APAC Harmonization: New Activities

Transcription

1 APAC Harmonization: New Activities CMC Strategy Forum Japan 2013 December 09, 2013 Japan Pharmaceutical Manufacturers Association (JPMA) Kozo Akasaka 1

2 Agenda 0. What is APAC? 1. Collaboration of JPMA 2. Situation of Asia 3. APAC Current 4. APAC Structure and Agreement 5. Future of APAC 2

3 What is APAC? APAC = Asia Partnership Conference of Pharmaceutical Association Not APEC = Asia-Pacific Economic Cooperation 3

4 The initiation of Asia Partnership Conference of Pharmaceutical Association Mr. Hasegawa, Chairman of Japan Association of Corporate Executives 4

5 1. Collaboration of JPMA 5

6 JPMA International Collaboration through Bilateral Annual Meetings UK JPMA/DoH, ABPI (17 th meeting in Nov 2012) RUSSIA JPMA/AIPM(1 st meeting in Jun 2012) JPMA/ARPM(1 st meeting in Sep 2013) FRANCE JPMA/LEEM with CEPS, HAS (20 th meeting in Feb 2013) KOREA JPMA, MHLW, PMDA/ MoHW, KFDA, HIRA, KPMA (11 th meeting in July 2013) GERMANY JPMA/VFA (9 th meeting in Nov 2012 ) CHINA JPMA, MHLW, PMDA/ NHFPC (MoH), CFDA, RDPAC (7 th meeting in 2013) EFPIA JPMA/EFPIA (Feb 2012~) TAIWAN MHLW, PMDA, JPMA/ Taiwan-FDA, CDE, IRPMA (7 th meeting in 2011) 6

7 New International Collaboration Framework IFPMA PhRMA (US) EFPIA (EU) JPMA (Japan) KPMA/KRPI A (Korea) RDPAC (China) OPPI (India) Others Collaboration between JPMA and Asian Pharmaceutical Associations. 7

8 2. Situation of Asia 8

9 World Pharmaceutical Market Overview(1) Developed markets will account for 57% of total spending, down from 73% in Japan will retain 10% of drug spending in 2016, essentially unchanged except for the impact of the biennial price cuts expected in 2012, 2014 and

10 World Pharmaceutical Market Overview (2) % US Canada EU rest EU Japan Pharmerging rest World Pharmerging= India, China, Brazil, Mexico, Russia, Turkey 6

11 Growth of Population and Aging Society (Million People) Total Population Asia (%) Ratio of over 65 China India Indonesia Japan Japan 35 Korea Korea China Africa 20 Indonesia 15 Europe North America 10 India 5 South America 0 (Source: Census and Population projection Statistics Bureau, Ministry of Internal Affairs and Communications and Future population estimate of Japan National Institute of Population and Social Security Research (estimate in December 2006) 11

12 Niche is Becoming Possible with Respect to Drug Discovery in Asia due to Bio-related National Policies Biomanufacturing CT developmt (S. Korea) Drug discovery Infrastructure (Japan) Chemical Synthesis (India) Life Science Res (China) Bio Research Life science (Taiwan) Pharma Manufacturing Res (Thailand) Bio Research (Malaysia) Research Infrastructure (Singapore) The specialty typical in drug discovery in Asia 11

13 Emerging Bio-clusters in the Asian Region due to National Policy to Promote Healthcare Innovation and Biotechnology State Measures Bio-clusters Japan South Korea China Singapore Strategies to Revitalize Japan approval in Life Growth Strategy was set forth as an important item, and a setup to assist the creation of innovative drugs and medical devices is being established. Bio-Vision 2016 strengthens the competitiveness of bio-industry through development and globalization. The 12 th 5-year plan designated seven sectors as strategic newly-emerging industries. One of these is biotechnology, and the government aims to increase the share of biotechnology industries in GDP from 4% (2010) to 8% (2015). Various measures (incl. Bio-polis) enhance functions as a hub for manufacturing/r&d of high-tech fields including biotechnology. International strategy comprehensive special zones and local revitalization comprehensive special zones were established, aimed at creating economic effects and jobs. 16 bio-clusters across 3 zones. International collaboration established. Bio-pharmaceutical industry parks are located in approx 50 sites throughout the country. Numerous public financial investments have been made. Efforts typified by Bio-polis. Bio-industrial promotion by the government is urged onward respectively in other ASEAN countries. 1 3

