Vaccines have been a major force in reducing the occurrence of infectious diseases worldwide. However, many ethical issues surround the development and use ofVaccines. These issues include (1) requiring vaccination by law; (2) the development and testing of vaccines; (3) informed consent about the benefits and risks of vaccination; and (4) the equitable distribution of vaccines.
In a joint statement UNESCO International Bioethics Committee (IBC) and the UNESCO World Commission on the Ethics of Scientific Knowledge and Technology (COMEST) mentioned that Pandemics show the interdependency of countries. The IBC and COMEST call for international cooperation and solidarity.
The IBC and COMEST firmly reject "vaccine nationalism", as the "predatory rush" - in other words the political-economic power to pay for large quantities of vaccines in order to distribute them to one's own citizens - is unfair on a global level (Canada bought enough doses to vaccinate its population five times9, the United States four times, the European Union three times).
UNISCO Ethics committee mentioned that the first ethical requirement is to ensure the supply for safe, effective, available and affordable vaccines, which means research and clinical trials that comply with sound scientific methodology. The enormous pressure to find a vaccine should not affect the time needed to ensure the quality of the result and the primacy of safety and wellbeing of each participant during trials.
The same is true for regulators, who should not compromise the quality of their evaluation and follow-up during the transition from the experimental phase toward the industrial-scale production and distribution.Bangladesh has decided to import three brands of Covid 19 vaccine from AstraZeneca from India, Sinovac China and Sputnik from Russia. Some Bangladeshi pharmaceutical industries are negotiating with these countries to manufacture these vaccines in Bangladesh.
If allowed these three brands to import and manufacture in Bangladesh shall create an oligopoly and it is illegal as per Competition Act of 2012. On the other hand, Globe Biotech Limited, the only Bangladeshi company that has developed a Covid-19 vaccine, has submitted a protocol on January 17, 2021 to Bangladesh Medical Research Council (BMRC) for ethical approval to conduct the clinical trial of their vaccine Bangavax.
Earlier on December 28 last year, the Directorate General of Drug Administration (DGDA) permitted Globe Biotech to manufacture Bangavax for clinical trials. Globe Pharma have been waiting for months to get clearance from the Bangladesh Medical Research Council (BMRC). Last year BMRC has approved the phase 3 trial of a COVID-19 vaccine developed by a Chinese firm Sinovac.
The National Research Ethics Committee-NREC functioning under the BMRC should set standards, advise the Departments and the Ministry of Health and Family Welfare on the management of research ethics for Bangladesh and arbitrate on the matters of ethics.Dr ShahlaKhatun also pointed out that the BMRC would only provide "ethical permission" for human trials. "It is the government which will finally decide whether or not Globe Biotech will be allowed to conduct trials," she said.
BMRC, as a focal point for health research in Bangladesh has undertaken initiative to facilitate and fund research on COVID-19 pandemic control in Bangladesh. To streamline the enthusiasm for an effective outcome, BMRC recommends the some areas for COVID-19 pandemic research including clinical trials of Vaccines and Therapeutics.
The objectives of BMRC are to identify problems and issues relating to medical and health sciences and to determine priority areas in research on the basis of health care needs, goals, policies and objectives. BMRC has responsibility is to review of preliminary and final research reports and give advice on strategic implications of completed research projects and send review reports to the Directorate General of Health Services and Directorate General of Family Planning. As part of good research governance, research requires ethical approval.
(a) To safeguarding the dignity, rights, safety and wellbeing of all potential research participants.
(b) To protect the rights of a researcher to carry out legitimate investigation, as well as the reputation of the institution.
(c) To minimize potential for claims of negligence made against the researchers, the institution concerned and any collaborating individual or organization.
(d) To require evidence of ethical approval in refereed journals.
(e) To influence the research design with ethical consideration.
(f) To avoid potential problems letter on, by trail to ensure that the main ethical issues are address before the research starts.
As per National Research Strategy (Memo No: MOHFW/ Hospital -2 / Misc-16/07/06, date: 05 January, 2009) the followings are the Role of BMRC on ethical issues. 1. Co-ordinate health research by liaising with all research stakeholders. They have given responsibility of upholding the bioethics. Bioethics is the understanding of right, responsibility, justices and moral interaction in living being. Bioethics teaches how to balance between different benefits, risks and duties. BMRC may consider the following points for approval of any study of a vaccine
(1) Respect for human dignity and protection of rights and welfare ofhuman subjects.
(2) Risk of research should be reasonable in relation to expected benefits.
(3) The investigators should be competent enough to safeguard the welfare of the research subjects (research participants).
(4) Research design should be sound and the researcher should be complement enough to conduct the study.
(5) Researcher should oversee whether prevailing legal provisions and administrative arrangement ensure that the human rights and welfare of subjects involved in health research are adequately considered and protected in conformity with the ethical principles.In some television and printed media reports that BMRC wants to slow due some other reasons.Dr. Syed Modassar Ali, the BMRC Chairman, told tot media that "We are not rushing through to approve new vaccines as we had done during the emergency situation and it takes time to cross three stages."
Although other department of the government shall look after market completion, polices etc.BMRC is going beyond jurisdiction to create an oligopoly situation of three brands of vaccine and depriving the nation from an own successful research. Bangladesh could be proud of global standard research by a local company.
MSSiddiqui, Legal Economist,
e-mail: [email protected]
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