated. The National Council for Pricing and Reimbursement compiles a positive drug list that determines which drugs are covered by national health insurance and the state budget. The positive drug list comprises four groups of medicinal products defined in article 262 of the Medicinal Products in Human Medicine Act:

  1. outpatient drugs reimbursed by the National Health Insurance Fund (NHIF) as

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