Unproven cancer treatments: how gaps in EU law enable fraudulent clinics
Can someone police please?
Recent investigations of journalists in Belgium, Spain, Germany and Austria brought to light an expensive dendritic cell therapy offered to cancer patients at a private clinic in Spain. This treatment is unregulated and unproven, raising an important question.
How is this even possible?
When it comes to cell therapies and other advanced treatments, known as Advanced Therapy Medicinal Products (ATMPs), one should know that, in some cases, doctors can legally give experimental treatments outside of clinical trials. This must be done openly and according to specific rules. These rules are part of a European law called the "hospital exemption", but how these rules are applied can vary from one European country to another.
The European Union has limited power when it comes to stopping health fraud, because, in general, European law allows the EU to support, coordinate, or add to the health policies of individual countries, but not control them. As a result, some questionable clinics can operate across different European countries by exploiting gaps in the regulations.
Doctors have therapeutic freedom
Another factor to consider is the therapeutic freedom of individual doctors. This means that doctors in different European countries have varying levels of freedom to choose treatments based on differences in healthcare systems, laws, medical guidelines, and cultural factors. For example, doctors may prescribe a drug for a condition that it has not been officially approved for (this is called off-label use). However, if something goes wrong, the doctor is legally responsible for that decision.
What can be done?
In conclusion, unless European countries are willing to give more power to the EU to combat health fraud by changing the law, it will remain difficult to properly sanction suspicious clinics in Europe.
If the European Medicines Agency (EMA) were given more authority, like the United States Food and Drug Administration (FDA), it could have more tools to fight fraud. For example, it could issue warnings, stop the sale of dangerous products, impose fines, and even bring criminal charges. This would help protect public health and make sure consumers are not misled by unsafe or ineffective treatments.
