Regulatory, Pricing and Reimbursement Overview: Belgium
An intro to the legal situation for regulatory, pricing and reimbursement in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
The Federal Agency for Medicines and Health Products (‘FAMHP’) is the competent authority for drugs, biologicals and medical devices in Belgium. In particular, the FAMHP is in charge of controlling the quality, safety and efficacy of those products.
The Federal Public Service of Economy (‘FPS Economy’) sets the prices of those products.
The National Institute for Health and Disability Insurance (‘NIHDI’) sets the conditions for reimbursement of those products.
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
For drugs and biologicals, the general framework, including in relation to the authorisation, of drugs, biologicals and medical devices can be found in the following laws and regulations:
- Law of 25 March 1964 on medicines;
- Royal Decree of 14 December 2006 on medicines for human and veterinary use;
- Law of 15 December 2013 on medical devices;
- Royal Decree of 15 July 1997 on active implantable medical devices;
- Royal Decree of 18 March 1999 on medical devices;
- Royal Decree of 14 November 2001 on in vitro diagnostic medical devices.
Specific provisions relating the pricing of medical products and certain medical devices are found in:
- Royal Decree of 10 April 2014 (Royal Decree laying down the conditions of admissibility, time limits and practical arrangements for price fixing requests, price increase requests, price notifications and (price) communications of medicines, objects, apparatus and substances similar to medicines, and raw materials).
Finally, the reimbursement of the medical products is governed by :
- Law of 14 July 1994 on compulsory health insurance and compensation;
- Royal Decree of 1 February 2018 laying down the procedures, time limits and conditions for the intervention of compulsory health care insurance and compensation in the costs of pharmaceutical specialties;
- Royal Decree of 24 June 2014 laying down the procedures, time limits and conditions for the intervention of compulsory health care insurance and compensation in the costs of implants and invasive medical devices.
3. What are the steps to obtaining authorization to develop, test, and market a product?
The authorisation for medicines can be obtained via the following steps:
- Pre-clinical trials;
- Clinical trials;
- Marketing authorisation (‘MA’).
The MA can be requested by introducing a national procedure, a centralised procedure, a mutual recognition procedure or a decentralised procedure (see also Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 1).
The procedure to obtain an authorisation for medical devices is quite different. To put a medical device on the market, it needs to bear the CE marking. Depending on the class of the medical device, the marking must either be submitted to a notified body for approval and/or be notified to the FAMHP (for more details, please refer to Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 9).
4. What are the approximate fees for each authorization?
The fees for the MA of the medicines are the following, depending on the type of procedure chosen by the applicant:
|Type of Procedure||Fees*|
|National Procedure||Full MA||31.855,39 €|
|Generic MA||27.725,57 €|
|Centralised Procedure||From 291.800,00 €|
|Decentralised Procedure and Mutual Recognition Procedure||If Belgium = CMS||Full MA||10.838,86 €|
|Generic MA||9.324,08 €|
|If Belgium = RMS||Full MA||51.153,47 €|
|Generic MA||42.960,36 €|
* Fees for 2019 and for each file submitted.
The fees for medical devices are as follows:
|Type of Medical Device||Fees*|
|Notification of clinical research for active implantable medical devices||10.436,42 €|
|Notification of clinical research for medical devices in vitro diagnostic medical devices||10.436,42 €|
|Notification of clinical research for in vitro diagnostic medical devices||393,85 €|
* Fees applicable as from 31 May 2019.
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
MAs are valid for five years. An application for renewal of a national MA must be submitted through the national procedure or the mutual recognition procedure at least nine months prior to the expiring date of its validity. After the first renewal, MAs are valid for an indefinite time.
Since 1 January 2016, the use of the electronic form for the submission of a MA renewal application has become mandatory.
