Skip to main content

Twenty years of traditional and complementary medicine regulation and its impact in Malaysia: achievements and policy lessons

Abstract

Background

Many countries are trying to integrate traditional and complementary medicine (T&CM) into their health care systems. However, it is not easy to integrate T&CM within a given health care system. This study aims to draw policy outcomes and lessons from the case of Malaysia, which has been making efforts for over 20 years to integrate various types of T&CM into the national health care system (NHS).

Methods

Documents were searched in major databases and websites using words such as Malaysia and T&CM, and additional documents were secured using snowballing techniques. Data were classified and organized according to the World Health Organization health systems framework.

Results

Malaysia has focused on managing the safety and quality of T&CM, and to that end it has been institutionalized by enacting specialized laws rather than by applying existing medical law directly. Malaysia was able to institutionalize T&CM by adopting a step-by-step approach that considered the appropriateness of administrative policies and measures.

Conclusions

Malaysia's experiences in implementing its T&CM policies will raise practical implications for countries struggling to integrate their existing T&CM into the NHS and utilize it for universal health coverage.

Peer Review reports

Introduction

March 1, 2021 marks a historic milestone in the history of the Malaysian Health care system. Since that date, anyone wishing to practice in any recognized practice areas (RPAs) of Traditional and Complementary Medicine (T&CM) in Malaysia must register as a practitioner and hold a recognized qualification (Article 21) [1]. If anyone practices in an RPA without undergoing formal registration, they could face fines and/or imprisonment. Furthermore, no one will be able to practice in any area that is not designated as an RPA once the T&CM Act has been fully implemented. Over the last twenty years, the Malaysian government (MG) has developed policies to institutionalize and incorporate T&CM into the national health care system (NHS) and enforced regulatory measures for its practitioners and services. Consequently, it has reached the final stage of integrating T&CM into the NHS and is using it as a societal resource to provide universal health coverage (UHC). The policies and regulations represented by compulsory registration and professionalization have had an unprecedented impact on the reshaping of T&CM, and will bring about significant changes in the NHS of Malaysia, especially in terms of the relationship between modern medicine and T&CM and the provision of primary health care (PHC). The World Health Organization (WHO) recognizes the contribution of T&CM to UHC and encourages its member states to integrate and utilize T&CM for UHC [2, 3]. The WHO presents South Korea and China as examples of countries that have fully integrated T&CM into their NHS [3]. Both countries formally and successfully incorporated T&CM into their NHS in the mid-twentieth century, considerably earlier than any other countries. However, each country has institutionalized T&CM mainly in its own specific form of T&CM within a relatively homogeneous culture; while other T&CM modalities have been excluded from integration. Therefore, there will inevitably be a limit to how much any country can follow the experiences of, and draw lessons from, Korea or China with a single form of T&CM if countries start to integrate various types of T&CM characterized by cultural, political, or economic diversity.

Since Malaysia’s T&CM has a multiethnic and multicultural character, a wide variety of T&CM modalities coexist [4]. Furthermore, it is associated with a strong ethnic identity and is regarded as a cultural heritage. The MG is also taking a generous approach to various types of health care [5], and has been evaluated as an “in-process country” in which the integration of T&CM into the NHS is most actively under way [6]. The MG has steadily introduced diverse legislation on T&CM relatively early on, and has implemented or is planning to implement various measures for its institutionalization. Accordingly, when countries with cultural, political, or economic diversity make efforts to integrate various types of T&CM, it will be more pragmatic to refer to Malaysia rather than to Korea or China. This study delineates the status of T&CM, the dynamics of its institutionalization, and the challenges in Malaysia. It will allow us to consider issues and challenges that countries will face and learn policy implications if they set out to integrate T&CM into their NHS for UHC in other local settings and worldwide.

Methods

The current study applies case study methodologies used in social science. This type of study carries out to grasp the social issues, event or phenomenon of interest on both historical and contemporary scenes [7]. It does not set hypotheses or estimate statistical relationship, but rather providing rich description of the case and draw the insights from phenomena in question. This study mainly relies on the literature review. Firstly, Databases such as PubMed, Google Scholar, and Malaysian Citation Index were searched with terms including ‘Malaysia’, ‘Traditional Medicine’, ‘Traditional and Complementary Medicine’, ‘Traditional Chinese Medicine’, ‘Traditional Malay Medicine’, ‘Traditional Indian Medicine’, and ‘ASEAN Traditional Medicines and Health Supplements Product Working Group (TMHS PWG)’. However, it was limited to obtain sufficient information through a conventional academic database search. Therefore, we referenced Malaysian government documents, research reports, legislative data, annual reports, academic papers in order to find T&CM data. We also reviewed data uploaded on the websites of the relevant organizations such as the T&CM Division (T&CMD) of the Ministry of Health Malaysia (MoH), the Malaysian National Pharmaceutical Regulatory Agency (NPRA), and the WHO.

