1.  EXECUTIVE SUMMARY

  1.1.  The Parkinson's Disease Society (PDS) welcomes the Science and Technology Committee's inquiry into proposals published by the Department of Health in December 2006 regarding the regulation of the creation of hybrid and chimeric embryos for research purposes.

  1.2.  The PDS believes that research involving hybrid cell lines offers exciting possibilities for the development of leading edge technologies that could lead in turn to the development of new treatments and ultimately potential cures for a wide rage of conditions, such as Parkinson's, which alone affects millions of people in the UK.

  1.3.  We are concerned about the potential implications the proposed Government reforms to the Human Fertilisation and Embryology Act (1990) could have on this important area of research, and have set out the nature of our concerns in the following submission. We are urging the Government to fully engage with the research community and patient groups on this specific issue before introducing legislation that could have the effect of preventing or delaying progress in these important research approaches.

2.  PARKINSON'S DISEASE

  2.1.  Parkinson's disease is a progressive neurological disorder that affects all activities of daily living including talking, walking, communication, swallowing and writing. It is estimated that 120,000 people in the UK have Parkinson's, one in 500 of the general population. Approximately 10,000 people are newly diagnosed with Parkinson's each year in the UK.

  2.2.  Parkinson's occurs as a result of a loss of cells that produce the neuro-transmitter dopamine. Dopamine is one the chemical messengers that we have in the brain which enables people to perform coordinated movements. As yet it is not known why these cells die.

  2.3.  Parkinson's is often characterised by three key motor symptoms: tremor, muscle rigidity and slowness of movement. Other symptoms that may develop include difficulties with balance, sleeping problems, speech difficulties, problems with the digestive system, pain, depression and dementia, however Parkinson's affects every individual differently and not everyone will experience all of these symptoms.

  2.4.  The cause of Parkinson's is not known, however the best available research indicates that it is likely to be caused by a combination of genetic and environmental factors. In the last fifteen years a number genetic mutations linked to certain forms of Parkinson's have been identified, although research to date suggests this accounts for less than 10% of Parkinson's cases.

  2.5.  There is currently no known cure for Parkinson's. Although a number of treatment options are available to treat the symptoms, none of the existing therapies can halt the disease's underlying progression. Medication is most commonly prescribed, however it is in most cases only effective for a relatively short time. Side-affects inevitably appear that can be as disabling as the original symptoms. Surgical interventions are also available in the form of deep-brain stimulation, however only a relatively small proportion of people with Parkinson's will meet the clinical criteria for this procedure.

  2.6.  Stem cell research offers a significant opportunity for gaining a greater insight into Parkinson's and for exploring techniques to replace with healthy cells the dopamine producing nerve cells that have died. This may ultimately lead to a cure, allowing people to lead a life that is free from the symptoms of Parkinson's.

3.  THE PARKINSON'S DISEASE SOCIETY

  3.1.  The PDS was established in 1969 and has approximately 30,000 members, a further 30,000 supporters and over 300 local branches and support groups throughout the UK.

  3.2.  The Society provides support, advice and information to people with Parkinson's, their carers, families and friends, and information and professional development opportunities to health and social services professionals involved in their management and care. The Society also develops models of good practice in service provision, such as Parkinson's Disease Nurse Specialists, and campaigns for changes that will improve the lives of people affected by Parkinson's.

  3.3.  In 2006 the Society spent more than £4 million on funding research into the cause, cure and prevention of Parkinson's, and improvements in available treatments. Our members play a key role in shaping our research priorities and assessing all applications for research funding.

  3.4.  The PDS has invested more than £1.5 million in stem cell research over the past five years and currently funds 12 projects at research facilities throughout the UK. The Society is a member of the UK Stem Cell Funders' Forum, which was established in response to recommendation 9 of the Pattison Report[41] that emphasised the need for co-ordination between organisations supporting stem cell research.

  3.5.  Our members have demonstrated strong support for stem cell research to date and have played an active role in campaigning in support of this area of research, including playing a key role in drafting the Society's response to the Donaldson Report[42] given to the House of Lords Select Committee on stem cell research[43].

4.  THE GOVERNMENT'S PROPOSALS

  4.1.  The PDS is concerned that the Government proposes to ban the creation of hybrid and chimeric embryos in vitro despite their apparent recognition of the potential scientific value that leading edge techniques such as these may hold for research into serious medical conditions[44].

  4.2.  The Government proposals state that the forthcoming Bill, which revises the Human and Fertilisation Act (1990), will allow for regulations to be drawn up, outlining the circumstances in which hybrid and chimeric embryos can be created for research purposes. However we are concerned that such a delayed approach could severely hamper progress in this area. Even if regulations were brought forward at the earliest opportunity, there would still be a missed opportunity to have this matter of considerable public interest fully debated by Parliament. In the worst-case scenario, regulations may never materialise, as has happened following previous legislation.

  4.3.  The PDS notes that the Government's proposals have been drawn up following a consultation largely concerned with reproductive technologies. We are urging the Government to engage fully with the research community and patient groups on the specific issue of research involving the creation of hybrid and chimeric embryos in vitro prior to the introduction of any legislation that could have the effect of delaying progress or preventing research of this kind.

