07 April 2017 - Authored by:Tine Carmeliet
On 23 March 2017, the Belgian Council of Ministers approved the Multiannual Framework Agreement for Patients (Meerjarenkader voor de patient) that was signed by the Belgian Minister of Health and the Belgian pharmacists associations, APB and OPHACO, on 15 March 2017. The agreement aims to implement optimal pharmaceutical care for patients, in particular by confirming and strengthening the key role of pharmacists in primary care.
The framework agreement provides for an extension of the current regulatory framework in order to allow the online sale of prescription-only medicines. This marks a significant change with regards to the current legal regime that restricts online sale to non-prescription medicines provided pharmacists obtain a specific licence. The online sale of prescription-only medicines would be subject to a strict regulatory framework guaranteeing the safety and quality of the process. In particular, pharmacists selling prescription-only medicines online would be required to set up a system allowing the identification of the patient (most likely through a log-in procedure using the patient’s identity card and including contact details and medical history) and to provide professional advice where necessary. The proposed extension responds to increasing public demand, in particular from chronically sick, elderly people with limited mobility and people with busy schedules. New regulations establishing a regulatory framework for the online sale of prescription-only medicines are expected to be drafted in early 2018.
In addition, under the framework agreement, pharmacists will no longer be allowed to charge a surplus when delivering prescription-only medicines during night (22:00 – 08:00) and weekend duty, unless it clearly concerns a non-urgent prescription. Instead, pharmacists will be compensated with a so-called “permanence fee” for night and weekend duty.
The framework agreement also requires pharmacists associations to establish and implement a self-monitoring system for magistral preparations, which are medicinal products that are prepared in a pharmacy in accordance with a medical prescription for an individual patient. In December 2016, the non-profit organisation MFK (Medisch-Farmaceutische Kwaliteitszorg) published a Charter for Magistral Preparations aimed at improving the regulation of such preparations. The quality of magistral preparations has been under scrutiny in Belgium since the Belgian consumer organisation Test Aankoop published the results of a study indicating that 80% of magistral preparations did not meet the required standards. In order to improve the quality of such preparations, an extension of the regulatory framework regarding their outsourcing is currently also being considered.
The framework agreement further introduces the concept of the “house pharmacist” (huisapotheker), intended to facilitate care for patients between forty-five and seventy-five years old who suffer from a chronic disease. It will explore the possibility for pharmacists to store medicines and medical devices extra muros, and contains provisions to improve the spreading of pharmacies on the Belgian territory.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, March 2017 Issue (Thomson Reuters).