News

Legal alert no. 47

Legal Alert no 47 - Definition of the reference countries to be considered in 2018 for the authorization of the prices of the new medicines and for the annual revision of the prices of the medicines at the hospital market and at the ambulatory market, and maintenance of the exceptional criteria to attend to in the revision of the prices

On the past November 20th, it was published, in the Portugal Official Gazette, the Ministerial Order no. 359/2017, which establishes that the reference countries to be considered for the authorization of the new medicines’ prices and for the annual revision of medicines’ prices at the hospital and ambulatory markets, for the year of 2018, are Spain, France and Italy.

This Ministerial Order maintains the exceptional criteria to be attended to in the revision of prices for 2018, according to which, from the enforcement of the annual revision of prices’ regime (foreseen in article 16 of the Ministerial Order no. 195-C/2015, dated from June 30th - current wording) it may not result a reduction of the maximum retail selling price superior to 10%, regarding the maximum retail selling price in force.

Finally, under the Ministerial Order no. 359/2017, dated from November 20th, the enforcement of article 17 of the Ministerial Order no. 195-C/2015, dated from June 30th (in its current wording) - regarding the annual revision of the maximum retail selling price of generic medicines - is suspended in 2018. Nevertheless, the generic medicines which maximum retail selling price is higher than the maximum retail selling price of the medicines of reference are excluded from the above mentioned suspension.

It is also suspended, in 2018, the enforcement of article 20 of the Ministerial Order no. 195-C/2015, dated from June 30th (in its current wording) - regarding the annual revision of the maximum acquisition prices of generic medicines by the institutions and services of the National Health Service.

The Ministerial Order no. 359/2017, dated from November 20th, entered into force on the past November 21st.

To access the full version of this Ministerial Order, please go to:  https://dre.pt/home/-/dre/114223781/details/maximized.  

Did you find this useful?