|Year : 2019 | Volume
| Issue : 4 | Page : 162-165
Traditional chinese medicine in Malaysia: A brief historical overview of laws and regulations
Hon Foong Wong1, Shih Chau Ng1, Wen Tien Tan2, Huiying Wang2, Xun Lin2, Si Woei Goh2, Bao Ling Hoo2, Chyong En Chai2, Jun Liu2
1 International Education College, Shanghai University of Traditional Chinese Medicine, Shanghai, China; Department of Chinese Medicine, Centre for Complementary and Alternative Medicine, International Medical University, Kuala Lumpur, Malaysia
2 International Education College, Shanghai University of Traditional Chinese Medicine, Shanghai, China
|Date of Submission||08-Nov-2019|
|Date of Acceptance||08-Nov-2019|
|Date of Web Publication||24-Dec-2019|
Prof. Jun Liu
Department of Golden Cabinet, College of Basic Medical Sciences, Shanghai University of Traditional Chinese Medicine, 1200, Cailun Road, Zhangjiang High-tech Park, Pudong New District, Shanghai
Source of Support: None, Conflict of Interest: None
Although traditional Chinese medicine (TCM) has been a part of the Malaya and the Malaysia people's method of maintaining health and well-being for many centuries, it was never been enrolled in the public health-care system. However, the rising cost of Western drugs and the increasing number of people frequenting TCM has driven the government to search for cheaper options and to look into its safe practice. In 1992, the government mandated all TCM herbal products to be registered with the National Pharmaceutical Control Bureau. All TCM products sold in Malaysia are now Good Manufacturing Practice certified. The government has also established a Traditional and Complementary Medicine Division within the Ministry of Health. Between 2008 and 2014, a traditional and complementary medicine unit was set up in major hospitals in all states. TCM is one of the main services offered by the unit. In 2016, the government enacted the Traditional and Complementary Medicine Act to regulate the TCM practice. Subsequently, a 10-year blueprint has been drawn to support the development of all traditional and complementary medicines in Malaysia. This article aims to provide a brief overview on the regulatory development of TCM in Malaysia.
Keywords: Development of traditional Chinese medicine, historical overview, laws and regulations, Malaysia, Traditional Chinese medicine
|How to cite this article:|
Wong HF, Ng SC, Tan WT, Wang H, Lin X, Goh SW, Hoo BL, Chai CE, Liu J. Traditional chinese medicine in Malaysia: A brief historical overview of laws and regulations. Chin Med Cult 2019;2:162-5
|How to cite this URL:|
Wong HF, Ng SC, Tan WT, Wang H, Lin X, Goh SW, Hoo BL, Chai CE, Liu J. Traditional chinese medicine in Malaysia: A brief historical overview of laws and regulations. Chin Med Cult [serial online] 2019 [cited 2020 Mar 31];2:162-5. Available from: http://www.cmaconweb.org/text.asp?2019/2/4/162/273894
This article is a continuation of a previously published article in issue 3 of the Chinese Medicine and Culture 2019. The previous article examined the education and research development of Traditional Chinese medicine (TCM) in the Malay Peninsula. TCM education and research did not take off until Malaysia gained independence. Prior to 1950s, TCM in Malaya relied heavily on China. A large proportion of TCM practitioners were either trained in China or naturalized directly from China. The restrictions placed on Chinese immigrants in 1950s had prompted the TCM associations to initiate their own educational training. At the same time, local periodicals and journals were established, but many of them sustained for a few publications only. A paradigm shift from grassroots to government in driving TCM education was later observed at the turn of the century. There are now a few private higher education institutions offering TCM program in accordance to the good standards set by the Malaysian government.
This article aims to provide a brief overview on the regulatory development of TCM in Malaysia.
| Regulations of Traditional Chinese Medicine|| |
TCM has been a part of the Malaya and the Malaysia people's method of maintaining health and well-being for many centuries. Despite its tremendous contributions to society, TCM has never been recognized as an effective and systematic way to tackle health issues by the government. Instead, similar to other traditional and complementary medicine, TCM was regarded as a folklore medicine which lacks scientific evidence to rationally support its usage. However, the rising cost of Western drugs and the increasing number of people frequenting traditional and complementary medicine compelled the Malaysian government to search for alternative cheaper health maintenance options and to look into the safe practice of these areas. On May 12, 1979, the first Malaysia Traditional and Complementary Medicine symposium was held at the University of Malaya. As the representative of TCM, Professor Ngeow Sze Chan was invited to be present at the symposium. The symposium marks the initial dialogue of incorporating TCM into Malaysia's regulated health-care framework.
At the beginning, there were skepticisms, anxieties, and resistances among TCM practitioners toward regulating the industry. Negotiations occurred between the government and the TCM associations from 1980s to 1990s in search of an understanding. A solution was mutually agreed upon that TCM practitioners and TCM products would be separately regulated. In 1992, traditional and complementary medicines including TCM products sold in the Malaysia market were mandated to be registered with the National Pharmaceutical Control Bureau (国家药品管制局), the same Ministry of Health Agency which regulates drugs and pharmaceutical supplies used by Western medicine. It is the first action taken by the government in ensuring the quality and safety of traditional herbal products. Thus, all TCM products sold in Malaysia are now mandated to carry a registration number, the content and quantity of active ingredients, name and address of the manufacturer, as well as importer on the label. A hologram sticker can also be found on the products. Consumers can use these features to differentiate a genuine licensed product for their safe consumption. Five years later, the government further required that all manufacturers of traditional medicines comply with the Good Manufacturing Practice. The Bureau was later renamed as the National Pharmaceutical Regulatory Agency in 2016.
