Partnerships forPublic Awareness and

Patient Protection

The GPHF-Minilab Project

German Pharma Health Fund (GPHF)Global Pharmaceutical AntiCounterfeiting Forum,

Geneva, Switzerland, September 22-25, 2002

An Initiative of Research Based Pharmaceutical Companies in Germany

The German Pharma Health Fund

l Is a charitable organisation funded by voluntarycontributions of research based pharmaceuticalcompanies in Germany

l Initiates projects in developing nations with pilotcharacter for other focal points and countries

l Supports local strategies in order to improve thebasic health care system

l Solutions delivered must help local people to helpthemselves

An Initiative of Research Based Pharmaceutical Companies in Germany

GPHF-Projects

Medical Projectsl TB, AIDS, Shistosomiasis etc.

Pharmaceutical Projectsl Drug Donations in Emergency Situations

l Drug Supply Management Capacity Building

l Drug Quality Verification Programme (Minilab)

www.gphf.org

Global Trade in Counterfeit Medicines

Incorrect ingredient

16%

Correct ingredient

7%

No active ingredient

60%

Incorrect amount

17%

Percentagebreakdown of data on325 of 771 cases ofsubstandard drugs -including antibiotics,antimalarials andantituberculosis drugs- reported from aroundthe world to WHOdatabase between1982 and 1999

Global Trade in Counterfeit Medicines

Fake and Substandard drugs cause treatmentfailure and waste money

An Initiative of Research Based Pharmaceutical Companies in Germany

Dangers of Tradein Counterfeit Medicines

Get Sick, Quick: The dangers of counterfeit drugsTempo, Indonesia, September 3-10, 2001

Malaria: Dozens dead in Cambodia fromcounterfeit drugs United Nations Wire May 30, 2000

What‘s in that pill? In Latin America fake drugsare as lucrative as cocaineBusiness Week, June 18, 2001

Fake Antimalarials in Southeast Asia

Genuine Hologram Fake Hologram

An Initiative of Research Based Pharmaceutical Companies in Germany

AntiCounterfeiting Measures

A Shared Responsibility Solved Best by Partnership between

- Authorities- Industry- Distributors- Consumers

An Initiative of Research Based Pharmaceutical Companies in Germany

AntiCounterfeiting Measures

Authority Contribution

• Registration and surveillance

• Reliable enforcement

• Punishment by capital law

• Information campaigns

An Initiative of Research Based Pharmaceutical Companies in Germany

AntiCounterfeiting Measures

Authority Contribution (cont‘d)

Adding Ressources to

Drug Regulatory

Drug Inspection

Drug Quality Control

Enforcement

Detection of fake drugs …

… needs dedication, passion, motivation and money

An Initiative of Research Based Pharmaceutical Companies in Germany

AntiCounterfeiting Measures

Industry Contribution

• Qualified staff, housing and equipment

• Strict batch control and documentation

• Independent Bureau of Investigation (PSI)

• Authentic dosage forms and packaging

Authentic Packaging

Printing

Mixing of diffent print techniquesincluding micro text

Colours

Thermoaktive coloursUV detectable coloursChemical active coloursCoin reactive panels

Microencapsulation

Colours and fragances, bothelectronically detectable

Engraving

Multilayer foils with specialeffects Hologramms

2 D HologrammDigital ImageMulti channel effects

Embossing

Laser technologyMicro text

Labels

CodesMikrochips

An Initiative of Research Based Pharmaceutical Companies in Germany

AntiCounterfeiting Measures

Distribution Channel Contribution/Regulation

• Licensed importers, wholesalers, retailers withqualified staff and pharmacy departments only

• Tied distribution channel with a limited numberof levels and suppliers

An Initiative of Research Based Pharmaceutical Companies in Germany

AntiCounterfeiting Measures

Consumer Contribution

• Drug purchase from pre-qualifiedsuppliers only

• Capacity gap closing on drug qualitytesting

GPHF AntiCounterfeiting Solutions

Information Education

TrainingMinilab

An Initiative of Research Based Pharmaceutical Companies in Germany

Information

Principles• Delivering facts and information about the danger of trade in counterfeit medicines and

its danger to health

• Not hiding the problem but not exaggeratingor panic making

• Finding common sense and understanding ofminimum quality standards

An Initiative of Research Based Pharmaceutical Companies in Germany

Information

Two Principle Messages

• Trading in Counterfeit Medicines isDangerous and Detrimental to Health

• Sugar Pills Labelled as Antimalarialsare a Crime

An Initiative of Research Based Pharmaceutical Companies in Germany

Information

Target Groups• Expert Communities

Doctors, Pharmacists, Hospitals, Authorities,Industry, Wholesalers, Retailers, public, privateand religious driven Development Agencies andRelief Organisations

