Life Sciences Bit: Belgian Medicines Act to ensure supply of medicines to pharmacies
On 28 March 2019, the Belgian Parliament adopted an amendment to the Medicines Act in order to accommodate for possible shortages of medicines in Belgian pharmacies.
The amendment aims to ensure a continuous supply of medicines to pharmacies and patients.
Background of the amendment
In Belgium, only authorised individuals or entities can distribute medicines for human use through wholesale channels. The relevant authorisations are granted by the Federal Agency for Medicines and Health Products (“FAMHP”).
The Belgian Medicines Act moreover provides that the wholesale of medicines for human use can only be made to other authorised wholesalers, to pharmacies or, in some cases to physicians authorised to keep and distribute certain medicines.
There is also a special category of “wholesale-distributors”, who have public service tasks and are, among other things, obliged to hold an assortment/stock of medicines to respond to the needs of a defined geographical area and to complete orders in this area without any delay. Other wholesalers are legally obliged to respond to all orders of wholesale-distributors. Their orders cannot be refused.
Notwithstanding these obligations, the Belgian legislator identified several issues related to the (un)availability of certain medicines for Belgian patients. The amendments that were adopted should counter such issues.
Measures to prevent the unavailability of medicines for Belgian patients
(1) The amended Belgian Medicines Act now contains an additional provision that allows the Belgian government to define by Royal Decree when a medicine is deemed to be “temporarily unavailable”.
While each instance of “temporary unavailability” of a medicine should be notified to the FAMHP, this notion is not defined in the Medicines Act, which has caused divergent interpretations and practices.
(2) Another novelty is the legal obligation for wholesale-distributors to only supply medicines to other authorised wholesale-distributors, to licensed pharmacies and to hospitals, including university hospitals.
With this novelty, and from a public health perspective, the Belgian legislation wants to prevent medicines destined for the Belgian market being sold on other markets by wholesale-distributors. From now on, only ‘normal wholesalers’ can thus export medicines from the Belgian market (provided that they have an export license).
The only exception to the above relates to the situation of clinical trials. Wholesale-distributors can still supply medicines to ‘normal wholesalers’ for use in the context of a clinical trial, if this does not endanger their geographical supply obligation.
Once the amendments are published in the Belgian official gazette, they will enter into force. Several delegations for the establishment of implementation rules are, however, given to the government. Such implementing Royal Decrees will (hopefully) be adopted without much delay.
Should you have any questions regarding the above, please do not hesitate to contact Stéphanie De Smedt, Aleksandra Sanak or your regular Loyens & Loeff adviser.
StéphanieDe SmedtSenior associate Attorney at Law
Stéphanie De Smedt is senior associate within the Litigation & Risk Management Practice Group of our Brussels office.
She is head of the IP/IT & Data Protection Team in Belgium and is team leader of the firm-wide Healthcare and Life Sciences Team.