WHO TBS 출장보고_20141125.hwp

WHO 기술세미나(TBS) 참가 보고서
2014. 11
건강보험심사평가원
연구조정실 약제평가연구팀
목
차
Ⅰ 출장개요············································································································
출장 목적········································································································
기술세미나 개요············································································
부서의 역할··················································································
일정표·············································································································
상세 프로그램··································································································
.
1
1.
1
2. WHO
(TBS)
1
3. WHO EMP
2
4.
3
5.
3
Ⅱ
기술세미나 상세내용·······································································
첫째날·············································································································
둘째날············································································································
셋째날············································································································
넷째날············································································································
다섯째날········································································································
. WHO
1.
2.
3.
4.
5.
III.
(TBS)
결론 및 활용방안·····························································································
9
9
14
20
23
26
28
Ⅰ
1.
출장 개요
출장 목적
□ 개요
○ 출장명
기술세미나 참석
○ 기간
일 토
○ 출장자 연구조정실 부연구위원 김동숙
○ 장소 스위스 제네바
본부 빌딩 호
: WHO
: 2014. 11. 2(
(TBS)
) ~ 8(
)
:
:
, WHO
, M
605
□ 목적
○ 세계보건기구
기술세미나
참석
○
의약품 관련 최근 정책동향 파악 및 향후 전략에 대한 자료수집
○ 기술세미나 참석자들간의 국제 교류 및 해외 유관기관과의 협력 증진
※ WHO/EMP는 모든 사람들이 필수의약품에 접근할 수 있도록 정책을 실행하는
부서로, 매년 필수의약품 정책에 대한 세미나 및 회의를 개최하고 있음.
(WHO)
(Technical Briefing Seminar, TBS)
WHO
2. WHO
○
기술세미나(TBS) 개요
이전
에서는 년 이래
로 매년
를 개최하고 있음
○ 이 세미나는 다양한 의약품 관련 이슈에 대해 기술적으로 업데이트하고
있음 참석자와 전문가들간에 의약품의 질 접근성 사용 관련 주제에 대
해 토론하는 기회임
○ 세션은 부서원 여러
지역의 직원
같은 파트너
기관
구성원들이 진행
WHO EMP(Essential Medicines and Health Products,
of
Essential
Medicines
and
Pharmaceutical
Policies)
Technical Briefing Seminars (TBS)
.
,
: Department
1998
.
,
.
EMP
,
WHO
, WHO Collaborating Centres
- 1 -
, UNICEF
UN
3. WHO
□
○
와 EMP
의약품 정책
는 국제적 지역적 국가적 수준에서 의약품과 필수의약품 관련 영
역에서 활동을 수행하고 있고 이는 본부의
부서
에서 수행하고 있음
WHO
WHO
,
,
,
EMP
Essential Medicines and Health Products)
□
○
(Department
.
부서의 활동
부서는
지역사무소 및 국가사무소와 협력하고 있고 모든 국
가에서 필수의약품과 기술에 대한 접근성이 향상될 수 있도록 장려하는
비전을 명백하게 하는
을 위해 주요 이해당사자와 자
문을 구하고 있음
WHO EMP
EMP
WHO
,
WHO
action
plan
.
그림
1. WHO EMP
홈페이지
(http://www.who.int/medicines/en/)
□
영역
○ 기술적 영역
의약품 정책 접근성 사용
WHO EMP
-
of
,
,
- 2 -
공중보건 혁신 지적재산권
○ 의약품 규제
기술적 용어 및 기준
의약품 백신 진단도구 및 장치 질관리
안전성 및 감사
-
,
,
-
,
,
-
그림 업무영역
2.
- 3 -
4.
5.
일정표
일자(요일)
일
월
화
수
목
금
토
일
11. 2.(
)
11. 3.(
)
11. 4.(
)
11. 5.(
)
11. 6.(
)
11. 7.(
)
11. 8.(
)
11. 9.(
)
활동내역
서울 출발
세미나 및 회의
세미나 및 회의
세미나 및 회의
세미나 및 회의
세미나 및 회의
제네바 출발
서울 도착
Day 1
Day 2
Day 3
Day 4
Day 5
상세 프로그램
- 4 -
- 5 -
- 6 -
- 7 -
※날짜 요일은 스위스 시간 기준임
,
.
- 8 -
Ⅱ
1.
WHO 기술세미나(TBS) 상세내용
첫째날
가.
