WELDING GMBH & CO. KG - POSTBOX D HAMBURG 2005 km Is there a problem?

Transcription

1 Counterfeit in the API Supply Chain Karl Metzger, Welding GmbH & Co. KG, Hamburg Is there a problem? What are we talking about Piracy - Software - CDs - DVDs Counterfeit - T-Shirts - Medicinal Products - Sunglasses - Watches - Money - Sportshoes

2 Counterfeit Medicine What are we talking about: WHO Definition A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply both to branded or generic products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or false packaging. Counterfeit Medicine The definition of counterfeit medicinal products should be made more clearly: Proposal A counterfeit medicinal product is a product that is not the medicinal product which it pretends to be. This means that every medicinal product in the market that does not comply with its Marketing Authorization is counterfeit medicine regardless if the non-compliance was caused by - fraud, - (gross) negligence or - accident

3 Just panic or a real challenge? What are we talking about: Estimations and... No exact data are available on the number of Counterfeit Medicines. Different estimations state that from 7% to 33% of the medicinal products in the European market are Counterfeit Medicines. ~40% of the medicinal products in Latin America (mainly Argentina, Colombia, Mexico) are Counterfeit Medicines. ~70% of the medicinal products in West Africa are Counterfeit Medicines. Counterfeit in numbers What are we talking about:... offical figures ~100 children died in Haiti after ingestion of cough syrup containing a highly contaminated excipient >10 people died in the USA after ingestion of medicinal products containing Gentamycine from non-traceable sources ~200,000 people in China die per year caused by Counterfeit Medicines in one Member State of the EU the staff of the police focusing on Counterfeit Medicines was reduced by ~80%

4 Description of the Situation Due to - a lack of supervision and a - more and more competitive market higher incentive to counterfeit medicines Counterfeit is a world-wide problem. It is not limited to certain types of products or 3 rd world countries. Probably the type of counterfeit varies in different regions. Description of the Situation Counterfeit may appear at each step of the legal(?) distribution chain Counterfeit does not only arise from active fraud but from passive gross negligence as well.

5 Why Counterfeit? single entrepreneurs organized crime Lack of Ethics Relation of Quality and Price A cheap price is a shortcut to being cheated (Kong Fu Zi (Confucius, BC)) Source: John Ruskin ( ) There is hardly anything in the world that some man cannot make a little worse and sell a little cheaper, and the people who consider price only are this man's lawful prey. It's unwise to pay too much, but it's unwise to pay too little. When you pay too much you lose a little money that is all. When you pay too little you sometimes lose everything, because the thing you bought was incapable of doing the thing it was bought to do. The common law of business balance prohibits paying a little and getting a lot it cannot be done. If you deal with the lowest bidder, it is well to add something for the risk you run. And, if you do that, you will have enough to pay for something better.

6 G ood Manipulation P ractice Typical non-compliance issues in the API supply chain the Gentamycin Case Road map of Gentamycine M1 M3 M4 M5 M6 M7 M8 M9 M10 M11 A B C M2 Manufacturer in China Sources in China BT1 BT3 BT4 BT5 BT6 BT7 BT2 Broker/Trader in Europe Manufacturers of Medicinal Products in Germany Source: U. Holzgrabe: Quality of APIs results of a research of different Gentamycin products, 6th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients, Budapest, 2003 European Manufacturer

7 Common practice or exception? Blending - of different batches - with different qualities - from different manufacturers It s your turn! How can this be detected? - Audits / Inspections Who can detect it? - Customer (Medicinal Product manufacturer) - Authorities Which skills (and tools) are needed? - detailed knowledge of the supply chain - appropriate analytical methods

8 Common practice or exception? Neutralisation - Erasing of relevant information to decrease the traceability back to the original manufacturer, etc. It s your turn! How can this be detected? - Controls during receipt of goods - Audits / Inspections Who can detect it? - Customer (Medicinal Product manufacturer) - Authorities Which skills (and tools) are needed? - Good Common Sense

9 Common practice or exception? Submission of / reference to a DMF/ASMF of a compliant source but use of an other sub-standard API for the manufacturing of a medicinal product It s your turn! How can this be detected? - Assessment of data - Inspections Who can detect it? - Authorities Which skills (and tools) are needed? - Experience

10 Common practice or exception? Purchasing - from unidentified manufacturers - via non-qualified suppliers It s your turn! How can this be detected? - Inspections Who can detect it? - Authorities Which skills (and tools) are needed? - Experience

11 Common practice or exception? Contract Manufacturing - from 9 to 5 for the client - From 5 to 9 on the toll manufacturers account It s your turn! How can this be detected? - Audits / Inspections Who can detect it? - Contract giver - Authorities Which skills (and tools) are needed? - Basic knowledge of book keeping

12 Current initiatives Counteract the Counterfeiters! WHO FDA TGA Council of Europe - Stakeholder Survey views on best co-operation practices, measures and experiences applicable to counterfeit (falsified, fake) medicines (January 2005) - Seminar Counteract the Counterfeiters (Palais de l Europe, Strasbourg, September 2005) Responsible Parties that should be aware Increasing awareness Source: Council of Europe Seminar Counteract the Counterfeiters (Strasbourg, September 2005) Medicines Regulators Customs/Border Police State/Local Police Judicary Other Government Agencies -Trade - Health -Tax - Asset Seizing - Anti-Corruption - Consumer Protection - Education - Laboratories Healthcare Professionals -Doctors -Nurses - Pharmacists - Wholesalers/Distributors Anyone else? - Public

13 Tools to Counteract the Counterfeiters Increasing resources Legislation Money Equipment Personnel Information Mainly from the Holder of the Marketing Authorisation (Product information, Details of Packaging Material, ) Source: Council of Europe Seminar Counteract the Counterfeiters (Strasbourg, September 2005) Training Increasing skills How should the training be provided? What training should be provided? Basic Training Joint Training Train-the-Trainer Training Material (e.g. slides, videos, CDs/DVDs, e-learning) Source: Council of Europe Seminar Counteract the Counterfeiters (Strasbourg, September 2005)

14 Who should deliver it? Sharing knowledge Authorities? Industry? (infringing competition or anti-corruption laws/policies?) Experts! (e.g. retired) - Pharmacists - Investigators - Custom s Officers Source: Council of Europe Seminar Counteract the Counterfeiters (Strasbourg, September 2005) Which Member States are the priority for training? Detecting the weak points Risk Assessment Target countries for entering the market Countries of origin Source: Council of Europe Seminar Counteract the Counterfeiters (Strasbourg, September 2005) Countries with - lack of experience - lack of information

15 RF-ID a simple calculation (example) You think RF-ID will be the appropriate tool to counteract counterfeit? Are you serious? You better spend some of the money to improve the quality and security of your supply chain! Medicinal Product - Price of API: 5 /kg - Formulation with 500 mg API/unit - Package with 20 units API costs: 0.05 /package RF-ID - Costs for the RF-ID - Costs for the infrastructure Conclusion Raising awareness Improving skills The term Counterfeit Medicinal Product should be defined more unambigious and clearly Regulations and responsibilities should be laid down Appropriate structures should be set up

16 Quality is never an accident. It is always the result of intelligent effort. Source: John Ruskin ( )