Strengthening International Cooperation
in Healthcare and Medical Industry
Ⅰ. Korea : General Overview of Korea
•  Official Name : Republic of Korea(
ROK)
•  Capital : Seoul
•  Population : 50.2 million
•  Major Language : Korean
•  Major Religions : Christianity, Bud
dhism, etc
•  Literacy : 98% of the population
•  Area : 99, 434 km2
1
Ⅰ. Korea : Past & Present
Korea 50 years ago : Poverty and Diseases
After
Korean War
Pictures
§  After the nation was torn by the Korean War, Korea suffere
d from severe poverty and disease. In 1960, Korea was o
ne of the poorest countries in the world with its national inco
me per capita of only $76.
§  (Picture 1) Distribution of relief supplies
§  (Picture 2) A charity card for Korean children
§  (Picture 3) Vaccination of tuberculosis
2
Ⅰ. Korea : Past & Present
Korea Now : Miracle
Miracle
§  The economy of Korea dramatically grew since 1970 through i
ndustrialization. The national income per capita increased 300
times to $28,739.
§  The Gross Domestic Product of Korea ranks 11th in the worl
d, and its shipbuilding, steel, automobile, semiconductor indust
ries boast no.1 technology and competitiveness.
§  As the national status elevated greatly, Korea produced the U
N Secretary General, Ban Ki-moon, and a global star, PSY wi
th the Korean Wave.
3
Ⅰ. Korea : Past & Present
Korea Now : Global Contribution
Closing down
WHO office in
Korea
§  As Korea joined the OECD, the WHO closed down its co
Contribution
to WHO and
Developing
Countries
§  Korea contributed a total of $15.1 million to the WHO, t
untry office in Korea in 1999.
he 11th-largest benefactor member country.
§  In regard to bilateral ODA, Korea offers grants worth $66.
3 million and loans worth $50.3 million.
4
Ⅰ. Korea : Past & Present
Korea Now : Expansion of G2G Cooperation
MOU for a
bilateral
cooperation in
healthcare
service and
industry
§  Mongolia, Uzbek, Kazak, Vietnam and others(17nations) for c
ooperation in healthcare services.
§  UAE, Saudi Arabia and other nations for patient referrals.
§  Ecuador, Colombia, Chile and many other nations for cooper
ation in pharmaceuticals and medical device industry.
5
Ⅱ. Korea’s Health Status
OECD Health at a Glance 2014
§  Korea’s life expectancy has risen rapidly amo
ng OECD members since 1960s, and it is one of
the nations with the largest decline in infant
mortality since 1970s.
§  * Life expectancy: 52.4(’60) -> 81.3yrs(’12)
§  * infant mortality: 9.8(’70) -> 2.9(’12)
6
Ⅱ. Korea’s Health Status
Key Factors behind Korea’s Success in Health
Economic
§  Improvement in hygienic environment, quantitative and qu
Healthcare
System
§  Establishment of affordable healthcare system with Nati
Technology
§  Development of medical technology through training ex
Education
§  Promotion and education for public health (anti-smoking
alitative advancement in nutrition supplies thanks to econ
omic development
onal Health Insurance
cellent medical professionals
, body weight management, sodium consumption, etc.)
§  Continuous development and promotion policy for phar
maceutical and medical device industries
7
Ⅲ. Korea’s Healthcare
Public Healthcare System
Ministry of Health & Welfare (MoHW)
Central
National Health Insurance
Corporation (NHIC)
: Head quarter
Centers for Disease Control
& Prevention (KCDC)
Province
(Department of Health)
(16)
NHIC
Regional headquarters
(6)
County
(Community Health Center
/Public Hospitals)
(300)
NHIC
Branch offices
(178)
National Quarantine
TEXT
Stations
Ministry of
Food & Drug Safety
(MFDS)
Regional FDA Offices
(6)
(13)
8
Ⅲ. Korea’s Healthcare
Korea Healthcare Overview
Korea Healthcare Overview 1
The single public insurer Insurer
National Health Insurance
Corporation, NHIC
Insurance
compensation
Health Insurance
Review and
심사기구
Assessment
Service , HIRA
(건강보험심사평가원)
Ministry of Health AND
Welfare
Contribution
Insured
Review, Payment
Claim
(planning, supervising)
Medical service
Self contribution
Providers
9
Ⅲ. Korea’s Healthcare
Korea Healthcare Overview 2
10
Ⅲ. Korea’s Healthcare
Universal health insurance
96.3% of the whole population (48 mil. persons)
- Employee insured (51.5%)
- Self-employed insured (44.8%)
# Medical Aid : 3.7% (low income)
# Total Expenditure on Health-to-GDP Ratio
OECD Aver
age.
