You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

March 14, 2012

Towards Greater Harmonisation – The View from Southeast Asia

World Intellectual Property Review

The 10 nation members of the Association of Southeast Asian Nations (ASEAN) have committed to implement an ASEAN Economic Community (AEC) by 2015. As of January 1, 2010, with the full implementation of the ASEAN Free Trade Agreement (now called the ASEAN Trade in Goods Agreement), the trading bloc has created a single market of more than 600 million people, making it the world’s ninth largest economy, with a GDP growth of 7.5 percent.

Foreign direct investment into ASEAN rose to $76 billion in 2010, doubling the 2009 level. Comparisons to EU economic integration are frequent, but unlike that merged economy, ASEAN lacks singular regulation and harmonised rules and regulations. Among the key challenges posed by integration, ASEAN members will need to implement an effective system for the registration, enforcement and commercialisation of intellectual property (IP) within the AEC.

Current plan

Although the development of IP laws and enforcement mechanisms differ from one member state to another, ASEAN recognises the importance of effective IP policy, which must be consistently implemented in all member states. In 1995, ASEAN adopted the IP Rights Action Plan, which provides a framework for establishing effective IP policy in the region. The ASEAN Working Group on IP Cooperation (AWGIPC) was commissioned to oversee development of the action plan. The first phase of implementation ran from 2004 to 2010, and was aimed at IP creation efforts, public recognition and awareness of IP concepts and setting up regional enforcement frameworks.

The second phase of the action plan (from 2011 to 2015) is aimed at transforming ASEAN into an innovative and competitive region through the use of IP. In addition to carrying on from the three goals of the first phase, the second phase has addressed additional issues of IP harmonisation at the IP office level and the preparation for member states’ participation in global IP systems.

In light of this, significant improvements can be expected in the IP field within the next few years. For each type of IP, the AEC harmonisation may have several implications for protection, use and enforcement of an IP asset. In particular, the implications for trademarks, patents, and copyright are likely to have the largest impact on businesses in the region.

Trademarks

The AEC harmonisation plan for trademarks will be based primarily on the Madrid Protocol. Unlike the EU model, ASEAN’s integration plan for trademarks does not currently include a Community Trademark (CTM) scheme. According to the action plan, ASEAN members are required to accede to the Madrid Protocol by 2015. At present, only Singapore and Vietnam are members of the Madrid Protocol. Thailand has been working toward accession for several years, and is expected to join by 2015.

Patents

Importantly, the AEC envisions that all countries will become members of the Patent Cooperation Treaty (PCT) by 2015. Currently, four ASEAN member states have not joined (Brunei Darussalam, Cambodia, Laos, and Myanmar). Member states are charged with the responsibility to issue appropriate guidelines for PCT implementation in their country, and to amend any relevant legislation. AEC IP harmonisation strongly advocates implementation of the ASEAN Patent Examination Cooperation (ASPEC) system. It is hoped that the system will be fully operational by 2012, and will be used for 5 percent of all patent applications at this time. Other plans include the establishment of a regional network of at least 20 regional patent libraries to increase access to global scientific information.

Patent office capacity building is a specific AEC IP harmonisation goal, with training programmes for patent examiners to feature heavily in coming years. Various international patent offices have committed to providing training and best practice recommendations, with ASEAN patent examiners receiving training in neighbouring patent offices. Of note is plant variety protection, with Singapore and Vietnam, which have joined the International Union for the Protection of New Varieties of Plants (UPOV), expected to share their experience to help other member states bring their plant variety protection regimes up to international standards.

Copyright

Copyright harmonisation has received less emphasis than has been given to trademarks or patents, but it does feature in the action plan, with member states encouraged to undertake studies on the contributions of copyright industries to their economies and then share those conclusions with other members, including uniform recordal procedures. Thailand is taking the lead under the AEC in sharing information on how to build and operate collecting societies for effective use of copyright.

Conclusion

ASEAN IP offices have for years faced difficulties such as outdated office infrastructures, insufficiently trained examiners, tremendous backlogs of patent and trademark applications and, of course, rampant IP infringement. The AEC is striving to develop the necessary framework for regional cooperation in many areas of IP. The framework goals, if met, will not only improve regional cooperation, but will achieve harmonisation on some legal facets of IP and will help to bring many IP regimes up to best practice international standards. This will allow stakeholders in the member states to capitalise better on their untapped IP assets and, we hope, serve as a catalyst to improve innovation and encourage technological solutions to what are certain to be daunting, yet exciting, challenges to a rising integrated economy.


