Malaysia

News and developments

International Trade Law

WTO Trade Remedies in Malaysia: Anti-Dumping, Subsidy, Countervailing and Safeguard Measures

Introduction The evolution of international trade and governance can be traced through the development of the former provisional agreement, the General Agreement on Tariffs and Trade (“GATT”). It has then transformed into the current World Trade Organisation (“WTO”). Emerging from discussions at the 1944 Bretton Woods Conference, the idea of a global trade body had first taken shape as the proposed International Trade Organization (“ITO”). As support for ITO waned from the U.S Congress, GATT was subsequently established in 1947 as a temporary framework among 23 nations. After decades of negotiations and reforms, the Uruguay Round (1986–1994) led to the creation of the WTO in 1995, which now governs nearly all global trade and provides a more structured and authoritative system. By 2003, the WTO had expanded to 146 members— representing nearly 97 percent of global trade.1 Malaysia, being a member of the WTO since 1 January 1995 and a signatory to the GATT 1947 shortly after its independence since 24 October 1957,2 is committed to promoting fair and transparent trading practices and has further entered into an Agreement on Implementation of Article VI of GATT (“Implementation Agreement of Article VI of GATT”). Malaysia is thus, guided by the Implementation Agreement of Article VI of GATT with regard to the conditions, scope, and procedures for imposing trade remedies. Trade remedies would include antidumping duties, countervailing duties, and safeguard measures. All of which are designed to protect domestic industries from unfair or injurious foreign competition while adhering to international trade rules.3 Anti-Dumping   Under the WTO Anti-Dumping Agreement, which was formerly known as the Implementation Agreement of Article VI of GATT, a framework is provided for member countries to address issues of dumping. Dumping occurs when goods are exported at prices below their normal value in the home market and this practice subsequently causes material injury to domestic industries in the importing country. Following the provisions of the Agreement, WTO member countries that are affected by dumping will be able to take retaliatory actions in the form of imposing a balanced anti-dumping obligation. However, an antidumping duty can be imposed by an importing country only when there is evidence that foreign firms have sold their products below normal value and that this practice has caused harm to the domestic industry.4 Consequently, when dumping has taken place and the importing industry is affected, an increase in price to a certain level may be undertaken by the exporting company to avoid an anti-dumping import duty.5   Building on these global rules, Malaysia has established its Countervailing and Anti-Dumping Administration to investigate and take remedial measures against unfair trade practices by foreign manufacturers or exporters.6 In doing so, Malaysia follows the principles recognised by the WTO and GATT, which condemn the dumping of goods into another country at prices below their normal value when such practices cause or threaten material injury to the established domestic industries.   The Ministry of International Trade and Industry (“MITI”) considers a product to be dumped if it is sold at a price below its normal value. A product is deemed to be sold below normal value if its price is:7   Less than the comparable price of the like product in the course of trade for consumption in the exporting country; or,   In the absence of such a domestic price, less than either: -   (i) The highest comparable price of the like product for the export country in the ordinary course of trade, or (ii) The costs of production of the product in the country of origin, plus reasonable allowances for selling costs and profits.   Between January 2017 and June 2022, Malaysia initiated 25 anti-dumping cases according to the most recent WTO notification.8 As of 30 June 2022, Malaysia has 25 anti-dumping measures in force with iron and steel being the primary products that are affected.   The practical application of Malaysia’s anti-dumping laws was recently illustrated in the Federal Court case of Menteri Kewangan & Ors v Diler Demir Celik Endustru Ve Ticaret AS9 (also known as Diler Iron and Steel Co Inc). The case had arisen from investigations into the import of Turkish steel sold in the Malaysian market, relating to Diler Iron & Steel Turkey Steel Imports. The Court had held that Sections 17 and 18 of the Countervailing and Anti-Dumping Duties Act 1993 must be read together to uphold the Parliament’s intent—to ensure a fair comparison between export price and normal value, which is generally determined at the ex-factory level within reasonable limits.     Subsidies and Countervailing Measures   The Agreement on Subsidies and Countervailing Measures (“SCM Agreement”) governs both the granting of subsidies and the countervailing measures. Both measures are what countries may apply to offset their adverse effects. According to Article 1.1 of the SCM Agreement, subsidies exist when there is a financial contribution by a government or any public body within the territory of a Member State that confers a benefit.10 On this, Article VI of the GATT 1994 and the SCM Agreement define countervailing duties as a special duty that is levied to offset any subsidy bestowed either directly or indirectly, upon either the manufacture, production, or export of any merchandise.11   Despite these provisions, Malaysia has rarely applied countervailing duties. To date, Malaysia has not initiated any countervailing investigations reported to the WTO. This trend is similar in other Regional Comprehensive Economic Partnership members such as Singapore, Thailand, and the Republic of Korea.12 Countervailing duties may be used sparingly because in most competitive markets, foreign subsidies benefit consumers. They are only justified in imperfectly competitive markets, where domestic producers incur losses that outweigh consumer benefits. Consequently, countries apply countervailing duties selectively, targeting cases of clear harm to domestic industries.13     Safeguard Measures   A safeguard measure refers to a temporary tariff or quota that is imposed to protect a domestic industry from serious injury caused by a sudden surge of imports resulting from fair foreign competition.14 Unlike anti-dumping or countervailing duties, which are designed to address unfair trade practices such as dumping or subsidisation, safeguard measures may be applied even when foreign exporters compete fairly.15 Their purpose is to provide domestic industries with temporary relief and time to adjust to the impact of increased imports.16   Safeguard measures are governed by the Safeguards Act 2006 and the Safeguard Regulations 2007, which regulate their investigation, imposition, and revocation, with MITI overseeing such matters.17   Safeguard measures derive their legal authority from Article XIX of GATT. Initially, these measures were seldom used, as some governments preferred implementing “grey area” measures as an alternative.18 Nevertheless, these measures were subsequently superseded by the WTO Safeguard Agreement, which subjects any safeguarding actions to a time limit (also known as sunset clauses).19     Conclusion   Coming full circle, Malaysia’s application of the WTO framework in its own laws demonstrates its commitment to upholding fair and transparent trade practices while safeguarding the interests of domestic industries. As aforementioned, though active steps have been taken in addressing dumping activities by way of anti-dumping laws, other trade remedies, such as countervailing measures have yet to be invoked. This leaves room for further development in Malaysia’s trade remedy practice. Given that the global trade dynamics will inevitably shift along with emerging challenges, Malaysia is likely to see a growing body of cases that test and refine the practical application of its trade laws and the remedies provided in ensuring fair trade practices.     Crowley, Meredith A. ‘An introduction to the WTO and GATT.’ Economic Perspectives 27, no. 4 (2003), 43. World Trade Organization, ‘Malaysia and the WTO’ <https://www.wto.org/english/thewto_e/countries_e/malaysia_e.htm> accessed 27 November 2025. Ministry of International Trade and Industry, ‘Trade Remedies’ <https://www.miti.gov.my/index.php/pages/view/1672?mid=1029> accessed 27 November 2025. Crowley, Meredith A (n 1) 52. World Trade Organization, ‘Briefing note: Anti-dumping, subsidies and safeguards’ https://www.wto.org/english/thewto_e/minist_e/mc9_e/brief_adp_e.htm accessed 27 November 2025. Royal Malaysian Customs Department, ‘Malaysia National Trade Repository (MNTR)’, http://mytraderepository.customs.gov.my/en/ntm/ctp/an_dump/Pages/an_dump.aspx accessed 27 November 2025. Ibid. World Trade Organization, ‘Trade Policy Review’ (WTO, 16 June 2023) WT/TPR/S/436/Rev.1 < https://web.wtocenter.org.tw/file/PageFile/386100/WTTPRS436R1.pdf> accessed 27 November 2025. [2025] MLJU 3103. Cen, Jia Zhen, ‘Disciplining the responses to cross-border subsidies: the case study of EU and US trade remedy investigations against products from Indonesia and Thailand’ (2024) < https://digital.car.chula.ac.th/cgi/viewcontent.cgi?article=13344&context=chulaetd> accessed 27 November 2025. World Trade Organization, ‘Subsidies and Countervailing Measures” (WTO) <https://www.wto.org/english/tratop_e/scm_e/scm_e.htm> accessed 27 November 2025. Koesnaidi, Joseph Wira, and Yu Yessi Lesmana, ‘Trade Remedies Chapter’ (2022) (Jakarta: Economic Research Institute for ASEAN and East Asia) < https://www.eria.org/uploads/media/discussion-papers/FY22/Trade-Remedies-Chapter.pdf> accessed 13 November 2025. Crowley, Meredith A (n 1) 42-57. World Trade Organization (n 12). Crowley, Meredith A (n 1) 42-57. World Trade Organization, ‘Safeguard Measures’ (WTO) <https://www.wto.org/english/tratop_e/safeg_e/safeg_e.htm> accessed 27 November 2025. World Trade Organization (n 8). H. H. Weiler, Sungjoon Cho, Isabel Feichtner, and Julian Arato, International and Regional Trade Law: The Law of the World Trade Organization, Unit XV: Safeguard Measures (New York: NYU School of Law, 2016). Ibid.     Written by: Philip Teoh (Partner) [email protected] Nik Aisha Tasnim Nik Syahril (Trainee Solicitor) [email protected]     Corporate Communications Azmi & Associates 26 January 2026
19 May 2026
Artificial Intelligence

Synthetic Media and Deepfakes: Legal Responses to Identity, Dignity and Truth in the Age of AI

Introduction: When Seeing Is No Longer Believing Rapid advances in Artificial Intelligence (“AI”) technology have transformed how digital content is created and consumed. While AI has enabled innovation and efficiency, it has also introduced serious risks of exploitation, misappropriation, and deception. One of the most disruptive developments is synthetic media, which is a content generated or manipulated by AI to convincingly imitate real people. As synthetic media becomes increasingly indistinguishable from reality, modern legal systems are being forced to reassess traditional legal assumptions surrounding consent, truth, and ownership.   Understanding Synthetic Media and Deepfakes   Synthetic media refers to digital content created by AI rather than by direct human touch. Common examples include deepfake videos, virtual humans, and augmented reality visuals. A deepfake is a specific form of synthetic media, first popularised in 2017 through online face-swap videos. Since then, deepfake technology has evolved rapidly, enabling the creation of highly realistic audio and video that can depict individuals saying or doing things that never occurred.         How Deepfakes Work: The Technology Behind the Deception   At its core, deepfake technology uses AI to learn patterns from real human faces and voices and then reproduce them. Although the results may appear futuristic or fictional, the process relies on established machine-learning techniques. The primary system used is Deep Learning, particularly Generative Adversarial Networks (“GANs”). A GAN consists of two competing AI systems: a generator, which creates fake images or videos, and a discriminator, which attempts to distinguish fake content from real content. Through repeated competition, the generator improves until the fake content becomes highly realistic.   In addition to GANs, many deepfakes use autoencoding techniques, involving an encoder and a decoder. The encoder breaks facial images into core features such as eye shape and mouth movement, while the decoder reconstructs a face using those features. By combining one person’s facial identity with another person’s movements, AI produces convincing face-swap videos where the motion is real, but the identity is fabricated. This technical sophistication explains why deepfakes pose significant legal challenges.     The Legal Response: Three Emerging Pillars   As of 2026, legislatures worldwide have begun responding to synthetic media by restructuring regulation around three key legal pillars which are safeguarding intellectual property, the protection of personal dignity and preservation of democratic integrity.   Pillar I: Intellectual Property and Digital Personality Rights   Traditionally, intellectual property law offers limited protection over a person’s voice or likeness, as these were not historically considered “copyrightable”. Nevertheless, deepfake technology has exposed the inadequacy of this approach.   As a response, the United States (US) has taken significant legislative steps. For instance, Tennessee enacted the Ensuring Likeness, Voice, and Image Security or ELVIS Act 2024, expanding the right of publicity to protect an individual’s voice and likeness from unauthorised AI replication.   At the federal level, the Nurture Originals, Foster Art, and Keep Entertainment Safe or the NO FAKES Act 2024 further strengthens protection against unauthorised AI-generated recreations.   These laws were catalysed by the viral 2023 release of “Heart on My Sleeve”, which is a song falsely attributed to Drake and The Weeknd as the tune ended up being created using AI by a TikTok user Ghostwriter977. Before being exposed as fake and removed from the platform, the track spread rapidly across the TikTok and Spotify acquiring hundreds of thousands of listens as well which heavily highlighted how AI could commercially exploit an artist’s identity, voice and likeness without consent, prompting urgent legislative reform.   Another high-profile example occurred in October 2023, whereby AI-generated version of Tom Hanks was used in advertisements for a dental plan that he never appeared in or otherwise endorsed. Therefore, the NO FAKES Act is created to address these non-consensual digital replications and to hold individuals or companies liable for the production of unauthorised digital replication of individuals. Together, these developments signal a legal shift toward recognising digital personality as a protectable proprietary interest.   Pillar II: Personal Dignity and Non-Consensual Deepfakes   The protection of personal dignity is the most strictly regulated area, particularly concerning non-consensual intimate deepfakes. In the US, the Tools to Address Known Exploitation by Immobilizing Technological Deepfakes on Websites and Networks Act or TAKE IT DOWN Act 2025 has been enacted to criminalise the distribution of non-consensual intimate deepfakes and requires online platforms to remove such content within 48 hours of a valid request.   This reformation was also driven by the real-world harm. In October 2023, a male student from Aledo High School, Texas had taken “innocent” photos of 14-year-old female students and used AI to create sexually explicit versions of them which then circulated on Snapchat. At the time, Texas law contained loopholes that failed to cover manipulated images, and schools lacked authority over off-campus conduct. Victims and their families were left without meaningful legal recourse, prompting national advocacy that culminated in the TAKE IT DOWN Act 2025.   Similarly, in Jane Doe v ClothOff (2025), a minor in New Jersey sued over an AI platform known as “ClothOff” that converted her fully clothed social media images into hyperrealistic porn content. The case became a landmark federal lawsuit highlighting the necessity of platform liability and rapid content removal mechanisms under the new legislation.   New Zealand offers a notable example of legislative reform as well. Under the Harmful Digital Communications Act 2015 (“HDCA”), posting an “intimate visual recording” without consent is a criminal offence punishable by fines or imprisonment. However, the original law struggled to address AI-generated imagery, as deepfakes were not considered “real” recordings.   To address this loophole, New Zealand introduced the Deepfake Digital Harm and Exploitation Bill, amending the Crimes Act 1961 and the HDCA to explicitly include synthetic or altered imagery. This reform ensures that AI-generated intimate deepfakes are treated as real for criminal law purposes.   This also alerted the New Zealand government as the Netsafe New Zealand, an approved agency under HDCA, which reported 68% spike in “digital extortion” in New Zealand cases linked to AI deepfake threats with victims as young as nine years old. These statistics underscore the urgency of strengthening legal protections against synthetic media harms.   Pillar III: Democratic Integrity and Transparency Obligations   Apart from that, synthetic media poses systemic risks to democratic integrity, particularly the risk of AI-powered misinformation and political manipulation. To address this, jurisdictions are increasingly mandating transparency.   The European Union Artificial Intelligence Act (EU AI Act) imposes strict disclosure obligations under Article 50, requiring AI-generated or AI-modified content, including deepfakes, to be clearly labelled. Where deepfakes are used in real-time contexts, disclaimers must appear from the first second of display.   Norway, as a member of the European Economic Area (EEA), has aligned its national framework through the proposed Norwegian AI Act 2026. Adopting a risk-based approach, with the statutory appointment of the Norwegian Communications Authority (Nkom) as the primary supervisory body and emphasising transparency and preventative governance.     Conclusion: Law in the Age of Synthetic Reality   In conclusion, synthetic media has fundamentally challenged existing legal frameworks. As AI blurs the line between reality and fabrication, the law is increasingly repositioning itself to protect human dignity, democratic trust, and personal identity. While regulatory approaches differ across jurisdictions, a common trend is evident considering that AI is no longer treated as a neutral tool but as a technology requiring active legal governance.       Written by: Ahmad Hafiz Zubir (Partner) [email protected] Nik Afifah Hana Nik Husni (Trainee Solicitor) [email protected]     Corporate Communications Azmi & Associates 6 February 2026
19 May 2026
Intellectual Property

