New legislation concerning various health-related matters in Belgium

Summary of relevant changes for the industry

From 01 January 2018:

• Procedures relating to reimbursement for pharmaceutical preparations, baby foods, foods for special medical purposes (FSMPs), medical devices (excluding external prosthetic devices, active implantable medical devices, and invasive medical devices), and capillary prostheses will be simplified and the admissibility criteria and the reimbursement procedure will be determined via Royal Decree.
• Companies putting these products on the Belgian market and seeking reimbursement will have to ensure the availability of these products. There is now a strict procedure in this regard (new article 7octies of the law of 14 July 1994).

A Royal Decree can establish a special procedure for amending the conditions for the re-imbursement of a pharmaceutical product, in order to have the pharmaceutical product re-imbursed for patients younger than 18 years, when the pharmaceutical product is already reimbursed for patients older than 18 years. Such Royal Decree has not been adopted yet.

From 01 September 2016, confidentiality measures for the exchange of sensitive infor-mation during the negotiations of agreements with the Belgian National Institute for Health and Disability Insurance (INAMI / RIZIV) have been upheld. Very few exceptions will apply.

From 11 July 2016, in case of unavailability, pharmaceutical companies will be able to avoid the automatic exclusion from the list of reimbursed products under article 72bis of the law of 14 July 2014 if their pharmaceutical products are mainly intended for hospital use and the company does not enter into an agreement for a public tender within a 12 month period from the day the reimbursement is applicable to the product. In case unavailability persists, the product will be excluded from the list in any case the 1st day of the 60th month following the day where the reimbursement is applicable the product.

From 11 July 2016, the Federal Agency for Medicines and Health Products (FAMHP) is entitled to propose draft rules to the Minister of Healthcare in order to create a self-monitoring system (système d’auto-contrôle / systeem van autocontrole) across all sectors within its scope of activities.

The law of 19 December 2008 on human body material is amended in relation with human body material intended for scientific purposes (biobanks), mainly in order to create a specific regime for “transformed material”. With regard to human body material intended for scientific purposes, the law of 19 December 2008 is still not in force. A Royal Decree will first need to be adopted.