APPENDIX 3: CALL FOR EVIDENCE |
26 July 2012
The House of Lords Science and Technology Committee,
chaired by Lord Krebs, is conducting an inquiry into regenerative
medicine. The Committee will be looking, in particular, at whether
the UK is in a position to facilitate the translation of knowledge
from world-leading research to treatments and to benefit from
the commercial opportunities that they present. It also seeks
to explore how realistic some of the reported claims of regenerative
treatments and therapies are, both in the UK and internationally.
The term "regenerative medicine" is used
to refer to any methods to replace or regenerate human cells,
tissues or organs in order to restore or establish normal function.
This includes cell therapies, tissue engineering, gene therapy
and biomedical engineering techniques, as well as the more traditional
therapies of pharmaceuticals, biologics and devices. Examples
of such treatments are the transplantation of a new trachea grown
using the patient's own stem cells and the use of a hormone (Erythropoietin)
to promote red blood cell production. The inquiry will also extend
to cell therapies that have applications in other areas of medicine,
for example, the use of cell therapies to control immune responses
to conditions such as paediatric steroid resistant GvHD,
or the use of stem cells for drug screening.
The UK is a world leader in many areas within the
field of regenerative medicine, particularly the platform technology
cell therapies. Foresight's Technology and Innovation Futures
report states that regenerative medicine could be a driver of
growth for the pharmaceutical sector if regulatory, financial
and translational research challenges can be overcome.
Regenerative medicine has the potential not only to lead to significant
improvements in the treatment of chronic diseases (such as diabetes
and certain kinds of blindness) but also to generate economic
benefits for the companies that develop therapies and related
infrastructure (such as manufacturing equipment). The deadline
for written evidence submissions is Thursday, 20 September 2012.
The Committee invites submissions on the following
points, with practical examples where possible (please only answer
the questions of relevance to you):
THE RESEARCH BASE
(1) How does the UK rank internationally in the
scientific field of regenerative medicine?
(2) Where does the UK have strengths and weaknesses
in the field?
(3) Who are the major funders of research in
the field of regenerative medicine? What funding is available
to support this research?
APPLICATION OF THE SCIENCE
(4) Is the science being translated into applications?
What are the current applications of the science of regenerative
medicine for the treatment of disease in the UK and internationally?
Which treatments are available on the NHS or through private healthcare?
(5) What potential does regenerative medicine
hold to treat disease in the next 5-10 years? What is the reality
versus the headlines about what the science will deliver?
BARRIERS TO TRANSLATION
(6) Are the actions outlined in the Government's
Strategy for UK Life Sciences, their report: Taking
Stock of Regenerative Medicine in the UK, and the Research
Council and Technology Strategy Board's Strategy for UK Regenerative
Medicine sufficient to encourage the safe development of regenerative
medicine treatments and to overcome the significant regulatory
barriers and challenges to innovation in this inter-disciplinary
field? If not, what more action is required? In particular:
(a) What difficulties are encountered when conducting
clinical trials and how could these be overcome?
(b) What other difficulties are encountered conducting
translational research within the NHS and how could these be overcome?
(c) What barriers are encountered when seeking
approval for the use of such treatments on the NHS or through
BARRIERS TO COMMERCIALISATION
(7) What is the current, and potential future,
commercial value of the sector to the UK economy? What is its
value to society?
(8) Where there is market failure, are Government
providing sufficient incentives in the current commercial environment
to attract investment in companies working in this high risk area?
If not what more should Government do?
(a) What role does patenting play in the commercial
development of regenerative treatments?
(b) What business models are most appropriate
to support the development of regenerative treatments?
(c) What are the barriers to securing finance
to develop such treatments?
(d) Are the pricing structures for the use of
such treatments on the NHS appropriate to support their development?
(e) What infrastructure barriers exist within
the NHS, or externally, that prevent the scaling-up or commercial
development of such treatments?
(9) What could the UK learn from its competitors
about supporting the development and commercialisation of regenerative
(10) How do regulations that govern the development
of regenerative medicines in other countries and at an EU level
impact on the development of regenerative medicines in the UK?
(11) Is there sufficient harmonisation between
the standards and regulations that govern the development of regenerative
medicines in different countries?
(12) What risks do UK citizens face when travelling
to other countries for regenerative treatments? How do the safeguards
in place to protect their interests in the UK compare to those
334 Graft versus Host Disease, a common disease amongst
transplant or tissue graft patients where the hosts immune system
attacks the transplanted cells. Back
See: http://www.bis.gov.uk/assets/bispartners/foresight/docs/general-publications/10-1252-technology-and-innovation-futures. Back