Beyond Reasonable Doubt

Scenarios - Pharmaceutical

In 1999 the Food and Drug Administration (FDA) in the USA mandated a Code of Federal Regulations; Electronic Records and Electronic Signatures (21 CFR Part 11). This lead to the Pharmaceutical industry collaboration known as SAFE-Biopharma where the membership, who compete to bring new drugs to market, cooperated and financed the development of their industry standard for Digital Trust that ALL members would benefit from. Digital Trust was recognised as too important and would require an industry-wide strategy of cooperation as opposed to any pursuit of some competitive advantage – no compete on Digital Trust made perfect sense. Many other sectors can learn and benefit from the many advantages of this approach – standardisation and economies of scale.

All the members each have a vested interest in protecting their highly valuable research in Life Sciences, New Drug Development and highly sensitive clinical trials data. The capital investment commitments (knowledge and financial) made by Pharmaceutical companies is in the 10’s of millions of dollars / pounds annually and often stretches to 10 years and more as they seek FDA approval to bring a new drug to market and accrue a return on investment. In 2004, the Pharmaceutical Research and Manufacturers of American (PhRMA) reported that approximately 40% of all Research and Development costs are attributed to paper based business processes ($9 Billion in the U.S. alone).

In addition to ‘keeping the wrong people out’ of sensitive information repositories, the introduction of the FDA’s Electronic Submissions Gateway (ESG) and the SAFE-Biopharma e-signature standard has served to reduce paper based processing costs and significantly, removal of the latency of paper based processing reduces the time to market. Pharmaceutical R&D investments are recovered over a longer payback period in the patent / licence period of a new drug – e-signatures also make business sense.

The SAFE-Biopharma industry collaboration has been a success in the USA and offers direction to counterparts in the EU and further. However, the new challenge is that next generation of e-signatures adoption will need to embrace our new regulatory environment (GDPR / UK Data Protection Act) that governs the processing of our Personal and Professional Identity Data (PPID).

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