Posted in Legislative Research on Apr 07, 2020

This bill was posted on the Pyidaungsu Hluttaw website on 24th of December 2019.

Current Status (07.04.2020) – awaiting submission to Hluttaw for debate

(1) Backgrounder

The bill will become the first dedicated law for commercial laboratories, if approved. It is known that bill drafting started at least two years ago, led by Myanmar’s Food and Drug Administration (FDA). Once approved, the new law will be related with other laws such as National Drug Law, National Food Law and Consumer Protection Law.

(2) Bill Summary

The bill includes provisions related to licenses required to operate laboratories, the duties of license holders, executive body formation, the appointment of persons in charge of labs, issues of quality control and testing samples, and prohibitions.

  • • Its objectives are:
    • to increase the number of qualified laboratories
    • to create a registration system for laboratories
    • to protect consumers and users from harm
  • The Ministry of Health and Sports (MoHS) will form a Supervising Committee for Laboratories, with the Director General of the FDA as chairperson and members including related director generals, directors and other experts.
  • The Committee will formulate policies, regulations and guidelines for laboratory practices, including waste disposal, ensuring equal quality and accuracy among labs, determining the appellate laboratory (a laboratory that will test for the final result when either party is dissatisfied and files an appeal), and support for training so laboratories can meet international standard ISO/IEC 17025.
  • Any government department/organisation, private organisation or individual who wants to run a lab has to apply for a license to the Committee. Those permitted must ensure a quality control system inside and outside of the lab for standard performance, ensuring accurate results, and displaying documentary evidence.
  • The license holder has to form an executive body and that body is responsible for appointing the person in charge of the lab, quality control, and the maintaining the skills of the lab. Moreover, it has to maintain the lab qualifications, oversee health and safety, and report to the Committee for any changes to the nature of the lab services or its location.
  • Those who want to test food, drugs, medical devices and cosmetics have to apply to a licensed laboratory, after meeting a number of prescribed requirements. If they do not comply with the prescriptions, the laboratory should not test the submitted sample. For more precise results, the samples can be also sent to other licensed labs.
  • If not satisfied with the lab result, the sample can be sent to the appellate lab within 7 days. The appellate lab has to reply within one month, and its result is final.
  • To examine the lab, the Committee has to appoint a qualified inspector. They have to examine the lab regularly, and randomly. If labs are found to be avoiding regulation, reports can be made to the Committee, and the Committee can apply administrative penalties.
  • Those dissatisfied with administrative penalties can appeal to the MoHS within 60 days, and for administrative penalties, the Ministry has a final say.
  • Prohibitions and penalties are also included, but the bill exempts labs and lab results connected with research, personal use, or non-commercial uses.

Relevant Laws

Myanmar Public Health Law (1972)

National Drug Law (1992)

National Food Law (1997)

Consumer Protection Law (2019)

Link

Bill Text

Contact

Moe Aung, The Ananda, moeaung@theananda.org