Essential Medicines and Universal Health Coverage :
Kees
Koncheere, Director EMP
de
□
○ 필수 의약품이란 인류의 우선적인 기초적인 보건 의료 요구를 충족시켜
주는 의약품 필수 의약품은 의약품의 효용성 안전성 그리고 상대적인
비용 효과성의 근거와 공중 보건과의 관련성을 고려하여 선택됨
공중 보건과의 관련성은 질병의 발생률과 유병률 질병에 대한 부
담
에 근거 지역 국한적인 요구
잠재적인 영향 또는 고 효율에 대한 근거 정치적인 영향
○ 필수 의약품의 제품 설명서가 최근의 임상적 근거 및 연구를 반영하지
못하고 있는지 명확히 함
○ 필수의약품 목록
에 포함되는 주요기준으로써 안정성 및 유효성
그리고 공중 보건 중요성을 보여줄 수 있는 근거를 고려
□ 부서 구성
Defining public health relevance
(
.
)
,
-
.
-
1)
2)
(Global Burden of Disease estimate
4)
) 3)
5)
(EML)
EMP
- 9 -
나.
Global Price Reporting Mechanism (GPRM):
Njuimfack, HIV/AMDS
□ 에이즈 약제에 대한 가격 보고 방식
(WHO
Boniface
Dongmo
홈페이지
)
다. Access to Essential Medicines and Universal Health Coverage :
Kees
de Koncheere, Director EMP
□
○
Universal Health Coverage
All
people
obtain the
health services
they need
(including prevention,
promotion, treatment, rehabilitation, and palliation), of sufficient quality
○
to be effective;
○
○
hardship
The
use
of
these
services
dose
not
expose
the
user
to
financial
A direction not a destination
Thus, moving "towards UHC" is something that every country can do
- 10 -
□
UHC
□
○
달성을 위해 고려해야할 구성요소
Considerations in priority setting for UHC
In moving towards UHC, questions focus on:
- The population covered by the package of interventions: Who ?
- The services that can be provided: Which services ?
- The proportion of service costs that can be covered: How much ?
○
Health
technology
framework
for
assessment
different
types
of
(HTA)
provides
decisions
and
a
can
decision-making
be
applied
in
all
how
to
health care systems
- In fragile health systems: to identify basic essential care packages
-
In
middle-income
countries
with
limited
coverage:
to
decide
extend the package of health care services provided
- In systems with established UHC: to inform decisions ‘'at the margin’':
what extra services to provide and at what cost
- 11 -
□
○
○
Future issues
Access to essential medicines within UHC framework
Growing internationalization of medicines regulation
- Regional harmonization/convergence initiatives
○
○
○
○
Innovation,
targeting
new
product
development,
how
to
price
innovation for global access ? - global public goods
MDGs and NCDs
Medicines pricing : R&D + access/affordability + competition
Need for promoting the appropriate use of medicines
□ 세계보건기구 총회
○
(WHA 67th)
Follow-up of the Report of the Consultative Expert Working Group on
Research and Development: Financing and Coordination - Health R&D
○
○
demonstration projects (DP)
Resolution A67.22 Access to Essential Medicines
Resolution
A67.23
Health
Intervention
○
support of Universal Health Coverage
○
products
○
quality, safety and efficacy
○
○
antibiotic resistance
○
○
Resolution
Resolution
Resolution
A67.20
A67.21
A67.25
on
on
Regulatory
Access
on
to
and
System
Technology
Strengthening
biotherapeutic
Combating
Assessment
products
Antimicrobial
for
and
resistance,
in
medical
ensuring
including
Resolution A67.6 on Hepatitis
Resolution
A67.19
on
Strengthening
of
palliative
care
as
a
component
of integrated treatment within the continuum of care
SSFFC Mechanism (counterfeiting)
Resolution A67.14 on Health in the post-2015 development agenda
- 12 -
라. Priority Setting in Universal
Health Coverage :
Kees
de
Koncheere,
Director EMP
□
○
Health Intervention & Technology Assessment
Health technology is the application of organized knowledge and skills
in
the
form
of
interventions,
devices,
medicines,
vaccines,
procedures
and systems developed to solve a health problem and improve quality
○
of lives
Technology
policy
○
□
○
○
assessment
analysis.
It
in
studies
health
the
care
medical,
is
a
multidisciplinary
social,
ethical,
and
field
of
economic
implications of development, diffusion, and use of health technology.
HITA does not make the decisions, however the systematic assessment
of the evidence makes the trade-offs between alternative actions clear
HITA methods in WHO
WHO Model List of Essential Medicines
Package of Essential Noncommunicable (PEN) disease interventions for
○
primary health care, 'best buys' for NCDs
○
database of around 500 health technologies
○
in lowand middle-income countries.