8.9
Kore
a
USA Swiss Japa
n
6.8
16.0 10.8
*OECD Health Data 2009, OECD
8.1
Medical aid
3.7%
Self-employed
44.8%
Employee
51.5% 11
Ⅲ. Korea’s Healthcare
Advanced Healthcare System
The Korea healthcare system has achieved both efficiency
and equity.
- The whole population is covered by the national health
insurance scheme.
- Foreign expatriates are covered by the national insurance
- Very short waiting time
n  National Hospital Evaluation Program in place
- Service quality of hospitals is managed by the government
n  Long Term Care Insurance System, introduced in July 2008
- In-home services (bath, nurse), Institutional services and
necessary devices for over 65 year old people and patients
with senile diseases even below 65 years old
n
12
Ⅴ. Competitiveness of Korean Healthcare system
Contents
1. Global Healthcare System of Korea
2. Pharmaceutical Industry in Korea
3. Medical Device Industry in Korea
13
1. Global Healthcare System of Korea(1)
Global Healthcare Industry in Korea
Foreign Patients to Medical Korea Overseas Expansion of Korean
Medical Institutions
(persons)
* Target estimates since 2012
9
14
1. Global Healthcare System of Korea(2)
Korea is a leading country in medical treatment, technology and research
§  Korea’s competitiveness in the
treatment of cancers, cardiac and
vascular diseases, spinal disc and
organ transplantation belongs to the
world’s top tier.
§  Korea ranks Asia’s best in
international medical journal
publication.
§  Korea is one of the top countries for
the clinical trial cases in the world.
15
1. Global Healthcare System of Korea(3)
World-Class
Healthcare
Services
§  Level & Quality of medical technology and services in Ko
rea are about 90% of that in the U.S.
§  Pioneering new markets such as U-Health based on outs
tanding IT convergence technology and
infrastructure
§  Paperless hospitals have become the standard with PAC
S and EMR(EHR)
§  Shortened waiting time by utilizing cooperative treatment
system and one-stop service
§  Leading Asia in Robotic Surgery
16
2. Pharmaceutical Industry in Korea(1)
120 Years of History, Now Moving toward Globalization
1890s
~1950s
Industry
Modernization
Public
Sector
Private
Sector
•  Joined WHO(‘50)
•  First state
examination of
Pharmacists(‘55)
•  Pharmacy schools
established
•  First Korean Pharma
product (1897)
•  Emergence of
modern pharma
companies(1910)
1960s
1970s~
1980s
Infrastructure
Localization
Quality
Advancement
•  Foreign Capital
Inducement Act of
Korea(‘60)
•  Protective Trade
Policy on drugs –
Import of finished
drugs not allowed to
stabilize domestic
production(60s)
•  API Development Policy
– priority on domestic
APIs(70s)
•  Introduction of KGMP(‘77)
•  Product Patent System(‘87)
•  New drug development
system(KGLP(’86),
KGCP(’87))
•  Universal National Health
Insurance(‘89)
•  Start of technical Tie-up•  Localized Production of
Agreements and Joint high quality generics
Venture with MNCs
through licensing-in
•  Subsidiaries of MNCs
1990s
New Drug
Development
•  Compulsory
GMP(‘94)
•  Start of national
pharmaceutical R&D
support(‘92)
•  Joined WTO(‘95)
•  Compulsory BE
Test(‘92)
•  Increasing R&D
investment
•  First new drug
developed in
Korea(‘99)
2000s
Globalization
•  Separation of dispensing and
prescribing function(‘00)
•  Introduction of DMF(‘04)
•  Korea-EU FTA(‘11)
Korea-US FTA(‘12)
- currently 12 FTAs
•  Pharmaceutical industry
development Special law(‘12)
- 41 Innovative K-Pharma
companies
•  First Korean new drug
approved by US FDA(‘03)
•  Korean recombinant DNA
tech drug(growth hormone)
approved by FDA(‘07)
•  First Biosimilar approved by
EMA(‘13)
17
2. Pharmaceutical Industry in Korea(2)
Market
§  Market Size : US 11.7 Billion(2013)
- Around 4.2% average annual growth
New Drug
§  25 New Drugs(2015), 33 IMD(Incremental Modified Drug) p
roducts approved
- 2~3 New drugs coming out to the market every year
Bio-Pharma
Competency
§  High quality bio products
- 1st stem cell therapy, 1st biosimilar approved, 20 biosimilar
clinial trials undergoing
•  Stable supply of Vaccines
Clinical Trials
