The Supreme Court (SC) has dismissed the petition filed by 74 children who were injected with the anti-dengue Dengvaxia vaccine and sought the provision of free medical services and treatment if needed.
The petition pleaded for a continuing mandamus and named as respondents the Department of Health, Department of Education (DepEd), and the Department of the Interior and Local Government (DILG).
Aside from the 74 children who were represented by their parents, the petitioners included the Gabriela Party-List and the Association for the Rights of Children in Southeast Asia (ARCSEA).
They claimed that the respondents failed to protect the right to health of those who were subjected to the DOH’s dengue immunization program. They also claimed that they were used as "guinea pigs" in an experiment conducted by the government and pharmaceutical giant Sanofi Pasteur, manufacturer of Dengvaxia.
Specifically, the petitioners asked the SC to order the government to “publicly disseminate, on a regular basis, the report of the Task Force created and designated to monitor and review the school-based immunization program involving Dengvaxia and submit the same to the House of Representatives and Senate Committees on Health; and conduct further study and review on the safety and efficacy ofDengvaxia.”
They also asked the government “create a registry or list of all those who had been inoculated with Dengvaxia; provide free medical services to all inoculated children and monitor any adverse effects caused by the vaccine; provide free medical treatment and hospitalization to inoculated children if they suffer from a Dengvaxia-related illness; and conduct initial and free consultations of inoculated children in all areas covered by the program.”
In a full court decision written by Senior Associate Justice Marvic M.V.F. Leonen and made public last Feb. 6, the SC ruled that granting the petition for mandamus would violate the principle of separation of powers between the three branches of the government – the legislative, executive and judiciary.
“Mandamus does not lie unless the acts to be performed are enjoined by law. The duty of respondent-government agencies to perform the acts must be clearly provided for by law. Neither petitioners nor this Court can order respondent-government owned agencies how to perform their functions with respect to any immunization program, otherwise, this Court will effectively usurp the power and prerogatives of the executive in their enactment of their programs,” the SC said.
At the same time, the SC said it does not have supervisory powers over executive departments and agencies.
“These administrative agencies possess the competence, experience, and specialization in their respective fields. On the other hand, this Court does not have the expertise to resolve these technical issues,” it stressed.
“To reiterate, this Court cannot claim superiority over respondent-government agencies and decide for them the policies in managing the immunization program. The reliefs prayed for by the petitioners involve purely administrative and discretionary functions.”
In the petition, the SC was told the free medical services sought “shall continue until it would have been determined and declared by competent medical and/or scientific experts that the threat/s brought about by the Dengvaxia vaccine have been minimized or eliminated.”
Tracing the history of the Dengvaxia immunization in the country, the SC said that in 2015, during the Climate Change Summit in Paris, France, late former President Benigno C. Aquino III and then DOH Secretary Janette Garin met with officials of Sanofi Pasteur to discuss Dengvaxia which was expected as the first vaccine against the dengue virus.
Thereafter, the Department of Budget and Management issued a P3.5 billion special allotment for the purchase of Dengvaxia.
Through a series of memoranda, the DOH and the DILG announced the implementation of the school-based dengue vaccination program in National Capital Region, Region III, and Region IV-A covering all elementary students nine years old and above.
Reports of numerous ill-effects of Dengvaxia, including alleged deaths, prompted Congress to conduct separate investigations on the safety and efficacy of the vaccination program, as well as its procurement process. Deaths allegedly caused by the Dengvaxia vaccines have also been filed in court.
In November 2017, Sanofi Pasteur released an updated information on Dengvaxia, which stated that the vaccine is only beneficial to those "who had prior infection" and that those who were not previously infected by the dengue virus may develop "cases of severe disease ... following vaccination upon a subsequent dengue infection."
Sanofi Pasteur did not recommend vaccination to those who had no history of dengue. Thereafter, the Food and Drug Administration suspended the sale, marketing, and distribution of Dengvaxia.
In December 2017, the petition was filed with the SC by the 74 children and others. The SC required the government agencies named as respondents to answer the petition.
In their answer, the government agencies told the SC that the petition has been rendered moot because they already accomplished the reliefs sought by petitioners
The agencies told the SC that the DOH has been proactive in disseminating information regarding the dengue immunization program. They cited DOH Administrative Order No. 2018-0008, a risk communication program on Dengvaxia. Also, they said the DOH has submitted reports of the immunization program to the Congress and has fully cooperated in the investigations.
The FDA, they said has been studying and reviewing the safety and efficacy of Dengvaxia, and coordinates with Sanofi Pasteur for the submission of Periodic Safety Update Report as well as any global safety issues or alert from other national regulatory agency.
Also, they said the DOH has already created a master list of children who were inoculated with Dengvaxia, but this cannot be released in view of the Data Privacy Act of 2012, and has issued the Interim Guidelines on the Surveillance of Adverse Effects among Dengvaxia Vaccinees, where all vaccinees were identified and issued a Dengvaxia identification card.
But they said the National Privacy Commission issued an advisory to the Department of Health, declaring that the information contained in the master list is classified as sensitive personal information.
At the same time, the government agencies said that the DOH has taken measures to ensure immediate assistance to vaccinees should they manifest adverse symptoms. They added that vaccinees are presently being monitored by the DOH and mechanisms are put in place for the early diagnosis, referral, and management of dengue, if any.
They pointed out that the medical services for dengue-related symptoms are also provided for free.
The SC said:
“We cannot find any serious or systematic inability of respondents in the performance of their duties. Considering that these are agencies possessing the technical knowledge and specialization in their fields, the judgments of the Food and Drug Administration and the Department of Health are given significant weight and should not be impulsively disturbed.
“When the vaccine was approved by the Food and Drug Administration, there is a reasonable presumption that the approval is based on science and the subsequent recommendation by the Department of Health enjoys a presumption of constitutionality. The presumption becomes heavier and more pronounced when there is a public health crisis such as a pandemic.
“Therefore, litigants who challenge the rolling out of the vaccine, as mandated by the Department of Health as experts in the field, must overcome the heavy presumption of constitutionality. Petitioners failed to ground their petition on scientific and empirical bases. They did not present studies and research which demonstrates that the vaccine failed to satisfy safety and health standards. There are no sufficient scientific grounds proving grave error in the Food and Drug Administration's and the Department of Health's approval and distribution of the vaccine.
“In any case, the reliefs sought by petitioners were already satisfied by respondents. In their Memoranda, respondents submit that they have been disseminating public information regarding the immunization program under Department of Health Administrative Order No. 2018-0008.
“Moreover, the Department of Health has submitted their reports to the Congress while the Food and Drug Administration has been studying and reviewing the safety and efficacy of Dengvaxia. The Department of Health has also been monitoring the children inoculated with Dengvaxia and has offered medical services to them for free.
“A master list of children inoculated with Dengvaxia was also created but due to privacy concerns, it cannot be released to the public as advised by the National Privacy Commission.
“In all, this Court refrains from intervening in the discretionary functions and prerogatives of the Executive department. Moreover, considering that mandamus may only be granted to enforce clear legal rights provided by law, this Court should dismiss the Petition for Mandamus.
“ACCORDINGLY, the Petition for Mandamus is DISMISSED. SO ORDERED.”
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