WHO-CHOICE,
OneHealth
Assessing
Tool
CHOosing
designed
medical
Interventions
to
devices
inform
and
population
- 13 -
that
national
assistive
are
Cost
Effective
strategic
health
devices
for
global
planning
an
ageing
2.
둘째날
가. WHO Essential Medicines List
2015
:
Concept/Process
and
Update
on
EML
Nicola Magrini, EMP/PAU
□ 정의 및 목록
○ 필수 의약품이란 인류의 우선적인 기초적인 보건 의료 요구를 충족시켜
주는 의약품 필수 의약품은 의약품의 효용성 안전성 그리고 상대적인
비용 효과성의 근거와 공중 보건과의 관련성을 고려하여 선택됨
공중 보건과의 관련성은 질병의 발생률과 유병률 질병에 대한 부
담
에 근거 지역 국한적인 요구
잠재적인 영향 또는 고 효율에 대한 근거 정치적인 영향
○ 년 차에서는 개 성분
○ 년 월 기준 성인 개 의약품 소아 개 성분
□ 목록
(
)
.
,
-
.
-
1)
2)
(Global Burden of Disease estimate
4)
) 3)
5)
1977
1
2013
4
208
374
□ 필수의약품 기준
○
○
,
278
Disease burden and public health need
Sound
and
adequate
data
on
the
efficacy,
safety
and
comparative
cost-effectiveness of available treatments
- Need for special diagnostic or treatment facilities considered
○
"Absolute cost of the treatment will not constitute a reason to exclude
a
medicine
from
the
Model
List
- 14 -
that
otherwise
meets
the
stated
selected criteria”"
□ 년 월 전문가 위원회 개최 전 필수의약품 신청기간
○ 개월간 개회
○ 신청서가 접수되면 명의 패널에게 신청서가 보내짐
2015
4
6
: 2014.6.15-11.30
, 2-3
.
□ 신청서 양식 템플릿
/
□ 필수의약품 및 근거 표
- 15 -
□ 의약품 정책
○ 의약품 정책이란 의약품 체계에 영향을 주는 정부의 의식적 노력을 의미
함
.
나.
Responsible and appropriate (rational) use of medicines :
Jane
Robertson, EMP/PAU
□ 적절한 의약품 사용의 개념
○
Relies on a number of elements
- Availability, affordability, and use in practice of effective medicines
○
Availability
- Procurement, distribution of quality-assured essential medicines
- Regional, urban/rural differences in LMICs; private vs public sector
○
Affordability
- Medicine prices (also taxes, mark-ups, dispensing fees etc.)
- Role of insurance and social protection policies, public financing
○
Use in practice
- Prescribing & dispensing accord with national EMLs, STGs
□
○
WHO definition of ‘'rational use of medicines’':
‘'Medicine
receive
the
individual
○
use
is
rational
appropriate
requirements,
(appropriate,
medicines,
for
an
in
proper,
doses
adequate
correct)
that
period
of
when
meet
time,
patients
their
and
at
own
the
lowest cost both to them and the community.
Irrational (inappropriate, improper, incorrect) use of medicines is when
one or more of these conditions are not met.’'
- 16 -
□
○
‘'Responsible use of medicines’'
‘'the
activities,
capabilities,
and
existing
resources
of
health
stakeholders are aligned to ensure patients receive the right
system
medicines
at the right time, use them appropriately, and benefit from them’'.
□
○
WHO indicators
Access
- Availability of key medicines
- % of prescribed medicines dispensed in public health facilities
- Average stock-out duration; adequate record keeping
- Affordability of treatment for adults and children <5 years of age
- Price of key medicines/ Average cost of medicines
- Price of paediatric medicines
- Geographical accessibility of public health facilities
○
Quality
- % medicines expired;
- adequacy of storage and handling
○
Rational use of medicines
- % medicines adequately labelled
- % patients knowing how to take medicines
- Average number of medicines per prescription
- % patients prescribed antibiotics
- % patients prescribed injections
- % prescribed medicines on the essential medicines list
- % medicines prescribed by generic name (INN)
- Availability of standard treatment guidelines
- Availability of essential medicines list
- % tracer cases treated according to protocols/STGs
- % prescription medicines bought with no prescription
○
Other information
- % of facilities complying with the law (presence of a pharmacist)
- 17 -
- % facilities with dispensing by a pharmacist
-
%
facilities
with
dispensing
by
nurses,
pharmacy
aide/health
assistant
or untrained staff
- % facilities with prescribing by a doctor
-
%
facilities
with
prescribing
of
prescription
medicines
by
nurses,
trained health workers/health aides
- % facilities with prescribers trained in rational drug use
다.