Finally, by applying the snowball sampling technique [8], additional references were obtained from the previously collected data. The data were classified into five factors, i.e. governance (legislation, administrative organizations), human resources (education, practitioners), finance, services (utilization, provision, quality management), treatment tools (herbs, medicines, devices), thus reorganizing the WHO’s conceptual framework for health care systems [9]

Results

Governance

The MoH has designated seven types of T&CM: Traditional Malay Medicine (TMM), Traditional Chinese Medicine (TCM), Traditional Indian Medicine (TIM), Homeopathy, Chiropractic, Osteopathy, and Islamic Medical Practice (IMP) as RPAs in Malaysia (Table 1) [1, 10]. The MG initiated the integration of T&CM into the NHS via the professionalization of practices and practitioners, which were previously entrusted only to a laissez-faire market mechanism. This shows an awareness of the growing demand for and supply of T&CM in the unregulated market and the increasing influence of T&CM on public health. The government has engaged with T&CM through administrative measures such as legislation, policies, and guidelines. Currently, the MoH is responsible for overall T&CM; the Ministry of Human Resources and Ministry of Higher Education for education and the training of practitioners; the Ministry of Agriculture and Food Industries (MAFI) for herb management; the NPRA for the supervision of T&CM products; and the Medical Device Authority (MDA) for regulation of the medical devices (Fig. 1) [4, 14]

Table 1 Brief descriptions on each T&CM in Malaysia
Fig. 1
figure 1

Malaysia’s T&CM sector-specific departments system (recited and edited) [4, 14]

T&CM policy, governing organization, and administrative measures

The MG has officially recognized T&CM as a part of health care that is directly connected to public health, and accordingly initiates governmental interventions to secure the quality, safety, and effectiveness of T&CM.

In 1996, the MG formed, for the first time, a unit to take charge of T&CM affairs in the MoH and embarked on the management of T&CM. In 1998, a joint public–private T&CM Standing Committee was formed to advise on government policies for developing and regulating T&CM. In 2001, the government expressed its determination to promote and regulate T&CM by publishing the National Policy on Traditional/Complementary Medicine. In the Policy [15], the MG declared the institutionalization, professionalization, and integration of T&CM into the NHS in the name of quality and safety. In 2004, the T&CM Unit was raised to the status of a T&CMD, which went on to play a leading role in drafting and enforcing the T&CM Act and designing a T&CM development plan. The T&CMD is composed of the following five sections and has about fifty staff: Policy and Development; Management and Training; T&CM Practice; Inspectorate and Enforcement; and T&CM Council [16].

Since its establishment, the T&CMD has continuously carried out specific and practical promotions or regulatory measures that have had substantial impacts. In 2006, T&CM services began to be provided at MoH hospitals. In 2008, the first drafting of a T&CM bill was completed, and the voluntary registration of T&CM practitioners took off. In 2010, regional branches in charge of T&CM affairs began to be established at the state level; and in 2012, government T&CM services were extended to the PHC level [4, 17].

Since the enactment of the T&CM Act in 2013, T&CM has undergone dramatic changes. The Act explicitly stipulates statutory and mandatory registration, required qualifications, the disciplinary proceedings of punishments, the enforcement of stop orders and closure orders, and search and seizure, etc. Since 2016, by enforcing the Act clause by clause, the MG has adopted a “phased approach” that promotes the integration and institutionalization of T&CM by stages. It also emphasizes “appropriateness” in developing regulations and health care models [4]

In 2018, the MG once again made a breakthrough with the completion of a ten-year initiative (Traditional and Complementary Medicine Blueprint 2018–2027), which lays out the regulatory integration and economic development of T&CM [4]. The T&CMD evaluates that forty-seven out of seventy-one action plans began to be implemented in 2019 [17], and that fifty-five action plans were initiated and eight completed in 2020 [18]. If the strategic objectives and action plans proposed by the Blueprint are fully accomplished, T&CM services are anticipated to become a genuine, full-scale health care profession, and practitioners to become fully qualified professionals, by 2027. As such, they will be subject to statutory regulation and formal management substantially equivalent to conventional medicine (Table 2).

Table 2 History of the institutionalization of traditional and complementary medicine in Malaysia

Legislation for T&CM

The main gist of the T&CM Act − enforced in 2016 − is to guarantee the quality and safety of T&CM [1]. The Act covers the overall regulations on the management and supervision of T&CM services and practitioners, and contains the following provisions: specification of the RPAs; the designation and revocation of T&CM bodies; the self-regulatory framework; practitioners’ certifications and the management of educational institutions; the compulsory registration of T&CM practitioners and their cancellation; and the issuance of certificates to practitioners. Once the relevant clauses have been enforced, the Act will prohibit any practices that do not fall under the category of RPAs [1].

The Act imposes various qualifying requirements and obligations upon T&CM practitioners for the purpose of quality assurance, while granting them a monopolistic privilege and imposing accompanying duties similar to those of medical practitioners. Furthermore, its clauses broadly cover diverse matters ranging from medical malpractice and patient rights to the supervision and punishment of professional misconduct. In addition, it accords to the government the discretionary power to appoint the date of entry into force of a particular provision and to issue administrative orders.

Human Resources

Education and training: improving the quality of education through regulation

As a substantial percentage of Malaysia’s T&CM practitioners provide T&CM services without having received any systematic education or training, the government has strengthened quality control by introducing various regulations on educational requirements, the design of a standard curriculum, and mandatory certification at the minimum level [10].

