The New Reality in our Supply Chain Requires Collaboration to Combat and Gain the Upper Hand
By Martin VanTrieste
Recent criminal activity involving intentional adulteration of pharmaceutical raw materials for economic gain is rare but requires an increased awareness and diligence to prevent and detect. This new reality, along with the globalization of the supply chain, presents challenges that we have not faced previously and as such requires new approaches to meet these challenges.
Rx-360 is a not-for-profit organization designed to protect patients from situations like intentional adulteration, but it can only be effective if old paradigms are quickly discarded and new ways of thinking are quickly adopted. One such paradigm is the fear of working proactively and collectively to address common problems, especially as it pertains to patient safety. Of course, there are legitimate concerns related to anti-trust and anti-competitive laws and regulations. Rx-360 takes these concerns seriously and has adopted a robust Anti-Trust and Anti-Competitive policy and insists that members abide by the terms of its membership and confidentiality agreements to address these concerns.
Rx-360 has also benchmarked with other similar consortiums serving other industries such as Fair Factories Clearinghouse serving the apparel industry (www.fairfactories.org), and CHWMEG serving multiple manufacturing industries (www.chwmeg.org) to determine the best methods to work collaboratively but also ensure compliance with applicable law. It is instructive that Fair Factories Clearinghouse’s business model has been reviewed by the U.S. Department of Justice (DOJ), which issued a Business Review Letter that provides some comfort that DOJ does not consider Fair Factories Clearinghouse a candidate for antitrust enforcement actions.
Click here to see the DOJ letter pertaining to Fair Factories Clearinghouse.
These benchmarking exercises suggest that working collaboratively to conduct audits, share information, develop technologies and adopt standards can be an effective and compliant approach to combat global threats to the supply chain so long as each individual company makes independent decisions related to supplier selection and utilization. This approach can also include working collaboratively on corrective actions with suppliers.
Another form of collaboration that is critical to success is working with professional and trade organizations in a non-competitive manner to avoid dilution of industry resources which can result from redundant work on similar problems. For example, IPEC (International Pharmaceutical Excipients Council) is designed to enhance GMP and GDP compliance pertaining to excipients. So Rx-360 hopes to collaborate with IPEC by endorsing the standards developed by IPEC pertaining to excipient GMPs, GDPs, standardized pre-audit questionnaires, standardized Certificates of Analysis templates, etc. Rx-360 wants to create an open and transparent process so that all organizations feel comfortable collaborating with Rx-360. Organizations like the EFCG (European Fine Chemicals Group), BIO International, ISPE (International Society of Pharmaceutical Engineers) have expressed interest in collaborating. Through such collaboration, we can direct our limited resources and subject-matter experts to rapidly and effectively deal with our new realities.
Finally, you may have heard me say at various conferences that “patient safety should never be used as a competitive advantage.” To help illustrate what I mean by this statement, I want to share a personal story with you. I remember a Volvo automobile commercial from my childhood that stated how Volvo invented and patented the seat belt. The commercial went on to say that Volvo wanted to compete on features related to comfort, performance and price, but that consumer safety was something too important to use as a competitive advantage. As such, Volvo would not enforce their patents, and encouraged all automobile manufacturers to implement seat belts into their designs.
I can’t help but wonder how many thousands of lives have been saved by this decision. I know I owe the lives of two of my daughters to their use of seat belts during a horrible traffic accident that totally destroyed the car they were driving. Take a look at the following picture of their car and you would have to agree with me that the Volvo decision many years ago saved their lives.
With Rx-360, we will follow this same principle – to be transparent in our approach and commit to an open architecture for any intellectual property developed by the consortium, which can be available for any organization to use freely. I invite each biotechnology, pharmaceutical, generic manufacturer and supplier to make a similar commitment by joining Rx-360 and working collaboratively to protect patients.
With patient lives on the line, we must work together. When it comes to processes, systems and practices that will enhance patient safety, we cannot compete between ourselves. Through collaboration we can drive implementation with a sense of urgency and a greater possibility of preventing or detecting threats to the global supply chain such as intentional adulteration of a raw material.