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6-Regulation: MEPs vote to ban stem cell research

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                                  PART I
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TITLE:  MEPs vote to ban stem cell research
SOURCE: British Broadcasting Corporation, UK
DATE:   Apr 10, 2003

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MEPs vote to ban stem cell research

European MPs have voted against allowing scientists to carry out research
on stem cells taken from embryos. The vote by members of the European
Parliament (MEPs) could now see this type of research outlawed across the
EU. At present, it is legal in the UK but is banned in other member
states, while others have no regulations at all. MEPs will have to vote
on the proposed new law again before it can come into effect. It also
needs the support of individual member states. However, if a majority of
EU ministers back the proposal this type of research could come to an end
in the UK.

Disease cures

Supporters of stem cell research say it could hold the key to cures for a
wide range of serious diseases, including Alzheimer's and Parkinson's.
Stem cells are cells at an early stage of development which have the
potential to turn into many different types of tissue. We are going to
start working very hard to ensure these amendments don't go through David
Bowe MEP They can be taken from adult tissue samples, or samples taken
from human embryos. It is thought that embryonic stem cells may prove to
be much more versatile in being adapted for medical use than adult cells.
But opponents say it is unethical to use embryos because they represent
the first stages of human life and it should be banned. Under the
proposals, cloning for human reproduction will be outlawed and research
using embryonic stem cells will be restricted. There would also be new
rules on obtaining tissue samples. Critics say these would make research
impractical or too expensive.

David Bowe, Labour's environment spokesman in the European Parliament,
criticised the result. "I am quite annoyed about it. It is wrong for the
religious right to assert its own moral view on the rest of us." "There
is no moral consensus in Europe on this and it really should be left up
to individual member states to decide." Mr Bowe said he was confident the
proposed ban could be defeated when the legislation is considered again
by MEPs. We are very disappointed with this initial vote Sir George
Radda, Medical Research Council "We are going to start working very hard
to ensure these amendments don't go through," he told BBC News Online.

But Maria Louise Flemming, the Austrian Christian Democrat MEP who tabled
the amendments calling for the ban, defended the result. "From the moment
of the conception, you create all the individual characteristics of a
person," she said.

British criticism

British experts have criticised the vote in the European Parliament in
Strasbourg. Sir George Radda, chief executive of the Medical Research
Council, said: "We are very disappointed with this initial vote. If it
were to lead to legislation it would severely limit embryonic stem cell
research and its potential to combat serious human diseases."

Professor Lord May of Oxford, president of the Royal Society, said: "We
are very disappointed that the European Parliament has backed this
cynical manipulation of the legislative process by a small minority who
want to overturn the rights of individual member states to make their own
democratic decisions about whether to allow research on human embryonic
stem cells and therapeutic cloning."

Linda Kelly, chief executive of the Parkinson's Disease Society,
criticised the vote. "The result of today's vote is potentially a major
step backwards," she said. Annwen Jones, chief executive of the Juvenile
Diabetes Research Foundation, said: "We are disappointed at the result of
this vote and its implications for research towards a cure for diabetes,
in which so much progress has been made, as well as for many other
conditions. "The UK has the best environment for this type of research
and it is imperative it continues."

Dr Moira Murphy, director of research at Diabetes UK, said: "People with
diabetes deserve the best possible chance in life. Stem cell research
using embryonic cells could one day provide a cure. The people of Britain
have said they are in favour of this research. "Our doctors should be
allowed to try and put an end to the daily injections and the threat of
blindness, heart disease and amputations which are part of the life of
people with diabetes."

A survey published this week suggested a majority of Britons backed the
use of human embryos for medical research in certain circumstances.

