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Genetics and Bioethics

Genetics: A key component of innovation

Genetics is the study of variation in the DNA sequence of genes, and how this can affect certain traits. Genetic variations are usually hereditary, but can occur spontaneously.

This is potentially significant for medicine, as the risk and seriousness of many diseases are influenced by whether or not a person carries certain genetic variants. Identifying the genetic variants associated with a particular disease can help us find out whether an individual is at risk, and may allow us to gain added insight into how they will respond to treatment – in terms of both recovery and side effects. Genetic research is therefore essential to provide people with more targeted, personalised, safe and effective treatment.

Genetic variants are one form of biomarkers – measurable characteristics that may carry information about a person’s health or likely response to treatment. Many biomarkers, such as blood sugar and cholesterol, are well known. Others made available by recent progress in basic biology are still being researched, but show great promise. At Roche, we are investigating the use of new biomarkers to improve our understanding of disease and to make our drugs more targeted, effective and safe. We employ a range of cutting-edge technologies, including:

  • Genetics – the study of inherited or spontaneous variation in the DNA sequence of genes
  • Genomics – the study of all the genes in a cell, tissue, or organism, and their the state of activity
  • Proteomics – the study of all the proteins in a cell, tissue or organism, and how they function
  • Metabonomics – the study of the small organic molecules, such as hormones, that an organism produces in different circumstances.

As we can see, genetic research draws on a variety of areas that we must coordinate. To do this, we established Roche Genetics, a matrix organisation that coordinates our work in genetics, genomics and proteomics so it makes an effective contribution to the Group’s R&D and business objectives. This core group of specialist research scientists deals specifically with new technologies and updates our internal standards and guidelines appropriately.

Roche Genetics also makes sure that employees working in related areas are fully informed about issues and developments in genetics and how they affect science, policy, public opinion and the regulatory and legal environment. It provides expert support in:

  • Evaluating genetic and other biomarker studies for Roche researchers worldwide
  • Incorporating biomarker concepts, including genetics, into clinical trials for Roche scientists
  • Obtaining regulatory approval for new diagnostic and therapeutic products.

Bioethics: Our commitment to high ethical standards in genetic research

Charter on genetics

We drew up the Roche Charter on Genetics in the late 1990s with the help of internationally-recognised experts, to help ensure excellence and social responsibility in our genetic research. It underscores our commitment to rigorous standards and goes far beyond national and international regulations.

The charter embraces the following principles and values, which are based on guidelines issued by the World Health Organization (WHO):

  • A commitment to scientific rigour and excellence
  • Respect for individuals’ right to self-determination
  • Compliance with national and international standards
  • Prevention of the misuse of genetic data
  • A commitment not to create genetically identical human beings (human cloning)
  • Timely communication of research results
  • Responsible use of genetic information obtained through research
  • The importance of guidance and counsel from an independent advisory group

Science and Ethics Advisory Group

In 1999, we established an independent panel to provide us with advice on genetic research and its applications in healthcare. Known as the Science and Ethics Advisory Group (SEAG), the panel includes internationally respected experts in genetics, bioethics, law, sociology, as well as members of the community. It provides guidance on issues relating to genetic research and periodically reviews the governance of Roche Genetics. The SEAG also provides a forum for an ongoing dialogue and debate on ethical issues arising from genetic research and the long-term storage of specimens and data for open-ended research that is not yet precisely specified.

We also promote and participate in public dialogue on genetics. We believe in people’s right to information about new discoveries and research findings, and are committed to the transparent and timely communication of any research findings important to the public at large.

Bioprospecting

Bioprospecting is a term for the collection and analysis of natural materials as potential sources of new medicines.

Many communities have used natural resources in their traditional medicines for generations. We recognise that these communities have the right to maintain access to such resources, and that their knowledge should be respected. It is also critical that resources are conserved and that the biological diversity surrounding them is not damaged when they are collected.

Roche does not carry out any activities of this type, nor do we have any plans to. Should this change in the future, we will abide by the 1992 UN Convention on Biological Diversity. This addresses issues relating to conservation and equal access to resources.

More details of our position on these issues can be found in our Global Statement on Biodiversity.