T&CM education in Malaysia is divided into two tracks—academic and skills education—the main goal of which is the quality control of institutions that provide academic education. As the universities that run T&CM courses must pass an assessment by the Malaysian Education Qualification Agency (MQA), T&CM educational institutions are struggling to meet the education standards specified for each type of T&CM and to overcome the challenges associated with a lack of the resources required to ensure the quality of education. Moreover, the T&CM Act stipulates stronger quality assurance of practitioners by requiring them to complete a residency of at least one year after completing the regular curriculum [1]. Although this provision has not yet been implemented, it will enter into force on the date appointed by the MoH. As of March 2021, among the private educational institutions that have operated the T&CM curriculum for RPAs, only four RPA—TMM, TCM, Homeopathy, and Chiropractic—have been certified by MQA [19]. Currently, eleven private universities and institutions provide seventeen accredited T&CM educational programs, while none of the public institutions provide T&CM education. Additionally, capacity-building courses in the fields of TMM, TCM, TIM, and homeopathy have been instituted for Malaysian practitioners who have not yet completed any formal training courses but who have acquired adequate practical experience, allowing them to qualify for registration [20, 21].

The TCM, under the strong influence of TCM in China, has established the most systematic education system among the seven types of T&CM. Currently, six of the eleven T&CM accredited universities provide TCM education; seven private universities have a TCM curriculum in Malaysia [19, 22].

Practitioners: moving from self-regulation towards statutory professionalization

T&CM practitioners make up a significant proportion of the health care workforce in Malaysia. However, the official number of practitioners has apparently begun to decrease since the introduction of formal registration. The MG formerly encouraged T&CM practitioners to voluntarily register with the MoH and promoted practice quality by allowing self-regulation by each professional organization [23]. Since the T&CM Act entered into force, the regulations have been gradually strengthened, including the switch to a system whereby licenses are only issued to practitioners who have received a certain level of training and a certification (Table 3) [24, 25]. In particular, from April 1, 2024, after the three-year transitional period of statutory registration, unregistered practitioners will not be able to provide T&CM services in any RPA. Furthermore, more and more practice areas will be prescribed as RPAs, and “no one shall have the right to practice in any practice area which is not an RPA” if the MG fixes a date for implementation of the relevant provision of the Act [1]. As of 2018, the number of T&CM practitioners who had registered voluntarily stood at 16,162, equivalent to 26.4% of the total number of medical doctors (61,158) [26]. In 2016, T&CM practitioners, TCM practitioners accounted for the largest share at 44.9%, followed by IMP practitioners (33%) and TMM practitioners (12%) [27]. The decrease in the T&CM workforce is remarkable among foreign practitioners, and this decline is expected to continue for the time being due to the tightened regulations [27].

Table 3 Qualifications of registered practitioners and designated bodies in Malaysia (recited and edited) [24, 25]

These regulations are expected to raise the quality and status of T&CM practitioners, who will be recognized as independent professionals above a certain level. However, the level of occupational recognition as a profession and the timing of such an achievement are likely to differ for each T&CM.

Finance

Spending on T&CM

Expenditure on T&CM as a proportion of total health expenditure is rather low, despite being widely used in Malaysia [28]. In the public sector, T&CM services are provided only in fifteen government hospitals as of 2020, and most of the T&CM services are provided by almost private institutions [18]. Although the magnitude of T&CM OOP has more than doubled over the past decade (2009–2019), the proportion of all OOP has remained around 3% [29]. In 2019, about 93.2% of the out-of-pocket payment for health care in Malaysia was spent on modern medicine, and only 3.59% (180 million USD) was spent on T&CM in 2019 [29]. The cost of T&CM services provided in MoH hospitals is covered with government subsidies, while T&CM services in the private sector must be fully paid for by the patients themselves [30]. Since T&CM spending is concentrated on the private sector, it is difficult to estimate its exact figure due to the lack of relevant data. Recently, a project to collect data on the basic costs, including a survey to calculate the appropriate price of T&CM services, is currently under way [31].

Services

Service utilization: common but highly dependent on the private sector

The utilization of T&CM services is common in Malaysia, and most of them are provided in private institutions. According to Peltzer et al., Malaysia’s T&CM utilization rate is 55.6%, the highest among ASEAN countries [32]. Other studies also report that 80.2% of patients use T&CM services [33], and the utilization by type of T&CM shows a similar percentage with regard to ethnic groups. TMM users, reportedly the largest group, account for 52%, followed by TCM users at 20%, and complementary therapy users at 6.2% [34]. T&CM is mainly used to alleviate pain caused by musculoskeletal diseases (64.3%) and nervous system diseases (12.1%) [35], following a similar trend observed in other countries [36].

T&CM services in public health care facilities and extension to the PHC level

A pilot project to provide T&CM services was launched in MoH hospitals in 2006 as part of a policy to integrate T&CM into the NHS. The MG has expanded the provision of T&CM services at the hospital level and extended them to the PHC level. As of 2020, fifteen MoH hospitals were providing a total of six T&CM practices in eighteen indications. Among the T&CM services covered, acupuncture accounts for the largest share with 37,989 cases (64.2%), followed by traditional Malay massage (18.6%), herbal therapy as an adjunct treatment for cancer (11.6%), External Basti therapy (3.2%), Varmam therapy (1.8%), and Shirodhara (0.6%) in 2019 [18].

