EU: Human Genetic Technology — June 2008 The Law Library of Congress - 3

Directive have been incorporated by the European Patent Convention through a decision of the
Administrative Council of the European Patent organization in 1999.°

The Directive provides that the human body cannot be subject to a patentable invention. The key
language is as follows: “[the] human body, at the various stages of its formation and development, and
the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot
constitute patentable inventions.”’ It also stipulates that “an element isolated from the human body or
otherwise produced by means of a technical process, including the sequence or partial sequence of a gene,
may constitute a patentable invention, even if the structure of that element is identical to that of a natural
element.”

Recital 41 of the Directive defines “cloning” as “any process, including techniques of embryo
splitting, designed to create a human being with the same nuclear genetic information as another living or
deceased human being.”” Pursuant to Article 6, the following are unpatentable:

processes for cloning human beings;

processes for modifying the germ line genetic identity of human beings;

uses of human embryos for industrial or commercial purposes; and

processes to modify the genetic identity of animals which are likely to cause suffering
without any substantial benefit either to animal or to humans. 10

In spite of the objectives of the Directive to harmonize patent legislation among the EU Members
and at the same time clarify which elements are subject to patent and which are not, application and
implementation of its provisions by EU Members proved to be cumbersome. Even though the
implementation deadline was set for 2000, by 2003, few EU Members had implemented it, forcing the
European Commission to institute legal proceedings against the Members. By 2004, most of the old EU
Members had implemented the Directive.'' As of January 2007, all twenty-seven EU Members had
transposed the directive into their national legislation. #

The Directive was challenged before the European Court of Justice in 1998. The Court upheld the
provisions of the Directive related to non-patentability of the human body. It added that the Directive
affords sufficient protection to the rights of human dignity and integrity, since it forbids patenting of the
human body or of the discovery of elements of the human body. The issue arose due to legal action
instituted by Netherlands, which requested that the Court of Justice annul the Directive. In its arguments,
Netherlands, supported by Italy and Norway, claimed inter alia that neither plants, nor animals, nor
human biological materials should be patentable and that the Directive in allowing the grant of patents for
isolated parts of the human body, “undermines the inalienable nature of living human matter which is a
component of the fundamental right to human dignity and integrity.”

© See Report from the Commission to the European Parliament and the Council, Development and Implications of
Patent Law in the Field of Biotechnology and Genetic Engineering, 7 COM(2002) 545 final.

7 Directive 98/44/EC, art. 5, para. 1.
8 Id., art. 5, para. 2.

° Id.

' Id. art. 4.

"’ For an analysis of this Directive and other issues related to patents in genetic testing, see Sirpa Soini, et. al.,
Patenting and Licensing in Genetic Testing: Ethical, Legal and Social Issues, 16 Eur. J. Hum.Genetics 10 (2008).

State of Play of the Implementation of Directive 98/44/EC, Jan. 15, 2007, available at htip://ec.curopa.cu
ctindprop/docs‘invent/state-of-play_en.pdf

'® See Press Release No. 48/01, Judgment in Case C-377/98 Netherlands v. Parliament and the Council (Oct. 9, 2001),
available at http:/eur-lex.europa.eu/LexUriServ/LexUriServ do2uri=CELEX:61998J0377:EN:HTML (last visited June 16, 2008),

internal



Comparative Analysis: Human Genetic Technology — June 2008 The Law Library of Congress - 3

use of IGM in research. The UK is tentatively moving towards permitting the use of IGM in
research, through a bill currently before the House of Commons.

Cloning

All countries in this study prohibit human cloning for reproductive purposes. Australia,
Israel, New Zealand, and the UK permit cloning for therapeutic purposes.Russia’s ban on cloning
provides a mechanism to cancel the ban if new knowledge and changes in moral, social, and
ethical rules occur.

The United Nations General Assembly has adopted a declaration on human cloning that
calls upon its member states to prohibit all forms of human cloning. Currently, all the countries
involved in this study expressly prohibit cloning for reproductive purposes. All the countries but
Russia, which does not have any provisions regulating the punishment for illegal activities
relating to genetic engineering, subject individuals that violate this law to a range of criminal
penalties, from imprisonment for up to ten years to fines. The United Nations Educational,
Scientific and Cultural Organization (UNESCO) unanimously adopted the Universal Declaration
on the Human Genome and Human Rights in 1997. This is a non-binding instrument, but
UNESCO is encouraging states to follow its principles, notably that reproductive cloning of
humans should not be permitted, but the Declaration acknowledges that freedom of research in
this area is “necessary for the progress of knowledge.”

The European Union’s Charter of Fundamental Rights of the Union expressly prohibits
the cloning of human beings. In addition to this, the European Parliament adopted a resolution in
2000, which stated that therapeutic cloning is contrary to public policy. Despite this resolution,
some countries in the EU permit therapeutic cloning.

