The Supreme Audit Office (NIK) warns that samples taken from patients for genetic testing are sent to laboratories abroad, including outside the EU, often without patients’ knowledge or consent. The state does not know the scale of the phenomenon, and access to genetic counselling clinics has worsened.
Who and what was audited
NIK published the audit results on Thursday, 22 October. The audit covered the Ministry of Health and 13 healthcare entities with genetic laboratories that, in 2022–2025, performed tests financed by the National Health Fund (NFZ). According to media reports citing the report, tests in the audited facilities met quality requirements. Concerns relate to supervision, data protection and availability of consultations.
Samples abroad, scale unknown
A Polish laboratory address on a result does not mean the entire analysis was performed in Poland. A facility may commission reading of the material to a foreign subcontractor, and then interpret the data itself and issue the result to the patient. According to NIK, material is sent to other countries, including non-EU ones, often without patients’ knowledge or consent. The audit notes that some foreign laboratories create their own databases from the material they receive.
From January 2022 to 30 September 2025, the President of NFZ issued 86 decisions concerning genetic testing abroad. However, NIK assesses that such tests are many times more numerous, as some facilities commission them without the Fund’s knowledge. As „Rzeczpospolita” reports, citing „Gazeta Wyborcza”, one company commissioned 337 whole-exome sequencing (WES) tests from a German entity in 2023–2025, which were billed to NFZ. The report does not give the number of patients whose samples were sent without their knowledge.
Genetic data is a special category of data under the GDPR. It can reveal health predispositions of the patient’s relatives as well. The diagnostician signing the result will not verify the stages performed abroad, so according to NIK, the risk of erroneous results and inappropriate clinical decisions is growing.
No registry and queues for clinics
Due to the lack of a mandatory registry of laboratories, the Ministry of Health does not know the number of tests, laboratories, clinics or biobanks. According to reports on the audit, during the period examined the ministry did not inspect entities performing such tests. A comprehensive law on genetic testing still does not exist; according to rp.pl, the first assumptions were drafted in 2013 (some media give 2017).
Access to consultations has also worsened. For urgent cases, the average waiting time rose from 48 days in 2022 to 124 days in 2025. For stable cases, it rose from 115 to 223 days. According to media citing NIK, the longest waits are in Lesser Poland (488 days) and Silesia (456 days).
What NIK wants
The Chamber recommends that the health minister urgently prepare a law. It should include a mandatory registry of entities performing tests, linking testing with counselling, quality standards (ISO 15189 standard), and supervision of sending material abroad. The ministry explains that it is still working on the regulations.
What it means for patients
Today, patients have no guarantee of information about where their sample will go. Before a test, including one financed by NFZ, they can ask the facility whether the analysis or part of it will be performed outside Poland, who processes the data and how long it is stored. They can also request information from the data controller under the GDPR. No date for enacting the law has been given.
