Adverse reaction reports received from the Danish Patient Compensation Association

14 July 2017

The marketing authorisation holder of a medicinal product shall not submit reports to the Danish Medicines Agency about any adverse reactions appearing from decisions about compensation for medicinal injuries, which the company has received from the Danish Patient Compensation Association.

Section 6(1) and (2) of the Danish executive order no. 898 of 23 June 2016 on the monitoring of adverse reactions from medicinal products stipulate that the marketing authorisation holder must submit reports to the Danish Medicines Agency of any suspected adverse reactions seen in Denmark which are reported to the company by a healthcare professional, a patient, a relative, or of which the marketing authorisation holder can reasonably be expected to have knowledge from scientific literature or safety studies.

The provision does not impose an obligation to report adverse reactions appearing from the Patient Compensation Association’s decisions about compensation for medicinal injuries of which the Patient Compensation Association informs the marketing authorisation holder in accordance with section 3(2) of the Danish executive order no. 428 of 9 May 2011 on the administration of cases about compensation for medicinal injuries.

The Patient Compensation Association submits decisions, in which the Patient Compensation Association has determined that the injured person is entitled to compensation or reimbursement, to the marketing authorisation holder. These decisions are also submitted to the Danish Ministry of Health as the Patient Compensation Association hereby makes a statement to the ministry about the Danish state’s opportunity to seek recourse pursuant to the Danish Product Liability Act. The marketing authorisation holder must be informed of the Patient Compensation Association’s decision about compensation since the Danish state may subsequently decide to bring an action for damages for product liability against the company. To the extent to which the Danish state pays compensation for medicinal injuries pursuant to the Danish Act on the right to complain and receive compensation within the health service, the Danish Ministry of Health will be subrogated to the patient’s claim against pharmaceutical producers and middlemen pursuant to the Danish Product Liability Act, see section 53(1) of the Danish Act on the right to complain and receive compensation within health service.

The Patient Compensation Association sends a copy of all decisions in cases about compensation for medicinal injuries to the Danish Medicines Agency, see section 3(1) of the Danish executive order on the administration of cases about compensation for medicinal injuries. The Danish Medicines Agency receives the decisions to ensure that any information about adverse reactions is registered and forms part of the monitoring of the safety of medicinal products.

The Danish Medicines Agency is responsible for ensuring that any information about adverse reactions received from the Patient Compensation Association is registered and sent to the relevant marketing authorisation holders and the European Medicines Agency (the EudraVigilance database). This will also apply after 22 November 2017 as the Danish Medicines Agency will register information about adverse reactions received from the Patient Compensation Association and shall only send the information to the EudraVigilance database operated by the European Medicines Agency.

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