The fees that have to be paid for renewal are the following:
|National Procedure||5.905,59 €|
|Centralised Procedure||14.400,00 €|
|Decentralised Procedure and Mutual Recognition Procedure||If Belgium = CMS||1.070,58 €|
|If Belgium = RMS||12.035,33 €|
* Fees for 2019.
In the event of duly justified reasons related to pharmacovigilance (please refer to Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 5), the FAMHP may require an additional five years renewal at the same conditions than the first one.
6. How does the authorization process differ between brandname products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
Generic products can be authorized through a so-called abbreviated procedure, meaning that the applicant is not required to submit a complete file to receive a MA and can rely on the documents already submitted for the brandname product.
The presentation of pre-clinical and clinical trials is not required if the applicant can demonstrate that the medicine for human use is a generic of a reference medicine for human use which is or has been authorised for at least eight years in Belgium or in another Member State (i.e. so-called data protection). Once this period of data exclusivity has expired, the MA application can be submitted, as well as the pricing and reimbursement application. However, an additional two (or in some cases three) year period is required before the generic drug can be marketed (i.e. so-called market protection).
The same rules apply equally to local and foreign manufacturers.
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
There is no specific regulation for combined products. The combination of medical devices and/or medicines requires that both products have individually obtained the respective authorisations.
However, it is important to emphasize that even if biologic products are classified as medicines, they are subject to different rules than the medicines in general.
8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
The FAMHP is responsible for monitoring the correct application of the laws and decrees in force in the field of medicines. To this end, the FAMHP is legally authorised to carry out inspections, searches, analyses, interrogations, seizures, etc. within companies operating in the medical field.
The regulatory regime is based on the EU directives on medicines and medical devices and is in line with the European Medicines Agency expectations and requirements.
9. What is the potential range of penalties for noncompliance?
In the event of a violation of one of the above-mentioned provisions, the FAMHP may impose various sanctions such as: imposing an administrative fine, withdrawing or adapting official documents, taking a health measure or introducing a ban.
In case of serious violations, the firms are also liable to criminal sanctions, namely imprisonment from eight days to three years and/or a fine of 50,00€ to 100.000,00 €.
10. Is there a national healthcare system? If so, how is it administered and funded?
Any person residing in Belgium is subject to a regime of compulsory insurance. Any Belgian resident over 25 years (whether they are employees, self-employed, unemployed, retired, students, etc.) must join a Belgian health insurance fund, which allows them to access publicly funded health care. Indeed, the health insurance funds allow the insured party to be reimbursed in whole or in part for certain medical intervention and medicines.
Sources of funding for the health care system include the following:
- Social contributions paid by employers, workers and self-employed persons;
- State subsidies;
- A percentage of VAT revenues.
These funds are managed by the NIHDI, which is the federal body that organises, manages and controls health care in Belgium, which in turn distributes the funds received between the various health insurance funds.
11. How does the government (or public) healthcare system function with private sector healthcare?
The public healthcare system is the mandatory system under Belgian law and it reimburses treatment at an official price per intervention. Still, there is a difference for what the type of healthcare professional, conventionalised or not, is concerned.
The health insurance fund comes to an agreement with the healthcare professionals, inter alia regarding the prices. Healthcare professionals who agree with the official prices, are conventionalised and obliged to charge the official prices only. Partially conventionalised healthcare professionals charge the official prices in certain facilities (e.g. the hospital) and own prices in other facilities (e.g. their own private practice). Non-conventionalised healthcare professionals always charge their own prices.
12. Are prices of drugs and devices regulated and, if so, how?
Once the marketing authorisation is granted, the pharmaceutical firm can only market the product following the setting of a maximum price by the FPS Economy. The request for setting the price must be submitted to the Pricing Service of the FPS Economy. Within 90 days and after the latter has issued an opinion, the Minister of the Economy takes a ministerial decree indicating the maximum authorised price for the medicine.
For reimbursable medicines, the procedure for admission to reimbursement by the Drug Reimbursement Commission of the NIHDI is carried out in parallel with the price setting procedure.
