With an approaching serialisation deadline, following the introduction of new legislation in the pharmaceuticals market to deal with the threat of counterfeit drugs, Clinical Trials Insight talks to Lars Højberg, life sciences expert at NNIT, about the best strategy for complying with serialisation.
The threat seems to be growing. According to data from the World Health Organization, counterfeit drugs make up 30–40% of the supply chain in developing countries. For established economies it’s significantly less, but given the size of the market, millions of prescriptions are still compromised every year.
Today, things are changing. Regulations are now in place across the globe, with Argentina, Brazil, India and Turkey all opting in. It seems like good progress but, for the industry, things aren’t as easy as they appear: the product serialisation process is a multifaceted business – every aspect of a prescription drug has to be tracked and traced from production, right through to distribution; few places have agreed on the same set of rules, timings differ from region to region and the requirements around technology are rarely the same. Barcodes are a good example. In the US and the EU, a data matrix 2D barcode has been adopted as the preferred solution, but in China more traditional linear barcodes are being used. The challenge for pharmaceutical companies is devising a solution that is able to handle these technologies in a way that complies with the different regulations.
“The increased complexity makes it harder for companies to navigate,” says Lars Højberg, life sciences expert at NNIT. “Ever since the announcement of the serialisation legislation, companies have been in a state of denial and paralysis. The task just seems too big. But the ‘do nothing’ and the ‘wait and see’ approaches are putting life sciences businesses at risk.
“Companies can’t keep dodging the bullet. The regulation will step into effect – and if you are not ready by then, your licence to sell will be at stake. Eventually, procrastination will land you in the soup.”
The predominant perception in the industry is that implementation costs are high, and introducing new processes and technologies will create a drop in efficiency.
While this is to some extent true, it is a limited picture. Serialisation is also a means to safeguard scientific investment, and as such the regulations introduce serious business benefits. The global imitation market is worth 2–4%, meaning regained revenue can easily finance the entire serialisation investment.
While there is no business case to support this, according to Lars Højberg it is highly likely that this will be the case for most life sciences businesses.
“Every day we see cases where counterfeit products have been found in certain markets,” Højberg says. “This regulation means companies will also be able to better safeguard the investments they made in drug development.
" Ever since the announcement of the serialisation legislation, companies have been in a state of denial and paralysis. The task just seems too big. "
“The starting point for most companies is that they want to invest the least possible money in the serialisation solution. The way they see it nowadays is that it is not adding value to their business, and while I can sympathise with the feeling of facing what seems like an unsurmountable task, I also think that they are blind to the bigger picture and the greater benefits going beyond the mandatory compliance.”
Fears over complexity are certainly understandable. But there are solutions at hand. Having a consolidated strategy that is anchored and sponsored by corporate management can make all the difference.
“It’s about taking a holistic view on how the business is running,” Højberg says. “Most of the consultants and businesses we know take responsibility for only a part of the solution. But with this type and scale of implementation you will not succeed without a holistic approach acknowledging all the multiple centres affecting each other.
“It’s crucial to take an end-to-end approach, encompassing strategy, processes, IT and equipment from production to distribution – and this is what NNIT offers; we provide a panoptical view, or you might call it a game master’s view, on the company. This way we bring the life sciences business into compliance and we facilitate the many business benefits of serialisation.