The Covid-19 pandemic started to rear its head in the latter part of 2019, right before the close of the previous decade. Curiously and just in time, early in 2019, Republic Act No. 11332, otherwise known as the “Mandatory Reporting of Notifiable Diseases and Health Events of Public Health Concern Act” was enacted to replace the 90-year old1 “Law on Reporting of Communicable Diseases” (Act No. 3573). Republic Act No. 11332 has the general objective of “protecting the people from public health threats through the efficient and effective disease surveillance of notifiable diseases including emerging and re-emerging infectious diseases, diseases for elimination and eradication, epidemics, and health events…” 2
As early as 2017, the Philippine House of Representatives Committee on Health chaired by Dr. Angelina Tan approved the house bill that aimed “to ensure the establishment and maintenance of efficient and effective disease surveillance and response system by using evidence-based data or research in making reports in the formulation of health policies and health advocacies on notifiable diseases”. 3According to Senator Ejercito, the proponent of the bill in the Senate, there was a need to enact this law because the old law, Act No. 3573, did not contain numerous new diseases which have been discovered since its enactment. 4 In other words, while the old law required the reporting of diseases, its effectivity was limited by the list of diseases provided in the law. On the other hand, R.A. No. 11332 does not contain any such restrictive list. Rather, it mandates the Epidemiology Bureau of the Department of Health (DOH) to regularly update and issue such a list of notifiable diseases and health events of concern to the public. 5
One of the powers granted by R.A. No. 11332 to authorized health personnel of the DOH is the power to enforce the conduct of epidemic investigations, contact tracing, and testing of samples and specimen. 6 In order to conduct testing, however, the clinical laboratory where the testing will occur must be registered and licensed by the DOH, in accordance with Republic Act No. 4688 7 and DOH Administrative Order No. 2007-0027 8 which provides for the guidelines for the licensure of clinical laboratories. The objective of both R.A. No. 4688 and DOH A.O. No. 2007-0027 is to prescribe a minimum standard for clinical laboratories to ensure that the tests conducted therein are accurate and precise in order to safeguard public health and safety.
Testing for COVID-19: A Chronology of Events, Laws and Rules
On January 7, 2020, a new type of coronavirus was identified in China. 9 Initially, it was called the 2019 Novel Coronavirus Acute Respiratory Disease (2019-nCoV ARD); the disease was later renamed to COVID-19 by the World Health Organization (WHO).
On January 20, 2020, China first reported a case of human to human transmission of COVID-19. A day later, the DOH issued Department Memorandum No. 2020-0034 or the “Interim Guidelines on the Preparedness and Response to Novel Coronavirus (2019-nCoV) from Wuhan, China (as of Jan. 21, 2020)”. As early as January 21, the DOH stressed the importance of rapid collection and testing of specimens from suspected patients. The issuance also provided the manner of testing specimens, which is generally by the collection of respiratory material (through nasopharyngeal and oropharyngeal swabbing).
The Philippines confirmed its first case of COVID-19 on January 30, 2020. On March 12, President Rodrigo Duterte declared a strict community quarantine in the National Capital Region from March 15 until April 12. On March 16, the President declared an enhanced community quarantine (ECQ) in the whole of Luzon. On March 24, Republic Act No. 11469, otherwise known as the “Bayanihan to Heal As One Act” was signed into law.
On March 26, 2020, despite clamor from many citizens residing in the City of Marikina, one of the cities in Metro Manila, Philippines, the Covid-19 testing center set up in the said city was disapproved by the DOH due to biosafety considerations and incomplete trainings and proficiency tests, among others. 10It must be noted that Covid-19 testing centers are complex diagnostic centers requiring high levels of biosafety standards and protocols so as to avoid being itself a source of the highly communicable disease as well as to ensure the safety of the testing personnel. A month later, after pursuing the required trainings and tests and following the DOH biosafety recommendations, the Marikina City mayor announced that its Covid-19 testing facility has been successful in obtaining accreditation by the DOH. 11
On March 31, the DOH issued Department Circular No. 2020-0160, which would serve as the guidelines for the use of COVID-19 rapid antibody-based test kits. The issuance stated that only Food and Drug Administration (FDA)-approved rapid antibody test kits may be used and that these kits cannot be used as the sole test to definitively diagnose COVID-19. According to the DOH, the gold standard for definitively diagnosing COVID-19 are real-time reverse transcription polymerase chain reaction test kits (RT-PCR test kits). Also, the DOH emphasized that because of the high risk of misinterpretation, rapid antibody-based test kits cannot be used for mass-testing or self-testing. The RT-PCR test kits used for Covid-19 are not the same as the familiar home-based testing kits, such as the over-the-counter pregnancy tests. Unlike these home-based test kits, Covid-19 RT-PCR test kits need to be sent to a high-level molecular biology laboratory with the proper equipment, reagents and trained personnel for further processing in order to obtain and interpret results.
