THE ASEAN ECONOMIC COMMUNITY IS FORMALLY ESTABLISHED by Sebastian MELCHOR

The ASEAN Economic Community (AEC) will officially commence on January 1, 2016 after the heads of ASEAN member states today, Sunday November 22, 2015, signed the 2015 Kuala Lumpur Declaration on the Establishment of the ASEAN Community. Twelve years in the making, the foremost goal of the AEC is to turn the region into a single market and production base by eliminating remaining trade barriers and harmonising standards.

In addition to signing the 2015 Kuala Lumpur Declaration on the Establishment of the Asean Community the Asean heads of State also adopted a declaration on the bloc’s growth to 2025, mapping out a plan for further regional integration and community building efforts.
In practice, Asean countries have already done away with most tariff barriers, but now have to ensure that a truly single market and production base is created, with freer movement of goods and services.

Home to over 630 million consumers, according to its statistics the combined GDP of ASEAN economies is expected to grow from US$2.6 trillion to US$4.7 trillion by 2020. Seen as a bloc it will be the seventh largest economy today, and has the potential to be the fourth largest in the world as early as 2030.

 

ASEAN countries move closer to full harmonization of health supplements by Sara Aparicio Hill

AS THE END OF 2015 DEADLINE TO START THE ASEAN SINGLE MARKET GETS NEARER, THE ASEAN (ASSOCIATION OF SOUTH EAST ASIAN NATIONS[1]) HAS TAKEN BIG STRIDES IN ORDER TO HARMONISE STANDARDS AND CONFORMANCE FOR HEALTH SUPPLEMENTS[2]. THE ASEAN ECONOMIC COMMUNITY ("AEC"), ONE OF THE THREE PILLARS OF THE ASEAN COMMUNITY, AIMS TO CREATE A SINGLE MARKET AND PRODUCTION BASE AND AN ECONOMIC REGION THROUGH REGIONAL INTEGRATION. AN IMPORTANT PRINCIPLE OF THE AEC IS THE “FREE FLOW OF GOODS”. IN THE FIELD OF HEALTH SUPPLEMENTS, THE FREE FLOW OF GOODS WILL BE ACHIEVED VIA HARMONISATION IN AREAS SUCH AS PRODUCT DEFINITION, LISTS OF FORBIDDEN PLANTS AND ADDITIVES, OR MAXIMUM LIMITS OF VITAMINS AND MINERALS. HOWEVER, LACK OF MUTUAL RECOGNITION IN NON-HARMONISED AREAS SUCH AS NUTRITION LABELLING, AND NO STRICT ENFORCEMENT OF THE SINGLE MARKET RULES REMAIN A TEST TO BE PASSED BY ASEAN.

The ASEAN Agreement on Health Supplements harmonises and implements the technical requirements and guidelines for health supplements, and should be transposed into national laws of the ASEAN Member States by the end of 2015. These Member States have divergent requirements for the marketing of health supplements, therefore harmonisation has been a significant challenge to be overcome by them.

The ASEAN Agreement on Health Supplements covers, amongst others, the following areas:

§  Definition of health supplements;

§  Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances

§  Guiding Principles for the Use of Additives and Excipients

§  Guidelines on Limits of Contaminants

§  Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies

§  Guidelines on Stability and Shelf-Life

§  Guiding Principles on Safety Substantiation

§  Guidelines on Claims and Claims Substantiation
Guidelines on Good Manufacturing Practice

§  Guidelines on Labelling Requirements

§  General Principles for Establishing Maximum Levels of Vitamins and Minerals

REGISTRATION PROCEDURE

The ASEAN Agreement on Health Supplements states that health supplements should only be placed on the market upon granting of marketing authorisation by the Regulatory Authority in the respective Member State. However, as of today there is still no firm position from the ASEAN Member States regarding whether a registration procedure will be mandatory, and if so how registration in one Member State would affect registration in other Member States[3].

CAN I RELY ON MUTUAL RECOGNITION IN ASEAN?

Some areas like nutrition labelling are not harmonised by the ASEAN Agreement on Health Supplements. In the absence of harmonisation in the AEC, mutual recognition does not work as it does in the EU. In ASEAN, Mutual Recognition Arrangements (MRAs) are agreements made between two or more parties who agree to mutually recognise or to accept some, or all, aspects of each other’s conformity assessment of product standards. Therefore, mutual recognition is not an ensconced principle which applies automatically in all Member States in non-harmonised areas.

ENFORCEMENT

An ASEAN Member State may prohibit the marketing of health supplements in its market, as it deems appropriate, for reasons specific to protection of animal, or plant life, environment and cultural or religious sensitivity. If a Member State places a restriction or ban on specific health supplements, then it must notify the other Member States justifying the reason for said prohibition, to the competent ASEAN body. Disputes on the interpretation or implementation of the ASEAN Agreement on health supplements are resolved via the wider ASEAN Protocol on Enhanced Dispute Settlement Mechanism.

Based on the above, in practice disputes will ultimately be resolved on a political level, unlike in the EU where the Commission has broad enforcement powers against the Member States. Therefore, it remains to be seen whether ASEAN will be able to ensure there is a mechanism in place that prevents its Member States from hampering the free flow of goods[4]. 

 

[1] Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam.

[2] Health supplements are considered healthcare products in ASEAN, and not food products.

[3] For example, Singapore who currently has no registration or notification requirement still has not stated whether there will be a registration procedure in the near future.

[4] However, there have been unofficial mentions of establishing an ASEAN wide “supra-scientific assessor”, which would leave less room for the ASEAN Member States to issue divergent scientific opinions on which to base marketing prohibitions.

One step further in the ASEAN Economic Community Integration by Sebastian MELCHOR

The Asian marketplace is home to 620 million consumers, and similarly to the European Union,  wants to be the next market to declare itself a single market and production base, starting  in December 2015. The ASEAN Member countries (Brunei Darussalam, Cambodia, the Republic of Indonesia, the Lao People’s Democratic Republic, Malaysia, the Union of Myanmar, the Republic of the Philippines, the Republic of Singapore, the Kingdom of Thailand and the Socialist Republic of Viet Nam) are moving towards integration by creating a common economic area guided by principles such as the free flow of goods.

In the field of "health" supplements in particular, the ASEAN Healthcare Integration Roadmap, contemplated measures such as harmonising technical requirements and exploring possible Mutual Recognition Arrangements, to eliminate technical barriers to trade for health supplements without compromising public health and safety of ASEAN consumers. 

This will be achieved by a closer ASEAN cooperation on standards and conformance of these products to facilitate trade in the region. For instance, there are instruments like a Negative List of Substances; and Guidance on the use of additives and excipients, on safety substantiation, on claims and claims substantiation, Good Manufacturing Practice, labeling requirements, or general principles for establishing maximum levels of vitamins and minerals in health supplements.