The EU IVD Regulation

For more than a decade, GeneWatch UK has exposed companies making misleading claims about genetic test results (see Genes and marketing). Academics and the US Government Accountability Office (GAO) have also found many companies making misleading claims about genetic test results and people's risk of future illness. The EU's new draft IVD (In-Vitro Diagnostics) Regulation is supposed to regulate medical tests, including genetic tests. In October 2015, this Regulation entered "trialogue" (negotiations between the EU's Council, Commission and Parliament) to agree a final version of the text.

The proposed EU Regulation includes genetic tests used to predict future illness or drug response in its scope, including computer algorithms that combine multiple genetic and non-genetic factors to make personalised risk predictions. The proposed Regulation requires companies to provide information on some important characteristics of their tests, such as their predictive value. However, in the first version of the regulation, developed by the European Commission, there was no requirement for the "notified bodies" which will act as regulators to check any of this information, or to publish the evidence behind the claims. This meant that companies could use "black box" computer algorithms to predict risk without clinicians, patients or independent scientists being able to check any of their claims, making the regulation effectively meaningless. Proposed amendments made by the European Parliament's ENVI committee have since considerably improved transparency, so that summaries of evidence will have to be published, and the full dossiers will be made available on request. In September 2015, the EU Council strengthened oversight of the dossiers, although the Council's version of the text also omitted some of the improvements requested by the European Parliament.

Another proposed improvement made by the ENVI committee to the draft regulation is that tests marketed with a recommendation to take a particular drug depending on the outcome of the test (known as "companion diagnostics") will require companies to supply evidence that the combination of the test and the drug improves health outcomes. However, this proposal is not included in either the Council or the Commission versions of the text.

The proposed Regulation is an important step forward in improving oversight of genetic tests. However, it remains unclear how much scrutiny the evidence submitted by commercial companies will get before tests are placed on the market. Notified bodies will be appointed by each EU member state and companies can choose to terminate a contract with a notified body and choose another one at any time.

Although some European countries restrict Direct to Consumer (DTC) sales of genetic tests, requiring oversight by doctors, there is debate about whether or not to include similar restrictions in the Regulation.


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