A. Introduction
The HUGO Ethics Committee subscribes to the following four
principles presented in the HUGO Statement on the Principled Conduct of Genetic
Research (1996):
Recognition that the human genome is part of the common
heritage of humanity:
Adherence to international norms of human rights:
Respect for the values, traditions, culture, and integrity
of participants: and
Acceptance and upholding of human dignity and freedom.
The above Statement further provided:
"That undue inducement through compensation for
individual participants, families and populations should be prohibited. This prohibition
does not include agreements with individuals, families, groups, communities or populations
that foresee technology transfer, local training, joint ventures, provision of health care
or of information, infrastructures, reimbursement of costs, or the possible use of a
percentage of any royalties for humanitarian purposes".
The Committee believes that the issue of benefit-sharing
merits further discussion because expenditures by private industry for genetic research
now exceed the contributions of governments.
Many new products, including vaccines and drugs for common
diseases, are now based on genetic research. Much government or nonprofit research will
eventually be commercialized. Companies involved in human health may have special moral
obligations.
The HUGO Ethics Committee considers it important to further
outline the underlying principles and issues related to benefit-sharing, with a view to
making recommendations.
In order to do so, it has examined the historical
background, possible definitions of community, beliefs about the common heritage of
humankind, and the principles of justice and solidarity before applying these principles
to the concept of benefit-sharing.
B. Historical Background
HUGO has addressed controversies surrounding research in
its previous statements. The issue at hand for the Ethics Committee is whether and how to
distribute profits that may accrue to commercial enterprises, governments, or academic
institutions on the basis of the participation of particular communities.
This issue predates genetics by many years. In the past,
many researchers sought no specific reward for biomedical research. More recently, due to
increasing private investment, researchers and institutions often demand a share of
monetary benefits deriving from their research.
Moreover, in the interest of justice, the last decade has
witnessed an emerging international consensus that groups participating in research
should, at a minimum, receive some benefit. In this consensus, the concept of benefit was
often limited to the possible therapeutic benefit of participating in clinical trials or
of payment to research participants.
Certain objections regarding research involving indigenous
populations raised awareness of the need to develop further the concept of
benefit-sharing, these concerns apply not only in the developing world, but also among
research participants in developed nations.
C. Defining Community.
Community is a term that can never be dissociated from the
social perceptions of those both inside and outside the community. The type of community
most easily visualized has some combination of shared geography, history, race, culture,
and religion, such as a tribe living in a given territory.
There are many different types of communities. Communities
of origin are founded on family relationships, geographical areas, cultural, ethnic, or
religious groups in which one is born or raised. For example, the extended family
constitutes a community based on inheritance. Communities of circumstance are groups in
which one finds oneself, by choice or chance, later in life. These include groups based on
shared interests, workplaces, labor unions, and voluntary associations.
Both types of communities can be defined across several
dimensions, including geography, race/ethnicity, religion or disease state. For example, a
small town may be a community of origin if most inhabitants were born there, or a
community of circumstance if most are newcomers. Persons with the same disease could form
a community of origin if there is a family history, as may be the case for monogenic
disorders (single gene), or a community of circumstance, which is usually the case for
common multifactorial diseases. People with common multifactorial diseases, such as heart
disease, hypertension, cancer, or diabetes may not regard themselves as communities.
D. Common Heritage.
As a species, we all share in essence the same genome. This
common genome allows for reproduction between all groups of mankind. At this collective
level, the genome is the common heritage of humanity. In contrast, apart from identical
twins, individuals exhibit significant variation. Rare variant genes at different gene
loci are the causes of the vast number of monogenic conditions. Most diseases are partly
based on normal genetic variation (i.e. polymorphisms). Diseases where genetic
polymorphisms are of importance are much more frequent than monogenic conditions. Many
persons with such polymorphisms will escape disease if lifestyle, dietary and
environmental factors are favorable, since the diseases in question are caused by
interaction between genes and environment. Furthermore, most common diseases know no
national or political boundaries.
The chance of discovering a gene that could lead to a
product may vary among populations. The search for genes may therefore focus on specific
populations or families. Sometimes, findings in families with extremely rare diseases may
have implications for larger groups with more common disorders.
While not respected by all
nations, the concept of common
heritage also resonates under international law (e.g. the sea, the air,
space, …).
Applied to human genetics, it maintains that beyond the individual, the
family, or the population, there is a common shared interest in the genetic heritage of
mankind. Therefore, the Human Genome Project should benefit all humanity.
