International and ANVISA Traceability Requirements

Transcription

1 International and ANVISA Traceability Requirements 1 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev Supply Chain Issues 2. COUNTERFEITING 3. Worldwide Initiatives - General Overview 4. Worldwide Initiatives (Analysis Coding & tecniques Recommandations by EFPIA, epedegree, Brazilian Resolution) 5. Worldwide Iniziative Technology Overview 6. Worldwide Initiatives - Track&Trace Solutions 7. Worldwide Mandatory Requirements The Brazilian Resolution 2 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev Supply Chain & Counterfeiting 3 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

2 normally the issue of traceability is related to the distribution phase of finished product, but we ve to remind that is a matter of the whole supply chain 4 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 Challenges Presented by Globalization More foreign facilities supplying the U.S. and EC Increasing volume of imported products More outsourcing of manufacturing Greater complexity in supply chains Imports coming from countries with less well developed regulatory systems Greater opportunities for economic fraud 5 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 Manufacturer Wholesaler(s) Pharmacist 6 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

3 7 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

4 Highlight some desired parameters of the Supply Patient Safety and Patient Trust (on Product and Manufacturer) Supply Chain Efficiency (costs/time/availability / ) Market Volume (& Value) Quality on Supply Chain (is the final part of the product life cycle) Harmonization and Control 10 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 Focusing on some of the Major Problems, we will identify: Stock Management (&availability) Product Localization (Logistic, Strategy, ) Supply Chain Traceability Plus the emerging Phenomenon of COUNTERFEITING 11 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 EFPIA: White paper on the anti-counterfeiting of medicines (November 2005) 12 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

5 13 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 Security Complexity Patient safety Uninterrupted supply chain to patients Regulatory compliance Operational excellence and inventory control Regional capabilities and access Produt supply strategies Customer service levels 14 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev COUNTERFEITING 15 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

6 The common definition of Counterfeit is: A medicine that is deliberately and fraudulently MISLABELED with respect to identity and/or source Counterfeiting can be applied to both branded and generic products and counterfeit products may include: products with the correct ingredients or with the wrong ingredients without active ingredients with insufficient active ingredients or with fake packaging 16 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 A counterfeit medicine is any non-authentic tablet, capsule and/or packaging that appears the same as an authentic product Counterfeit medicines are frequently, deliberately and knowingly sold in the legitimate supply chain How can anyone tell the difference? 17 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 Counterfeit medical products put patients at risk. They undermine the credibility of health systems, waste money, and reduce confidence in the authorities responsible for public safety Dr. Margaret Chan - Director General WHO, January Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

7 Counterfeiting is an increasing business 10% of the overall good is counterfeited (estimated) Medicines and Medical Devices are the third counterfeited category The WHO estimates that 8-10% of the world's supply of medicines is counterfeit Counterfeit medicines estimated volume in 2010: $ 200 billion. 50% of products sold via the internet could be counterfeit or have a lower quality 30% of certain drugs consumed in developing countries is counterfeit 19 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev HEROIN VIAGRA (sildenafil citrate) Cost: Cost of active ingredient: 237 /Kg Street value: ,00 /Kg 47 /Kg Street /Kg value: Counterfeiting is shown to be significantly more profitable than illicit drugs 20 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 No active pharmaceutical ingredient (Norvasc Canada) Wrong active pharmaceutical ingredient (Lipitor UK) Too much active pharmaceutical ingredient (Viagra South Korea) Completely different active pharmaceutical ingredient (Viagra Hungary) Toxic substances (Ponstan Columbia) 21 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

8 Counterfeits dispensed via the internet were manufactured at this site in china. The network included hundreds of brokers in US and EU. 22 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 Not just patent protected medicines: Pfizer is seeing increases in counterfeiting of its off-patent medicines such as Lincocin (an antibiotic), Cytotec (used to protect against stomach ulcers caused by pain medication) and Xanax (to treat panic disorders) Not just lifestyle medicines: range of medicines counterfeited now includes biologicals (Pfizer has seen its growth hormone Genotropin counterfeited in Sweden 2007 and South Africa 2008) Not just high value medicines: recent seizures have included the Medi-fake EU-wide operation in which over 34 million illegal medicines were seized in only a two-month period. This included the biggest single seizure of illegal medicines ever recorded in Europe at Brussels airport: reportedly 2.2 million tablets (including 1.6 million painkillers) increasingly life-saving medicines are at risk PDA-EMEA 2009 Joint Conference Andrew Bonser Pfizer 23 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev Worldwide Initiatives (General Overview) 24 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev

9 DATA DATA DATA DATA DATA POINT OF ENTRY MANUFACTURE DISTRIBUTOR WHOLESALE POINT OF EXIT RETAIL PHARMACY PATIENT Have to be Under Control 25 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev. 1.0 Proposed Draft EU legislation recommends measures to increase the security of medicines and the medicines supply chain; Measures to enforce Good Manufacturing and Good Distribution Practices Measures to improve supervision of actors in the distribution chain (e.g. wholesalers, traders) Measures to improve the security and safety of Active Pharmaceutical Ingredients Prescription medicines may need to have: Covert, overt, and forensic devices Tamper evident features Identification at individual pack level 26 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev but.. o how to identify individual packs? o what type of technology is needed? o how can it be applied across Europe and integrated into differing national requirements/technologies? 27 Buenos Aires ETIF International and ANVISA Traceability Requirements G. Rossi 2010 rev