Health Council: make NIPT available to all pregnant women
The NIP test must be made widely available to all pregnant women. This adviseert the Health Council to Minister Schippers. If the minister accepts the advice, pregnant women who want to know whether their unborn child has Down, Edwards or Patau syndrome can choose for themselves whether they want to have this tested with the combination test or with the NIP test.
The Non-Invasive Prenatal Test (NIPT) is a relatively new blood test that can detect three types of chromosomal abnormalities in the unborn child. Through a laboratory analysis of the mother's blood, it can be determined whether the DNA of the unborn child has one of the three abnormalities.
NIPT as an alternative
In 2014, a trial with the NIPT was started in the Netherlands, on the advice of the Health Council. The test was then only available for women who, after the combination test, appeared to have an increased risk of having a child with one of those three abnormalities. When the Health Council gave a positive recommendation for a trial, the council could not yet determine whether the NIPT test would also be reliable enough instead of the combination test. In the meantime, more research has been done and the Health Council concludes that the NIPT is also suitable as an alternative to the combination test.
Test tourism
Midwives and hospitals are seeing an increase in demand from pregnant women for the test. And also an increase in the number of pregnant women who go abroad because they are not eligible for the test in the Netherlands. In Germany and Belgium, the NIPT has been available to all pregnant women for some time now.
Prenatal screening
In the Netherlands, approximately 180 thousand babies are born each year. During pregnancy, expectant parents are offered prenatal screening for congenital abnormalities at two points. They decide for themselves whether they want to make use of this. The 20-week ultrasound is reimbursed as standard from the basic insurance, for the combination test a personal contribution applies if there is no medical indication.
The combination test involves a risk assessment of whether a child has one of the three chromosomal abnormalities mentioned. If the risk is increased, the pregnant woman can opt for further testing. Previously, this consisted of an amniocentesis or chorionic villus sampling, in which tissue from the fetus is taken via a needle. A major disadvantage of the latter test is the (small) risk of miscarriage. Since the NIPT has been permitted in research, women can choose the less invasive blood test as an alternative.
Yes, unless
In February it was already announced that a majority of the Lower House wants the test to be available to all pregnant women. Minister Schippers said in March that she aims to have this happen by 1 January 2017, unless the Health Council has major objections.
It turns out that there are none. The Council advises granting the permit for a broader trial with the test, but under four conditions. The information provided to pregnant women must be adjusted, a quality standard must be established, research must be conducted into undesirable side effects and the right not to know must be guaranteed.
Who pays?
How the financing will look like is not yet known. The Council writes that the price for the NIPT as a primary test is not yet known. The committee emphasizes that an important starting point for the prenatal screening program must be that there is equal access. "If women have to pay the costs for the primary test themselves, this can lead to unequal access to prenatal screening."
Ethical and legal
Opponents of the NIP test presented the black book This is Down Syndrome in the House of Representatives in February . They fear that parents will feel pressured not to have a child with Down syndrome born because the test has become widely available.
The Health Council states in its advice that making the NIPT widely available raises various ethical and legal questions. Questions that relate to stigmatisation, safeguarding freedom of choice and informed choice. Since these aspects are important for the entire prenatal screening programme according to the Council, these issues will be addressed in a separate advice.
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