Counterfeit Medicines A danger to public health

1
Counterfeit Medicines A danger to public health

• Maureen Kirkman
• Head Scientific and Regulatory Affairs,
• Pharmaceutical Manufacturers Association
• November 2006

2
What is meant by Counterfeit medicines?

• Dr. Harvey Bale of IFPMA
• Products marketed with the intent to deceive
• He terms these A Global Health Risk
• Worldwide problem WHO published Guidelines to
  assist states to deal with counterfeit medicines
  in their health systems
• Presence of counterfeit, stolen or substandard
  medicines usually where controls are weak
• 15 R D based pharmaceutical companies fund a
  group, the PSI, Pharmaceutical Security
  Institute -staffed with experts with
  international experience to investigate cases on
  a worldwide basis.

3
Counterfeit or Diverted medicines

• What are they?
• Can be branded or generic medicine which contain
  
• the right active ingredient in insufficient
  quantity
• no active ingredient
• another active ingredient to the one on the
  label
• fake packaging
• the right amount of active ingredient but from an
  unapproved source
• The last group of medicines are often termed
  Diverted medicines

4
Substandard medicines

• Medicines may be substandard when
• expiry date extended unofficially
• incorrect storage - quality problems
• goods intended for destruction saved and
  repackaged

5
Illegal medicines

• In South Africa, only medicine registered by the
  Medicines Control Council can be sold.
• Unregistered medicines are illegal.
• There are a number of exemptions
• All old medicines are listed
• Medicines used in Clinical trials are usually
  unregistered
• Complementary medicines including traditional
  African, Chinese, Indian ayurvedic, homeopathic
  and other herbal medicines not yet registered

6
Stolen medicines

• South Africa does have a problem
• Theft of medicines in SA is high, especially in
  State sector
• In 1996 the MOH requested the private sector to
  make recommendations to combat theft of
  medicines
• Medicine Theft Committee combined DOH and
  private health care sector made recommendations
  to address the problem
• Auditor General stated in 1996 and repeated in
  2002 that extent of theft was impossible to
  quantify due to poor controls but he estimated
  that gt 50 of medicines purchased by the State
  were stolen
• Highjacking of containers and theft from airport
  storage contributes to the theft problem in pvt
  sector

7
Theft Committee Recommendations 1996

• Marking all products sold to the State
• For State use only Not for sale
• Applying an EAN 128 barcode to all packaging
  material
• to enable tracking of any movementProduct
  identification including strength, dosage form
  and pack size but also Batch No. and expiry date
• Note this would require better controls
  throughout including the State, and would need
  scanners to monitor the movement of stock
• Better estimations of quantities for State
  Tenders and appropriate controls
• 1998 -Accepted by MOH in principle but not
  implemented

8
Co-operation State and Industry

• State Tender 2001 required special marking on
  labels
• Agreement reached with industry to mark only
  selected groups of products
• Intention - a survey after June 2002 on
  completion of the Tender to determine if any
  deterrent effect
• In 2002 about 19 companies were voluntarily
  marking products For State use only- not for
  sale
• However
• SA products marked For State use only- not for
  sale have been found on pharmacy shelves in
  neighbouring countries
• former Registrar of Medicines, Precious
  Matsoso

9
Counterfeits and substandard medicines

• Not just - or mainly - a commercial issue
• Serious health implications
• There are no quality counterfeits
• Can harm or even kill patients
• Affects developing countries more than developed
  weaker regulatory systems and less controls
• Differentiated pricing systems encourage
  counterfeits

10
The perfect crime?

• Huge profits to be made global earnings 35 B
  p.a.
• Has attracted organised crime -drug mafia
• Is very hard to detect and harder to combat -
  Counterfeiters and thieves operate with impunity.
  Operators are sophisticated and ruthless while
  monitoring and regulatory controls are weak
• Counterfeit medicines are manufactured in one
  country, packaging is printed in another, product
  is packed in a third
• Penalties in most countries make these crimes
  worthwhile - Huge rewards for little risk
• Almost impossible to distinguish between real and
  fake medicines - can imitate genuine medicines
  almost perfectly
• Victims and the attending health care
  professionals often are not aware of the fact
  that they have not received the real medicine.

