Guillermo Delgado-P.
Prof. Henry T. Greely
Professor of Law
Stanford Law School
Crown Quadrangle Stanford University
Stanford, California 94305-8610
U.S.A.
Fax: (415) 725-0253
2 November, 1993
Dear Prof. Greely,
I have your e-mail of 25 October which arrived while I was in
Washington and which I saw first on 28 October.
In that letter you state that you understand that we "are not supporters of
the Project" and this is correct. You go on to say that you believe that
some of our "concerns have been assuaged since the May press
releases". This is not correct. I don't think I have given you any cause
to understand otherwise.
RAFI'S POSITION:
We still believe that the Human Genome Diversity Project must be
approved by indigenous peoples' organizations and must function under
the auspices of the United Nations. We continue to be concerned that
commercial benefits could arise from the Project and that they may not
be shared equitably. We are justifiably concerned that intellectual
property rights might be applied related (directly or indirectly) to human
cell lines collected under the Project. You have agreed with this concern
in your e-mail to me of 23 July in which you stated "...this does point
out another way in which cell-lines could have economic value and one
I hadn't thought of. I agree we need to think harder about the economic
value..."
We are further concerned that the information acquired could lead to
further discrimination against indigenous peoples or even be used for
population-targeted biological weapons.
At one time or another during our correspondence or in meetings of the
Project, you have acknowledged the legitimacy of all of these concerns
- with the exception of that of biological weapons. While we appreciate
your awareness of the issues (including that of the indirect use of human
material for commercial benefit which had not occurred to you), our
concerns have not been assuaged but heightened simply because the
Project has admitted that it does not even know enough about indigenous
people to be in touch with their organizations and that it seems not to
understand the difference between consulting individuals and consulting
representative bodies.
We are also disturbed that the Project seems to want to avoid an open
United Nations environment for discussion and management and prefers
instead to work through private foundations or through single
governments without appreciating how suspect the motivations and
commitments of foundations or governments are for indigenous peoples.
To us, these represent fundamental failures, on the part of the Project,
in comprehending the socio-political environment in which the Project
must perform. From Project information you and others have sent to me
and from your various letters, I must acknowledge that you are trying
hard to understand all of this - but that understanding seems framed in
an assumption that the Project is inevitable and its critics had best join
the parade or loose any opportunity to improve its operation.
I am not at all convinced that a worldwide campaign to collect
indigenous human cell lines is inevitable. I certainly do not think it
should proceed unless it is organized properly.
Let me add that I also hope these differences can be resolved, and that
an equitable and cooperative relationship can be developed between
indigenous peoples organizations and those who have medical or
anthropological reasons to be interested in human genetics. As you
request in your 25 October letter, RAFI will make these comments
widely available through electronic bulletin boards and mail.
THE NEWS RELEASE:
Turning to your e-mail of 27 October which, due to illness, I was only
able to read on 1 November, I do regret that you did not receive a copy
of the 25 October news release. This was not an intentional slight and
had more to do with my own travel and illness than anything else. In
fact the news release had been drafted for distribution in Geneva on 15
October but was delayed as a result of the pace of events in Geneva and
the need to obtain text approval on three continents and two languages.
Other than the omission of sending you a copy, there is nothing else in
the news release that I regret.
RAFI did not say - nor did we intend to imply - nor do you suggest that
we intended to imply ("Now, I know Ms. (Mr.?) Christie probably
meant that the issue looming behind this particular controversy is the
HGD..." - your e-mail of 27 October) that the Human Genome Diversity
Project is behind the patent application related to the human cell line of
the Guaymi person. We meant exactly what you said we meant - that
concern for this patent application is heightened by the pending HGD
Project where the danger exists that human cell lines collected through
the project will be patentable. No one I have talked to has given any
other interpretation to this, and I would be quite amazed if any press
report arises with such an erroneous interpretation. Should either of us
discover such a news report, I will be happy to clarify the statement
directly with the media involved. End of point.
I have not talked to any reporters but I am told that others in RAFI, very
properly, referred reporters to you rather than attempting to speak for
you or comment on the implications for your Project. Would you have
preferred that we do otherwise?
CURRENT COLLECTIONS:
Until yesterday, I had understood that the HGD Project had not formally
begun collecting human cell lines. On reading your 25 October letter to
SAIIC yesterday I learn that the European arm of the HGD may have
begun some work in Europe. ("...the project is not collecting any
samples (except possibly a few in Europe, through the European regional
committees)"). We are aware that people and institutions associated
with the Project have been collecting human cell lines independently of
the Project. HGD reports and news stories have mentioned collections
along the Nile River, for example. We have also been told of U.S.
citizens involved in collections in Chile, Colombia, and Panama. I have
not assumed that these collections were in any way authorized by the
HGD Project. Nevertheless, I am concerned that those involved in
these collections may also be associated with the Project, if and when it
does get underway.
Some months ago, I suggested that the HGD project should survey what
collections have been made, in what countries and among which peoples,
and where they are stored. You told me this would be difficult but that
you would look into it. I think that this is an urgent task and - as I have
told you before - there should a moratorium on any collection work until
the issues that have been raised are resolved.
