Belgium - Bill Tackles Medicine Shortages
A number of members of parliament introduced last week a private members’ bill that has the twin objectives of tackling medicine shortages and combating the trade in falsified medicines (bill 54 3599/001 – the “Bill” – see attached).
The Bill will modify the Law of 25 March 1964 to (i) allow the concept of “temporary cessation of supply of medicines” to be determined by Royal Decree; (ii) allow the Minister to make recommendations of suitable therapeutical alternatives in case of temporary shortages of specific medicines; (iii) preclude wholesalers (“WS”) with a public-service WS status from supplying ordinary WS; and (iv) impose particular shortage-related obligations on parallel traders which previously only applied to the marketing authorisation holders.
The proposed ban on public-service WS to supply ordinary WS (and therefore limit their supplies to, broadly, other public-service WS, pharmacists and hospitals) is designed to ensure the steady supply of medicines to the local market and, conversely, cut down on exports that threaten public health. Under specific conditions, the ban will not apply to medicines earmarked for clinical trials.
The Bill establishes criminal sanctions for specific violations of Regulation 2016/161 which lays down safety features for the packaging of medicines for human use.
The current caretaker government no longer commands a majority in the federal Chamber of Representatives. However, the Bill may be assured of an ad hoc majority in that it has already been given a time slot in the session of the committee for public health scheduled on 12 March 2019.
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