Import/Export Issues

The countries involved in the study have various measures regarding the import and
export of human embryos that are cumulatively fairly restrictive and clearly intended to prevent
the export or import of embryos to bypass national laws. France requires that the import or
export of embryonic or fetal tissue cells be authorized by a government agency, and the
authorization is only granted if the tissues and cells have been obtained in compliance with the
principles of the French Civil Code. An additional condition for the export of tissues and cells is
that any research project involving these materials must involve a French research body. Russia
prohibits the export of cloned embryos across its state borders. The UK permits the export of
embryos and stem cells, provided they are sent to a licensed facility that is either within the EU
and licensed in accordance with EU directives, or in accordance with the laws of the country the
embryo or stem cells are being exported to. Embryos or stem cells may not be exported “if they
could not lawfully be used in licensed treatment services in the United Kingdom in the manner or
circumstances in which it is proposed that the gametes or embryos be used by the receiving
centre.”

Australia prohibits the import or export of human embryo clones and human embryos for
commercial trade purposes, and the import and export of human embryos is further regulated at
the state level. New Zealand prohibits the import or export of in vitro embryos that are formed
contrary to the laws of the country or those over fourteen days in development.


EU: Human Genetic Technology — June 2008 The Law Library of Congress - 7

establishments which are “accredited, designated, authorized or licensed” as such and also to ensure that
imported tissues and cells can be traced from the donor to the recipient and vice versa.

With regard to exports, Member States must ensure that exports to third countries comply with
the provisions of the above directives. In addition, Members must ensure that the following additional
requirements are met:

© Directive 2006/17/EC Implementing Directive 2004/23/EC As Regards Certain Technical
Requirements for the Donation, Procurement and Testing of Human Tissues and Cells. in case of
emergency, the import or export of certain tissues and cells may authorized directly by the
competent authorities;

© direct distribution to the recipient of specified tissues and cells for immediate transplantation can
be done with the agreement of the competent authority, provided that the supplier is accredited,
designated, authorized or licensed for such activity; and

© import and export of tissues and cells refer to in a) and b) must meet the general quality and
safety standards specified in the above directives.

Prepared by Theresa Papademetriou
Senior Foreign Law Specialist
June 2008


International Organizations: Human Genetic Technology — June 2008 The Law Library of Congress - 4

citing the “different ethical views about the value of human prenatal life.” Instead it recommended a
review of national level protocols and the process of information and consent of the couples involved.”*

The report does recommend that such pre-implantation diagnosis be limited to situations where it
is indicated for medical reasons, not for selection based on gender alone. It goes on to call unethical
selecting and implanting embryos with a similar genetic disease or condition to that of one of the parents,
testing for normal physical and mental characteristics, and analysis of the embryo to see if it is fit as a
donor of blood stem cells after birth to save the life of a sibling. The latter is considered acceptable only
if the embryo is also tested for the disease that affects the sibling. The fact that there is no match should
not be considered grounds for not selecting a healthy embryo.”°

In 2004, based in part on reports received from various nations under the DHGD, UNESCO
issued a statement on genetic privacy and non-discrimination.”° In the statement, nations were urged to
ensure that no one be subjected to discrimination based on genetic information, that those undergoing
genetic testing be assured of privacy, and that “prior, free, informed and express” consent be given for
any use or storage of human genetic data. This resolution calls on nations to promote standards for these
protections.” Through this resolution, UNESCO is asking countries to undertake to write the specific
standards and procedures that will be applied domestically, as well as deciding to continue considering
the ethical, legal, medical, employment, insurance, and other implications of genetic privacy and non-
discrimination issues.”*

World Health Organization (WHO)

The World Health Assembly issued a resolution in 1997 discussing human reproductive
cloning,” calling it “ethically unacceptable and contrary to human dignity and integrity.” The Assembly
re-affirmed that position in a resolution of the 51 Assembly meeting in 1998.*° That resolution also
urged Member States to continue debate on the issue and take steps to prohibit reproductive cloning.*!
The Director-General of the WHO was asked to establish a group of experts to clarify concepts and
develop guidelines on the use of cloning for non-reproductive purposes; to monitor the implications of the
use of cloning for human health; to ensure that Member States are informed of developments, so that they
can make decisions about national regulatory frameworks; and to report on actions taken to future
meetings of the Assembly.”

* Id.

id

26 Resolution 2004/9, from the 46" plenary meeting, July 21, 2004, available at http://www.unesco.rw'files
Adocs/shs/ecosoc_eng.pdf.

7 Id., paras. 3-4.

28 Jd., paras. 6 & 9.

2 Cloning in Human Reproduction, Resolution WHA 50.37, May 14, 1997, described on the WHO Web site at
http://www.who.in’genomics/publications‘governance/wha/wha049/en/index.html.

2° Ethical, Scientific and Social Implications of Cloning in Human Health, Resolution WHA 51.10, May 16, 1998,
available at hitp:/www.who.invethics/en/WHAS1_10.pdf

3" Id., para. 2.
2 Id., para. 3.


2008-01108

LAW LIBRARY OF CONGRESS
REGULATION OF HUMAN GENETIC TECHNOLOGY
INTERNATIONAL ORGANIZATIONS
Executive Summary

The United Nations Educational, Scientye and Cultural Organization
(UNESCO) has adopted a number of declarations and guidelines on the human genome
and genetic data, placing principles for genetic technology in a human rights framework.
One of these documents, the Universal Declaration on the Human Genome and Human
Rights, has been endorsed by the United Nations General Assembly. The UN has also
adopted « declaration on human cloning. It should be noted that these documents are not
in the form of binding treaties or agreements. The World Health Organization has also
issued resolutions and reports on aspects of genetic technology.

