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Belgium - New Royal Decree Allows Pharmacist to Replace Unavailable Prescription Medicine by Alternative

  • 11/07/2022
  • Articles

The RD marks the second implementing measure of the Law of 20 December 2019 modifying various laws to tackle medicine shortages (see, Van Bael & Bellis Life Sciences News and Insights of 3 February 2020). The first implementing measure established a stock monitoring system for wholesaler-distributors with a view to increasing transparency of the medicines supply chain (see, Van Bael & Bellis Life Sciences News and Insights of 20 December 2021).

The RD marks the second implementing measure of the Law of 20 December 2019 modifying various laws to tackle medicine shortages (see, Van Bael & Bellis Life Sciences News and Insights of 3 February 2020). The first implementing measure established a stock monitoring system for wholesaler-distributors with a view to increasing transparency of the medicines supply chain (see, Van Bael & Bellis Life Sciences News and Insights of 20 December 2021).
 
Except for a limited number of medicines and medicine groups which can only be substituted with the prior agreement of the prescribing physician (e.g., biological medicines and anti-epileptic medicines; see, Annex to the RD), the RD generally authorises pharmacists to replace unavailable prescription medicines by available alternatives, subject to compliance with the following rules: 

  • before proceeding to substitution, pharmacists should verify whether the physician’s prescription contains any specifications as to the required form of administration (in which case the replacing medicine should meet these specifications) or information about an allergy to an excipient (in which case substitution is not permitted);
  • before proceeding to substitution, pharmacists should ensure that the proposed form of administration is suitable for administering the prescribed dose;
  • the pack size of the replacing medicine should correspond as closely as possible to the pack size of the prescribed medicine, considering the needs of the patient;
  • in case there are various possible replacing medicines, the RD establishes a cascade assessment system which prioritises (i) reimbursable medicines over non-reimbursable medicines; and (ii) within each category, the cheapest replacing medicine over more expensive alternatives. If there exists no reimbursable replacing medicine, pharmacists should obtain the patient’s informed consent before delivering a product which is not the cheapest available alternative;
  • pharmacists should inform patients of the reasons for substitution, i.e., the unavailability of the prescribed medicine and the need to continue the treatment; and
  • pharmacists should inform the prescribing physician of the substitution of the unavailable medicine and provide the prescribing physician with details regarding the replacing medicine.

By way of compensation for their efforts to find the cheapest replacing medicine, pharmacists may apply a margin of 5 percent on the public sale price per dosage-unit of the cheapest available medicine. However, they should inform the patient of this surcharge.
 
The RD will enter into force on 18 July 2022.
 
We understand from statements in Parliament by the Minister of Social Affairs and Public Health back in February 2021 that further implementing measures of the Law of 20 December 2019 are forthcoming (see, reference in Van Bael & Bellis Life Sciences News and Insights of 11 June 2021). These further implementing measures would aim at (i) determining the procedures and conditions under which unavailable medicines may be made subject to a temporary export limitation or prohibition; and (ii) ensuring that neither the patient, nor the government or the mandatory health insurance would have to bear the additional costs resulting from the unavailability of a medicinal product.

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