PIASA POSITION PAPER: COUNTERFEIT MEDICINES

PIASA | Pharmaceutical Industry Association of South Africa| |tel: +27 11 805 5100

Medicines are an attractive target for counterfeiting because they are high-value items and fakes can be made relatively cheaply.

Trade in counterfeit medicines is known to be widespread and affects both developing and developed countries and ison the increase.

A World Health Organisation (WHO) survey 1 of counterfeit medicine, running January 1999 - October 2000 including 20 countries, found that 60% of counterfeit medicine cases occurred in poor countries and 40% in industrialised countries. The WHO estimates the counterfeit medicines comprise 6% of the world market.

The Food and Drug Administration (FDA) of the United States of America2 estimates that 10% of pharmaceuticals worldwide are counterfeits and 25% of medicines in developing countries are fake or substandard.

DEFINITION

The absence of а universally accepted definition not only makes information exchange between countries very difficult but it also limits the ability to understand the true extent of the problem at global level. In order to address this problem the following definition has been developed by the World Health Organization:

"А counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products:

  • with the correct ingredients
  • with the wrong ingredients
  • without active ingredients,
  • with insufficient active ingredients or

with fake packaging or which has been repackaged or re-dated [e.g. expiry date extended unofficially and could, therefore, be substandard]

Commonly counterfeited medicines

In wealthier countries the most frequently counterfeited medicines are new, expensive lifestyle medicines, such as hormones, steroids, medicine proscribed to treat sexual dysfunction medicine and antihistamines. In developing countries the most counterfeited medicines are those used to treat life-threatening conditions such as malaria, tuberculosis and HIV/AIDS. A fairly recent phenomenon is the appearance of counterfeit herbal and complementary medicines, particularly in Asia where patients have been harmed by counterfeits.

Where and How?

Counterfeit medicines come from national or international sources, organised crime and unscrupulous and greedy import-export agents. It is often virtually impossible to tell the difference between real and fake medicines from a visual inspection.

The internet is a source of many counterfeit medicines since it is usually impossible to determine the country of origin of the medicine or information, thus creating a situation where control over the distribution chain is lost.

HOW DOES IT IMPACT ON HEALTHCARE

For the patient counterfeiting poses serious health and safety issues. It diminished public confidence in health care systems, health care professionals, healthcare products and the pharmaceutical industry.

To the pharmaceutical industry, counterfeit medicines are of significant concern, not only because of the potential safety hazards and the substantial financial loss to the companies concerned, but also because of the risk of damage to the company’s reputation if its products are perceived as ineffective or harmful.

WHAT IS BEING DONE?

IFPMA (International Federation of Pharmaceutical Manufacturers Associations) is a partner with WHO in efforts to improve drug quality and fight counterfeiting around the world. The Counterfeiting and Drug Quality Working Group is composed not only of WHO and IFPMA, but also the International Generic Pharmaceutical Alliance (IGPA), the World Self-Medication Industry (WSMI) and Centrale Humanitaire Medico-Pharmaceutique (CHMP), a Non-Governmental Organisation of pharmacists committed to improving drug quality in developing countries.

The WHO launched an action plan against substandard and counterfeit drugs on 11 November 2003.

Special markings or holograms on packaging materials, different colours used for tablets and capsules sold to the State or for aid programmes and other measures for tracking the movement of pharmaceuticals from manufacturer to final selling point have been introduced by industry, but experience has shown that counterfeiters soon develop the technology to cope with such measures.

HOW THE INDUSTRY CAN HELP

Develop, establish and maintain consistent:

•Innovative labelling

•Constant monitoring of products in market

•Alert consumers and health care professionalsto the dangers of counterfeit or substandard medicines

•Ensure approved supply chains are used

•Maintain Batch tracking records

•Maintain tight security measures to ensure that products, and especially packaging material, are not diverted from legitimate distribution channels

•Systems in place for speedy response to any reports of stolen or counterfeit products found on the market

•Consider possibility of special marking of products or packaging for State or special aid projects for regulatory authority

WHERE THE REGULATORY AUTHORITIES CAN SHARPEN CONTROL

•Effective registration process to cover ALL medicines available on the market

•Effective inspectorate with adequate resources, human and financial to

–Control and monitor medicines on the market

–Rapid alert and response systems;

•Effective training of police and customs police

•Stronger and more specific legislation to take action against counterfeiters of medicines; Enforcement of legislation to prosecute and demand severe penalties since the selling of illegal unregistered medicines, stolen medicines or counterfeit medicines are serious crimes resulting in harm to consumers /patients and the economy

•Education of health care professionals and the public to assist in identifying illegal, stolen, substandard or counterfeit medicines

•Ensure an effective reporting system for patients to report lack of efficacy or unexpected adverse events or to report product with a different appearance

THE HEALTH CARE PROFESSIONALS ROLE

•To be alert to counterfeits

–by monitoring own stock

–to track and follow up consumer complaints

–to be on alert for treatment failure

–to inform drug companies and authorities of suspect products

–only use approved and licensed suppliers in your supply chain

•Regulation of and self-regulation by pharmacists, doctors and wholesalers in the distribution chain

References:

1

2

Date: November 2011

PIASA | Pharmaceutical Industry Association of South Africa| |tel: +27 11 805 5100