This event was the opportunity to discuss with stakeholders and authorities in EU countries the results of the evaluation of Directive 85/374/EEC on the liability for defective products
The conference began with the presentation by an external contractor of the results concerning the 5 criteria of the evaluation (effectiveness, efficiency, coherence, relevance and EU added-value).
The discussion also covered the findings of the evaluation which explicitly looked at whether the Directive is still fit-for-purpose where new technological developments, such as the Internet of Things and autonomous systems, are concerned.
The presentation was followed by an open discussion on the conclusions.
The representatives of AMALYSTE (French Association of Stevens-Johnson Syndrome Victims), APESAC (French Association of Victims of Valproate) and Les Filles DES Association (French Distilbene victims), speaking on behalf of the French Collective of Victims of Medicines, raised the issue of itemising drugs and the unsuitability of the 3- and 10-year limitation periods. Indeed, considering the non-transparency of clinical trials and the asymmetry of information between patients and firms regarding adverse effects, victims need more than three years after the onset of a serious adverse effect to prove that the product was defective and that it is related to their damage. Victims also need more time as they first need time to recover from the reaction to the drug, which often takes years – for those who survive. Moreover, victims of long-term adverse effects (e.g. Distilben affects subsequent generations) cannot be compensated within the 10-year limitation period following the entry of the drug onto the market, and this is not acceptable. AMALYSTE also explained that the notion of “defective product” is not suitable for drugs because judges consider that the product is not defective when the information about the risk of serious adverse events has been indicated on the leaflet.
Therefore, it is never possible for the victim to demonstrate at the same time both the causality and the defect of a drug in connection with the damage. Either the adverse effect of the medicine is unknown and it is therefore hard to establish the link (causality), or it is known and was therefore published in the leaflet, which means that the medicine was not defective. Furthermore, for the victims of drugs whose leaflet did not indicate the risk when the adverse effect occurred because the risk was unknown, the firm benefits from an exemption of liability for potential risk. This implies that scientific uncertainty results in full responsibility being laid on the patient. The victims associations described the health issues faced by victims due to serious adverse effects of drugs. The French Collective of Victims of Medicines added that the Product Liability Directive does not require partial payment by the producer of the expert assessment costs, which is now entirely the responsibility of the victim, and it does not set a timeframe for compensation. The inadequacy of the directive to make it possible for drugs victims to be compensated for their damages led some countries to set up dedicated compensation funds, e.g. France for Benfluroex. The President of APESAC explained that it was necessary to create a compensation fund for victims of valproate in France in order to circumvent the problem of the 10-year limitation in the directive. These funds are, however, limited to certain drugs, corresponding with the media pressure they trigger and the responsibility of the authorities themselves. Prescrire/Medicines in Europe Forum added that consumers do not choose their medicines, as they are prescribed; and new technologies mean a new medicine can be approved faster, that is, with shorter clinical trials and with fewer trial participants, meaning that some drugs entering the market are less safe. The Product Liability Directive is not adapted to the current situation in the field of medicines where new and emerging legal regimes result in patients not only being deprived of additional protection, but are at risk of losing the protections they previously enjoyed.
French Collective of Victims of Medicines explained that the Product Liability Directive is not suitable when it comes to burden of proof, as expert opinions can amount to 20.000 EUR in costs while victims are already dealing with high medical costs. The producers should be required to cover half of the costs for expert opinions. He also added that a maximum length of court procedure should be agreed, as well as a mechanism that would ensure swift payment of compensation. Les Filles DES Association shared these views.
AMALYSTE claimed that one of the inconsistencies is that while pharmaceuticals are covered by the general “defective product” liability, they are not covered by the General Product Safety regime (in particular the definition of “safe product”) but by a specific safety regime, and this should be adjusted by defining a specific liability regime for drugs. This means that drugs should be removed from the scope of the directive.
AMALYSTE added that the Product Liability Directive and the relevant case law have brought a lot of clarification. However there are still issues with the transposition of the Product Liability Directive, which has resulted in differences in consumer experience in different Member States. In Germany, for instance, the directive does not apply to drugs, and victims benefit from a more favourable national regime. Prescrire/Medicines in Europe Forum agreed that further action is required, especially to restore balance with regard to liability for healthcare products, as currently the absence of producer liability and of compensation for victims of drugs does little to strengthen the safety of medicines in Europe. Strict liability for producers should be introduced as in this case the consumers do not choose their products.