I.          OBJECTIVES

The objectives of this initiative are to:

-          Strengthen regional integration through liberalisation and facilitation measures in the area of trade in goods, services and investments; and

-          Promote private sector participation.

II.         MEASURES

The initiatives within incorporate recommendations in the Bali Concord II as well as those gathered from private and public sector representatives from all ASEAN countries.

Full implementation of these recommendations is key for ASEAN to achieve our goal of integrating the healthcare sector by 2010.  However they are not meant to be exhaustive, and ASEAN should continue to incorporate other necessary measures as and when appropriate.  This roadmap includes issues specific to the Healthcare sector, as well as horizontal issues cutting across all sectors. 

III.        COVERAGE

The scope of product coverage for the healthcare sector appears as Attachment 1. 

COMMON ISSUES

I

Tariff Elimination

1

Eliminate CEPT-AFTA tariffs on all identified products

Coordinating Committee on the Implementation of the CEPT Scheme for AFTA (CCCA)

ASEAN 6:  2007

CLMV:  2012

II

Non-Tariff Measures (NTMs)

2

Establish the Database of ASEAN NTMs to ensure transparency[1]

CCCA

30 June 2004

3

Establish clear criteria to identify measures that are classified as barriers to trade

30 June 2005

4

Establish a clear and definitive work programme for the removal of the barriers.

31 December 2005

5

Adopt the WTO Agreement on Import Licensing Procedures and develop implementation guidelines appropriate for ASEAN.

31 December 2004

III

Rules of Origin

6

Improve the CEPT Rules of Origin by:

Task Force on CEPT Rules of Origin (ROO-TF)

31 December 2004

-          making it more transparent, predictable and standardised taking into account the best practices of other Regional Trade Agreements including the rules of origin of the WTO; and

-          adopting substantial transformation as alternative criteria for conferring origin status.

IV

Customs Procedures

7

Extend the application of the ASEAN Harmonised Tariff Nomenclature (AHTN) for extra-ASEAN trade.

Expert Committee on Customs Matters (ECCM)

on-going

8

Develop a simplified, improved and harmonised customs declaration form.

31 December 2005

9

Ensure full implementation of the Green Lane System for CEPT Products, or similar systems, at entry points of all Member States.

31 December 2004

10

Develop implementation guidelines, as appropriate, for Member States which are not members of the WTO to fulfill the obligations of the WTO Agreement on Customs Valuation

31 December 2004

11

Adopt service commitment (client charter) by ASEAN customs authorities.

31 December 2004

12

Develop the Single Window approach, including the electronic processing of trade documents at national and regional levels

Inter-Agency Task Force on Single Window

31 December 2005

V

Standards and Conformance

13

Accelerate the implementation/ development of sectoral Mutual Recognition Arrangements (MRAs), as appropriate

ASEAN Consultative Committee on Standards and Quality (ACCSQ)

beginning 1 January 2005

14

Encourage domestic regulators to recognise test reports issued by testing laboratories which are already accredited by National Accreditation Bodies in ASEAN that are signatories to ILAC and APLAC MRA

on-going

15

Set clear targets and schedules for harmonisation of standards, wherever required; where international standards are not available, and when requested by industry, align national standards among Member States.

31 December 2005

16

Harmonise and/or develop, wherever appropriate, technical regulations for national application.

31 December 2010

17

Ensure compliance with the requirements, rights and obligations of WTO Agreements on Technical Barriers to Trade and the Application of Sanitary and Phyto-Sanitary Measures

on-going

18

Explore development of ASEAN policy on standards and conformance to further facilitate the realisation of the ASEAN Economic Community.

beginning 2005

VI

Logistics Services

19

Expedite the development of integrated transport logistics services within ASEAN through:

Senior Transport Officials Meeting (STOM)

beginning 2005

-          Promotion of efficient door-to-door cargo transport and cross-border transport facilitation through the expeditious implementation of the ASEAN Framework Agreement on the Facilitation of Goods in Transit, and the ASEAN Framework Agreement on Multimodal Transport;

-          Improvement of land transport network infrastructures and services to achieve better inter-connectivity, inter-operability and inter-modality with the national, regional and international maritime and air transport gateways;

-          Strengthening intra-ASEAN maritime and shipping transport services; and

-          Establishment of enabling and conducive policy environment for increased private sector involvement and/or public-private partnerships in the development of transport infrastructure and the provision and operation of transport logistics facilities and services.

