Fighting Spirit

Grant Lindman is director of Eli Lilly’s global anticounterfeiting operations and is passionate about fighting fake medicines. Here, Lindman takes a quick tour of industry success stories and shares Eli Lilly’s current initiatives.

What does your role entail?

It’s essentially about coordination. We’re a large global company and a lot of different functions are involved in developing a global anticounterfeiting strategy. For instance, I work closely with legal, security, brands teams, quality and safety, as well as our authentication lab. I’ve been working in the company’s anti-counterfeiting operations for almost 10 years. Patients depend on medicines to improve their lives – and pharma companies work hard to provide these medicines. Counterfeiters undermine all our hard work. It’s very frustrating and it’s a problem that really motivates me.

Looking at the company’s overall strategy, there’s no silver bullet for fighting fakes, so Eli Lilly has adopted a three-pronged approach. We want to secure enhanced integrity of the legitimate supply chain; deter major counterfeiters through legal actions, investigations and use of technology; and then partner with governments, non-government organizations and trade associations to elevate the issue and raise awareness about the threat of counterfeit medicine.

How big is the problem of counterfeit medicines?

It’s difficult to really understand the size because counterfeiters are criminals; they don’t publish business plans or statistics about their activity! A lot of recent evidence has suggested that criminal organizations, such as narcotics gangs, are getting into the counterfeiting business and these criminals are smart. Estimates floating around the industry value the counterfeit problem at anywhere between $75 billion and $200 billion a year.

I think every big pharma company is seeing counterfeits of their products in various markets, and there’s definitely growing awareness of the problem. But although we’re seeing reports of more counterfeiting or seized products in a specific market, does that mean there are more counterfeits, or is the industry just identifying it more? I think it’s a little bit of both.

When counterfeit medicines started to appear, the counterfeiters mainly targeted lifestyle products, such as erectile dysfunction medicines and hair growth products. Now, all kinds of medicines are targeted. It’s not just innovative, branded drugs either; we’re also seeing counterfeit generic medicines, which is something many people in the industry didn’t expect as they are viewed as lower cost products.

Counterfeiters are getting smarter – how do you keep up?

Counterfeiters are all about deceiving people and exploiting someone else’s brand, so they need their products to look good. Several years ago, counterfeit products were easier to spot, but recently they’ve upped their game and the packaging tends to look very professional to the naked eye. Even the fake tablet itself can seem high quality, but it’s unlikely to have the correct ingredients. There have been lots of different reports of what can be found in counterfeit medicine – brick dust, lead and boric acid to name just a few. Counterfeiters don’t care what’s in the medicine. They just need it to look good.

At Eli Lilly, we’ve set up an authentication lab where we test for counterfeits. If customs or law enforcement seize suspected counterfeit versions of our products then we send samples to our lab for chemical and visual tests. The information is then sent to law enforcement and used in court proceedings and prosecutions.

How does the problem vary between different regions?

In developed countries, the legitimate supply chain is pretty secure so counterfeiters often try to sell things over the Internet. But in developing countries, the supply chain tends to be a little more porous so there may be opportunities for the counterfeiters to inject their products into that supply chain. Counterfeiters are organized and they usually understand the differences between markets and will take a targeted approach. For example, in developing countries, there is a big problem with counterfeit antimalarials and HIV drugs. In Europe and the US, there have been several reports of counterfeit cancer and heart medication.

What action is Eli Lilly taking to fight fakes?

One of the initiatives that we’re focusing on is serialization. Last year, we announced an investment of over $100 million in this area. A lot of countries are passing regulations in this area and it’s a good step towards better securing the legitimate supply chain.

We also want to deter counterfeiting in the first place so we partner with law enforcement and we have experts who can testify in court. When counterfeiters are prosecuted, we help to support the effort through legal actions too. We also do training with law-enforcement and customs officials so that they can understand what a legitimate product should look like and who they need to contact at our company if they have a question. And when these questions do come through, we try to get them answered quickly so that they can take action if necessary.

Another important area is partnerships. We need to work together as an industry to beat the criminal gangs, so we work with governments, non-government organizations and trade associations as well. Where you find counterfeits of one company’s products you will likely find another company’s products too. The Pharmaceutical Security Institute is one organization that does a lot of data capturing on these issues.

What recent success stories can you tell us about?

Interpol has something called Operation Pangea, which targets online sales of fake medicines. The operation takes place every year and is a huge partnership that involves the whole supply chain, as well as customs, police, regulators and more. We took part in this operation in 2014. It involved 1200 different investigations, more than 9.4 million fake medicines being seized, removal of more than 19,000 advertisements for elicit pharmaceuticals via social media platforms, and the closure of more than 10,000 websites. It spanned multiple countries, highlighting the global nature of counterfeiting. We took part in the more recent 2015 operation too.

In the area of safe online medicines, there’s another organization that we work with called The Alliance for Safe Online Pharmacy. We’re supportive of people using the Internet but they need to know if an online pharmacy is safe. The National Association of Boards of Pharmacy has registered the domain name of ‘.pharmacy’, which online pharmacies can apply to use. The application and approval process involves stringent vetting to ensure that the pharmacy is legitimate. When a patient sees an online pharmacy with the right URL, they will know it is reputable.

Finally, regulators are also working hard in this fight. For example, the FDA has partnered with Fight the Fakes (http://fightthefakes.org/), which is a campaign to raise awareness of the dangers of fake medicines. Regulatory agencies are becoming increasingly aware of their role in fighting fake medicine and how they can help to educate the public. After all, patients look to them for advice on all health related matters.

What is the key weapon in the fight against fake medicine?

Partnerships! Operation Pangea shows what we can achieve in collaboration. We also need to work together on securing a legitimate supply chain. There’s a big serialization push at the moment, but if all partners in the supply chain do not use the technology, then it doesn’t really add value.

And there’s still more that must be done. In particular, I think we need tougher penalties for counterfeiting. In the US, for example, the penalties are tougher for running a narcotics business than they are for counterfeiting medicine.