Protecting pharmaceutical innovations from counterfeit attacks

Clarivate Analytics recently released its Cortellis Drugs to Watch 2019 report, which analyzed seven drugs set to enter the market this year and achieve “blockbuster” status ($1 billion in annual sales) by 2023.

Blockbuster drugs face great market potential and are often a “make or break” for some pharmaceutical companies especially those with a limited drug pipeline or small portfolio. As with any new product they can face an onslaught of competitive challenges in the market but the one competitor that must not be forgotten is the threat posed by counterfeiters.

The pharma industry is one of the most regulated sectors in the developed world yet medicinal drugs still represent an attractive target for imposters. According to the OECD some of the reasons for this include a lack of adequate regulation in the developing world and the ease with which consumers can be duped. As a result consumers are left to trust suppliers.

Where pharmaceutical fakes have traditionally focused on mass-produced drugs with limited differentiation from other medicines the World Health Organisation (WHO) has found substandard and falsified medical products from all therapeutic categories across both generic and innovator brands. It estimates that one in 10 medical products in low and middle-income countries is substandard or falsified.

These products may contain little to no active ingredient or the wrong ingredient altogether. Sometimes they are contaminated.

Difficulties in detection

Fakes can be difficult to detect as often there are no adverse reactions and therefore the drug can fail to treat the disease for which it was intended. Shockingly 250 000 children each year are believed to die from substandard or fake malaria and pneumonia drugs. But it’s not just the developing world at risk; WHO reports findings from all over the globe.

Many consumers now use the internet as a tool for self-diagnosis but the rise of online pharmacies has only exacerbated the problem. Many of these entities are not registered even though they seem genuine.

According to the Food and Drug Administration (FDA) in the U.S. only 4% of online pharmacies meet federal and state laws. This is particularly worrying considering that as far back as 2017 29% of consumers were buying medicines online.

Unauthorized online drug distribution is widespread and growing rapidly. As new drugs are launched into the market the issue will only increase as infringers seek to take advantage of new revenue streams.

Consumers need to be protected; and while vigilance from their side is important so too is the fact brands need to take a proactive approach in identifying fake drug sites and enforcing takedowns. So where should brand managers start?

These five tips can help protect pharmaceutical brands online:

Shield new drugs before launch. As a product nears release it’s advisable to watch closely for the availability of relevant Active Pharmaceutical Ingredients (APIs) as well as any discussions about off-labeling the drug.

Monitor multiple online distribution channels. These channels can range from online pharmacies to e-commerce markets and social media and tweets. Brands need to be especially aware of potential drug diversion activity which redirects traffic to fraudulent sites.

Identify areas of geographical concern. Brands should pay the closest attention to China and India – 80% of unauthorized drugs originate here. Therefore resources should be used to monitor grey market activity in these areas.

Utilize an end-to-end attack strategy. Using outside law enforcement support can assist brands with takedowns and support them in evidence collection and prosecution.

Mine data for actionable intelligence. Analyzing all data sources can help brands to identify pharmacy networks as opposed to individual sites. This can expose common payment systems enabling brands to better focus their protective measures.

It’s imperative that pharmaceutical brands take proactive action against unauthorized online pharmacies. Learn more today about technology and services that can bolster these efforts.