Partnerships for Public Awareness and Patient Protection The GPHF-Minilab Project

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1 Partnerships for Public Awareness and Patient Protection The GPHF-Minilab Project German Pharma Health Fund (GPHF) Global Pharmaceutical AntiCounterfeiting Forum, Geneva, Switzerland, September 22-25, 2002

2 The German Pharma Health Fund Is a charitable organisation funded by voluntary contributions of research based pharmaceutical companies in Germany Initiates projects in developing nations with pilot character for other focal points and countries Supports local strategies in order to improve the basic health care system Solutions delivered must help local people to help themselves

3 GPHF-Projects Medical Projects TB, AIDS, Shistosomiasis etc. Pharmaceutical Projects Drug Donations in Emergency Situations Drug Supply Management Capacity Building Drug Quality Verification Programme (Minilab)

4 Global Trade in Counterfeit Medicines

5 Global Trade in Counterfeit Medicines Fake and Substandard drugs cause treatment failure and waste money Incorrect ingredient 16% Incorrect amount 17% Percentage breakdown of data on 325 of 771 cases of substandard drugs - including antibiotics, antimalarials and antituberculosis drugs - reported from around the world to WHO database between 1982 and 1999 Correct ingredient 7% No active ingredient 60%

6 Dangers of Trade in Counterfeit Medicines Get Sick, Quick: The dangers of counterfeit drugs Tempo, Indonesia, September 3-10, 2001 Malaria: Dozens dead in Cambodia from counterfeit drugs United Nations Wire May 30, 2000 What s in that pill? In Latin America fake drugs are as lucrative as cocaine Business Week, June 18, 2001

7 Fake Antimalarials in Southeast Asia Genuine Hologram Fake Hologram

8 AntiCounterfeiting Measures A Shared Responsibility Solved Best by Partnership between - Authorities - Industry - Distributors - Consumers

9 AntiCounterfeiting Measures Authority Contribution Registration and surveillance Reliable enforcement Punishment by capital law Information campaigns

10 AntiCounterfeiting Measures Authority Contribution (cont d) Adding Ressources to Drug Regulatory Drug Inspection Drug Quality Control Enforcement

11 Detection of fake drugs needs dedication, passion, motivation and money

12 AntiCounterfeiting Measures Industry Contribution Qualified staff, housing and equipment Strict batch control and documentation Independent Bureau of Investigation (PSI) Authentic dosage forms and packaging

13 Authentic Packaging Printing Mixing of diffent print techniques including micro text Engraving Multilayer foils with special effects Mikrochips Embossing Laser technology Micro text Colours Thermoaktive colours UV detectable colours Chemical active colours Coin reactive panels Microencapsulation Colours and fragances, both electronically detectable Labels Hologramms 2 D Hologramm Digital Image Multi channel effects Codes

14 AntiCounterfeiting Measures Distribution Channel Contribution/Regulation Licensed importers, wholesalers, retailers with qualified staff and pharmacy departments only Tied distribution channel with a limited number of levels and suppliers

15 AntiCounterfeiting Measures Consumer Contribution Drug purchase from pre-qualified suppliers only Capacity gap closing on drug quality testing

16 GPHF AntiCounterfeiting Solutions Information Education Training Minilab

17 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 exaggerating or panic making Finding common sense and understanding of minimum quality standards

18 Information Two Principle Messages Trading in Counterfeit Medicines is Dangerous and Detrimental to Health Sugar Pills Labelled as Antimalarials are a Crime

19 Information Target Groups Expert Communities Doctors, Pharmacists, Hospitals, Authorities, Industry, Wholesalers, Retailers, public, private and religious driven Development Agencies and Relief Organisations The General Public

20 Information Instruments Information material Brochures, posters, videos etc. for a broad dissemination down to primary health facilities Public Relation Information material to expert panels, journals, programmes, projects and full set of media for multiplication purposes

21 Information GPHF Activities Broschures 16,000 Posters 600 Videos 500 Presentations 60 Media Reports 300

22 Information GPHF Poster

23 Information Instruments (continued) Internet Information displayed, exchanged and linked to other existing health information networks Direct Contact Presentations on health projects, programmes and faires, expert meetings and conferences

24 Information GPHF- Minilab at EXPO 2000

25 The GPHF- Minilab Project Closing the capacity gap on drug quality control Education & Training

26 GPHF-Minilab Solution Protection against counterfeits and substandard drug products Simple drug quality testing and patient protection in developing nations

27 Features of the GPHF-Minilab Acetylsalicylic Acid Aminophylline Amoxicillin Ampicillin Artesunate Cefalexine Chloramphenicol Chloroquine Ciprofloxacin Cloxacillin Cotrimoxazole Erythromycin Ethambutol Furosemide Glibenclamide Griseofulvin Isoniazid Mebendazole Mefloquine Metamizole Metronidazole Paracetamol Penicillin V Prednisolone Pyrazinamide Quinine Rifampicin Salbutamol Sulfadoxine/ Pyrimethamine Tetracycline

28 Features of the GPHF-Minilab 1. Verification of Product Integrity 2. Verification of Drug Availability 3. Verification of Drug Identitity 4. Verification of Drug Content

29 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 for one Minilab assay is about 4, for one assay in a fully fledged laboratory in India about 100 and in Europe about a 1000

30 Current Use of GPHF-Minilabs Region Minilabs World 85 (100%) Africa 60 ( 71%) Asia 14 ( 17%) Europe 8 ( 9%) Caribbean 2 ( 2%) Latin America 1 ( 1%) Number of Countries 25

31 Education & Training 10 Training Sessions in Ghana, Tanzania, Kenya, Philippines, Nepal and India

32 Education & Training 350 copies disseminated to health facilities in more than 30 countries

33 Information & Education Adhoc information as emergency response to counterfeit attacks on antimalarials in southeast Asia

34 Domestic Minilab Project Partners German Technical Cooperation German Protestant Institute for Medical Mission German Catholic Medical Mission Institute German Protestant Overseas Service German Doctors for Developing Countries German Medicines Aid Action Medeor German-Ghanaian Economic Association German Association of Research-Based Pharmaceutical Companies Malteser Order International Service Technology Transfer Marburg Universities of Bonn, Düsseldorf and Saarland

35 International Minilab Project Partners World Health Organization Food and Drug Board of Ghana Pharmacy Board of Tanzania Faculty of Pharmacy, University of Kabul EPOS Basic Health Project in North India Organisation of Eastern Caribbean States African Medical and Research Foundation of Kenya Pharmaceutical Chamber (ANDI) of Colombia Memisa Medicus Mundi of Spain Missio of Bozenen-Brixen in Italy Conférence Episcopale Togo Catholic Drug Centre of Ghana Evangelical Lutheran Church of Tanzania (Infusion Unit Project)

LOGO. Falsification of Medicines. Drug Chemistry and Technology Basics, Cleaner Production and Mega-Trends in Pharmaceutical Industry

LOGO. Falsification of Medicines. Drug Chemistry and Technology Basics, Cleaner Production and Mega-Trends in Pharmaceutical Industry LOGO Drug Chemistry and Technology Basics, Cleaner Production and Mega-Trends in Pharmaceutical Industry Falsification of Medicines Dr. As. Prof. Anastasiya Sladkova Dr. Sci. Prof. Natalya Loginova 1 Questions