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​ 

May 27, 2025
On May 16, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 12/2025/TT-BYT on registration of drugs and drug materials (Circular 12). Circular 12 will come into effect on July 1, 2025, replacing Circular No. 08/2022/TT-BYT (as amended), which provides the current regulations on drug registration, along with Circular No. 16/2023/TT-BYT on registration of drugs under toll manufacturing and technology transfer, and Circular No. 07/2017/TT promulgating the list of non-prescription drugs. Some of the key stipulations of Circular 12 are outlined below. Regulation of non-prescription drugs Circular 12 abolishes the detailed list of over-the-counter (OTC) drugs previously stipulated in Circular No. 07/2017/TT-BYT. Instead of relying on a fixed list for classification, Circular 12 introduces a new framework based on principles, criteria, and specific methods for determining the status of non-prescription/OTC drugs. This approach aims to enhance safety, ensure timely access, reflect actual usage and supply conditions, and align with international standards. Drugs that have already been approved will retain their classification (i.e., as prescription or non-prescription) throughout the validity of their marketing authorization (MA), and reclassification will be considered when the MA is renewed. If a change in classification is requested, the MA holder must submit a variation registration dossier to the Drug Administration of Vietnam (DAV). For drug registration dossiers currently under evaluation by the DAV, the classification will be assessed in accordance with the new provisions set out in Circular 12. Drug registration The new regulations under Circular 12 loosen the requirements on providing a Certificate of Pharmaceutical Product (CPP). For all drug registration cases, a single CPP will suffice, provided it is issued by the competent authority of the manufacturing country or by an authority from a country that is a member of the European Medicines Agency (EMA) or a Stringent Regulatory Authority (SRA), and confirms
May 15, 2025
Vietnam’s Ministry of Health (MOH) has published for public consultation a draft amendment of the Law on Donation, Recovery, and Transplantation of Human Tissues and Organs and Donation and Retrieval of Cadavers, a law which has been in effect since 2007. Among its changes, the draft amendment notably includes new provisions on stem cells, a hot-button topic with social, legal, and ethical ramifications extending beyond the medical field. There are currently no specific regulations on stem cells under Vietnamese law—only the MOH’s technical guidance—leaving many controversial issues unsettled. Key points related to stem cells that may impact the activities of researchers and institutions in Vietnam and abroad are highlighted below. Requirements for Stem Cells Under the draft amendment, stem cells are defined as cells naturally occurring in the body, having the ability to divide and differentiate into various types of cells. The draft amendment outlines conditions for stem cell donation, establishes requirements for medical facilities authorized to receive stem cell donations, and specifies the rights of stem cell donors. Under the draft amendment, it is prohibited to receive, screen, or produce stem cells at facilities that do not satisfy conditions. Establishment of Private Stem Cell Banks In addition to state-owned stem cell banks, the draft amendment also addresses independent stem cell banks established by private investors. In general, the stem cell banks (whether public or private) must obtain an operation license by meeting various conditions on personnel, equipment, facilities, and management systems to be further guided by the government. Notably, stem cell banks will have the right to cooperate with foreign entities in exchanging stem cells for treatment, education, and research purposes. Prohibition on Creating Embryos for Stem Cell Research or Therapy Considering the ethical concerns over the use and destruction of embryos, the draft amendment expressly prohibits the
May 2, 2025
Attorneys from Tilleke & Gibbins have updated the latest edition of Doing Business in Thailand, a Q&A-style guide from Thomson Reuters Practical Law that offers an overview of key legal considerations for companies operating in jurisdictions worldwide. The contribution outlines the country’s legal and regulatory framework for foreign investment and business operations and reflects the latest legislative developments. The chapter addresses the following core topics: Legal system: Structure of the courts and the codified nature of Thai law. Foreign investment: Business restrictions under the Foreign Business Act, sector-specific regulations, exchange control rules, and investment incentives. Business vehicles: Overview of partnerships, private and public limited companies, and other legal entities. Employment: Labor protections, employment contracts, foreign worker requirements, and termination procedures. Tax: Corporate and personal income tax, indirect taxes, and tax obligations for residents and non-residents. Intellectual property: Registration and enforcement of patents, trademarks, designs, and copyrights. Data protection: Key provisions of the Personal Data Protection Act and related compliance obligations. Competition law: Regulatory framework under the Trade Competition Act. Anti-bribery and corruption: Relevant legislation and enforcement mechanisms. E-commerce and digital business: Legal regime for online transactions and digital platforms. Marketing and advertising: Consumer protection laws and regulations affecting advertising and marketing practices. Product regulation and liability: Safety standards, liability regimes, and roles of enforcement authorities. Practical Law, a legal reference resource from Thomson Reuters, publishes a range of guides for hundreds of jurisdictions and practice areas. The insurance and reinsurance guide is a valuable resource for legal practitioners, covering numerous jurisdictions worldwide. To view the latest version of the guide, please visit the Practical Law website and enroll in the free Practical Law trial to gain full access.
March 7, 2025
On November 22, 2024, the Ministry of Health (MOH) in Laos issued Decision No. 3730/MOH, which regulates the management, processing, production, and use of biopharmaceutical products, genes, and stem cells. This decision came into force on January 18, 2025, 45 days after its publication in the Lao Official Gazette on December 4, 2024. This decision signifies Laos’ recognition and acceptance of biopharmaceutical products, genes, and stem cells for use in medical treatments and the beauty industry, and it aligns with the ongoing development of biomedical sciences in the country. Definitions The MOH’s decision defines biopharmaceuticals, gene therapy, and stem cells as follows: “Biopharmaceutical products” refers to a type of biological or drug product that is produced or synthesized from natural substances, objects, or chemicals. This group of products includes blood, blood components, allergens, cells or cellular components, gene therapies, tissues, protein-based medicines, drugs derived from living cells, and biologics, which can be produced from sugars, proteins, amino acids, or substances with complex characteristics derived from organic sources such as human, animal, and plant parts; yeast; and microorganisms. These products exclude vaccines and biosimilar products, which will be specified under separate regulations. “Gene therapy” refers to a treatment approach that applies the principle of arranging amino acids (which could involve DNA or RNA sent to the patient’s cells in the form of a drug with the purpose of treating a certain disease). “Stem cells” are defined in the decision as cells or immature cells that can be sourced from various organs in the They are characterized by being undifferentiated, having the potential for differentiation, and being self-renewing. Stem Cell Production The decision outlines comprehensive provisions for managing and using raw materials in stem cell production. Key points include: Production location standards: Ensuring facilities meet specific standards of the MOH. Personnel