The MG has also made steady attempts to integrate T&CM services into the PHC sector. Traditional Postnatal Care (TPC), for example, began to be provided to mothers by private practitioners under the pilot project conducted at the clinic level in Johor State in 2012. The mothers who participated in the TPC project reported a high level of satisfaction. Finally, TPC services were transferred to local PHC clinics from the MoH hospitals in 2018 in accordance with the TPC Transformation Plan. In 2020, TPC began to be provided in fifteen rural clinics and eighty-nine health clinics in fifteen states (Table 4) [17, 18]. This represents the first government attempt to expand the role of T&CM at the PHC level in Malaysia, and is in line with the WHO’s conviction that “Traditional medicine can contribute to strengthening primary health care” [37].

Table 4 History of transition of traditional prenatal care services to the primary health care level

Management of service quality

The MG manages service quality in terms of practices, practitioners, and users. First, safe and good quality practices are encouraged by the distribution of (good) practice guidelines (PGs) [38, 39], the provision of direct education to practitioners by the [27], and the periodic registration of practitioners. Since 2007, the MoH has published and revised three good PGs and general PGs for eleven therapies, basically fostering self-regulation by T&CM practitioners. These activities show that the government undertook sincere efforts to secure the standardization and safety of T&CM practices very early on.

Second, measures for the supervision and punishment of T&CM providers have been put in place. Under the T&CM Act, the MoH may appoint officials with the authority to issue orders for the suspension or closure of T&CM services and premises once the relevant provisions take effect [1].

Third, it is preparing a mechanism that allow T&CM users to complain or file for a dispute resolution. The MoH annually publishes the results of complaint by users by type of T&CM. This mechanism is stipulated in the T&CM Act, and the MoH has shown a very high level of responsiveness with regard to consumers, notifying persons who file a complaint, responding the receipt of their report within 24 h [18, 30].

It is noteworthy that the government has shown its commitment and determination to ensure that the public receive safe and good quality T&CM services by strengthening the obligations of T&CM practitioners and the rights of users simultaneously. Once these measures have settled, the quality of T&CM practices is expected to improve further.

Therapeutic apparatus

(Raw) Herbs: grey area

Medicinal herbs are used both as a self-cure by patients and as a professional remedy by practitioners. However, they fall within a rather grey area of ​​regulation in Malaysia. Fifty-six percent of Malaysian women use herbs, which are consumed in the form of raw herbs (25.1%), medicines and health supplements (17.2%), and others (13.2%) [40]. From the pharmaceutical point of view, herbs are classified into two forms: extemporaneous traditional preparations, which are directly prescribed and dispensed as raw and/or dried medicinal herbs by T&CM practitioners; and herbal products, which are processed and distributed through pharmaceutical companies for treatment purposes. While the former are exempt from the registration obligation, the latter are subject to GMP requirements, approval, and registration regulations, similar to those for synthetic drugs [41, 42]. Therefore, herbal therapies directly prescribed by T&CM practitioners still lie outside the scope of public administration.

In terms of safety and efficacy, they need − in principle − to be regulated throughout the entire value chain of T&CM medicines, i.e. herbal cultivation, collection, processing, manufacturing, and development. There is also growing recognition of the need to regulate the herbal value chain; however, what, how, and to what degree it should be regulated still remains unclear inside the government. The governance of herbal affairs is scattered across the MAFI, the Ministry of Science, Technology, and Innovation, and the NPRA. As such, this lack of herbal policy coordination is contributing to a corresponding lack of appropriate regulation of the value chain [43].

T&CM products (medicines): the large gap between regulation and the market

T&CM medicinesin the form of finished products— are supervised by the NPRA across the entire process encompassing registration, manufacturing, importing, distribution, prescription, and post-marketing surveillance. Practically speaking, however, the quality of T&CM medicines is not ensured in the market. This might be attributed both to the existence of a market mechanism designed to evade regulation and to the misuse of loopholes in the regulatory system.

A social consensus was reached early on that Malaysia should regulate T&CM products and practitioners separately [44]. In 1992, mandatory registration was introduced for herbal products, and from 1999 T&CM medicines manufacturers were obligated to comply with the GMP [45]. The NPRA manages T&CM products by categorizing them into ‘health supplements’, ‘natural products’ (NPs) (traditional and homeopathic medicines), and ‘NPs with a therapeutic claim’. As for NPs, like synthetic drugs, they fall within the scope of governmental regulation in three key aspects: efficacy, safety, and quality. Practically, however, the immediate goal of regulation centers on ensuring quality and safety, with efficacy issues placed lower down the agenda [4, 46]. To tackle the efficacy issues of T&CM medicines, the government created a new ‘NPs with a therapeutic claim’ registration track that can be applied to T&CM medicines with proven efficacy, but no T&CM medicines have met the requirements as yet. The NPs track only requires historical evidence of efficacy from pharmacopeia or traditional medical books when filing an application for registration to the NPRA, and does not require the robust clinical studies that are essential for synthetic drugs. Despite these eased regulations, manufacturers of T&CM medicines prefer to register their products as health supplements to circumvent the requirement to provide evidence of efficacy [47]. T&CM medicines account for about half of the products registered annually to the NPRA. For instance, T&CM medicines accounted for 52% (12,208 items) of all the products registered in 2019 [48]. Two-thirds of licensed pharmaceutical manufacturers produce T&CM medicines (173 locations, including health supplement manufacturers). This suggests that small manufacturers, motivated by the less strict registration standards, could easily enter the market for T&CM medicines; however, T&CM products are often recalled as they do not meet the safety and quality standards [49] and complaints in NPs and health supplements also are continuously reported [50].

