CIOMS: Council For International Organization of Medical Services

This essay provides an overview of the Council for International Organizations of Medical Sciences (CIOMS), a non-governmental organization established by UNESCO and WHO to promote public health through guidance on health research ethics, safety, pharmacovigilance, and medical product development. The essay details the history of CIOMS, its working groups, and its focus on assisting and encouraging activities in biomedical science and research. It highlights the significance of the first working group, which addressed international reporting of adverse drug reactions, and emphasizes CIOMS's role in formulating guidelines for ethical medical practices and ensuring the safe use of medicines globally. The essay concludes that CIOMS plays a crucial role in contemporary pharmacovigilance practice by providing an internationally recognized format for reporting information about adverse drug reactions to regulatory bodies.

Running Head: CIOMS
Council For International Organization Of Medical Services (CIOMS)
Essay
6/11/2018

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Introduction
In 1948, UNESCO (United Nations Educational, Scientific, and cultural Organization) and
WHO (World Health Organization) consulted about the possibility of establishing a self-
regulating and independent organization for facilitating more synchronization in the planning
and timing of global medical congress. Then an agreement between these two was formed for
the formation of a permanent council for coordination of global biomedical society. Then the
council was formally constituted in 1949, called CIOMS (Council for International
Organizations of Medical Sciences).
History of CIOMS
In 1949, UNESCO and WHO, both establish a global, non-governmental and non-profit
organization that works on the mission of advancement of public health through the guidance
on health research ethics, safety, pharmacovigilance, and development of medical products
(1). In 1952, its name was changed to Council for International Organization of Medical
Sciences. In late 1970s, in association with WHO, CIOMS undertook its work and launch it
guidelines on ethics in relation to biomedical research. Generally, these guidelines are general
instructions and directions about medical research and social value of biomedical science
research (2). The main agenda behind forming CIOMS was to help in exchanging of
scientific information and views related to biomedical science and research by safeguarding
and coordination between global organizations of medical sciences, by publicize their work,
and by providing them medical assistance whenever and wherever necessary (3). The head
office of CIOMS is situated in Geneva (Switzerland) near to WHO and UN head office. The
main focus area of CIOMS is to assist and encourage the activities in biomedical science and
research. The CIOMS also issues regular guidance documents on medicine safety and
numerous features of pharmacovigilance.
CIOMS and Working Groups
CIOMS conducted a conference in 1977 on “Trends and prospects in drug research and
Development” and proposed about a governing body which is independent and auto
regulating body that support the discussion about the policies between national regulatory
authorities and research based pharmaceutical companies, and when specifies a group of
experts to make recommendations on medical concerns, that was called working group of
CIOMS (4). The first working group of CIOMS was set up in 1986 on pharmacovigilanece, a
working group on “international reporting of adverse drug reaction” to find out the resources
behind systematizing and homogenizing international adverse drug reporting by drug
manufacturers to regulatory bodies. The first report on the working group- I was published in
1987 and the final report on working group – I “International reporting of adverse drug
reaction” was published in 1990. In 2018, CIOMS launching a working group- XI which