United Nations

The Universal Declaration on the Human Genome and Human Rights (UDHGHR), which was
adopted by UNESCO by unanimous acclamation on November 11, 1997, was endorsed by the UN
General Assembly on December 9, 1998.' It states that “The human genome underlies the fundamental
unity of all members of the human family, as well as the recognition of their inherent dignity and
diversity. In a symbolic sense, it is the heritage of humanity.”? In stressing the right to human dignity,
the UDHGHR further states, “The human genome in its natural state shall not give rise to financial
gains.”* It describes the rights of the persons concerned in genetic research, including the right to privacy
and to give consent to all procedures,’ and declares clearly that reproductive cloning of human beings
“shall not be permitted.”* However, it also affirms the freedom of research, describing it as “necessary
for the progress of knowledge.”*

The UDHGHR has sections on promotion of its principles and on implementation. They provide
that States should take steps to promote and implement UDHGHR principles though education.’ The
UDHGHR also refers to the International Bioethics Committee of UNESCO, calling on it to organize
appropriate consultations and make recommendations to follow-up on the UDHGHR conceming
“identification of practices that could be contrary to human dignity, such as germ-line interventions.”

' Text available from the UNESCO Web site in many languages, htip://portal.unesco.ory/shs/en/ev.php-

URL_ID=1881&URL_DO=DO TOPICKURL SECTION=201.htm! (last visited June 9, 2008).
? Id. art. 1.

Id, art. 4.

* Id., arts. 5-9.

* Id., art. 11.

° Id., art. 12, para. b.
7 Id., arts. 20-24.
* Id. art. 24.


Comparative Analysis: Human Genetic Technology — June 2008 The Law Library of Congress - 4

Concluding Remarks

The legislative regime involving the many aspects of human genetic engineering varies
from country to country depending upon a number of factors, both cultural and religious, as well
as the prevailing social views of the status of the embryo. The combination of these factors and
the country’s resulting decision as to whether the benefits accorded to society through the use of
embryos in research or reproductive technology overrides the costs has had an impact on the
legislative measures that are in place.

Prepared by Clare Feikert
Senior Foreign Law Specialist
June 2008


International Organizations: Human Genetic Technology — June 2008 The Law Library of Congress - 3

diagnosis and health care (including screening and predictive testing);

medical and other scientific research;

forensic medicine and civil, criminal, and other ‘egal proceedings; and

any other purpose consistent with the Universal Declaration or the Human Genome and Human
Rights (UDHGHR) and international bwenan rights law in general."°

The DHGD proposes that ‘the data be collected, processed, used, and stored on the basis of
“transparent and ethically acceptable procedures. States should endeavor to involve society at large in *~
decision-making process ... in particular in the case of population-based genetic studi-—“"" It envistons
that independent, multidisciplinary, and pluralist ethics committees sho»! ve created that would be
consulted regarding the establishment of standards, regulations: #14 guidelines for work in the field.
Informed consent of the person whose data is handle4 snould be obtained on the basis of clear, balanced,
adequate, and appropriate information, inel#ding details about the purpose for the collection of the data
and how the data will be stored and used.'” In addition, the declaration calls for every effort to be made

to ensure that the data are not used to discriminate in a way that infringes on human rights. "

The DHGD also contains provisions calling for accuracy and security in the processing of human
biological data; for States to regulate the cross-border flow of such data to foster international
cooperation, together with adequate protection of the data and samples; and for sharing the benefits of the
research.!? The articles on promotion and implementation of the declaration suggest that countries take
either legislative or administrative measures to give effect to the DHGD principles and enter into
agreements with each other to enable developing countries to build their capacities to participate in
research in the field. In addition, the DHGD suggests that States develop ethics education and training for
researchers as well as the public at large.*” The UNESCO International Bioethics Committee (IBC) and
the Intergovernmental Bioethics Committee are directed to contribute to the implementation of the
DHGD by collaborating in monitoring and evaluating that implementation. The two committees also
should formulate proposals to further the effectiveness of the Declaration and make recommendations to
UNESCO on the matter.”'

The IBC issued a report in 2003 on Pre-Implantation Genetic Diagnosis and Germ-Line
Intervention At that time, correction of specific genetic abnormalities in germ cells or early stage
embryos (i.e., germ-line intervention) had not yet been carried out. The report concluded, in part, that
“[bJecause of the many technical problems and uncertainties about possible harmful effects on future
generations, germ-line intervention has been strongly discouraged or legally banned [in domestic
legislation].””> The IBC declined to make a general statement on pre-implantation genetic diagnosis,

—_—_—

"5 [d., art. 5.

6 Id., art. 6.
"Id

"8 Id., art. 7.

19 Id., arts. 15-19.
2 [d., art. 23-24.
1 Id., art. 25.

2 SHS-EST/02/CIB-9/2 (rev. 3.), Apr. 24, 2003, available at hitp://unesdoc.unesco.org images/0013/001302
130248e.pdf.

23 [d., section VII, “Conclusions.”


