Macau Business | January 2022 | Special Report | Traditional Chinese Medicine – Breathing a new life
Macau is no longer one of the few regions in Asia without a comprehensive legal framework on the registration of TCM
If for no other reason, this month’s law (No.11/2021) comes into force to replace legislation dating to the colonial period.
When that now-outdated law was designed, the reality of traditional Chinese medicine (TCM) in Macau was wholly different from what is experienced today – not least because of the current commitment to development of TCM on the part of the Government.
With the need for a new law often discussed, legislation to answer present and future challenges has been gestating for years, but its birth was not easy.
A 2019 SWOT analysis carried out by Manlin Peng, School of Management, Guangdong University of Science and Technology, specifically cited lack of regulation as one of the sector’s primary flaws.
“There is no legal definition for Chinese patent medicine in Macau, nor has a registration system been launched. The friendly, neighbourly relationship between Macau and Portugal has meant that the import and export of traditional Chinese medicine has never been legislated,” Professor Peng writes.
The Dongguan-based scholar adds that (at the time of writing) “Macau is the only region in Asia where there is no legislation on the registration of TCM.” Another shortcoming identified by Professor Peng was the lack of a functioning registration system for Chinese medicine practitioners, which in 2019 was “still in the initial stage and not legalized.”
According to Loretta Lou, Faculty of Social Sciences, University of Macau, without modern legislation and “in an environment where TCM is in fierce competition with biomedicine, it is understandable that some TCM practitioners feel they have to establish their legitimacy through miracle-making.”
The lecturer and Macao Fellow in Social Sciences began researching TCM in 2005 and knows the sector well. “Despite the hopeful future, delayed recognition of TCM within Macau’s legal-medical framework has caused a lot of anxiety for TCM doctors there.”
Ms Lou is clear: “Unlike practitioners in San Francisco and Shanghai, TCM doctors in Macau fear being further marginalized as ‘miracle healers’. Indeed, most TCM doctors I spoke to in Macau agreed miracles are not ‘made’ easily, if they can be ‘made’ at all, despite the fact that miracle-making serves as an ‘undeniable sign of professional accomplishment’ for some TCM doctors.”
Another scholar researching Macau’s TCM sector is Kou Seng Man. A study led by Kou, published in 2018, states: “The insufficiency of qualified staff and the delay in the publication of related legislation are issues that urgently need to be resolved with a view to the development of the Chinese traditional medicine sector in Macau.”
He therefore points to the “improvement of legislation, namely norms related to the accreditation of physicians, medication management and management of health institutions” as being among the top priorities.
The AIPPMCM, Macau’s largest TCM professional association, is happy with new law. “In the past, due to the lack of regulatory standards for Macau’s pharmaceuticals, it was difficult for Macau’s Chinese medicine products to enter the mainland market,” association president Shi Chong Rong points out, adding, “regarding the detailed rules for the implementation of this new law, the relevant government departments have also held a number of seminars with the industry, so that everyone has a sense of mind and preparations.”
The AIPPMCM assures Macau Business that “in terms of the neat implementation of the new law, the industry fully approves and supports it.”
The University of Macau’s Dr Lou provides context: “Without doubt, Macau’s medical landscape is shaped by its colonial legacy. While TCM doctors in the PRC were endowed with ‘a clear-cut professional identity’ as early as 1955, in Macau,it was only in the 1990s that the Macau Portuguese government regulate the licensing of private health care services and the qualifications required for entering the profession of Chinese medicine (Decree-Law No.84/90/M).
Now, Macau at last has a law that could allow for development of the TCM sector.
The Law on Pharmaceutical Activity in the Scope of Traditional Chinese Medicine and Registration of Traditional Chinese Medicines (No.11/2021) was published in the Official Bulletin on 26 July 2021 and came into force on the first day of 2022.
Among the main changes it stipulates is the creation of a new government bureau to oversee pharmaceutical products – TCM products included.
According to the Government, the Pharmaceutical Supervision and Administration Bureau is required for full implementation of the new law.
Another difference enacted in the new law is that medication patents will only protect data from original, own research. The provisions state that patented new medicines will enjoy six years of protection, to cover data related to pharmacology, toxicology research and clinical trials.
The legislation defines “Chinese medical extracts” as products used as mediums that have been manufactured from plants, animals or minerals, or their by-products, and “Natural medicines” as medicinal products derived from nature.
Among the most controversial issues to arise during discussion of the law was the impact on stores selling, for example, Chinese herbal tea or soup packages. This commercial activity was safeguarded such that “those who have been granted a pharmacy or drugstore licence under the terms of Decree-Law No.58/90/M are exempt from obtaining a Chinese pharmacy licence to carry out the activity of selling non-prescription traditional Chinese medicines to the public.”
In the opinion of the Chief Executive, Macau demonstrates with this new law that “it is committed to developing the TCM industry and that, in the future, medicines can be registered in Macau and sold in the GBA and, eventually, other regions.”