14 continuation Thailand Taiwan Malaysia India Hong Kong TCELS was established under the Ministry of Science and Technology to support bioventures. A Biotechnology Takeoff Action Plan was enacted in 2009, backing up development efforts to turn Taiwan into a partner in the international biomedical field. The government also creates employment opportunities, aimed at reinvigorating the biomedical industry. The newly developed Eight Development Strategies includes the pharmaceutical industry in the Development of growing industry. The 12 th 5-year Plan which is expected to follow the previous 5-year Plan to maintain increased public investment in HC Same as China Efforts typified by the Thailand Science Park. As a base for bio-industries, the New Hsinchu Science and Biopharmaceutical Industry Park was opened in Manufacturing bases focusing on a medical center as well as incubation facilities are currently being built. As the biotechnology base, the Malaysian Government constructed Bio-Xcell in Nusajaya, Iskandar region in the Malaysian State of Johor, and completed it in The former 5-year Plan included the promotion of innovation through the creation of bio-clusters in its 3 rd Action Plan. Currently, there are clusters in the BT field in 3 areas of India. Efforts typified by the Hong Kong Science Park. 14

15 Many countries in Asia have positioned HC innovation and promotion of biotechnology as a key pillar and numerous bioclusters have been established Japan South Korea China Singapore National Policy New Growth Strategy developed in June 2010 positions HC innovation as Life Innovation and includes it as one of 7 national policies Bio-Vision 2016 clearly sets a goal to strengthen competitiveness of bioindustry through the development and globalization Twelfth 5-year Plan (~2015) designates seven sectors as strategic newly-emerging industries, one of which is biotechnology with biomedicine as its key field Various measures such as Biopolis enhance functions as a hub for R&D/manufacturing of high-tech fields including semiconductors, information processing and biotechnology Bio-cluster Bio-cluster is being concentrated in line with Local Cluster Plan centering on special zones for structural reform and each local government. Total of 16 bio-clusters across 3 zones. International collaboration is being advanced Research institutions are cluster mainly in provincial cities. Lots of public investments are allocated Efforts typified by Biopolis 15

16 continuation Thailand Taiwan Malaysia India Hong Kong The National Science and Technology Strategic Plan (~2013) sets out funding measures in the field of pharmaceutical research, etc. Under the Action Project for Six Emerging Industries of Government, which includes biomedicine, establishment of public-private funding VCs and formulation of incubation centers continue. Act on Development of Biomedical Industry gives temporary tax breaks to bioventures. The Tenth Malaysia Plan (~2015) named pharmaceuticals in Development of Growing Industry, the 7 th item among newly-identified 8 New Development Strategies, though it was left off the 12 National Key Economic Areas Twelfth 5-year Plan (April 2012~), which is under development, is expected to follow the previous 5- year Plan to maintain increased public investment in health care Same as China Efforts in line with the key strategies set out in the National Science and Technology Strategic Plan are under way (Efforts typified by Thailand Science Park) With support from Government, bioclusters (mostly bio-incubation centers) and bio parks are being constructed. President Mahathir (then) advocated the concept of BioValley Malaysia in the early 2000s, which primarily focuses on foodfield. Recent reporting indicates that clusters in the field of medicine have been further formulated centering on institutions of higher education The former 5-year Plan included the promotion of innovation through the creation of bioclusters in its 3 rd Action Plan. Currently, there are clusters in the BT field in 3 areas of India Efforts typified by Hong Kong Science Park 16

17 (year) 8.0 Drug Lag in Each Country Average period from first launch Top 100 drugs in global sales Excluding drugs launched before and some double brand drugs/diagnostics) Source: 2012 IMS Health. IMS World Review LifeCycle (No copies or duplications.) Office of Pharmaceutical Industry Research s analysis based on IMS data OPIR News No.35 (March 2012) 17

18 Significance of Collaborations in Asia The economic center is moving to Asia, but the concept of a unified Asia is far from realization Needed for Asia along with economic growth is to create a favorable environment Drug development capabilities, innovative drugs can be originated in Asia, delivered to Asian economies Improvement of QOL for Asian will further boosts national economies and develop societies Pharmaceutical industry in Asia needs to work & grow together 18