ASEAN FDAs – A harmonisation model for IP?

While harmonisation of IP registration systems within the 10 nations of ASEAN may be a few years in the making, regional Food & Drug Administrations (FDAs) and Departments of Agriculture have already begun to streamline and harmonise registration procedures.

Cosmetics. On January 1, 2008, ASEAN member states implemented the ASEAN Harmonization Cosmetics Regulation Scheme. As a result, a streamlined system and an efficient registration process have replaced the previously chaotic system, and there is now just a solitary category for cosmetic products.

Pharmaceuticals. While currently each local FDA has different requirements for registering pharmaceutical products in each ASEAN country, the pharmaceutical industry is leading the way for the implementation of a harmonised regulatory scheme which aims to eliminate technical barriers to trade. The various FDAs have implemented the ASEAN Common Technical Requirements and Dossier (ACTR/ACTD) on Quality, Safety and Efficacy, which provides guidelines on analytical and process validation, stability studies, and bioavailability/bioequivalence.

Medical devices. Each member state has until 2014 to implement the new requirements established by the Medical Device Working Group, to finalise the harmonisation process for all medical devices.

Food. In 2009, the AEC adopted the ASEAN Integrated Food Security Framework and Strategy Plan of Action for ASEAN Food Security and is currently considering using the Codex General Standards for Food Additives (GSFA) as the basis for harmonisation.

Agricultural products and livestock. Harmonisation of agricultural products is also well underway, with the 2006 ASEAN Good Agricultural Practices for Fresh Fruit and Vegetables (ASEAN GAP) adopted as a standard for the production, harvesting, and post-harvest handling of fruits and vegetables in the region. Other harmonisation standards include accreditation of livestock establishments and livestock products.

