The President's Council on Bioethics (PCBE)
The President's Council on Bioethics (PCBE)
Nineteenth Meeting
December 2-3, 2004
Report by Laura Bishop, Ph.D. 202-687-3638
CGREL Summary Note: Models of Public Consultation/Public Engagement
Community Studies Issues (Patricia Marshall) pp. 134-137
December 2, 2004
3:45 PM Session 4: Biotechnology and Public Policy
Presentation by Francis Fukuyama and Franco Furger
Johns Hopkins University
Human Biotechnology Governance Project
"Beyond Bioethics: New Approaches to the Governance of
Human Biotechnology"
(a PowerPoint® handout for the presentation is available.
I will fax it to you. The presentation did not follow the handout
exactly because Fukuyama limited comments on the international
regulation because of other Council sessions scheduled for Friday.)
Francis Fukuyama (member of PBC) and Franco Furger spoke about
their Human Biotechnology Governance Project (HBGP). This project
is based at Johns Hopkins and has a website at http://www.biotechgov.org/.
The website is also accessible through Prof. Fukuyama's faculty
website at http://www.sais-jhu.edu/faculty/fukuyama/
(look for link to Biotech Governance Project on the left menu).
Reference was also made to a newsletter from the HBGP; a subscription
link exists on the HBGP page. The HBGP consists of a Washington,
DC-based study group with 39 members and representatives from
interested groups (BIO, ASRM, FASEB, AAAS, PCBE). The group
has had 11 presentations with many, but not all, members present
at each presentation.
In brief summary, Fukuyama and Furger (F&F) would like
to develop an independent regulatory agency to govern and permit
stem cell research to go forward. At the outset, they would
adopt an intermediate position re human embryos and the acquisition
of stem cells from human embryos; namely, human embryos do not
have a sanctity of life status equal to that of human infants,
but such embryos should be treated with more regard and respect
than simple clumps of cells. Human embryos and cells deriving
from them would only be used for the most important research
(stem cell research is one kind of such research), but the research
would only proceed with respect and regulations. F&F feel
that a prior social consensus (compromise) on the status of
human embryos and abortion would be required in order to move
forward and permit stem cell research to occur. Their goal is
to develop a regulatory body that will authorize stem cell research.
Regulations that will govern human stem cell research will
be similar to those that govern human reproductive technologies
and therefore their thinking has drawn on the models in this
area of medicine/biotechnology, especially the regulatory models
offered by the Canadian and the British systems.
For regulatory models in general, the HBGP has looked at contrasting
types of regulatory agencies and commissions in industry and
commerce, e.g., Interstate Commerce Commission (1897-1995),
Federal Civil Aviation Commission - later Civil Aeronautics
Board and Federal Aviation Authority; various federal regulatory
agencies, e.g., FDA, NIH; federal legislation; state legislative
regulation; self-regulation by associations, e.g., SART, ASRM;
and international regulatory models, e.g., HFEA in UK and the
Canadian Assisted Human Reproduction Agency established under
the 2004 Assisted Reproduction Act.
After considering all these models, F&F outline four possible
baskets of alternatives (see p. 8, middle slide):
1) maintain/augment the status quo
2) use direct legislative intervention
3) depend on self-regulation
4) create a new regulatory authority
See the pros and cons outlined for each of these approaches
(slides on pages 8-9)
F&F suggest that a new regulatory system with an independent
agency is required rather than using the existing regulatory
system because:
1) FDA and NIH have a narrow mandate that is insufficient to
deal with issues raised by stem cell research;
2) the introduction of attention to and authority over ethical
issues needs to be part of regulating stem cell research and
it is hard to retrain existing structures to attend to new ideas/ethical
concerns and to new responsibilities or requirements;
3) the need to avoid agency capture by single interest or special
interest groups or industry or medicine interest groups requires
independence
F&F identify that the downside of this approach is the
cost in creating such a new agency and the precedent setting
nature of regulating medicine.
The new regulatory system would consist of a balanced and independent
agency. F&F also propose a public participation mechanism
that they say is a new feature of such a regulatory agency.
They feel that the public is not as divided as the special interest
groups that tend to show up at public hearings of regulatory
bodies. The public participation mechanisms that they identified
are two in nature.
Deliberative Panels (and Surveys):
This approach would multiply the current consensus conference
idea that has been used by NIH and some other agencies. Deliberative
panels would number in the dozens (rather than one consensus
panel) and would be more broadly representative by age, gender,
geography, economic status, etc. These panels would be similar
to structured town hall meetings and the participants would
spend 2-3 days at a time empaneled to discuss issues at hand.
Survey results can be predicted by the way in which questions
are asked. See the example of surveys on research cloning (middle
slide, page 10). The surveys prepared by the independent agency
would be neutral and provide the agency with representative
and independent information about public opinions that the agency
would need to have effective and capable decision making. Such
surveys could also be targeted to elicit input on issues that
the independent agency needs some public consultation.