11
Increasing trend?

• April 1999 WHO database reports 771 cases 77
  from developing countries of counterfeits or
  substandard medicines - increasing worldwide
• In wealthier countries most frequently
  counterfeited medicines are new expensive
  lifestyle medicines hormones, steroids and
  antihistamines, more recently products for
  erectile dysfunction
• In developing countries the most frequently
  counterfeited medicines are those used to treat
  life-threatening conditions malaria, TB and HIV
  AIDS
• In Nigeria estimates of counterfeit medicines
  present on the market range from 50 70 . In
  Pakistan 50 China 50 85 Indonesia 8
  Russia 5-10 in SA - unknown but unrealistic
  to think it is less than in developed countries

12
Sources of counterfeit medicines

• World wide India, Russia, China, Brazil
  even SA has been implicated
• WHO estimates that 10 of pharmaceuticals
  worldwide are counterfeits and
• 25 of medicines in developing countries are
  fake or substandardOften generic or
  complementary medicines for malaria, TB and HIV
  AIDS
• 11 November 2003 WHO launched an action plan
  against substandard and counterfeit drugs
• WHO survey of 20 countries between Jan 1999 to
  Oct 2000 found 60 of counterfeits occurred in
  poor countries and 40 in the developed world

13
Some other countries which have had problems with
counterfeit medicines

• China
• Taiwan
• Philippines
• Sri Lanka
• Pakistan
• India
• Bangladesh
• Cambodia
• Laotian Peoples Republic
• Vietnam
• Myanmar Burma
• Thailand

• Egypt
• Nigeria, Gabon, Ghana, Kenya, Mali, Mozambique,
  Zimbabwe, Sudan
• Niger
• Brazil
• Europe e.g. UK, Spain, Italy, Germany,
  Netherlands
• USA
• Australia
• Lebanon
• Haiti

14
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
• Vietnam
• Antiretrovirals counterfeited antimalarials
• Africa - Some basic antibiotics have been
  counterfeited

15
PSI

• India
• PSI Pharmaceutical Security Institute -15 major
  pharmaceutical companies reports fake oncology
  drugs found in Indian hospitals injection
  actually contained generic tetracycline but was
  labelled as modern oncology medicine
• Sometimes only when a patient dies who should
  not, does anyone suspect counterfeits

16
Even in the developed world

• USA 2004
• Mislabelled anti-anaemia drug sold to wholesalers
• Lower strength relabelled as higher strength
• Cost 2,5 M but made profit of 45 M
• Counterfeit Zocor from Mexico no active
• Counterfeit carisprodol different potency
• In 2002 , fake Combivir for HIV AIDS actually
  Ziagen
• Holland 2004
• Seizure of counterfeit Lipitor 20 mg
• United Kingdom 2005
• MHRA seized counterfeit Lipitor 20 mg
• Fake asthma medication 2002
• Customs seized 231 151 fake VIAGRA in one year
• Fake Growth hormone sold to body builders -900
  per 7 vials

17
The internet

• Growth in use of Internet has increased
  counterfeit medicine trade internationally
• Technology has outstripped the ability of
  regulators to control the results of its use
• On daily basis, offers of high schedule
  prescription only medicines from virtual
  pharmacies are appearing on e-mails and the
  internet Our licensed doctors will write your
  prescription
• These websites provide an ideal entry point for
  illegal, stolen or counterfeit medicines to the
  distribution chain
• Hard to identify original source country of
  internet offers - may be several countries
  involved
• Very hard to control especially if originating
  outside SA borders. This dilemma not solved.

