Proliferation of counterfeit and diverted medicines has developed into a global problem and poses a serious threat to patient safety.

What Is a Counterfeit?

According to the World Health Organization ("WHO"), "A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products, and counterfeit products may include products with correct ingredients or wrong ingredients, with insufficient quantity of active ingredient or with fake packaging."i Counterfeit products also include medicines that were genuinely manufactured, but where packaging or documents relating to the medicine's history/distribution were altered.ii Such products may include genuine medicines approved for sale in one market, but illegally diverted and sold elsewhere.

Safety

Counterfeit medicines can pose serious and sometimes life-threatening health risks to patients. The WHO notes that counterfeit medicines are not equivalent in quality, safety, and efficacy to genuine medicines and often do not contain any, or the correct amount of, active ingredient, and also may contain impurities.iii Additionally, counterfeit medicines may be produced in unsafe manufacturing conditionsiv and travel through insecure supply chains. Nor are counterfeits inspected by government regulators charged with the wellbeing of patients and product safety.v

Gilead's Position

At Gilead we are inspired by the opportunity to address unmet medical needs for patients living with life-threatening diseases around the world. The nature of Gilead's products makes ensuring authenticity and safety of our medicines fundamentally important

Gilead's Anti-Counterfeiting Team consists of brand protection, legal, security, supply chain, quality, and packaging professionals who collaborate to address the threat to patient safety associated with counterfeiting and diversion of Gilead medicines. Gilead's Anti-Counterfeiting Team uses measures to detect, stop, deter, and report illicit sales of counterfeit medicines.

Online Pharmacies

The WHO estimates that over 50 percent sold online are counterfeit.vi

Gilead recommends that patients take great care when purchasing medicines online and be wary of websites that:

  • Permit purchases without a prescription
  • Offer medicines at low, "too good to be true" prices
  • Send spam/solicitations offering to sell medicine
  • Are located outside of your country, or claim to source products from other countries
  • Require payment up front, payment via a means not connected to the pharmacy website, or direct transfers between banks

If you believe a website is selling counterfeit medicines, you may report the site to the FDA (http://www.fda.gov/Safety/ReportaProblem/ucm059315.htm) or the health regulatory authority in your country.

Safe Purchasing Tips

Always meet with your doctor to determine which medicine is right for you and use only the medicine prescribed. Gilead recommends that you always fill your prescriptions at a reputable pharmacy.

Before taking a medicine, always inspect packaging and contents for damage, alterations, or differences from other prescriptions for the same medicines. Key signs a medicine may be counterfeit include different active ingredients or dosage amounts, manipulated expiration dates, spelling errors, poor print quality, and broken seals/packages.

If you are unsure of the authenticity of a medicine, ask your healthcare professional before taking the medicine. If you suspect a medicine to be counterfeit, report the medicine to your doctor and pharmacy.

Resources

http://www.gilead.com/medicines/consumer-product-safety-improvement-act http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
CounterfeitMedicine/
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
BuyingMedicinesOvertheinternet/default.htm
http://www.who.int/mediacentre/factsheets/fs275/en/


iWorld Health Organization, First International Meeting on Spurious/Falsely-Labeled/Falsified/Counterfeit Medicines. 1992.
iiThe European Parliament and the Counsel of the European Union, Directive 2011/62/EU, Relating to Medicinal Products for Human Use, as Regards to the Prevention of the Entry into the Legal Supply Chain of Falsified Medicinal Products. June 8, 2011.
iiiWorld Health Organization, Counterfeit Drugs: Guidelines for the Development of Measures to Combat Counterfeit Drugs 1999.
ivWorld Health Organization, Counterfeit medicines, Fact Sheet No. 275. Updated Jan 2016 http://www.who.int/mediacentre/factsheets/fs275
vWorld Health Organization, Counterfeit Drugs: Guidelines for the Development of Measures to Combat Counterfeit Drugs 1999.
viInterpol, The Dangers of Counterfeit Medicinal Products. http://www.interpol.int/Crime-areas/Pharmaceutical-crime/The-dangers

At Gilead we are inspired by the opportunity to address unmet medical needs for patients living with life-threatening diseases around the world.