Fighting counterfeits to protect patients

Whereas purchasing a fake watch may result in criminal prosecution and a fine for the buyer, illegal medicines jeopardise the health of consumers and, at worst, can even cost them their lives. According to the World Health Organization (WHO), counterfeit medicines result in up to a million deaths per year.

There is no uniform definition of the word “counterfeit”. Ultimately, the consequences for the consumer are what matters most. Frequently the active substances are present in insufficient quantities or not at all. Fake drugs are often nothing but sugar pills or vials of water. Even worse, many counterfeiters make medicines with the wrong active substances or dilute them with dangerous binding agents. In the context of lifestyle drugs, replacing the originals with sugar pills simply means an unsatisfied customer. For patients whose lives depend on prescription medicines, however, the consequences of counterfeiting are dramatic.

Pius Waldmeier is Head of the Global Roche Anti-Counterfeiting Commission (GRACC), established in 2004. The commission is made up of a team of experts from all different functions who campaign to bring counterfeit medicines to light around the world and prevent them from entering the official supply chain. The Commission’s number one priority is to protect patients. It defines strategies for combating counterfeiting, theft and unauthorised parallel imports, coordinates investigations into counterfeit drugs and handles follow-up activities. Pius is concerned about recent developments, which have seen the market for counterfeit products expand as a result of globalisation and internet sales: “In the past, counterfeit products were manufactured in garages and back yards in relatively small quantities. The fakes were often unsophisticated, making them easier to identify. Today, factories with an impressive number of employees and state-of-the-art technology and equipment are capable of manufacturing and packaging deceptively genuine-looking counterfeits.”

The scale of the counterfeit medicines business is making it increasingly difficult to control. We are doing our best to prevent fake medicines from getting into the official supply chain and to the patient.

We have added numerous security features so that the staff of clinics and pharmacies can identify counterfeits with the aid of special technology. However, these measures are not sufficient, says Pius: “To save space – in fridges, for example – hospitals often store medicines unpackaged – important information is lost. If in clinics the waste is not disposed of carefully, the empty boxes may be stolen, sold and filled with counterfeit medicines that are then brought onto the market.”

Gottlieb Keller, Roche General Counsel, points out the company's responsibility: “Roche takes every single suspicion of falsification very seriously and continuously endeavours to make its products more counterfeit-proof. What is needed most of all, however, is consistent action from legislators, the police, the customs authorities and the healthcare sector. There must be no compromises when it comes to patient safety.”

But we can’t go into battle alone. Cecilia Fant, Pharmaceutical Security Institute (PSI), is cooperating closely and regularly with the representatives of GRACC: “Fake medicines endanger patients around the world. The PSI was established to address this problem over twenty-five years ago. Today, the team at Roche works diligently with its partners in the PSI and law enforcement agencies in multi-national efforts to identify and disrupt criminal organizations manufacturing, distributing and selling unsafe medicines.”

To increase safety, in the European Union from February 2019, all prescription medicines will be provided with legally required safety features. These will allow a complete tracing and to test the authenticity of a product.

Together with all partners, we are fighting a difficult battle: “We are only one step ahead of the counterfeiters, and they are doing everything they can to catch up. That is why we must remain vigilant in the fight against drug counterfeiting and regularly add new security features to our products” Pius says.

All over the world counterfeit medicines count for an estimated one to three percent of medicines in circulation in developed countries and significantly more than 50% in some African countries. Many of these medicines are produced in Asia (mostly in China and India) in large quantities and circulated around the world via various distribution channels, such as illegal online pharmacies, around half of whose medicines are counterfeit. Even the closure of thousands of websites has failed to significantly reduce the sale of medicines over the internet. Punishments for counterfeiters are hardly a deterrent as they are far too mild in many countries.