AMR and appropriate use of antimicrobials :
EMP/PHI
Nicola
□ 항생제 과다사용과 내성 문제
○ 국가별 항생제 사용량과 폐렴균의 페니실린 내성간의 상관성
- 18 -
Magrini,
라. Innovation of New Antibiotics :
□ 임균에 대한 항생제 감수성의 변화양상
Zafar Mirza, EMP/PHI
□ 새로운 항생제 개발을 위해 제안된 이니셔티브
○ 내성 등의 문제로 새로운 항생제 개발이 필요함
.
- 19 -
3.
셋째날
가. Regulation, Norms and Standards :
□ 더 좋은 의약품에 대한 접근성 사다리
Lembit Rago, EMP/RHT
□
○ 차
는 년 월 일 브라질에서 개최되었음
국제적 규제 시스템의 효율성 향상
기준의 및 감시체계 통합을 위한 네트워크 형성
정보 공유를 위한 노력 등이 이뤄지고 있음
Regulatory harmonization
16
ICDRA
2014
8
(International
Conference
of
Drug
26-29
Regulatory
Authroties)
.
-
.
나. INN and Nomenclature : Rafaella Balocco
□
○ 년
○
, EMP/TSN
INN(International Nonproprietary Name) programme
1950
To
○
○
WHA resolution 3.11
provide
one
single
name
worldwide
for
active
substances
년 규정이 작동
는
1953
INN list
에 출간되었음
WHO Drug Information
- 20 -
.
pharmaceutical
○ 온라인으로 접근가능
□ 활용
○
: Mednet - INN EXtranet
Stem
Names
of
"pharmacologically/chemically
-related"
substances
have
a
common stem
- To indicate chemical and /or pharmacological group relationship
- Published for 'established series of related compounds'
- INN and stems have protection within trade mark arena
-
WHO
publication
"The
use
of
stems
in
the
selection
of
INN
"
Stem
book 2013
- pre-stems list
다. Capacity building and technical
cooperation
□
and
assistance to regulators; Regulatory
harmonization
initiatives
:
Samvel
Azatyan,
RHT/RSS
What WHO is doing to support regulators
1)
Developing
evidence,
maintaining
knowledge
and
understanding
of
situation and needs of regulatory systems worldwide. This is done by:
-
proactively
seeking
information
on
national
level,
including
assessing
national regulatory systems upon request from Member States
-
Internationally,
by
participation
and
contribution
in
regional
and
sub-regional regulatory networks:
•
•
•
•
2)
International Conference on Harmonization (ICH);
Asia-Pacific
Economic
Cooperation
Regulatory
Harmonization
Steering Committee (APEC RHSC);
Organization of Islamic Cooperation;
African Medicines Regulatory Harmonization Initiative (AMRH).
Based
on
assessed
needs,
providing
direct
country
support
through
technical advice, trainings, seminars, and other specific capacity-building
activities
–
in accordance with the Institutional Development Plans (IDPs).
3) Developing and continuously improving tools to assist regulatory work
- 21 -
(e.g.
standards,
guidelines,
manuals,
databases
and
other
information
materials, as well as tools for exchange of regulatory information):
-
Implementation
pharmaceutical
of
products
WHO
Certification
moving
in
scheme
international
on
the
commerce
-
quality
update
of
and
expansion to include starting materials
4)
Providing
direct
technical
advice,
activities
including
and
training
support
training,
regional/sub-regional
seminars,
establishing
networks
to
(e.g.
and
other
specific
subregional/regional
through
Technical
networks
through
capacity-building
centres
Working
of
excellence
Group
on
Regulatory Capacity Development in Africa).
5)
Organizing
representation
and
facilitating
dissemination
in
regional
of
and
information
global
regulatory
through
different
initiatives
relevant
platforms.
6) Promoting WHO’s regulatory strengthening work and its output to
ensure
visibility
and
accessibility
to
interested
http://apps.who.int/prequal/ .
- 22 -
regulatory
counterparts:
넷째날
4.
가. Innovation and Access :
□ 형 간염약제
○ 특허만료일은
년 미국 는
는 년 월 승인
○ 비용
미국은 정당
주 치료비
독일
영국
이집트
○ 년
는 억달러를 벌어줬음
생산비는
으로 추정
Peter Beyer, EMP/PHI
C
Sofosbuvir
2024/2028
EMA
2014
-
$1,000, 12
-
: $66,000
-
: $57,000
-
: $900
Gilead
-
년 월 승인했고 유럽
2013
12
,
$84,000
110
.
$68-136
Source:
use
FDA
1
1
2011
,
in
A.