18
Harmful effects to public health

• Stolen medicines may not be stored correctly or
  may be redated
• making them substandard and ineffective or even
  harmful
• Peoples health is put at risk
• Also detrimental to public health
• Causes human suffering
• Burden on health services
• Patients do not respond as quickly or may not
  respond at all
• Counterfeit or substandard vaccines and
  antibiotics
• may have a deleterious effect on a wide section
  of the population

19
Harm to patients

• Directly harmful effect through
• Harmful ingredients diethylene glycol
  antifreeze. In Haiti, Nigeria, Bangladesh, India
  and Argentina gt500deaths
• Ineffective contraceptives unwanted and
  unexpected pregnancies
• Nigerian DG of Health
• claims fake drugs are responsible for growing
  number of cases of hypertension, heart failure,
  stroke and other illnesses
• Deaths have resulted from counterfeit medicines
• -SE Asian countries malariabetween 33 50
  fakes Of 1 M deaths p.a. WHO estimates 200 000
  deaths in Asia could be avoided
• -In 2001, deaths of 192 000 patients in China
  medicine reported from ineffective treatments
  with fakes.

20
Harm to the economy

• Erosion of public confidence in
• public health care systems,
• health care professionals
• the pharmaceutical industry
• regulatory and law enforcement authorities
• Detrimental to reputation and financial standing
  of original manufacturer
• Loss of almost 20 of total medicines market in
  SA to crime
• Impacts on the price of medicines for the
  legitimate buyers
• Impacts on viability of the pharmaceutical
  industry and health care delivery
• WHO highlighted reluctance of companies to report
  fake medicines in 1999

21
South Africa situation

• Theft and counterfeits result in losses of gtR 1
  R 1,5 B p.a50 of all medicines purchased by
  State lost to theft. Auditor-General
• When SA joined global market increased our
  exposure to both legal and illegal drugs
• Extent of counterfeiting is not known however
  in both the Adlam case and the Vally case,
  counterfeits were found mixed with genuine
  product
• Theft occurs in both public and private sector
• Thefts at Airports, from Customs, Military
  Institutions, State Medical Depots and
  provincial stores, Manufacturers, Hospitals,
  Clinics, Pharmacies, freight forwarders, couriers
• Hijackers and fraud

22
South AfricaCounterfeit stolen medicines

• Distribution channel provides easy entry to
  counterfeits and stolen medicines via
• wholesalers, distributors, pharmacies and mail
  order pharmacies, courier companies, parallel
  importersBeing addressed by requirement for
  licensing
• the grey market ie. secondary wholesalers and
  parallel importers, complicated the distribution
  channel and controls further Amended legislation
  outlaws grey market
• the Internet
• No successful control methods found as yet
• flea markets and other non-professional channels
  especially for unregistered medicines
• MCC aware but control system not yet fully
  operational

23
SA examples

• Crime would be reduced if there were no buyers
• Manufacturer
• Product worth R 80 000 went out with refuse
• Distributors
• Contract security companies bribed to look other
  way
• Losses of R 80 000 to R 540 000 have been
  reported.
• Community pharmacy and dispensing doctors
• Buying medicines from a car boot
• Selling to shortline wholesalers
• Examples reported September 2002

24
SA examples

• Hospitals
• Delivery to isolated Clinics linked to a hospital
• Product worth R250 000 stolen by delivery driver
• Mothers and children did not receive the intended
  medicines
• Jhb Airport
• Thieves slip product out of shrinkwrap then
  replace with empty packs or stones
• Hijackers
• Collusion with drivers
• bump on head share the spoils
• Roundtripping
• VAT fraud
• - Export products are found back on SA market

25
SA Case studies

• SA Case Adlam and partners in crime
• Investigators found deblistering equipment, and
  printers to redate labels and cartons for
  relabelling and repackaging of State Stocks
• Also removal of special markings For state use
  only on packs,
• For Derrick Adlam and partners in crime penalty
  was a slap on the wrist
• Used provision in justice system to plea
  bargain by pleading guilty to 34 counts of
  counterfeiting
• Avoided lengthy and costly trial and succeeded in
  paltry fines given the size and value of their
  illegal operation and only suspended jail
  sentences
• Vally case charges also involve some
  counterfeit medicines

