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What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

Healthcare professionals Healthcare professionals (eg, doctors, pharmacists and dentists) can inform the Belgian Centre for Pharmacovigilance for Medicines for Human Use through the ‘yellow card’ system regarding any suspicion that they have concerning adverse effects of medicines which they come across in daily practice.

It is particularly important to report the following situations:

  • Serious adverse effects – adverse effects that have led to hospitalisation or prolongation of hospitalisation, that have been life-threatening or have caused death, permanent or significant disability or inability to work, or congenital disorder or malformation.
  • Unexpected adverse effects – adverse effects of which the nature, seriousness and the evolution do not correspond with the summary of product characteristics.
  • Suspected adverse effects – adverse effects that are known but of which the frequency, seriousness or result is abnormal.
  • Adverse effects occurring in the following situations:
    • vulnerable populations (eg, children, pregnant or breastfeeding women, the elderly and patients with hepatic of renal failure);
    • administration of vaccines;
    • switching from one specialty to another during treatment, regardless of whether it concerns the switch between original medicines, from a generic to an original medicine, from an original to a generic medicine or between generic medicines; and
    • inappropriate or off-label use of a medicine.

It is also important to report any adverse effects of so-called ‘black triangle drugs’. These include medicines that contain a new active substance and new biological medicines. They are indicated by the symbol ▼ in the Répertoire Commenté des Medicaments. The ▼ symbol appears for the first three years after the medicine in marketed.

It is important that these ▼ medicines are followed closely as soon as they are marketed. At the time that a medicine is authorised, knowledge about its adverse effects is still limited. The clinical studies conducted for marketing authorisation are mainly intended to show the efficacy of the medicine and have limitations in detecting adverse effects:

  • the number of patients included in the studies is usually too low to detect rare adverse effects;
  • the duration of the studies is not long enough to detect adverse effects that appear at a later stage; and
  • the studies do not usually include patients that present a high risk of adverse effects (eg, paediatric or elderly patients, patients with important comorbidity or polymedication, and patients with kidney and liver failure).

The Belgian Centre for Pharmacovigilance for Medicines for Human Use requests that healthcare professionals report any suspicions they may have of adverse effects – serious and non-serious – with ▼ medicines, even when there is some doubt about causality.

Healthcare professionals are encouraged to report all adverse effects that they consider medically significant, even if they do not meet the abovementioned criteria.

The causality between the suspected medicine and the adverse effect should not necessarily be established to report.

PatientsPatients experiencing an adverse effect after taking a medicine are recommended to contact their doctor, pharmacist or dentist who will fill in the reporting form.

Marketing authorisation holdersMarketing authorisation holders who are informed about a serious adverse effect by healthcare professionals, investigators for clinical trials or scientific publications, must report this to the Belgian Centre for Pharmacovigilance for Medicines for Human Use within 15 days of receipt of the information. In this context, a ‘serious adverse effect’ is defined as an adverse effect that:            

  • causes hospitalisation or prolongation of hospitalisation;
  • is life-threatening;
  • causes death;
  • leads to permanent or significant disability or inability to work; and
  • causes a congenital disorder or malformation.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

Pharmacovigilance data may include:

  • information that identifies a patient and the reporter; and
  • personal data about the patient (eg, sensitive personal data and contact details).

Although the EU General Data Protection Regulation (GDPR) considers obtaining a data subject’s consent before processing as the fundamental basis of data protection law, there are legal grounds other than consent for processing pharmacovigilance data – principally:

  • Article 6(1)(f): “processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party”; and
  • Article 9(2)(i).

Processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of the quality and safety of healthcare and of medicinal products or medical devices, on the basis of EU law or member state law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subjects (eg, professional secrecy).

Under Article 17(1) of GDPR, a data subject has the right to obtain the erasure of personal data without undue delay from the data controller. However, under Article 17(3)(d), the so-called ‘right to be forgotten’ does not apply if the processing takes place:

For archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) in so far as the right referred to in paragraph 1 is likely to render impossible or seriously impair the achievement of the objectives of that processing.

The general principle of data minimisation and purpose limitation should apply to pharmacovigilance data processing. This type of data should not be processed for any other purpose and should not be held after the data storage period expires. 

As pharmacovigilance data is often transferred across borders, relevant systems must be in place to ensure GDPR compliance relating to international data transfers.

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