THE CIVIL LIABILITY OF ENTITIES CONDUCTING MEDICAL ACTIVITIES FOR DAMAGES CAUSED BY MEDICINAL PRODUCTS AND MEDICAL DEVICES UNDER POLISH LAW
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Polish regulations provide a variety of mechanisms of liability for damages caused by medicinal products and medical devices, including a fundamentally significant mechanism – civil liability. Such a liability may assumed by different categories of entities, including their producers, trading entities or entities conducting medicinal activities and using medicinal products/ medical devices under the subject’s activities. The civil liability regime of entities conducting medicinal activities is conditional upon the formal and legal status of the entity conducting medicinal activities and the relationship binding them with a patient on the basis of tortious and contractual principles. Statutory obligations to apply such liability regimes may frequently prevent (or even inhibit) the rectification of damage caused by medicinal products and medical devices, which gives rise to proposals to modify the general principles of liability and seeks solutions to provide an optimal system of compensation for such damages.
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