Liberalisation of the distribution circuit for certain medical devices
The Royal Decree repeals paragraphs 3, 6, 7, 8 and 9 of Article 10bis of the Royal Decree of 18 March 1999 on medical devices.
Under these paragraphs, the receipt, distribution and storage of certain medical devices in Belgium could only be carried out by specific health care professionals, i.e. hospitals pharmacists or retail pharmacists. In addition, certain medical devices were required to be dispensed in person to the patient in a pharmacy. This included:
- Sterile medical equipment in contact with the patient (e.g. dressings, compresses).
- Sterile injections, infusions, transfusions or drainage equipment, catheters and probes, any equipment for medical and obstetrical procedures presented as sterile, including irrigation solutions and haemodialysis concentrates.
- Implantable medical devices (sterile or not).
- Medical devices for birth control and/ or the prevention of sexually transmitted diseases.
- Devices that are similar to medicinal products and/or have been previously registered.
- Systems and kits comprising of the devices referred to above.
In addition, Article 10bis provided that the receipt, distribution and storage of devices that are used in dentistry, including custom-made devices (such as amalgam, crowns and prostheses) and systems and kits comprised of these devices, could only be carried out by dental practitioners.
Liberalisation of the distribution circuit for Active Implantable Medical Devices
The new Royal Decree also repeals Article 19 of the Royal Decree of 15 July 1997 on active implantable medical devices. This Article provides that hospital pharmacists alone can receive, store and deliver active implantable medical devices. This meant that hospital pharmacists alone were able to distribute active implantable medical devices.
The impact on medical device companies
The new Royal Decree intends to liberalise the receipt, distribution and storage of the medical devices referred to above. Currently, the distribution of these medical devices is the prerogative of certain specific categories of health care professionals. Only dental practitioners, hospital pharmacists and retail pharmacists are allowed to sell them.
On 7 February 2019, medical device companies will be able to use new distribution channels for these medical devices. Supermarkets, para-pharmacies, as well as other distribution points, will then be able to be used provided that they are compliant with the Belgian rules regarding the distribution of medical devices. These new distributors will, however, have to adhere to the same strict quality, safety and traceability criteria as pharmacists. All distributors of medical devices will therefore also be required to register with the relevant Belgian authority.
However, medical devices prescribed by a doctor will only be reimbursable when the prescription is used in a pharmacy. Supermarkets will not be able to process such a prescription and the user of the medical device can only be reimbursed by the Belgian health care system if they possess such a prescription. Users of medical devices may, therefore, in cases where they have received a prescription for a medical device, prefer to go to a pharmacist.
Belgian Minister of Health, Maggie De Block has explained that:
“If explanations and advice are needed, people will continue to talk to their pharmacist. The new regulations will mainly impact the sale of simple products such as sterile dressings. It will soon be easier to obtain them, and at a more affordable price. ” (please find the link here)
The new legislation is expected to mainly impact medical devices for day-to-day use, such as sterile bandages. In several other EU Member State markets, the distribution of circuits for medical devices has already been liberalised.
Please contact our team if you have any questions regarding the Belgian rules on the distribution of medical devices or the new Royal Decree.
Authored by Fabien Roy, Helene Boland and Alexander Wenzel