16 January 2020 - Authored by:Tine Carmeliet
The Federal Agency for Medicines and Health Products (FAMHP) has launched PharmaStatuts a new online platform that collects and publicly discloses information about the availability of medicines in Belgium. The platform aims at reducing the impact of unavailable medicines on patients. In addition, it aims to facilitate the flow of information between all parties involved in the health sector. It is expected that eventually, this initiative will be strengthened by further co-operation on a European level.
The power of this application is its streamlined approach that gathers as much information as possible from all the actors involved in the medicinal process and discloses it via a user-friendly tool available for all.
The application is currently in its first phase. By using the current functionalities of the application, the reporting obligations for marketing authorisation holders and parallel importers on changes regarding the availability of medicines are already simplified. They can also directly answer requests and claims from pharmacists or wholesaler-distributors via the application.
Via other functionalities that have already been implemented, the application informs patients about the availability of a specific medicine, its commercialisation and any possible alternative. PharmaStatus does not include medicines for which authorisation has been revoked or suspended.
In its second phase, planned for the beginning of 2020, pharmaceutical companies, pharmacists and wholesaler-distributors will be able to communicate about the unavailability of a specific medicine by notifying the marketing authorisation holders via the application. Thanks to the information shared on the platform, pharmaceutical companies will be able to align their production more to market needs.
In the future, we can expect an increase of the information available on the platform. FAMHP will put in place extra resources to follow up on reports of unavailability and push new legislative initiatives.
This article was co-authored by Aurore Dacier de Biasi.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, January 2020 Issue (Thomson Reuters).