All of us take medicines, either occasionally or on a regular basis. As such, we might all suffer from an adverse event or from the side effects provoked by pharmaceutical products, even when they have been on the market for years. Some rare adverse events can be extremely severe and seriously harm patients in the long run (for instance Stevens-Johnson syndrome, which can be caused by a variety of very common medicines, such as antibiotics and over-the-counter anti-inflammatory drugs).
Nevertheless, victims of adverse events in Europe are helpless and cannot get compensation from the producers of the medicines responsible for the damage they suffer. This is the paradox created by an EU directive concerning liability for defective products (Directive 85/374/EEC). This text sets up a regime of strict liability of the producers for a broad range of goods, including pharmaceuticals, medical devices and all health products. It was adopted in 1985, following major scandals over pharmaceuticals and blood product safety in the EU, and was originally planned to protect consumers’ rights.
However, it has proved to be much more favourable to the industry’s interests; it constitutes a true deadlock for patients, whose legal actions are blocked by a number of obstacles (very short time limits; concept of “defect” not adapted to medicines; disproportionate burden of proof due to information asymmetry; etc.). The imbalance of risks and responsibilities between patients and pharmaceutical companies is even more pertinent with the trend towards early access to medicines, as the safety profile of these drugs is based on limited data and implies higher potential risks of severe adverse events. Victims of adverse incidents involving implantable medical devices, which undergo less stringent safety controls than pharmaceuticals (CE marking instead of market authorisation), also struggle to get compensation.
In short, the EU directive not only failed to enforce the fundamental right of victims to get compensation, it also decreased their chances to obtain damages in court as it replaced more favourable pre-existing liability regimes in most EU countries.
France Assos Santé wants patients’ rights and safety to come first, overriding any industry interest. That is why we advocate for a substantial revision of the directive and for the creation of a European liability regime that would actually protect patients, making it easier for them to obtain compensation from producers. That is the message we bring to the EU expert group that was created by the European Commission in May last year to interpret and evaluate the liability directive.
If you want to know more about the liability directive and the expert group’s work, or if you are willing to share your experience as victims of adverse reaction or incident relating to pharmaceuticals and other health products, please contact Charlotte Roffiaen and Sophie Le Pallec.
If you have a view as to what action, if any, EPF should take on this matter, please contact firstname.lastname@example.org.
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