Memorandum by Lilly UK
1. Lilly is pleased to have the opportunity
to contribute to the debate on the use of human genetic databases
which it sees as an important development in the management of
medicines provided to patients. The databases will also benefit
the discovery process in the search for the answers that matter
for new medicines in both target and patient selection.
2. (Question 1). The Company is not involved
in any projects collecting genetic information in the United Kingdom,
nor does it have ongoing major projects elsewhere in the world.
It does, of course follow the activities of the Icelandic Government
and its relationship with the DeCode Company and works with other
organisations as an extension of its gene based research programmes.
The Company does work with human tissue samples but has not seen
this as an opportunity to generate databases of DNA profiles.
As indicated above it has collaborative research programmes with
companies such as Millennium Pharmaceuticals Inc based in Boston
to identify genes of interest as future targets for medicines
research. These projects are invariably oriented towards specific
3. (Question 2). The Company seeks to be
aware of database development because it will be of value in selection
of patient populations that will benefit from innovative gene
based medicines, potentially from both increased efficacy and
also reduced side effects. Pharmacogenomics, the study of variability
in medicine response due to heredity and pharmacogenetics, the
science underpinning the genetic basis for individual variations
in response to therapeutic agents, are both critically important
disciplines in modern medicine discovery and development. We do
not see alternative ways to achieve this data other than the creation
of human genetic databases.
4. (Question 3). The Company Policy is to
comply with the highest standards of ethical behaviour in all
its activities. It will comply with best practice in the collection,
storage and protection of such data but as indicated does not
at present have in-house databases involving systematic data collection
from patient populations. The Company does have data from individual
patients' tissues provided under appropriate protocols and with
patient anonymity preserved.
5. (Question 4). Lilly UK recognises that
the whole area of genetic information raises many questions of
ethics, accountability and open communication with individuals
and groups. It tries to participate in the debate with governments
and patient groups as well as experts in these fields. It does
believe that there need to be mechanisms to allow benefit for
research investment and risk taking which are balanced by the
wider needs of the community.
6. (Question 5). The Company has been a
user of databases to date and does not see that it will move into
a database generator or provider role. It does expect that the
advances in gene sequencing, functional genomics and bioinformatics
will be valuable in the application of information deriving from
human genetic databases. It does not see that there is a special
case to differentiate such data from the limited human genetic
information used to date.
7. (Question 6). The Icelandic data is valuable
in that it derives from a genetically constrained population.
Much value will be gained from comparing such data with that from
a more heterogeneous population. It is clear that medicines will
continue to be costly to develop and those which will benefit
substantial populations will clearly be preferred. One of the
more interesting questions which will be addressed by human genetic
databases is the number of subpopulations residing in the major
disease areas which remain without effective therapy.