2023 pharmaceutical industry vision

2023 PHARMACEUTICAL

INDUSTRY VISION AND OBJECTIVES

Özlem KOCAAĞAOĞLU 31 / 07 / 2015

| 12023 PHARMACEUTICAL INDUSTRY VISION

AGENDA

●Informations of Current Status

●Comparing Qualities of Bric Countries and Turkey

●Objectives of Action Plan

●Main Target Areas Of Vision 2023

●Pharmaceutical Industry Status With Vision 2023 Plan

●Conclusion and Evaluations


INFORMATIONS OF CURRENT STATUS

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Drug Investments ’04-12

2023 PHARMACEUTICAL INDUSTRY VISION


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Drug Investments ’04-12



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The Amount of Clinical Research in Million People ,2005 - 2011


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VS


COMPARING QUALITIES OF BRIC COUNTRIES AND TURKEY

●Critical Achievement Indicators

● World Economic Forum Global Competitiveness Index (2011-2012)

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Inovation Capacity Scientific Research Instutition Quality University-Industry

Cooperation in r&d Quality of

Education System

China 23 38 29 54

Brasil 31 42 38 115

Russia 38 60 75 82

India 35 34 50 38

Turkey 71 89 74 94Turkey’s

Goal First 20 First 30 First 20 First 40



● INSEAD Global Inventiveness Index (2011)

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Global

InventivenessInovation

Infrastructure

China 34 73

Brasil 58 57

Russia 51 118

India 125 59

Turkey 74 130

Turkey’s Goal First 30 First 55



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2011



● World Economic Forum Global Competiveness Index ’11-12

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Goal 25.



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‘’ World Bank Doing Business ‘11 Index ’’

Turkey’s Accredited Drug Amount For Last Five Years

Average GMP Certification Period



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‘’ World Bank Doing Business ‘11 Index ’’

Average Authorisation Period


OBJECTIVES

Increasing total exportation to 500 million $

Increasing the total R&D expenses to 3% of national income

Increasing the national income to 1,5 trillion $ which will make Turkey the 10th largest economy in the world

Turkish pharmaceutical industry will become

the regional central office and a production and R&D center on a global scale

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Main Objective


MAIN TARGET AREAS OF VISION 2023 PLAN

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Executive and Executive and Legal Regulations Legal Regulations

Support MechanismsSupport Mechanisms Resource and Resource and SubstructuresSubstructures


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Improving Basic and Clinical Research

ACTION PLAN


IMPROVING BASIC AND CLINICAL RESEARCH

EXECUTIVE AND LEGAL REGULATIONSEXECUTIVE AND LEGAL REGULATIONS I. Determination of the Basic Research Policy for Life Sciences The life sciences should accepted as ‘priority areas ‘

Updating the law for supporting the education and finance The Strategy of Life Sciences Document for the pulling and

training of qualified person in R&D area

The Strategy of Science and Technology Document for becoming R&D center

Determining a foundation for finance and coordination of researches National Institue of Health (NIH)

Medical Research Council (MRC)



II. Preparing a Plan for Institutions

Constructing a platform for collaboration of university and industry Massachusetts State Life Sciences institue Inovita : Life Sciences and Technologies İstanbul Colloboration Platform

Improving regulations of ‘teknokent’ Improving collaboration between academia to private sector through the Technology Transfer Office



III. Necessary Regulations to Become Competitive in Clinical Research

Shorten the time of evalution and approval Electronic database, Continuity of ministry staff, Adding ‘‘approval period’’ as a key performance indicator for Ministery of Health ‘Fastest approval period’ 4 week authority , 4-6 week ethical approval

Arrangement of payment system Recognition of university researches out off the ‘‘döner sermaye’’.



SUPPORT MECHANISMSSUPPORT MECHANISMS

I. Constituting and Diversifying R&D Finance Funds

Setting up government-led venture capital funds for small and middle scaled institutions

$1 Billion $1,2 Billion

Where every 5 of 12 drug is produced

Currently there is a law stating that for research fund to be used at least 2 phases of a researches needs to be locally

Requiring 50 R&D employee should be abolished.