VII

Outsourcing and Industrial Complementation

20

Identify and develop specialisation of production processes, research and development (R&D), and testing facilities based on comparative advantages of individual Member States

Working Group on Industrial Cooperation (WGIC), with inputs from the private sector

on-going

21

Develop guidelines to promote outsourcing arrangements among Member States, as applicable.

VIII

ASEAN Integration System of Preferences

22

Endeavour to expand the coverage of the ASEAN Integration System of Preferences (AISP) Scheme by including products in the priority integration sectors

CCCA

on-going

IX

Investments

23

Accelerate the opening up of sectors currently in the Sensitive List (SL) by transferring these sectors into the Temporary Exclusion List (TEL) under the Framework Agreement on the ASEAN Investment Area, using the ASEAN-X formula.

Coordinating Committee on Investment (CCI)

beginning 2004

24

Reduce restrictive investment measures in the SL

beginning 2004

25

Complete the progressive elimination of restrictive investment measures in the TEL

on-going[2]

26

Identify programmes and activities to promote investments in ASEAN

31 December 2005

27

Promote manufacturing processes across different ASEAN countries to take advantage of their comparative strengths through:

-          the establishment of a network of ASEAN free trade zones to facilitate outsourcing activities

beginning 2005

-          undertaking more efficient joint ASEAN facilitation and promotion measures to promote FDI

on-going

28

Promote and facilitate joint/cross border investments in manufacturing activities through:

on-going

-          special incentives, where appropriate, to be given by CLMV for investments from ASEAN

-          special measures, where appropriate to be given by ASEAN 6 to promote and facilitate relocation of investment to CLMV countries especially for labour intensive manufacturing activities

X

Trade and Investment Promotion

29

Intensify intra- and extra ASEAN joint promotion efforts regularly

CCI; ASEAN Chambers of Commerce and Industry (ASEAN-CCI); and relevant Industry Clubs/ Associations

on-going

beginning 2005

30

Organise regular private sector initiatives to undertake:

CCI;

ASEAN Business Advisory Council (ASEAN-BAC);

and ASEAN-CCI

on-going

beginning 2005

-          more efficient joint ASEAN facilitation and promotion measures to promote FDI ASEAN selling-buying missions; and

-          promotional activities to assist CLMV countries

31

Undertake more effective joint ASEAN facilitation in promotion measures and develop new sources of inward foreign direct investments, particularly from potential countries such as the People’s Republic of China, India and the Republic of Korea

on-going

XI

Intra-ASEAN Trade and Investment Statistics

32

Establish an effective system to monitor intra-ASEAN trade and investment through:

Working Group on Statistics; Working Group on Foreign Direct Investment Statistics; and CCCA

on-going

-          provision of updates to the ASEAN Secretariat of the latest trade (goods and services) and investment statistics

-          preparation of consolidated industry profile, by the respective associations, which among other matters, cover information such as production capacity and product range

XII

Intellectual Property Rights

33

Expand the scope of ASEAN intellectual property rights cooperation beyond trademarks and patents by including cooperation in copyrights information exchange and enforcement

ASEAN Working Group on Intellectual Property Cooperation (AWGIPC)

31 December 2004

XIII

Trade in Services

34

Member States shall accelerate the liberalisation of trade in services earlier than 2020.  This could be achieved through:

-          Setting clear targets and schedules of services liberalisation for each priority sector and each round towards achieving freer flow of trade in services by 2010;

Coordinating Committee on Services (CCS) and CCI

on-going

-          Accelerating the development of Mutual Recognition Arrangements (MRAs);

before 2008

-          The application of the ASEAN-X formula; and

on-going

-          Promotion of joint ventures and cooperation, including in third country markets.

on-going

XIV

Movement of Business Persons, Skilled Labour, Talents and Professionals

35

Develop an ASEAN Agreement to facilitate the movement of business persons, including the adoption of an ASEAN Travel Card, taking into account Member States’ domestic laws and regulations.

Directors-General of Immigration Departments and Heads of Consular Affairs Division of the Ministries of Foreign Affairs (DGICM)

31 December 2005

36

Develop an ASEAN Agreement to facilitate the movement of experts, professionals, skilled labor and talents, taking into account Member States’ domestic laws and regulations

CCS

31 December 2005

37

Accelerate completion of MRAs to facilitate free movement of experts, professionals, skilled labor and talents in ASEAN, taking into account Member States’ domestic laws and regulations

31 December 2008

XV

Facilitation of Travel in ASEAN

38

Harmonise procedures for the issuance of visas to international travelers

DGICM

31 December 2004

39

Provide visa exemption for intra-ASEAN travel by ASEAN nationals

2005

XVI

Human Resource Development

40

Develop and upgrade skills and capacity building through joint trainings and workshops.