Although the regulation of T&CM products commenced earlier than that of practitioners, it has not gone further. Thus, the MoH have concluded that an appropriate regulatory mechanism for T&CM medicines needs to be designed [4]. Considerable policy efforts and time should be invested to achieve a certain level of quality for T&CM medicines and expand the regulatory scope to cover the efficacy issue.

Medical devices: unclear

The regulatory mechanism for medical devices became full-fledged in Malaysia with the enactment of the Medical Device Authority Act [51] and the Medical Device Act [52] in 2012. It was introduced later than the regulatory mechanisms for other elements of the health care system, such as practices and medicinal products. According to these laws, ‘all medical devices’ are regulated across the entire process of their production, importation, use, and disposal. The scope of ‘all medical devices’ is interpreted to cover medical devices used for T&CM, such as acupuncture, cups for cupping, and vessels. However, it is unclear yet whether these treatment tools have been identified by the MG as medical devices requiring safety considerations.

Discussion

This study aims to analyze the status of T&CM, the process of its institutionalization, and the challenges in Malaysia, and to derive implications for countries that are considering the integration of T&CM services into their NHS and utilize them for UHC.

The MG aims to institutionalize T&CM into the NHS by adopting a phased approach. The MG has instituted a specialized law that reflects the situation of T&CM rather than applying the existing law, which is customized for medical affairs. Malaysia has achieved a considerable level of T&CM institutionalization in terms of legislation, administrative measures and regulations, and the establishment of the necessary organizations. In particular, enforcing the T&CM Act has laid the groundwork for a major leap forward Malaysia’s T&CM—which was considered to be in a state of “structured chaos” caused by “the lack of any appropriate legislation”—to a “structured order” [53]. The MoH’s active administrative drive and persistent engagements have might played a pivotal role in materializing the T&CM Act’s potential with the formation of T&CM governance, professionalization, institutionalization, and final integration into the NHS. Timely legislation and the government’s strong policy commitment are considered to have exerted synergistic effects on the regulation and development of T&CM in Malaysia. Thus, the WHO evaluates Malaysia’s success as an exemplary model for the institutionalization of T&CM and its integration into the NHS for UHC [54]. The MG has employed a realistic approach that prioritizes the issues of quality and safety while leaving effectiveness for the future agenda in terms of policy planning and implementation. It has adopted the evolutionary concept of ‘appropriateness’—for example, appropriate regulation— and a ‘phased approach’, taking into account the current status of T&CM industries over time and place, rather than applying a ‘one-size-fits-all’ policy or a ‘one-policy-fits-all’ stance.

It is worth noting that the MG, represented by the MoH, has maintained a strong and consistent policy of integrating T&CM through professionalization and regulation over twenty years. As a governing agency of the government’s policy and will, the MoH set up the T&CMD, commissioned T&CM affairs, and kept the T&CMD stable for a long period, in order to coordinate the different interests of diverse stakeholders. During that period, officials of the T&CMD were assumed to be more knowledgeable and experienced in terms of policy design, implementation, and stakeholder negotiation. For example, the IMP entered the RPA just before the tabling of the T&CM Act at the National Assembly [55], the drafting of which required more than a decade of policy commitment. This shows that countries which are planning the integration of T&CM need to reach a social consensus based on a strong policy will and long engagements with T&CM stakeholders situated in different milieus, where various types of T&CM coexist.

T&CM is generally known to play its own role in the private PHC sector and remains outside the regulation. For this reason, the WHO aims to promote T&CM as an essential resource for UHC in the PHC, by ensuring that T&CM practices are backed up with evidence of their quality and safety [37, 56]. The MG has been pushing for the adoption of T&CM practices—with proven quality and safety—at government health care facilities. Therefore, a health care program designed by the T&CMD was implemented in local MoH offices.

When a country tackles the issues of how and where to locate T&CM at the PHC, the TPC program could be a good example of the role of T&CM in achieving UHC. TPC program was initiated as a health care program utilizing a particular T&CM practice at the governmental level and is now on course for transfer to the local primary level for expanded access. The regulation of T&CM products, including medicines and devices, remains in a grey area. One of the main reasons for this is that T&CM medicines are regarded as lying somewhere between food and drug products. Thus, difficulty in regulating such products is an issue that should be globally addressed, rather than a local challenge remaining unresolved in Malaysia alone. The use of T&CM products is often inextricably linked to cultural factors as well. Therefore, it is difficult to find a ‘one-policy-fits-all’ solution due to the great diversity of products in terms of origin and form. T&CM in Malaysia, in particular, is mainly characterized by manual techniques, while the utilization of herbal medicines or therapeutic tools is limited to specific modalities such as TCM. Thus, Malaysia’s T&CM regulation is focused on practices and practitioners, and T&CM products remain low on the list of policy priorities. It is also necessary to point out the limitations of the study. First, the current study dealt with the unique case of Malaysia—in progress—that integrates various modalities of T&CM in a country. Accordingly, few scientific studies have not been conducted yet, and many of the data in the analysis were sourced from government documents. In addition, as data in the study were analyzed from a descriptive perspective without setting a specific hypothesis, further studies are necessarily analyzed. For example, the dynamic process and consequences of policy change could be explored through qualitative research such as interviewing various stakeholders.