‘THE LIBRARY OF CONGRESS
101 INDEPENDENCE AVENUE, S.E.
WASHINGTON, D.C. 20540-3230

LAW LIBRARY (202) 707-5077
DIRECTORATE OF LEGAL RESEARCH, (202) 707-1820 (FAX)
WESTERN LAW DIVISION

June 17, 200:

LL File No. 2008-01 KAD

TO: The Honorable Brad Sherman, Chairman,
Subcommittee on Terrorism, Nonproliferation and Trade
Committee on Foreign Affairs
U.S. House of Representatives

Attention: Don MacDonald

FROM: Clare Feikert ‘ fit A

Senior Foreign Law Specialist

SUBJECT: Human Genetic Engineering

In response to your June 5, 2008 request, please find attached reports on Australia, Canada,
France, Germany, Israel, New Zealand, Russia, the United Kingdom, International Organizations, and the
European Union and a brief comparative analysis of these reports.

If you have any questions concerning this issue, please call me at (202) 707-5262 or email me at
cfei@loc.gov. It has been my pleasure to assist you, and I hope that this information will be helpful.

The Law Library of Congress is the legal research arm of the U.S. Congress. We invite you to
visit the Law Library Web site at www.loc.gov/law, which details all of our services and provides access
to the Global Legal Information Network, a cooperative international database of official texts of laws,
regulations, and other complementary legal sources of many foreign jurisdictions. Should you need
further assistance with any other matter pertaining to foreign, comparative, or international law, please
contact the Director of Legal Research by email at law@loc.gov or by fax at | (866) 550-0442. Research
requests may also be directed to the Law Library’s Congress-only Hotline at (202) 707-2700, which is
staffed whenever either Chamber is in session.

Attachments


2008-01108
LAW LIBRARY OF CONGRESS

REGULATION OF HUMAN GENETIC TECHNOLOGY
EUROPEAN UNION
Executive Summary

In the area of science and biotechnology, the European Union (EU) is legally
bound to respect human rights and freedoms for its citizens. Such obligations arise from
the Treaties establishing the EU and also from the Charter of Fi undamental Rights. The
Charter explicitly prohibits human cloning. Furthermore, EU legislation on biotechnical
inventions stipulates as unpatentable processes for cloning of human beings and uses of
human embryos for industrial or commercial purposes.

Processing of genetic data, which falls within the definition of personal data, is
subject to the EU’s strict rules on privacy and personal data protection, established in
1995.

Under the Seventh Framework Program on Research and Technological
Development for the period of 2007-2013, any research proposal, in addition to the
technical standards, must undergo an ethical review. Otherwise, such proposals do not
qualify for EU funds.

I. Introduction

The European Union is founded on respect for human rights and fundamental freedoms, which
also form part of the legal traditions of its Member States. The Treaties establishing the European
Community/European Union, including the Lisbon Treaty which is in the process of ratification by EU
Members, contain language to the effect that the Union guarantees the rights and freedoms of its citizens.

‘Advances in the area of sciences, genomics, and biotechnology have generated extensive debates
within the European institutions and other EU bodies. Central to these discussions at the EU level are the
right to dignity and integrity of human beings and the right to confidentiality of personal data. These are
deemed to be core human rights which must be respected and balanced against other issues, such as
freedom of research and science and advancement of medicine for the betterment of mankind.

In general, ethical issues fall within the purview of the Member States, under the subsidiarity
principle. However, the EU’s approach in adopting legislation on ethical questions in the area of genetics
is to include specific reference to its legal obligation to respect human rights and observe ethical
standards, For instance, under the Seventh Framework Program for Research for the period of 2007-
2013, approved in 2006, research projects, to be eligible for EU funds must undergo an ethical review in
addition to the technical evaluation.

At the European Union level, ethical questions arising from new developments in science and
technologies are examined by the European Group on Ethics in Science and New Technologies (EGE).
Its task is to draft opinions for the European Commission in connection with the legislative drafting and
implementation of Community legislation.' The European Parliament has also established its own

"The European Group on Ethics in Science and New Technologies (EGE) is an independent, multidisciplinary, group
that plays an advisory role to the European Commission, Web site updated June 13, 2008, available at hitp:‘iec.
europa.cu/european_group_ethics/index_en.htm.



International Organi:

tions: Human Genetic Technology — June 2008 The Law Library of Congress - 5

The WHO has published a number of reports on issues related to human genetic technology, such
as Review of Ethical Issues in Medical Genetics,** and several reports on Cloning in Human Health.**
The WHO maintains a database of regulations from various nations and reports on policy matters related
to genetic technology.”*

Concluding Remarks

A number of resolutions, reports, and declarations have been adopted by international bodies that
discuss human genetic technology, data, and techniques such as cloning. They seek to insure human
dignity through the application of a human rights framework to developing policies in the field. The
documents are not binding agreements, but rather general statements of principles that encourage nations
to adopt legislation to protect human rights through privacy and consent procedures, and through a ban on
human reproductive cloning.

