Pharmacovigilance Agreements: Negotiating Safety Data Exchange Timelines: To Agree to Disagree? That is the Question

Abstract

Pharmaceutical companies often enter into contractual arrangements with other companies to advance the development or expand patient access of licensed medicines. These partnerships include specific agreements detailing the exchange of safety-related data between the companies. Such agreements are used to fulfil regulatory reporting obligations, thereby ensuring timely awareness of potential safety considerations and formal maintenance of clinical trial applications and marketing authorisations. The authors conducted potentially the first benchmarking survey of contracts covering safety data exchange within the pharmaceutical industry. Data were analysed to establish the most common types of safety data exchanged, and the associated data exchange timelines. These data may provide an opportunity for companies to assess how their own timelines compare with others, and to consider whether there are actions they may take that could potentially improve negotiation and procedural efficiency. Ninety percent of the recipients responded to the survey, providing information from 378 individual contracts which included data from clinical trials and from postmarketing sources. Results showed less variability in the safety data exchange timelines of clinical trial ICSRs compared to the timelines of postmarketing ICSRs; these results may reflect greater harmonisation of regulatory reporting requirements for clinical trials. The variability captured in the benchmarking data reflects the challenges that contribute to the complexity of safety data exchange agreements between partner companies. The goal of the survey was to serve as a basis for future research and pursuit of additional insights that foster transparency. The aim was also to encourage the consideration of alternative approaches to address some of the challenges that we identified. Use of technology could facilitate the process of recording, tracking, and monitoring of safety data exchange within a partnership, improve efficiency through real time monitoring, and provide further insights. A proactive approach to developing agreements is essential for improved patient access and to maintain patient safety.

Keywords: Contracts; Data management; Mandatory reporting; Pharmacovigilance; Regulations; Safety data exchange agreements.