March 7th 2017
Population Screening Act:  essential terms  explained

Certain forms of population screening have to be licensed by the Minister of Health, Welfare and Sport. This applies, for instance, to population screening for ‘serious diseases or defects for which no treatment or prevention exists’. But what is meant exactly by the term ‘serious untreatable disease’? And when is there an ‘offer’ of population screening’? That is what this advisory report is about.

Summary

In order to protect people from population screening that may be harmful to their health, certain types of population screening are subject to licensing. This is provided for in the Population Screening Act (Wet op het bevolkingsonderzoek or WBO). There is uncertainty about the interpretation of some terms used in this Act. This concerns primarily the scope of the term ‘offer’ (decisive for the question as to whether it is a population screening) and of the criterion ‘serious diseases or defects for which no treatment or prevention exists’ (decisive for the question as to whether a licence is required). In this advisory report the Committee on Population Screening of the Health Council of the Netherlands examines how these terms have been interpreted to date, and the limitations of that interpretation. Moreover, it makes recommendations on the text and the associated notes for the revision of the Act. The Committee bases its advice on the legislative history and previous advisory reports issued by the Health Council.

According to the Committee, the term ‘offer’ must be given a wide interpretation. There is an offer of population screening when people are invited or encouraged by a health care provider or other type of provider to take part in medical screening for diseases or defects (or risk indicators for the same) while they do not have an actual treatment demand or medical indication. The same goes for individuals taking the final initiative (e.g. after reading an advert for a so-called total body scan).

There is also an offer of population screening if the detection does not focus on a specific condition (unspecified screening) or if candidates are pre-selected on the basis of for example a questionnaire, an interview or the measurement of physical aspects such as weight or length (graduated screening). Where the offer of a population screening ends and becomes a diagnostic process depends on the purpose, and the way the population screening is structured and organized.

From a legal point of view, the licensing criterion in the WBO, namely ‘serious diseases or defects for which no treatment or prevention exists’, is an all or nothing criterion. Given the purpose of the Act of protecting people, the Committee advises against too easily assuming that a condition can be treated. When in doubt, the qualification ‘treatable or untreatable’ should be based on the scientific knowledge of the anticipated favourable effect on the clinical result of the treatments available for a particular condition. When assessing the licensing criterion ‘serious diseases or defects for which no treatment or prevention exists’, the seriousness of the condition and the severity of the consequences of the condition play an important role as well. After all, according to the Act a licence is only required when a condition that is both untreatable and unpreventable is also serious.

The Committee recommends that the Minister, when revising the WBO, make clear in the Act itself or in the accompanying notes that both unspecified screening and graduated screening are covered by the term ‘offer’ as defined in the Act. Moreover, it recommends that the Minister include a text in the notes that, when in doubt, a condition should not be too easily qualified as ‘treatable’. A licence is only required when diseases that are untreatable and unpreventable may be serious or may have severe consequences. Moreover, it wants the Minister to consider giving a wider and more explicit interpretation of the criterion ‘serious', when necessary in the text of the Act, than in the current text of the Act and the accompanying notes. A condition can also be serious because of the invasiveness of the options available, like terminating a pregnancy.