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22
9 ASEAN ་⸆ရ⏘ᴗ䛾⌧≧䛸㝣ᴗ䛾䝡䝆䝛䝇ᶵ 䇷䝬䝺䞊䝅䜰䛾䝆䜵䝛䝸䝑䜽ᕷሙ䜢୰ᚰ䛻䇷 찵牜ꂽ 䝰䝝䝯䝗䞉䜰䝈䝭䞉䜰䝣䝬䝗䞉䝝䝑䝃䝸 ᪥ᮏ䛾䝆䜵䝛䝸䝑䜽་⸆ရᕷሙ䛿䚸ᚋ 5 ᖺ⛬ᗘ䛿ᡂ㛗䛜⥆䛟䛜䚸䛭䛾ᚋ䛿㢌ᡴ䛱䛻䛺䜛 䛸ண䛥䜜䜛䚹䝞䜲䜸䝅䝭䝷䞊〇ရ䛾㛤Ⓨ䛻䜚㐜䜜䛯᪥⣔䝆䜵䝛䝸䝑䜽་⸆ရ䝯䞊䜹䞊䛻 䛸䛳䛶䛿䚸ᾏእᕷሙ䠄䛸䛟䛻᪂⯆ᅜᕷሙ䠅䜈䛾㐍ฟ䛜⥅⥆ⓗᡂ㛗䛾㘽䛸䛺䜛䚹 ᪂⯆ᅜ䛾་⸆ရᕷሙ䛷䛿▱㈈ไᗘഛ䛜㐍䜏䚸᪂⸆䝯䞊䜹䞊䛾㐍ฟ䛜άⓎ䛧䛶䛔䜛䚹 䛻䚸䝆䜵䝛䝸䝑䜽་⸆ရ䜢䜚ᕳ䛟⌧ᆅ≧ἣ䜒ᨵၿ䛧䛶䛔䜛䚹ရ㉁⟶⌮ᇶ‽䚸ᢎㄆᑂᰝ ᇶ‽䛺䛹䛜ഛ䛥䜜䜛䛣䛸䛻䜘䜚䚸᪥ᮏ〇䛾㧗ရ㉁䠄䛚䜘䜃㧗౯᱁䠅䛺䝆䜵䝛䝸䝑䜽་⸆ရ䛜 䜜䜛䜘䛖䛺⎔ቃ䛜ฟ᮶䛴䛴䛒䜛䚹 ᮾ༡䜰䝆䜰୰㐍ᅜ䛾ᐩ⿱ᒙ䚸䛚䜘䜃ᙼ䜙䜢デ䜛་ᖌ㐩䛿䚸་⸆ရ䛾ရ㉁䛻ᑐ䛩䜛ព㆑䛜 㧗䛔䛸ᛮ䜟䜜䜛䚹䛭䛖䛧䛯㟂せ⪅䛿ඛⓎ་⸆ရ䠄≉チ⸆䠅䜢䛖ഴ䛜䛒䜛䛜䚸㧗ရ㉁䝆䜵 䝛䝸䝑䜽䜢㑅䜆⬟ᛶ䜒䛒䜛䚹䛸䛟䛻䚸་⸆ศᴗ䛜㐍䜣䛷䛔䛺䛔ᅜ䛷䛿䚸㧗ရ㉁䜢䜰䝢䞊䝹 䛧䛴䛴ඛⓎရ䜘䜚䜒㧗䛔⸆౯ᕪ┈䜢ᥦ౪䛷䛝䜛䝆䜵䝛䝸䝑䜽䝯䞊䜹䞊䛜䝅䜵䜰䜢⋓ᚓ䛧䜔䛩 䛔䛸ᛮ䜟䜜䜛䚹 䛯䛰䛧䚸㏙䛾䜘䛖䛺䝡䝆䝛䝇䛻䛿䚸ᆅሙ䝯䞊䜹䞊䜔᪥⣔௨እ䛾እ㈨䝆䜵䝛䝸䝑䜽䝯䞊䜹䞊 䛜᪤䛻┠䜢䛴䛡䛶䛔䜛䚹䛣䜜䜙䛾ᴗ䛸➇த䛧䛺䛜䜙┈䜢䛒䛢䜛䛻䛿䚸㈍ඛ䛾㑅䛸 ရ㉁㠃䛻䛚䛡䜛ᕪ䠄᪥ᮏ〇ရ䛺䜙䛷䛿䛾㧗ရ㉁䛾䜰䝢䞊䝹䠅䛜㔜せ䛸䛺䜛䛰䜝䛖䚹䛭 䛾䛯䜑䛻䛿䚸㈍䜢་⸆ရ♫䛻௵䛫䜛䛾䛷䛿䛺䛟䚸᭷ຊᆅሙᴗ䜢䝟䞊䝖䝘䞊䛸䛧䛶㏄ 䛘䜛䛣䛸䛜᭷ຠ䛰䛸ᛮ䜟䜜䜛䚹 ᮾ༡䜰䝆䜰ㅖᅜ䛾ᆅሙᴗ䛿䚸୰つᶍ䠄㧗 100 ൨ᮍ‶䠅䛷䛒䛳䛶䜒ᅜ㝿ᒎ㛤䛧䛶䛔 䜛♫䛜ከ䛟䚸ᥦᦠ┦ᡭ䛸䛧䛶㨩ຊⓗ䛰䛸ᛮ䜟䜜䜛䚹䜎䛯䚸䝬䝺䞊䝅䜰ᨻᗓ䛺䛹䛿䝆䜵䝛䝸䝑 䜽་⸆ရ㒊㛛䛻䛚䛡䜛┤᥋ᢞ㈨䠄〇ᕤሙ䛾ᘓ㐀䛺䛹䠅䜢ዡບ䛧䛶䛔䜛䚹 ᅜᨻᗓ䛻䜘䜛䝆䜵䝛䝸䝑䜽་⸆ရ䛾ᅜ⏘䛻䛡䛯䛻䛿␃ព䛩䜉䛝䛰䜝䛖䚹ᅜ⏘ ᨻ⟇䛜ᙉ䛥䜜䜜䜀䚸㐍ฟᣐⅬ䛛䜙࿘㎶ᅜ䜈䛾㍺ฟ䛜㞴䛧䛟䛺䜛䛣䛸䜒⪃䛘䜙䜜䜛䚹᪥ᮏ ᨻᗓ䛜ᅜ䛾ᨻ⟇䜔ᕷሙ⎔ቃ䜢⥅⥆ⓗ䛻ㄪᰝ䛧䚸ሗⓎಙ䛩䜛䛣䛸䛜᭷ຠ䛷䛒䜛䚹 271

