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Balancing Regulation Against Access to Innovative Pharmaceuticals. Vicki Ehrich Chief Operating Officer PIASA 25 July 2007. Benefits of local industry investment and presence. Registration and ‘early’ launch of new medicines Local investment in education and training
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Balancing Regulation Against Access to Innovative Pharmaceuticals Vicki Ehrich Chief Operating Officer PIASA 25 July 2007
Benefits of local industry investment and presence • Registration and ‘early’ launch of new medicines • Local investment in education and training • Local investment in clinical research • Industry investment in therapeutic areas • Local supply to State Sector • Skills and technology transfer • Pipeline for generic medicines
Attracting Pharmaceutical Investment • Financial Incentives • Stimulation of Innovation • Secure IP Framework • Efficient regulatory framework • Large volume / funded market • Access to high level skills pool
IP Framework • Bolar provision • Data protection • Compulsory licensing/parallel imports • Voluntary licensing
Large volume / funded market • ‹ 1% world market • No developed regional market • No regulatory harmonization • Stagnant private market • Low value government market • Little access to donor demand • Global competitiveness? • Export incentives?
Members of PIASA Abbott Laboratories South Africa (Pty) Ltd Adcock Ingram Healthcare (Pty) Ltd Alcon Laboratories (Pty) Ltd Altana Madaus (Pty) Ltd Astra Zeneca Pharmaceuticals (Pty) Ltd Bayer Schering Pharma (Pty) Ltd Boehringer Ingelheim (Pty) Ltd Bristol-Myers Squibb (Pty) Ltd Galderma Laboratories (Pty) Ltd GE Health (Pty) Ltd Genop Healthcare (Pty) Ltd GlaxoSmithKline South Africa (Pty) Ltd iNova Pharmaceuticals (Pty) Ltd Janssen-Cilag (Pty) Ltd Key Oncologics (Pty) Ltd Merck (Pty) Ltd Novo-Nordisk (Pty) Ltd Schering-Plough (Pty) Ltd Sekunjalo Health Care Ltd Servier Laboratories SA Pty) Ltd Solvay Pharma (Pty) Ltd Stiefel Laboratories (Pty) Ltd Tyco Healthcare (Pty) Ltd UCB Pharma South Africa (Pty) Ltd Wyeth South Africa (Pty) Ltd