Worries about increasing regulatory scrutiny and penalties top the list of API and drugmaker concerns about supply chains according to a survey by contract distributor UPS.
The firm – which provides distribution services and competes with DHL, TNT, Marken and World Courier – quizzed 375 pharma industry executives for their thoughts on the global drug supply chain in its “Pain in the chain” survey and found that – for the second year running – compliance issues were the major headache.
UPS spokesman Dan Ganon told Outsourcing-pharma.com that regulatory actions on both sides of the Atlantic are changing how the pharmaceutical industry operates.
“FDA seizures and injunctions have increased over 25 per cent per year since 2008, and warning letter issuance is up over 51 per cent per year on average. A similar trend is occurring in Europe as concerns regarding counterfeit medicines continue to grow. Increased regulatory scrutiny is one factor driving attentive focus on compliance throughout the supply chain.”
Respondents also voiced concerns about the pace of change, the regular introduction of new laws impacting supply chains and the inconsistency with which they are applied as an issue, according to Ganon.
“[The] survey sheds some light on the specific areas of regulation that are top of mind with respondents by looking at focus areas on which respondent systems investments have been focused, and the barriers to growth they cite – track and trace, transaction reporting, order verification and validation, international trade regulations, and product quality requirements.”
It's the stupid economy
The other major regulatory worry raised by survey participants is the negative impact the economic climate is having on government level reimbursement decisions.
“A third factor which is increasingly cited by healthcare supply chain managers is the importance of regulatory compliance in order to be reimbursed, as governmental organizations continue to grow in importance in the payor side of the equation.
“In these difficult times, governments have taken, or are considering, austerity measures. This is forcing companies to cut costs, especially from their supply chains.”
Theft of APIs and drug products is also an issue for pharmaceutical supply chain managers according to the survey, with some 57 per cent of respondents citing security measures as an area of focus.
“Theft deterrence has taken on increased importance as an increasing number of controlled substances and higher value products have entered the market. Freightwatch and other leading security analysts have reported on increased targeting of pharmaceutical shipments, and high profile distribution facility break-ins have increased attention in this arena.
“At the same time the World Health Organization has reported that counterfeit pharmaceuticals cost the industry approximately $46B a year, so this is a significant global focus for manufacturers.”