19 3. APAC Current 19

20 APAC Participating Economies Organization HKAPI The Hong Kong Association of the Pharmaceutical Industry Economy Hong Kong IPMG International Pharmaceutical Manufacturer Group Indonesia IRPMA International Research-based Pharmaceutical Manufacturers Association KPMA Korea Pharmaceutical Manufacturers Association KRPIA Korean Research-based Pharmaceutical Industry Association Taiwan Korea Korea OPPI Organization of Pharmaceutical Products of India India PhAMA Pharmaceutical Association of Malaysia Malaysia PHAP The Pharmaceutical and Healthcare Association of the Philippines Philippines PReMA The Pharmaceutical Research and Manufacturers Association RDPAC R&D-based Pharmaceutical Association in China Thailand China SAPI Singapore Association of Pharmaceutical Industries Singapore JPMA Japan Pharmaceutical Manufacturers Association Japan Guests: Expotent from PhRMA, EFPIA, IFPMA, Interpharma, FPMAJ, government (MHLW, PMDA, Malaysia, Singapore, Vietnam) and research institutes 20

21 First APAC (2012. March 15, 16) 21

22 Second APAC (2013. April.11&12) APAC = Asia Partnership Conference of Pharmaceutical Association 22

23 Second APAC article The Nikkei News Paper Apr. 26,

24 The Healthcare and Medical Strategy Understanding Among 1) Chief Cabinet Secretary 2) Minister of State for Information Technology (IT) 3) Minister of State for Science and Technology Policy 4) Minister of Public Managmt, Home Affairs Posts & Telecomn 5) Minister of Foreign Affairs 6) Minister of Education Science Sports and Culture 7) Minister of Health, Labor and Welfare 8) Minister of Economy, Trade and Industry and 9) Minister of Land, Infrastructure and Transportation June 14,

25 The Healthcare and Medical Strategy (June 14, 2013) Page Creation of novel technologies (R&D and practical application) (2) R&D promotion in private sector 2 Environmental development for Open Innovation i) Provide financial support via various funds and other forms of assistances to small-to-medium-sized companies and ventures to foster the next-generation industries through promoting open innovation ii) Toward advanced cooperation for creation of innovative new drugs, support efforts being made at the Asia Partnership Conference of Pharmaceutical Association (APAC) to promote creation of an open innovation platform through collaboration between industry, academia, government, and ventures of Asian countries 25

26 Mission of APAC To expedite the launch of innovative medicines for the peoples in Asia We, people living in Asia to change Asia from inside (1 st APAC) Toward a cooperation with government and academia (2 nd APAC) 26

27 We, people living in Asia to change Asia from inside Analysis and discussion on issues in Asian pharmaceutical markets based on the country reports Agreement to the mission and the collaboration among Asian pharmaceutical associations Select the issues APAC EWG work Regulations and Approval Drug discovery alliance Participation of Government (MHLW, PMDA, etc.) 27

28 Agenda of 2 nd APAC (2013. April.11&12) Toward a cooperation with government authorities and academia Review of issues and discussions on possible EWG Review of progress of RA/DA EWGs Panel Discussions for RA with regulators and for DA with research institutes from Asia Key Note speech for UHC system in Japan, and The EU system for Regulation of Medicines 28

29 Analysis of Possible Hindrance for Access to Medicines in Asia to Decide Issues 29

30 Challenges and Issues in Access to Innovative Medicines in Asia Cost containment measure for drugs expenditures Drug price system Medical infrastructure Reimbursement/HTA Distribution/logistics Counterfeit medicines Access to medicine Intellectual property Compulsory licensing Pharmaceutical R&D Quality Medical Insurance System Approval system National income/gdp Source: 1 st APAC (2012, 3.16) 30

31 Healthcare Systems in Asia Financial Resource Person Insured Details Hong Kong Indonesia Tax Private insurance Primary care provided at 100% selfpayment or private insurance Public officers /military personnel, regional health insurance Workers social security and insurance system for public officers cover 50.2% of the population (in 2007) Taiwan Universal care Public universal HC system established in 1991 Korea India Malaysia Social insurance Universal care Insurance National /local public officers Insurance for Poverty group Public universal HC system established in 1989 Covers 5% of the population 90% of workers are uninsured No public HC insurance system. And Insurance system for the poor is available 31