Five days before the ECQ was set to expire, President Duterte extended the quarantine to April 30. On April 9, the DOH issued Administrative Order No. 2020-0013, revising an earlier Administrative Order which provided guidelines for the inclusion of COVID-19 in the list of notifiable diseases for mandatory reporting to the DOH. This issuance required facilities such as hospitals and laboratories to report to the DOH the results of all tests administered to detect COVID-19.
To ensure the accuracy and reliability of data and results related to COVID-19 testing, the DOH issued Department Memorandum No. 2020-0180 which states that the confirmatory test for COVID-19 are the RT-PCR test kits approved by the FDA and validated by the Research Institute for Tropical Medicine (RITM). The DOH reiterated that rapid antibody-based test kits cannot be the sole test administered to diagnose COVID-19, and that if one were to use these kits, the same must be approved by the FDA and locally-validated by the RITM or the Department of Science and Technology (DOST). This reiteration was important so as to remove false reliance from the rapid antibody test kits, which could lead infected patients to further spread the disease after obtaining false negative results.
On April 23, the DOH issued Department Memorandum No. 2020-0188 to help organize and ensure the efficiency of COVID-19 testing. Among other guidelines, the issuance stated that patients and healthcare workers who have severe conditions and those who have mild conditions but are vulnerable shall be prioritized by all DOH-licensed laboratories for COVID-19 testing. Furthermore, in accordance with PhilHealth Circular No. 2020-0010, health facilities are prohibited from charging the patient or soliciting donations from patients to cover the cost of testing. Instead, the issuance mandated that the testing facilities shall reimburse the costs of testing from the appropriate PhilHealth benefits and/or any benefit provided by Health Maintenance Organizations or Private Health Insurance.
On April 24, the President extended the ECQ to May 15. On April 28, the DOH issued Department Circular No. 2020-0194, an advisory stating that the GenAmplify COVID-19 rRT-PCR Detection Kit manufactured by Manila HealthTek Inc. can only be used upon the positive recommendation of the RITM. On May 4, the DOH issued Administrative Order No. 2020-0016, which provided for the minimum national health system capacity standards for COVID-19 preparedness and response strategies. Among other guidelines, the issuance called upon the national government, to be led by the DOH, to administer at least 30,000 tests per day by May 30 by developing testing facilities and ensuring access to these facilities.
On May 12, President Duterte declared that Metro Manila, Laguna, and Cebu City will be under a Modified Enhanced Community Quarantine (MECQ) until May 31. 12
Issues Related to COVID-19 Testing
Privacy
In the government’s fight against COVID-19, it is important that patients faithfully disclose relevant information to healthcare workers. To encourage this faithful disclosure, patients must be assured that their information shall be protected and kept private. Under Republic Act No. 1133213 , it is unlawful to disclose private and confidential information regarding a patient’s medical condition or treatment without the consent of the patient or his/her next of kin. Therefore, under this law, the results of a COVID-19 test may not be disclosed without proper authority. A violation of this law is penalized with a fine of at least Twenty thousand pesos but not more than Fifty thousand pesos or imprisonment of at least one month but not more than six months, or both, at the discretion of the court.
According to the DOH-National Privacy Commission (NPC) Joint Memorandum Circular No. 2020-0002, access to the personal health information of COVID-19 patients shall be limited to the concerned healthcare providers, public health authorities, and DOH partner agencies. Furthermore, because they have access to such information, they are required to “comply with the DOH COVID-19 surveillance and response protocols and standards, including guidelines on privacy and data protection, and processing and disclosure of COVID-19-related data.” 14 The Circular also prohibited the disclosure of the patient’s personal health information to the public or the media without the written consent of the patient or his/her authorized representative or next of kin.
Authority to Test
In order to ensure the quality of services and the accuracy of testing, the DOH issued Administrative Order No. 2020-0014, which states that only DOH licensed COVID-19 testing laboratories may administer COVID-19 tests. In order to obtain a license to operate however, the laboratory must be fully compliant with the standards and requirements that the RITM and the Health Facilities and Services Regulatory Bureau (HFSRB)/Center for Health Development-Regulations, Licensing, and Enforcement Division (CHD-RLED) provide.
