Falsified Medicines: a Criminal Activity that Endangers the Life of Patients



Today, falsified medicines know no border. A falsified product can be made in China or India, exported to Great Britain and infiltrated through a wholesaler into the legal distribution chain, or purchased on the Internet anywhere in the world. Falsified drug trafficking exists all over the world and concerns both original medicines and generics.

Branded products, antibiotics, antihypertensives, anti-retrovirals, anti-malarials, generic drugs, vaccines … falsified drug trafficking affects all therapeutic classes. Today, it is a highly lucrative criminal activity that leaves hundreds of thousands of people victims. The international anti-counterfeit medicines research institute (IRACM) estimated that US$1,000 invested in falsified drugs results in a profit of US$500,000 compared with US$20,000 dollars for heroin trafficking, a profit level 25 times higher.

Yet, the fight against falsified medicines is not new. In the 1980s, WHO was already highlighting the need to improve disadvantaged countries' access to quality drugs, with the issue of drug falsification an underlying problem.

Counterfeit medicines can cause complications for patients, and can even lead to death. Between 1990 and 2006, in Africa, Latin America and Caribbean, more than 1,000 people (including children) treated with a counterfeit cough syrup died from a toxic solvent.

The problem of drug falsification is worsening. The expansion of this highly profitable phenomenon has been aided by the development of the Internet as well as the weakness of sanctions imposed on counterfeiters.

In 2016, in Indonesia: Sanofi led to the dismantling of four clandestine laboratories (falsification, expired vaccines that were relabeled, etc.), as well as a criminal network active since 2003, whose profits reached €25,000 per month!

The same year, in Mexico: Five laboratories shared a detection campaign in 72 pharmacies to find counterfeit products in the cardiovascular and diabetes lines. This shared process allowed to collectively present results to health authorities and police in order to encourage them to take action against criminal networks and strengthen the control of distribution networks.

This highly lucrative criminal trade has been aided by the development of the Internet, which has become the preferred place to do business for counterfeiters. More than 90% of online pharmacies are illicit1 and more than 60% of counterfeit products are sent by parcel post2.

The Illicit web sites are constructed in the same way as a legal buying site. Some people will buy drugs online because the products are cheaper or not found in their country. In some parts of the world, buying drugs is a major expense in the family budget Internet is a way to have freely access all kinds of medicines, even without prescription.

"This pharmaceutical crime thrives and generates high profits. The financial attractiveness is very strong and criminal organizations of all sizes are involved in this traffic,” according to pharmacist Geoffroy Bessaud, Associate Vice-President, Corporate anti-counterfeiting coordination Corporate Security.

The revenues generated by this illegal traffic is estimated as at least 10-15% of the world market, or US$100-150 billion, and even as high as US$200 billion, a figure that has almost tripled in one years, to a study from the World Economic Forum.

Infographic about criminal activity which generates high incomes

Criminals take advantage of the fact that unlike drug trafficking, the trade in counterfeit medicines remains largely unpunished.

While responsible for hundreds of thousands of deaths a year worldwide, it is considered a mere offense of intellectual property infringement, says the IRACM. Indeed, in some countries laws are sometimes obsolete and may require revisions to adapt to the complex nature of pharmaceutical crime and its expansion trend. In addition, weak bribery law may also favor bribery by fake drug criminals.

“With more and more people purchasing everyday items including medicines online, criminals are exploiting this trend to make a profit, putting lives at risk in the process” said INTERPOL’s Executive Director of Police Services, Tim Morris.

While the situation has slightly evolved over the last 5 years, several countries still apply low and non-deterrent penalties as for example in Senegal where “10 people were arrested in a government-led operation targeting the illegal sale of drugs on public roads. 850kg of products have been seized. Resellers themselves were arrested and went to court for, inter alia, illegal practice of the profession of pharmacist. The president of the court sentenced seven defendants to one month in prison”3.

A report from the European Commission published in late January 2018 still highlights major disparities between EU states and as elsewhere, the adoption of harmonized and dissuasive legislation by EU states is essential for an effective fight against falsified medicines.

Example from France:

  • Maximum penalty against fake drug trafficking: 7 years in prison and 750 000 € fine
  • Maximum penalty against drug trafficking: 10 years in prison and a € 7,500,000 fine

To fight against this phenomenon and to allow an effective international cooperation and to protect the patients, the Council of Europe elaborated the first International treaty against counterfeit medical products, i.e. Convention MEDICRIME establishing specific offences, and laying down a framework for national and international cooperation. While this convention was opened to member and non-member states in 2011, the success is unfortunately mitigated since only 13 countries have ratified it until now.

A borderless trafficking that threatens public health worldwide

Infographic about falsified medicines around the world

It is difficult to quantitatively identify the proportion of counterfeit medicines on the market but in most industrialized countries it represents less than 1% of the volume of the market, unlike countries in Africa, parts of Asia or in Latin America where it reaches 30%.

  • Developing countries are the most affected and drug counterfeiting is a real menace for people in Africa. Malaria drugs falsified would be responsible for more than 120,000 child deaths in 20134.
  • Asia, particularly India and China, are the biggest producers and suppliers of counterfeit medicines. 20% of medicines sold on the national market and 35% of those manufactured in India and sold on all continents still do not comply with the rules in force according to WHO. “This is all the more disastrous as it affects the most vulnerable populations," stated WHO in the spring of 2017.

It is therefore estimated that 75% of counterfeit medicines5 in the world come from China and India, transiting through the open ports of the Middle East to conceal their origin. This traffic operates mainly for emerging countries with a low standard of living where distribution channels are poorly controlled and the reimbursement rate is weak. This is often true in countries where there is a lack of health coverage in the country.

However, Europe and the United States are not immune. According to the European customs, shipments of fake products are regularly intercepted and 90% of falsified medicines seized by customs in Europe in 2016 came from China or India6.

Sanofi’s commitment to the fight against counterfeit drugs

In 2008, Sanofi created the Central AntiCounterfeiting Laboratory dedicated to the analysis of drugs suspected of being counterfeit in Tours, France. The laboratory, which uses cutting edge of technology, is now a world reference site.

“We need to have the proper tools to fight the phenomenon, and the Central Anticounterfeiting laboratory is definitely one of the most advanced ones” explains G. Bessaud, Associate Vice-President, Corporate anti-counterfeiting coordination Corporate Security.

In the past 10 years, more than 37,000 suspect products from all around the world have been examined at the laboratory in Tours, with some collected in pharmacies, hospitals or the Internet.

“When falsification is confirmed, Sanofi alerts local authorities," says G. Bessaud.

In 2016, Indonesian police officers dismantled a system of trafficking in fake vaccines marketed under the Sanofi brand. Distributed in the country’s health centers and hospitals since 2003, they contained no dangerous substances but the children injected were not immunized against serious diseases like polio.

"Counterfeiters are criminals. They exploit all opportunities: shortages, new products and the most sought-after brands. They even copy the molecules still in the research phase," said G. Bessaud. Trends change: "Ten years ago, it was mainly tablets. Now, 40% of fake drugs are injectable: vaccines, insulin, etc...” The database created by Sanofi includes the signature chemical from all samples, allowing it to establish matches when new drugs are sent to it.

References

  1. National Association of Boards of Pharmacy, 2017
  2. EUIPO, Mapping Economic Impact Study, 2016, p. 55
  3. IRACM – August 1st 2017
  4. https://www.fic.nih.gov/News/Pages/2015-global-pandemic-of-fake-medicines-poses-urgent-risk.aspx
  5. Rapport OCDE « overview of global counterfeit medicines », 2014
  6. Rapport OCDE: European customs 2016