Prepared by Constance A. Johnson
Senior Legal Research Analyst
June 2008

33 D.C. Wertz, J.C. FLETCHER, & K. BERG, REVIEW OF ETHICAL ISSUES IN MEDICAL GENETICS (2003), available at
http:/Avww.who.in’genomics’publications/en/ethical_issuesin_medgeneti Dreport.pdf.

4 See, eg, WHO, Firty-SECOND WorLD HEALTH ASSEMBLY, CLONING IN HUMAN HEALTH: REPORT BY THE
SECRETARIAT (Apr. 1, 1999), available at hitp://www.who.invethics/en’A52_12.pdf; and WHO, Firty-THIRD Wor-p HEALTH
ASSEMBLY, CLONING IN HUMAN HEALTH: REPORT BY THE DIRECTOR-GENERAL (May 10, 2000), available at
http://www.who.inethics/en/AS3_15.pdf.

35 WHO, http:/www.who.int’genomics’elsi/regulatory_data/topic‘testing/en/ (last visited June 6, 2008).


International Organizations: Human Genetic Technology — June 2008 The Law Library of Congress - 2

A key aspect of the UDHGHR is that it is not a legally binding instrument, in the way that a
multilateral convention would be. It has therefore been described as one of “just the first steps towards
the elaboration of an international biomedical law ... .””

The UN General Assembly has also adopted a declaration on human cloning.'® It calls for
Member States to:

e adopt all measures needed to protect human life in the application of life sciences;

e prohibit all forms of human cloning;

* adopt measures needed to prohibit the application of genetic engineering techniques that may be
contrary to human dignity;

¢ take measures to prevent the exploitation of women in the application of life sciences;

e adopt and promptly implement legislation to bring these principles into effect; and

* in the financing of medical research, take into account pressing global issues such as HIV/AIDS,
tuberculosis, and malaria, all of which have a particular impact in developing countries.

UNESCO

The International Declaration on Human Genetic Data (DHGD) of October 16, 2003, was
adopted unanimously at UNESCO’s 32nd General Conference.'’ It was based on the UDHGHR and on
prior UNESCO resolutions and is designed to ensure the, “Respect of human dignity and protection of
human rights and fundamental freedoms in the collection, processing, use and storage of human genetic
data, human proteomic data’? and of the biological samples from which they are derived ....” In addition,
the DHGD states that any such handling of human biological samples must be consistent with the
international law of human rights and that the provisions of the Declaration apply in all cases except in
the investigation, detection, and prosecution of criminal offenses and in testing for parentage. In those
two situations, domestic law that is consistent with the international law of human rights applies. °

The DHGD also is written as a declaration, not a treaty, so it repeatedly uses terms like “every
effort should be made to ensure that” and “it is ethically imperative that,” which underline the fact that it
is not a binding, international agreement, but a rather a set of standards. '*

The DHGD outlines the purposes for which human genetic and proteomic data may be collected,
processed, used, and stored. They are:

°® Roberto Andormo, Biomedicine and International Human Rights Law: In Search of a Global Consensus, BULLETIN
OF THE WORLD HEALTH ORGANIZATION 959-963 (2002). The author is a member of the UNESCO International Bioethics
Committee.

10 United Nations Declaration on Human Cloning, A.RES.59/280, Mar. 8, 2005, available at hitp:/daccessdds.

un.org/doc/ UNDOC/GEN/N04/493/06/PDF/N0449306.pdf?OpenElement.

i UNESCO Web site, _hittp://portal.unesco.org/shs/en/ev.php-URL_ID=1882&URL_DO=DO_TOPIC&URL
SECTION=201 html (last visited June 6, 2008).

Human proteomic data is defined in article 2 of the DHGD as “information pertaining to an individual's proteins
including their expression, modification and interaction.”

© DHGD, art. 1.
TM See, e.g. id., arts. 6 & 7.



Comparative Analysis: Human Genetic Technology — June 2008 The Law Library of Congress - 2

New Zealand Yes No Yes — non- Yes
reproductive

Russia Yes No Yes — non- Yes
reproductive

UK Yes No Yes - non- Yes
reproductive

The Use of Human Embryos in Research

Australia, Canada, Israel, New Zealand, Russia, and the UK, have taken a pragmatic
approach to the use of human embryos in research and permit it, within the limits of their
legislation. All these countries recognize that the embryo has a special status and have drafted
laws to take this into account, permitting the use of embryos but restricting the time period in
which they can be used. Australia, Canada, New Zealand, Russia, and the UK require that a
license be obtained from the countries regulatory body before embryos can be used, to ensure that
embryos are only used when absolutely necessary and that their use is according to the purposes
of the law. These countries all have general public support of this type of research being
undertaken on human embryos.

Russia has not altered its laws on this issue for the past seven years. France and Germany
have restrictive regimes regarding the use of embryos. Germany currently has a law that provides
legal protection to embryos, from the moment the cell nuclei fuse, and also provides embryo
status to “any totipotent cell that has been taken from an embryo and that is capable of partition
and of developing into an individual.” Given that the embryo is protected, Germany thus has a
restrictive policy on human genetic engineering and does not permit any form of cloning or
inheritable genetic modification, and only allows limited pre-implantation genetic diagnosis on
unfertilized ovum. It only permits stem cell research on specific imported stem cell lines. France
has a general rule that prohibits research on embryos; however, it excludes from this rule research
on embryos and embryonic stem cells if this results in major therapeutic benefits and there is no
alternative method of research available, and in such cases allows for a trial of five years, after
which time the Parliament will review the law.

