Pharmaceutical pricing and reimbursement
Pharmaceutical pricing and reimbursement

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

  • Pharmaceutical pricing and reimbursement
  • European level rules on pricing and reimbursement of medicinal products
  • UK framework on pricing and reimbursement of medicinal products
  • Primary care system—licensed, branded prescription medicines
  • Voluntary Scheme for Branded Medicines Pricing and Access
  • Statutory scheme
  • Wholesale, distribution and clawback
  • Primary care system—generic prescription medicines
  • Primary care system—OTC medicines
  • Primary care system—unlicensed medicines
  • more

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

European level rules on pricing and reimbursement of medicinal products

The pricing and reimbursement of medicinal products and medical devices is not harmonised across the EU. This means that the national authorities of each Member State are free to decide how to set the price of medicinal products and the amount that will be reimbursed under their respective social security systems.

This lack of harmonisation has resulted in the EU Member States developing different schemes and policies, adapted to their own economic and healthcare needs. For example, in some EU Member States, a specific price or level of reimbursement must be approved, while in other Member States a system