| Stem cells are cells found in most, if not all, | | | | professional bodies within the EU which has |
| multi-cellular organisms. They are the building | | | | resulted in a somewhat fragmented approach |
| blocks of the body which have the ability to | | | | with decisions having to be made on a national |
| renew themselves through mitotic cell division and | | | | basis. This is time consuming, inefficient and costly. |
| differentiate into a diverse range of specialised cell | | | | Currently there are proposals being debated in the |
| types such as muscle or nerve cells. Scientists are | | | | European Parliament which, hopefully, will go some |
| learning how to 'tweak' stem cells so that they | | | | way to resolving this. It has taken many years to |
| can be used to treat degenerative diseases etc. | | | | get to where we are today and it is likely to take |
| When IVF was first announced it was frowned | | | | at least another decade before we reach any |
| upon but now it is accepted as being a normal and | | | | level of true harmonisation. |
| fairly routine procedure. Given enough time to | | | | Europe isn't on its own in having a fragmented |
| raise awareness of the benefits of stem cell | | | | approach to stem cell therapies. America's |
| therapy it is anticipated that, like IVF, it will | | | | regulations vary considerably from State to State |
| become accepted practice. In fact, cell therapy is | | | | and under the Bush administration federal funding |
| currently being used for the treatment of patients | | | | for stem cell medical research has been |
| with leukemia so already there is a certain level of | | | | extremely limited. The new US President, Barack |
| public acceptance for this type of treatment. | | | | Obama, however, has stated that he will lift the |
| Patient groups such as the Parkinson's Society are | | | | restrictions imposed by President Bush. "I believe |
| encouraging the use of stem cell therapy by the | | | | that the restrictions that President Bush has |
| very nature of the disease itself. It is those | | | | placed on funding of human embryonic stem cell |
| people suffering from slowly degenerative | | | | research have handcuffed our scientists and |
| diseases who are most likely to push for clinical | | | | hindered our ability to compete with other |
| trials in man. It may be too late to help them but | | | | nations," he said. As president, Obama says he will |
| they are keen to help treat subsequent sufferers | | | | guarantee that all research on stem cells is |
| with the aim of eradicating the disease altogether. | | | | conducted "ethically and with rigorous |
| In addition, we have an ageing population which is | | | | oversight."[2] Europe is waiting to see what |
| yet another reason why there is a greater | | | | happens with Obama at the helm of the US |
| demand for research into cell and organ | | | | because it is likely that whatever happens in |
| replacement therapies. | | | | America will also have an impact on regulations |
| The commercial aspect of stem cell therapy | | | | within the EEC. |
| should not be overlooked. There are existing | | | | In the meantime, it is important that we do not |
| treatments which, in the future, could be replaced | | | | lose sight of the fact that the research and |
| with stem cell therapy. For example, the current | | | | development of stem cell therapies has huge |
| treatment for patients with age-related macular | | | | potential for human health. It took many years |
| degeneration (AMD) is a 4 to 6 weekly injection in | | | | for IVF to become a normal part of our |
| the diseased eye at a cost of £1,200 per | | | | healthcare system. Given enough time to raise |
| injection. These injections could be replaced with | | | | public awareness and to harmonise legal and |
| the use of embryonic stem cells. A procedure | | | | regulatory systems, stem cell therapy will also |
| which would take 40 minutes and last 2 to 3 | | | | become accepted treatment. In the transition |
| years at an approximate cost of £5,000.[1] | | | | phase regulatory compliance consultants like GRS |
| This one example demonstrates a considerable | | | | continue to monitor and offer advice to |
| saving and most importantly, improvement to the | | | | organisations at the leading edge of healthcare |
| patient's quality of life. | | | | technology. |
| Stem cell activities are regulated by different | | | | |