RELATED INSIGHTS​ 

September 9, 2026
On August 5, 2026, the Consumer Case Division of Thailand’s Civil Court rendered a judgment in a case involving a beauty clinic that advertised acne scar treatments using claims that the clinic was operated by a specialist physician and that the treatment, allegedly involving stem cell technology, could permanently remove acne scars. The plaintiff brought a claim against both the physician-owner and the clinic company, alleging that the advertisements were false and induced her to purchase the treatment. The court found that the clinic was liable for the false representations and that the physician-owner, as both the authorized director of the company and the medical practitioner who provided treatment, was jointly responsible. Although the plaintiff could not fully prove all damages claimed, the court awarded compensation of THB 20,000, together with interest. While the judgment arose from a consumer protection dispute, it serves as a valuable reminder that medical facility advertisements in Thailand are regulated and may expose clinics and healthcare providers not only to regulatory enforcement but also to civil liability from patients who rely on misleading promotional claims. Regulatory Framework Governing Medical Facility Advertisements Medical facility advertising in Thailand is governed by the Medical Facility Act B.E. 2541 (1998), as amended by the Medical Facility Act (No. 4) B.E. 2559 (2016). The principal secondary legislation is the Department of Health Service Support (DoHSS) Notification Re: Rules, Procedures, Conditions, and Fees for an Advertisement or Publication Concerning a Medical Facility, which came into force on November 25, 2019. Under this notification, “advertising” includes any act, by any means, that causes members of the public to see, hear, or otherwise become aware of a message, sound, or image for the commercial benefit of a medical facility. This broad definition covers not only traditional media but also clinic websites, social
September 9, 2026
On June 30, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 11 of 2026 on Food Packaging, which expands the list of approved food-contact substances and recognizes a broader range of permissible functions for those substances. The new regulation, which revokes BPOM Regulation No. 20 of 2019, reflects developments in packaging technology and materials science. Although the new regulation provides more advantages to business actors by adding more food contact substances to the approved list for use in food packaging, there are more stringent rules and restrictions for testing. One of the most significant changes is a comprehensive migration-testing framework that sets out requirements for packaging materials, testing conditions, food simulants, and specific migration limits. Overall and Specific Migration Under BPOM Regulation No. 20 of 2019, migration requirements were primarily set out within the lists of approved food-contact substances and packaging materials. BPOM Regulation No. 11 of 2026 instead expressly requires packaging materials that come into direct contact with food to meet both overall and specific migration limits. These are defined as follows: Overall migration: The total quantity of all substances that migrate from the packaging, regardless of whether the substances are hazardous or nonhazardous to health. Specific migration: The quantity of a particular identified substance known to be hazardous to health that migrates from the packaging. Stricter Limits on Heavy Metals The overall migration limit for plastic packaging remains unchanged under both regulations at 60 mg/kg or 10 mg/dm². However, the new regulation introduces significant changes to the regulation of heavy metals. Under the 2019 regulation, four heavy metals—lead, cadmium, chromium VI, and mercury—were subject to a single combined limit of 1 mg/kg. The 2026 regulation, however, requires each heavy metal to meet its own individual specific migration limit, adds arsenic as
September 7, 2026
Indonesia’s Constitutional Court (Mahkamah Konstitusi) has reinstated a key provision limiting pharmaceutical patent protection, signaling a renewed commitment to balancing patent rights with public access to medicines. In its ruling to Case No. 255/PUU-XXIII/2025, the court partially granted a petition for judicial review of Law No. 65 of 2024, which had amended the country’s Patent Law, and ordered the restoration of a provision that had excluded certain pharmaceutical inventions from patentability. The decision took effect immediately upon its pronouncement at the court’s plenary session on August 28, 2026. Background The petition challenged the removal of article 4(f) from Law No. 13 of 2016 concerning Patents (Patent Law), as amended by Law No. 65 of 2024. Article 4(f) had excluded from patentability certain inventions relating to new uses of known substances. The petitioners argued that removing this provision would open the door to patent protection for second medical use inventions and facilitate patent evergreening—practices that can extend exclusivity periods, delay generic market entry, and reduce public access to affordable medicines. The petitioners included several patient advocacy and public-interest organizations: the Indonesian Dialysis Patients Community Association, the Indonesian Association of Drug Abuse Victims (PKNI), the Indonesian Pulmonary Hypertension Foundation (YHPI), the Rekat Peduli Indonesia Foundation, and the Indonesian Positive Women’s Association (IPPI), along with the Indonesia for Global Justice Association and four individual petitioners. The petitioners also challenged the constitutionality of the phrase “interested party” in article 70(1) of the Patent Law, arguing that it should be construed expressly to clarify who has standing to appeal a decision to grant a patent before the Board of Patent Appeal, and to allow a broader range of parties—such as patent holders, licensees, consumer organizations, prosecutors, aggrieved third parties, and others who may suffer direct or indirect harm from the grant of a patent—to
September 4, 2026
Blind boxes and collectibles have become increasingly popular, driven by the excitement of not knowing which character or design will be revealed until the package is opened. While most visible in the art toy market, the same concept is also used in the food industry. Confectionery, snacks, and other food products are sometimes sold with toys, character figures, cards, or other collectibles. A package might, for example, contain one of ten possible characters, with consumers knowing that an item is included but not which one they will receive. Some collections may also feature rare or “secret” items. For food businesses, however, adding a randomized toy or collectible involves more than a marketing decision. The food, the nonfood item, and the randomized mechanism may each raise different regulatory considerations in Thailand. Thai FDA Requirements for Nonfood Objects Packaged with Food The main food regulatory consideration is Ministry of Public Health Notification No. 310 B.E. 2551 (2008), which regulates food packaged together with things or objects that are not food. Under Notification No. 310, certain nonfood objects may be packaged together with food where they fall within specified exceptions, including objects that serve the following purposes: Maintaining the quality or standard of the food, such as a desiccant or oxygen absorber; Serving as a seasoning or as part of food preparation, such as chili powder sachets or seasoning sachets contained in instant noodle packages; or Functioning as an eating or food-preparation utensil, such as a spoon or fork included with instant noodles. Other nonfood objects that do not fall within these categories generally should not be placed inside the food container together with the food. Where a toy, collectible, or other nonfood object is intended to be sold together with a food product, businesses should therefore carefully consider the nature of