Memorandum by Roche Products Ltd|
1. ABOUT ROCHE
1.1 Roche has been committed to improving
the health and well-being of people in the UK, from birth to old
age, for more than 90 years. Our aim is to enhance the quality
of life for everyone.
1.2 Today, we are market leader in three
of the four business areas in which we operatepharmaceuticals,
diagnostics, consumer health and vitamins. We are the second largest
foreign investor in UK healthcare and plough back more than 20
per cent of our turnover into research and development, well above
the industry average. By taking an integrated approach to healthcare,
we can offer superior solutions that are tailored to the individual.
The development, production and marketing of
innovative tests and systems to improve the detection, screening,
evaluation and monitoring of disease.
The discovery, development, production and marketing
of clinically and cost-effective prescription drugs to combat
human disease. Roche has significant research and products interests
in obesity and weight management, oncology, diabetes, cardiovascular
diseases, transplantation, renal medicine, virology and influenza,
The development, production and marketing of
some of the UK's best-known over-the-counter healthcare brands,
including Sanatogen®, Rennie®, Redoxon®,
Aspro®, Radian®-B and Berocca®.
The development, manufacture and marketing of
vitamins, carotenoids and various pre-mixes for animal and human
nutrition, food production, healthcare and cosmetics industries.
1.3 Roche first established a UK sales and
marketing presence in 1908, with research and manufacturing activities
starting 30 years later. Roche now employs almost 3,000 people
in the UK at facilities in Welwyn Garden City, Witham, Lewes,
Heanor, Dalry and Belfast.
2. ROCHE GENETICS
2.1 Genetics is the study of heredity: how
biological information is transferred from one generation to the
next as well as how that information is expressed within an organism.
2.2 Genomics is the study of genes, and
is commonly used to describe the process of locating, characterising
and discovering the function of genes. A relatively new but rapidly
expanding field of research, genomics can be applied to humans,
animals, plants and bacteria.
2.3 Genomics looks set to revolutionise
human healthcare. Many common human diseases have been shown to
have a genetic basis or component, which can affect disease onset
or response to treatment. By understanding gene function, researchers
can gain an in-depth and fundamental insight into human disease,
and hence develop new or improved therapeutics and diagnostics.
2.4 Roche has been strongly committed to
research since its founding over 100 years ago. Today, genetic
research is a major part of Roche's Research and Development programme
as we believe it to be an essential and indispensable element
in providing better health care, provided it is implemented based
on scientific, ethical, social and legal principles.
2.5 Roche is applying research in human
genetics, genomics and proteomics to develop strategies and products
for individualised healthcare delivery. The emphasis is on developing
integrated solutions spanning the full range of medical services,
from disease prevention and diagnosis to treatment. Roche is committed
to pursuing this work in accordance with the standards set forth
in the Roche Charter on Genetics (see Appendix 1 [not printed]).
3.1. What current Roche projects involve collecting
genetic information on people living in the UK?
Roche is currently collecting DNA samples from
consenting subjects within the UK, as part of the following clinical
drug development trials worldwide:
(i) NK1 receptor antagonist in the treatment
(ii) Trocade in the treatment of Rheumatoid
(iii) Xeloda in the treatment of Colon Cancer.
All such DNA samples will be held within an
anonymised genetic databank, and thus such samples will not be
associated with data as to country of collection.
3.2. What other projects are about to start?
Potentially anonymised DNA collection may be
sought in planned trials of Xenical® in the treatment
of obesity but it is not yet certain if such trials will incorporate
recruitment within the UK.
3.3. Are there collections of material (eg
tissue samples) in existence that could be used to generate databases
of DNA profile?
3.3.1 Yes. All DNA data-banking within the
UK has been undertaken in accordance with Roche's own standards
and policies governing the Roche Sample Repository and with ethical
approval and subject consent. A copy of Roche's Patient Information
Brochure relating to the collection and storage of samples is
appended (Appendix 2 [not printed]).
3.3.2 The resulting databank holds anonymised
DNA samples with matching clinical data derived exclusively from
Roche sponsored trials. Access to the Repository is strictly controlled
and subsequent investigations are limited to the original therapeutic
area of ascertainment. Clinical data will not be added prospectively
or retrospectively from other sources.
3.4 Why are these genetic databases being
assembled? To what purposes will they be put?
In keeping with the Roche Charter on Genetics,
Roche is committed to making maximal use of the evolving techniques
of pharmacogenetics to help provide more effective and safer pharmaceuticals.
