Introduction
Reference countries
Exceptional criteria
Suspended APR
Deadlines
List of essential medicines
Extraordinary price review


Introduction

The public expenditure on medicines sold in pharmacies increased significantly in 2022 compared with the previous year. At the same time, there were shortages of some medicines in pharmacies and, in many cases, this led to consumption being diverted to more expensive alternative medicines.

Administrative Regulation 35/2023(1) was published to deal with this situation. It:

  • updates the reference countries to be taken into account in 2023 when defining the prices of new medicines and in the annual revision of the prices of medicines:
    • purchased by institutions and departments of the National Health Service (NHS); and
    • dispensed in the outpatient market; and
  • establishes exceptional criteria to be followed in the procedures for the annual review of the price of medicines, thus allowing an increase in the retail price of medicines that cost €15 or less.

Reference countries

In 2023, the reference countries of the previous year are maintained:

  • Spain;
  • France;
  • Italy; and
  • Slovenia.

Exceptional criteria

The exceptional criteria set out Figure 1 are to be observed in the Annual Review of Medicine Prices (APR) 2023.

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Figure 1: exceptional criteria

Suspended APR

Excluded from the suspension are generic medicines (outpatient and hospital markets) that have a maximum price which is higher than the maximum price of the reference medicine resulting from the 2023 APR or, if applicable, the 2023 price increase, in which case the maximum price of the generic medicine may not exceed the latter values.

Deadlines

The deadlines for marketing authorisation holders or their legal representatives to submit lists of prices to be applied in 2023 are as follows:

  • annual review of the maximum retail price of non-generic medicines – these had to be submitted by 15 February 2023, with prices taking effect on 1 March 2023; and
  • annual review of the maximum retail price for generic medicines – these must be submitted by 15 March 2023, with prices taking effect on 1 April 2023.

List of essential medicines

By 26 April 2023, the Portuguese National Authority for Medicines and Healthcare Products is expected to draw up a list of essential medicines, the criticality of which may justify the application of specific measures, including an increase in the maximum price.

Extraordinary price review

In addition to the above review, it is expected that there will be an extraordinary review of the prices of medicines on the grounds that they are excessively costly to the NHS.

The health minister will decide on the application of such an extraordinary review. They will also determine the criteria for determining what is considered "excessive cost".

For further information on this topic please contact Eduardo Nogueira Pinto, Eliana Bernardo or Joana Baeta Vieira at PLMJ by telephone (+351 213 197 300) or email ([email protected], [email protected] or [email protected]). PLMJ website can be accessed at www.plmj.com.

Endnotes

(1) Ministerial Order 35/2023 was published on 26 January 2023 and came into force the following day. This ministerial order was subject to a declaration of rectification (Declaration of Rectification 6/2023 of 6 February 2023).