Conclusions

The MG faces T&CM policy challenges that are shared globally, particularly in ASEAN countries. Nevertheless, Malaysia is an uncommon country in that it has institutionalized multiple forms of T&CM to a considerable extent, not only administratively and legally, but also socially. It places higher policy priority on the quality and safety of T&CM, and aims to achieve its goal by professionalizing and integrating practices and practitioners into the NHS. Malaysia’s achievements and experiences would provide valuable lessons and implications for countries that are planning to expedite the integration of T&CM into the NHS for UHC. It would not be an easy task, and might take a long time.

Availability of data and materials

All data are publicly available.

Abbreviations

GMP:

Good Manufacturing Practice

IMP:

Islamic Medical Practice

MAFI:

Ministry of Agriculture and Food Industries

MG:

Malaysian government

MoH:

Ministry of Health Malaysia

MQA:

Malaysian Education Qualification Agency

NHS:

National health care system

NPRA:

Malaysian National Pharmaceutical Regulatory Agency

NPs:

Natural products

PGs:

Practice guidelines

PHC:

Primary health care

RPAs:

Recognized practice areas

T&CM:

Traditional and complementary medicine

T&CMD:

T&CM Division

TCM:

Traditional Chinese Medicine

TIM:

Traditional Indian Medicine

TMM:

Traditional Malay Medicine

TPC:

Traditional Postnatal Care

UHC:

Universal health coverage

WHO:

World Health Organization

References

  1. Traditional and Complementary Medicine Act (Malaysia). 2016.

  2. World Health Organization. World Health Assembly Resolutions and Decisions (WHA62/2009/REC/1) - WHA62.13 Traditional medicine. 2009. Accessed 1 Feb 2021.

  3. World Health Organization. WHO traditional medicine strategy: 2014–2023. 2013. https://apps.who.int/iris/handle/10665/92455. Accessed 10 Mar 2021.

  4. Ministry of Health Malaysia. Traditional and complementary medicine blueprint health care 2018–2027. 2018. http://tcm.moh.gov.my/ms/upload/Blueprint.pdf. Accessed 5 Feb 2021.

  5. Medical Act (Malaysia). 1971.

  6. Park YL, Canaway R. Integrating traditional and complementary medicine with national healthcare systems for universal health coverage in Asia and the Western Pacific. Health Syst Reform. 2019;5(1):24–31. https://doi.org/10.1080/23288604.2018.1539058.

    Article  PubMed  Google Scholar 

  7. Crowe S, Cresswell K, Robertson A, Huby G, Avery A, Sheikh A. The case study approach. BMC Med Res Methodol. 2011;11(1):100. https://doi.org/10.1186/1471-2288-11-100.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Noy C. Sampling knowledge: The hermeneutics of snowball sampling in qualitative Research. Int J Soc Res Methodol. 2008;11(4):327–44. https://doi.org/10.1080/13645570701401305.

    Article  Google Scholar 

  9. World Health Organization. Monitoring the building blocks of health systems: a handbook of indicators and their measurement strategies. 2010.

  10. Malaysian Qualifications Agency. Programme standards: traditional and complementary medicine. 2nd Edition. 2021. https://tcm.moh.gov.my/ms/upload/smptk/standard/PSTNCM2NDED.pdf. Accessed 23 Dec 2021.

  11. National Center for Complementary and Integrative Health. Health information https://www.nccih.nih.gov/health. Accessed 28 Dec 2021.

  12. Ravishankar B, Shukla VJ. Indian systems of medicine: a brief profile. Afr J Tradit Complement Altern Med. 2007;4(3):319–37. https://doi.org/10.4314/ajtcam.v4i3.31226.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  13. National Health Service UK. Osteopathy. https://www.nhs.uk/conditions/osteopathy/. Accessed 28 Dec 2021.

  14. World Health Organization. WHO Global Report on Traditional and Complementary Medicine. 2019. https://www.who.int/traditional-complementary-integrative-medicine/WhoGlobalReportOnTraditionalAndComplementaryMedicine2019.pdf. Accessed 13 Sept 2021.

  15. Ministry of Health Malaysia. National Policy on Traditional/Complementary Medicine. 2001. http://mps.org.my/html/National%20Policy%20on%20Tra%20Med%20Malaysia.pdf. Accessed 8 May 2021.

  16. Ministry of Health Malaysia. Official Portal Traditional and Complementary Medicine Division. http://tcm.moh.gov.my/en/index.php/pengamal. Accessed 28 Dec 2021.

