Frequently Asked Questions

Research falls under the WMO if the following two conditions are met:

• there is medical research;

and

• the test subjects are subjected to extra actions in relation to the standard of care process, and / or a test behavior is imposed on the test subject (e.g. assignment to a specific treatment based on randomization).

All medical studies and investigations that do not fall under the “WMO” Act can be classified as nWMO investigations. For example, observational (non-interventional) research, retrospective database research, non-direct patient-related research (e.g. research from a biobank).

The Assessment Framework currently only applies to (medical scientific) nWMO studies that are initiated and / or financed by pharmaceutical companies. Pharmaco-economic research with a view to the (continuation of) financing of medicines also does not need to be tested.

No, unfortunately this misinterpretation is often used in the media. Phase IV describes drug research that is conducted within registered indication for the drug. Phase IV research can fall under the WMO (if it meets the two criteria from question 1) or outside the WMO.

However, all phase 1, phase 2 and phase 3 studies are by definition subject to WMO.

Studies that fall under the WMO must meet all the requirements set by the Wet Medisch-wetenschappelijk Onderzoek bij Mensen WMO (Medical Research involving Human Subjects Act). In the case of drug research, these are also the quality requirements of Good Clinical Practice (GCP). For studies that do not meet the conditions for research subject to WMO (see above), there are limited legal quality requirements (the most important of which can be found in the Kwaliteitswet Zorginstellingen (Healthcare Institutions Quality Act) and the Wet op de Geneeskundige Behandelovereenkomst (Medical Treatment Agreement Act). In addition, there are the Gedragscodes Goed Gedrag (Gezondheidsonderzoek) en Goed Gebruik (Good Conduct Codes of Conduct ( Health research) and Good Use), on the basis of which the relevant field parties guarantee the integrity and quality of research through self-regulation.

Every research (WMO or nWMO) seeks to answer a scientifically valid question. In the past, some nWMO investigations have been the subject of negative publicity. This concerned studies that were later known to be primarily intended as a marketing tool for the pharmaceutical industry (so-called “seeding trials”). The research-oriented pharmaceutical industry also believes that such research should not be able to take place and is of the opinion that nWMO research must meet objective testing criteria. That is why these companies have contributed to the development of the Assessment Framework for nWMO research. With this Assessment Framework, healthcare providers are guaranteed that research that does not fall under the WMO has also passed the test of relevance, quality, feasibility and the chance of implementation. It has also been tested whether the research complies with the rules for drug advertising and therefore does not involve any undesirable influence on prescription behavior.

Finally, many nWMO studies are aimed at mapping the effects of medical interventions in daily practice (note: such studies are not necessarily nWMO studies, see Question 2). Certainly, with regard to more expensive medicines, it is nowadays often subject to a “provisional reimbursement” regime. During the provisional reimbursement period, the effect of the medication in daily practice will be determined in order to determine whether the provisional reimbursement should be converted into a definitive reimbursement. Because of the availability of resources, (mainly because of their optimal application), it is important for healthcare providers to cooperate in the research.

See question 5.

On the Review page.

Pharmaceutical companies that initiate and / or finance (medical scientific) nWMO studies must submit the study to the DCRF for review.

Previously, this was an obligation based on the self-regulation of the stichting Code Geneesmiddelenreclame (CGR). Since 1 January 2015, the CGR has embraced the Assessment Framework for such reviews and the assessment is performed by expert nWMO Advisory Committees. Until July 1, 2015, the companies that had an approved Standard Operating Procedure (SOP) regarding CGR standards were exempted from the mandatory preventive assessment. Since 1 July 2015, the approval of these SOPs has expired and all individual nWMO studies must be reviewed.

There is currently no legal obligation.

Pharmaceutical companies are obliged, as agreed in the covenant for testing nWMO research, to have such studies tested through the Assessment Framework (see also “Handbook” and “Review”. See also question 16.

Investigations commissioned by ZIN, that use the collected data to complete predictive models, so-called pharmacoeconomic studies, do not yet fall within the scope of the Assessment Framework (see also question 2).

Nonetheless, these investigations must meet the standards for reimbursement and personal data protection (see “Standards”). It is also possible that such studies are subject to WMO and should in that case be submitted to a certified METC for assessment.

Patient registries that are set up and / or financed by the (pharmaceutical) industry must be reviewed. Please note: if patients are subject to extra testing or actions compared to standard of care within patient registries, the registry could be fall under the WMO (see Question 2).

From a technical point of view, conducting retrospective research on body materials falls outside the scope of the WMO. Pharmaceutical companies that want to conduct such a study should use the Assessment Framework for this, on the same basis as stated under question 16.

In addition, however, it is common practice that any research that requires material from a biobank is assessed by an ethical review committee. Companies are therefore advised to contact the ethics review committee in these cases.

Yes, all (medical scientific) drug studies set up by pharmaceutical companies that do not fall under the WMO must be tested through the nWMO Assessment Framework. This does not include market research that does not monitor the use of medicines by individual patients, but the position and possibilities for using a medicine in the market. Pharmaco-economic research commissioned by ZIN with a view to the (continuation of) financing of medicines is still outside the scope of the Assessment Framework. Nonetheless, these investigations must meet the standards for reimbursement and personal data protection (see “Standards”).