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 diseases.

  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.