Although other departments 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.

1. Published: 02:09 AM, 09 May 2021
Ethics of oligopoly in Vaccine market
https://dailyasianage.com/news/261364/ethics-of-oligopoly-in-vaccine-market
M S Siddiqui
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

2. 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.

3. (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.
M SSiddiqui, Legal Economist,
e-mail: mssiddiqui2035@gmail.com