THE HUMAN GENOME AND THE PATENT
Paris, September 11 (No.
2001-97) - The current explosion in the number and variety of applications for
patents on the human genome is giving rise to increasingly strident controversy.
Will the rapid growth of intellectual property protection impede research
holding the promise of dramatic breakthroughs in the fight against HIV/AIDS,
cystic fibrosis, muscular dystrophy and diabetes, among other diseases and
health conditions? Will the cost of licensing fees for new therapies confine
their use to the rich alone? Is there a contradiction between the TRIPS
Agreement (The Agreement on Trade-Related Aspects of Intellectual Property
Rights) negotiated in the World Trade Organization (WTO) and internationally
protected economic, social and cultural rights?
“Ethics, intellectual property and
genomics” is one of the topics which the International Bioethics Committee of
UNESCO will address in the course of its 8th
session, to be held from 12 to 14 September at UNESCO Headquarters, in Paris.
The issue is an “extremely urgent” one
according to a report prepared to help the Committee in its deliberations.
Unless the rise in patents in relation to the human genome is soon curtailed,
“the cost of future therapies and genetic tests will become prohibitive for
most human beings and nations,” warns the report. Thus “a remarkable
opportunity for humanity to act in a way defensive of the entire human species
will be lost.”
The great progress made in pharmaceutical
development between 1920 and 1970 - penicillin and other antibiotics and
vaccines - took place at a time when there was little demand for intellectual
property protection. Things began to change thereafter as most recently
illustrated in the case of HIV therapeutic drugs. “Although essential to the
right to life and health of millions” patents have, with few exceptions,
reduced access to such drugs to the wealthier countries. “This”, says the
report “led to a public outcry, development of generic drugs, abandonment of
court action taken to enforce property rights in South Africa” and widespread
Resentment is compounded by “the lack of
effective and fair benefit-sharing” and technology transfers to developing
countries from which genetic material are commonly taken. In August 2000, the UN
Commission on Human Rights pointed to potential sources of conflict in relation
to the TRIPS Agreement and identified these as “inter alia, impediments
to the transfer of technology to developing countries, the consequences for the
enjoyment of the right to food of plant variety rights and the patenting of
genetically modified organisms, “bio-piracy” and the reduction of
communities’ control (especially indigenous communities) over their own
genetic and natural resources and cultural values, and restrictions on access to
patented pharmaceuticals and the implications for the enjoyment of the right to
The 20-year duration of patent protection as a
universal rule “is arguably excessive” as regards genomic sequences which
compose the human genome thread and the rapid advance of knowledge about them,
adds the report. Patents already granted and applied for will add greatly, and
for many years, to national health budgets. For developing countries as well as
for the poor in developed countries, the costs of licensing fees may mean that
beneficial therapies or useful tests will effectively remain out of reach for a
long time to come.
The growing tendency, witnessed of late, to
seek and secure the widest possible patent rights over sequences of the human
genome of uncertain future utility is likely to have “large consequences
downstream as the significance of a particular gene - or of that gene in
interaction with others or with environmental factors - comes to be known”.
Another source of concern is that the
continuous decline in public funding for general research and the consequent
increased proportion of research funded by the private sector may be skewing
priorities towards areas offering a potential for maximum financial rewards as
opposed to “those that reflect the greatest human needs”.
“Ultimately”, says the report, “there is
a conflict or tension between ethical principles - those that uphold the right
to protection of the creative inventions of the human mind and those that uphold
the right to life, the right to health protection and promotion and the
solidarity of the entire human family. In the context of intellectual property
law it is necessary to resolve this conflict in a just way. The present
intellectual property law, municipal, regional and international, falls short of
In the course of its eighth session, the
International Bioethics Committee will also discuss problems related to the
gathering, treatment, storage and use of genetic data.
Progress in genetic research continues to
accelerate, opening up fresh possibilities of previously undreamed-of
applications and posing new ethical problems. Examples include the ground rules
relating to the setting up and management of genetic data banks which are now
proliferating, questions concerning the observance of human rights and
fundamental freedoms raised by the use made of such data, the fact that such
data are increasingly employed for non-medical purposes, and related issues.
Owing to the growing importance of these
issues, the Director-General of UNESCO, Koïchiro Matsuura, has proposed that
preliminary work aiming at the development of an international instrument on the
subject be initiated. This instrument would spell out the principles under which
genetic data should be collected, treated, stored and used.
“The changing conditions in which
genetic research is being conducted creates a strong case for a universal
international instrument”, argues a document prepared for this session of the
IBC. “These changing conditions include the increasing involvement of the
private sector, the rapid increase in
the number of genetic databases, the controversial nature of some proposed uses
and the international character of genetic research (…). In particular,
researchers working in developed countries may seek raw genetic data from people
living in developing countries where they may not be the same level of
protection as applies elsewhere. The need to recognize the rights of vulnerable
populations in respect to genetic data is crucial.”
A hearing of Commissioners for the protection
of personal data from Belgium, Canada and France will be held on Thursday 13
September as part of the discussion on this issue.
Other issues to be examined in the course of
the IBC’s eighth session include:
- Ethical challenges in brain research:
cerebral imaging, grafts, implants;
- Ethical aspects of proteonomics;
- Coordination of activities and reflection
concerning bioethics carried out by various international organizations with
a view to increased cooperation.
Furthermore, a Round Table on “Education in
Bioethics and Youth” will take place at UNESCO Headquarters on Wednesday 12
September, during which youth representatives will have an opportunity to
express their perceptions and expectations and to raise questions regarding
The International Bioethics Committee of UNESCO
is a multicultural and pluridisciplinary committee composed by 36 independent
experts. The IBC has done pioneering work in the field of bioethics with the
elaboration of the Universal Declaration on the Human Genome and Human Rights,
which was adopted by the General Conference of UNESCO and endorsed by the United
Nations General Assembly in 1998.
The IBC is chaired by Ryuichi Ida (Japan),
Professor of International Law at the Faculty of Law of the University of Tokyo
and Member of the International Law Association.