Why drug traceability is vital
It struck me this week that I've been in anti-counterfeiting and traceability for exactly twelve years, after a somewhat left-field move from a general career in the pharmaceutical industry. In that time I've seen counterfeits of almost everything medical, from cancer drugs to dental drills, in locations from Los Angeles to Lagos. Nothing shocks me now, but that doesn't mean my inner fire is burned out - more on that later.
Back in 2006, one of my first introductions to counterfeits was a call from a major multinational medical device manufacturer. They had discovered millions of fake versions of their glucose testing strips. My then company helped the brand owner to enhance the security features on their packaging, which provided both visible and covert differentiation from the fakes and bought some respite from the problem. At the time, I was professionally appalled that criminals could put the lives of diabetes patients at risk, but not personally connected with the issue. Many more cases came and went, as the world grew accustomed to counterfeit medicine incidents involving Avastin, Heparin and many others.
At the same time, the regulatory environment was gradually evolving towards a traceable supply chain. It is much harder for counterfeiters to infiltrate the health system on an industrial scale if genuine medicines and medical devices are serialised (coded), checked and traceable. Twelve years ago was the Stone Age, with no more ability to find and recall an individual drug pack in 2006 than our forebears had in 1906. After a few iterations (remember the California Pedigree era?) we now have the Drug Supply Chain Security Act (DSCSA) in the USA, the Falsified Medicines Directive (FMD) in the EU, and various other regulations worldwide. The momentum is irreversibly towards global, pack-level traceability.
Implementing the hardware, IT systems and working processes needed to meet these laws is hard work and not without significant cost to manufacturers, distributors and dispensers. Many of you know that I have some skin in the game here, and if you want to discuss technical specifics then please get in touch, but this article isn't about whether one software vendor is better than another. It is about why implementing traceability is a gift to future generations.
There are three key weapons against fakes.
- Make genuine products more difficult to counterfeit
- Secure the supply chain
- Enable early warning
Traceability systems address all three areas. Sure, unique codes can be copied and the occasional fake pack might get through but those duplicate codes create a signal that can be seen and investigated. Similarly, passing traceability data between business partners during normal commerce builds a picture of what the healthy supply chain should look like so that deviations from the norm are then easier to spot. The DSCSA and FMD (and other laws in Argentina, Brazil, China, Russia, and Saudi Arabia, amongst others) are not perfect and they will not eradicate fake medicines. Smoke alarms and sprinkler systems don't prevent fires - but on average they make them smaller and less dangerous and therefore save a lot of lives.
In 2013, a few months before President Obama signed the DSCSA into law, my younger son was diagnosed with Type 1 diabetes. Unlike the more common Type 2, which has a more gradual onset in later life and clearer causes, what used to be known as "juvenile diabetes" is a random, sudden disease that mostly affects otherwise healthy young people. A hundred years ago it would have been fatal but modern medicine is a wonderful thing. Thanks to genuine and high quality medicines from Novo Nordisk and Sanofi, reliable medical devices from Roche and Abbott, and clean, unadulterated needles from various manufacturers, and not least the steely resilience of a tough-minded young man, the diabetes is manageable.
If we want our children and grandchildren to inherit the glories of today's healthcare, free from the pollution of counterfeits, we need to fight for it against the faceless criminals who seek profit at any price. Making our medicine supply chain traceable and more secure is going to be painful, expensive and time-consuming. There will be stumbles along the way. But if you are involved in implementing traceability systems for DSCSA, FMD or other reasons, then your work is not just "compliance". It is as vital to the health of future generations as that of your colleagues in new drug discovery. Take heart when technical difficulties arise, fight management inertia, and keep the goal of safe, genuine medicines in sight. Future generations will thank you.
Postscript:
I am riding the Prudential RideLondon 100 mile cycle event next month in aid of JDRF, the Type 1 diabetes charity. All money raised will go directly towards research to find treatments and cures for Type 1 diabetes. Click here if you'd like to donate. I'll double the total that's raised via my page.