•  Seoul ranks No.1 for industry sponsored clinical trials amon
g all cities worldwide(2013)
18
2. Pharmaceutical Industry in Korea(3)
14
19
3. Medical Device Industry in Korea(1)
Overview of the Korean Medical Devices Industry
World Medical Devices Market Size
Domestic Market Size
Market Size Level in the World
Domestic Production/ Export/ Import
Growth Rate (for recent 5years)
Market Size/ Production/ Export/ Import
about $ 340.3 billion
about $5.2 billion
ranks 11th in the world (1.5%)
about $ 4.3 billion, $2.4 billion, $ 2.9 bil
lion
7.0%, 11.3%, 11.2%, 4.5%
Number of Korean Medical Devices
producing/ Exporting/ Importing Companie
s
about 2786, 813, 2172
Growth Rate (for recent 5years)
producing/ Exporting/ Importing Companie
s
about 10.7%, 8.7%, 9.1%
20
3. Medical Device Industry in Korea(2)
World Overview Medical Markets Fact Book 2014
World Overview, Medical Device Market, Total(US$ mn)
Rank
Country
2009
2010
2011
2012
2013
2014
CAGR
1
2
3
4
5
USA
Japan
Germany
China
France
97,693.6
21,644.6
19,694.7
7,355.2
12,263.5
109,405.3
26,066.2
20,870.8
9,438.8
13,066.3
118,268.9
29,227.8
24,105.3
11,850.4
13,981.0
119,587.6
32,500.8
23,552.8
14,058.4
13,541.6
125,384.3
30,160.5
25,567.8
16,119.0
14,433.6
133,823.1
31,078.2
26,802.9
18,747.9
15,014.5
6.5%
7.5%
6.4%
20.6%
4.1%
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
United Kingdom
Italy
Canada
Russia
Brazil
South Korea
Spain
Australia
Mexico
Netherlands
India
Switzerland
Belgium
Sweden
Austria
9,685.1
9,670.9
5,336.4
4,587.2
3,476.9
3,501.2
5,081.0
3,328.3
2,578.2
2,978.9
2,027.6
2,844.5
2,117.7
2,097.9
1,937.2
9,415.9
9,650.7
5,744.1
5,520.6
4,718.7
4,240.9
5,110.3
3,856.4
2,961.5
3,167.9
2,478.5
2,976.7
2,160.9
2,208.5
2,065.1
9,656.7
9,790.6
1,726.8
6,812.7
5,206.3
4,746.8
5,121.6
4,557.2
3,165.7
3,594.6
2,829.5
3,353.6
2,372.1
2,431.0
2,139.0
9,830.4
8,460.4
6,877.7
8,426.3
5,444.3
4,880.0
4,599.5
4,841.7
3,327.9
3,498.3
3,178.9
3,273.0
2,273.9
2,331.7
2,150.3
10,248.8
9,187.2
6,846.5
6,716.4
5,648.4
5,109.3
4,918.8
4,903.9
3,672.7
3,778.0
3,226.0
3,554.1
2,477.9
2,541.1
2,235.9
11,306.4
9,398.9
6,505.1
6,485.3
5,759.4
5,233.7
5,000.8
4,631.5
4,159.5
3,920.6
3,724.5
3,192.8
2,581.5
2,462.9
2,312.8
3.1%
-0.6%
4.0%
7.2%
10.6%
8.4%
-0.3%
6.8%
10.0%
5.6%
12.9%
2.3%
4.0%
3.3%
3.6%
3. Medical Device Industry in Korea(3)
2014 Top 10 in Medical Devices Production / Imports / Exports
Production
Imports
Exports
1
Dental Implants
Stents
Ultrasound Imaging Systems
2
Ultrasound Imaging Systems
Soft Contact Lenses
Dental Inplants
3
Soft Contact Lenses
Dialyser
Soft Contact Lenses
4
PACS
Artificial Knee Joints
Personal Heaters
5
Digital X-Ray Imaging Systems
MRI Systems
Digital X-Ray Imaging Systems
6
Sight Corrective
Ophthalmic Lenses
Sight Corrective
Ophthalmic Lenses
Medical Probes
7
Medical Probes
Chemiluminescence assay (CLIA)
analyser
PACS
8
Dental Precious Metal Alloy
IV Tubes & Catheters
IVD reagents for
infectious disease marker
9
Personal Heaters
CT Imaging Systems
IVD strip for self testing
10
CT Imaging Systems
IVD reagents for clinical Immunoch
emistry
Laser therapy units
22
3. Medical Device Industry in Korea(4)
2014 Korea’s Leading Exporting Devices
As of
2014
23
3. Medical Device Industry in Korea(5)
IT-Combined
Products
IT-Combined
Products
IT-Based Products with Technology and
Production Capacity
–  Ultrasound Imaging Systems: No.1 Item in Production in Korea,
World No.1 Market Share in OB/GYN
R&D Infrastructure & Technology
More R&D Investment by Government and
Businesses
25.2 %
17%
–  PACS: World No.1 penetration rate by domestic players(90%)
–  Dental CT: Vatech , 35% Annual Growth for last 8 Years
Government
Businesses
Average Annual Growth
for Recent 3 Years
Technology :
Still lower than advanced countries,
but the gap with the Top Technologies has been
considerably reduced for 2 years (‘08-’10)
•  Health Care (1.9 Y Gap),
•  Bio (1.7Y Gap)
•  Improved Technology in
Medical Device R&D
(3.5%), Bio Chip Sensor
(4.7%)
•  Announced U-Health
Mega Project by Gov’t
24
Ⅵ. Strengthening International Cooperation in Healthcare
Contents
1. Cooperation for Global Healthcare Service