5.  DEFINING HYBRID AND CHIMERIC EMBRYOS

  5.1.  The PDS urges the Government to use the forthcoming legislation to clarify the definitions of hybrid and chimeric embryos. We propose that the definition used in Canadian law should be taken as a starting point, as suggested previously by the Science and Technology Committee.[45]

Definitions of chimeras and hybrids in Canadian law[46]

A "chimera" is

(i)  an embryo into which a cell of any non-human life form has been introduced; or

(ii)  an embryo that consists of cells of more than one embryo, foetus or human being.

A hybrid is:

(i)  a human ovum that has been fertilized by a sperm of a non-human life form;

(ii)  an ovum of a non-human life form that has been fertilized by a human sperm;

(iii)  a human ovum into which the nucleus of a cell of a non-human life form has been introduced; (iv)  an ovum of a non-human life form into which the nucleus of a human cell has been introduced; or

(v)  a human ovum or an ovum of a non-human life form that otherwise contains haploid sets of chromosomes from both a human being and a non-human life form.

6.  HYBRID CELL LINES AND RESEARCH

  6.1.  Using definition (iv) of Canadian law, hybrids are derived from animal eggs that have had their nucleus removed and replaced with the nucleus of a human cell. These can then be used to study diseases with genetic factors that are associated with certain forms of Parkinson's disease.

  6.2.  The generation of hybrid cell lines is a key aspect of stem cell research and the development of new technologies that will be vital for the ultimate development of a cure for conditions such as Parkinson's. Hybrid cell lines are much easier to generate than human stem cells and provide a tool with which to gain a greater insight into how to transform stem cells into other types of cells, such as nerve cells.

  6.3.  The generation of hybrid cells of this type is carried out in three stages:

—  Isolation of animal eggs.

—  Removal of the genetic material and replace it with that derived from a human cell.

—  Growth of the cells in the laboratory to give rise to stem cells.

  6.4.  The ovum will not be re-implanted into the uterus so an embryo cannot be generated and would only be grown for up to 14 days[47]. The cells will be treated in the same way as stem cells derived from human embryos.

7.  RESEARCH INTO PARKINSON'S INVOLVING HYBRIDS

  7.1.  Research involving hybrid cell lines offers considerable potential to develop our understanding of Parkinson's and its treatment by:

(a)  Offering a greater understanding of how to transform stem cells into dopamine-producing nerve cells. This may be of use in the future for transplantation of the cells into the brains of people with Parkinson's to replace those cells that have died.

(b)  Creating stem cells containing DNA derived from skin cells obtained from people with a genetic form of Parkinson's. These can be transformed into nerve cells to increase our understanding of the effect of these mutations on the cells, how they function, and why the nerve cells are more likely to die in Parkinson's.

(c)  From point 2, it may then be possible to identify targets for new drugs that would halt or reverse the progression of the condition or even prevent it.

(d)  The technology underlying the generation of hybrid cell lines will also inform on the potential for therapeutic cloning which would provide new cells, likely to be genetically identical to the patient, with a greatly reduced risk of rejection, a common problem associated with the transplantation procedure.

8.  THE GOVERNMENT'S COMMITMENT TO STEM CELL RESEARCH

  8.1.  The PDS welcomes the Government's support for stem cell research to date, including their pledge to invest an additional £50 million into stem cell research in the years 2006-07 and 2007-08 in response to the Pattison Report[48]. We also note the announcement this month by the Scottish Executive of their investment of £24 million for the Scottish Centre for Regenerative Medicine (SCRM), for the development of regenerative medicine using stem cell technologies.

  8.2.  The PDS further welcomes the Government's commitments, made in response to the Pattison report, to ensure a flexible regulatory framework that does not stifle the development of the full range of safe and effective new cell therapies for the benefit of patients and to promote public dialogue on stem cell research[49]. We feel these two points reinforce our call to have research involving hybrid cell lines addressed explicitly in the forthcoming legislation, rather than opting for an outright ban with the promise of regulations, for which there is no timescale attached, to follow.

January 2007

42   Stem cell research: medical progress with responsibility, a report by the Chief Medical Officer's expert group, Department of Health, June 2000. Back

43   The PDS gave written and oral evidence to the House of Lords Select Committee's inquiry into stem cell research-report published February 2002. Back

44   Review of the Human Fertilisation and Embryology Act: Proposals for revised legislation (including establishment of the Regulatory Authority for Tissue and Embryos), Department of Health, December 2006. Back

45   Select Committee on Science and Technology's inquiry into Human Reproductive Technologies and the Law, paragraph 64. Back

46   Taken from the Select Committee on Science and Technology's inquiry into Human Reproductive Technologies and the Law, paragraph 64. Back

47   According to current legislation on the study of human embryonic stem cells, the HFE Act (1990) Back

48   UK Stem Cell Initiative report and recommendations, November 2005. Back

49   Government response to UK Stem Cell Initiative report and recommendations, December 2005. Back