The role of the Pharmaceutical Industry in the National Development Plan

1. The role of the Pharmaceutical Industryin theNationalDevelopment Plan Rafael Gual Director General CANIFARMA October 2015

2. Pharma Industry; facts & figures

3. Pharma Industry; facts & figures *II Compendio estadístico de la Industria Farmacéutica 2014. 13º world market 2nd Latinamerican market 2013 Sales: 14.5 bDlls (ex-Factory prices) Nominal annual growth: 3.9%*

4. Pharma Industry; facts & figures Sales in values Source: II Compendio Estadístico de la IF*Values without inflation

5. Pharma Industry; facts & figures * INEGI. Sistema de cuentas nacionales de México **II Compendio estadístico de la Industria Farmacéutica, CANIFARMA 2014 3.4 % Manufacturing Domestic Product 0.6 % Gross Domestic Product* Investment 2013: 2.7 bDlls (18.3% / sales) Investment 2007 - 2013: 15.4 bDlls**

6. Pharma Industry; facts & figures GDP of the Pharmaceutical Industry 2001-2014 2008 Peso value without inflation Fuente: Elaboración IIIFAC con información del Sistema de Cuentas Nacionales, INEGI.

7. Pharma Industry; facts & figures Total investment (million pesos)

8. Pharma Industry; facts & figures • 16.7% of total investment in R&D • In 2013: 378 mDlls* • 4% Basic Research • 76% ClinicalResearch • 20% Technologicaldevelopment *II Compendio estadístico de la Industria Farmacéutica, CANIFARMA 2014

9. Pharma Industry; facts & figures Research & development

10. Pharma Industry; facts & figures 3,765 millions of units (installedcapacity) 60.8% utilizedcapacity 90.3% nationalrequirements 83.4% nationalmanufacturing 90% withmanufacturingfacilities *II Compendio estadístico de la Industria Farmacéutica, CANIFARMA 2014

11. Pharma Industry; facts & figures 2013 Exports: $1.03 bDlls 2007 – 2013: increasedby 65.1% Exports of medicines mainly and incomegeneration Exportmarkets: 47.9% South America 23.5% Europe 18.1% Central America Animportantdevelopmentpotential *II Compendio de la Industria Farmacéutica, CANIFARMA 2014

12. The Pharmaceutical Industry Development Program and Sector Plans

13. The Development Program • Pharmaceutical Industry Development Program • Designed in accordance to National Development Plan • Following five presidential goals • Defining times & actors • Common industry-government goals • The patient as our main priority

14. The Development Program Line 1. Sanitaryregulatoryframework To foster and improvethesanitaryregulatoryframework Line 2. Research, technologicaldevelopment & innovation To turn Mexico intothe center of technological development of the pharmaceutical industry in Latin America and become the leader in basic and clinical research Line 3. Industrial policy To become a pillar of theeconomy and an industrial modelwithhighagregatedvalue and articulationwithothersectors Line 4. Healthrights To fosterthecontribution of thepharmaindustry to thehealthprotectionrights

15. The Development Program • The industrial policy of the ministry of Economy has considered 15 priority sectors. The Pharma Industry has been considered an emerging sector along with Medical devices and Biotech. Sectores Maduros Sectores Dinámicos Sectores Emergentes • - Metal mecánico • Textil vestido y cuero calzado • Madera y muebles • Siderúrgico • Alimentos y bebidas • Biotecnología • Farmacéutico • TI • Industrias Creativas • Dispositivos Médicos • Automotriz y Autopartes • Aeroespacial • Eléctrico • Electrónico • Químico Impulsar la Productividad Incrementar la Competitividad Atraer y fomentar los sectores emergentes

16. The Development Program A better regulatory framework Agile procedures Backlog reduction Legal certainty Purposeful interaction with authorities Cooperation spirit between I&G

17. Strategic participation Strategic participation of Industry in the development of Mexico’s Health and Economy

18. Strategic participation In recent years the promotion policy of generics has allowed advancement in the goal of access: "The Government policy of generics as achieved a reduction... of 61% in prices... which represents an average saving of $1,047 pesos, from $1,652 to $605 pesos“ Mexicans reduced "... their expenditure on drugs as a percentage of total expenditure on health from 32.2% in 2010 to 28% in 2013..." Similarly,... drug expenditure as a percentage of GDP decreased from 2% to 1.73% "

19. Strategic participation • Public policy actions should be focused on tackling the problems diagnosed by the 2013-2018Health Sector Program • Public expenditure on health (47.3%) OCDE (72.2%) • NHS administrative expenditure (10%) OCDE (4%) • Configuration of NHS is heterogeneous and disarticulated • As a consequence access to health services and drugs is obstaculized.

20. Strategic participation *Felicia Knaul, Héctor Arreola, Christian Borja, et. al. Competitividad y Salud: la propuesta. Fundación Mexicana para la Salud, México, 2003, p. 6. Nationaleconomy and health A country’sproductivityisbaseduponthreeresources: people, physical capital and natural resources. Healthplays a Paramount role forpeople to maximizetheireconomicalpotentialsince: “Aninefficientorunderfundedhealthsystemprevents a country fromaspiring to thehighestlevel of growth and competitivity. Thecost of thisinefficiency has animpactoncompanies, workproductivity and families”.*

21. Strategic participation 2013-2018 Health Sector Program: Optimization of NHS functions The idea that the resources dedicated to providing health services are an investment on the country itself must underlie the center of the national agenda in the short, medium and long terms.

22. Strategic participation In order to facethehealthchallengesahead, itis indispensable to designpublicpoliciesthatoptimizeinvestmentsonhealth. Thisisone of themainchallengesforthe NHS, and itrequirestheparticipation of allinvolvedactors so as to design and implementcollectiveactions to build a viable universal healthsystemtoday, in 2015.

23. The role of the Pharmaceutical Industry in theNationalDevelopment Plan rgual@canifarma.org.mx THANK YOU