Objective: To present information gathered over the years 2017-2019 from current and potential customers including large innovative pharmaceutical companies, orphan drug, and generics companies, on their views of outsourcing pharmacovigilance functions, in particular the EU QPPV role, and the impact of Brexit.

Method: Following decisions on outsourcing pharmacovigilance functions including the EU QPPV role, a questionnaire is sent to companies and/or a personal conversation is scheduled to understand the companies’ reasons why and how the decisions were made. Response rates and answers are analyzed and compared.

Results: The results are currently preliminary and will be finalized by the time of creation of the poster and presentation at the DIA Europe meeting in February 2019. 26 companies in different stages of marketing different medicinal products that were in touch with Syneos Health due to their interest in outsourcing post-marketing pharmacovigilance functions in the EU/EEA, including the EU QPPV role, were asked to provide feedback on their decision what and how to outsource. While the analysis of response rate and answers is still ongoing, the following areas of interest were already identified: all companies considered Brexit an issue for pharmacovigilance outsourcing and wanted to ensure that any future EU QPPV, be it outsourced or in-house, would be based in an EU country outside the UK. Besides this, main issues that companies considered when deciding on outsourcing pharmacovigilance functions were pricing and technological setup. Specifically, the feedback received shows pricing being a higher concern than quality, i.e. companies asked far more questions and spent more time analyzing the budget than the time spent analyzing the service providers’ experience, processes, and track record. A difference here appears to be in the size of the companies: while smaller companies in the process of launching their first product and with no previous experience with pharmacovigilance inspections were primarily concerned about cost, larger companies with products on the market and experience with inspections were more interested in quality and experience of the provider. Finally, the digital setup of the service provider was a primary consideration, with companies being interested in service providers capable of providing cloud-based safety databases as compared to traditional license and local server database models.

Conclusion: While further conclusions may be reached once data analysis is complete, it seems clear from the preliminary results that virtually no company currently outsourcing pharmacovigilance functions is expecting the possibility of an EU QPPV to be able to remain in the UK after Brexit to become a reality. No matter the legal landscape after Brexit, this mindset is certainly having a significant impact on the EU QPPV function as a whole, considering that the majority of EU QPPVs pre-Brexit were based in the UK. The preliminary data also points to pharmacovigilance being regarded primarily as a cost issue in the early stages of marketing a medicinal product, while quality in this area is typically a major consideration in post-inspection phases of marketing. Finally, digital capabilities such as a cloud-based database were identified as a major consideration for outsourcing in pharmacovigilance. With this in mind it seems safe to assume that further developments in this area, such as AI-based pharmacovigilance applications, will become more and more of a consideration as development in this area continues.

Considerations for outsourcing EU QPPV services taking into account the impact of Brexit

DIA Europe 2019

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