Hill
et
large-scale
al.
"Minimum
treatment
costs
access
for
producing
programs
in
hepatitis
C
developing
DAA
for
countries",
Clinical Infectious Diseases, Feb 13, 2014
□
○
What are the options?
Gilead
signed
agreements
with
seven
Indian
companies
on
sofosbuvir
allowing exports to 90 countries (+ India)
○
Negotiates
licenses
for
HIV
in
public
interest
(currently
no
mandate
for hepatitis); better conditions and broader scope
–
e.g.
atazanavir
license:
110 countries and additionally countries where the
patent was not grant ed
○
Countries can issue compulsory licenses to locally produce or import a
medicine; no emergency necessary; abusive prices can be a legitimate reason
-Producing active pharmaceutical ingredient can be a challenge
- Import requires a source for generic sofosbuvir
- 23 -
나. Global Platform on Innovation and Access (GPIA) and Global Health
Observatory :
Claudia Nannei, EMP/PHI
□
제안서
○ 홈페이지에 업로드되어있음
Platform
.
□ 구조
○
Information Hub
- Regular reporting
- Monitoring system
- Indicators
○
Knowledge Repository
- Virtual Library
- Rational use, HTA
- Knowlege bases
○
Virtual Forum on Innovation
- Communities
- Search Engines
- Theme topics
- Profiles
- Forum
- 24 -
□ 개발 진행과정
○ 차 버전
○ 검증단계
○ 베타버전
○ 차 버전
1
2,3
다. Turkish Medicines and Medical Devices Agency :
□ 터키의 의약품 규제업무는 의약품 및 기술 당국과 사회보장 기관으로 구분
되어 분장
○ 의약품 및 기술당국
은
년 월
에서 년
이후 현재의
로 변화
○ 정부기구로 규제 평가 모니터링 업무를 수행
Gulsen Oner
(Turkish
1946
2
General
Directorate
of
Medicines
&
Medical
Pharmaceuticals
&
Devices
Agency)
Pharmacy
,
2012
Turkish Medicines & Medical Devices Agency
,
,
□ 이 기관의
에 대해 소개
○ 명의 약사 명의 의사 명의 생물학자 명의 행정 명의 전문가로
구성
○ 의 활동
로 의약품 사용량 점검
교육 등
Rational Drug Use Unit
7
, 5
, 1
, 1
RDU
- ATC/DDD
-
- 25 -
, 2
IT
5.
다섯째날 (Safety and Surveillance)
□
○
Collaborate on surveillance and monitoring of SSFFC medical products
를 위해서 여러 전략을 취하고 있음
UHC, MDG, Increase Access
□ 보고해야 할 사항
○ 의심되는 제품은 반드시
(Medical
Products
that
.
에 부작용에 대해 보고해야 함
SSFFC
are
.
suspected
or
confirmed
to
be
:
SSFFC
,
or
to have caused unexpected adverse reactions, including lack of efficacy)
○ 국가기준에 맞지 않는 것으로 의심되는 제품
(Genuine
medical
products
that
are
suspected
or
confirmed
intentionally manufactured in non-compliance with National standards)
○ 전용된 제품
(Medical products which are confirmed as diverted)
- 26 -
to
be
□
○
○
○
○
○
년 월 현재
개국에서 워크숍 개최
명의 인원 교육
개의 기관 교육
개 이상의 의심되는 제품 보고
개국에서 발생
2014
10
80
230
18
500
62
- 27 -
Ⅲ
결론 및 활용방안
□ 유익한 사항 및 향후 활용방안
○
를 획득하기 위한 필수의약품 관련 정책에 대해 체계적으로
정리하는 기회가 되었음
○ 필수의약품 관련 정책동향 파악
○ 필수의약품 선정 일정 등에 대해서 인지할 수 있었음
○ 기술세미나 참석자들간의 국제 교류 및 해외 유관기관과의 협력 증진
○ 향후 국내에서 필수의약품 선정 전문가 위원회 등 협력 기전 마련 필요
○ 항생제와 관련해 세계적으로 이슈가 되고 있는 주제임을 확인할 수 있었
음
○ 의약품의 올바른 사용 개선 필수의약품 목록을 통한 항생제 내성 제기
규격화된 치료지침 국가적 계획 및 전략 보건 인력 교육 약물 및 치료
위원회 의약품 정보 센터 소비자에게 제공하는 정보 캠페인 등 합리적
이고 책임성 있는 의약품 사용에 대해 재확인할 수 있었음
WHO UHC
.
.
.
,
,
,
,
.
,
,
.
- 28 -

Download Report