The new normal: What's influencing serialisation
Jean-Marie Aulnette, VP EMEA sales, TraceLink, discusses the three influencers shaping the new norm in serialisation.
The pharmaceutical industry now has the power to stamp out counterfeit drugs from entering the global supply chain, an initiative that is collaboratively supported by drug manufacturers, distributors, dispensers, and governments around the world. Track and trace provides full transparency as medicines move from manufacturer to dispenser to patient. It eliminates medicines unfit for distribution and ensures patient safety. But without the right strategy and mindset, it also creates the type of challenges that can sink a company doing business in global markets.
By the year 2020, drug serialisation and traceability regulations will cover more than 80 percent of the global drug supply across more than 50 countries. Before long, track and trace will be baked into the DNA of every successful company producing, distributing, or dispensing prescription medicines. Companies who look at track and trace as just another project to tick off, or choose a compliance solution merely for expediency sake, won’t adequately evolve their DNA and put their business at risk.
Building a track and trace roadmap for success requires looking at three critical influencers: the constant evolution of global regulations, standards, and business processes; supply chain compliance as “business-as-usual;” and strong collaboration among supply partners. Let’s take a look at each one.
Regulations: Continuous evolution
Expect ongoing developments in global track and trace regulations to be the norm over the next decade. In the last year alone, the EU, the US, China, Brazil, and every other market that has embarked on track and trace to date have implemented changes to their regulatory requirements. To be successful, you’ve got to incorporate agility into your company’s operational infrastructure. Preparing for change starts with deploying a solution that is purpose-built for pharmaceutical supply chain compliance, and provides built-in flexibility when changes occur. If your solution can’t easily adapt to change, you’ll face unpredictable customisation and IT services costs, and a much higher total cost of ownership. With a track and trace architecture that accommodates ever-evolving laws, you can buffer your enterprise from continual churn and high cost.
Compliance: Business as usual
Plan to integrate serialisation into and across your organisation. Track and trace will revolutionise standard operating procedures, affecting business areas that may never have been linked in the past. Your company needs to be track and trace enabled in obvious areas, like IT and Manufacturing, but also in Supply Planning and Customer Service. With compliance as a critical component of your operational strategy, assess how prepared you are to overhaul your traditional operating procedures for complete track and trace implementation. Where will a track and trace program live within your organisation? How will track and trace become an efficient and effective component of product delivery, and an enabler to your long-term success? Find out the answers now, before it’s too late.
Supply partners: collaboration is the key
Pharmaceutical businesses across the supply chain depend on one other. The 2016 Global Drug Supply, Safety and Traceability Report revealed that in addition to achieving their own individual goals, companies often have demands that they expect trade partners to meet. More than 50 percent of those surveyed about lot-level requirements for the US Drug Supply Chain & Security Act (DSCSA) noted that they wanted suppliers and customers to make system changes suited to their company’s needs. Any company preparing for serialisation must consider how the lack of standards around data formats and exchange will open the door for customers and suppliers to make demands. Without a collaborative solution in place, accommodating these requests will magnify the burden of achieving compliance.
Now is the time to ask: How will my company adapt in an environment of continuous change, and are we prepared to handle evolving laws and business requirements? Do we have enough in-house expertise and resources to manage these changes, or should we partner with a provider that specialises solely in track and trace compliance for the life sciences? As we forecast our budget for track and trace, will our costs be predictable annually, or should we expect there to be hidden costs for customisation and change orders if we have to make modifications? How do we work effectively with our trading partners to ensure uninterrupted product flow?
Those who understand the complexities of today’s supply chain, embrace interoperability, and proactively evolve their DNA in an environment of continuous change will set themselves up for success. Those who do not are likely to miss regulatory deadlines and delay the flow of critical medicines to key markets, putting both business performance and patients’ lives at unnecessary risk.