THE GUAYMI PATENT:
I understand from your 27 October letter that you feel you have played
a role in stopping the patenting of the Guaymi cell line. Although it is
not clear to me what pressures may lead the U.S. Government to drop
the patent claim (if they finally do), I think we should set the record
straight.
First, I have both acknowledged and thanked you for your letters to U.S.
Government officials and I have passed this information on to the
Guaymi General Congress and others. I have no doubt that you are
personally opposed to the patent claim. I also have no doubt that the
HGD Project recognizes that the pursuit of such a claim would
fundamentally jeopardize its ability to collect human cell lines overseas.
I assume that both interests were at work, and I would expect that the
National Institute of Health and the Center for Disease Control were also
anxious not to put the Project at risk.
Your letters were preceded, however, by letters from Isidro Acosta as
President of the Guaymi General Congress, who asked the Secretary of
Commerce to drop the application. Prof. Acosta, who is a lawyer, also
wrote to the Commissioner of the Patent and Trademarks Office and to
the American Type Culture Collection. In addition, he wrote to the
Director-General of the World Intellectual Property Organization, and he
met with senior officials of the General Agreement on Tariffs and Trade
(GATT) in the TRIPS (intellectual property) Secretariat. Prof. Acosta
and a colleague from the Guaymi General Congress attended the
intergovernmental conference of the Biodiversity Convention (10-15
October), met with several governments and nongovernmental
organizations, and with the active support of the World Council of
Churches, participated in a news conference in Geneva opposing the
patent claim. The biodiversity conference heard statements against the
patent claim and the issue became something of a "cause celebre" during
the meeting. The Worldwide Fund for Nature (WWF) and Swissaid also
joined in the news conference. Prof. Acosta attended the conference as
a delegate of the World Council of Indigenous Peoples. I suspect all of
this may have something to do with the U.S. Government reconsidering
its position.
Further, the ATCC and the Department of Commerce have responded to
the Guaymi General Congress and a meeting is being arranged, probably
on 15 November, between Prof. Acosta and Mr. Bruce Leighman,
Under-Secretary of Commerce.
It was only on 29 October that I had verbal confirmation from both the
CDC and the NIH that they had recommended that the patent be
dropped. I contacted lawyers that day and I was advised that it would
be best to maintain the pressure until written proof is obtained. I regard
this as good advice since there seems to be confusion within the
Government as to who has the patent claim and who has control of the
cell line deposit. Even on 28 October, RAFI was asked by the NIH and
the CDC to fax them copies of the ATCC Deposit Description and the
cover sheet from the world patent claim. On 29 October, the CDC was
still trying to understand the role of the Department of Commerce in the
claim. Further, the patent deposit officer at the ATCC was telling me
that the deposit is the legal property of Dr. Lairmore and not the U.S.
Government.
For all of these reasons, we believe that the patent issue should be
pursued until the claim is formally dropped. I doubt that you would
suggest otherwise.
Just as you learned - through RAFI's discovery of the Guaymi patent
claim which we communicated to you on 30 May - that human cell lines
can provide material that can be used in a patent, you may also want to
take note of the ambiguities and uncertainties in the deposit and patent
systems as they vary from country to country.
CELL LINE REPATRIATION:
The Guaymi General Congress has asked that the cell line be repatriated
to Panama. The Congress is fully prepared to contribute to medical
research but it believes that national sovereignty and human rights issues
are involved here and that there was no adequate "oral informed consent"
given for the export and subsequent patent claim related to this cell line.
The ATCC has told me that the cell line was admitted to the collection
under the terms of the Budapest Convention and that the United States,
as a signatory to that Convention, is obliged to retain the cell line for
thirty years. Copies of the sample, the ATCC suggests, can be returned
to Panama. Panama is not a signatory to the Budapest Convention, and
as I mentioned to you on the telephone, it seems particularly
inappropriate to invoke that Convention against a people and a country
that are not parties to it.
The CDC tells me that they may be willing to move the cell line from
the patent deposit to the general deposit. They say that they will state in
writing that they will not patent the material. They will also send a copy
to the Guaymi General Congress and give the Congress the right to
commercialize the cell line as they wish. However, commercial parties
will be allowed to have access to the cell line in the United States and the
CDC will not prevent other parties from commercializing products
derived from the cell line.
In other words, the Guaymi cell line, or parts thereof, could become part
of other patent claims or commercial uses.
This is not acceptable. The cell line must not remain in the United
States. It must be returned to the Guaymi General Congress. Once
returned, I have no doubt the Congress would do its best to cooperate
with legitimate public sector medical researchers who will respect the
wishes of the Guaymi in the handling of human materials.
If the United States finds itself caught in a legal conundrum that makes
it impossible to return the cell line at this time, an interim measure may
be for the U.S. to turn over legal deposit at the ATCC to the Guaymi
General Congress. If the ATCC was prepared, as they told me, to let
Lairmore surrender the deposit to the Government, it should be possible
for the Government to surrender control to the Guaymi.
Would you agree with this position? If not, where would you disagree
and what would you propose?