Generative AI Works and Copyright Law: A Comparative Legal Perspective

Introduction The EU AI Act defines Generative AI as "foundation models used in AI systems specifically intended to generate, with varying levels of autonomy, content such as complex text, images, audio, or video." (Art. 28b (4) AI Act). Recent advancements, such as multi-modal systems capable of processing and generating different forms of content within a single framework, demonstrate that generative AI is no longer an experimental technology confined to specialist environments. Instead, it has become an accessible and widely used tool in everyday creative and commercial activities. This technological shift has renewed a fundamental legal question: to what extent does copyright law apply to works produced by, or with the assistance of, artificial intelligence? Traditional copyright doctrines of authorship and originality were developed on the assumption that creative works are the result of human intellectual effort. The growing autonomy of generative AI systems challenges this assumption and places pressure on existing legal frameworks.   Unlike conventional software, these systems may operate with minimal human intervention, raising complex issues concerning creative control, ownership, and legal responsibility. This article focuses on generative AI outputs and examines how different legal systems distinguish between AI-assisted works and fully autonomous AI-generated content, particularly in relation to authorship and copyright protection.   Different jurisdictions have responded to these challenges in markedly different ways. This article examines three contrasting approaches: Italy’s reaffirmation of human authorship, Ukraine’s introduction of a sui generis regime for AI-generated outputs, and China’s evolving judicial treatment of AI-assisted creativity.     The Italian Approach: Reaffirming Human Authorship   Italy is the first country to adopt a law on the protection of AI (Law 132/2025), which came into force on 10 October 2025. The legislation is based on and integrates EU Regulation 2024/1869, adopted on 13 June 2024. Italy has addressed the copyright implications of artificial intelligence through targeted amendments introduced by Article 25 of the Italian Artificial Intelligence Law. Section IV of the Italian AI Law contains only this provision, which makes two significant amendments to Law No. 633 of 1941, Italy’s longstanding Copyright Act (Legge sul Diritto d’Autore, “LDA”). These amendments are aimed at responding to the growing challenges posed by AI technologies while preserving the traditional foundations of copyright law.   The recent law introduces amendments to Italian Copyright Law, whereby Article 1 now reads as follows:   “Works of ‘human’ intellectual creation of a creative nature are protected under this law, including those belonging to literature, music, figurative arts, architecture, theatre, and cinematography, regardless of the mode or form of expression, even when created with the aid of artificial intelligence tools, provided they are the result of the author’s intellectual effort.”   This amendment expressly confirms that copyright protection extends to works created with the assistance of AI systems, so long as the work remains the product of a creative and original human intellectual contribution. At the same time, it implicitly excludes fully autonomous AI-generated outputs from copyright protection, as such outputs lack the necessary human intellectual effort.   Under this approach, AI may function as a creative tool, but copyright subsists only where a human author exercises meaningful creative control. Outputs generated entirely by AI systems without significant human involvement fall outside the scope of copyright protection. Italy therefore firmly rejects AI authorship and reinforces the traditional link between copyright and human intellectual effort.     Ukraine’s Sui Generis Regime for AI-Generated Outputs   In contrast to Italy’s human-centric approach, Ukraine has adopted a more innovative legislative solution. In 2022, Ukraine amended its Law on Copyright and Related Rights to introduce a sui generis form of protection specifically designed to regulate outputs generated without human involvement.   The purpose of this reform is to address a legal gap by providing protection for AI-generated outputs that do not satisfy traditional copyright requirements. Under Ukrainian law, such outputs are classified as non-original objects generated by a computer program. For the protection of an AI-generated output, Art. 33(1) of the Ukrainian Copyright Law provides for two criteria: firstly, it is an object that differs from existing similar objects; secondly, it is formed as a result of the functioning of a computer program without the direct participation of an individual in the formation of this object. At the same time, works created by humans using computer technologies are expressly excluded from this category and remain protected under ordinary copyright law.   Sui generis protection lasts 25 years from 1 January of the year following creation and covers only economic rights, as AI-generated outputs are not recognised as “works” and do not attract moral rights. Rights may vest in parties connected to the AI system, such as the initiator, developer, or licensee. Protection applies where the output is novel, automatically generated by software, and created without human creative input beyond activation.   This regime ensures legal certainty for commercially valuable AI-generated content without redefining authorship, supplementing traditional copyright law with a tailored mechanism for automated creation.     Judicial Approaches in China   China on the other hand offers a contrasting model, relying primarily on judicial interpretation rather than legislative reform. Chinese courts have adopted a pragmatic, case-by-case approach that focuses on the extent of human intellectual contribution involved in the creation of AI-generated outputs.   In Li Yunkai v. Liu Yuanchun (2023) Jing 0491 Min Chu No. 11279 (2023), the Beijing Internet Court held that an AI-generated image produced using Stable Diffusion qualified for copyright protection. The court applied four factors, assessing whether the output fell within the fields of literature, art, or science, possessed originality, was expressed in a tangible form, and resulted from intellectual achievement.   The court held that the plaintiff’s active design choices through prompts, layout, composition, and iterative refinements demonstrated sufficient human creativity to confer originality. While AI systems and developers were not recognised as authors, the plaintiff was deemed the author due to his creative control over the image-generation process. This reasoning was later reinforced by the Changshu People’s Court in 2025, further confirming that users who exercise deliberate and creative control over AI outputs may qualify for authorship. Chinese courts have also emphasised transparency and good faith disclosure of AI usage, reflecting an approach that seeks to balance copyright protection with technological innovation.   Conclusion   Italy, Ukraine, and China adopt different approaches but share one principle: AI systems are not recognised as legal authors, and copyright protection depends on human intellectual contribution. Italy excludes fully autonomous AI outputs, Ukraine introduces a sui generis regime for non-original AI content, and China recognises copyright in AI-assisted works where users exercise meaningful creative control.   These divergent approaches reflect the lack of international harmonisation and differing policy priorities. As generative AI becomes more autonomous and widespread, copyright law will need clearer standards and greater transparency to remain effective and relevant.     References: Lavagnini, S. (2025, December 5). Italy adopted the first national law on artificial intelligence. AIPPI. https://www.aippi.org/news/italy-adopted-the-first-national-law-on-artificial-intelligence/. Mayidanyk, L. (2021). Artificial intelligence and sui generis right: A perspective for copyright of Ukraine? Access to Justice in Eastern Europe, 3(11), 144–154. https://doi.org/10.33327/AJEE-18-4.3-n000076. Lai, S., Lim, D., Shi, L., & Tay, J. (2021). Legal implications – Beijing Internet Court grants copyright protection to AI-generated artwork. Allen & Gledhill LLP. https://law.nus.edu.sg/trail/legal-implications-beijing-internetcourt-copyright/#_edn1.       Written by: Ahmad Hafiz Zubir (Partner) [email protected] Nur Alya Azahan (Trainee Solicitor) [email protected]     Corporate Communications Azmi & Associates 23 February 2026
19 May 2026
FinTech & Digital Assets Law

Tokenisation in Malaysia: Navigating the Digital Asset Revolution

Introduction The global momentum behind digital assets is accelerating rapidly, transforming financial systems into more efficient, inclusive ecosystems. In the United States, 2025 introduced the GENIUS Act, establishing a comprehensive framework for payment stablecoins and offering regulatory clarity to support broader digital asset adoption1. This regulatory certainty aims to require stablecoins to maintain one-for-one reserves and embed AML/CFT obligations for issuers2. This has boosted institutional adoption, with over half of traditional hedge funds reporting exposure to digital assets in 2025, according to recent industry surveys3. In other countries such as Singapore, which has solidified its fintech hub status through policies that integrate blockchain into banking, payments, and asset management while attracting billions in real-world asset (RWA) investments4. Another example is Hong Kong that is easing virtual asset rules and launching a 2025 tokenisation pilot to enhance liquidity and digital investments, with regulatory reforms designed to provide broader access for tokenised financial products5. In the Middle East, jurisdictions such as the UAE have established clear licensing pathways and regulatory regimes that support stablecoin issuance and RWA platforms, positioning the region as a leader in compliant digital asset markets6. RWA tokenisation is predicted to become mainstream, shifting from early pilots to scalable, user-centric infrastructure7.   For Malaysian companies, understanding tokenisation is imperative amid the digitisation of trillions of assets. Failure to adapt risks strategic obsolescence. Tokenisation enables fractional ownership of high-value assets like property or art, democratising access for smaller investors and enhancing liquidity8. It also streamlines operations through programmable smart contracts, reducing costs and settlement times from days to seconds9.   In a volatile economic landscape, companies must grasp tokenisation to capitalise on opportunities in supply chain finance, intellectual property management, and even employee incentives via tokenised equity10.   Before we proceed, a crucial distinction must be made between digitalisation and tokenisation. Digitalisation involves converting physical or analogue assets into digital formats (such as scanning documents into PDFs), improving accessibility without altering ownership structures. Tokenisation, however, encodes rights to an asset on a blockchain as digital tokens, enabling features like divisibility, automated logic, and peer-to-peer transfer, creating “digital twins” of real-world assets that are cryptographically secure and interoperable across platforms11.     What is Tokenisation?   Tokenisation refers to the process of converting real-world assets or rights, such as real estate, stocks, bonds, or even intellectual property, into digital tokens on a blockchain or distributed ledger technology (DLT). These tokens represent ownership stakes or claims, secured by cryptography and verifiable in real-time without intermediaries. At its core, tokenisation bridges the physical and digital worlds, making illiquid assets tradable and accessible globally.   These key features distinguish tokenisation from traditional asset management, such as fractional ownership, which allows high-value assets to be divided into smaller, affordable units. For instance, a multimillion-ringgit property can be tokenised into thousands of tokens, enabling retail investors to own fractions without the barriers of full purchase. This democratises investment, particularly in emerging markets like Malaysia, where it could unlock capital for SMEs and infrastructure projects.   The second feature of tokenisation is programmability, which embeds smart contracts into tokens, automating actions based on predefined conditions. A tokenised bond might automatically distribute interest payments or enforce compliance rules, reducing administrative overhead and errors. This programmability extends to governance, such as voting rights in tokenised funds or conditional transfers in supply chains.   Another feature of tokenisation is interoperability, which ensures that tokens can move seamlessly across compatible blockchains or platforms, fostering composability where tokens interact like building blocks. In finance, this means combining tokenised assets in novel ways, like using a tokenised sukuk as collateral for a loan on another network. However, challenges like standardisation and regulatory harmony must be addressed to realise its full potential.   In Malaysia, tokenisation aligns with national digital economy goals, potentially boosting sectors like Islamic finance through Shariah-compliant tokens. Yet, it requires robust infrastructure to mitigate risks like cybersecurity threats or market volatility.     Regulatory Authorities in Malaysia   Tokenisation is reshaping how value moves in Malaysia, and the regulatory landscape is evolving just as quickly. At the centre of this shift are Bank Negara Malaysia (BNM) and the Securities Commission (SC) Malaysia, each playing a distinct but complementary role.   BNM is focused on what keeps the financial system safe and stable. As transactions migrate onto distributed ledger technology platforms, it guards the fundamentals of our monetary system, ensuring the Malaysian Ringgit remains the single unit of account and that settlement always ties back to central bank money. This includes supervising tokenised deposits issued by licensed banks, reviewing proposals for Malaysian Ringgit-denominated stablecoins and setting expectations on how permissioned and programmable platforms should operate12.   The SC looks at tokenisation through a different lens, one centred on investor protection and market integrity. It regulates tokenised assets that function as securities under the Capital Markets and Services Act 2007, which includes tokenised bonds and sukuk, tokenised fund units and platforms that allow trading or custody of tokenised investment products. If a token promises investment exposure or economic rights, chances are it belongs in the SC’s domain13.   Adding to this framework is the Labuan Financial Services Authority (Labuan FSA), which oversees offshore and innovative digital finance. Labuan FSA facilitates tokenisation through guidelines on securities token offerings and credit token companies, enabling blockchain ecosystems for digital assets in a tax-efficient international financial centre14.   Naturally, tokenisation does not fit neatly into traditional regulatory categories. It blends payments, investments and technology infrastructure all at once. As a result, greater coordination through mechanisms like the Digital Assets Innovation Hub (DAIH) and proposed inter-agency working groups illustrates Malaysia’s direction which is in encouraging innovation while upholding consumer protection and market integrity.     Legal Classification of Tokens   Financial integrity is central to tokenised platforms. Businesses must comply with Anti Money Laundering and Counter Financing of Terrorism (AML/CFT) rules, as well as customer due diligence and know-your-customer (KYC) requirements. These obligations are enforced by BNM’s Financial Intelligence Unit (FIU), which plays a critical role in ensuring that tokenisation does not create new pathways for illicit activity. When tokenised systems process personal data or identity information, businesses must also comply with the Personal Data Protection Act (PDPA), and in some cases may come within the oversight of the Malaysian Communications and Multimedia Commission (MCMC), especially where cross-border data transfers or platform infrastructure introduce additional risks.   These compliance expectations operate alongside Malaysia’s core financial statutes, including the Financial Services Act 2013, the Islamic Financial Services Act 2013 and the Payment Systems Act 2003. These laws continue to govern the institutions and infrastructure that tokenised platforms rely on as they integrate into the broader financial system.   How a token is classified makes all the difference. Investment-style tokens fall under the SC. Tokens that operate like money or bank liabilities fall under BNM. Utility or access tokens may fall outside financial regulation, but still face obligations under consumer and data protection law. Among the categories BNM highlights15, two are especially important for companies exploring tokenised financial products.   Tokenised deposits are digital versions of bank deposits issued by licensed institutions, which means they fit neatly within the existing two-tier monetary system. Stablecoins, on the other hand, are designed to maintain a stable value relative to a reference asset. Malaysia is open to exploring Malaysian Ringgit-denominated stablecoins, but only where they can preserve the singleness of money and meet strong expectations around value stability and redemption.   For businesses, the key takeaway is simple. Tokenisation offers new opportunities, but it also brings a new layer of regulatory and operational responsibility. Whether you are designing an investment product, experimenting with programmable payment flows or integrating distributed ledger technology (DLT) based settlement into your operations, the right structure and the right compliance framework will determine how far your product can go.   Early legal planning is essential. It helps avoid regulatory surprises, builds trust with users and investors and positions your organisation at the front of Malaysia’s emerging digital financial ecosystem.     Malaysian Policy Direction   Malaysia’s approach to tokenisation emphasises a balanced, innovation-friendly framework. BNM’s 2025 Discussion Paper outlines a three-year roadmap from 2025 to 2027, starting with conceptual exploration and progressing to live pilots for tokenised assets by way of proof-of-concepts in key areas like SME financing, Islamic finance and programmable payments.   Furthermore, the BNM’s 2025 Discussion Paper shows a preference for permissioned networks where participants are vetted, prioritising security and system stability. There is strong emphasis on KYC, identity verification and consumer protection to safeguard users, requiring robust due diligence to prevent fraud and ensure transparency.   As Malaysia moves toward the era of tokenised assets, Azmi & Associates stands ready to assist businesses in navigating the regulatory landscape, structuring compliant tokenised offerings and designing governance frameworks that inspire confidence among regulators and investors alike.     References: https://www.bbc.com/news/articles/cd78lvd94zyo. https://www.whitehouse.gov/fact-sheets/2025/07/fact-sheet-president-donald-j-trump-signs-genius-act-into-law. https://www.aima.org/article/press-release-crypto-friendly-regulatory-changes-accelerate-institutional-investment.html. https://www.ainvest.com/news/singapore-crypto-ecosystem-ultimate-institutional-grade-investment-destination-2025-2512/. https://www.thestar.com.my/business/business-news/2025/11/03/hong-kong-to-ease-digital-asset-rules-launch-tokenisation-pilot-scheme. https://www.regulationtomorrow.com/dubai-and-saudi/cbuae-payment-token-services-regulation/. https://www.coindesk.com/business/2025/06/26/real-world-asset-tokenisation-market-has-grown-almost-fivefold-in-3-years. https://www.investopedia.com/you-can-sell-real-estate-on-the-blockchain-here-s-why-you-should-consider-it-11750095. https://www.thunes.com/insights/blockchain-cross-border-payments/#aioseo-how-do-blockchain-cross-border-payments-work. https://www.investopedia.com/terms/t/tokenised-equity.asp. https://www.mckinsey.com/featured-insights/mckinsey-explainers/what-is-tokenisation. https://www.bnm.gov.my/-/dp-at. https://www.sc.com.my/resources/media/media-release/sc-seeks-public-feedback-on-proposed-framework-on-tokenisation-of-capital-market-products. https://www.labuanfsa.gov.my/clients/asset_120A5FB8-61B6-45E8-93F0-3F79F86455C8/contentms/img/documents/Legislation_and_Guidelines/Guidelines/Capital_market/2023/FAQ_Guidelines%20on%20Labuan%20Securities%20Token%20Offering_09102023.pdf. https://cointelegraph.com/news/malaysia-central-bank-roadmap-pilot-asset-tokenisation.     Written by: Amera Mohd Yusof (Founding Partner, Amera & Associates Advocates) [email protected] Fadlin Khabir Mohamad Khalid (Associate) [email protected] Shahirrah Shaziman (Legal Intern) [email protected]     Corporate Communications Azmi & Associates 27 March 2026
19 May 2026
Investment Funds & Financial Services Regulation Law

Setting Up a Fund Management Company in Malaysia: The Legal and Compliance Requirements