32 continuation Financial Resource Person Insured Details Philippines Universal Care Public universal HC system established in 1995 but 1/3 of the population not insured. Thailand Tax Universal Care Public universal HC system (2002): combination of insurance for public officers, employee s health insurance and private insurance China Social insurance Universal Care 1) Urban employees, 2) Urban residents 3) New villages Covers 95% of the population. Public universal HC system established in Singapore Japan Health saving system Social insurance Minimal level of government involvement, compulsory saving system Universal Care Public universal HC system established in co-payment (15%) Source: 1 st APAC (2012, 3.16) 32

33 Drug Pricing System List price Free price Korea Japan (comparative Pricing method/cost calculation method) (Positive List System/ Pharmaco-economics) Taiwan (Reference prices based on 10 other countries) China (National Reimbursement Drug List: List price / Patented Drug: individual price) India (Patented drug: free price/ drugs on price control list: List price) Hong Kong Thailand Indonesia Singapore Malaysia Philippines Source: 1 st APAC (2012, 3.16) 33

34 Major Issues to Discuss in APAC Difficult to pick a theme to encompass some countries specific challenges Need to comprehend and follow up the actual situation of each economy Regulation/Approval and Drug Discovery as common themes to be addressed at the 1st APAC RTD 34

35 Agreements Reached at 1 st APAC Goals: Share information on the challenges faced in each economy and build a platform to transmit all necessary proposals to relevant stakeholders Topics Discussed in the Conference Regulations and Approvals Prepare recommendations to realize early submission and approval of NDA in Asia and supply quality drug at global standards from Asia Drug Discovery Alliances Promote open innovation in Asia in order to realize drug discovery that originates in Asia Actions Form an APAC SC for planning a APAC meeting and oversee WG for Regulations/Approvals and Drug Discovery Alliance 1 st meeting pic. in

36 5. APAC Structure and Agreement 36

37 APAC Structure APAC (Asia Partnership Conference of Pharmaceutical Associations) SC (Steering Committee) DA-EWG (Drug discovery Alliances) RA-EWG (Regulatory & Approval) DA Expert Team (Support from JPMA) RA Expert Team 37

38 Agreement Reached in the 2 nd APAC General Collaborate with the public sector, and academia in Asia to work toward the realization of our mission 38

39 Regulations and Approvals Establish a road map, aiming at speeding up and coordinating new drug applications and approvals in Asia Work with the regulatory authorities of each economy Ensure complementarity with existing regulatory harmonization initiatives in Asia 39

40 Drug Discovery Alliances Facilitate information exchange for collaboration, and dispatch a delegation for analysis of needs Build networks and establish an environment for industry, the public sector, academia, and venture in Asia Foster partnership and promote open innovation, participate in symposiums and conferences relating to drug discovery in Asia 40

41 Assessment & gap analysis Consultation with regulators Assessment of readiness Current Status and Future Direction Current State Identified Issues Road Map Goal APAC Mission Analysis Report IND NDA Clinical Trial GMP Step Regulatory acceptance for an early initiation of multi-national clinical trials in Asia Regulatory acceptance and Co-review system for NDA Simultaneous NDA in all Asian countries Acceleration of mutual recognition of GMP inspection To expedite the launch of innovative medicines for the peoples in Asia FY 2012 Collaboration with relevant stakeholders RA EWG APAC 12 April

42 Drug Discovery Alliances Improve Drug Discovery Capability through Open Innovation 42

43 6. Future of APAC 43

44 Updates on the Progress of Consideration Toward the 3rd APAC APAC-SC Regulations and Approvals EWG Vision of APAC & organization Expansion of participating associations, governments, and academia Cooperation with Governments, GRevP (Policy documents, collaboration with stakeholders) Harmonization of regulatory requirements for NDAs Drug Discovery Alliances EWG Building a platform for open innovation through bilateral discussions 44

45 Future of APAC Establish APAC as a Forum all relevant stakeholders discuss and decide for collaborations toward improving HC in Asia Work with Regulators and Academia in Asia to achieve the mission Incorporate all the Asian Associations 3 rd APAC will be held in April 2014 in Tokyo 45

46 To Expedite the Launch of Innovative Medicines for the Peoples in Asia <<Roadmap for Asia Origin Drug Discovery Infrastructure>> April 10th and 11th, 2014 Imperial Hotel, Tokyo Fujinoma-Room 46

47 Thank you very much! 47