On January 28, 2019, the Belgian government announced some key changes to the distribution channels of medical devices in Belgium. The Royal Decree of December 19, 2018 liberalizing the distribution channel of medical devices will have a great impact on how medical devices are accessing the Belgian market. Here below we have answered some key questions:
What is the big change?
Until now, the distribution and sale of certain medical devices has been the prerogative of defined healthcare professionals and healthcare organizations (e.g. hospital or retail pharmacists and dental practitioners). The distribution of active medical devices was restricted to hospital pharmacists only.
This will change with the entry into force of the new legislation. New actors will be able to dispense those medical devices directly to patients and healthcare professionals, including supermarkets and manufacturers themselves.
Self-evidently, these new actors will need to comply with the same levels of quality and safety and will be subject to the same requirements under the applicable legislation (including the FAMHP Good Distribution Practices (GDP)). This implies that any new distributor will need to be registered with the Belgian Federal Agency for Medicines and Health Products (FAMHP). However, this obligation of registration does not currently apply to manufacturers, the FAMHP clarified.
The changes to the existing framework have been introduced to:
- align the distribution model for medical devices with evolving patient needs and new standards in patient care;
- align Belgian legislation with the EU principle of free movement of goods for CE marked medical devices and remove restrictions which are not motivated by safety reasons;
- overcome barriers to international trade by removing the classification rules applied in Belgium but
When does the new legislation kick in?
The new legislation will become applicable as of February 7, 2019.
Does it apply to all medical devices?
No. From the outset it should be noted that not all medical devices were subject to restricted distribution through defined distribution channels. Certain medical devices were already freely available.
The new legislation liberalizes the distribution of medical devices, such as, but not limited to, the following:
- sterile medical equipment that comes into contact with a patient (such as dressing materials, compresses);
- sterile injection-, perfusion-, transfusion-, or drainage equipment, probes and catheters, and any equipment intended for medical or obstetric interventions that is presented as sterile, including irrigation solutions and concentrates for hemodialysis;
- implantable medical devices (sterile or not);
- medical devices intended for birth control and/or those intended for the prevention of sexually transmittable diseases;
- medical devices similar to drugs and/or that have been previously registered as such (so-called "drug look alikes" such as eye drops);
- medical devices used in dentistry, including custom-made devices (such as amalgams, crowns and prostheses);
- systems and kits consisting of medical devices referred to above;
- active medical devices.
Finally, it should be noted that restrictions to the distribution of specific medical devices can be imposed when this is justified on the basis of safety reasons.
It is expected that the liberalization will affect primarily medical devices for day to day use (such as sterile dressings)
I am a manufacturer of medical devices - how does it affect me?
- check if your medical devices are affected by the changes;
- you can consider selling medical devices directly (possibly online);
- the changes will create more competition in the supply chain and generate cost savings - it is expected that patients will be able to benefit from savings through more affordable prices;
- you can enter into new distribution arrangements with supermarkets, para-pharmacies and other
actors (provided they are duly registered with the FAMHP).
(New) Distributors should be aware of specific local rules in Belgium that may apply, such as the obligatory registration on the FAMHP web portal, the FAMHP GDP, compliance with anti-gift provisions and Belgian transparency reporting obligations.