Discrimination
As stated earlier, it is crucial in the fight against COVID-19 that patients disclose accurate information regarding their health and travel history. This honest disclosure will not be achieved if patients have a fear of being discriminated for having symptoms or being COVID-19-positive. As a response to these types of discrimination, all local government units in Metro Manila have enacted Anti-Discrimination ordinances for the protection of Covid-19 patients and health workers. One of these ordinances is Manila City Ordinance No. 8624, which makes it unlawful “to commit any act or make utterances which cause or tend to cause stigma, disgrace, shame, humiliation, harassment or otherwise discriminating against a person infected, under investigation or monitoring due to Covid-19, health worker or front liner…” 16
Consent
Another problem governments may face in fighting the virus would be, for one reason or another, the stubborn and unreasonable refusal by patients to get tested and treated for COVID-19. According to the DOH, one of the rights of a patient is the right to refuse to be subjected to any procedure without his written informed consent. However, this right is not without exceptions, one of which is “when the health of the population is dependent on the adoption of a mass health program to control [an] epidemic.” 17 In other words, if the matter concerns public health, such as the COVID-19 pandemic, the patient may not unjustifiably refuse to be tested.
Public Health
If a patient tests positive for COVID-19, the government can legally compel him/her to isolate himself/herself and/or to undergo treatment. According to R.A. No. 11332, it is unlawful for a person identified as having one of the notifiable diseases to refuse to cooperate with public health authorities.
In addition, Proclamation No. 922, declaring a state of public health emergency throughout the Philippines, states that “all citizens, residents, tourists, and establishment owners are urged to act within the bounds of the law and to comply with the lawful directives and advisories to be issued by appropriate government agencies to prevent further transmission of the Covid-19 and ensure the safety and well-being of all” 18and that “the Secretary of Health may call upon the Philippine National Police and other law enforcement agencies to provide assistance in addressing the Covid-10 threat.” 19
The foregoing summary provides the legal framework by which Covid-19 testing in the Philippines is currently being performed. Evident from the multitude of laws, regulations and issuances is the care that is given to this method of pandemic control since Covid-19 testing is a complex diagnostic tool which could be positively used to curb the current spate of Covid-19 infections, but may also cause a negative downturn if improperly handled.
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This article is intended for informational purposes only and should not be considered as legal advice.
[1] Available at http://www.congress.gov.ph/press/details.php?pressid=10064
[2] Sec. 2, Republic Act No. 11332.
[3] Available at http://www.congress.gov.ph/press/details.php?pressid=10064
[4] Available at https://news.mb.com.ph/2019/02/05/senate-oks-bill-amending-law-on-reporting-communicable-diseases/
[5] Sec. 5, Republic Act No. 11332.
[6] Sec. 4, Republic Act No. 11332.
[7] “An Act Regulating the Operation and Maintenance of Clinical Laboratories and Requiring the Registration of the Same with the Department of Health, Providing Penalty for the Violation Thereof, and for Other Purposes.”
[8] “Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines”.
[9] Available at https://www.covid19.gov.ph/covid-19-timeline/
[10] Available at https://newsinfo.inquirer.net/1248821/doh-thumbs-down-marikina-citys-covid-19-testing-center
[11] Available at https://www.msn.com/en-ph/news/national/marikinas-covid-19-testing-lab-gets-doh-accreditation/ar-BB13pQd8
[12] Available at https://cnnphilippines.com/news/2020/5/12/Metro-Manila-Laguna-Cebu-ECQ-COVID-19.htmlfbclid=IwAR0VB5CCsFHLh3AxOY2lGUR1jdJ9lVukppCMgZChDX8DH8_rCeCOHcx-cjc
[13] Mandatory Reporting of Notifiable Diseases and Health Events of Public Health Concern Act
[14] DOH-NPC Joint Memorandum Circular No. 2020-0002
[15] Available at https://newsinfo.inquirer.net/1261555/all-metro-manila-lgus-now-have-anti-discrimination-measures-iatf
[16] Sec. 3, Manila City Ordinance No. 8624.
[17] Available at http://samch.doh.gov.ph/index.php/patients-and-visitors-corner/patients-rights
[18] Sec. 4, Proclamation No. 922
[19] Sec. 3, Proclamation No. 922