E. Justice.
Justice is a central issue. There are at least three
different meanings of the concept of justice, all of which are relevant in our context of
benefit-sharing: 1) Compensatory justice: meaning that the individual, group, or
community, should receive recompense in return for contribution; 2) Procedural justice:
meaning that the procedure by which decisions about compensation and distribution are made
is impartial and inclusive; and, 3) Distributive justice: meaning an equitable allocation
and access to resources and goods. At present there is a great inequality between the rich
and poor nations in the direction and priorities of research and in the distribution and
access to the benefits thereof. When there is a vast difference in power between those
carrying out the research and the participants, and when there is a possibility of
substantial profit, considerations of justice support the desirability of distributing
some profits to respond to health care needs.
F. Solidarity.
The sharing of genes may call for strong solidarity within
certain groups of people. Members of a small group with rare genes who have helped
research would be particularly deserving recipients of benefits. Moreover, research
efforts should promote health universally and so include developing countries. In the
future, much prevention and treatment will be based on genetic knowledge. It is in
everyone's best interest that wealthy and powerful nations as well as commercial entities
foster health for all humanity.
G. Benefit-Sharing.
A benefit is a good that contributes to the well-being of
an individual and/or a given community (e.g. by region, tribe, disease-group...). Benefits
transcend avoidance of harm (non-maleficence) in so far as they promote the welfare of an
individual and/or of a community. Thus, a benefit is not identical with profit in the
monetary or economic sense. Determining a benefit depends on needs, values, priorities and
cultural expectations.
In genetic research in general, benefit-sharing has also
been established as a principle of international law in the area of biodiversity and
genetic resources in food and agriculture.
People with common multifactorial diseases, may have few
shared beliefs about benefit. Indeed, benefit will often be that of eventual prevention or
treatment and affordable medical services.
Prior consultation with individuals and communities and
their involvement and participation in the research design is a preliminary basis for the
future distribution of benefit and may be considered a benefit in itself. Such prior
discussion should include consideration of affordability and accessibility of eventual
therapy, and preventive and diagnostic products of research.
The actual or future benefits discussed should not serve as
an inducement to participation. Nor should there be any financial gain from participation
in genetic research. This does not exclude, however, the possibility of reimbursement for
an individual's time, inconvenience and expenses (if any), even if there is a general
distribution of benefits to the community. Participants should be told of such general
distribution at the outset.
In the very rare case where the extended family or a small
group/tribe harbours an unusual gene, yet the research eventually benefits those with
another disorder, justice may require that the original group deserve recognition. In this
situation, benefits could be provided to all members of the group regardless of their
participation in the research. Limiting the returns to only those who participated could
create divisiveness within a group and is inconsistent with solidarity.
Even if there are no results or profits, at a minimum,
individuals, families and groups participating in research should be thanked (e.g. letter,
or a small token or gift where the culture expects this). They should also receive
information about the general outcome(s) of research in understandable language. The
ethical advisability of provision of information to individuals about their results should
be determined separately for each specific project. Moreover, immediate benefits such as
medical care, technology transfer, or contribution to the local community infrastructure
(e.g., schools, libraries, sports, clean water, ...) could be provided.
In the case of profit-making endeavours, the general
distribution of benefits should be the donation of a percentage of the net profits (after
taxes) to the health care infrastructure or for vaccines, tests, drugs, and treatments,
or, to local, national and international humanitarian efforts.
Recommendations
Whereas:
- we all share a common genetic heritage, and
- there are different definitions of community, and
- communities may have different beliefs about what
constitutes a benefit, and
- genetic research should foster health for all human
beings,
The HUGO Ethics Committee recommends:
1) that all humanity share in, and have access to, the
benefits of genetic research.
2) that benefits not be limited to those individuals who participated in such research.
3) that there be prior discussion with groups or communities on the issue of
benefit-sharing.
4) that even in the absence of profits, immediate health benefits as determined by
community needs could be provided.
5) that at a minimum, all research participants should receive information about general
research outcomes and an indication of appreciation.
6) that profit-making entities dedicate a percentage (e.g. 1% - 3%) of their annual net
profit to healthcare infrastructure and/or to humanitarian efforts.
HUGO Ethics Committee
Barth Maria Knoppers - Chair
Ruth Chadwick - Vice Chair
Hiraku Takebe - Vice Chair
Michael Kirby Kare Berg Ren-Zong Qiu Darryl
Macer José-Maria Cantu Dorothy C Wertz Thomas H Murray Addullah S Daar Ishwar Verma Eve
Marie Engels