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work upon “patient involvement in development and safe use of medicines” with the purpose
of elaborating realistic approaches. It is probable that this working group will work for next
three years (2018-2021). In person meetings are expected 2-3 times per year with the first
meeting was held in 19-20 April 2018 in Geneva. Since 1949, from last 6 decades CIOMS
has promoted number of activities all over the world in certain field of medical sciences and
research whenever the global cooperation is called for and has adopted a distinctive
cooperation between a specific global medical association, stakeholders and societies (5).
Working Group-I
(International Reporting Of Adverse Drug Reactions)
The first working Group of CIOMS was constituted in 1986 on pharmacovigilance, a
working group on “international reporting of adverse drug reaction” with the objective of
developing a global uniform and standard method for drug manufacturers to report speedily
and effectively to governing bodies on post marketing adverse drug reactions. Working
Group –I was included individuals from governing bodies and pharmaceuticals drug
manufacturing companies, experts representative from universities and this group setup the
norms that serious medically authenticated and unanticipated ADRs should be considered as
the essential source of safety signals and marketed drug products through warranting
advanced data collection and evaluation and reporting to authorities (6). The first initial
report was issued on working group-I was in 1987 and final report in 1990. After that there
was a series of more than 12 publications in the area of pharmacovigilance. The final report
on Working Group-I includes recommendations about conventions and definitions, report
content and format.
The main objective of working group-I were as follows:
1. To find out the reasons behind the adverse drug reaction of a medical product.
2. CIOMS reports are not essential for ‘trials’ or ‘practices’ where unexpected
conclusion has not been made; the exceptions to this rule relates to natural report,
which should constantly be observed as doubtful reactions (7).
3. The drug manufacturers should consider local recommending text when determining
whether a serious ADR is ‘expected’ or not for advanced reporting purpose.
4. Contact the drug manufacturers and the different regulatory bodies and explain the
objective and initiative taken by CIOMS working group against the ADR.
5. To identify initial notification about the ADR to drug manufacturers companies are
frequently lacking in detailed information, CIOMS report should be filed once they
have following information:
 A recognizable cause
 A particular patient
 A suspected drug
 A suspected reaction
6. The main objective behind the first working group is to prevent adverse drug reaction
and taken preventive measures against it. The main goal of CIOMS is safe and secure

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use of prescribed medicines, the assessment and communication of the risks and
benefits of medical drugs on the market and education of, and the facility of
information to consumers about drugs (8).
Conclusion
CIOMS is a global non-profit and non-governmental body that was jointly established by
WHO and UNESCO for the purpose of guiding drug manufacturers, researchers and
governing body all over the word and plays an important role in contemporary
pharmacovigilance practice. CIOMS running various programmes on drug safety and security
since 1980s which incorporates various working groups. These working groups formulated
various guidelines for the drug manufacturer and researchers for ethical medical practices.
The first CIOMS working group was focused on adverse drug reactions and the preventive
measures against ADR. The CIOMS reporting format is only internationally recognized
format that reporting information about ADR to the regulatory bodies.

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References
1. CIOMS. Mission. [Internet]. 2018 [cited 2018 June 14]. Available from:
https://cioms.ch/about/
2. CIOMS. Pharmacovigilance. [Internet]. 2018 [cited 2018 June 14]. Available from:
https://cioms.ch/pharmacovigilance/becoming-the-cioms-member-2/
3. WHO. Safety, monitoring and medical products. [Internet]. 2016 [cited 2018 June
14]. Available from:
http://www.who.int/medicines/areas/quality_safety/safety_efficacy/
EMP_ConsumerReporting_web_v2.pdf
4. PrimeVigilance. CIOMS and Pharmacovigilance. [Internet]. 2018 [cited 2018 June
14]. Available from: http://www.primevigilance.com/resources/what-is-
pharmacovigilance/cioms-and-pharmacovigilance/
5. Basicmedicalkey. CIOMS. [Internet]. 2016 [cited 2018 June 14]. Available from:
https://basicmedicalkey.com/cioms/
6. Rolfes L, Hunsel V.F, and Puijenbroek, V.E. The Impact of Experiencing Adverse
Drug Reactions on the Patient’s Quality of Life: A Retrospective Cross-Sectional
Study in the Netherlands. [Internet]. 2016 [cited 2018 June 14]. Available from:
http://www.ff.ul.pt/ufs/files/2015/09/CuriosidadeCientifica_Maio2016.pdf
7. The Uppsala Monitoring Centre. Adverse reaction terminology WHO-ART.
[Internet]. 2016 [cited 2018 June 14]. Available from: http://www.umc-
products.com/DynPage.aspx?id=4918
8. International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
MedDRA MSSO: Medical Dictionary for Regulatory Activities Maintenance and
Support Services Organization [Internet]. 2016 [cited 2018 June 14]. Available from:
http://www.meddramsso.com