Pre-implantation Genetic Diagnosis

PGD is permitted in Australia, Canada, France, Israel, New Zealand, and the UK.
Australia, France, New Zealand, and the UK restrict the use of PGD to the diagnosis of certain
disorders and do not permit the use of PGD for the purposes of sex selection. Germany has a
very restrictive regime in place on the use of PGD, and only permits its use on unfertilized eggs.
Israel does not have any laws in place that regulate the practice of PGD, and its use is regulated
on a case-by-case basis for medical reasons by hospital committees. Israel allows the use of PGD
for the purposes of sex selection in extremely limited circumstances, which extends to family
balancing. The use must be approved by a State Committee and currently that Committee has
only approved the use of PGD for sex selection in one instance, for “humanitarian purposes.”

Inheritable Genetic Modification

All the countries involved in the study do not permit the use of IGM for reproductive
purposes, with many considering that this is contrary to human dignity. The majority restrict the



EU: Human Genetic Technology — June 2008 The Law Library of Congress - 4

Meanwhile, new developments in genetic engineering and application of the Directive generated
new issues. The European Commission proceeded to clarify such issues in two reports: on the
Development and Implication of Patent Law in the Field of Biotechnology and on Genetic Engineering,
prepared in 2002 and 2005. *

The EGE, which is entrusted by the above Directive with the task of examining all ethical issues
arising from biotechnology, prepared an opinion in 2002, on ethical aspects of patenting inventions
involving human stem cells. 'S The EGE clarified that “only stem cell lines which have been modified by
in vitro treatments or genetically modified so that they have acquired characteristics for specific industrial
application, fulfill the legal requirements of patentatiblity” can be patented. Regarding processes
involving human stem cells, whatever their source, since there is no specific ethical obstacle and provided
that they meet the other legal criteria for a patent, they can be patented."*.

Advanced Therapy Medications

Regulation No. 1394/2007 on Advanced Therapy Medicinal Products’? defines “advanced
therapy medicinal product” to include the following;

¢ agene therapy medicinal product;
¢ asomatic therapy medicinal product; and
© atissue-engineered product.'*

The Regulation establishes for the first time the term “engineered cell or tissue.” A tissue-
engineered product, which could include cells or tissues of human or animal origin, is a product that
contains or consists of engineered cells or tissues and is administered to humans with the objective of
regenerating, repairing, or replacing a human issue. '° This Regulation also makes a general reference to
the effect that it is in compliance with fundamental rights, the principles enunciated in the Charter of
Fundamental Rights of the EU, and those embodied in international instruments adopted by the Council
of Europe.

Privacy Concerns Related to Genetic Data

In general, the EU has strict rules concerning privacy and personal data protection. Genetic data
falls within the definition of article 2(a) of Directive 95/46/EC on the Protection of Individuals with
Regard to the Processing of Personal Data and on the Free Movement of Such Data.*! Personal data is
defined as “any information relating to an identifiable natural person (data subject); an identifiable person
is one who can be identified, directly or indirectly, in particular by reference to an identification number
or to one or more factors specific to his physical, physiological, mental, economic, cultural, or social
identity.”

See Report from the Commission to the Council and the European Parliament, Development and Implications of
Patent Law in the Field of Biotechnology and Genetic Engineering, COM(2005) 312 final

'S Ethical Aspects of Human Stem Cell Research and Use, Nov.14, 2000, available at http://ec.europa.ew’
european_group ethics/docs/avis15_en.pdf.

"6 Id, at 15.

7 2007 O.J. L 324 121.

'8 [d., art. 2, para. I(a).
"9 Id., art. 2, para. 1(b).
2 [d,, Recital 8

* 1995 O.J.L 281 31.


EU: Human Genetic Technology — June 2008 The Law Library of Congress - 6

(hESC) EP7 Research Project stipulating the guidelines to be followed during the ethics review of any
research proposals on human embryonic stem cells under the 7" Framework Program.”*

The Seventh Framework Program of the European Community for Research, Technological
Development and Demonstration covers the period 2007-2013.” Each research proposal that raises
ethical questions is subject to at least two independent ethical reviews: a) in the Member States where the
research will be carried out; and b) at the European Union level.

As a general basic requirement, the Seventh Framework program specifies that that all research
activities undertaken under this program must follow fundamental principles, including those contained in
the Charter of Fundamental Rights of the European Union, and must take into account the opinions of the
European Group on Ethics in Science and New Technologies.

The following fields of research shall not be financed under the Seventh Program;

* research activity on human cloning for reproductive purposes;

* research activity intended to modify the genetic heritage of human beings which could
make such changes inheritable;

¢ research activities intended to create human embryos for the purpose of research or for
the purpose of stem cell procurement by means of somatic cell nuclear transfer.*”

The following fields of research may be financed:

¢ research on human stem cells, both adult and embryonic, depending on the contents of
the proposal. Applications to receive funding for research on human embryonic stem
cells must include licensing and control measures that must be applied by the national
authorities of the Member States;

© derivation of human embryonic stem cells, by institutions, organizations, and researchers
that must be subject to strict licensing requirements.”!