RESOURCE AND SUBSTRUCTURESRESOURCE AND SUBSTRUCTURES

I. Increasing The Research Tendency in Hospitals and Universities Integration of qualified people to R&D

Providing opportunities for academicians to work in Turkey and abroad simultaneously

Providing enough free time to academicians to participate R&D activities in private sector

II. Developing Infrastructure for Health Information Systems

Arranging and improving the existing databases Purifying data base from credentials Creating voluntary data bank

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Workshop

Inventory


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ACTION PLAN

Increasing Pharmaceutical Exports and Enhancing

Product Quality


INCREASING PHARMACEUTICAL EXPORTS AND ENHANCING PRODUCT QUALITY EXECUTIVE AND LEGAL REGULATIONSEXECUTIVE AND LEGAL REGULATIONS

I. Determining The Action Plan of Priority Areas

According to stimulus package new priority areas are some biotechnological ,blood and oncological products

II. Determining The Movements For Increasing Export Volume

Adjusting the prices accordingly to global prices Documentation obligation should be abolished for export targeted products

.

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One product on a single-track


INCREASING PHARMACEUTICAL EXPORTS AND ENHANCING PRODUCT QUALITY

SUPPORT MECHANISMSSUPPORT MECHANISMSI.Simplifying and Supporting the Information Transfer of Highly Technological Products

Becoming Eurasia Production Base with the aid of middle and high technologic products Simplifying to get the temporarily work permit for international expert


INCREASING PHARMACEUTICAL EXPORTS AND ENHANCING PRODUCT QUALITY RESOURCE AND SUBSTRUCTURESRESOURCE AND SUBSTRUCTURES

I. Training Qualified People For Pharmaceutical Industry Taking advantage of turkish academicians informations


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ACTION PLAN

Becoming the Regional Central Office


BECOMING THE REGIONAL CENTRAL OFFICE

EXECUTIVE AND LEGAL REGULATIONSEXECUTIVE AND LEGAL REGULATIONS

I. Supplying Tax Advantage for International Administrators

RESOURCE AND SUBSTRUCTURESRESOURCE AND SUBSTRUCTURES

I. Improving Competitive Capacity of Working Conditions and Human Resources

Improving labour force that administrative quality

Supplying of necessary physical conditions

Simplification of working conditions of alien labor for needed areas


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ACTION PLAN

Obtaining Permanent Investment


OBTAINING PERMANENT INVESTMENT

EXECUTIVE AND LEGAL REGULATIONSEXECUTIVE AND LEGAL REGULATIONS

I. Regulations should balance with public health, public authority and sectorII. Increasing the access of innovative medicines

III.GMP and documentation applications should be done at the same timeIV.Applying risk-based audit system to GMP audits V. Accordingly to EU criteria documentation should be concluded in 210 daysVI.Improvements for protection of intellectual property rights

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Budget Control

Arregements

Applying current rate to all drugs

Applying reference

prices

Extra guard time for patent

New law for penal sanction

Data guard time

8+2+1 year


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PHARMACEUTICAL INDUSTRY STATUS WITH VISION 2023 PLAN



The access of innovative medicines is increased with recovering market access conditions.

Some drug firms determined turkey as global drug supplier.

With increasing clinical researhes drug firms started to choose their central office in Turkey due to the qualified labor force and easiness of working conditions.

Improved intellectual property rights led to increase the molecule developing studies.


● Turkey Drug R&D Evaluation and Comparison, 2006-2023

• 1 Increases from 700 to 3600 • 2 327 to 1650• 3 218 to 1117

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Compared values from the foreseen

of without plan



● Turkey Pharmaceutical Industry Evaluation and Comparison

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12,5 B.$

10,3 B.$

1,9 B.$

Without Plan



• Comparison of current deficits of with and without the plan

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From the foreseen of

without the plan



CONCLUSION AND EVALUATIONS

● The ‘‘Vision 2023 Plan’’ aims to progressing pharmaceutical industry beyond to 2023. It will increase public health quality and supply social and economic development and increase competitiveness.

● Commen movements of public, pharmaceutical companies, universities and research institutes will be helpful to accomplishing the plan of action.


THANK YOU


2023 pharmaceutical industry vision

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