Viewpoint: Pharma supply chains need radical surgery

Pharmaceutical supply chains have never been in such turmoil and under such attack from governments and regulators globally. The evidence is stark and mounting. Product counterfeiting, whilst an evil prevalent in many high value industries, has become endemic in pharmaceuticals.

Even more worryingly, however, are the cases where adulterated materials and product have passed through multiple stages in the supply chain without being detected by the quality systems designed to prevent such events.

In response, regulators are demanding tightened controls on the global supply, manufacture, movement and storage of goods intended for human consumption. Stakeholders are joining together to address the many issues involved. Vitally important though this is to prevent possible further death or injury to patients, it is only part of the solution. These issues are symptoms of an underlying pathology borne of a modus operandi that is no longer ‘fit for purpose’. The supply chain patient is sick and in need of treatment.

The message here is that ‘childhood (early-stage product development) neglect’ is the underlying cause of the issues we now see - and this begins at the ‘birth’ of a molecule. Once the patent clock is ticking, no-one wants to stand in the way of the route to regulatory approval or spend too much time designing a proper supply chain.

The underlying pathology

So what goes on in those early days? In the haste to beat the patent clock, drug developers are ‘trained’ to move into human administration as quickly as possible. This often means spending as little time and resource as possible in the precursor stages - where the initial manufacturing methods, suppliers, specifications, contractual agreements and process details are first formed.

This means limited involvement of key stakeholders, such as commercial manufacturing, procurement and marketing. Having done ‘just enough’ to get into the clinic, change inertia does the rest. And of the one in 250 drugs that eventually get approved, the supply chain is wanting in many different ways. We then have to live with excessively multi- staged, heavily outsourced supply chains, with arms length customer-supplier relationships that lead to poor upstream and downstream visibility - providing perfect opportunity for counterfeiters and adulterators to do their worst.

Only a life-style change will do

So what is the solution? Pharma senior executives must start to take their supply chains seriously, as does every other successful industry sector.

These other sectors (such as semiconductor, aerospace, automotives) design, manage and continuously improve their supply chains. They deal with uncertainty of product success by taking maximum time at the earliest stage and use prototypes. They engage the key business players, including suppliers that have strong innovation records. They employ supply chain management competencies throughout the product lifecycle. In other words - THEY DO NOT NEGLECT THEIR SUPPLY CHAINS – and neither should the pharma industry.