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This staff working paper was discussed at the Council's October 2002 meeting. This working paper was prepared by staff solely to aid discussion, and does not represent the official views of the Council or of the United States Government.

Staff Working Paper

Regulating the New Biotechnologies: Observations and Procedural Options for the Council

Since January, the Council has spent time looking at various new biotechnologies (such as human cloning, stem cell research, sex selection, and various techniques for altering or improving human performance), and has also taken time to look at several international approaches to publicly addressing bioethical questions (including those of Canada, Germany, and the United Kingdom). It has also begun to look at the U.S. system of regulation, starting with local Institutional Review Boards (IRBs).

In an April 10, 2002, memo to the Council reviewing current U.S. biotech regulation, Prof. Fukuyama argued that:

broad legislative bans will not be an appropriate approach for dealing with a number of foreseeable future technologies. For this, a regulatory model (that is, where Congress delegates authority to a regulatory body under broad guidelines) will be necessary. But the current regulatory system in the United States for human biotechnology is inadequate to make some of the decisions that will have to be made.

Detailing what he regards as the gaps in the U.S. regulatory system, Fukuyama suggested that new institutions are necessary, but added that "a great deal may be achievable through self-regulation," citing as an example the Recombinant DNA Advisory Committee (RAC) created as a tool for self-policing by scientists after the Asilomar Conference of 1975.

In its July 2002 report on human cloning, a majority of the Council called for "a federal review of current and projected practices of human embryo research, preimplantation genetic diagnosis, genetic modification of human embryos and gametes, and related matters, with a view to recommending and shaping ethically sound policies for the entire field." And it offered itself to "undertake the preliminary steps of such a process and to provide advice on further steps."

To help Members undertake these preliminary steps, the staff here attempts to put on paper some of the lessons we seem to have learned to date.

General Lessons to Date

1. The need for some system of regulation has been widely shared around the world.

As we have seen in this and other countries, the rise of new biotechnologies often raises serious ethical concerns in the minds of the public, including concerns about the sanctity of human life, privacy, discrimination, eugenics, unequal access to benefits, and dehumanization. In several countries, including those we have studied, this has prompted the exploration and in some cases the creation of new regulatory systems or agencies.

2. Most countries focus their debate and regulation on questions of assisted reproduction and genetics in particular.

In his April 10 memo, Fukuyama suggested five areas for possible regulation: preimplantation genetic diagnosis (PGD); germ-line engineering; the creation of human-animal hybrids and chimeras; novel research techniques (as, for example, research cloning or creating female embryos in order to harvest eggs from their ovaries); and security against bio-terrorism. Most of these areas involve the interaction of genetic and reproductive technologies. Most of these areas more or less unavoidably involve human embryos.

In those countries that have undertaken some regulation of biotechnology, attention has focused largely on assisted reproduction, privacy issues surrounding knowledge of the human genome, genetic embryo-screening technologies, cloning, and research on human embryos. This may be so for a number of reasons: they are present areas of concern, and not just prospective worries about potential developments; they often involve the rights and safety of individuals, the practice of medicine, and the status of the human embryo; and they can be readily perceived and understood by the general public.

The arena of genetics and assisted reproduction appears to us to be most in need of present attention, and the most reasonable focus for proposed regulations. With the advent of new prospects for genetic screening and genetic engineering, many new ethical issues will soon emerge. At present, these areas are largely unmonitored and unregulated in the United States. Regulation tends to fall under existing, general health-and-safety and practice-of-medicine regulations created within the separate states. Monitoring is almost nonexistent by the federal government, and is spotty and fragmentary among the states.

3. The experience of other countries shows that different sorts of approaches are possible, each in line with the character and history of its society.

While the different countries we have studied, and several others, have taken up the challenge of regulating ART and embryo research, they have done so in quite different ways, each representing the priorities and inclinations of the nation in question. In Germany, for example, where the national constitution makes protection of the rights and dignity of the human person a paramount purpose of the state, the development and handling of embryos outside the human body, except to create a pregnancy, is essentially forbidden, and assisted reproduction is restricted so as to reduce the likely loss of nascent human life. In Britain, by contrast, where public opinion is not so focused on the question of embryos as such, the concern seems more to be to achieve a balance of values: a desire to promote useful biomedical research, on the one hand, and a desire to ensure that embryo research and assisted-reproduction techniques are used only for ends deemed socially acceptable (with a certain emphasis on protecting the welfare of children born as a result of assisted reproduction). Hence, the UK requires that all unimplanted embryos be destroyed after a certain period of time but also requires licenses for all embryo research and novel uses of ARTs. Canada may fall somewhere between these two positions, and places great emphasis on social solidarity and consensus in determining regulatory approaches, though its system of oversight and regulation is only now taking shape.