The Evolving Landscape of Fund Management Industry in Malaysia The Malaysian fund management industry has demonstrated remarkable resilience and growth. Data from 2024 highlights that the industry’s Assets Under Management (“AUM”) exceeded RM 1.1 trillion, a significant leap from RM 975.5 billion in 2023. This upward trajectory is not merely a statistical anomaly but reflects a broader deepening of the capital market, which now stands at RM4.2 trillion.   This expansion aligns with a key component of Malaysia’s national economic strategy. The Securities Commission Malaysia (“SC”) highlighted this vision through the Capital Market Masterplan 3, a five-year plan aimed at creating a capital market that is more relevant, efficient, and diversified.1 Notably, the government has announced that this AUM growth is attributed to strong demand, further supported by recent budgets initiatives such as the Single-Family Office Incentive Scheme and the ASEAN Business Entity status. As of late 2025, the Single-Family Office Incentive Scheme has approved six family offices with nearly RM 400 million in AUM, targeting RM 2 billion by the end of 2026. These initiatives are specifically designed to attract private wealth and skilled talent.2   With sustained demand and government policies designed to attract capital, the environment remains favourable for new entrants. To make full use of this opportunity, investors must understand the licensing structure and regulatory requirements that govern the industry. This article sets out the key legal framework and the practical considerations involved when establishing a Fund Management Company (“FMC”) in Malaysia.     Licensing Requirement of Fund Management Companies   The establishment and operation of an FMC is governed primarily by the Capital Markets and Services Act 2007 (“CMSA 2007”). Schedule 2 of the CMSA 2007 defines fund management as the undertaking, on behalf of any other person, the management of a portfolio of securities or derivatives, or the management of an asset in a unit trust scheme. Consequently, any entity performing fund management activities must obtain a Capital Markets Services Licence (“CMSL”) issued by the SC.   Before filing a license application, an applicant must decide which licensing pathway best suits their intended business model. The SC’s Licensing Handbook sets out two primary routes, each with different capital requirements and operational limitations.   Feature Boutique Portfolio Management Full-Fledged FMC Min. Paid-Up Capital RM 500,000 RM 2 million Min. Shareholders’ Funds RM 500,000 RM 2 million AUM Limit < RM 750 million No Limit Client Type Sophisticated Investors only Retail & Sophisticated Client Number Limit Max 50 Clients No Limit Dedicated Compliance Officer No (can be outsourced) Yes (Mandatory)     The Full-Fledged Fund Management Company Licence   This category represents the standard institutional licence. It permits for the broadest scope of business operations, allowing holder to manage unlimited assets for both retail and sophisticated investors.   To operate at this level, the SC imposes rigorous financial and human capital requirements. The applicant must maintain a minimum paid-up capital and shareholders’ funds of RM 2 million at all times. Structurally, the compliance standards are strict. The FMC must appoint a licensed director who holds a Capital Markets Services Representative’s License and has a minimum of 10 years of relevant experience. Furthermore, it is mandatory to appoint a dedicated and SC-registered compliance officer. The officer must meet minimum competency requirements, such as possessing a relevant degree with three years of experience and passing the relevant SC licensing examinations.3     The Boutique Portfolio Management Company Licence   Recognising the need for a more accessible entry point for niche players, the SC introduced the Boutique Portfolio Management license. This category significantly lowers the financial barrier, requiring a minimum paid-up capital and shareholders’ funds of only RM 500,000. Furthermore, a licensed director is not mandatory, and the applicant is permitted to outsource the compliance function to a qualified provider, subject to the SC’s prior approval.   However, this lower entry barrier comes with strict operational restrictions, as follows:   The company cannot manage assets exceeding RM 750 million; Services must be restricted solely to sophisticated investors (high-net-worth individuals or corporates); and The FMC is limited to a maximum of 50 clients.   Regardless of the pathway chosen, all applicants (both the corporate entity and its key personnel) must meet the SC’s fit and proper criteria. This involves a thorough assessment of an applicant’s probity, financial integrity, reputation, character and ability to perform their functions efficiently, honestly and fairly.     The Licensing Process: Application, Timelines and Costs   For prospective entrants, navigating the procedural aspects of licensing is as significant as meeting the capital requirements.   The Application Process All applications for a CMSL must be submitted through the SC’s Electronic Application System (EASy). The submission requires a comprehensive business plan, including corporate profiles, organisational structures and five-year financial projections. Crucially, the applicant must demonstrate that its directors, chief executive, and key management personnel meet the fit and proper criteria set out in Section 64 of the CMSA 2007.   Timelines The SC is committed to a client charter of six weeks for the processing of a new CMSL application, provided the submission is complete and meets all fit and proper criteria.4 However, applicants should factor in additional time for the SC to conduct readiness audits or interviews to assess the competency of key personnel.   Application Fee The fee for a new CMSL application is RM 2,000.5   Costs and Annual Licence Fees Investors must also account for the revised fee structure under the Capital Markets and Services (Fees) Regulations 2025, which comes into operation on 1 January 2026. The fee structure is moving towards an AUM-based calculation (e.g., 0.0125% for equities, 0.01% for bonds/mixed assets, 0.0025% for money market/private mandates), with a minimum annual fee of RM 20,000.6     Digital Assets and Digital Investment Managers   The growth of financial technology presents new business opportunities for modern FMCs. However, this area requires careful attention because the legal framework differs depending on whether a company wishes to manage digital assets (like cryptocurrencies) or operate as a Digital Investment Manager (“DIM”), typically referred to as a “robo-advisor".   Management of Digital Assets   Under the Capital Markets & Services (Prescription of Securities) (Digital Currency and Digital Token) Order 2019, digital assets such as digital currencies and tokens as classified as securities. Therefore, FMCs managing these assets must do so through SC-registered Digital Asset Exchanges (“DAX”) such as Luno, HATA Digital, MX Global, SINEGY, and Tokenize.   The SC’s Guidelines on Digital Assets focus mainly on DAX and Initial Exchange Offering (“IEO”) operators. There is limited guidance for traditional FMCs that wanted to manage digital assets as part of a broader investment strategy. Therefore, it is strongly advisable for FMCs to rely on the SC’s broad standards of care, skill and diligence when dealing with these asset classes.7   Digital Investment Manager   A DIM is not a new type of asset, but a new method of management. A DIM is a fund manager that provides automated discretionary portfolio management using innovative technology to perform core functions such as risk-profiling, asset allocation and rebalancing.   A DIM does not operate under a separate license category. Instead, it operates as a variation to the existing CMSL for fund management. A new applicant or an existing FMC (either Boutique or Full-Fledged) can apply to the SC to have their license varied to include DIM services. Applicants must satisfy the SC that they possess the necessary digital value proposition, technology capabilities, and necessary expertise.8 The SC has licensed a number of DIMs to date, including Akru Now Sdn Bhd, Amanah Saham Nasional Berhad, CP Global Fintech Solutions Sdn Bhd (Airo), GAX MD Sdn Bhd (MYTHEO), Kenanga Investment Bank Bhd, Raiz Malaysia Sdn Bhd, StashAway Malaysia Sdn Bhd, UOB Asset Management (Malaysia) Bhd and Wahed Technologies Sdn Bhd.     Our Firm’s Role in Your Success   Setting up a Fund Management Company in Malaysia is a detailed and highly regulated process. The CMSA 2007 and the SC’s guidelines impose specific obligations that apply from the application stage to day-to-day operations. Getting these steps right at the beginning is essential, particularly when choosing between a Boutique or Full-Fledged licence, preparing for the SC’s fit and proper assessment and establishing governance standards that meet statutory duties.   The growth of digital assets and the DIM model also requires careful legal and operational planning, as these areas operate under evolving legal frameworks. In this environment, non-compliance with evolving standards can lead to significant implications for both the company and its directors.     Tengku Zafrul Tengku Abdul Aziz, ‘Capital Market Master Plan 3 (CMP3) Launch’ (Speech at the CMP3 Launch, Kuala Lumpur, 21 September 2021), accessed 20 May 2025. Securities Commission Malaysia, ‘Malaysia Gazettes Single Family Office (SFO) Rules’ (Media Release, 6 October 2025). Securities Commission Malaysia, Licensing Handbook (SC-GL/LH-2007, revised 14 April 2023) para 4.02(17). Securities Commission Malaysia, Licensing Handbook (SC-GL/LH-2007, revised 14 April 2023) para 6.03(3)(a). Capital Markets and Services (Fees) Regulations 2025, Regulation 2(2)(a). Capital Markets and Services (Fees) Regulations 2025, Schedule 3, Paragraph 7(d). Securities Commission Malaysia, Guidelines on Conduct for Capital Market Intermediaries (SC-GL/3-2021, revised 29 March 2024) para 8.01. Securities Commission Malaysia, Licensing Handbook (n 3) para 4.02(4B).     Written by: George Law Ngo Jun (Associate) [email protected] Melvyn Quek Ter Mi (Trainee Solicitor) [email protected]     Corporate Communications Azmi & Associates 15 April 2026
19 May 2026
Real Estate & Property Law

Corporate Sale and Leaseback Transactions – Key Legal Advantages & Challenges

In today’s dynamic business landscape, companies are constantly looking for smarter ways to manage their assets and improve cash flow. One option that has become increasingly popular, especially in the real estate market, is the corporate sale and leaseback transaction. In essence, a sale and leaseback involves a company (known as the seller-lessee) selling a property it owns to another party (the buyer-lessor), and then immediately leasing that same property back. In other words, the company turns its real estate into cash but continues to occupy and use the premises for its business operations. In return, the company pays rent to the buyer-lessor, who now holds legal ownership of the property.1   It is a transaction that combines the best of both worlds the seller gains liquidity while maintaining control over its operational space, and the buyer secures a long-term investment with steady rental income.     Why Companies Are Turning to Sale and Leaseback Arrangements   There are several reasons why this structure attracts corporations, especially those looking to strengthen their balance sheets.   Firstly, it is an efficient way to raise capital. Instead of taking on new debt or issuing shares, companies can unlock the value tied up in their property assets. The funds received from the sale can then be channelled into core business activities such as expansion, research and development, or debt reduction. For businesses in capital-heavy industries, this can be a crucial source of funding.   Secondly, it helps companies reduce their exposure to certain ownership risks. Once the asset is sold, risks associated with property ownership like market depreciation, uninsured damage, or even structural defects in newly built properties may shift to the buyer-lessor, depending on how the deal is structured. Although most leases still require the seller-lessee to bear day-to-day operational responsibilities, the bigger and long-term risks are now shared or transferred to the investor.2     Legal Complexities Beneath the Surface   Despite the clear advantages, sale and leaseback transactions are rarely straightforward. They are, by nature, legally intricate because they combine two separate but interdependent agreements - the sale and the lease. If not carefully handled, even small inconsistencies between the two documents can lead to significant disputes later on.   Due diligence plays a vital role here. For the buyer-lessor, it means verifying the property’s title, ensuring there are no encumbrances or restrictions, and confirming the property’s value and physical condition. More importantly, the buyer must assess the tenant’s (or seller-lessee’s) financial strength and long-term stability. After all, the investment’s value largely depends on the tenant’s ability to pay rent consistently throughout the lease term.   This evaluation should include corporate searches, financial checks, and legal assessments to confirm that the seller-lessee is properly incorporated and in good standing. A company with weak financials or an uncertain future poses a significant risk to the investor, especially when the lease runs for 10, 20, or even 30 years.3 For the seller-lessee, understanding the lease terms is equally crucial. Key provisions such as termination rights, rent review clauses, renewal options, and maintenance obligations must be clearly defined.  Ambiguity in these areas can lead to disagreements down the line.4 The parties should also plan for contingencies, for example, what happens if the property is damaged, compulsorily acquired, or becomes unfit for use.   Ultimately, both parties must have a clear picture of their legal responsibilities before proceeding. Engaging legal advisers early in the process helps ensure that the documentation reflects commercial reality and protects each side’s interests. Practical Implications for the Seller-Lessee   Once a sale and leaseback deal is completed, the seller-lessee effectively becomes a tenant in what used to be its own property. This shift comes with practical consequences.   The most obvious one is that the seller no longer enjoys ownership rights. While they can continue operating the business as usual, they no longer benefit from any future appreciation in the property’s value. If the property increases significantly in worth over the years, that gain belongs entirely to the buyer-lessor. The seller-lessee can only reacquire the property if the lease includes a buy-back option, usually at the market rate at that time.5   The seller’s control over the property also becomes more limited. Any major alterations, renovations, or changes in use typically require the lessor’s consent. This can be frustrating for companies that rely on flexibility in their operations or anticipate frequent upgrades to their facilities. That said, these constraints can be mitigated through careful negotiation. For example, the seller-lessee can seek a longer lease term, built-in renewal rights, or specific clauses allowing certain modifications without further approval. Such foresight can make a big difference in maintaining operational independence after the transaction.   From the buyer-lessor’s viewpoint, a sale and leaseback provide an opportunity to acquire a high-quality, income-generating asset. It offers predictable returns through long-term rental payments, often backed by reputable corporate tenants.   However, this comes with its own set of challenges. The buyer assumes the risks of ownership, including property maintenance, market fluctuations, and tenant default. If the tenant experiences financial distress, the buyer could face delays in rental payments or even difficulties repossessing the property. Therefore, the success of the investment depends heavily on careful risk assessment and prudent legal documentation.     Conclusion   Corporate sale and leaseback transactions can be a win-win arrangement when structured thoughtfully. For companies, it is an effective way to free up capital without disrupting operations. For investors, it is a reliable avenue to secure steady, long-term returns.   However, the transaction is not without its challenges. The legal and financial intricacies involved require careful planning, clear documentation, and thorough due diligence. Every clause in the sale and lease agreements matters from who bears the maintenance costs to what happens when the lease ends.   Given these complexities, companies should not approach sale and leaseback transactions casually. Seeking expert legal and commercial advice at every stage can make a significant difference between a successful deal and a problematic one.   At Azmi & Associates, our team has the experience and expertise to guide clients through each phase of a sale and leaseback arrangement, from structuring and negotiation to documentation and completion. When handled properly, this strategy can help businesses unlock real value from their assets while positioning themselves for sustainable growth.       PwC, ‘6.2 Sale and leaseback transactions: introduction’ (PwC Viewpoint) https://viewpoint.pwc.com/dt/us/en/pwc/accounting_guides/leases/leases__4_US/chapter_6_sale_and_l_US/62_sale_and_leasebac_US.html accessed 10 November 2025. ‘Easing Liquidity Concerns by Unlocking Capital from Real Estate: Sale & Leaseback Transactions’ (Clifford Chance, May 2020) https://www.cliffordchance.com/content/dam/cliffordchance/briefings/2020/05/EASING-LIQUIDITY-CONCERNS-BY-UNLOCKING-CAPITAL-FROM-REAL-ESTATE.pdf accessed 10 November 2025. Emma H Mulvaney and others, ‘Sale-Leaseback Due Diligence Considerations’ (Frost Brown Todd, 29 May 2025) https://frostbrowntodd.com/sale-leaseback-due-diligence-considerations/ accessed 10 November 2025. MTR Legal, ‘Sale & Lease Back offers advantages and disadvantages’ (MTR Legal, 12 August 2025) https://www.mtrlegal.com/en/sale-lease-back-offers-advantages-and-disadvantages/ accessed 10 November 2025. Robert D Mitchell, ‘Sale-Leaseback of Commercial Real Estate: Pros and Cons’ (Robert D Mitchell) https://www.robertdmitchell.com/article/sale-leaseback-commercial-real-estate/ accessed 10 November 2025. Written by: Mohd Sallahudin Abdullah (Partner) [email protected] Nur Farah Yasmin Md Nor (Associate) [email protected]   Corporate Communications Azmi & Associates 13 January 2026
19 May 2026
Life Sciences & Biotechnology Law