26
USA

• Law Enforcement in the USA is now taking a strong
  stance people have died.
• Involvement of FDA, US Customs, US Dept of
  Justice, US Drug Enforcement Agency working
  togetherVs
• Organised crime Medicines Mafia
• Enforcement is going after organised crime
  bosses
• People and organisations involved in
  counterfeiting are frequently involved in other
  criminal activities
• Large minimum fines e.g. 250 000 and/or 10
  years in jail plus asset forfeiture
• Maximum fine is now 5 Million.e.g.
• In 2001 127 convictions Fines and forfeiture of
  29M
• In 2002 48 convictions Fines and forfeiture
  937M

27
Impact on South Africa

• Total pharmaceutical market in SA approx. R 10,5
  B per annum approx. R 2,5 -3 B to State
• Huge loss of total medicines market to crime
• Reputation of original manufacturer will be
  adversely affected if
• -any products are found to be counterfeit
• -any person suffers adverse effects or injury
  from substandard or counterfeit medicine
• Original manufacturer could suffer huge financial
  losses affecting the viability of his business in
  SA
• Impacts on the price of medicines for the
  legitimate buyers
• Impacts on continued viability and effectiveness
  of health care delivery in SA

28
No magic bullet

• Recommendations are for
• Tracking system
• Special markings
• Holograms on packaging materials,
• DNA marking on packaging or product
• Other measures for tracking the movement of
  pharmaceuticals from manufacture to final selling
  point
• RFID tagging possible in 2007
• Different colours of product
• used for tablets and capsules sold to the State
  or for Aid programmes
• needs additional stability data

29
Measures to combat illegal and counterfeit
medicines

• Internationally
• Pharmaceutical Security Institute PSI
• Industry managed and funded by 15 major
  pharmaceutical companies
• Staffed with ex FBI, Interpol
• Intergovernmental co-operation on international
  pharmaceutical crime
• Involves medicines regulatory authorities,
  police, departments of justice, customs
• Private security firms offering a variety of
  measures

30
Measures to combat illegal and counterfeit
medicines in SA

• What is needed?
• Appropriate strategies
• Political will
• Adequate funding and human resources
• Change perception at DOJ and DOH
  -Pharmaceutical theft and counterfeiting must be
  regarded as priority crimes
• Must be recognition of danger to public health
• Partnership MRA and government health, justice
  customs, police must partner private sector
  health industry and professionals
• Adequate enforcement of existing
  lawsProsecution and severe penalties including
  confiscation and destruction of the medicines and
  asset forfeiture

31
Measures to combat illegal and counterfeit
medicines in SA

• Education
• Of health care professionals and the public
• To assist in spotting illegal, stolen,
  substandard or counterfeit medicines
• Introduce special markings and tracking systems
• Ensure an effective easy reporting system for
  patients professionals to report lack of
  efficacy or unexpected adverse events
• Of distribution chain to purchase from
  legitimate, authorised and validated sources only
• to maintain an audit trail of medicines bought
• Professionals
• To be on alert for treatment failure
• Statutory councils zero tolerance
• to impose severe sanctions on members found
  guilty of manufacturing, distributing supplying
  or selling stolen or counterfeit medicines

32
Measures to combat illegal and counterfeit
medicines in SA

• Companies need to
• Ensure their security systems are sound
• Proper control systems in place
• Proper tracking of all products throughout the
  manufacturing and packing process, warehousing
  and distribution
• Proper audit trail to be in place in case of
  recalls
• 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

33
Conclusion

• Essential to recognise the potential harm to the
  public and the economy
• Treat as serious crimes the selling illegal
  unregistered medicines, stolen medicines or
  counterfeit medicines
• Partnership -All sectors of Government, the
  private sector and the public to work together to
  combat these crimes
• Training and awareness campaigns with active
  industry involvement
• DOH, MCC, SAPS, Customs and Justice to use and
  enforce legislation to prosecute and demand
  severe penalties
• All control measures to be strengthened
• Ensure all roleplayers are alert and aware of the
  dangers and are kept informed and updated

34
(No Transcript)