Dr. Valerio Reggi

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  • First of all, what is Known Good Quality? Known Good Quality refers to vaccines which are licensed, controlled and released by an NCA which exercises the six critical control functions and there are no unresolved quality problems reported The six critical control functions are those which have been determined by the WHO Expert Committee on Biological Standardization, an expert group drawn from a panel representing the most knowledgeable authorities from all regions of the world, to be essential to the task of a competent and independent NCA. The need for their exercise will vary with the vaccine source.
  • First of all, what is Known Good Quality? Known Good Quality refers to vaccines which are licensed, controlled and released by an NCA which exercises the six critical control functions and there are no unresolved quality problems reported The six critical control functions are those which have been determined by the WHO Expert Committee on Biological Standardization, an expert group drawn from a panel representing the most knowledgeable authorities from all regions of the world, to be essential to the task of a competent and independent NCA. The need for their exercise will vary with the vaccine source.
  • First of all, what is Known Good Quality? Known Good Quality refers to vaccines which are licensed, controlled and released by an NCA which exercises the six critical control functions and there are no unresolved quality problems reported The six critical control functions are those which have been determined by the WHO Expert Committee on Biological Standardization, an expert group drawn from a panel representing the most knowledgeable authorities from all regions of the world, to be essential to the task of a competent and independent NCA. The need for their exercise will vary with the vaccine source.
  • First of all, what is Known Good Quality? Known Good Quality refers to vaccines which are licensed, controlled and released by an NCA which exercises the six critical control functions and there are no unresolved quality problems reported The six critical control functions are those which have been determined by the WHO Expert Committee on Biological Standardization, an expert group drawn from a panel representing the most knowledgeable authorities from all regions of the world, to be essential to the task of a competent and independent NCA. The need for their exercise will vary with the vaccine source.
  • First of all, what is Known Good Quality? Known Good Quality refers to vaccines which are licensed, controlled and released by an NCA which exercises the six critical control functions and there are no unresolved quality problems reported The six critical control functions are those which have been determined by the WHO Expert Committee on Biological Standardization, an expert group drawn from a panel representing the most knowledgeable authorities from all regions of the world, to be essential to the task of a competent and independent NCA. The need for their exercise will vary with the vaccine source.
  • First of all, what is Known Good Quality? Known Good Quality refers to vaccines which are licensed, controlled and released by an NCA which exercises the six critical control functions and there are no unresolved quality problems reported The six critical control functions are those which have been determined by the WHO Expert Committee on Biological Standardization, an expert group drawn from a panel representing the most knowledgeable authorities from all regions of the world, to be essential to the task of a competent and independent NCA. The need for their exercise will vary with the vaccine source.
  • My second point is that we should join forces with all stakeholders and improve coordination and synergies at the international level. What is IMPACT? It is the first attempt at coordinating international efforts of governments, intergovermental organizations and global NGOs. Combating counterfeit medicines requires that we join forces and that we all play our specific roles in a concerted and coordinated way. IMPACT, functioning on the basis of existing structures/institutions, aims at achieving results!
  • Dr. Valerio Reggi

    1. 1. a WHO initiative to combat counterfeit medical products Dr V. Reggi - World Health Organization
    2. 2. WHO definition “ a medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients, with the wrong ingredients, without active ingredients, with the incorrect amount of active ingredients or with fake packaging”
    3. 3. A counterfeit medical product is …. …… not a medical product! Arbitrary and unpredictable composition Manufactured evading regulatory control Manufactured and sold hiding its real origin Meant to deceive, unsafe
    4. 4. It is not primarily an IP issue! It is mainly a personal and public health problem! Medical products are not bags, CDs, watches or T-shirts! A counterfeit medical product …. 2005: 3 women killed in Argentina by a counterfeit iron preparation 2006: 300+ people killed in Panama by mislabelled glycerine
    5. 5. … jeopardizes the credibility of health care delivery systems, pharmaceutical supply systems, … and governments! A counterfeit medical product ….
    6. 6. IMPACT is a taskforce launched by WHO to gather all the most important international actors in the fight against the counterfeiting of medical products IMPACT aims at coordinating global action in order to promote and protect public health. What is IMPACT ?
    7. 7. “ IMPACT approach”: collaboration among all those concerned is essential FAKE MEDICAL PRODUCTS OTHER PUBLIC SECTOR INSTITUTIONS MANUFACTURERS DISTRIBUTION SYSTEM PATIENTS PERIPHERAL PUBLIC SECTOR INSTITUTIONS BORDER CONTROL AUTHORITIES POLICE & OTHER ENFORCEMENT AUTHORITIES HEALTH PROFESSIONALS DRUG REGULATORY AUTHORITIES JUDICIARY MEDIA
    8. 8. IMPACT AFTER 1 YEAR <ul><li>Secretariat: WHO </li></ul><ul><li>5 working groups: </li></ul><ul><ul><li>legislative and regulatory infrastructure </li></ul></ul><ul><ul><li>regulatory implementation </li></ul></ul><ul><ul><li>enforcement </li></ul></ul><ul><ul><li>technology </li></ul></ul><ul><ul><li>communication </li></ul></ul>
    9. 9. LEGISLATIVE & REGULATORY INFRASTRUCTURE http://www.who.int/entity/impact/events/FinalPrinciplesforLegislation.pdf
    10. 10. ENFORCEMENT <ul><li>Coordination of operations among participating countries </li></ul><ul><li>Internet monitoring and purchases </li></ul><ul><li>Training materials and manuals to improve skills of enforcement officers </li></ul><ul><li>Improve information exchange </li></ul>
    11. 11. INTERPOL and WHO are strengthening their collaboration to support countries to combat counterfeit medical products
    12. 12. ENFORCEMENT “ ASEAN+China” Conference - November 2007, Jakarta 10 ASEAN Member Countries + China Drug regulatory authorities, police, customs, associations of health professionals, manufacturers, wholesalers, NGOs. Result : - launched the establishment of a SPOC-based network; - preparatory work for new coordinated operation (in the wake of Jupiter South-East Asia operation that lead to identifying source of counterfeit antimalarials)
    13. 13. IMPACT toolkit <ul><li>Experience from different countries; </li></ul><ul><li>Model legislation & regulations; </li></ul><ul><li>Training materials and methodologies; </li></ul><ul><li>Tools and manuals to assist national authorities in implementing activities; </li></ul><ul><li>Tools and methodologies for the assessment of national/regional situations. </li></ul>
    14. 14. What can countries do? <ul><li>Strengthen legislation ensuring a) counterfeiting medical products is a crime and b) punishment is commensurate to the consequences that it has on personal health and on the credibility of national health systems. </li></ul><ul><li>Strengthen regulatory oversight (including in so-called ‘free zones’) ensuring that all manufacturers, importers, exporters, distributors and retailers comply with the appropriate requirements that are necessary for a secure distribution chain. </li></ul><ul><li>Improve collaboration among governmental entities (such as health, police, customs, local administrative units, judiciary), private sector and civil society in order to effectively combat counterfeiters. </li></ul><ul><li>Develop a communication strategy to ensure that health professionals, the general public and the media are aware of the dangers associated with counterfeit medicines. </li></ul>
    15. 15. Thank you www.who.int/impact

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