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2.

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279

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2007 .

3 55-79

2009 . 2009 7 14

2011 .

http://www.ide.go.jp/Japanese/Publish/Download/Overseas_report/1110_kubo.html

2014 1 31

2013a .

http://www.mhlw.go.jp/stf/houdou/2r9852000002z7fr-att/2r9852000002z7it.pdf 2014

1 31

2013b . 2013

http://www.mhlw.go.jp/seisakunitsuite/bunya/kenkou_iryou/iryou/shinkou/dl/vision_201

3a.pdf 2014 1 31

2013c . 2013

http://www.mhlw.go.jp/seisakunitsuite/bunya/kenkou_iryou/iryou/shinkou/dl/vision_201

3b.pdf 2014 1 31

2009 . 20

http://www.mhlw.go.jp/shingi/2009/05/dl/s0520-4d.pdf 2014 1 31

2009 . MPS

http://www.nichiiko.co.jp/stu-ge/phplib/s_getdoc_mpi.php?member&filepath=20090325

GEshare.pdf 2014 1 31

2010 . DKSH

http://www.nichiiko.co.jp/finance/gif/4541_2010070602.pdf 2014 1 31

2013 . BioLab

http://www.nichiiko.co.jp/finance/gif/4541_20130909_893701684500877.pdf 2014 1

31

2014 .

http://www.nichiiko.co.jp/finance/gif/4541_20140124_01.pdf 2014 1 31

290

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2007 .

