Quality and effectiveness of vaccines, medicines and medical laboratories
Quality and effectiveness of vaccines, medicines and medical laboratories
Diseases can only be prevented and treated if the appropriate means are at hand, that is to say, the human or veterinary vaccines, medicines and medical devices that are made available to patients. Sciensano helps the Federal Agency for Medicines and Health Products (FAMHP) to assess these means and ensure their quality, safety and effectiveness.
- We have been designated as National Reference Laboratory for the quality control of registered medicines and compounded drugs. Among them, special attention is paid to the study of illegal and counterfeit medicines and products, whose circulation has intensified with the Internet.
- Our centres of reference and our epidemiologists monitor the effectiveness of treatments and the resistance of pathogens (that is to say agents such as bacteria, germs, etc. that cause disease) to antibiotics.
- In the field of vaccine assessment, Sciensano works on several fronts: in close cooperation with the European authorities and the World Health Organization (WHO), we evaluate and monitor the quality of each batch of vaccines and plasma derivatives prior to their marketing.
- Sciensano evaluates the effects of vaccination in Belgium (including against HPV or human papillomavirus, a common sexually transmitted infection) and, finally, we track the effectiveness of vaccination on diseases that are part of the vaccination schedule (such as measles or mumps).
- Medical laboratories that analyse human samples and deliver a diagnosis are subjected to continuous and stringent monitoring . These laboratories only receive approval from us if they meet strict criteria.
- As is the case for GM food, Sciensano and the Biosafety Advisory Council advise the FAMHP within the context of the biosafety assessment of clinical trial applications involving GMOs in Belgium and applications for the marketing of GM medicinal products at European level.
SOME EXAMPLES OF OUR ACTIONS
Quality control of medical laboratories
Sciensano is responsible for the quality control of medical laboratories in Belgium. In a medical laboratory involved in clinical biology or pathology, samples of human origin are analysed under the responsibility of specialists in the field. These specialists interpret the results of the analyses in order to provide a diagnosis or monitor certain diseases or disorders in the patient. The correct handling of sample material and standardisation of analytical methods are essential in monitoring the quality of the diagnosis and the subsequent treatment. The Federal Public Service Public Health, Food Chain Safety and Environment delegates control of the quality of medical laboratories to Sciensano. An approval may be granted and maintained only if all legal requirements are met. As part of the approval, Sciensano’s missions include conducting inspections. In addition, Sciensano organises an external quality assessment (EQA) for all licensed medical laboratories.
External Quality Assessment
During an external quality assessment, identical samples are sent to all laboratories and the results are subsequently compared and communicated to the laboratories.
We organise a mandatory programme for external quality assessment in various fields of clinical biology and pathology. Our objective assessments are based on robust statistical calculations and aim to continuously improve the quality of laboratory analyses. These assessments also offer them the opportunity to evaluate their own results and compare their methods with those of other laboratories. Due to the rapid development of this field, we adapt our external quality controls continuously and we inspect accredited laboratories by applying innovations in scientific knowledge, methods and technologies.
Medical laboratories, like any laboratory, pet shop, or greenhouse or production facility where pathogens are handled and/or genetically modified (GMO) must also comply with rules on biosafety. Sciensano is the centre of expertise officially recognised by the competent regional authorities in this field to support them in risk assessment and inspection of installations.
Quality control of medical devices for in vitro diagnosis
An “in vitro diagnostic medical device” is a product used to provide, from a sample taken from a patient, highly qualitative medical information:
- concerning a physiological or pathological condition
- concerning a congenital abnormality
- to determine the safety and compatibility with potential recipients
- to monitor therapeutic measures.
Supporting the Federal Agency for Medicines and Health Products (FAMHP) which is the competent authority for the registration of in vitro diagnostic devices (IVD) marketed by Belgian manufacturers and agents, Sciensano can provide expertise in particular in the event of non-compliance of the product or in case of an incident. We can analyse the nature and risk of the problem and check that all corrective actions have been taken and implemented.
Quality control of medicines and vaccines
As a National Reference Laboratory for the control of medicines, we contribute to continuous quality control of medicines and compounded products (medication prescribed by a doctor to his patient and prepared in a pharmacy) and their raw materials. Sciensano evaluates the quality of medicines and especially the health risks related to the consumption of illegal and counterfeit medicines. Indeed, alongside standard medicines that are purchased through the regular channels, counterfeit drugs are also present on the Belgian market. A phenomenon that has snowballed with the boom in Internet use.
In this context, we work with FAMHP inspectors who transmit to us suspect samples found during checks. We analyse them for the presence of impurities or unknown pharmacological compounds that pose a potential risk to the health of users.
Our teams are also responsible for the quality control of vaccines for human and veterinary uses and blood products. We check the compliance of each batch of these biological medicines prior to their marketing. Vaccine quality is controlled in several ways: each production batch of a medicine must have a “passport” that details its specific production process. This passport includes, for example, the specific vaccine strain(s), critical control points, the production schedule with dates and test results. Sciensano is also involved as an expert in these same areas: the assessment of the “quality” aspects of registration applications, inspections of “good practice” in blood transfusion centres, contribution to the drafting of regulations, etc.
At the request of the FAMHP or the European Medicines Agency (EMA), we also perform tests on veterinary vaccines after marketing). Whether medicines, vaccines or products derived from blood, we perform these checks to ensure that the public receives products without any defects.
Effectiveness of vaccines and medicines
By performing their analyses, our experts also assess the effectiveness of medicines and vaccines to fight against infectious diseases. This is the case, for example, for the treatment against tuberculosis. Although TB is seen, rightly, as a disease “of the past”, it remains a major public health problem affecting both men and animals. Around 1150 human cases are detected each year in Belgium and, worldwide, a third of the population carries the pathogen.
As part of the fight against vaccine-preventable diseases, Sciensano follows the evolution of the impact of vaccination on them. We study in particular the effects of vaccination against the human papilloma virus (HPV) in Belgium. HPV is a highly contagious virus that is the most common sexually transmitted infection. Our researchers are responsible for monitoring HPV infections and associated diseases once the vaccine has been approved.