SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner
except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting; and (b) any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country. In addition, healthcare professionals and author - ities who, in the course of their activity, become aware of a serious incident must also notify it to the AEMPS, through the electronic site ena - bled for this purpose, who will transfer it to the manufacturer of the affected product. Patients and users are also allowed to notify serious inci - dents to the AEMPS using the electronic proce - dure enabled for this purpose, without prejudice to the notification they may have made to the manufacturer, another economic agent or the healthcare professional. Food and Nutritional Products In accordance with Article 19 of Regulation No 178/2002, if a food business operator considers or has reasons to believe that any of the food that it has imported, produced, processed, man - ufactured or distributed does not meet the safety requirements, it shall immediately withdraw that food from the market when the food is no longer subject to its immediate control and shall inform the competent authorities thereof. In the event that the product may have reached consum - ers, the operator will effectively and accurately inform consumers of the reasons for its with - drawal. Moreover, if the competent authorities
deem it necessary, the operator will recover the products that have already been supplied to consumers when other measures are not suffi - cient to achieve a high level of health protection. 1.5 Penalties for Breach of Product Safety Obligations The intentional or negligent breach of product safety obligations may be subject to adminis - trative and criminal sanctions. Furthermore, any person responsible for such a breach can be also liable for damages. The most notorious criminal case in this regard was the rapeseed oil case, in which more than 30 industrialists were prosecuted during the late 1980s due to their participation in the com - mercialisation of a supposedly edible oil that was adulterated with rapeseed oil (for industrial use and forbidden for foodstuffs). The rape - seed oil contained a toxic chemical substance that caused the death of more than 300 peo - ple and left more than 25,000 affected. In 1992, the Supreme Court sentenced the industrialists responsible to significant convictions of impris - onment and to payment of the correspondent compensation to the affected persons. Because of the large compensation, some of the convict - ed industrialists became, and were declared, insolvent. As a result, the affected persons started legal proceedings against the Spanish state to also declare its pecuniary responsibility due to the negligence of its officials in the process. The judicial battle ended in 1997 when the Supreme Court sentenced the state as a subsidiary liable party to pay compensation of more than 500 mil - lion pesetas to those affected.
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