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The global pharmacovigilance market is growing and is still expected to grow. In 2013, post-market safety surveillance accounted for 60% of the global pharmacovigilance market and should reach $6 billion by 2020. Main drivers for increased reporting of adverse drug reactions include compliance requirements and liability resulting from high-profile product failures. Implementation of a reporting system to comply with regulatory requirements for a Phase I study can cost about $100,000, before the first serious adverse event (SAE) even occurs [1]. The reporting system collects and processes tremendous volumes of data in a very cumbersome, laborious, time-consuming and costly manner. For example, recent upgrades of electronic gateways to a new standard (E2B[R3]) forced significant adjustments to databases and made data processing even more time-consuming.

Despite ever-increasing volume of pharmacovigilance data, the amount of actionable information acquired remains very limited. For example, Roche-Genentech failed to identify a safety signal in a pool of 80,000 individual case reports [2].

The unintended and unforeseen consequences of treating pharmacovigilance as a cost center are multiple and varied. Past efforts to transfer data processing to low cost destinations resulted in lower demand and consequently a talent shortage in the U.S. and Western Europe, especially at more senior levels. The lack of investment in pharmacovigilance can result in delays of product market authorization approvals due to inadequately prepared submission documents, or deficiencies in product labeling that may contain information that does not accurately describe the product’s safety profile. Aggressive marketing of approved products to enhance patient access can be counterproductive if the target group generates disproportionately high share of adverse event reports [3].

Pharmacovigilance as an industry is currently at a crossroads. The case collection methods hardly changed for decades. If the industry continues to pursue the existing strategies, the cost of compliance with constantly changing regulations will continue to grow, without adding any benefit in terms of improved patient safety or reduced liability for the market authorization holders. Innovative approaches to pharmacovigilance have the potential to reshape the industry for the better in a variety of areas:

  • Attract and develop talent through thoughtfully designed training, and reshape the field into an attractive, technologically innovative profession with clearly defined mission and purpose
  • Decrease dependence on remote workforce to avoid offshore processing of sensitive patient information.
  • Leverage novel technologies such as data mining, natural language processing, artificial intelligence, blockchain and machine learning to improve data integrity, consistency of assessments and increase efficacy
  • Shift focus from mere compliance to active verification of performance of products in real-life use: improve the quality and granularity of data to produce actionable datapoints.

The current state of play in the pharmacovigilance business resembles a dinosaur that became too big for its current environment. Novel technologies can revolutionize pharmacovigilance and return the field to its original purpose and mission.

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[1] Transparency Market Research, 2014: “Pharmacovigilance Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2014 – 2020”. Transparency Market Research.
[2] Biotechnology Life Science and Industry Magazine, 2017. “Roche does not have to pay US $685 fine”. Biotechnology Life Science and Industry Magazine
[3] Price, John. 2018. “Pharmacovigilance in Crisis: Drug Safety at a Crossroads.” Clinical Therapeutics 40 (5): 790–97. https://doi.org/10.1016/j.clinthera.2018.02.013.

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