Biotechnology Industry in Malaysia: An Overview of the Legal Framework

Introduction Over the past two decades, Malaysia’s biotechnology industry has evolved from a niche sector into an increasingly strategic pillar of the national economy. Recognising the potential of biotechnology to drive economic development, technological advancement, and sustainability, the Malaysian Government has positioned the biotechnology as a key sector within its broader innovation-led growth strategy. This ambition is underpinned by a deliberate legal and regulatory framework designed to enable safe, sustainable, and commercially viable development. To support this vision, Malaysia has adopted a multi-layered approach encompassing policy guidance, regulatory oversight, funding support, tax incentives, and infrastructure development. This framework seeks to foster innovation while ensuring public health, environmental protection, and compliance with national and international legal standards.     Policy Direction and Institutional Support   The cornerstone of Malaysia’s biotechnology legal framework is the National Biotechnology Policy 2.0 (NBP 2.0), launched in 2022 as a continuation of the original 2005 policy. The NBP 2.0 emphasizes a bio-innovation society aimed at wealth generation and social well-being through three focus areas: agriculture and food security, healthcare and well-being, and the industrial circular economy.   To implement these objectives, the Government established the Malaysian Bioeconomy Development Corporation (Bioeconomy Corporation), formerly known as the Malaysian Biotechnology Corporation. As the lead agency, it provides regulatory guidance, mentorship and funding support. The rebranding from the “Malaysian Biotechnology Corporation” to the “Malaysian Bioeconomy Development Corporation” reflects Malaysia’s strategic shift toward a regulated bioeconomy model that leverages biological resources for national growth.     A Diverse Regulatory and Sectoral Ecosystem   Malaysia’s biotechnology landscape is broad, segmented into four primary subsectors, each operates within its own regulatory framework, governed by specific legal instruments and oversight government agencies:   Healthcare Biotechnology Healthcare biotechnology, including biopharmaceuticals, vaccines, and diagnostic tools, is regulated primarily by the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health (MoH). The NPRA ensures compliance with safety, efficacy, and quality standards through clinical trial approvals, product registration, and post-market surveillance.   Agricultural Biotechnology Agricultural biotechnology contributes to food security and agri‑innovation. Regulation in this area is conducted through sectoral agencies including the Department of Agriculture (DOA) under the Ministry of Agriculture and Food Security (MAFS), which administers guidelines related to plant and animal health, pest management, and biotechnology applications. Regulated activities involving Living Modified Organisms (LMOs) are also subject to the Biosafety Act 2007, which mandates risk assessment and approvals for release, import, export, and contained use of LMOs to manage risks to health and the environment.   Environmental Biotechnology Environmental biotechnology, including waste management and bioremediation, intersects with environmental law. The Ministry of Natural Resources and Environmental Sustainability (NRES) oversees policies relevant to environmental protection. Development proposals with significant environmental footprints may trigger an Environmental Impact Assessment (EIA) under the Environmental Quality Act 1974.   Industrial Biotechnology Industrial biotechnology supports bio-based manufacturing, including biofuels, bioplastics, and other sustainable materials biologically derived industrial products. The Ministry of Investment, Trade and Industry (MITI), through the Malaysian Investment Development Authority (MIDA), promotes investment incentives that encourage biotechnology adoption in industrial processes. Legal compliance is required in areas including product standards and environmental regulations.   Certain biotechnology activities in Malaysia may require specific licences, approvals, or notifications depending on the nature of the work involved. For example:   Environmental Impact Assessment (EIA) Large-scale biotechnology projects with potential significant environmental effects must obtain the EIA approval from the Department of Environment (DOE) under the Environmental Quality Act 1974.   Healthcare Biotechnology Approvals Clinical trials, product registration, or manufacturing of healthcare biotechnology products must comply with NPRA requirements, including adherence to Good Manufacturing Practice (GMP) standards prior to market authorisation.   Biosafety Approvals Activities involving LMOs are regulated under the Biosafety Act 2007. Risk assessments demonstrating appropriate biosafety measures are in place to protect human health and the environment are required and formal approvals must be obtained before commencing regulated activities such as release, import, export, or contained use of LMOs.     Intellectual Property Protection and Commercial Value   In the biotechnology sector, intellectual property (IP) is more than a legal right — it is often the core commercial asset of the business. The value of a biotechnology company is frequently anchored in the strength of its innovation, proprietary data, and know-how, all of which are protected through an effective IP strategy. Malaysia’s stable statutory environment provide biotechnology companies with the legal tools to secure proprietary innovations, attract investment, and commercialise technologies responsibly:   Patents Act 1983 [Act 291] – protects inventions and grants exclusive rights to inventors. Recent 2022 amendments have streamlined processes for microbiological deposits in compliance with the Budapest Treaty. Trademarks Act 2019 [Act 815] - safeguards brand identity and goodwill for biotechnology products. Industrial Designs Act 1996 [Act 552] - protects the visual design of biotechnological tools and apparatus. Copyright Act 1987 [Act 332] - covers original works, including bioinformatics software and proprietary genomic databases. Geographical Indications Act 2022 [Act 842] – protects products linked to specific regional qualities, particularly relevant to agricultural biotechnology. Trade secrets - protected under common law principles related to confidential information.     Emerging Legal Frontier (2025 to 2026 Updates)   The 2026 legal landscape is increasingly defined by the integration of emerging technologies and global standards:   National Biotechnology Ethics Guidelines: Launched on 9 September 2025, these guidelines establish 15 core ethical principles, including transparency and social responsibility, to govern frontiers like gene editing and cultured meat.   Enhanced Medical Device Control: The Medical Device (Prescribed Medical Device) Order 2026, gazetted in January 2026, introduces stricter oversight for aesthetic and cosmetic biotechnology devices (such as laser systems and High-Intensity Focused Ultrasound (HIFU)), with full enforcement beginning on 1 June 2026.   AI and Data Governance: In line with the Personal Data Protection (Amendment) Act 2024, biotechnology companies are navigating stricter genomic data privacy requirements and the voluntary National Guidelines on AI Governance & Ethics as the government moves toward statutory AI regulation.     Funding, Incentives, and Commercialisation Support   Access to financing is a persistent challenge for biotechnology companies, as traditional financial institutions and private investors (including venture capital and angel investors) often regard early-stage biotechnology ventures as high risk, particularly where intangible assets such as IP form the primary collateral. The Government has implemented specific legal and policy measures to address some of the gaps.   Legal and Incentive Framework for Biotechnology Development   BioNexus Status Awarded by the Bioeconomy Corporation, this status grants eligible biotechnology companies fiscal incentives, including income tax exemptions on non-IP income and investment tax allowances, which are governed by the BioNexus Bill of Guarantees (BOGs). The BoGs represent a formal recognition and commitment by the Malaysian Government to foster long-term growth by ensuring a stable and supportive environment for biotechnology companies, protect the interests of investors and mitigate political and regulatory risks particularly for international investors. Approvals for these benefits remain valid for the duration of the BioNexus Status, provided the company continues to comply with the terms and conditions outlined in the BioNexus 3.1 Framework.   The Bio-based Accelerator (BBA) Program: Nurturing the Biotechnology Pipeline The BBA program is a high-priority strategic initiative administered by the Bioeconomy Corporation to facilitate the transition of bio-based startups and SMEs into the high-value biotechnology chain. While BioNexus Status serves as the definitive incentive for mature, R&D-driven entities, the BBA addresses critical developmental gaps in technical skills, regulatory compliance, technology adoption, and financial readiness for earlier-stage companies. By infusing science, technology, and automation into operations, the BBA empowers companies in the agriculture, industrial, and healthcare sectors to achieve the operational maturity required to eventually qualify for expanded fiscal incentives and government guarantees under the BioNexus regime. As of January 2026, the program aligns with the MADANI Government’s priorities, specifically exploring digital and AI-enabled solutions to accelerate commercial growth and strengthen Malaysia's global competitiveness within the circular economy.   The Malaysian Investment Development Authority (MIDA) Incentives MIDA incentivises qualifying biotechnology companies through legally prescribed measures such as Pioneer Status and Investment Tax Allowance, which reduce tax burdens and encourage capital investment in high-growth biotechnology manufacturing and value-added activities. These incentives are embedded within Malaysia’s tax laws, providing a predictable legal framework for investors and industry participants.   IP-Backed Financing   Recognising the growing importance of IP as a commercial asset, under the 13th Malaysia Plan (13MP) (2026 to 2030), the Government emphasis strengthening the innovation ecosystem, including initiatives to promote IP-backed financing by encouraging financial institutions to understand and extend credit against intangible assets such as patents and proprietary data. This policy direction necessarily engages the development of a supporting legal framework that clarifies IP valuation, security interests, enforcement rights, and insolvency treatment, to protect lenders and borrowers alike. While IP-based lending remains nascent in practice, this policy direction reflects concerted efforts to broaden access to financing beyond traditional physical collateral requirement. It enables companies, including biotechnology firms, to unlock value from their intangible assets.   Public-Private Partnerships (PPPs)   The Government actively encourages PPPs between academia, public research institutions, and private industry to enhance R&D capabilities, foster knowledge transfer, and accelerate commercialisation pathways. These collaborations are typically governed by carefully drafted agreements defining IP ownership, licensing rights, confidentiality, funding arrangements, and risk allocation, ensuring that the interests of all parties are clearly defined and legally protected throughout the research and commercialisation lifecycle.     Infrastructure and Ecosystem Support   Infrastructure remains integral to biotechnology enterprise growth. In response, Malaysia has developed biotechnology parks, shared laboratories, incubation facilities, and ecosystem platforms that operate within established legal and regulatory framework to provide physical infrastructure, technical expertise, and business support for startups and scaling firms. These facilities are typically supported by governance structures and contractual arrangements that address issues such as facility access, intellectual property use, compliance obligations and risks management, helping companies bridge the gap between research and commercial markets.     Talent Pool and Talent Development   A skilled workforce is essential to Malaysia’s biotechnology ambitions. In addition to scientists and technical professionals, the sector relies on legal and regulatory experts who can navigate complex areas such as intellectual property, biosafety, clinical approvals, and commercialization agreements. Malaysia already has a growing pool of such professionals in specialised law practices, universities, research institutions and biotechnology companies.   Talent development is supported through degree programmes, scholarships, professional training, and technology transfer initiatives from research institutions to industry. Collaborative partnerships are often formalised through agreements that define roles, IP ownership, confidentiality, and regulatory responsibilities, enabling professionals to apply both scientific and legal expertise in commercial settings. These efforts ensure biotechnology enterprises have the human capital necessary to innovate responsibly, comply with statutory obligations and operate effectively within Malaysia’s robust legal ecosystem, reinforcing the nation’s broader innovation and regulatory framework.       Conclusion   Malaysia’s biotechnology ecosystem reflects a deliberate integration of innovation, commercialisation and legal stewardship. Through policy direction, statutory oversight, licensing regimes, IP protection, targeted funding, tax incentives, and infrastructure development, Malaysia has established a legal and regulatory environment that balances growth with public health, environmental protection, and investor confidence.   For businesses and investors exploring opportunities in Malaysia, understanding this legal and regulatory landscape and ecosystem enablers, is essential to successfully navigating opportunities, managing risks and realising the potential of Malaysia’ dynamic biotechnology sector.     Written by: Airene Ho Eu Ghee (Senior Counsel) [email protected]     Corporate Communications Azmi & Associates 1 February 2026
19 May 2026
Private Client

The Inception of Family Offices in Malaysia: US$233 million (RM1.1 billion) Acquisition by the Valiram Family Office

Introduction The close of 2025 marked a landmark acquisition by a Malaysian Single Family Office, illustrating the evolving scale and institutional maturity of family offices within the Malaysian investment landscape. The family office involved in the acquisition is none other than the Valiram Family Office. The Valiram Family Office preserves and manages the wealth of the founder of the Valiram Group, Jethanand Utumal Valliram. The Valiram Group holds substantial wealth and is widely recognised for managing and operating international retail brands such as Victoria’s Secret, Michael Kors, Bath & Body Works, and others.   The Valiram Family Office is in the process of acquiring a 40% stake in The Exchange TRX retail mall and a 60% stake in an adjacent office tower, for a total consideration of approximately US$266 million, with completion expected in the first half of 2026.   This acquisition is significant not merely because of its size, but because it reflects a broader structural shift in how Malaysian Ultra-High-Net-Worth families manage, preserve, and deploy capital.   A Single Family Office (SFO) is a private and dedicated structure established to manage the wealth, investments, governance, succession, and legacy of a single family. Unlike traditional holding companies or ad-hoc investment vehicles, an SFO centralises investment decision-making, asset holding, risk management, and inter-generational planning within a professionally governed framework tailored exclusively to the family’s objectives.   The scale of this acquisition undertaken by a Malaysian Single Family Office underscores Malaysia’s growing emergence as a viable jurisdiction for the establishment of family offices and the utilisation of related incentives. While Singapore remains the dominant regional hub, Malaysia offers comparative advantages in terms of cost efficiency, regulatory flexibility, cultural familiarity for Malaysian families, and increasingly deliberate policy support.   In this regard, Malaysia has taken an important policy step by introducing a government-led Single Family Office initiative administered by the Securities Commission Malaysia. Under this framework, qualifying Single Family Offices are recognised within a regulated incentive regime, subject to prescribed substance, governance, and investment requirements.   A defining feature of the Malaysian initiative is the requirement that such Single Family Offices be established within Forest City, Johor Bahru, a designated Special Financial Zone. This location-based requirement reflects the government’s broader objective of anchoring family office activity within Malaysia, encouraging real economic substance, professional employment, and long-term capital deployment.   Recent policy developments therefore signal Malaysia’s intent to capture a meaningful share of regional family office assets, positioning the country as a complementary hub alongside Singapore and Hong Kong rather than as a direct competitor. The Valiram Family Office stands as a compelling illustration of this emerging trend.     The Valiram Family Office: A Case Study   A brief examination of the historical origins of the Valiram brand indicates that the Valiram Group was established in Kuala Lumpur in 1935 as a textile trading business, marking over nine decades of commercial presence. Today, the Valiram Group has expanded globally and is recognised as the leading luxury goods retail operator in Southeast Asia. The group is currently led by third-generation family members, Sharan, Ashvin, and Mukesh Valiram, who have significantly expanded the group’s footprint and diversified its investment strategy. This generation was instrumental in bringing international brands such as Tory Burch, Michael Kors, Victoria’s Secret, Swiss Watch brands, and Bath & Body Works into the Valiramportfolio.   The Valiram Group represents a prominent example of a Malaysian family transitioning from a purely operating-business legacy into a structured family office model, as reflected in the establishment and activities of the Valiram Family Office. Through this structure, the family is able to separate operating risk from investment capital, professionalise asset management, and pursue long-term investment strategies beyond the retail sector.   One of the most significant recent strategic moves by the Valiram Family Office was its investment in the Tun Razak Exchange (TRX) precinct in Kuala Lumpur. In late 2025, the family office reportedly agreed to acquire a 40% stake in The Exchange TRX retail mall and a 60% stake in the TRX Campus office tower from Australian developer Lendlease. The transaction, valued at approximately A$400 million (around RM1.1 billion), underscores the family office’s focus on large-scale, long-term commercial real estate assets. The Exchange TRX has rapidly established itself as one of Malaysia’s most prominent retail destinations, featuring over 400 tenants and demonstrating strong performance in its first year of operations. This investment leverages the Valiram Group’s deep expertise in retail while extending its exposure into premium commercial real estate.   Beyond asset selection, the Single Family Office structure provides important structural advantages, particularly in relation to tax efficiency and investment execution. When properly structured, an SFO enables investments to be documented and held through carefully designed vehicles, reducing transactional friction and allowing capital to be deployed efficiently. In addition, returns on investment such as dividends, distributions, or capital gains may be managed in a tax-efficient or tax-neutral manner, subject to applicable laws and incentive frameworks. These features make the SFO particularly suitable for families deploying patient capital into long-term assets such as commercial real estate and hospitality.   In October 2025, the Valiram Family Office further diversified its asset base when a family-controlled subsidiary, Harum Aspirasi, acquired the 519-room Impiana KLCC Hotel for approximately RM315 million from Magma Group Bhd and KLCC Holdings Bhd. This acquisition further signals the family office’s strategic pivot towards income-generating commercial property and hospitality assets, reinforcing its role as a long-term capital allocator rather than a short-term investor.   The professionalisation of such a structure necessarily involves the active participation of legal advisers. Lawyers play a central role in assisting Single Family Offices by designing the legal architecture of the structure, advising on appropriate entities, drafting governance instruments, and aligning investment documentation with regulatory and tax requirements. In the context of large-scale acquisitions such as those undertaken by the Valiram Family Office, legal advisers also serve as risk managers, ensuring compliance, safeguarding control mechanisms, and embedding dispute-avoidance features within the overall structure.     Conclusion   The Valiram Family Office exemplifies how established Malaysian family businesses are increasingly adopting the Single Family Office structure to manage wealth beyond their core operating businesses. Through this model, the family is able to manage diversified assets across retail, commercial real estate, and hospitality; deploy patient capital into long-term, high-value projects; and preserve and grow family wealth within a structured governance framework that supports inter-generational continuity.   More broadly, the emergence of Single Family Offices in Malaysia marks a significant evolution in the country’s wealth management landscape. With the introduction of a formal government-led SFO initiative under the Securities Commission Malaysia, and the designation of Forest City, Johor Bahru as a dedicated base for such structures, Malaysia has signalled its commitment to becoming a credible and attractive jurisdiction for family offices.   Supported by policy incentives, professional expertise, and increasing institutional capacity, Malaysia is well-positioned to attract both domestic and international families seeking a stable, cost-efficient, and well-regulated environment for long-term wealth management. The Valiram Family Office illustrates this broader trend, demonstrating how Malaysian families are leveraging structured governance, professional legal support, and institutional-grade investment platforms to safeguard legacy, diversify wealth, and contribute to sustainable economic development.       References: Goh, Thean Eu. 2025. Malaysia’s Valiram Family Office Pays A$400 Million for Stake in Local Mall, Office Tower, December 24. Chong, Jinn Xiung. 2022. V for Valiram: Meet the Brothers behind Malaysia’s Luxury Retail Empire, February 4. Kaur, Sharen. 2025. Valiram Family Expands Prime Real Estate Holdings with RM1.1 Billion TRX Acquisition, December 24. Nambiar, Presenna. 2025. Magma, KLCC Holdings Sell Impiana KLCC Hotel for RM315m to Valiram-Backed Buyer, October 10.     Written by: Mohamad Redzuan Idrus (Partner) [email protected] Dhina Dharshan Ganesan (Associate) [email protected]     Corporate Communications Azmi & Associates 30 January 2026
19 May 2026
Press Releases

Azmi & Associates Strengthens Our Corporate & Commercial Team with the Appointment of Airene Ho as Senior Counsel