Consultative Colleges:
These colleges would not be empaneled as a town hall meeting.
They would be ongoing meetings - in order to deliberate about
issues and to solicit public views. Facilitators would use technology
such as the Internet and email to keep the conversation ongoing.
F&F's comments re models of public consultation used thus
far:
(These are questions that they have considered.)
Q. What constitutes public interest?
A. It is not adequate to simply use the responses of all the
interest groups that show up at public hearings because these
groups tend to be more polarized than the American public is
and to represent a narrower set of views than the American public
generally holds.
Q. Current survey responses as a means to attain accurate idea
of public opinion?
A. Answers to surveys can be skewed simply by the way in which
a question is asked and the language used to ask the question.
The way that the question is asked leads to certain answers
(see examples re research cloning). The American public is not
where the scientific research community is - surveys about human
embryonic stem cell research result in a pro answer. Need independent,
neutral survey technique to provide a regulatory agency with
the representative and accurate information needed to permit
them to be effective and capable in decision making about biotechnology.
The Administrative Practice Act is not adequate already so
far in public consultation - by the time the comments are requested
and are made, the suggested rules have already gone through
consultation with a number of groups and the comments really
don't seem to change the rules to any great extent. The notice
and the comment occur too late in the process.
Some public hearings have occurred to limited effect
A newer approach is to use consensus conferences or citizen
panels. These efforts educate a small group of people who then
provide responses regarding a particular biotechnology / scientific
/ medical development and associated questions posed to them
by the organizers. NIH and environmental groups have used this
approach and it is one used extensively outside the US, e.g.,
in Denmark, Japan, and Switzerland. There are also many precedents
for this type of public consultation at the federal level, especially
in environmental law.
The problem with using non-governmental groups to represent
public opinion is that they are not accountable, there are no
clear rules about their membership and advocacy, they are not
clearly broadly representative, they are more about organization
and administration, and it is not clear that they represent
public interests. Another danger is that their role in deliberation
might lead to further polarization.
Questions asked by Members of the President's Council on Bioethics
Q. Jim Wilson - If you look at the history of federal regulation
there seem to be two strategies: ICC, FCC, CAB, FAA, SEC are
all commissions that represent interests / OSHA, EPA, NHTSA
are all single-headed agencies. The first set have all failed,
while the second set have succeeded - I think because they are
single-headed agencies and someone can be held accountable.
FDA does not fit either model.
With commissions appoint obvious stakeholders. He favors some
degree of consultation, but he does not favor a deliberative
panel because it would quickly exhaust the country's capacity
for deliberation.
Why not use the successful model of the single-headed agency?
A. Fukuyama - someone Gelhorn made the same point to him in
another conversation about the proposal - good point - can be
more effective and do not have to seek agreement
F&F have asked the same questions about the degree of public
participation? and where should it be located?
--
Q. Alfonso Gomez-Lobo - Why delegate decisions about biotechnology
to 17 members of an independent agency rather than to Congress
or to the Courts which are already representative bodies?
A. Fukuyama - such decisions are now delegated to the marketplace.
F&F not taking a position so should create structure and
procedures to permit the American public to decide whether want
to happen.
--
A. Alfonso Gomez-Lobo - legislation does not create authority?
Q. Fukuyama - Congress has no time, inclination, authority
to make decision - should be a regulatory agency
--
Q. Gil Mileander - inadequate public participation and hard
to change bureaucratic structure - wouldn't these concerns dog
even a newly created independent agency?
A. Fukuyama - the independent agency would be representative
and deliberative, it would have a central core beyond the typical
regulatory agency
--
Q. Mary Ann Glendon - seems F&F and HBGP are serving the
important function of educating the public about the lack of
regulation, there are many tools in the legislators tool box
and the public may begin to request regulation. F&F should
seek opportunities to educate the public about the lack of regulation
in the area of human reproduction technologies.
A. Fukuyama ? - John Evans wrote a book about the history of
the whole bioethics profession, the history of bioethics is
to stave off regulation by using the self-regulatory model with
essentially toothless advisory commissions rather than a regulatory
agency
--
Q. Leon Kass - the model of "scientists raise questions
and ethicists resolve"
kind of moral judgment that a regulatory agency will have, not
to be sound moral reasoners but to be the nation's conscience
this proposal sounds like a high-level opinion poll survey
research group with the main virtue of learning to take the
public's temperature and blow with the wind
A. Fukuyama - need to have in place an institution that can
provide some real safeguards, F&F are not yet at that point
with the HBGP
--
Q. Peter Lawler - Congress legislate extensively and then a
regulatory agency would administer; the left is now libertarian
and so now we need to convince it that regulation is okay
-
Q. Paul McHugh - looking for this regulatory system that is
responsive to the American people through Congress to put sense
to free market system with all these abuses
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