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Medicines manufactured under these conditions

What do you want your Patients to receive??

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Counterfeit Medicines

A danger to public health

Matthew MoodleyLegal Director

Interim Chair – Pan African Co.

SAPRAA5 September 2008

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What is meant by “Counterfeit” medicines?

“Products marketed with the intent to deceive”

“A Global Health Risk”Affects all Countries

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Not a Generic Issue - What are counterfeit medicines

Branded or generic medicines which contain:

≠ the right active ingredient in insufficient quantity

≠ no active ingredient

≠ another active ingredient to the one on the label

≠ the right amount of active ingredient but from an unapproved source (Illegal generics or Diverted medicines)

Substandard medicines also fall within this category when:

≠ expiry date extended unofficially

≠ incorrect storage - quality problems

≠ goods intended for destruction –saved and repackaged

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The Effect of Counterfeits

Not just - or mainly - a commercial issue

Can harm or even kill patients

Serious health implications

There are no “quality” counterfeits

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Examples

Niger 1995: 2500 people died after receiving fake meningitis vaccine -WHO

Haiti 1998: 89 deaths from paracetamol syrup [diethylene glycol] and in

India 1998: 30 infant deaths as well

Cambodia 1999: Fake artusenate actually contained older anti malarial products to which resistance had developed [70 % of artunsenate sold was fake].

SE Asia 2001: 38 % of 104 antimalarials [mostly artusenate products] contained no active ingredient

China 2007

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Counterfeiting Manufacturing Methods

The conditions under which the counterfeit Viagra manufactured…

…demonstrates the dangers the counterfeits pose to public

health and safety.

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Counterfeit Ponstan, Colombia

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Counterfeit Viagra, Egypt Counterfeit Viagra, Egypt

Traces of road paint and methamphetamines

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Lignocaine

Counterfeited lignocaine injection discovered at a Central Hospital after reports of unusual hypersensitivity to the “locally” manufactured local anesthetic

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Cough Syrup

A student at a local polytechnic is being sought by the police for questioning regarding a counterfeit cough preparation seized from backyard manufacturing facilities in a residential area .

Cough Syrup

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Counterfeit Norvasc, Counterfeit Norvasc,

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Counterfeit LipitorCounterfeit Lipitor

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Channels to Market

Pharmacies/ Dispensing Doctors

• Prescription

• OTC

• Generic Counterfeit

Sex Shops

• Recreational use

• Counterfeit and herbals

Street corner vendors

• Recreational use

• Generally Counterfeit

Influencing factors

Cost Stigma of ED Rx

Availability No RX

Cost

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Medicines sold on streets

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Medicines sold in market places

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The perfect crime?

Organised crime

Huge profits to be made –global earnings $ 35 B p.a.

Penalties in most countries make these crimes worthwhile - Huge rewards for little risk

Counterfeit medicines are manufactured in one country, packaging is printed in another,

product is packed in a third

Almost impossible to distinguish between real and fake medicines - can imitate genuine

medicines almost perfectly

Victims often are not aware of the fact that they have not received the

“real” medicine

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The Effect of Counterfeits

Erosion of public confidence in

- public health care systems,

- health care professionals

- the pharmaceutical industry

- regulatory and law enforcement authorities

Loss of almost 20 % of total medicines market in SA to crime

Impacts on the price of medicines for the legitimate buyers

WHO estimates

- 10 % of pharmaceuticals worldwide are counterfeits and

- 25 % of medicines in developing countries are fake or substandard

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Significant Combined Effort to combat illegal and counterfeit Medicines in SA

Government Agencies

• Revising legislation

• Inter-departmental and cross-country working groups

• Impose severe sanctions on members found guilty of manufacturing, distributing supplying or selling stolen or counterfeit medicines

Need for Increased Education being addressed by all Players

• Of health care professionals and the public

• To assist in spotting illegal, stolen, substandard or counterfeit medicines

• To be on alert for treatment failure

All Pharma Industry Players

• Introduce special markings and tracking systems

• Ensure an effective easy reporting system for patients & professionals to report lack of efficacy or unexpected adverse events

• to maintain an audit trail of medicines bought

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What is being done

The Coalition in Africa

Enhancement of internal control measures

Working with DTI, SARS, Law Enforcement unit of MCC, SAPS, Customs, DOJ

Training and awareness campaigns with active industry support

• Pfizer training session with SARS and DTI (29 August 2007)

• Regional Anti Counterfeiting conference – (29 October 2007)

- SADAC Governmental Agencies

Local task team; streamlined reporting structure; simplified reporting

form, direct access email – counterfeitsZA@pfizer.com

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Success thus far - Lobombo

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Success thus far - Lobombo

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What can you do ?

Be Vigilant

Pharmacist are in the forefront

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What can you do ?

Differences in packaging are subtle but detectable

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What can you do

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Copy of a legitimate product no active ingredient

Counterfeit Genuine

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How can you identify a counterfeit?How can you identify a counterfeit?

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What do you want your Patients to receive??

Counterfeit Pfizer