In July 2007, the EGE recommended that the following criteria must apply to hESC: a) human
embryonic stem cell lines have to result from non-implanted IVF embryos; b) hESC lines banked in the
European Registry should be used where possible; c) if alternatives to hESC with the same scientific
potential as those derived from embryos are found in the future, their use has to be exploited; and d)
donor’s rights regarding informed consent, data protection, and free donation must be protected.**

Import and export of human tissues and cells, including fetal tissues and cells and adult and
embryonic stem cells, are regulated by Directives 2004/23/EC* and Directive 2006/17/EC.* With
regard to imports of tissues and cells from third countries, article 9 of Driective 2004/23/EC requires
Member States to take all necessary measures to ensure that such imports are undertaken by tissue

* Id.

> Decision No. 1982/2006/EC Concerning the Seventh Framework Program of the European Community for Research
Technological Development and Demonstration Activities (2007-2013). 2006 O.J. L412 1

3° Id, art. 6: Ethical Principles of the Seventh Framework Program.
aU id
*° EGE, supra note 27

% Directive 2004/23/EC on Setting Standards of Quality and Safety for the Donation, Procurement, Testing,
Processing, Preservation, Storage and Distribution of Human Tissues and Cells, 2004 0.J. L102 48.

Directive 2006/17/EC Implementing Directive 2004/23/EC As Regards Certain Technical Requirements for the
Donation, Procurement and Testing of Human Tissues and Cells, 2006 O.J. L38 40.


———_@—____

\ The Law Library of Congress
=»

=
REPORT FOR CONGRESS
June 2008

Directorate of Legal Research
LL File No. 2008-01108

REGULATION OF
HUMAN GENETIC TECHNOLOGY

Australia, Canada, France, Germany, Israel, New Zealand, Russia, the United Kingdom,
International Organizations, and the European Union, plus a brief comparative analysis of
these reports.

Directorate of Legal Research for Foreign, Comparative, and International Law
James Madison Memorial Building; 101 Independence Avenue, S.E.; Room LM 240; Washington, DC 20540-3200
Reception: (202) 707-5065 — FAX: 1 866-550-0442

www.loc.gov/law/congress


2008-01108
LAW LIBRARY OF CONGRESS
REGULATION OF HUMAN GENETIC TECHNOLOGY
COMPARATIVE ANALYSIS
Executive Summary

The countries of this study have taken either a regulatory approach to
human genetic engineering or have prohibited it completely. The various
approaches to this issue demonstrate the complex moral, ethical, and social
dilemmas that have presented themselves to governments. Various international
groups have put forth a number of principles in the form of declarations and
resolutions but there has yet to be a binding multilateral treaty on this issue,
reflecting the difficulty in negotiating such an instrument.

Introduction

The following comparative analysis is based on the Law Library of Congress Reports for
Australia, Canada, France, Germany, Israel, New Zealand, Russia, the United Kingdom,
International Organizations, and the European Union. All the countries involved in this report
have laws governing the use of embryos that take into account the unique cultural and religious
identities of the countries. All the countries of the report have expressed concern over the moral
and ethical dilemmas that are imposed by the use of human embryos in research and consider that
the embryo has special significance, demonstrated either by prohibiting its use in research and
genetic related testing completely, or through stringent regulations. There have been a large
number of efforts at the international level, in the form of declarations, reports, and resolutions, to
regulate the use of human embryos and genetic engineering, and to prevent cloning for
reproductive purposes. The European Union has produced a number of Directives that regulate
genetic issues amongst its Member States.

The following table shows whether the countries of the report permit pre-implantation genetic
diagnosis (PGD), inheritable genetic modification (IGM), cloning, and stem cell research.

Country PGD IGM Cloning Stem Cell
Research
Australia Yes No Yes — non- Yes
reproductive
Canada Yes No No Yes
France Yes No No Yes
Germany Yes -—limited to | No No Limited to
pre-fertilization certain imported
stem cell lines
Israel Yes Yes — non- Yes — non- Yes
reproductive reproductive



EU: Human Genetic Technology — June 2008 The Law Library of Congress - 2

committees. Moreover, the 1995 Directive on Personal Data established a Working Party, which advises
the European Commission on issues and impeding legislation that may have an adverse impact on EU
tules on privacy and personal data protection.

II. General Principles Governing Genetic Engineering and Genetic Data

The Lisbon Treaty, which is in the process of ratification by the EU Members, reiterates language
contained in earlier documents concerning the rights and freedoms of European citizens. Two key
provisions must be stated:

* the Union recognizes the rights, freedoms, and principles as established in the Charter of
Fundamental Rights of the European Union; and

© fundamental rights, as guaranteed by the European Convention for the Protection of Human
Rights and Fundamental Freedoms and as they result from the constitutional traditions common
to the Member States, shall constitute general principles of the Union’s law.

