Drug shortages are surfacing with increasing frequency. This was all the more evident during the covid pandemic. The origins of these shortages may stem from various causes such as: the unavailability of active ingredients, delays in production, a patent dispute, distribution problems....
To enable pharmacists, wholesaler-distributors and pharmaceutical firms to communicate about drug shortages and commercialisation, an online platform has been set up. The platform provides both the ability to consult the list of unavailable drugs and the ability for licence holders and wholesale distributors to signal shortages. Information is also provided on the platform about the reason for unavailability, the expected date of availability and alternatives. Pharmacists and wholesalers can contact the drug's marketing authorisation holder directly through the application. With this application, the Federal Agency for Medicines and Health Products (FAMHP) (FAGG) ensures streamlined communication between all stakeholders. The platform can be found at: https://farmastatus.be.
In order to limit the export of medicines in case of scarcity, the R.D. of 19 January 2023 was adopted. The R.D. allows the export of a medicine in case of unavailability to be subject to prior authorisation by the Minister of Public Health.
Under the R.D., an export authorisation by the Minister of Health is valid when :
- The unavailability of the medicine was notified to the FAMHP or determined by the FAMHP;
- The unavailability is likely to last more than one month;
- The administration of the medicine is urgent and necessary;
- The unavailability cannot or cannot sufficiently be remedied with other authorised medicines with the same therapeutic effect regardless of their active substance.
A list of unavailable or re-available medicines can also be found at https://farmastatus.be.
Drug wholesalers can apply for an export licence for the scarce medicine via the FAMHP website.
The Minister of Health decides on the export application within 5 working days after advice from the FAMHP (FAGG).
The Minister can: prohibit, authorise, limit the volume or request additional information, in which latter case the deadline is suspended. If there is no decision within the five days, the export is allowed.
An export refusal is a measure of equivalent effect that goes against the free movement of goods, but can be justified on public health grounds (Article 36 TFEU).
The European Commission has issued guidelines on this matter, which in summary state that export bans can be justified if they are effective and proportionate. This remains a question of fact where, among other things, the availability of alternative medicines must be considered.
The submission of the application thus presupposes special attention for marketing authorisation holders or wholesale distributors.
We will be happy to assist in submitting the application or answer any questions about the scheme.