2023 pharmaceutical industry vision
TRANSCRIPT
2023 PHARMACEUTICAL
INDUSTRY VISION AND OBJECTIVES
Özlem KOCAAĞAOĞLU 31 / 07 / 2015
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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
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INFORMATIONS OF CURRENT STATUS
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Drug Investments ’04-12
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INFORMATIONS OF CURRENT STATUS
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Drug Investments ’04-12
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INFORMATIONS OF CURRENT STATUS
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The Amount of Clinical Research in Million People ,2005 - 2011
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VS
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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
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COMPARING QUALITIES OF BRIC COUNTRIES AND TURKEY
● 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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COMPARING QUALITIES OF BRIC COUNTRIES AND TURKEY
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2011
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COMPARING QUALITIES OF BRIC COUNTRIES AND TURKEY
● World Economic Forum Global Competiveness Index ’11-12
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Goal 25.
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COMPARING QUALITIES OF BRIC COUNTRIES AND TURKEY
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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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COMPARING QUALITIES OF BRIC COUNTRIES AND TURKEY
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‘’ World Bank Doing Business ‘11 Index ’’
Average Authorisation Period
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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
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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
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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)
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IMPROVING BASIC AND CLINICAL RESEARCH
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
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IMPROVING BASIC AND CLINICAL RESEARCH
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’’.
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IMPROVING BASIC AND CLINICAL RESEARCH
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.
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IMPROVING BASIC AND CLINICAL RESEARCH
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
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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
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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
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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
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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
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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
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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.
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● 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
PHARMACEUTICAL INDUSTRY STATUS WITH VISION 2023 PLAN
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● Turkey Pharmaceutical Industry Evaluation and Comparison
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12,5 B.$
10,3 B.$
1,9 B.$
Without Plan
PHARMACEUTICAL INDUSTRY STATUS WITH VISION 2023 PLAN
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• Comparison of current deficits of with and without the plan
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From the foreseen of
without the plan
PHARMACEUTICAL INDUSTRY STATUS WITH VISION 2023 PLAN
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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.
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THANK YOU
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