                                  PART II
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TITLE:  Italy extends 1997 cloning ban for six months
SOURCE: Reuters, by Rosella Lorenzi
DATE:   Jan 3, 2002

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Italy extends 1997 cloning ban for six months

FLORENCE (Reuters Health) - Italy's Health Minister Girolamo Sirchia has
extended for another six months a ban on cloning enacted in 1997, while
waiting for the country's Senate to approve a law on assisted
reproduction. The ban, which forbids any form of experimentation and
intervention "even indirectly" in the field of human cloning, will be
valid until June 30, as written in the state official journal Gazzetta
Ufficiale. Sirchia also extended other articles, which prohibit the
commercialisation of "gametes and human embryos and any genetic
material." The validity of a 2001 ordinance, which bans imports of
embryos or gametes, has also been stretched to the same deadline. The
measure has been taken "considering that the reasons which prompted the
previous bans are still subsisting," the ordinance says. Italy has been
waiting for a law regulating assisted fertility for 36 years. A new,
controversial law, which was approved by the Italian parliament in June,
is due to be debated at the Senate in February. The new regulation would
include prison terms of up to 20 years, fines up to 1 million euros, and
the end of the individual's career for "anyone who realises a project
which aims to obtain a human being from one starting cell, genetically
identical to another human being, alive or dead."

                                  PART III
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TITLE:  French senate adopts cloning ban
SOURCE: Agence France Press,313,&item_id=28471
DATE:   Jan 30, 2003

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French senate adopts cloning ban

PARIS, Jan 30 (AFP) - The French senate this week adopted a series of
draft laws that would ban cloning in almost all cases, including for
research, commercial exploitation and medical uses. The measures, voted
Wednesday and Thursday, are in line with French President Jacques
Chirac's stated opposition to cloning, which he described last month as
"contrary to human dignity and criminal". The draft laws - that have yet
to be passed by the lower house of parliament to come into effect - would
prohibit the cloning of humans as well as the related technique of
creating cloned stem-cell cultures that can be used therapeutically.
Chirac's right-wing supporters, who dominate both the senate and the
lower chamber, adopted the ban on therapeutic cloning in a vote opposed
by the left-wing opposition.

                                  PART IV
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TITLE:  Italy Extends Ban on Gene Therapy Trials
SOURCE: Reuters, by Rosella Lorenzi
DATE:   Feb 6, 2003

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Italy Extends Ban on Gene Therapy Trials

FLORENCE (Reuters Health) - In a move judged "reasonable" by Italy's
leading gene therapy scientist, health minister Girolamo Sirchia has
extended a ban on all gene therapy trials involving retroviruses for
another four months.

Sirchia's instructions extend the ban, which was enacted in October 2002
in a special and "urgent" order, to the end of May.

The ban was enacted when a boy in France developed a leukemia-like
disease after undergoing gene therapy for x-linked severe combined
immunodeficiency (X-SCID), sometimes known as "bubble boy" disease. A
second boy was found to have the same problem in January 2003.

"The decision has been made since it is not possible yet to know the
reasons of the first serious adverse effect case, recorded in a clinical
trial abroad, which determined the first halt. We also took into
consideration a second case recorded in the same trial," Sirchia said in
an official note.

Both children had seemingly been cured of X-SCID before the leukemia
symptoms began and were among 10 gene therapy patients in France with the
condition who were living normal lives. In the treatment, genes are
inserted into immune system cells using a retrovirus.

"I find the health ministry's decision reasonable. However, I find even
more reasonable the US and German regulators' decision to give the green
light for the continuation of all gene therapy studies involving T
lymphocytes. Data on this therapy is larger and comforting," Dr. Claudio
Bordignon, scientific director of the San Raffaele Institute in Milan,
told Reuters on Wednesday

Leading the European effort in gene therapy, the San Raffaele Institute
is currently conducting three trials: a clinical study of gene therapy
for one type of SCID; an AIDS (news - web sites) gene therapy trial and a
study on the use of a "cell suicide gene" for the treatment of leukemias
and other tumors of the blood.

The first trial gained international recognition in June 2002, when
Bordignon and colleagues reported that they had used gene therapy to
restore the immune systems of two children with adenosine deaminase (ADA)
gene deficiency, which also causes SCID.

Additional rules in the health ministry's ban specify that the Italian
National Health Institute can approve ongoing trials upon evaluation of
the risk-benefit ratio for each patient.

Bordignon plans to ask authorization for three cases this month.

                                  PART V
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TITLE:  Parliament backs stem cell research
SOURCE: swissinfo, by Jonathan Summerton
DATE:   Mar 12, 2003

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Parliament backs stem cell research

The Senate has voted in favour of government proposals to allow research
on stem cells from surplus human embryos.

