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CMS Expert Guide to adverse effects of drugs and vaccines

International
08/03/2022
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The global pandemic has risen a growing awareness of the risks of adverse effects of drugs and vaccines. This unexpected event has put healthcare professionals in a situation whereby the standard protocols have not been appropriate, and medicines that are used under experimental protocols or sometimes off label. Notwithstanding the efficiency of the healthcare systems and the good safety standards, concerns have been raised on the possible adverse effects of medical treatment and, above all, of vaccines used to face the COVID-19 virus.

Patients, healthcare professionals, manufacturers of drugs and vaccines and public authorities have had to face new issues due to the emergency and the spread use of medicines.

In this framework, the law should provide efficient legal means to help patients to seek protection as well as companies involved in the production and marketing of products to address issues that may arise within them. This is also necessary to determine, taking into account the rules applicable to the burden of proof, the roles and responsibilities of the parties involved in developing and authorising a medicine. In this context, some countries have established specific dispute resolution procedures in order to provide an efficient and fair judgment.

For these reasons, this Expert Guide provides an overview of the roles and responsibilities of some of the entities involved in the production, marketing and administration of medicines, exploring the conditions necessary to determine if a damage occurred and the extent of each entity's responsibility. The Expert Guide also provides specific insights into vaccines, insurance issues, and the procedural specifics of handling medication injury cases.

Click here to access the guide.

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