- 0 - Medicines manufactured under these conditions What do you want your Patients to receive??

- 1 - Counterfeit Medicines A danger to public health Matthew Moodley Legal Director Interim Chair – Pan African Co. SAPRAA 5 September 2008

- 2 - What is meant by “Counterfeit” medicines? “Products marketed with the intent to deceive” “A Global Health Risk” Affects all Countries

- 3 - 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

- 4 - 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

- 5 - 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

- 6 - Counterfeiting Manufacturing Methods The conditions under which the counterfeit Viagra manufactured… …demonstrates the dangers the counterfeits pose to public health and safety.

- 7 - Counterfeit Ponstan, Colombia

- 8 - Counterfeit Viagra, Egypt Traces of road paint and methamphetamines

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

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

Counterfeit Norvasc,

Counterfeit Lipitor

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

Medicines sold on streets

Medicines sold in market places

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

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

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

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 –

Success thus far - Lobombo

Success thus far - Lobombo

What can you do ? Be Vigilant Pharmacist are in the forefront

What can you do ? Differences in packaging are subtle but detectable

What can you do

Copy of a legitimate product no active ingredient CounterfeitGenuine

How can you identify a counterfeit?

What do you want your Patients to receive?? Counterfeit Pfizer