• The General Public

An Initiative of Research Based Pharmaceutical Companies in Germany

Information

Instruments• Information material

Brochures, posters, videos etc. for a broaddissemination down to primary health facilities

• Public RelationInformation material to expert panels,

journals, programmes, projects and fullset of media for multiplication purposes

An Initiative of Research Based Pharmaceutical Companies in Germany

GPHF Activities

Information

Broschures 16,000Posters 600Videos 500Presentations 60Media Reports 300

Information

GPHFPoster

An Initiative of Research Based Pharmaceutical Companies in Germany

Information

Instruments (continued)

• InternetInformation displayed, exchanged and linkedto other existing health information networks

www.gphf.org

• Direct ContactPresentations on health projects, programmesand faires, expert meetings and conferences

Information

GPHF-Minilab

atEXPO2000

Education & Training

The GPHF-MinilabProject

Closing thecapacity gap

on drug qualitycontrol

An Initiative of Research Based Pharmaceutical Companies in Germany

GPHF-Minilab Solution

Protection against counterfeitsand substandard drug products

Simple drug quality testingand patient protection in developing nations

Features of the GPHF-Minilab• Cotrimoxazole• Erythromycin• Ethambutol• Furosemide• Glibenclamide• Griseofulvin• Isoniazid• Mebendazole• Mefloquine• Metamizole• Metronidazole

• AcetylsalicylicAcid

• Aminophylline• Amoxicillin• Ampicillin• Artesunate• Cefalexine• Chloramphenicol• Chloroquine• Ciprofloxacin• Cloxacillin

• Paracetamol• Penicillin V• Prednisolone• Pyrazinamide• Quinine• Rifampicin• Salbutamol• Sulfadoxine/ Pyrimethamine• Tetracycline

Features of the GPHF-Minilab1. Verification of Product Integrity2. Verification of Drug Availability3. Verification of Drug Identitity4. Verification of Drug Content

Minilab Operation Cost Estimate

One Minilab (1000 assays) 2550 €Transport to country ~ 650 €Transport in country ~ 100 €Duties (Range from 0 to 2000 €) ~ 1000 €Total cost estimate ~ 4300 €

One-week training option adds costs for travel expenses (~ 2500 €)and fees (450 €/Person)

For comparison purposes: based on the estimate above, the price forone Minilab assay is about 4 €, for one assay in a fully fledged labora-tory in India about 100 € and in Europe about a 1000 €

An Initiative of Research Based Pharmaceutical Companies in Germany

Region MinilabsWorld 85 (100%)Africa 60 ( 71%)Asia 14 ( 17%)Europe 8 ( 9%)Caribbean 2 ( 2%)Latin America 1 ( 1%)

Number of Countries 25

Current Use of GPHF-Minilabs

Education & Training

10 Training Sessionsin Ghana, Tanzania,Kenya, Philippines,

Nepal and India

Education & Training

350 copiesdisseminated tohealth facilitiesin more than30 countries

Information & Education

Adhoc information asemergency responseto counterfeit attacks

on antimalarialsin southeast Asia

An Initiative of Research Based Pharmaceutical Companies in Germany

Domestic Minilab Project Partners

German Technical CooperationGerman Protestant Institute for Medical MissionGerman Catholic Medical Mission InstituteGerman Protestant Overseas ServiceGerman Doctors for Developing CountriesGerman Medicines Aid „Action Medeor“German-Ghanaian Economic AssociationGerman Association of Research-Based Pharmaceutical CompaniesMalteser Order International ServiceTechnology Transfer MarburgUniversities of Bonn, Düsseldorf and Saarland

An Initiative of Research Based Pharmaceutical Companies in Germany

International Minilab Project Partners

World Health OrganizationFood and Drug Board of GhanaPharmacy Board of TanzaniaFaculty of Pharmacy, University of KabulEPOS Basic Health Project in North IndiaOrganisation of Eastern Caribbean StatesAfrican Medical and Research Foundation of KenyaPharmaceutical Chamber (ANDI) of ColombiaMemisa Medicus Mundi of SpainMissio of Bozenen-Brixen in ItalyConférence Episcopale TogoCatholic Drug Centre of GhanaEvangelical Lutheran Church of Tanzania (Infusion Unit Project) …