New Belgian Act on various health-related matters

A new act of 18 December 2016 on various health-related matters (the Act) has been published on 27 December 2016 in the Belgian Official Gazette. The Act brings several material changes to the legal and regulatory framework for medicinal products and medical devices in Belgium.

Several royal decrees need to be adopted in order to implement a number of provisions of the Act. Some provisions of the Act entered into force on 01 January 2017. Others will require the adoption of a Royal Decree before entering into force.

We have summarised hereunder ten key takeaways:

1. Sunshine Act:

Articles 41 to 48 of the Act introduce the obligation for “any economic actor” (whether located in Belgium or abroad, including MAHs, importers, manufacturers, distributors, brokers of medicinal products for human/veterinary use, as well as distributors, manufacturers, retailers of medical devices) to disclose all advantages (whether in money or in kind) which are granted directly or indirectly to healthcare professionals (HCPs), healthcare organisations (HCOs) and patient associations having their principal activity/seat in Belgium. Mdeon, which already hosts the betransparent platform, is likely to be appointed by the authorities in the course of 2017 to host the Belgian transparency website. Non-compliance with the sunshine act will be punished by fines ranging from €1,200 to €90,000.

It is expected that the first reference period prior to disclosure will be from 01 January 2017 to 31 December 2017, with the first publication likely by 31 May 2018 at the latest. The transfers of value will have to be disclosed in the three national languages. An implementing royal decree is expected to be adopted in the course of 2017 to clarify the practical aspects of the disclosure, and the types of transfers of value concerned.

2. Distribution of medical devices:

Distributors of medical devices pursuant to Title III of the medical devices act of 15 December 2013 are now defined as “any individuals and legal entities being part of the supply chain, other than the manufacturer or the importer, which make a product available on the EU market”. This definition is in line with the last available draft of the text of the upcoming European Regulation on medical devices. Said definition is relevant for: (i) the payment of the yearly fee on their medical devices turnover in Belgium and (ii) the registration with AFMPS/FAGG (on SADN/ABGD) for traceability purposes. It appears that distributors which were not caught by the former definition will also have to refer (and set up) a contact point for medical devices vigilance, which is part of the AFMPS/FAGG registration procedure. **However, the Act expressly excludes retailers of medical devices from the scope of both obligations.

The yearly fee (of maximum 0,40260921%) now also applies to manufacturers and importers (and not only to distributors); it will be multiplied by an additional quotient determined by the AFMPS/FAGG. In addition, the Act foresees the possibility to exempt distributors of devices showing limited levels of risks from registering online prior to undertaking their activities in Belgium. This exemption remains to be executed via royal decree.

3. Reimbursement of reference medicinal products:

The current system leads to an automatic decrease of the reimbursement basis for reference medicinal products having the same active ingredient as a generic product that has been available on the market for at least two months (so-called “reference reimbursement system”). This system is now being extended to decrease the reimbursement basis of medicinal products combining several active ingredients when the reference reimbursement system is applicable to at least one of these ingredients.

4. Supply of medicinal products:

The concept of medicinal products subject to a limited prescription ("médicaments sur prescription restreinte"/"geneesmiddelen die aan een beperkt voorschrift zijn onderworpen") is clarified. The Act also provides a framework for the supply of medicinal products and medical devices to outpatients by hospital pharmacists (eg in the context of home-based care after patients were hospitalised). A royal decree should further set out the conditions in which hospital pharmacists may deliver orphan medicinal products and prescription-only medicinal products - the delivery of which is reserved to hospital pharmacists - to outpatients. Rules have also been adopted to ensure the traceability of advanced therapy medicinal products (ATMP) used under hospital exemption, while ensuring that patients’ privacy rights are being respected.

5. Home-based care:

A legal framework has been created for companies responsible for the installation, maintenance and removal of medical devices in the context of home-based care (ie patient treatment outside hospitals). A specific self-monitoring (“autocontrôle”/“autocontrole”) system has been set up for these companies, the details of which will have to be determined via royal decree. To further implement the principle of self-monitoring, companies will be able to rely on guideline materials issued by AFMPS/FAGG to ensure product quality and quality assessment.

6. Federal agency for medicines and health products (AFMPS/FAGG):

Following concrete individual requests, AFMPS/FAGG will be entitled to provide advice on the interpretation of existing laws and regulations. A royal decree will define the conditions and rules surrounding this interpretation procedure. It is expected that these regulatory advices will be published on an anonymous basis.

7. Plasma-derived products: Self sufficiency programme:

The Act amends article 20/1 of the act of 05 July 1994 on blood and blood-derived product. Said article aims at organizing a tender (for a four year period) for the supply of certain albumin and immunoglobulin products (described in said article) to Belgian hospitals, in relation with a self-sufficiency programme.

8. Human corporal material:

The act of 19 December 2008 on human corporal samples is amended, in the framework of the implementation of EU Directives 2015/565/UE and 2006/86/CE of 8 April 2015, mainly with the view of improving traceability (in the European Economic Area) of human corporal material.

9. Testing outside clinical environment:

The concept of diagnostic orientation test (“test d’orientation diagnostique”/“diagnostische oriëntatietest”) is introduced into Belgian law as a new category of technical service to be performed by persons outside the clinical environment (eg social workers or educators members of non-profit organisations). Tests may be carried out as long as a training delivered by physicians or nurses has been followed, and provided that a physician or a nurse has delivered an individual authorisation for a specific period of time. Examples include HIV, cholesterol, HCV, glucose, lactate and EKG tests. The full list of diagnostic orientation tests (and related conditions) will be enacted via royal decree.

10. Sanctions and settlements:

The Act provides for new criminal sanctions, notably in the following cases: (i) actions related to the counterfeiting of medical devices or IVD medical devices, (ii) specific circumstances (eg death, physical damage, repetition of the same offence) leading to several sanctions being doubled, (iii) transgression of the sunshine act, (iv) violation of the home-based care provisions, (v) breach of the act of 07 May 2004 concerning experiments on the human person. Both INAMI/RIZIV and AFMPS/FAGG will further be entitled to settle and reach financial compromises before going to court, under different circumstances and in their fields of expertise.

The Act is available online in French and Dutch.

Feel free to contact Annabelle Bruyndonckx or Olivier Mignolet should you wish to discuss some of the changes introduced by the Act.