Delegation : Netherlands
Committee : World Health Organization (WHO)
Topic
Area B : International Drug Research
Ethics
Name : Duwi Riyadi Putra (Universitas Indonesia)
The
issue of international drug research ethics is eminently paradoxial. Netherlands deeply understands that
international drug research has brought, without question, a plethora of
advantages for people. In the other hand, this sort of research has been an
endlessly debatable issue for years since the research frequently violate the
research ethics. The emergence of ethics rule, Netherlands believes, is
something we got to take a closer at. It is until 1946 when the Nuremberg Code
was released, the momentum of creating responsibility that should be burdened
to the researchers starts to begin. Soon after that, Declaration of Helsinki
and International Ethical Guidelines for Biomedical Research Involving Human
Subjects published consecutively in 1964 and 1993. Considering these facts,
Netherlands believes that balancing both the scientific development and human
right is the major problem, what regulation suit the most to balance it is the
homework of us.
The
historical backdrop of drug research ethics in Netherlands started in 1999 when
Dutch Law on Research Involving Human was established. At the same time,
Netherlands established The Central Committee on Research Involving Human
Subject, which its primary obligation is to protecting subjects
taking part in medical research by reviewing the research on the basis of the
statutory provisions laid down for them and taking account of the interests of
medical progress.[1] By CCMO,
Netherlands will always try to enforce the ethics to be implemented in all
biomedical researches.
Without
forgetting the significance of drug research for the sake of human health,
Netherlands proposes two solutions regarding the mechanism of international
drug ethics.
1. Regarding to the issue of
limiting placebo-controlled trials in order to minimize the exploitation
possibility, Netherlands stands in her stance that
placebo-controlled trials is still needed yet the matter of how it will be conducted is something we should deal with in the
first place. In response to that, Netherlands insist on creating of fully binding guideline telling the regulation of how far
the placebo-controlled trials guidelines could be implemented in biomedical research involving human subject. Netherlands believes that what
we need the most now is not the matter of how the placebo-controlled trials could be limited, but how we could
decide the best measurement which regulates to what extent this sort of trial suit the best in biomedical research.
2. Answering the best mechanism
regarding the informed consent in biomedical research involving human subject, Netherland proposes the establishment of an internationally accepted agreement which cooperate with insurance companies worldwide. In the end, once the researcher
would like to run a biomedical research which involves human subjects, they got to agree on some regulations which will be conducted
by the agreement first, particularly the readiness of providing life insurance to all human subjects in the
research.
At the end of the day,
Netherlands would be open to take roles in attempt to find the best solution of
this problem.
[1]“About the CCMO”,
CCMO, accessed from http://www.ccmo-online.nl/main.asp?pid=2, on April 22nd,
2012, at 22.30 WIB
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