JK_WMA

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Revision of the Declaration of Helsinki
Cape Town
December 2012
Julian Kinderlerer
Who am I?
1. Professor of
Intellectual Property
Law at UCT
2. President of the
European Group on
Ethics
Who am I?
1. Professor of
Intellectual Property
Law at UCT
2. President of the
European Group on
Ethics
My interests are in fostering
innovation in Africa, and
ensuring that the benefits of
new technologies are
available to those who need
them. This includes the
need to ensure the
availability of appropriate
therapies and information
Who am I?
1. Professor of
Intellectual Property
Law at UCT
2. President of the
European Group on
Ethics
Who am I?
1. Professor of
Intellectual Property
Law at UCT
2. President of the
European Group on
Ethics
Who am I?
1. Professor of
Intellectual Property
Law at UCT
2. President of the
European Group on
Ethics
Who am I?
1. Professor of
Intellectual Property
Law at UCT
2. President of the
European Group on
Ethics
The EGE is an independent,
pluralist and multidisciplinary
body advising the European
Commission, Parliament and
Council on ethics in science and
new technologies in connection
with Community legislation or
policies.
The EGE members serve in a
personal capacity and are asked to
offer independent advice to the
Commission
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The Group has always consisted of scientists, lawyers,
philosophers, ethicists and philosophers – a difficult
balancing task with only 15 members. The range of
expertise needed is vast, for we have to look at issues
that relate to scientific disciplines that may not be
reflected in our expertise, and therefore we have to
spend time learning from those that have studied the
discipline and from those that have studied the
underlying ethical, legal and social issues before we are
able to provide coherent advice.
EGE
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• There are global issues, like those of climate change and the
manner in which economic crises impact on individual rights or
even the changes in the demography (ageing population, a
change in the distribution of diseases and of the mechanisms of
diagnosis and treatment).
• We have a responsibility to consider those living in Europe and
those living elsewhere whose well-being may impact on ours.
• The impact of science and technology on our lives is constantly
evolving, and the need to ensure that the ethical analysis are
fully considered.
EGE
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We are in awe of those who drafted the Helsinki Declaration, for it
provided a standard, not to attempt to attain, but rather as an
absolute baseline of behaviour for those conducting medical
research.
EGE
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The defendants in this case are charged with
murders, tortures, and other atrocities committed
in the name of medical science. The victims of
these crimes are numbered in the hundred of
thousands. A handful only are still alive; a few of
the survivors will appear in this courtroom. But
most of these miserable victims were slaughtered
outright or died in the course of the tortures to
which they were subjected.
9 December, 1946, United States v. Karl Brandt et al
Who am I?
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1. The voluntary consent of the human subject is absolutely
essential. . . . The person . . . should have legal capacity to give
consent . . . be able to exercise free power of choice, without the
intervention of any element of force, fraud, deceit, duress, over-
reaching, or other ulterior form of constraint or coercion . . . and . .
. have sufficient knowledge and comprehension of the elements of
the subject matter involved as to enable him to make an
understanding and enlightened decision. . . .
….The duty and responsibility for ascertaining the quality of the
consent rests upon each individual who initiates, directs or
engages in the experiment. It is a personal duty and responsibility
which may not be delegated to another with impunity.
Nuremberg Code
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Dr Wouter Basson used his medical knowledge to destroy life
while he was the head of the apartheid government’s chemical
and biological weapons programme, according to US bioethics
expert Professor Steven Miles.
“The ethical core of medicine is to promote health. Dr Basson’s
work caused death and imminent death and brain damage,”
Miles on Tuesday told the Health Professions Council of South
Africa (HPCSA) hearing into whether or not to revoke Basson’s
medical licence.
Basson was head of the government’s chemical and biological
warfare research programme, Project Coast, from 1981 to
early 1993. In 2002, he was acquitted in the Pretoria High
Court of a raft of criminal charges ranging from murder and
fraud to drug trafficking. He now runs a cardiology practice in
Cape Town.
South Africa: No excuses: Basson destroyed human life, says expert
Katharine Child – Sep 27 2011 Mail & Guardian
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The purpose of the proposal aims “at achieving an
internal market as regards clinical trials and
medicinal products for human use” while at the
same time setting “high standards of quality and
safety for medicinal products”.
The EGE has concerns regarding the draft regulation:
1. the marginalisation of research ethics committees
2. the nomination process for the reporting member state
3. the narrow grounds upon which another member state can
disagree with the reporting member state
4. the timelines for review and authorisation which in our view are
simply unrealistic.
Title goes hereThe draft provides for an investigator to consider a refusal to
participate or a withdrawal by an individual.
The EGE believes that any “explicit” wish in relation to either
participation or withdrawal by an incapacitated adult or a minor
must be respected
The EGE has concerns regarding the draft regulation:
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The proposed Regulation does not refer to ethics committees but
rather leaves it to the Member State concerned to determine the
appropriate body or bodies to be involved in the assessment of a
clinical trial, indicating that it would be a matter of internal
organisation within each Member State.
The EGE is deeply concerned that any reference to the notion of
‘ethics committee’ will disappear out of the European legal
framework for clinical trials and question the validity of omitting a
globally accepted mechanism for safeguarding the rights of
research participants and investigators alike ….
The EGE has concerns regarding the draft regulation:
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Multi-disciplinary evaluation of clinical research was established in
the second version of the Helsinki Declaration in 1975 and has
subsequently been incorporated into legally binding documents
such as the Council of Europe Convention on Biomedicine and its
Additional Protocol on Biomedical Research.
Changing the structure of ethical evaluation of Clinical Trials is
likely to hamper the marketing authorisation process of new
medicines, and, instead of increasing competitiveness of Europe,
it may adversely affect it.
The EGE has concerns regarding the draft regulation:
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The EGE has emphasised the importance of ethical research in its
Opinions:
25 Ethics of Synthetic Biology,
22 human Embryonic Stem Cells in FP7 Research Projects,
21 Nanomedicine
19 Umbilical Cord Blood Banking,
17 Clinical Research in Developing Countries,
15 Human Stem Cell Research and Use,
13 Healthcare in the Information Society
11 Human Tissue Banking,
10 Ethical Aspects of FP5
4 Gene Therapy.
The EGE has concerns regarding the draft regulation:
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The EGE recommends that EU Institutions
• Explicitly provide for research ethics committee evaluation of
proposals in the interests of protecting the rights of research
participants
• Give consideration to how best to avoid any type of ethics
shopping, which may weaken the legitimacy of the evaluation
e.g. by rotating the reporting member state function
• Consider expanding the grounds upon which a Member State
can disagree with the Reporting Member State in the interests
of building consensus and respecting ethical subsidiarity
• Set realistic timelines which should serve to expedite the
process while allowing a robust consideration of the issues.