Before a medicine is authorised on the market and the patient receives a reimbursement for it, a whole procedure has to be gone through. We go through the most important steps. 

A drug is first extensively tested in a laboratory before it is studied and tested in humans. Different phases of studies examine the efficacy and safety of the medicine. These are the clinical studies. After these studies have been successfully completed, the manufacturer can apply for market access. This can be done on a European or national level.

Adoption at European level

A dossier shall be submitted to the European Medicines Agency (EMA). Once approved, the medicine is authorised for all EU Member States.

Approval at national level

The Federal Agency for Medicines and Health Products (FAMHP) is responsible for assessing the application dossier in our country. The Commission for Medicines for Human Use (CGH) assesses the quality, safety and efficacy of the medicine. This committee consists of 8 effective members, each with their own field of expertise. The dossier managers of the FAMHP, the NIHDI and a representative of an ethics committee also have an advisory vote.

Patient representatives have also been on the reformed committee since the summer of 2016. Currently, these are the Flemish Patients Platform (as a substitute for LUSS, the Walloon umbrella association) and the health insurance funds. They act as patient representatives when weighing up the benefits and risks of a medicine. The VPP reviews the files with its patient associations in order to pass on bottlenecks and experiences during the discussion. We also keep our associations informed of the further progress of the dossiers.

The advice of the commission for medicinal products for human use is delivered to the Minister of Health, who takes the final decision. The Committee for Medicinal Products for Human Use is also responsible for giving advice on:

• medicines made available through emergency medical programmes.
• scientific questions related to medicines.

Refund

At the same time as the price application to Economic Affairs, a company submits an application for reimbursement to the NIHDI. 90 days after the dossier has been submitted, the Committee for the Evaluation of Medicinal Products (CTG) approves the evaluation report. This report describes the scientific value of the medicine compared to the alternative medicines. At that time, the applicant passes on the price set by the Minister of Economic Affairs to the CTG. On day 120, the applicant receives a preliminary substantiated proposal about the added value class, the reimbursement conditions, the reimbursement category and the basis of reimbursement. She can respond to this. On day 150 at the latest, the CTG formulates the final reasoned proposal. The Minister of Social Affairs receives this and has a maximum of 30 days to make a decision.

The company can subsequently request a change in the reimbursement conditions at any time, e.g. when a medicine is granted a new indication. The Minister or the Commission itself can also start an initiative for revision. This happens regularly in these times of savings.

The CTG has 22 voting members: 7 academics, 8 representatives of the mutual health organisations, 3 pharmacists, 4 doctors. A 2/3 majority is needed to formulate a valid opinion. Starting next year, the president, an academic, will also have the right to vote.

Some medicines are very expensive and, in order to encourage responsible use, reimbursement may be limited to certain target groups that require the consent of the health insurance fund's advising physician. In addition, each medicine is granted a reimbursement category (A, B, C, Cs, Cx). This indicates the extent to which the health insurance provides an allowance. It is good to know that the co-payments for medicines in cat. A, B and C count towards the Maximum Invoice. This also applies to the flu vaccines that are reimbursed in category Cs.

Many patients have questions about the reimbursement of a medication file that has been submitted and is awaiting reimbursement by the NIHDI. Usually it is not clear whether the medication will be reimbursed and from when. Through the contacts in the Riziv (which we built up through the Observatory for Chronic Diseases), we try to bring the associations into contact with the NIHDI so that they receive a quick answer.

Reference content; © (2021) Flemish Patients Platform. The Flemish Patients Platform defends the interests of the patient in political policy and health institutions. www.vlaamspatientenplatform.be.