Senior Labour Officials Meeting (SLOM)

on-going

SPECIFIC ISSUES

XVII

Investments

41

Allow higher share of ASEAN ownership / participation in selected healthcare   establishments, subject to domestic laws and regulations of each ASEAN country, on an ASEAN-X basis

CCS and CCI

on-going

42

Set up “one-stop centre” in each ASEAN country responsible for facilitating investments, including healthcare projects

CCI

31 December 2008

XVIII

Standards and Conformity

Pharmaceutical Products

43

Study the feasibility of an ASEAN Mutual Recognition Arrangement (MRA) for pharmaceutical / medicinal products

ACCSQ Pharmaceutical Product Working Group (PPWG)

30 December 2005

44

Implement the ASEAN Common Technical Dossier

31 December 2008

45

Harmonise the labelling standards for pharmaceutical/medicinal products

31 December 2006

46

Explore the feasibility of adopting a harmonised placement system for pharmaceutical / medicinal products into the ASEAN markets

31 December 2009

47

To facilitate the approval process, the ASEAN-X formula can be applied. The recognition of the approval proc­ess can only be realised when Mem­ber States fully implement the ACTD

after 31 December 2008

48

Explore the feasibility of implementing a flexible twinning system, where member states voluntarily pair with one or other member states to co-operate in enhancing mutual regulatory capacity and resource development

on-going

49

Formalise a post-marketing alert system for defective and unsafe pharmaceutical/medicinal products.

31 December 2005

Cosmetics

50

Accelerate implementation of the ASEAN Harmonised Cosmetic Regulatory Scheme (AHCRS), and automatic listing for cosmetics products

ACCSQ ASEAN Cosmetics Committee (ACC)

1 January 2008

51

Formalise a post-marketing alert system for defective or unsafe cosmetic products

31 December 2005

Medical Device and Equipment

52

Medical Device and Equipment Working Group to look into integration measures, which includes the following:

ACCSQ Medical Device and Equipment Working Group

beginning 2005

-          Developing a common submission dossier template for product approval in ASEAN

-          Exploring the feasibility of an abridged approval process for medical devices which regulators of benchmarked countries or recognised regional regulators have approved

-          Exploring the feasibility of adopting of a harmonised system of placement of medical devices into the ASEAN markets based on a common product approval process

-          Formalising of a post-marketing alert system for defective or unsafe medical devices or equipment

-          All ASEAN countries to consider joining the Asian Harmonisation Work Party (AHWP) and work in parallel with the Global Harmonisation Task Force (GHTF) on technical harmonisation efforts

Traditional Medicines and Health Supplements

53

Exchange, review and analyse information on the existing regulatory framework/regime including standard definition, terminologies, and technical infrastructure in Member Countries

ACCSQ Traditional Medicines and Health Supplements Working Group (TMHSWG)

31 December 2006

54

Identify areas for possible harmonisation and MRAs

31 December 2009

55

Study the existing regulatory frameworks/regime of selected countries and internationally accepted technical guidelines

31 December 2006

56

Enhance the technical infrastructure including mutual confidence in testing and conformity assessment

2004 onwards

57

Formalisation of a post-marketing alert system for unsafe traditional medicine or health supplements

31 December 2007

XIX

Capacity Building

58

More established ASEAN countries to provide training and host attachment programmes for medical and health-related workers from less developed ASEAN member states.

Relevant ASEAN Professional Associations, e.g., ASEAN Association of Radiologists

on-going

59

Provide more exchanges and training for medical and health-related professionals from less developed member states. This is especially necessary for areas of key shortages like specialists and skilled operators of medical equipment MRI and CT scanners

60

To strengthen cooperation within ASEAN countries in the area of capacity building, i.e., exchange of experts, regulatory infrastructure and human resource development, within available resources

ACCSQ

on-going

61

Member states to consider modelling their technical standards and regulations after ASEAN harmonised technical standards and regulations which is to be evolved from acceptable international or regional technical standards and regulations.  This lowers the cost of setting up regulations and is a step towards harmonisation of regulations within ASEAN

XX

Movement of Patients

62

Minimise visa requirements for intra-ASEAN travel by ASEAN nationals to facilitate cross border movement of patients and accompanying persons

CCS and DGICM

31 December 2005