The lessons of these models, therefore, may not finally be in the specific approaches they have taken, but in the ways in which their approaches mirror the character, preferences and social and political history of each country. In the United States, attitudes about human embryology and genetics, about private enterprise and government regulation, and about scientific progress are different in important ways from all the other countries we have studied. This means that any system of regulation would have to take into account the ways in which Americans have thought about the issues in question, as well as the character of the American political and economic system. A system of oversight and regulation would need to keep in mind not only what it seeks to prevent or advance, but also on whose behalf it acts. Participation of the biotech industry, academic biomedical researchers and physicians, policy makers, and the general public would be needed in exploring what needs to be done.

4. Designing and establishing systems of regulations takes a great deal of time and effort.

The experience of all the countries we have studied, as well as the example of other sorts of regulation in the United States demonstrates that establishing a new system of oversight or regulation requires a lot of time, and several distinct political steps. The British HFEA was established six years after its creation was proposed to parliament. The Canadian system has been over seven years in the making. The process generally requires a proposal from an advisory body, discussions in the legislature, with input and comment from industry and the public, and a process of negotiation and legislation.

5. In the United States, existing institutions appear to be insufficient to handle the questions raised by the new biotechnologies.

From the cursory review we have been able to undertake to date, it is unlikely that any existing institution, or combination of institutions (the FDA, the NIH, the RAC, IRBs, or the USPTO), has both the authority and the ability to respond fully to the public's various ethical concerns regarding the new biotechnologies or to undertake the task of regulation. And it further seems that the scope, mission, and culture of each of the existing institutions would make it difficult for that institution to take on such new regulatory missions. More likely, new institutions are required.

How to Proceed?

Work on suggesting new regulatory institutions will have to begin from the very earliest stages. The purpose, form, authority and scope of the system would have to be discussed and some general outlines might emerge for further development by others. In terms of how Council work might proceed, a number of possibilities present themselves, which may be pursued separately or simultaneously:

a.) A formal subcommittee of the Council may be formed, consisting of any members who wish to take part and devote their time to the project. The Subcommittee, supported by staff, would be dedicated to exploring the regulatory issues and would be charged with presenting a document or general outline to be considered by the whole Council by a specified date.
b.) Council staff may be charged with the task of presenting the Council with a general outline or options by a specified date. The staff may be tasked with exploring possible models, seeking comment and advice from industry, experts and scholars, and developing a proposal. This staff work may be specifically directed by the subcommittee on regulation (should the Council decide to form one).
c.) The Council may assign the project, with specific instructions, to a number of outside experts who would be called upon to offer proposals for regulatory models and report to the Council by a specified date.

Any of these options would need to be guided by answers to a specific set of questions, which need to be addressed before serious work on a regulatory system could begin. The Council may want to assign these questions to a subcommittee, staff, or others, or it may wish to answer them for itself before assigning the follow-up to anyone. These questions include:

a.) What needs to be regulated? What should be the scope of any system of regulation, what should it cover, under what organizing principle might its jurisdiction be established, and why? As noted above, other countries have tended to organize their systems around the human embryo-whether as a subject of research or a product of ART-or around human reproduction. Should we follow the same principles?
b) What is the purpose of the system? What should be the general principles of regulation? What publicly important purpose should the oversight or regulation serve? What needs will it meet that are currently unmet? What general principles and aims should guide the specific design of the regulatory system? Should it aim principally at safety, at protection of rights, at the advancement of science and knowledge, at respect for some concept of human dignity, or at some particular hierarchy or combination of these or other principles? The principles chosen at the outset would offer general guidelines for both the structure and the work of any actual regulatory system.
c) Who should do the regulating? How can things be arranged to secure both the best possible scientific information and the best ethical and prudential advice? How can things be arranged to prevent them from being co-opted by the special interest groups? How can things be arranged so that genuine public concerns will be addressed and the various important strands of public opinion can be represented in the deliberative processes?

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