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Maximum Retail Price and Post Marketing Surveillance: A Reaction from National Players

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Maximum Retail Price and Post Marketing Surveillance: A Reaction from National Players

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    1. Maximum Retail Price and Post Marketing Surveillance: A Reaction from National Players Beau Agana VP-Mfg, Phil. Chamber of Pharmaceutical Industry, Inc.

    2. Collective Voice of the Filipino drug manufacturers, traders and distributors marketing branded generic medicines for the past 5 years. 100+ member-companies and growing

    3. What PCPI believes We offer Filipinos quality branded & unbranded generic medicines at a range of prices much lower than innovator brands. In many major therapeutic areas, our products have successfully grabbed significant market share from the innovators. Our measures of success: Market Share in Volume not Value Weighted Average Price of the molecule has been declining

    4. Need to revise the limited definition of “generics”. Limited definition Only company-branded & unbranded generics Expanded Definition Branded Generics Company-branded Generics Unbranded Generics

    5. Simvastatin LIMITED Definition Branded Zocor Vidastat Afordel Unbranded PHAREX Simvastatin Simvastatin, DLI EXPANDED Definition Innovator Brand Zocor Generic Brands Vidastat PHAREX Simvastatin Afordel Simvastatin, DLI

    6. Just Two Examples All data in the presentation are sourced from IMS PHIL.PHARMACEUTICAL INDEX 2ND 2008 Figures are in Philippine Pesos unless otherwise indicated.

    7. Simvastatin Value

    8. Simvastatin Volume

    9. Simvastatin Pricing

    10. Co-Amoxiclav Value

    11. Co-Amoxiclav Volume

    12. Co-Amoxiclav Pricing

    13. Maximum Retail Price Branded and Unbranded Generics have brought down Weighted Average Price of many major therapeutic areas. The New Law allows National Players to market generic counterparts on Day 1 of patent expiration. Any price control mechanism should be selective imposed on patented molecules.

    14. On Post-Marketing Surveillance

    15. PCPI believes That we accept our responsibility in maintaining quality of our products throughout the supply chain. That our members are exerting best efforts to comply with quality requirements of regulatory agency. That as important as guaranteeing the quality, efficacy & safety of medicines is

    16. PCPI Post-Marketing Surveillance is a very important element of the regulatory framework. We wholeheartedly support BFAD efforts to allocate more resources and implement better PMS strategies: Risk-based sampling strategies Assisting in capacity-building of manufacturers for CGMP Improved Pharmcovigilance programs through networks and partnerships

    17. Maraming Salamat Po!

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