Azmi & Associates is pleased to announce the appointment of Airene Ho as Senior Counsel in the Firm’s Corporate & Commercial Practice Group, effective 15 January 2026. Airene Ho Eu Ghee Senior Counsel [email protected] Airene was admitted to the Malaysian Bar in 1997 and brings more than 25 years of legal experience spanning private practice and in-house leadership roles. She began her career as an Advocate & Solicitor, practising for seven (7) years before spending more than two decades in the corporate sector as General Counsel and Head of Legal for leading organisations. She has since returned to legal practice. During her time in private practice, Airene advised and represented a diverse clientele on complex corporate, commercial, intellectual property, and litigation matters. Her notable assignments include: Acted for a leading U.S. software company and secured a landmark software piracy decision against copyright infringers, reported in Malaysian media. Successfully defended an appeal on the assignment of debt, reported as Arab-Malaysian Bank Bhd v Teamsystems Interior Sdn Bhd [2004] 6 CLJ (Supp) 232. Led a team advising Pengurusan Danaharta Nasional Berhad, Malaysia’s national asset management company, on the recovery of non-performing loans during the 1997–2000 financial crisis. As an in-house counsel, Airene has advised on complex and high-value matters across multiple jurisdictions, including acquisitions, investments and divestments, joint ventures, strategic collaborations, and complex cross-border disputes. Her experience spans the real estate and life sciences / biotechnology sectors, where she served as a strategic adviser to Boards and senior leadership teams, delivering commercially aligned legal solutions to support organisational growth and resilience. She has also gained exposure to sustainability-related initiatives involving the voluntary carbon market. Drawing on her complementary experience in both private practice and in-house leadership, Airene is particularly passionate about transactions at the intersection of corporate, commercial, and intellectual property law, especially where business objectives align with environmental and sustainability priorities. Airene holds an LL.B (Hons) from the University of East London and an MBA. She has passed the Patent Agent Examination and is a MIM Certified Professional in Intellectual Property Management (MIM-CPIPM). This appointment reflects the Firm’s continued commitment to strengthening its leadership and delivering high-quality, commercially focused legal solutions. We are delighted to welcome Airene and look forward to her valuable contributions to the Firm and its clients. Corporate Communications Azmi & Associates 20 January 2026
20 January 2026
Press Releases

Azmi & Associates Appoints Two (2) New Partners, Strengthening IP and Litigation Capabilities

Azmi & Associates is pleased to announce the appointment of Ahmad Hafiz Zubir as Partner, General & Intellectual Property (IP) Litigation Practice, together with the full consolidation of Hafiz Zubir & Co. (“HZC”) into Azmi & Associates, as well as the appointment of Hadi Mukhlis Khairulmaini as Partner within the Firm’s Litigation Practice Group, all effective 1 January 2026. This strategic move represents a deliberate step to accelerate growth in the Firm’s IP capabilities, broaden our offering in general civil litigation and SME corporate advisory, and expand our geographic footprint within the Bangi–Putrajaya corridor, an area of increasing commercial and innovation activity. With these appointments, the Firm now counts twelve (12) Partners within its Litigation Division, reflecting both the expanding scale and increasing sophistication of our dispute resolution and arbitration portfolio. This growth aligns with the Firm’s commitment to strengthening its position as a leading advocate in complex, high-value, and technically demanding legal matters. [caption id="attachment_54140" align="alignnone" width="210"] AHMAD HAFIZ ZUBIRGeneral & IP Litigation Practice [email protected][/caption] [caption id="attachment_54138" align="alignnone" width="210"] HADI MUKHLIS KHAIRULMAINILitigation Practice [email protected][/caption]   Ahmad Hafiz Zubir has been appointed as the Firm’s 29th Partner.   Hafiz is the founding and principal partner of HZC since 2018, where he has established a respected specialist practice in intellectual property (IP), litigation, and dispute resolution. Hafiz has authored and contributed to several practitioner-focused publications, reinforcing his standing in the IP legal community. He is the author of "A Practical Guide on Trademark Registration in Malaysia" book, which was published in November 2025 by Sweet & Maxwell (Thomson Reuters) Malaysia.   He holds a Bachelor of Laws (Honours) from the International Islamic University Malaysia (IIUM) and a Master of Intellectual Property from Universiti Kebangsaan Malaysia (UKM). He is currently pursuing a PhD, reflecting his strong commitment to thought leadership and the advancement of IP jurisprudence.   His experience covers a broad range of IP disputes, including copyright infringement involving creative works and design concepts; trademark disputes relating to misrepresentation, passing off, and brand ownership; patent infringement involving the unauthorised making, use, or commercialisation of protected inventions; and industrial design infringement concerning the replication of registered designs. He also regularly advises on disputes between former business partners, particularly where intellectual property assets are central to the conflict.   Hafiz works closely with enforcement authorities on IP infringement matters, including assisting the Ministry of Domestic Trade and Cost of Living (KPDN) in raids and anti-counterfeiting enforcement. He has also handled numerous licensing, commercialisation, and royalty engagements with higher learning institutions and research bodies, including UKM, particularly in matters involving technology transfer and IP monetisation.   Beyond legal practice, Hafiz is actively involved in professional development and training. He is a certified trainer with the Human Resources Development Corporation and contributes to capability-building initiatives aimed at promoting awareness, understanding, and responsible use of intellectual property across industries.   Previously, he was a Partner at Khairil Ahmad & Co. and Adnan Sharida & Associates, and began his legal career as a pupil at RamRais & Partners. His experience across multiple platforms has given him a well-rounded perspective on litigation, client advisory work, and firm leadership. The appointment of Hadi Mukhlis Khairulmaini marks the Firm’s 30th Partner, representing a strategic expansion of our litigation leadership bench.   Hadi is an accomplished civil and commercial litigator with robust experience across all levels of the Malaysian judiciary.   His portfolio includes significant exposure to high-stakes commercial, utilities-related, and public law disputes, reflecting both technical sophistication and practical litigation strategy.   His entry into the Partnership is expected to further elevate the Firm’s capacity to manage complex mandates and deepen client confidence in our dispute resolution services.   Prior to joining Azmi & Associates, Hadi served as a Partner at Messrs. Steven Thiru, bringing with him a highly regarded litigation pedigree and a strong track record in high-value and complex disputes.   Hadi holds a Bachelor of Laws (Honours) degree from Universiti Teknologi MARA (UiTM), and was admitted to the Malaysian Bar in June 2009.   Over the course of more than 17 years in practice, he has developed extensive litigation experience spanning contractual and commercial disputes, negligence and tort claims, land and property matters, administrative and public law (including judicial review proceedings), employment and industrial relations disputes, as well as construction and infrastructure-related litigation.   He has consistently demonstrated courtroom credibility, having appeared regularly before the High Court and the appellate courts, including in a number of reported and precedent-setting matters. His advocacy style combines technical precision, sound judgment, and disciplined litigation execution.   Hadi began his legal career with Messrs. Shook Lin & Bok, where he completed his pupillage in 2008 and was subsequently retained as an Associate following his admission to the Bar. Over the course of seven years, he progressed to the rank of Partner, reflecting sustained performance, professional growth, and measurable client impact.   During his formative years at the firm, he received mentorship from Mr. Steven Thiru, former President of the Malaysian Bar, which helped him develop a robust foundation in complex civil and commercial litigation.     These appointments mark an important milestone in the Firm’s continued growth and commitment to excellence in intellectual property, litigation and dispute resolution. Please join us in extending a warm welcome to Ahmad Hafiz Zubir and his team, and Hadi Mukhlis Khairulmaini, as they embark on this new chapter with Azmi & Associates.   Corporate Communications Azmi & Associates 1 January 2026
02 January 2026

The Law of Confidence in Malaysia

Every employee owes a duty of good faith or fidelity to his employer which requires that he does not use or disclose any confidential information gained in the course of his employment without the employer's consent.The company’s confidential information is important as it allows the company to compete with its competitors. If the said confidential information is exposed to a third party, it will weaken the company’s competing powers against its competitors and subsequently cause huge loss to the company.1 It has to be noted that the duty of confidentiality extends even after the employment contract ends.2 The courts have held that what makes the information confidential is the fact that the maker of the document has used his brain and thus produced a result which can only be produced by somebody who goes through the same process. Hence, when the recipient of the information makes use of the information, he avoids from doing the work and saves himself the time and trouble of having to do the work notwithstanding the fact that he is capable of doing it.3 An employee's obligation of confidence applies to his employer's trade secrets4 such as manufacturing processes, secret formula, cost prices, quoted prices, specific needs and requirements of the customers and suppliers, status of all on-going negotiations with the customers, and price list.5 However, it has to be borne in mind that not all information will be classified as confidential. A former employee is not prevented from using the skill and knowledge in his trade of profession which he has acquired in the course of his employment.6 On termination of employment, only information that qualifies as a trade secret or its equivalent would be protected. Elements to Prove Breach of Duty of Confidentiality Duty of confidentiality can be traced back to the case of Coco v AN Clark (Engineers) Ltd [1969] RPC 41 wherein the court held that that there are three elements essential to a cause of action for breach of confidence namely:- that the information was of a confidential nature; that it was communicated in circumstances importing an obligation of confidence; and that there was an unauthorised use of the information. In deciding whether or not there is a breach of confidentiality committed by an employee, our courts have applied the principle formulated in the abovementioned case. The High Court in the case of Rotta Research Laboratorium SPA & Anor v Ho Tack Sien & Ors (Chai Yuet Ying, third party) [2015] 4 MLJevi 222, applied the three elements cited above in deciding that the Defendants had breached their duty of confidentiality as all three elements in the case of Coco v AN Clark (Engineers) Ltd were fulfilled. In this case, the court found that the Plaintiff’s information was of a confidential nature as the information includes detailed pharmaceutical data of a type of drug called Viartril-S and its manufacturing process. The Defendants too had access to the Plaintiff’s database of its distribution network, lists of customers and marketing information concerning the sale of Viartril-S. The confidential information was communicated in circumstances importing an obligation of confidence as the Second Plaintiff trusted the Defendants and made available their trade secrets to the Defendants so that they could perform their job as an employee and consultant of the Second Plaintiff respectively. The court found that the Defendants within a year after becoming involved with the registration of Viartril-S manufactured a similar type of drug, Artril 250. The Defendants then had successfully registered the product with unusual speed which indicated that the Defendants must have put into use the confidential information obtained in the course of their employment with the Second Plaintiff into the manufacturing of Artril 250 to their benefit. Remedies In the event that an employee or a former employee breaches his duty of confidentiality, the employer concerned may seek legal recourse by claiming for damages and/or seeking for injunction. Generally, for cases involving breach of duty of confidentiality, damages will not be an adequate remedy as it is difficult to quantify the loss suffered by the employer. To be able to claim for damages, the employer has to furnish evidence to show that the employer's trade secrets have been utilised by the employee to the detriment of the employer.7 It is sufficient for the employer to prove that there is a likelihood of damage such as proving that the goodwill of a business or its reputation is injured. On the other hand, if the employer could demonstrate that there exists a real risk of future injury, the employer would be granted a permanent injunction.8 When seeking for an injunction, the employers have to first properly identify the confidential information or else it may be difficult to enforce the said injunction.9 In view of the above, the duty of good faith or fidelity may be expressly or impliedly provided in the employment contract which not only requires the employee to observe his duty of confidentiality during the course of his employment but also requires the employee to refrain from disclosing the confidential information even after his employment ends. As such, an employee has to be cautious so as to not use, divulge and/or disclose to whomsoever, any confidential information and/or trade secrets obtained during the course of their employment with the former employer after the employment had ceased. Authors: Melinda Marie DÁngelus and Vanessa Iskandar Ng Footnotes Publicis (M) Sdn Bhd Dan Satu Lagi Lwnadele Wee Kay Ren Dan Satu Lagi [2007] 2 MLJ 395. Schmidt Scientific Sdn Bhd v Ong Han Suan [1997] 5 MLJ 632. Saltman Engineering Co Ltd & Ors v Campbell Engineering Co Ltd [1963] 3 All Er 413 At P 415 (Ca); Schmidt Scientific Sdn Bhd v Ong Han Suan [1997] 5 MLJ 632. Dato' Vijay Kumar Natarajan v Choy Kok Mun [2010] 7 MLJ 215. Schmidt Scientific Sdn Bhd V Ong Han Suan [1997] 5 MLJ 632. Vsl Prestressing (Australia) Pty Ltd V Dj Mulholland [1971] 2 MLJ 89. Worldwide Rota Dies Sdn Bhd v Ronald Ong Cheow Joon [2010] 8 MLJ 297. Ibid. Ocular Sciences Ltd v Aspect Vision Care Ltd [1997] RPC 289; China Road & Bridge Corporation v Dcx Technologies Sdn Bhd [2014] MLJU 406.  
30 October 2024

Process of Getting Work Permits for Expatriates in Malaysia

Expatriates and Work Permits The Malaysian government encourages employers in Malaysia to train and employ more locals in tandemwith the government’s policy and vision to have more locals trained and employed at all levels within various organizations to reflect the multi-racial composition of the country. Nevertheless, the current shortage in the amount of employees or lack in the availability of trained locals has resulted in employers bringing in expatriate individuals to fill in the respective posts, i.e. “Key Post”, “Time Post”, “Executive Post” and “Non-Executive Post”. For expatriates wishing to work in Malaysia, they are required to have work permits. These work permits are generally valid for between 6 months and 5 years, depending on the respective durations and salary ranges of the employment contracts and the types of visas according to the requirements set out by the Expatriate Services Division (ESD)1, a division under the Immigration Department of Malaysia of the Ministry of Home Affairs of Malaysia. ESD is responsible for the processing of applications and the issuance of work permits for expatriates here in Malaysia. In short, there are 3 types of work permits available to expatriate workers which are issued by the government. The 3 types of work permits available are the: Employment Pass, the Professional Visit Pass and the Residence-Pass Talent.2 This article seeks to discuss the process of getting the commonly sought and most suitable work permit type for expatriates – the Employment Pass. Additionally, those who fail to have work permits while working or rendering services in Malaysia can be liable to be fined up to RM10,000 or imprisoned for not more than 5 years or both.3 As such, it is vital for an expatriate to possess and for the employer to ensure that the expatriate possesses a valid work permit prior to working or rendering services in Malaysia. Process: Step-by-Step Procedures & Requirements In Malaysia, the Employment Pass will be applied by the person wishing to employ the expatriate (i.e., the employer). The application for the Employment Pass and related applications are done online mostly through the ESD portal. This potential employer must already have an account or register for one with ESD prior to the application process.4 When a potential employer wishes and is ready to employ expatriate, either of the following two (2) circumstances applies: - First-Time Hiring Subsequent Hiring For first-time hiring i.e. a potential employer who is employing an expatriate as the first instance exercise, the employer will first needs to be registered with ESD. The registration is a ‘one-time’ process and employers will not be required by ESD to re-register for each subsequent expatriate hire, unless the employer ceases to be registered with ESD or becomes de-registered with ESD (*in this situation, the employer needs to register with ESD afresh). This registration is necessary as the employer would not be able to proceed further to apply for the Employment Pass without first being registered. However, the registration is not automatic: the employer needs to apply to be registered. In order to become registered, the employer needs to undergo the following step-by-step procedures (brief): Create Login ID and Password. Insert Requisite Information and Upload Requisite Documents via ESD Portal. Evaluation of the Registration Application by ESD. Issuance of Registration Approval by ESD. Appoint Endorser, Company Login ID User, Submission Officer 1 and Submission Officer 2 via ESD Portal. Print Letter of Undertaking from ESD Portal. Set Face-to-Face Appointment with ESD via ESD Portal. Signing of the Letter of Undertaking at ESD’s Office and Submission of the signed Letter of Undertaking to ESD. Change Password via ESD Portal Per ESD’s client charter, the overall processing timeframe (from the initial step until the last step) is 14 working days upon ESD’s receipt of complete information and documents excluding the timeframe for various query stages (if any). For subsequent hiring i.e. existing employer of expatriate who is now employing subsequent expatriate(s), the employer can straightaway proceed with the application for the Employment Pass(es). The step-by-step procedures for the Employment Pass application are briefly as follows: - Application for Expatriate Post Approval (to the Approving Agency). Issuance of Expatriate Post Approval (by the Approving Agency). Application for Employment Pass (to ESD). Issuance of Employment Pass (by ESD). Per ESD’s client charter, the processing timeframe for the 1st Step and 2nd Step is 5 to 10 working days while the processing timeframe for the 3rd Step and 4th Step is 5 to 10 working days, leading the overall processing timeframe of 10 to 20 working days, upon ESD’s receipt of complete information and documents excluding the timeframe for various query stages (if any). Further, it should be noted that as a pre-condition, a potential employer is required to advertise for job vacancies to locals for the position requiring the expatriate via designated online platform before submitting the application for the Employment Pass5. The job vacancy needs to be advertised for a period of at least 30 days prior to the application for the Employment Pass6. During this period, the employer is required to conduct interviews of the locals7. This is a new requirement implemented by the Ministry of Human Resources (via one its agencies, the Social Security Organisation (SOCSO)) and adopted by ESD, quite recently on 1 January 2021 onwards8. Be that as it may, there are several exceptions to this requirement, as follows:-9 automatic exemption. important roles (C-Suite & Key Posts). expatriates with monthly income of RM15,000 and above. Representative Office/Regional Office (RERO). investors/ shareholders/owners. corporate transfers/secondments/trade agreements. international organization. sports sectors. conditional exemption (i.e. requiring exemption letter from SOCSO by way of formal application). specialized skilled positions. This is to say that in respect of any of these situations, the employer does not have to advertise the job vacancy, as normally required. This means that the employer can skip this step and straightaway apply for the Employment Pass. In summary, the brief process of obtaining Employment Pass is as per Table 1:10 STEP DESCRIPTION ACTING PARTY 1st Step* Application for Employer ESD Registration Employer 2nd Step* Registration of Employer with ESD ESD 3rd Step# Application for Expatriate Post Approval Employer 4th Step Issuance of Expatriate Post Approval Approving Agency 5th Step Application for Employment Pass Employer 6th Step Issuance of Employment Pass ESD TABLE 1 All in all, the overall processing timeframe ranges from 10 to 20 working days to 24 to 34 working days depending on the status of the potential employer (i.e. whether first-time expatriate hiring or subsequent expatriate hiring). However, in practice, the timeframe is typically longer due to various other factors. [Note: *This step is not relevant and no longer required upon the employer for subsequent expatriate hiring exercise (unless the employer has ceased to be registered or has becoming de-registered with ESD as explained above). The employer may straightaway proceed with the subsequent steps. #As pre-condition to the application for expatriate post approval, the employer needs to satisfy both the Approving Agency and ESD that an advertisement for job vacancy to the locals in respect of the position requiring an expatriate has been posted and interviews of the locals vis-à-vis the advertisement has been conducted, as mentioned above.] Conclusion It is important to note that the process of getting work permit for expatriate in Malaysia is quite long and arduous. The process involves filling in and completing some forms, preparing the requisite supporting documents and on frequent basis liaising with the relevant authorities (for example the Approving Agency and ESD) both via online and offline platforms, whereby the application for the work permit is done from within the country. Thus, it is highly recommended for potential employers of expatriates in Malaysia to engage professionals to help going through with the process in terms of procedures, formalities and requirements. Authors: Mohammad Ashraf Mohamed Sopiee and Fatin Razanah Redzuan Footnotes ESD ONLINE GUIDEBOOK V3.1 2017. https://esd.imi.gov.my/portal/about-us/esd/. IMMIGRATION ACT 1959/63 [ACT 155]. https://esd.imi.gov.my/portal/employers/#. FREQUENTLY ASKED QUESTIONS (FAQ): ADVERTISEMENT OF VACANCIES ON MYFUTUREJOBS FOR THE HIRING OF EXPATRIATES NO. 2/2020 | 29 DECEMBER 2020. Ibid. Ibid. Ibid. Ibid. https://esd.imi.gov.my/portal/employers/#.
30 October 2024