6

121-145

Bahri, Salmah 2013 . “Use of Health Economics Data in Listing and Pricing of

Pharmaceuticals: Ministry of Health Perspective,”

Bridel, Anna 2012 . “Explaining 1Care: Its Proposals, Rationale and Feasibility.” Centre

for Public Policy Studies.

http://www.cpps.org.my/upload/CPPS%201Care%20Policy%20Paper.pdf 2014 1

31

Business Monitor International 2013 . Malaysia Pharmaceuticals and Healthcare Report

Q3 2013.

Elis, Jamaludin 2013 . “Stuck in the Middle? The Way Forward for Local Malaysian

Pharmaceutical Industry.” Presentation at the National Regulatory Conference 2013,

National Pharmaceutical Control Bureau.

http://portal.bpfk.gov.my/aeimages//File/Track_2_-_Session_1_-_The_Way_Forward_fo

r_Local_Pharmaceutical_Industries_by_Mr._Jamaludin_Elis.pdf 2014 1 31

Fatokun, Omotayo, M. Izham M. Ibrahim, and M. Azmi Hassali 2013 . “Factors

Determining the Post-Patent Entry of Generic Medicines in Malaysia: A Survey of the

Malaysian Pharmaceutical Industry.” Journal of Generic Medicines, 10(1): 22-33.

Hassali, M. Azmi and Zhi Yen Wong 2014 . “The Pharmaceutical Industry in Malaysia.”

IDE Discussion Paper.

Iizuka, Toshiaki 2007 . “Experts’ Agency Problems: Evidence from the Prescription Drug

Market in Japan.” RAND Journal of Economics, 38(3): 844-862.

Iizuka, Toshiaki and Kensuke Kubo 2011 . “The Generic Drug Market in Japan: Will It

Finally Take Off?” Health Economics, Policy and Law, 6(3): 369-389.

IMS Consulting Group 2012 . “South East Asia’s Pharmerging Landscape,” Presentation at

IBC Asia South East Asia Pharmaceutical Forum.

http://www.imshealth.com/deployedfiles/imshealth/Global/Content/Healthcare/Life%20S

ciences%20Solutions/Generics/pharmerging_landscape.pdf

IMS Health 2010 . IMS LEAP Study 2010: Launch Evolution Across Pharmerging Markets.

http://www.imshealth.com/imshealth/Global/Content/Pharmerging/Document/Launch

Evolution Across Pharmerging Markets.pdf 2014 1 31

Jaafar Safurah, Kamaliah Mohd Noh, Khairiyah Abdul Muttalib, Nour Hanah Othman, and

291

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Judith Healy 2013 . “Malaysia Health System Review.” Health Systems in Transition,

3(1).

http://www.wpro.who.int/asia_pacific_observatory/hits/series/Malaysia_Health_Systems

_Review2013.pdf 2014 1 31

Ministry of Health 2013a . Health Facts 2013.

https://www.malaysianheart.org/files/526dc23a78fa1.pdf 2014 1 31

Ministry of Health 2013b . Outpatient Charges.

http://www.moh.gov.my/english.php/pages/view/151 2014 1 31

Ng, Carolyn, Bodi Zhang, and Lucas de Breed 2012 . “Braving Changing Indonesian Tides

in the Pharmaceutical Sector: Seizing Opportunities Amidst Local Challenges.” Deallus

Consulting.

http://www.deallusconsulting.com/wp-content/themes/Avada/pdf/Ng_thought_piece.pdf

2014 1 31

Schut, Frederick and Peter Van Bergeijk 1986 . “International Price Discrimination: The

Pharmaceutical Industry,” World Development, 14(9), pp.1141-1150.

Shafie Asrul A., and M. Azmi Hassali 2008 . “Price comparison between innovator and

generic medicines sold by community pharmacies in the state of Penang, Malaysia.”

Journal of Generic Medicines. 6(1): 35-42.

WikiLeaks 2013 . Secret TPP Treaty: Advanced Intellectual Property Chapter for All 12

Nations with Negotiating Positions.

https://wikileaks.org/tpp/static/pdf/Wikileaks-secret-TPP-treaty-IP-chapter.pdf 2014 1

31

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