Legal alert no. 88

Ministerial Order no. 44-A/2019, dated from January 31st, which regulates the regime of the prices of preparations and substances based on the cannabis plant for medicinal purposes

On the past January 31st, it was published, in the Official Gazette of the Portuguese Republic, Ministerial Order no. 44-A/2019, which regulates the regime of prices of preparations and substances based on the cannabis plant for medicinal purposes.

Law no. 33/2018, dated from 18th July, establishes the legal regime for the use of medicines, preparations and substances based on the cannabis plant for medicinal reasons, namely as regards to its prescription and supply in pharmacies. The principles and the purposes of this ministerial order were subject of regulation by Decree-Law no. 8/2019, dated from January 15th, which was based on the analysis of other Member States’ Medicinal Cannabis Programmes.

The ministerial order foresees that the price to be set for the preparations and/or substances based on the cannabis plant for medicinal purposes requires to be proposed and submitted to INFARMED – Authority of Medicinal and Health Products, hereinafter INFARMED, by the holder of the “autorização de colocação no Mercado” (authorization to commercialize), hereinafter TACM, of the preparations and/or substances based on the cannabis plant for medicinal purposes.

This should be in accordance with the regime set in a Ministerial Order to be approved by the Government member responsible by the Health area.

The price to be settled is subject to INFARMED’s approval, and it may be reviewed at any time, at the initiative of the TACM, provided that it is reported and accepted by INFARMED.

INFARMED may, within 15 working days from the reception date of TACM’s notification, oppose to the proposed price, for reasons of disproportionality when in comparison with the price in the international market. In this case, the TACM has to submit a new price. 

In case INFARMED does not issue any reply within the above mentioned deadline, it is considered that it accepts the proposed price.

With the acceptance of the price by INFARMED, the TACM has to inform the first of the starting date of the commercialization of the preparations and/or substances based on the cannabis plant for medicinal purposes. TACM is also required to inform INFARMED if, for any reason, it decides to suspend or even to cease the referred commercialization.

All the communications under this Ministerial Order have to be electronically made.

The provisions of this Ministerial Order will be reviewed within a year, for evaluation of the regime and potential development to a regime of maximum prices.

The Ministerial Order no.44-A/2019 entered into force on February 1st, 2019.

To access to the full version of this Decree-Law, please click here