  17. Ministry of Health Malaysia. Traditioinal and Complementary Medicine Division Annual Report 2019. 2020. http://tcm.moh.gov.my/en/index.php/archive/arkib-annualreport

  18. Ministry of Health Malaysia. Traditioinal and Complementary Medicine Division Annual Report 2020. 2021. http://tcm.moh.gov.my/en/index.php/archive/arkib-annualreport

  19. Ministry of Health Malaysia. Accredited traditional & complementary medicine higher education programmes in malaysia. http://tcm.moh.gov.my/en/index.php/education/higher-education. Accessed 14 Aug 2021.

  20. Ministry of Health Malaysia. Traditioinal and Complementary Medicine Division Annual Report 2018. 2019. http://tcm.moh.gov.my/en/index.php/archive/arkib-annualreport

  21. Ministry of Health Malaysia. Guideline on application as capacity building course (CBC) training centre and trainer. https://tcm.moh.gov.my/en/index.php/guideline/cbc-course. Accessed 23 Dec 2021.

  22. Wong HF, Ng SC, Tan WT, Liu J, Lin X, Goh SW, et al. Traditional chinese medicine in Malaysia: A brief historical overview of education and research. Chinese Medicine and Culture. 2019;2(3):114–7.

    Article  Google Scholar 

  23. Goh CS, Nor AH. Development and implementation of regulatory system for Traditional and Complementary Medicine (T&CM) practitioners. World Health Organization Regional Office for the Western Pacific. Manila: Meeting on Contribution of Traditional Medicine in Strengthening Primary health care; 2017.

  24. Attorney Generals' Chambers Malaysia. Traditional and complementary medicine regulations. 2021. Third schedule - Qualifications of registered practitioners (Paragraph 4(2)(a))

  25. Attorney Generals' Chambers Malaysia. Traditional and complementary medicine regulations. 2021. Fifth Schedule - List of practitioner bodies before the coming into operation of act (Paragraphs 4(1)(c) and 4(4)(d))

  26. Ministry of Health Malaysia. Health worker resources. https://www.moh.gov.my/index.php/pages/view/321?mid=281. Accessed 17 Dec 2021.

  27. Ministry of Health Malaysia. Traditioinal and Complementary Medicine Division Annual Report 2016. 2017. http://tcm.moh.gov.my/en/index.php/archive/arkib-annualreport

  28. Siti ZM, Tahir A, Farah AI, Fazlin SMA, Sondi S, Azman AH, et al. Use of traditional and complementary medicine in Malaysia: a baseline study. Complement Ther Med. 2009;17(5):292–9. https://doi.org/10.1016/j.ctim.2009.04.002.

    CAS  Article  PubMed  Google Scholar 

  29. Ministry of Health Malaysia. Malaysia national health accounts - Health expenditure report 1997–2019. 2021.

  30. Ministry of Health Malaysia. Consumer guideline for proper use of traditional and complementary medicine dervices In Malaysia. 2019. http://tcm.moh.gov.my/ms/upload/garispanduan/consumer/BukuPanduan_BI.pdf

  31. Ministry of Health Malaysia. Market survey on pricing strategy for T&CM services in Malaysia. 2018.

  32. Peltzer K, Pengpid S. Utilization and practice of traditional/complementary/ alternative medicine (T/CAM) in Southeast Asian Nations (ASEAN) Member States. Studies on Ethno-Medicine. 2015;9(2):209–18. https://doi.org/10.1080/09735070.2015.11905437.

    Article  Google Scholar 

  33. Johny AK, Cheah WL, Razitasham S. Disclosure of Traditional and Complementary Medicine Use and Its Associated Factors to Medical Doctor in Primary Care Clinics in Kuching Division, Sarawak. Malaysia Evid Based Complement Alternat Med. 2017;2017:5146478. https://doi.org/10.1155/2017/5146478.

    Article  PubMed  Google Scholar 

  34. Ministry of Health Malaysia. National Health & Morbidity Survey 2015 - Traditional & Complementary Medicine. 2015.

  35. Malaysia Holistic and Herbal Organization. Utilisation of traditional and complementary medicine in a primary care setting: a profile in malaysia. 2018

  36. Artus M, Croft P, Lewis M. The use of CAM and conventional treatments among primary care consulters with chronic musculoskeletal pain. BMC Fam Pract. 2007;8:26. https://doi.org/10.1186/1471-2296-8-26.

    Article  PubMed  PubMed Central  Google Scholar 

  37. World Health Organization Regional Office for the Western Pacific. Meeting on the contribution of Traditional medicine in strengthening primary health care. Manila, Philippines: 2017. https://apps.who.int/iris/handle/10665/260010. Accessed 29 Jan 2021.

  38. Ministry of Health Malaysia. Good Practice Guideline – traditional and complementary medicine. http://tcm.moh.gov.my/en/index.php/policy/guideline/goodpractice. Accessed 9 Feb 2021.

  39. Ministry of Health Malaysia. Practice Guideline – traditional and complementary medicine. http://tcm.moh.gov.my/en/index.php/policy/guideline/practice. Accessed February 9 2021.

  40. Tengku Mohamad TAS, Islahudin F, Jasamai M, Jamal JA. Preference, perception and predictors of herbal medicine use among Malay women in Malaysia. Patient Prefer Adherence. 2019;13:1829–37. https://doi.org/10.2147/ppa.S227780.

