Industry may be 'unrealistic' on meeting serialisation mandates

Concerns are growing that pharmaceutical and biotech companies will not be ready for when serialisation requirements come into force, a new report reveals.

According to Pharma IQ's Pharmaceutical Serialisation and Traceability 2016 report, 25.7 per cent of participants said their organisation has started serialisation rollout across multiple sites, while 13.5 per cent had fully implemented their approach.

But 20.3 per cent were only in the early planning phases, and 5.4 per cent had not yet started thinking about serialisation, down from 15 per cent in the prior survey.

Furthermore, 33 per cent of this year's participants don't know how many packaging lines they would need to upgrade in response to serialisation, though 36 per cent believed it would be less than 10. Meanwhile, almost a quarter (23 per cent) noted they didn't know what sort of budget they would need to implement and complete their serialisation approach.

Thirty-one percent of participants were most concerned about the challenges presented by the Asian market, while Europe and the US were seen as the least challenging (17.3 per cent and 20.7 per cent respectively) because of their harmonised approach.

"However, even with the harmonised approach and added clarity within the US and EU, the road to full compliance in these regions is highly pressured due to their time constraints," the report said.

For instance, the EU Falsified Medicine's Directive requires manufacturers to adhere to requirements by 9 February 2019, while the next level of the US DSCSA is due to come into force in late 2017.

According to respondents, 60 per cent believed the timeframe for the EU FMD was enough time for companies – but only just. Twelve percent disagreed it was ample time.

"The late adopters who have evaded until now are going to be critically reliant on excellence in project execution to get their programmes in place and delivered on time. Any implementation programme that is being initiated now faces a daunting amount of complex capability that must be delivered in a very short time with little or no opportunity to practice before the deadline hits," it said.

Mark Davidson of Bluesphere Health is concerned that vendors will be stretched too thinly over the coming years as they service companies that were slow to react to the mandates, and this may push prices up.

"Almost everyone thinks they will be fully ready within 24 months, which seems optimistic bordering on unrealistic," Davidson said. "I expect that latecomers and smaller companies will need to use less experienced vendors to get the job done. These might perhaps include new entrants with IT skills and expertise coming from outside pharma."

Meanwhile, the report also noted that fewer pharmaceutical employees feel confident their companies have a clear and robust roadmap for global serialisation compared with last year. Sixty-nine percent said their company was opting for a global approach to implementing serialisation, compared with 73 per cent last year.

According to the report, the vast majority of these companies with a distinct plan – generally the larger firms – are being proactive and aggressive in their roll-out of global programmes by building an agile future-proofed infrastructure that incorporates global regulatory requirements, focusing on cost, risk and time efficiency to ensure current and future competitive advantage. This is instead of a more incremental and localised approach.

"So many factors play into planning and strategy for [global serialisation]. First, global compliance is fluid. Countries are continuously changing laws while trading partners also change their strategies… Bottom line is that whether you should take a passive or an active approach to global compliance depends on your organisation's unique needs," said Jim Cummings, vice president of Advents (Americas), one of the report's partners.

This is the third annual Pharma IQ serialization report. The data in this year's report was collected between April and June 2016 covering big pharma and SMEs.