•  Medical Korea Academy
•  Saudi Arabia training program for Physician, Dentist
•  The Korean Medical Charity Program
2. Cooperation for Medical Industry
•  Expedite Product Registration
25
1. Cooperation for Global Healthcare Service
Medical Korea Academy(1)
Objectives
§  To increase trainees’ awareness about the environment in me
dical practice in Korea
§  To help trainees broaden their international networks for future
cooperation in health and medical field in Korea
Cost
&Expenses
§  Organizer will bear the following expenses
- Economy class round-trip airfare & accommodation
- Accident insurance
- Daily expense
- Academic activities such as registration fee for conferences
26
Medical Korea Academy(2)
Overview of the Program Organized by KHIDI
Medical Korea Academy
Program
Observation clinical training
Organizer
Korea Health Industry Development Institute (KHIDI)
Sponsor
Ministry of Health & Welfare of Republic of Korea
Participants
Medical Doctors from nations where number of foreign patients
growing for Medical Tourism
Duration
5 weeks/2 months
Eligibilities
· Min. 3yrs of clinical experience
· English Proficiency
Training Hospi
tal
Tertiary or specialized hospitals
which have the program for foreign medical professionals
27
Medical Korea Academy(3)
20 countries medical doctors completed Medical Korea Academy
Number of medical trainees
Others, 28
(Angola, 1)
Vietnam,
16
Cambodia,
17
China, 49
Kazak, 62
Uzbek, 19
Russia,
27
Mongolia,
35
Year
No. of trainees
2014
41
2013
40
2012
35
2011
33
2010
34
2009
36
2008
18
Total
253
28
Medical Korea Academy(4)
General Procedures
•  KHIDI Oversea Network
•  Korean Hospitals
Application collected
Candidate selected by KHIDI
Program
Monitoring &
Evaluation
Recruit Training
Hospitals
Trainees
Clinical Training in Korean Hospital
Matching
Training Hospital
22
29
Medical Korea Academy(5)
Sample Program
Introduction
§  National Health Insurance System
§  National Health IT
§  National Accreditation System of Healthcare Institution, etc.
Medical Laws
§  Medical Regulations in Korea
Information of
the Training
Hospitals
§  Rules and Regulations
§  Program Outlines
§  Duties and Job Descriptions
Observation of
Medical
Practice
§  Observing Medical Practices in Each Specialty
Participation in
Medical
Conference
§  Participating in Medical Seminar and conferences in order to share
further researches and advanced practices
30
Training Program for Saudi Arabia Physician & Dentist
§  Paid training of Saudi physicians began in June 2014. Curre
ntly, 34 physicians are being trained in Korea and training f
or dentists is scheduled to begin in October.
- Saudi Arabia is the fourth country to send its physicians to be trained
at Korea following the US, Canada and France
§  In case of doctors, three types of programs are being offered: S
ub-specialty, fellowship, short term program
§  In case of dentists, one-year language program and three-y
ear residency training is scheduled to be offered
31
The Korean Medical Charity Program
Overview of Program
Objective
§  To provide free treatment opportunities in Korea for low-income pati
ents in Overseas countries
Beneficiary
§  240 patients of 24 countries at leading Korean Medical organizatio
ns since its establishment in 2011
32
2. Cooperation for Medical Industry Cooperation
Expedite Product Registration
Homologation
with Ecuador
(‘14.3.11)
§  Drugs approved by the Korea Ministry of Food and Drug S
afety(MFDS) will be granted approval by the authority in E
cuador, requiring only reviews of certificates and documen
tations issued by MFDS for approval in Ecuador
Planning to
expand to
ALBA
§  ALBA members : Ecuador, Venezuela, Cuba, Nicaragua,
Proposal to
Angola MOH
§  Operation of working-level commission for Expedite Produ
Bolivia, Honduras, Dominican Republic, Antigua & Barbud
a
ct Registration of pharmaceutical and medical devices
§  Discussion topics including expedite product registration a
nd inspection cooperation for Active pharmaceutical ingre
dients(API)/finished product and medical devices
33
Muito o
brigado