Areas of Work Regulatory System Strengthening Access and

Areas of Work • Regulatory System Strengthening • Access and Rational Use • Blood, Radiological and Pharmaceutical Services

Regulatory System Strengthening • Systems approach/ Across all technologies. Contemplate the specificities off specific technologies • Exchange of Information: REPs (regulatory exchange platform secure) • Pan American Journal of Public Health: special issue (june 2016) • PANDRH: new Strategic Plan, Conference : October 2016, MEX • CRS: Caribbean Regulatory System 2 Title of the Presentation

Regulatory Strengthening: Assessment, monitor and evaluation

Access and Rationale Use • New doc on developing a Pharmaceutical Policy • Rational Use Strategy for PAHO MS • Agreement with GF on Supply chain management strengthening: direct TC for target countries 4 Title of the Presentation

Growing Participation of Member States

SF: types of commodities and criteria for selection Evidenceinformed WHO Essential Medicines Diagnostics Vector control Other Strategic Medicines Costeffectiveness Equity/ vulnerability Public Health impact 6

Pooling Demand / Reducing Price for Darunavir 600 mg tablet (USD) PAHO SF $ 1. 42 Country 1 $ 4. 24 Country 2 $ 2. 88 Country 3 $ 6. 57 Country 4 $ 6. 83 Country 5 $ 4. 72 Country 6 $ 6. 80 Country 7 $ 10. 86 Country 8 $ 7. 00 Country 9 $ 1. 43 Country 10 $ 3. 16 $- 7 $ 2. 00 $ 4. 00 $ 6. 00 $ 8. 00 $ 10. 00 $ 12. 00

Supporting Expansion of Treatment and Care 70, 000 Units of Antiretrovirals 60, 000 50, 000 40, 000 30, 000 20, 000 10, 000 - Series 1 2011 30, 000 2012 3, 394, 260 EFAVIRENZ 600 MG/ EMTRICITABINE 200 MG/ TENOFOVIR 300 MG and EFAVIRENZ 600 MG/ LAMIVUDINE 300 MG/ TENOFOVIR DISOPROXIL FUMARATE 300 MG 2013 6, 260, 580 2014 48, 354, 330 2015 65, 263, 830

SF Trends 2005 -2015 : Capitalization Account growth # Loans 2007 1 2008 1 2009 2 2010 0 2011 3 2012 5 2013 6 2014 5 2015 11

Collective Action to improve Access Products with several competitive (multisource) alternatives • Strategic Fund pools demand for countries, seek qualified generic/multisources, and lower price through improved competition. Products with supply issues due to lack of commercial interest Products under patent protection (monopolies and/or oligopolies) • Strategic Fund pools demand, and negotiates with suppliers to stabilize supply and the market. • Strategic Fund informs on price trends, and negotiate directly with suppliers. • Strategic Fund facilitates supply of priority donations for neglected diseases. • Strategic Fund supports/establishes the necessary linkages with country led negotiations to facilitate procurement.

• Mercosur and associated countries price negotiations o Led by MS o Hep C manufacturers o Price for entire region, through SF • Access and rational use of high cost and strategic medicines and other health technologies 11 Title of the Presentation