The Charter of Fundamental Rights of the European Union stipulates that in the field of medicine
and biology, the following must be respected:

e the free and informed consent of the person concerned;

the prohibition of eugenic practices, especially those which aim at the selection of persons;
¢ the prohibition on making the human body and its parts a source of financial profit;
the prohibition of the reproductive cloning of human beings.”

The Charter also prohibits discrimination based on genetic features.’
III. Genetic Issues Regulated by the European Union
Human Cloning

Article II-3, paragraph 2(d) of the Charter of Fundamental Rights of the Union, which was
proclaimed in Nice in 2000, explicitly prohibits the reproductive cloning of human beings. In 2000, the
European Parliament adopted a resolution on Human Cloning which stated that “therapeutic cloning”
which involves the creation of human embryos exclusively for research purposes raises “a profound
ethical dilemma” and is against the public policy. It urged the Member States to enact binding legislation
banning human cloning and to adopt criminal penalties for any violators.*

Patents
Directive 98/44/EC of the European Parliament and of the Council on the Legal Protection of

Biotechnological Inventions’ in general prohibits the patentability of inventions in cases where their
commercial exploitation would be contrary to public order or morality. The basic provisions of the

2 Art. 3 of the Charter of Fundamental Rights of the European Union, 2000, OFFICIAL JOURNAL [OJ] C 364 9.
3
Id., art. 21.

+ European Parliament Resolution on Human Cloning, adopted / Sept. 7, 2000, available at
hittp:/www.europarl.europa.cwomk/omnsapir.so/pv2?PRG=CALDOC& TPV=PROV&FILE=000907&TXTLST=1 &POS=1&SD
OCTA=8&Type_Doc=FIRST&LANGUE=EN. See also previous resolutions: 1989 on the Ethical and Legal Problems of
Genetic Engineering, 1993 on the Cloning of the Human Embryo, 1997 on Cloning, 1998 on Human Cloning.

$ 1998 OJ L 213 13.



EU: Human Genetic Technology — June 2008 The Law Library of Congress - 5

The Directive subjects certain categories of personal data which are extremely sensitive to stricter
safeguards. Health data fall within this particular group. The EGE has deemed that since genetic data
provide specific information on a person’s health status, physical details. or even ethnic origin, they must
be treated as sensitive data and should be subject to an increased level of protection.”

Consequently, genetic data are subject to the following standards:

° they can be processed only by health professionals subject to professional confidentiality and
secrecy for the purpose of preventive medicine, care and treatment, or medical diagnosis;”*

© genetic data can be collected for specific, explicit, and lawful purposes (finality principle) ;

* processing of genetic data must be adequate, relevant, and proportionate to the purpose for which
the data were collected (proportionality principle); and

© the data subject has the right to receive information prior to any genetic testing performed and
give explicit and informed consent.

On the issue as to whether genetic data belong to a specific individual or whether family members
have the right to access such data, the EGE argued that genetic data can be considered “a shared
information,” since family members may claim that they have the right to know of tests that could have
an impact on their own health.

Concerning the processing of genetic data in the area of employment, the Working Party has
concluded that processing should be prohibited in principle and that authorization could be possible under
very limited cases.** The expediency and legality of such processing were also assessed by the EGE. An
opinion of that group adopted in July 2003 on Ethical Aspects of Genetic Testing in the Workplace stated
that “there is, up to now, no proven evidence that the existing genetic tests have relevance and reliability
in the context of employment. They still have uncertain predictive value.”**

The Working Party also concluded that processing of genetic data for insurance purposes must be
banned in principle and allowed under very limited cases prescribed by law, in order to avoid
discrimination based on one’s own genetic profile. A 2001 report issued by the European Parliament
Committee on Human Genetics also urged that insurance companies must be prevented from requiring
genetic testing.”°

Research and Development

Human embryonic stem cell research is a controversial topic among the EU Members, and their
legislative measures reflect their diverging opinions and their different ethical, religious, social, and
political beliefs. In a 2007 opinion, the EGE made clear that “the ethical dilemma regarding the moral
status of the human embryo and its use in research still persists both within the EGE and the EU.””” The
opinion contained the Recommendations of the Ethical Review of the Human Embryonic Stem Cell

2 Id. See art. 29, Data Protection Working Party, Working Document on Genetic Data, Mar. 17, 2004, 12178/93/EN
WP 91, available at http://ec.curopa.ewjustice_home’fs/privacy/docs/wpdocs/200-4/wp91_en.pdf. The Working Party was
established under art. 29 of Directive 95/46/EC and functions as an independent advisory body to the European Commission on
issues related to data protection and privacy.

* Directive, id., art. 8.

TM The Working Party, Ethical Aspects of Genetic Testing in the Work Place, July 28, 2003, available at
hutp://ec.curopa.eweuropean_group_ethics/docs/avis18_en.pdf.

> [d., at Opinion2.9.

2° Temporary Committee on Human Genetics and Other New Technologies in Modern Medicine,
hitp://Avww.curoparl.curopa.cw/comparl/tempcom/genetics/intro_en.htm (last visited June 13, 2008).

27 EGE opinion, July 12, 2007, available at hup://ec.curopa.cu’european_group_ethics/activities/docs/press

release_opnion 22 final _follow_up_en.pdf.