    Article  PubMed  PubMed Central  Google Scholar 

  41. Goh CS. Regulation of traditional and complementary medicine (T&CM) in Malaysia: issues & challenges from a legal perspective. Presentation Material. World Cancer Congress Kuala Lumpur Convention Centre 2018. https://www.worldcancercongress.org/sites/congress/files/atoms/files/T1-1.pdf Accessed February 16 2021.

  42. National Pharmaceutical Regulatory Agency. Drug Registration Guidance Document. Third Edition 2021. https://www.npra.gov.my/easyarticles/images/users/1047/drgd/Main-Body-Drug-Registration-Guidance-Document-DRGD-3rd-Edition-January-2021_final.pdf Accessed October 18 2021.

  43. Ahmad F, Zaidi MS, Sulaiman N, Majid FA. Issues and challenges in the development of the herbal industry in Malaysia. Prosiding Perkem. 2015;10:227–38.

    Google Scholar 

  44. Wong HF, Ng SC, Tan WT, Wang H, Lin X, Goh SW, et al. Traditional chinese medicine in Malaysia: A brief historical overview of laws and regulations. Chinese Medicine and Culture. 2019;2(4):162–5.

    Article  Google Scholar 

  45. Malaysian National Pharmaceutical Control Bureau. Registration of Traditional Medicines in Malaysia. 1999.

  46. Ministry of Health Malaysia. Malaysian National Medicines Policy (2017–2021). 3rd Edition. 2017. https://www.pharmacy.gov.my/v2/sites/default/files/articles-upload/mnmp-term-3.pdf Accessed April 14 2021.

  47. Ismail SF, Azmi I, Ghani A, Daud M, Abd Jalil J, Safuan S. Regulatory control of herbal and traditional medicines in malaysia: issues and concerns. International Journal of Business and Society. 2020;21:192–204.

    Google Scholar 

  48. Ahmad R. Drug approval system in Malaysia. K-Pharma Academy (KPA) for ASEAN: National Pharmaceutical Regulatory Agency. 2019.

  49. Ministry of Health Malaysia. Ministry of Health Malaysia Annual Report 2011. 2012. http://vlib.moh.gov.my/cms/content.jsp?id=com.tms.cms.section.Section_2e51f573-a0188549-d5315d00-456216d4

  50. National Pharmaceutical Regulatory Agency. National Pharmaceutical Regulatory Agency Annual Report 2019. 2020. https://www.npra.gov.my/index.php/en/informationen/annual-reports/npra-annual-reports.html

  51. Medical Device Authority Act (Malaysia). 2012.

  52. Medical Device Act (Malaysia). 2012.

  53. Ministry of Health Malaysia. Empowering traditional and complementary medicine (T&CM) practices in Malaysia: problems and inroads made. Bulletin BPTK@KKM. 2009;5:8–9.

    Google Scholar 

  54. Ministry of Health Malaysia. Traditioinal and Complementary Medicine Division Annual Report 2017. 2018. http://tcm.moh.gov.my/en/index.php/archive/arkib-annualreport

  55. Anonymous. Islamic medicine included in traditional and complementary medicine Bill 2012. The Star. 2012. https://www.thestar.com.my/news/nation/2012/09/24/islamic-medicine-included-in-traditional-and-complementary-medicine-bill-2012. Accessed February 1 2021.

  56. World Health Organization Regional Office for the Western Pacific. Meeting on strengthening quality assurance of traditional medicines. Manila, Philippines; 2017. https://iris.wpro.who.int/handle/10665.1/13632 Accessed March 24 2021

Download references

Acknowledgements

We are grateful to Director Goh Cheng Soon, Traditional and Complementary Medicine Division, Ministry of Health Malaysia, and Professor Yun-Jin Kim, School of Traditional Chinese Medicine, Xiamen University Malaysia for their assistance in understanding the context of T&CM in Malaysia and data collection

Funding

This study was supported by the project for “Korea-Malaysia Cooperation on R&D on Traditional Medicine” of the Korea Health Industry Development Institute in 2018 (HI18C2490) and the project for “Oriental Medicine Policy-Based Research” (KIOM KSN2021422) of the Korea Institute of Oriental Medicine in 2021. Both are government agencies.

Author information

Affiliations

Authors

Contributions

OM and JE conceived of the study, conducted data collection and drafted the manuscript. JH supervised the data collection, analysis and reporting of the results. OM and JE oversaw the manuscript drafting by reviewing and providing feedback. JH ensured a critical review of the final document and approved the submission. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Ohmin Kwon.

Ethics declarations

Ethics approval and consent to participate

Since only published documents were used for this research there was no requirement for ethical clearance.

Consent for publication

Not applicable

Competing interests

The authors declare no conflict of interest

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Park, JE., Yi, J. & Kwon, O. Twenty years of traditional and complementary medicine regulation and its impact in Malaysia: achievements and policy lessons. BMC Health Serv Res 22, 102 (2022). https://doi.org/10.1186/s12913-022-07497-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1186/s12913-022-07497-2

Keywords

  • ASEAN
  • Malaysia
  • Traditional and Complementary Medicine
  • Integration
  • Institutionalization
  • WHO health systems framework