The procedure is slightly different for generic medicines. The request for setting the price has to be addressed to the Pricing Service, which issues a decision setting the maximum price for the generic drug within 30 days.
Medical devices, implants and hearing aids are also subject to price control. The request for setting the price must be submitted to the Pricing Service of the FPS Economy. Within 90 days, the Minister sets the maximum authorised price of the medical device in a ministerial decision. In addition, a request for price notification will have to be reintroduced in some cases, such as for innovations made to an existing implant.
Thereafter, if the company wishes to increase the price of the medicine or the medical device, a request has to be made to the Pricing Service.
13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?
Patients enjoy a wide coverage offered by social security. As a result, a significant portion of medicines is fully or partially reimbursed. The reimbursement rate varies according to the category in which the medicine is classified. There are 6 categories ranging from category A (100% refunded) to category D (no refund).
The NIHDI is the body that implements the rules for the reimbursement of medicines and medical devices.
A medicine is reimbursable if the following conditions are met:
- The pharmacist receives a prescription written by a general practitioner, specialist, dentist or midwife ;
- The pharmacist delivers the medicine ;
- The medicine is listed on one of the lists of medicines for which reimbursement is provided;
- The reimbursement conditions are respected.
For medical devices, the conditions for reimbursement vary according to whether they are non-implantable medical devices, implants and invasive medical devices or certain services provided by bandagers.
In practice, when the patient goes to a pharmacy, (s)he generally benefits from the “third-party payer system”. This basically means that if the medicine or medical device meets the required conditions, the patient does not have to pay the full amount of the price but only its personal part, called the “user charge provision”. It is also possible that the medicine or the medical device is fully reimbursed and the patient does not have to pay anything.
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
Medicines can only be dispensed through pharmacists (a public pharmacy or hospital pharmacy). The profession of pharmacist is only accessible to the holder of a legal diploma of pharmacy who is registered on the list of the Order of Pharmacists.
The pharmacist’s remuneration differs depending on whether the medicine is reimbursable or not:
i. Remuneration for non-reimbursable medicines:
The distribution margins for non-reimbursable medicines are calculated on the selling price excluding VAT, and are set as follows:
- Selling price including VAT ≤ 25,43 €: 31% of the selling price excluding VAT;
- Selling price including VAT > 25,43 €: 7,44 € per presentation.
ii. Remuneration for reimbursable medicines:
The pharmacists’ remuneration for reimbursable medicines consists of three pillars: a distribution margin, a basic fee per delivery and, potentially, and possibly a specific fee for a particular pharmaceutical care.
An agreement between pharmacists and insurers stipulates the fees for compounding and dispensing of reimbursable pharmaceutical products and specialities. The distribution margins for reimbursable medicines are calculated on the ex-factory price excluding VAT, and are set as follows:
- Ex-factory price excluding VAT ≤ 60 €: 6,42% of the ex-factory price excluding VAT;
- Ex-factory price excluding VAT > 60 €: 3,85 € + 2,12 of the ex-factory price excluding VAT.
As far as medical devices are concerned, pharmacies are not the only ones able to dispense them. Since February 2019, the distribution channel for medical devices is open. They can therefore be purchased from any distributor or even from the device manufacturer.
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
One of the pharmacist’s main obligations is to provide a medicine in accordance with the doctor’s prescription. There is no doubt that this obligation is an obligation of result.
In addition, the pharmacist has a marginal duty of verification. He is required to refuse to supply any medicine considered “manifestly” dangerous or contraindicated. Since the pharmacist is neither qualified nor materially capable of making a diagnosis and verifying the accuracy of the recommended treatment, he is only required to detect gross errors.
Finally, at the time of dispensing, the pharmacist has to clearly inform clearly the patient of the effects of the medicine, contraindications, side effects, interactions, possible precautions, doses and modalities of its use, without undermining the patient’s confidence in his doctor.