Article originally published in the Life Sciences Handbook, 2012

1. What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?

Legislation
The main legislative acts regulating medicinal products are the:

  • „„ Medicines Law 1964.
  • „„ Royal Decree of 14 December 2006 on Medicines for Human Use and Veterinary Use.

The main legislation regarding reimbursement of medicines is the:

  • „„ Law on the Mandatory Health Insurance of 14 July 1994.
  • „„ Royal Decree of 21 December 2001 Concerning the
  • Procedures, Terms and Conditions for Contribution by Mandatory Insurance for Health Care and Benefits towards Costs of Pharmaceutical Specialties.

Regulatory authorities
The Federal Agency for Medicines and Health Products (FAMHP) (Federaal Agentschap voor geneesmiddelen en gezondheidsproducten (FAGG) or Agence fédérale des médicaments et des produits de santé (AFMPS)) (see box, The regulatory authorities) is the regulatory authority responsible for these matters. FAMHP is a public service institute with legal personality.

The most important body for reimbursement of medicines is the Commission for Reimbursement of Medicines (Commissie Tegemoetkoming Geneesmiddelen or Commission de Remboursement des Médicaments) (see box, The regulatory authorities) of the National Institute of Health and Disability Insurance (Rijksinstituut voor ziekte- en invaliditeitsverzekering (RIZIV) or Institut National d’Assurance Maladie Invalidite (INAMI)).

The main authority for price regulation is the Federal Public Service Economy, SMEs, Self-employed and Energy; Directorate General Regulation and Organisation of Markets; Section Prices (see box, The regulatory authorities).

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Photo of Peter Bogaert Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in…

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he presents numerous innovative life sciences companies, including start-ups, as well as several industry associations.