The Laws Relating to Zero Emissions in Malaysia

In December 2021, Malaysia experienced three (3) consecutive days of heavy downpour, constant rain on an unprecedented scale affecting eight states. The country suffered an estimated loss of Ringgit Malaysia Fifteen Billion (RM 15,000,000,000.00) to the Malaysian economy,1 close to seventy thousand (70,000) victims affected2 and most unfortunately, a total of fifty-four (54) deaths and two (2) people missing.3 Described as a one in 100-year weather event,4 was this catastrophe a result of nature running its course, an act of God? Or was it caused by the acts and omissions of mankind? Experts believe that one of the main causes of the flood is due to climate change. Environmentalist, Dr Renard Siew claims that the flood “is a clear example of an unpredictable weather event as a result of high carbon emissions”.5 It is clear that climate change (more specifically, global warming due to carbon emissions) has contributed to this disaster, and many others throughout the globe. Thus, it is imperative that the necessary remedial action, including the enactment of laws regulating climate change, is taken by those responsible to combat this ever-growing global issue. This article seeks to explore the laws governing carbon emissions in Malaysia. In Malaysia, the Environmental Quality Act 1974 (“EQA 1974”) is the main legislation which governs the protection and conservation of the environment. Section 21 and 51 of the EQA 1974 provides the Minister charged with the responsibility for environment protection, the power to create regulations which specify the acceptable conditions for the emission of environmentally hazardous substances and pollutants as well as regulations prohibiting the emission into the environment of any gaseous matters. In exercising the powers conferred to it under Section 21 and 51 of the EQA 1974, the Minister has created several regulations which govern carbon emissions in Malaysia, most notably the Environmental Quality (Clean Air) Regulations 2014 (“Clean Air Regulations”) which provides that an owner or occupier of a premise involved in any activity or industry listed in the First Schedule of the Clean Air Regulations, including power plants, waste fuel plants, asphalt mixing plants and others, shall incorporate measures to reduce the emission of air pollutants into the atmosphere in accordance with the Best Available Techniques Economically Achievable. The Clean Air Regulations further make provisions for the equipping and monitoring of an air pollution control system, offences, penalties and others. The Clean Air Regulations ensures that owners of premises involved in the relevant activities and industries must now be prudent in its operations so as to ensure that it complies with the Clean Air Regulations which in effect, shall reduce the emission of air pollutants (including carbon) into the atmosphere. Further to the above, the Minister has also created regulations governing the emission of pollutants from different type of vehicles such as motorcycles and vehicles equipped with petrol and diesel engines. The said regulations provide that the engine of such vehicles must not emit pollutants in excess of the prescribed limit provided under the regulations. Compliance by vehicle manufacturers of these regulations will in effect, reduce the amount of vehicles on Malaysian roads which emit harmful levels of pollutants that shall translate to the reduction of carbon emissions by Malaysian vehicles. In 2011, the Renewable Energy Act 2011 (“REA 2011”) was passed by Parliament which aimed at increasing the production of green energy. The REA 2011 provides incentive for the generation of electricity from renewable resources by introducing a feed-in tariff scheme which gives feed-in holders a premium for each unit of electricity that is generated using renewable resources. Those who wish to participate in this scheme must firstly obtain a feed-in approval from the Sustainable Energy Development Authority (“SEDA”), the administrator and implementing agency of the scheme. The REA 2011 is one of the notable efforts by the Government to encourage companies to invest in the production of renewable energy, moving away from the unsustainable fossil fuels which is undoubtedly one of the highest contributors of carbon emission and global warming. On an international scale, Malaysia is a signatory of the Paris Agreement. The Paris Agreement is an international treaty on climate change. It was adopted by one hundred and ninety-six (196) parties at COP 21 in Paris, on 12 December 2015 and entered into force on 4 November 2016.6 Under the Paris Agreement, Malaysia is committed to reduce the emission of greenhouse gases by forty-five percent (45%) by 2030, in which thirty-five percent (35%) is unconditional and the remaining ten percent (10%) is conditional upon the receipt of climate finance, technology transfer and capacity building from developed countries.7 In respect of the Paris Agreement, Malaysia has showed its further commitment in saving the environment by updating its Nationally Determined Contribution (“NDC”), as follows: increase the unconditional reduction intensity by ten percent (10%); and expand the greenhouse gases coverage to include, Carbon Dioxide (CO2), Methane (CH4), Nitrous Oxide (N2O), Hydrofluorocarbons (HFCs), Perfluorocarbon (PFCs), Sulphur Hexafluoride (SF6) and Nitrogen Trifluoride (NF3). Such show of commitment would mean more efforts, policies and principles to be formed by Malaysia in the effort to cut down carbon emissions. Following this direction, the stakeholders, which includes the Ministry of Environment and Water, the Ministry of Finance8 and Bursa Malaysia are working on the development of a Voluntary Carbon Markets (“VCM”). VCM is a platform that conducts carbon credit trading between green asset owners and others with the sole-objective to move towards low-carbon practices.9 Malaysia is also in the initial stages of the development of Long-Term Low Emission Development Strategy (“LT-LEDS”). LT-LEDS primary role is to formulate strategies and actions for the mitigation of greenhouse gas emissions in Malaysia’s key economic sectors which include the manufacturing and processing industry sector, agricultural sector and waste sectors.10 The Minister of Environment and Water of Datuk Seri Tuan Ibrahim Tuan Man in a statement stated that the economic instruments such as carbon pricing including carbon taxes and domestic carbon trading schemes will be introduced under the LT-LEDS.11 Additionally, pursuant to the Paris Agreement, industry leaders such as PETRONAS and Shell Malaysia have shown its commitment towards achieving the net zero carbon emissions goal by among others: improve energy efficiency; provide low carbon energy; develop emission reduction technologies; and reduction of hydrocarbon flaring and venting.12 13 The initiatives by PETRONAS and Shell Malaysia shall hopefully serve as an example for other companies, especially companies in the oil and gas industry to take action on the issue of climate change. Given the seriousness of the environmental issues and setbacks detailed in the IPCC Sixth Assessment Report, the international parties together with Malaysia must work more efficiently to ensure the sustainability of the environment for our future generation. World renowned astrophysicist, Neil deGrasse Tyson once said “Every disaster movie begins with a scientist being ignored”.14 Environmentalists have warned us time and time again that appropriate measures must be taken now to combat climate change. We can no longer ignore these messages and we must act on it to prevent climate change related disasters, such as the 2021 Malaysian floods from reoccurring. The authors of this article hope that Malaysia shall take the issue of climate change more seriously by enacting more efficient laws to reduce carbon emissions and adopt proper enforcement of such laws. Authors: Nafis Zain Safwan Majid Zain and Umar Izat Nubli Footnotes https://www.bharian.com.my/berita/nasional/2021/12 /903555/negara-dianggar-rugi-rm15-bilion-akibat-banjir. https://www.utusan.com.my/nasional/tragedi/2021/12 /jumlah-mangsa-banjir-menghampiri-70000/. https://www.bernama.com/en/general/news_disaster .php?id=2040627. https://www.thestar.com.my/news/nation/2021/12/20 /24-hour-downpour-is-a-one-in-100-year-weather-event. https://www.channelnewsasia.com/asia/malaysia- once-100-years-flooding-climate-change-disaster -planning-2391316. https://unfccc.int/process-and-meetings/the-paris- agreement/the-paris-agreement. https://mydclimate.org/2021/10/04/7886/. https://www.theedgemarkets.com/article/mysay- carbon-pricing-and-its-future-malaysia. https://www.malaymail.com/news/malaysia/2021/12 /01/carbon-trading-already-a-complex-mechanism -to-be-made-shariah-compliant-par/2025078. https://themalaysianreserve.com/2021/09/28/kasa-to -announce-net-zero-emissions-measures/. https://themalaysianreserve.com/2021/09/28/kasa-to -announce-net-zero-emissions-measures/. https://www.petronas.com/sustainability/net-zero- carbon-emissions. https://www.shell.com.my/about-us/powering-progress/ achieving-net-zero-emissions.html#:~:text=Shell's%20s trategy%20to%20achieve%20net%2Dzero%20emissions &text=This%20includes%20short%2Dterm%20targets, 2050%20(compared%20to%202016). https://twitter.com/neiltyson/status/1254048358366416896 ?lang=en.
30 October 2024

Laws Relating to the Management of Scheduled Waste in Malaysia

Listed as the 25th most competitive economy in the world1, Malaysia engages in an exceedingly wide variety of industrial activities such as construction,mining, quarrying, and manufacturing, and these activities may lead to the production of hazardous waste. These hazardous wastes are classed as ‘scheduled waste’, scheduled waste refers to any wastes that possess hazardous characteristics and have the potential to adversely affect public health and the environment2. Scheduled wastes in Malaysia come from a variety of different sources. These include hospitals, dry cleaners, factories, agriculture, paint manufacturers, petrol storage facilities, automotive servicing, and other industries. Scheduled wastes are unavoidable as it is a by-product of several industries, as such the treatment and disposal of scheduled wastes must be properly managed to avoid the risk of these hazardous materials seeping into our daily lives and contaminating the soil or water supplies. In 2020 it was recorded that the amount of scheduled wastes produced by industries were 7,185.2 thousand metric tonnes, a 79% increase compared to 2019 where the amount of scheduled wastes recorded was 4,013.2 thousand metric tonnes3. A contributing factor to this could be the COVID-19 Pandemic, the quantity of clinical waste generated in 2020 rose 18.1% to 39.9 thousand metric tonnes as compared to 33.8 thousand metric tonnes in 2019. Three states in Malaysia recorded the highest amount of scheduled waste production, namely:4 Selangor at 28.5%; Johor at 16.8%; and Negeri Sembilan at 16.2%. The Environmental Quality Act of 1974 (“EQA”) is one of the primary pieces of legislation governing scheduled waste, the Act was administered by the Department of Environment under the Ministry of Natural Resources and it is a provision relating to the prevention, abatement, control of pollution and enhancement of the environment. The relevant sections which refer to the management of scheduled wastes include: Section 34B (the control of scheduled wastes); Section 22 (air pollution control); Section 24 (soil pollution control); Section 25 (water pollution control); and Section 29 (the control of wastes disposal to Malaysian waters). Following the amendment of the EQA in 1996 section 34B provides strict provisions which cover the control of exporting and importing scheduled waste, which include a penalty of RM500,000.00 or 5 years imprisonment or both for the illegal trafficking of scheduled wastes. Sections 22, 24, 25, and 29 all state that no person-shall, unless licenced, has the permission or authority to pollute or contaminate the air, soil, or water sources with scheduled waste, unless the Minister, after consultation with the Council, specifies that it is acceptable as outlined in Section 21 of the EQA. Other relevant regulations include: Environmental Quality (Prescribed Activities) (Environmental Impact Assessment) Order 2015; Environmental Quality (Prescribed Premises) (Scheduled Wastes Treatment & Disposal Facilities) Regulations, 1989; Environmental Quality (Prescribed Premises) (Scheduled Wastes Treatment & Disposal Facilities) Orders, 1989; and Environmental Quality (Prescribed Premises) (Scheduled Wastes) Regulations, 2005. In Malaysia, the EQR interprets ‘scheduled waste’ as any type of waste falling within the categories of waste listed in the First Schedule of the Environment Quality (Scheduled Wastes) Regulation 2005. There are 77 types of scheduled wastes listed within the First Schedule of the Environment Quality (Scheduled Wastes) Regulation 2005, which are compartmentalised into 5 categories, namely: SW 1 - metal and metal-bearing wastes; SW 2 - wastes containing principally inorganic constituents which may contain metals and organic materials; SW 3 - wastes containing principally organic constituents which may contain metals and inorganic materials; SW 4 -wastes which may contain either inorganic or organic constituents; and SW 5 - other wastes. The lack of technical knowledge of handling scheduled waste may be a hindrance to solving this problem, and could be a reason as to why some industries do not dispose their scheduled waste in the proper mandated manner as prescribed in the Environmental Quality (Scheduled Wastes) Regulations 2005 (“EQR”). Section 8 of the EQR clearly puts the onus on the individual/entity who generates the scheduled waste (“waste generator”) to ensure that the scheduled waste produced by them must not only be disposed of correctly but also stored and treated in the prescribed manner as outlined in Section 9 and 10 of the EQA. (1) Every waste generator shall ensure that scheduled wastes generated by him are properly stored, treated on-site, recovered on-site for material or product from such scheduled wastes or delivered to and received at prescribed premises for treatment, disposal or recovery of material or product from scheduled wastes.  (2) Every waste generator shall ensure that scheduled wastes that are subjected to movement or transfer be packaged, labelled and transported in accordance with the guidelines prescribed by the Director General. Section 9 of the EQR outlines the proper method of storage which waste generators must abide by, Section 9(5) states that scheduled wastes can be stored for 180 days or less depending on the amount of scheduled waste generated, so long as it does not exceed 20 metric tonnes. If the waste generator would like to store more than 20 metric tonnes of scheduled waste, Section 9(6) states that the waste generator may make an application to the Director General of Department of Environment Malaysia to ask for permission to do so – and if the application is deemed acceptable the Director General may grant a written approval either with or without condition, as outlined in Section 9(7) of the EQR. As scheduled waste comprises of various hazardous waste products, the management of scheduled waste must be meticulous to ensure it is treated and disposed of correctly, as such in addition to Section 9, Section 10 of the EQR goes on to provide the manner in which scheduled waste must be labelled for proper storage. Section 10(1) provides that the storage container must be labelled with the following details: the date of waste generated; the name of the waste generator; the address of the waste generator; and the contact number. Furthermore, not only must the container contain the 4 criterion above but also should be clearly labelled in accordance with the type(s) of scheduled waste it holds, as stated in section 10(2) of the EQR. If the waste generator would like treat or manage their scheduled waste beyond the confines of Section 9 above, Section 7(1) of the EQR allows for the waste generator to make a written application for ‘special waste management of scheduled waste’ and upon acceptance the Director General may grant an approval, with or without specified conditions for the actions: (1) A waste generator may apply to the Director General in writing to have the scheduled wastes generated from their particular facility or process excluded from being treated, disposed of or recovered in premises or facilities other than at the prescribed premises or on-site treatment or recovery facilities.  (3) If the Director General is satisfied with the application made under subregulation (1), the Director General may grant a written approval either with or without conditions. Malaysia established a waste management centre in compliance with the EQA and EQR to appropriately handle scheduled waste and counteract improper dumping practices and combat contamination which could lead to pollution and result in harming our quality of life. Kualiti Alam was established in 1991 and it owns and runs Malaysia's only fully integrated hazardous waste handling facility. Kualiti Alam is authorised to handle 76 of the 77 scheduled wastes mentioned in the EQR – except for radioactive waste, pathological waste, and explosive waste. Kualiti Alam offers a diverse range of waste management solutions such as: incineration facilities, physical and chemical treatment plants, solidification treatment plants, secure landfills, and clinical waste treatment centres. The regulations for the control of scheduled waste in Malaysia are reflective of the ‘cradle-to-grave’ principle5 where generation, storage, transportation, treatment and disposal are regulated. This concept focuses on the disposal component and as such creates a linear cycle of waste management. The cradle-to-grave concept neglects resource recovery, and minimizing waste generation, in this case scheduled waste to be specific. However, in recent years there has been a focus on zero waste emissions, as such there has been a movement to a ‘cradle-to-cradle’ principle. The ‘cradle-to-cradle’ principle was coined by Professor Dr. Michael Braungart6, and it is a principle which depicts the continuous and presumably limitless cycling of materials – creating closed-loop cycle as opposed to the liner cycle of the cradle-to-grave principle. In the cradle-to-cradle principle, materials which are chemically inert and recyclable can be repurposed once they are properly treated. Thus minimising the scheduled waste products in landfills. To encourage effective waste management, Malaysia has provided incentives for the storage, treatment and disposal of scheduled waste. The incentives include pioneer status incentive for five years to companies which are principally engaged in an integrated operation for the storage, treatment and disposal of scheduled wastes7. Although Malaysia has a comprehensive legislative framework and government assistance for proper waste management for scheduled waste, concerns of improper dumping, contamination, and pollution persist. Malaysia must continue to pursue a ‘closed loop cycle’ approach when it comes to waste management, reusing and recycling scheduled waste rather than filling landfills and perpetuating a linear cycle of scheduled waste disposal. Waste generators within the various industries in Malaysia must commit to disposing of and processing their scheduled waste in accordance with statutory regulations, as well as upcycling/recycling their waste products when possible. Authors: Siti Fitrah Mohamed Jamal and Loni Lee Footnotes https://www.imd.org/centers/world-competitiveness- center/rankings/world-competitiveness/ https://notionconsortium.com/schedule-waste- management/ Compendium of Environment Statistics, Malaysia 2021 (https://www.dosm.gov.my/v1/index.php? r=column/cthemeByCat&cat=162&bul_id =VFRCSEtSRlRWWmxoNlRLTTYrb1FVdz09&menu_id =NWVEZGhEVlNMeitaMHNzK2htRU05dz09) ibid. https://www.remondis-sustainability.com/en/inspiring /cradle-to-cradle/ https://epea.com/en/about-us/cradle-to-cradle#: ~:text=Cradle%20to%20Cradle%C2%AE%20is, innovation%2C%20quality%20and%20beneficial %20design. https://mida.gov.my/wp-content/uploads/2020/ 12/20200914160203_BOOKLET-7-ENVIRONMENTAL- MANAGEMENT-SERVICES.pdf.
30 October 2024