I believe that the issues that have emerged in this case are ones which
will come back again and again if the Human Genome Diversity Project
goes into operation without a full and formal dialogue with indigenous
peoples' organizations under the umbrella of the United Nations.
>From my telephone interpretation of your various missiles yesterday, I
understand that you have challenged the notion that there could be
commercial value in the HGD Project and you have also disputed the
potential for using human cell line-derived information for biological
warfare...
COMMERCIAL BENEFIT:
This week, national media in Canada reported research on 24 Nairobi
prostitutes among a survey group of 1700 who appear to have some
immunity to AIDS. Since the researchers are from here in Winnipeg,
and the funding came from colleagues in the International Development
Research Centre, I have known of this story for some time. There is
open speculation among researchers here as to the potential commercial
benefit that could come from this discovery. It's a long, long, step from
the discovery to a viable product - maybe even an impossible step - but
maybe it will be very profitable.
IDRC officials have also told me of another project in the Sudan where
they have discovered a community that appears to be highly- resistent to
malaria. This is more than the sickle-cell story I am told. This, too,
could be highly profitable.
I repeat the Limone, Italy account that made the news at the beginning
of this year. The Swedish, Swiss, and Italian pharmaceutical houses
have been visiting the community for a reason. Again, it appears to be
a gene or gene complex unique to the people in this community.
In other correspondence, we have both talked about the famous John
Moore cell line and the various estimates that the final commercial value
could run between $1 billion and $2 billion.
In Geneva in late September, I was told by a lawyer looking into the
issue, that the estimate of $2 billion was the most reasonable.
Those involved in the HGD Project may be in it for the history and
anthropology, but funding of the magnitude the project needs will only
come from medical research establishments or the U.S. Department of
Energy. They will only be involved if the Project contributes to medical
research. In the context of today's intellectual property claims, almost
anything that contributes to medical research can be patented and can be
profitable for somebody.
PATENT POLICY:
I am pleased to hear that the HGD Project has laid out some formal
ground rules against patents. However, I recall Dr. Walt Reid's advice
to you at your ethics workshop last February when he suggested that you
could be against the patenting of genes but that this would not stop the
patenting of proteins. Neither will it stop others from deriving
commercial products from the cell lines. This may well be beyond your
control. If it is, you should know it and advise indigenous organizations
that this is so.
For the record, let me quote the HGD Project's account of the exchange
you had with Dr. Reid ...
"Prof. Greely, seeking clarification, posed a hypothetical
question. If the Project discovered that an isolated
population had a gene that protected it against an
infectious disease and a researcher using the Project's
cell lines isolated the gene, found the protein for which
it coded, and patented not the gene but the protein as a
basis for a drug, would Dr. Reid expect problems? Dr.
Reid said that the major political concern in most
countries was the actual patenting of the gene.
Protection for the protein would be appropriate, although
he thought it should come with some sort of return to the
host country. Dr. Reid though the discovery of a human
gene that a commercial firm wanted to add to a crop's
genome would be a much trickier issue, although one
unlikely to arise. In such a case, the firm would want to
patent the gene itself. It would be useful to the Project
to say, from the beginning, that no patents will be
sought for genes taken from the Project's samples. A
firm interested in patenting the gene could always go
back independently to the country where the gene was
found and make whatever financial arrangements were
appropriate, but that would not implicate the Project."
Has the policy adopted by the international committee in Sardinia solved
this problem so that there can be no end-runs around the Project by
companies? Can you provide details of this policy so that indigenous
peoples can study it? There is a meeting of indigenous lawyers in The
Netherlands on 8 November and it would be helpful to have this policy
then for their consideration.
BIOLOGICAL WARFARE:
In a week when we have learned that human embryos have been cloned,
it seems poor timing to suggest what is impossible in biotechnology.
RAFI has been monitoring agricultural biotechnology closely since 1983
and many of the things we were told were impossible have now taken
place. With many indigenous communities today, it would certainly be
cheaper and faster for someone to commit genocide with a shotgun rather
than waiting a decade or more to develop biological weapons. The HGD
Project however, will undoubtedly stimulate other researchers to improve
their screening and manipulation techniques to take advantage of the
diversity that is uncovered. There is considerable evidence that
biological warfare has been used against livestock and crops and there
are oppressed indigenous peoples in certain regions of the world who
have already been the target of genocide. The Project will leave the
world with a great supply of described and screened human diversity and
techniques that could make it easier for individuals or governments to
design new biological weapons against specific populations. It alarms
me, a great deal, that as Chair of the Ethics Committee in North
America, you dismiss this possibility so readily.
RAFI'S VIEW
In your e-mail, you invited me to make RAFI's position clear with
respect to the Human Genome Diversity Project. I hope this letter
clarifies our views and responds to your various messages.
Because I am at home recovering these days, I have only had your faxed
messages read to me and I may have missed a point or two. If so, I am
sure you will bring them to my attention. Please feel free to circulate
this letter as widely as you wish. RAFI will do likewise. Now, it
seems, we're both annoyed.
Yours truly,
Pat Roy Mooney
Executive Director