May additional discoveries be reported to someone who requests Preventive Health Screening themselves?
Foundation for Client Interests in Preventive Health Research (SCPG) believes that every citizen, who consciously and voluntarily chooses preventive health research, should have the right to learn all research results without sharing them with third parties. However, the new Population Screening Act, which is likely to take effect Jan. 1, 2022, states that, in principle, a doctor at a company engaged in preventive health screening may not tell the client that something bad has been found. This is also known as a collateral finding. Lilian Ploumen (PVDA) is submitting an amendment...
What is the SCPG?
The SCPG has noted that preventive health screening is still a very limited part of mainstream health care provision. The foundation's goal is to keep the way open for citizens to quality preventive health screening, with respect to choice, accessibility, acquisition and ownership of the results of preventive health screening. Every citizen has the fundamental right to take charge of his own life. SCPG focuses in particular on the draft bill of the Population Screening Act, which contains elements that do not correspond to the objectives of the Foundation.
Citizens must have the right to decide on their own research results
The Foundation for Patient Interests in Preventive Health Research believes that every citizen should have the right to be informed of all test results, without these being shared with third parties. This also applies to those who consciously and voluntarily choose preventive health screening, and of course also if this person receives a result of a finding that was not consciously sought. This is also referred to as a 'secondary finding'.
Doctors are not allowed to tell what they have accidentally discovered
The first version of the bill already stipulated that a screening doctor may only report such a side finding to the client if the doctor would have a conscientious objection if he/she did not report it. We considered this to be an illogical phrase, knowing that the client has consciously opted for preventive screening. The current (and new) guideline 'Preventive medical testing' rightly stipulates that all agreements between the doctor (screening company) and the client should be fully recorded in advance, including the reporting of a secondary finding.
However, the State Secretary has now submitted an amendment to the bill to the House of Representatives that will allow the Health Care Inspectorate to gain full insight into the results of the screening process. This is despite the written agreement between doctor and client, despite the strict privacy laws in the Netherlands, and despite the professional secrecy of the doctor. The aim is clear: if the Inspectorate (i.e. the government) believes that the doctor has wrongly reported a secondary finding, the doctor will be fined for this, or worse. The result will be that physicians will probably never report these ancillary findings again. Obviously, this cannot be allowed to happen.
It's all the stranger when we consider that doctors at a commercial/professional screening organization usually do this part time. For example 2 days a week. The other days the doctor usually works at a regular hospital. The twist is that the doctor is legally obligated to report all results of a regular examination in a hospital to the patient, expected and unexpected findings. This means that the same doctor would be acting incorrectly if he/she failed to report a secondary finding. We will make every effort to prevent this unwarranted interference by the government. In this context, we will once again report our views to the members of the standing committee of the Ministry of Health, Welfare and Sport.
New guideline Preventive Medical Examination
The Stichting Cliëntenbelangen Preventief Gezondheidsonderzoek (Foundation for Client Interests in Preventive Health Research) is taking part in the sounding board group for the preparation of a new guideline on preventive health research. They will also express their views there.
The State Secretary has recently amended a number of aspects of the draft Act and has submitted the new version to the Council of State for its opinion. The expectation is that the law will be ready for decision-making next spring. It looks like the Population Screening Act will enter into force on 1 January 2022. At least.... if everything goes according to plan. Now that the government is outgoing, it remains to be seen whether this schedule will be met.
The Stichting Cliëntenbelangen Perventief Gezondheidsonderzoek will try as actively as possible to steer the law in the right direction.
Amendment by Ploumen
Fortunately, the Foundation for Patient Interests in Pervasive Health Research is not alone in this opinion. Herewith the complete amendment with Explanation that member of Parliament Mrs. Ploumen has submitted in January 2021, which also touches this topic.
Section IV(A)(2) amends section 9a proposed by subsection G as follows:
1. In the first paragraph the word "not" shall be deleted, after "data subject" insert "or his general practitioner" and "unless this is necessary in view of the disadvantage that may result for the data subject or others from not reporting" shall be replaced by "unless data subject has indicated that he does not wish to receive information, as referred to in Section 449 of Book 7 of the Netherlands Civil Code".
2. In subsection (2), the word "not" shall be deleted and after "person concerned" insert "or his general practitioner".
Note
This amendment is aimed at ensuring that any additional findings from population screening that may point to serious conditions are reported to the person concerned or their GP, so that follow-up testing is possible. The bill currently states that the provider only has to report findings for which a licence has been granted. This means that when an X-ray specialist sees in a woman's mammogram during a population screening for breast cancer that there are enlarged lymph nodes or that an implant has ruptured or is leaking, so that the woman is at risk of the serious disease ALCL (anaplastic large cell lymphoma), he/she need not report this because he/she only has a licence to screen for breast cancer. Of course, there is a risk that a woman will be wrongly alarmed when she has to go to her GP for follow-up screening. But with sufficient good information, the petitioner considers women capable of making up their own minds about whether to undergo follow-up screening. All the more so since failure to report adverse findings may have serious consequences.
Ploumen