The Legal Aspects of The Importation and Distribution of Foreign Produced Generic Pharmaceutical Drugs

Introduction To ensure the safety, quality and efficacy of marketed pharmaceuticals products in Malaysia, Drug Control Authority (“DCA”) is responsible for the registration and monitoring of the quality of pharmaceutical products.1 Being one of the DCA Secretariat, National Pharmaceutical Regulatory Agency (“NPRA”) plays a role in implementing regulatory scheme on quality of pharmaceutical products in the market through random sampling and analytical tests. It also administers the licensing scheme for pharmaceutical manufacturers, importers and wholesalers. Registration is imposed on companies intending to manufacture, sell, supply, import or possess or administer any drugs products, including generic drugs products.2 Generic Drugs Generic drug is a drug product that is essentially similar to a currently registered product in Malaysia. The term generic drug does not apply to Biologics.3 It is one of the categories of medicinal products under Control of Drugs and Cosmetics Regulations 1984 (“CDCR 1984”) apart from new drugs product, biologics, natural products and health supplements. The role of generic drugs is to provide high quality but affordable essential medicines, as it is proven to be cheaper than innovator brands (research-based) brands.4 Generic drugs may be classified into 2 groups5: Scheduled Poison (known as Controlled Medicine/Controlled Poison) – Products containing poisons as listed in the First Schedule under Poisons Act 1952; and Non-scheduled Poison (known as Non-Poison or Over-the-Counter/OTC) – Products containing active ingredients which are not listed in the First Schedule under Poisons Act 1952 and excluding active ingredient which is categorised under health supplements or natural products or cosmetics. Both categories of generic drugs above require registration with DCA.6 Procedures for Registration of Generic Drugs Similar to other medicinal products, the procedures for registration of generic drugs generally will be as follows: Preparation for Submission of Application Screening or Evaluation of Application. Outcome of Application. Inspection & Licensing. PART A: PREPARATION FOR SUBMISSION OF APPLICATION Submission of Registration with DCA Registration with DCA shall be done by the Product Registration Holder (“PRH”), a locally incorporated company, corporate or legal entity, with permanent address and registered with the Companies Commission Malaysia. For foreign company, it needs to appoint a local agent (a company incorporated in Malaysia) to be the PRH. The appointed PRH would then be responsible for all matters pertaining to the registration of the products.7 Registration is made via an online platform, Quest. A first-time PRH applicant shall first apply for Quest membership and purchase USB Token for submission of registration. Regulatory Requirements Prior to the submission, the PRH should make sure it complies with the regulatory requirements for generic drugs, including the following: (a) Bioequivalence (“BE”) Requirements The purpose of establishing BE is to demonstrate equivalence in biopharmaceutics quality between the generic medicinal product and a comparator medicinal product. This is to allow bridging of preclinical tests and clinical trials associated with the comparator medicinal product.8 During submission of registration, PRH of generic drugs shall submit a complete BE report with all the appendices and comparative dissolution profile data/report according to the relevant guidelines. The complete BE report should consist of BE study protocol, clinical study report, method validation report, bioanalytical report and pharmacokinetic and statistical report.9 (b) Other Requirements & Conditions (Labelling, Packing, Educational Materials) Apart from the above, the PRH and the foreign company (as the case may be) shall be aware of the other requirements, restrictions and conditions, as per Table 1. Items Details Guidelines Product Names Not Permitted to Be Registered Examples of non-permissible product names are: ·     Use of superlatives (kuasa – power, sihat – healthy, sembuh – heal, syurga – paradise) ·     20 disease names as stated in the Medicines (Advertisement and Sale) Act 1956 (e.g., diabetes, asthma, cancer) ·     Use of offensive or indecent names (Xenxual to symbolize sensual) ·     Use of product names similar to existing approved product names Further details are provided in Appendix 17 of the Drug Registration Guidance Document Third Edition, issued January 2022 (“DRGD 2022”). List of Permitted, Prohibited and Restricted Substances The PRH shall be aware of the following substances: ·     List of Prohibited Active Ingredients and its Combinations (such as Astemizole, and combination of Ampicillin + Cloxacillin, respectively) ·     List of Restricted Active Ingredients and its Combinations (such as Acetic Acid in Expectorant) ·     List of Prohibited and Restricted Excipients (such as Amaranth and Tartrazine, respectively) ·     List of Permitted and Restricted Colouring Agents (such as Calcium Carbonate and Guanine, respectively) Further details are provided in Appendix 18 of DRGD 2022. General Labelling Requirements The labelling shall include important information at respective positions such as at the packaging outer carton, immediate labels, or blister/strips.   The information includes the product name, dosage form, name of active substance(s), strength of active substance(s), batch number, manufacturing date etc. Further details are provided in Appendix 19 of DRGD 2022 Specific Labelling Requirements There are specific labelling requirements on all 207 specific substances, such as abiraterone, ace inhibitors, benzoyl peroxide, ginseng, methyl salicylate, opioid, paracetamol, tramadol, vitamin K etc. Further details are provided in Appendix 20 of DRGD 2022. Special Conditions for Registration of a Particular Product or Group of Products Special conditions are imposed on the registration of all 9 particular product or group of products, such as blood products, midazolam, paracetamol in combination with caffeine, vaccines (including COVID-19 vaccines) etc. Further details are provided in Appendix 21, DRGD 2022. Educational Materials For risk minimisation measures, the PRH shall provide educational materials to healthcare professionals and patients in reducing risk(s) for a particular product.   This applies to products containing active ingredient such as, sodium valproate and retinoids. Further details are provided in Appendix 22 of DRGD 2022. TABLE 1   Certificate Compliance with Good Manufacturing Practice (“GMP”) and Good Distribution Practice (“GDP”) are prerequisites for application for product registration.10 The PRH shall ensure the following: a) Good Manufacturing Practice (GMP)  GMP is imposed on foreign companies that manufacture medicinal products outside Malaysia.11 Those foreign manufacturers are subjected to GMP conformity assessments through acceptable GMP evidences. The valid GMP evidences differ according to the location of pharmaceutical manufacturer, as per Table 2. Location of Pharmaceutical Manufacturers Valid GMP Evidence in Malaysia Pharmaceutical manufacturer located on a site within jurisdiction of a Pharmaceutical Inspection Co-operation Scheme (“PIC/S”) Participating Authority. GMP evidence issued by its local National Drug Regulatory Agency (“NDRA”) Pharmaceutical manufacturer located in an ASEAN member country. GMP evidence issued by its local NDRA is accepted if the NDRA is included as a Listed Inspection Service under the ASEAN Sectoral Mutual Recognition Arrangement (“MRA”) for GMP Inspection of Manufacturers on Medicinal Products. Pharmaceutical manufacturer not located on a site within jurisdiction of a PIC/S Participating Authority. GMP evidence issued either by any PIC/S Participating Authority, or any NDRA that has a cooperation agreement such as MRA with PIC/S. TABLE 2 The absence of any valid GMP evidence as above would require the foreign companies to apply for Foreign GMP Inspection by NPRA, which shall be made by a Malaysian registered company acting on its behalf. b)Good Distribution Practice (GDP) GDP is required to ensure that foreign companies adopt proper distribution and store management procedures according to GDP, in relation to the premise, facilities, stock handling and control, disposal of materials or products, vehicles and transportation of products.12   PART B: SCREENING OR EVALUATION OF APPLICATION After the online submission of product registration application via Quest, the application shall undergo an initial evaluation (screening process), to ensure the submitted application is complete with the required data/information. Payment & Hard Copy Documents Only a complete application shall be accepted and approved for payment. Upon screening approval, the applicant is requested to proceed with: (a) payment as in table below; and (b) submission of hard copy documents (if applicable). For generic drugs, all documents can be submitted online, unless the files size are too large which require hard copy submission.13 The applicable fee for registration of generic drugs, are as per Table 314. Product Classification Processing Fee Analysis fee Total Fees Pharmaceutical ·       Generic (Scheduled Poison) ·       Generic (Non-scheduled Poison) RM1,000.00 Single Active Ingredient: RM1,200.00 RM2,200.00 Two/ more Active Ingredient: RM2,000.00 RM3,000.00 TABLE 3 Upon confirmation of payment, the application with the submitted data shall be evaluated. Review of applications shall follow a queue system. Evaluation for Product Registration For registration of generic drugs, 2 methods of evaluations are applicable, namely Full Evaluation and Abridge Evaluation, which are as per Table 4.15 Product Category Full Evaluation Abridge Evaluation Generics (Scheduled Poison) Applicable [Evaluation Timeline: 210 working days]16 Not Applicable Generics (Non-Scheduled Poison) (or known as OTC) Applicable to all products of this category, unless stated in Abridge Evaluation.   [Evaluation Timeline: 210 working days] Generics (non-scheduled poison) that are evaluated under abridged evaluation include, but are not limited, to the following: ·    Antiseptics/skin disinfectants: ·    Locally acting lozenges/pastilles ·    Topical analgesic/counterirritants. ·    Topical nasal decongestants ·    Emollient/demulcent/skin protectants. ·    Keratolytic. ·    Anti-dandruff. ·    Oral care. ·    Anti-acne. ·  Medicated plasters/patch/pad ·  Topical antibacterial   [Evaluation Timeline: 116 -136 working days] TABLE 4 In respect of Full Evaluation, the PRH needs to provide the information on 2 parts namely17: Part I - Administrative data and product information such as Product Particulars, Product Formula, Particulars of Packing, Label (Mock-up) For Immediate Container, Outer Carton, Proposed Package Insert, Consumer Medication Information Leaflet (RiMUP), and Supplementary Documentation. Part II - Data to support product quality (Quality Document) (such as Drug Product (Finished Product), Quality Overall Summary, and Drug Substance) Meanwhile, for Abridge Evaluation, the PRH needs to provide information on product such as Product Particulars, Product Formula, Particulars of Packing, Label (Mock-up) For Immediate Container, Outer Carton, Proposed Package Insert, Consumer Medication Information Leaflet (RiMUP), Particulars of Product Owner, Manufacturer, Importer and Other Manufacturer(s) Involved and Store address.   PART C: OUTCOME OF APPLICATION Decisions An application may be approved or rejected by DCA, and the decision shall be sent via email/official letter to the PRH. DCA has the power to at any time reject, as well as cancel or suspend the registration of any product if there are deficiencies in safety, quality or efficacy of the product or failure to comply with conditions of registration. Re-submission of product registration for a rejected application due to safety and efficacy reasons shall not be accepted within 2 years after the rejection.18 Product Registration Number For successful registration, the PRH shall be notified by DCA and a product registration number (i.e. MAL number) shall be assigned to the registered product via QUEST system. The registration number is specific for the product registered with the name, identity, composition, characteristics, origin (manufacturer) and PRH, as specified in the registration documents.19 The applicant shall refer to the product registration approval notification sent by DCA or the Approved Product Registration List in the NPRA website. The registration status of a product shall be valid for 5 years or such period as specified in DCA database (unless the registration is suspended or cancelled by DCA). PART D: INSPECTION & LICENSING Inspection Inspection of GMP and GDP are conducted to ensure the compliance of manufacturers, importers and wholesalers with the current GMP and GDP requirements.20 Licenses Once the product is registered, the applicant should apply for the applicable licenses as required in CDCR 1984 in the respective prescribed forms to NPRA.21 The applicable licenses, its prescribed forms and the processing fees can be summarised as per Table 5.22 Type of Licenses Prescribed Form in CDCR 1984 Processing Fees Manufacturer’s License (PRH that manufactures the registered products in the premises specified in the licence and sells by wholesale or supplies the products) Form 2 RM1000.00 Wholesaler’s License (PRH that sells by wholesale or supplies the registered products from the address of the business premises specified in the licence) Form 3 RM500.00 Clinical Trial Import License (PRH that imports any product for purposes of clinical trials, notwithstanding that the product is not a registered product) Form 4 RM500.00 Import License (PRH that imports and sells by wholesale or supplies the registered products from the address of the premises specified in the licence) Form 5 RM500.00 TABLE 5 Authors: Nur Izzatie Azlan and Zhilal Adnan Footnotes https://www.npra.gov.my/index.php/en/about /drug-control-authority-dca/about-the-dca. Regulation 7, CDCR 1984 https://www.npra.gov .my/index.php/en/prescription-main-page.html. National Pharmacy Call Center, What Prescribers Should Know About Generic Medicines, First Edition, 2013, pg.2. https://www.npra.gov.my/index.php/en/ prescription-main-page.html. https://www.npra.gov.my/index.php/en/component/content/article/37-english/faq/623 -product-registration.html?Itemid=1391. Drug Registration Guidance Document (DRGD) Third Edition, Second Revision January 2022, Appendix 16. Drug Registration Guidance Document (DRGD) Third Edition, Second Revision January 2022, page 49. National Pharmaceutical Regulatory Agency Foreign GMP Inspection Guidance Document, 8th Edition (September 2021) retrieved from https://www.npra.gov.my/easyarticles/images/users/1133/Guidance-Document-Foreign-GMP-Inspection- _Sep-2021_8th-Ed.pdf. Good Distribution Practice 2nd Edition 2013 retrieved from https://www.npra.gov.my/images/Guidelines_Central/Guidelines_on_Regulatory/Good%20Distribution%20Practice%202nd%20 Edition%202013.pdf. Drug Registration Guidance Document (DRGD) Third Edition, Second Revision January 2022, page 40. Ibid, Appendix 9. Ibid, Appendix 14. Ibid, Appendix 5. Ibid, Appendix 15. Ibid. Ibid. Ibid, page 49. Regulation 12, CDCR 1984. Regulation 13, CDCR 1984.
30 October 2024