To further regulate the industry, the government established a Traditional and Complementary Medicine Unit under the Family Health Development Division in 1996. TCM along with other traditional and complementary medicines including traditional Malay medicine, traditional Indian medicine, traditional Islamic medicine, homeopathy, osteopathy, and chiropractic were under the purview of the unit. This unit was subsequently upgraded and renamed as the Traditional and Complementary Medicine Division in 2004. The Division later set out a 10-year blueprint for the development of all traditional and complementary medicines in 2018 [Figure 1]. The aim of the blueprint is to regulate all traditional and complementary medicines and integrate them into the national health-care system. Challenges faced by TCM in the areas of practice, education, products, and research are also strategically addressed.
|Figure 1: A 10-year blueprint for the development of traditional and complementary medicine in Malaysia|
Click here to view
Prior to 2000, TCM services were mainly offered through private practices. However, the landscape started to change with the introduction of the National Policy on Traditional and Complementary Medicine in 2001 [Figure 2]. In 2007, the Malaysia government set up a traditional and complementary medicine unit at Kepala Batas Hospital (甲抛巴底医院), Penang. This marked the first sign that TCM services were offered at a public hospital. TCM has finally entered into Malaysia's public health-care system. In the subsequent years from 2008 to 2014, many similar units were set up in public hospitals in each state, namely Putrajaya, Johor, Terengganu, Sabah, Kedah, Negeri Sembilan, Sarawak, Pahang, Kelantan, Selangor, and Melaka. However, TCM services offered at these traditional and complementary medicine units were restricted to evidence-based practices that the government deemed to be sufficient. This includes acupuncture for chronic pain and stroke, as well as herbal treatment for cancer patients only. Moreover, these units do not accept walk-inpatients without a referral letter from Western medicine practitioners. Therefore, the general public still mostly visits private institutions for their minor ailments.
|Figure 2: Malaysia's National Policy on Traditional and Complementary Medicine|
Click here to view
On April 1, 2015, the government began to collect Goods and Services Tax (GST). Traditional medicines including TCM products were not exempted from tax, nor were they declared under zero-rated tax lists. This has resulted in an additional 6% consumption tax to all TCM products and rendered services. Owing to GST as a multi-tiered taxation system, not only were the patients burdened with the increased price but also TCM practitioners were slammed with additional cost. There are only a few medical insurances that accepted TCM-related claims. The Federation of Chinese Physicians and Medicine Dealers Association of Malaysia estimated that among the 6000 traditional Chinese medical halls in Malaysia, 30%–50% would have to transform their business models or risk closing down. Most of these Chinese medical halls were family businesses. The shortage of successor and the lack of experience in operating computed tax system were the reasons how GST had affected the TCM industry. The GST was later reduced to zero rated between June and September 2018. It was subsequently abolished and replaced with Sales and Service Tax by the new government after the Barisan Nasional political coalition lost the general election in May 2018.
In 2016, the Traditional and Complementary Act [Figure 3] was passed by the Malaysia Parliament, and it was gazetted to enforce by phase starting from August 1, 2016. The first phase of the enforcement includes setting up the Traditional and Complementary Medicine Council which governs matters related to the registration and practice of all traditional and complementary medicines. The Council was formed in January 2017. Recognized practitioner bodies and recognized practice areas have also been advised by the Council and gazetted by the Minister of Health. TCM is one of the recognized practice areas, and the Malaysian Chinese Medical Association is the recognized TCM practitioner body., This means that all TCM practitioners must apply for practice certificates annually from the Council before they could practice in Malaysia. In the future, they would also be required to complete a certain number of continual professional development courses as part of the renewal criteria of the practice certificate.
In addition, the Traditional and Complementary Medicine Council had ameeting with the Malaysia Qualification Agency (MQA), a quality assurance entity under the Ministry of Higher Education. A joint technical committee was formed between the Council and MQA on February 6, 2017. The main function of the committee is to provide MQA with recommendation on temporary and full accreditation of any tertiary education program in the field of traditional and complementary medicines. The committee has agreed on the existing program standards developed by MQA. Starting from June 2017 onward, all accreditations of TCM program will be jointly assessed by the Council and MQA through the committee.
| Conclusion|| |
It is clear that China and Malay Peninsula embarked on trading and cultural exchanges as early as the Han Dynasty (汉代). However, TCM was only introduced to the Malay Peninsula later in the 15th century. TCM was exported to the Malay Peninsula by the Chinese immigrants as part of their cultural identity. Although originating in China, TCM in Malaysia has undergone development and localization in stages. The early stage is setting up charity hospitals and clinics in the years leading up to World War II. TCM practitioners from China were relied heavily during the early stage. The second stage is establishing associations to conduct TCM education program locally post-World War II. The third and current stage is the recognition of TCM by Malaysian government. From the establishment of TCM services at public hospitals, through to embarking on a 10-year development blueprint, TCM has entered into the public health-care system. It is flexible enough to expand in foreign territory and has incorporated a variety of local herbs from traditional Malay medicine. TCM has come a long way in overcoming challenges and establishing its roots in Malaysia. By continuing to develop and localize, the TCM industry is foreseen to reach its high time and flourish in the near future.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
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[Figure 1], [Figure 2], [Figure 3]