But, as expected, it refused to give the go-ahead for research on the
embryos themselves until a new law is formulated.

The proposals still need to be approved by the House of Representatives
before they become law.

A Senate commission had already made changes to the draft legislation -
distinguishing between stem cell research and research on human embryos.

The distinction is one which Denis Duboule, a professor of biology at the
University of Geneva, says does not make a great deal of sense in
scientific terms.

"An embryo is a collection of stem cells and therefore if you take an
embryo and sort out the cells, you will have stem cells," he told swissinfo.

"In other words you need to work with embryos to derive stem cells, and
with a stem cell you can reconstruct an embryo."

You need to work with embryos to derive stem cells, and with a stem cell
you can reconstruct an embryo. Denis Duboule, Professor of Biology, Geneva

Government proposals

The Senate decided to allow the production of stem cells from surplus
embryos up to seven days old - down from the government's original
proposal of 14 days.

But it rejected the creation of embryos purely for research purposes and
banned cloning for the purpose of treating diseases.

Stem cells can only be derived from surplus embryos normally used for in-
vitro fertilisation (IVF), which would otherwise be destroyed.

Consent of the couple whose fertilised egg cells are being used would
also be required, as will proof that no other line of research can
achieve the same ends.

For research to go ahead permission will need to be granted by either the
Federal Office for Health or the ethics commission.

The importation of stem cells will be allowed but only under very strict
conditions: researchers will need to be able to prove that the cells
originated from surplus embryos. The use of stem cells and embryos for
commercial purposes will be forbidden.

Apparently normal embryos can be genetically abnormal. Joe Leigh Simpson,
Professor, Baylor School of Medicine, Houston

Women's health

Research on human embryos is already having an impact on women's
healthcare, according to Joe Leigh Simpson, professor of obstetrics and
gynaecology at Baylor School of Medicine in Houston, Texas.

He maintains that in IVF, the method of pre-implantation genetic
diagnosis - or testing of an embryo to find out whether it is healthy and
has the complete genetic make-up - has increased the success rate of IVF
treatment and reduced the number of multiple births.

At the same time it has led to a drop in the rate of miscarriages among
older women.

"The problem is that by simply looking at an embryo we cannot predict
whether or not it is normal," he told swissinfo.

"Apparently normal embryos can be genetically abnormal - and only by
being able to test are we able to find out exactly what the situation is."

Although pre-implantation genetic diagnosis is currently illegal in
Switzerland, Duboule believes at some point in the near future it will be
incorporated into Swiss law.

Ethical debate

The use of human embryos for research purposes has not only triggered a
legal debate in Switzerland, it has also led to an examination of the
moral issues involved.

Switzerland's advisory commission on biomedical ethics was involved in
deliberations as the government put together its proposals.

The main concern of the commission's president, Christoph Rehmann-Sutter,
was the protection of the "moral dignity" of human embryos.

"We must be clear about the reasons why we care about embryos ethically,"
he said. "Embryos are significant morally because they belong to human

"In a certain sense we must say that we have all been embryos at the
beginning of our life."

Duboule recognises the validity of the ethical debate surrounding
research on human embryos, but maintains that within the next 15 years it
will probably be a recognised form of research worldwide.

"I'm pretty convinced it's going to be routine," he said. "So it's
absolutely essential to have the proper legislation and legal tools to
organise this research."

                                  PART VI
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TITLE:  Vietnam to ban human cloning and surrogacy
SOURCE: Australian Broadcasting Corporation
DATE:   Feb 16, 2003

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Vietnam to ban human cloning and surrogacy

The Vietnamese government has approved a decree banning human cloning,
surrogacy and all means of choosing the sex of embryos. The law, which
will come into effect by May 1 will prohibit cloning of humans in all
cases and the diagnoses of an embryo's sex due to the boy-biased
psychology of Vietnamese people. The Thanh Nien newspaper said however,
the decree allows the application of reproductive technologies, such as
in vitro fertilisation. Foreigners can use assisted reproductive
technology services in Viet Nam, but they are banned from donating or
receiving eggs, sperm and embryos.