Shipping and International Trade in an Age of Disruption

When 2020 began, the key challenge which faced the shipping industry was the implementation of the Fuel Standards of IMO 2020 mandating lower Sulphur Fuel Content. Looming ahead was the massive global tragedy which was the COVID-19 Pandemic, which spared no nation, no industry. The Pandemic ravaged lives, decimated businesses and forced a rethink of how much we can prepare. Shipping was badly affected in many ways. We are certainly in the middle of a perfect storm – we were just getting out of the Pandemic. China is still closing ports, grappling with increase in Oil prices, drastic rise in shipping costs and adapting to the effects of the Trade Wars, and now the war in Ukraine. Covid At the height of the Pandemic in 2020, the plight of the passengers and crew on board Cruise ships and the cruise industry came into stark focus. Cruise ships - with large numbers of passengers and crew and an emphasis on communal dining and group activities - became incubators of the COVID-19 virus. The crews on board merchant vessels could not sign off as ports did not allow. The closure of businesses and ports also created disruption to supply chains. Where ports close because of the pandemic or where the crew of the vessels are infected, this affects the contract of carriage. The effect depends on the terms of the Charter, whether the particular disrupting event is covered. A vessel with infected crew will mean that the vessel will not be granted free pratique or clean bill of health by the port authorities and this may prevent the readiness of the vessel, owners time for loading or discharge, and the consequent effects of running of laytime and demurrage. This disruption caused multi-fold increase in freight costs, shortage of containers, congestion in ports. In turn, this resulted in shortages of key components in the supply chain halting or delaying production of automobiles, smartphones. Even the ubiquitous McDonald’s was not spared, with shortages of fries. The multi-fold rise of freight costs had caused considerable price increases in all manner of consumables. Now the Pandemic in the form of the Omicron variant is once again resurgent and has caused a massive and comprehensive lockdown in Shanghai, more extensive than other ones in China. Shanghai is a key Trade and Manufacturing base for global supply chains. This effects of this lockdown reverberate as globalization has made key supply chains inter-connected and what happens in key locations affect the whole chain. Ever Given and the Suez Canal The Mega Containership Ever Given ran aground while transiting the Suez Canal on March 23, 2021, lodging herself against both banks of the waterway. The blockage caused vessels backed up in the Mediterranean to the north and the Red Sea to the south. It is estimated that the costs to global trade was about $400 million per hour. The fragility of trade routes were exposed when the incident caused knock-on effects on the movement of cargoes globally, as 12 percent of global trade is carried on board ships using the canal. For six days, the world watched as a multi-national team of salvors, tug operators and the Suez Canal Authority (SCA) coordinated a race against time to free the ship and unclog the canal. A year later, the sister ship of Ever Given, Ever Forward is in April 2022 now stuck in Chesapeake Bay near the port of Baltimore, USA. This incident exposes the navigation risks faced by large merchant vessels. Trade Wars President Donald Trump launched a Trade War with China resulting in tit for tat imposition of tariffs on each other countries exports. This caused traders to devise ways to overcome them by disguising the origins of the cargo. China and Australia also cooled its trade relations, after Australia pushed for an international probe into the origin of the coronavirus without diplomatic consultations beforehand. China has targeted Australian barley, beef, wine, lobsters and coal over the past year after Canberra called for an inquiry into the origins of the coronavirus pandemic. The acts included China calling Chinese parties not to import the products from Australia and imposing high duties. Ukraine Putin’s invasion of Ukraine in March 2022 is bringing the World to the brink. The world was not prepared for this conflict. Countries reacted by imposing trade sanctions, cutting off Russia from international financial system and trade globally. Russian vessels, and sanctions implemented by major trading nations and disruption of Agriculture products. Ukraine is a key producer of wheat, barley, sunflower, corn, soybeans. A force majeure clause typically excuses parties from the performance of the contract following the occurrence of certain events. A company affected by the Russian sanctions must determine whether its contracts include force majeure provisions and whether the Russian sanctions are an event that excuses full or delayed performance under the contract. If sanctions are not explicitly mentioned as a force majeure event, a broad definition of war, hostilities, or conflict or act of government could cover the consequences of sanctions. From record low prices of Crude Oil, the Ukraine War has made oil prices to climb to record levels. Legal Effects Parties to shipping and related contracts e.g. Charterparties, FOB, CIF Contracts, bills of ladings and contracts of affreightment, fix their agreed price, provide for price adjustment clauses, force majeure and defences in the event of specified events arising. The allocation of risks is essentially a contractual one. If the purchase or transaction has become more difficult or more costly to perform, then one party will have to bear the increased costs of the transaction. Force Majeure Clauses or the common law principle of frustration will apply only if the transaction becomes impossible to perform, not more difficult or costly. If parties rely on standard contracts, it is highly likely these contracts do not adequately provide for the shocks that had hit shipping post 2020. To enter into the contracts without adequately considering the contract terms in the light of known and potential risks would be indeed foolhardy. Likewise, Insurance can protect to a certain extent. Parties should also seek advice from their broker or insurance intermediary as to whether the existing coverage adequate covers their transactional risks in the light of the current situation. For instance, most forms of marine cargo insurance do not cover delay or the insolvency of the carrier. The insurance cover is for transit risks and not transactional default or failure. Author: Philip Teoh
30 October 2024

Civil Remedies for Economic Espionage

Espionage is the practice of using covert means to obtain confidential information from non-public sources.1 Meanwhile, economic espionage is concerned with the unlawful targeting and theft of critical intelligence, such as trade secrets and intellectual properties.2 The value of such information lies in the ability of its owner to exclusively exploit the said information for economic gain. Because there is inherent economic value in such confidential information, a legal framework which protects against economic espionage is, therefore, a necessity. Once exposed, confidential information can also no longer be made secret, and the owner of such information loses the ability to exploit such information to the exclusion of others. Hence, civil remedies are also necessary to alleviate the losses which may be a consequence of economic espionage. This article will explore the concept of economic espionage and identifies how the laws of Malaysia have attempted to remedy economic espionage. Economic Espionage in Malaysia Unlike the United States of America (“the US”) and its Economic Espionage Act 1996, there is no specific law in Malaysia which governs economic espionage. However, as economic espionage often involves the use of technology, and is similar to the crime of theft, there are a few pieces of Malaysian legislation which may be referred to in cases of economic espionage.3 Firstly, when economic espionage involves cybersecurity breaches, provisions contained in the Communication and Multimedia Act 1998 and Computer Crimes Act 1997 are relevant.4 Secondly, when economic espionage is committed against Malaysia, laws such as the Security Offence (Special Measures) Act 2012 and Prevention of Terrorism Act 2015 may be relevant.5 Lastly, as the act of economic espionage is similar to the act of theft, the Penal Code may also be relevant in this case.6 However, the abovementioned laws have their weaknesses in that they are incapable of providing adequate protection for economic espionage.7 For example, section 378 of the Penal Code defines theft as “whoever, intending to take dishonestly any moveable property out of the possession of any person without the person’s consent, moves that property in order to such taking, is said to commit theft”. The “movable property” in question also includes the “corporeal property of every description”.8 Nonetheless, in view of the lack of a statutory definition of economic espionage and the definition of “moveable property” as defined above, it would appear that economic espionage may not necessarily be considered theft according to the Penal Code.9 Overall, Malaysia has yet to criminalise economic espionage and there is no well-founded legislation that governs and defines economic espionage. Civil Remedies While Malaysia has no legislation which specifically governs economic espionage, this does not necessarily mean there are no available remedies for the commission of such a wrong. Economic espionage involves the theft of confidential information by a person working for a particular entity. One way to protect against trade secret theft or economic espionage is through the use of non-disclosure agreements.10 The disclosure of confidential information to a third party can be a breach of the confidentiality requirement that an employee may be bound by during the course of his employment.11 Such disclosure of information may also involve the disclosure of trade secrets.12 To date, there are no reported cases with regards to economic espionage in Malaysia that have been committed against it. Nevertheless, the divulgence of trade secrets may be considered analogous to economic espionage. As such, cases involving the divulgence of the trade secrets of companies may serve as a reference for the types of civil remedies which could be available in cases of economic espionage. For instance, the case of Yukilon Manufacturing Sdn Bhd & Anor v Dato’ Wong Gek Meng & Ors (No 4),13 involved the first and second defendants utilising information gleaned from a joint venture with the first plaintiff to manufacture similar products with the fourth defendant.14 To prevent further losses to the first plaintiff, the court granted an injunction preventing the first and second defendants from continuing to manufacture and deal with products that closely resembled the plaintiffs’ product.15 A Mareva Injunction was also obtained to prevent the first and second defendant from removing from the jurisdiction, dissipating or dealing within the jurisdiction any assets of the fourth defendant.16 Lastly, an Anton Piller order was also granted for the plaintiffs to enter the premise of the fourth defendant to search for articles and/or documents for inspection and to remove them from the premises to the safe-keeping of the plaintiffs’ solicitors.17 As economic espionage is analogous to the theft of trade secrets, the remedies offered in the case of Yukilon may potentially be granted in cases of economic espionage as well. In cases of economic espionage and/or theft of trade secrets, the prevention of further damage should be prioritised. This would include preventing any further divulgence of trade secrets and/or obtaining damages for any losses suffered thus far. For example, in the case of Ganesh Raja A/L Nagaiah & Ors v NR Rubber Industries Sdn Bhd,18 the Court granted an injunction to prevent the defendants from using the plaintiff’s confidential information for their business to the detriment of the plaintiff.19 The Court in this case also granted an Order that damages be assessed by the Registrar.20 Economic Espionage in Other Jurisdictions As set out above, the US has specific legislation governing economic espionage. The ambit of such legislation was enlarged in year 2016 when the US Congress enacted the Defend Trade Secrets Act (“DTSA”) to provide for private civil actions including ex parte orders “providing for the seizure of property necessary to prevent the propagation or dissemination of trade secret”.21 DTSA is codified under 18 U.S.C: Crimes and Criminal Procedure. The civil remedies available under 18 U.S.C, section 1836 include the granting of injunctions22, the awarding of damages23, exemplary damages24, and the awarding of costs in cases where the claim of the misappropriation of the trade secret is made in bad faith.25 Additionally, Japan revised its Unfair Competition Prevention Act (“UCPA”) that provides civil and criminal remedies for trade secrets.26 Civil remedies provided in this act include injunctions against actual or likely infringement,27 damages of actual loss,28 and restoration of business reputation.29 The UCPA also aims to increase the effectiveness of civil remedies,30 which includes a reduction of the burden of proof for plaintiffs. The United Kingdom also has in place the Official Secrets Acts 1911-1989 that protects its country from espionage and unauthorised disclosures.31 In a civil context, English law, especially in cases of breach of confidence, provide for a wide variety of civil remedies which include search and seizure orders, injunctive relief, damages, accounting for profits, third party liability, constructive trusts over assets, and an order to reveal the source of disclosed information.32 Conclusion Ultimately, there is no specific law that provides for civil remedies for economic espionage in Malaysia. There is no reported case law in Malaysia regarding economic espionage as well. However, the characteristics of economic espionage resemble that of the theft of trade secrets. As such, case laws in relation to the divulgence of trade secrets can act as guidance to the type of civil remedies suitable in cases of economic espionage. In addition, remedies provided in other jurisdictions can also serve as a guideline for the civil remedies which may be available in cases of economic espionage. The above jurisdictions offer civil remedies such as damages, injunctions, and equitable remedies33 that are also available in Malaysia. Despite the lack of legislation specifically governing economic espionage in Malaysia, the civil remedies currently available in Malaysia are relevant to at least alleviate the losses caused by economic espionage or a similar wrong. Authors: Natalia Izra Dato’ Nasaruddin, Iris Tang Shu Ni and Gabrielle Lim Wai Yee Footnotes Centre for the Protection of National Insurance, “Espionage” (11 March 2021, CPNI), accessed 25 April 2022. Investopedia, “Economic Espionage”, (n.d., Investopedia), accessed 20 April 2022. Juriah Abd Jalil et al, ‘Business Under Threat: The Criminal Liability of Trade Secret Theft in Malaysia?’ (2020), International Journal of Business and Society, Vol. 21, 49-65, 58. Ibid. Ibid, Ibid. Ibid. Section 22 of Penal Code. Juriah Abd Jalil et al (n 5) 60. FindLaw, ‘Using Non-Disclosure Agreements to Protect Against Trade Secret Theft’, (19 May 2016, FindLaw), accessed 25 April 2022. Ashgar Ali Ali Mohamad, ‘Implied Term of Trust and Confidence in Contract of Employment’ [2005] 3 MLJ xxi, xxix. Ecooils Sdn Bhd v Raghunath Ramaiah Kandikeri [2014] 7 MLJ 309, page 323. [1998] 7 MLJ 551. Ibid Ibid Ibid at page 552. Ibid. [2016] 12 MLJ 461. Ibid Ibid Stimmel, Stimmel & Roeser, “The Economic Espionage Act”, (n.d., Law Offices of Stimmel, Stimmel & Roeser), accessed 21 April 2022. 18 U.S.C Section 1836(b)(3)(A). 18 U.S.C Section 1836(b)(3)(B). 18 U.S.C Section 1836(b)(3)(C). 18 U.S.C Section 1836(b)(3)(D). Intellectual Property Office, “The Economic and Innovation Impacts of Trade Secrets”, (19 April 2021, Gov.UK), accessed 21 April 2022. Article 3 UCPA. Article 4 UCPA. Article 14 UCPA. Thomas Landman, ‘The Secret Protection in Japan and United States: Comparison and Recommendations’, (2019), Brooklyn Journal of International Law, Vol. 44 Issue 2, 714-761, 750. LawCom, “Reforms to UK’s antiquated spying laws published by law commission”, (1 September 2020, Law Commission), accessed 21 April 2022. Bradley Limpert & Oxiana Iatsyk, Technology Contracting: Law, Precedents and Commentary, (2005), Carswell. Cheong May Fong & Lee Yin Harn, Civil Remedies, (Second Edition 2016, Sweet & Maxwell)  
30 October 2024

Mandatory Merger Notification on the Cards

Merger notifications in Malaysia are still nascent and limited to the aviation services sector regulated by the Malaysian Aviation Commission(“MAVCOM”) and communications and multimedia sector regulated by the Malaysian Communications and Multimedia Commission (“MCMC”). In fact, the country witnessed the first-ever competition-related merger decision in September 2021 via MAVCOM’s approval of Korean Air Lines Co, Ltd. and Asiana Airlines, Inc.’s merger and the market is now awaiting the decision of the MCMC on the proposed merger of the telco operation of Celcom Axiata Berhad and Digi.Com Berhad. Nevertheless, the incorporation of a merger control regime in the Competition Act 2010 (“CA 2010”) is on the horizon and expected to be completed by this year. Merger Control Regime Under CA 2010 Merger control provision was initially mooted during the formation of the CA 2010. However, it was later removed in the interest of capital market development in Malaysia and to encourage mergers and acquisitions (“M&A”) in order to strengthen the domestic economy and promote corporate competition globally. After almost 10 years in force, Malaysia Competition Commission (“MyCC”) noted the need to directly regulate M&A in addition to its existing power of monitoring anti-competitive behaviour and abuse of dominant position post-M&A. It has initiated the process of amending the CA 2010 in 2019. The merger control regime is reported to be in the form of a mandatory pre-closing merger notification requiring clearance from MyCC. Nonetheless, it remains to be seen what kind of merger notification and its mechanics that will be finally adopted by MyCC. Given the cross-sectoral ambit of the CA 2010, MyCC should carefully determine items such as qualitative and/or quantitative threshold of the parties or group involved, filings in cases of multiple transactions, applicable exemptions and sanctions so that changes in the market structure can be regulated without inhibiting M&A activities in Malaysia.   Aviation Services and Communications and Multimedia Sectors In both sectors, merger notification is a voluntary process. This means that the M&A parties are required to self-assess their transaction based on the threshold set and if their transaction may result in a substantial lessening of competition within their markets, they should submit a notification of their transaction to their authority for assessment and decision. For the aviation services sector, the notification mechanism is set out in the Malaysian Aviation Commission Act 2015 (“MAVA 2015”) and the Guidelines on Substantive Assessment of Mergers, Guidelines on Notification and Application Procedure for an Anticipated Merger or a Merger and Notification and Application Form for an Anticipated Merger or a Merger issued by MAVCOM. On the other hand, for the communications and multimedia sector, the notification mechanism is stipulated in the Guidelines on Mergers and Acquisitions issued by MCMC in 2019. One thing to note is that while the M&A parties retain the option to notify their regulator and may technically proceed with the deal without the regulator’s decision, they bear the risk of being investigated post-M&A if the transaction raises any competition concerns. M&A are likely to be investigated by MAVCOM if: the combined turnover of the parties in Malaysia in the financial year preceding the transaction is at least RM50 million or the combined worldwide turnover of the parties in the financial year preceding the transaction is at least RM500 million; or if the turnover thresholds are not met, the transaction has resulted or may be expected to result in substantially lessening of competition in any aviation services market. As for MCMC, M&A are likely to be investigated if: for proposed M&A, at least one of the parties to the M&A is a licensee in a dominant position; for completed M&A, the merged or acquired entity is a licensee in a dominant position; for horizontal proposed M&A, the M&A would result in the merged or acquired entity obtaining a dominant position with a market share of 40% or more post-M&A; at least one of the parties to the M&A is subject to an ongoing investigation by the MCMC in respect of any conduct prohibited under the Communications and Multimedia Act 1998 (“CMA 1998”); there is significant cross shareholding between the parties to the M&A of 40% or more; or the M&A have the purpose of or have or may have the effect of substantially lessening competition in the market. Conclusion With the upcoming amendments to the CA 2010, merger notification in Malaysia will no longer be limited to the two sectors. It will be extended to all M&A in Malaysia apart from those regulated under the MAVA 2015, CMA 1998, Energy Commission Act 2001 and Petroleum Development Act 1974 and Petroleum Regulations 1974 (upstream operations). In the aviation services and communications and multimedia sectors, as a general principle, merger notification should be made if the M&A may result in substantial lessening of competition within their markets. Once the new merger control regime is enforced under the CA 2010, it would not be far-fetched to say that a similar principle would also be applicable to those under the CA 2010. Parties to the M&A are advised to seek professional help to be cognisant of the upcoming changes to the law and structure their deal and contractual provisions accordingly. Author: Nur Sajati Asan Mohamed
30 October 2024
Content supplied by Azmi & Associates