Download Stem Cell Sciences Ltd – Position Statements

Submission on Stem Cell Research
From: Stem Cell Sciences Ltd
By: Dr Peter Mountford, CEO
Summary Conclusion
SCS supports the April 5th 2002 COAG decision to responsibly move forward unified
legislation enabling use of surplus human IVF embryos for stem cell research.
Stem Cell Sciences Ltd – Position Statements
1.
SCS supports unencumbered access to human embryonic stem cells for basic
and applied research by all qualified researchers, subject to appropriate
regulatory clearances and bound by the appropriate legislative guidelines.
We do not consider that in in vitro research using established hES cell lines
requires any further regulatory governance than research using any other cell
line.
2.
SCS supports the use of excess IVF embryos for the creation of new stem cell
lines and all other forms of justifiable in vitro research permitted within the
proposed guidelines
3.
SCS believes human embryo research requires stringent and tightly enforced
government regulation. Among these requirements should be:
- That the consultation process and documentation for potential embryo donor
consent should be consistent for all IVF clinics
- Donors should truly “donate”, that is, provide without unfair inducement or
financial benefit.
- There should be a cooling off period for donors, after agreeing to donate
4.
SCS believes all embryos donated by couples for the purposes of research
should be registered and allocated by an appropriate government authority,
with review and approval of the research team and the research project by
suitably qualified peers. Storage and distribution management of registered
embryos to qualified researchers could remain with the IVF clinic, however,
IVF clinics should not be able to determine who receives embryos, or which
specific embryo they will receive. [Quality and usefulness of embryos varies
dramatically]. We consider both of these issues to be very important.
5.
SCS believes that products derived from human embryo research, including
human embryonic stem cell lines and embryo cDNA libraries, should be made
available totally unencumbered of commercial constraints, to all qualified
researchers.
6.
SCS believes that a National Stem Cell Bank should be established, within an
independent government organisation, to distribute human stem cell lines to
researchers. This would be similar to the very recent September 9 British
Government announcement through its Medical Research Council (MRC),
that the National Institute for Biological Standards and Control (NIBSC)
would establish such a bank, operating independently of research institutions
and commercial organisations.
7.
SCS strongly opposes any commercial control and exploitation of such a
fundamental biological resource as human stem cells. SCS supports the
European Union’s Ethics Group recommendation to prohibit patenting of
unmodified human stem cells.
8.
SCS believes that approval to develop new human cell lines by academic
researchers as well as commercial entities should be subject to stringent
requirement including:
-
Meeting all suitable processes that will protect the privacy of the donors, who
should not benefit financially from such a donation
-
demonstrable competency of the researcher or organisation to achieve such a
result as proposed in their submission for cell line access
-
a guarantee from the researcher that all cell lines developed would be placed
into a National Stem Cell Bank, from which access would be provided to all
qualified researchers that do not have access to their own cell lines, or are
willing to provide their own cell lines to such a bank for the purposes of
unencumbered distribution by the Cell Bank.
9.
SCS believes that the introduction of the sunset clause limiting embryo
donation to embryos already frozen prior to a specific historic date as planned
under the draft legislation will be unnecessarily limiting. SCS considers it
likely to impose future restrictions on research and clinical development.
Company Overview
Stem Cell Sciences Limited (SCS ) is an Australian biotechnology business with a world
leading intellectual property (IP) and technology position in the area of Embryonic Stem
(ES) cells. The Company was founded in 1994 to commercialise stem cell research from
the University of Edinburgh’s Centre for Genome Research (CGR), with specific focus
on the growth, genetic manipulation and differentiation of ES cells. The IP developed by
SCS is being used to create more effective drug discovery and gene validation processes
and to pioneer the use of ES-derived somatic cells in regenerative therapies.
SCS is a public unlisted company that is majority owned and controlled by Australian
investors. Dr Peter Mountford, CEO and a co-founder of the company, has worked
actively in the stem cell field since 1991. He was the first postdoctoral scientist to join
professor Austin Smith’s newly established stem cell group at the CGR in 1991. This
research group, is now recognised as Europe’s leading ES cell research institute and
awarded Centre in Development status as the UK Medical Research Council’s Institute of
Stem Cell Research. On his return to Australia Dr Mountford founded the Monash
University Institute of Reproduction and Development’s stem cell research department
and continued as Group Leader of Stem Cell Biology within Professor Trounson’s
department until 1999 when he assumed his current role as CEO of SCS.
SCS has established research and development laboratories for a range of commercial
programs that utilise mouse ES cells. It would like to expand its Australian operations
(currently 8 staff) to include research with human ES cells derived from excess
Australian IVF embryos when legislation permits.
SCS has an operational British subsidiary, SCS (UK) Limited in Edinburgh, and in April
2002 established a new Japanese subsidiary. SCS has exclusive rights to stem cell IP
generated by the CGR’s team of 90 stem cell researchers, and collaboration agreements
with leading stem cell researchers at the newly established RIKEN Center for
Developmental Biology in Kobe, Japan.
SCS has 14 international patents or patent applications, which have enabled the Company
to establish a strong track record in securing successful research and licensing agreements
with international biotechnology and pharmaceutical companies, including Aventis,
Biotransplant Inc, Genentech and SmithKline Beecham. These alliances have provided
in excess of A$14 million of offshore investment in SCS’ technology platform. In
conjunction with Aventis it has developed a world first embryonic stem cell based
Alzheimer’s drug screening assay.
The Company’s ultimate goal is to deliver a safe and effective cell-based therapy to
global markets. As a pioneer stem cell company, specialising in stem cell research since
1994, it has built up considerable knowledge and an international reputation in the world
of stem cell research and development.
Peter S. Mountford PhD (Chief Executive Officer)
on behalf of Stem Cell Sciences