The Roche Sample Repository represents a resource of anonymised
DNA samples and accompanying medical data, aimed at meeting the
clinical requirements of introducing exploratory genetic analysis
into pharmaceutical research and development, whilst maintaining
optimal subject privacy and procedural transparency.
3.5 How are these activities funded?
Clinical genetic research is an integral part
of Roche's commitment to generate meaningful improvements in patient
care through scientific advances in therapeutics and diagnostics,
and as such is funded exclusively by Roche, as part of its drug
3.6 What practical considerations will constrains
The recent publication of a draft sequence for
the human genome, and the imminent availability of a high-density
genetic map from the publicly/privately funded SNP Consortium,
suggests that technical requirements are unlikely to be limiting
in the pursuit of pharmacogenetic medical advances in the near
future. As such, primary constraints seem likely to stem from
the operating environment dictated by regulatory requirements
for registration of novel drugs and local legislation and guidance
dictating optimal approaches to maintaining privacy for individual
3.7 Are there alternative ways of fulfilling
the same objectives, which do not involve the assembly of genetic
The major public health advances of the next
two decades must inevitably come from improvements in the prevention
and treatment of common disorders of middle to old-age. Such disorders
include coronary heart disease, osteoporosis, obesity, type II
diabetes mellitus and Alzheimer's disease. The cause of such diseases
are complex and "polygenic" in nature, stemming from
the interplay of several genetic determinants together with diverse
environmental factors. Consequently, the genetic aetiology of
such disease can only be understood through the study of population
genetics. As such, there is no scientific alternative to collection
of DNA samples from representatives of such populations. This
reality is reflected in the large-scale efforts currently underway
in both the public and private research sectors to build these
kinds of genetic investigational resources.
3.8 What is the genetic information that is
Genetic data stored within the Roche Sample
Repository is solely related to the results of genotyping markers
at and around candidate genes and loci believed directly relevant
to study of the therapeutic area from which the samples were originally
collected. That is to say, samples collected from subjects with
diabetes will only be associated with genetic data aimed at increasing
understanding of diabetes and related processes.
3.9 How is this genetic information being
stored, protected and kept secure?
At all times Roche serves as a responsible custodian
of donated genetic material and data, assuming total responsibility
for proper safekeeping and confidentiality of all samples and
associated data. Operational structures and processes have been
framed such as to ensure that only a strictly limited number of
specifically authorised Roche personnel have access rights to
both the clinical database and the Roche Sample Repository database.
Operational procedure specifically forbids any "assumptive"
re-identification of anonymised samples on the basis of unique
clinical data. All such processes are subject to appropriate internal
and external audits to monitor and ensure compliance.
3.10 What do you see as the Roche group's
3.10.1 Roche respects the right of every individual
to privacy and confidentiality regarding their genetic information.
As such, in addition to recognising corporate and individual obligations
to abide by national and international research standards and
applicable laws, Roche also voluntarily assumes pre-eminent responsibility
in preventing the misuse of genetic information obtained in the
course of its research activities. Such misuse of genetic information
has been deemed to include, but is not limited to, the support
of discrimination against, or exploitation of, any individual
or group of individuals. Roche recognises such responsibilities
as a matter of policy.
3.10.2 Further to such issues, Roche has
decided to adopt an anonymised approach wherever possible for
genotyping and banking of genetic data, which together with aggregate
reporting thereby ensures maximal subject privacy. All samples
entered into the Roche Sample Repository are assigned a new, independent
code within the dedicated database system. Subsequent and obligatory
deletion of the key linking clinical identifiers and encrypted
Repository database identifiers, delivers effective "anonymisation".
3.10.3 In order to prevent compromise of
such anonymisation through reporting of "exceptional"
genetic data, potentially capable of uniquely identifying a single
individual participating in any genetic collection, any and all
data collected within the Roche Sample Repository will only be
analysed and reported in aggregate. The Repository will not serve
to determine or interpret genetic information on an individual
3.10.4 Roche respects and actively supports
the right of every individual to absolute self-determination in
the ascertainment and use of genetic information, with regard
to both research and personal health care. Consequently, Roche
works to provide a complete transparency of purpose in all dealings
with subjects invited to participate in Roche Sample Repository
research protocols. This transparency extends to the planned and
potential uses of any donated DNA and derived genetic information
for the discovery and delivery of new and improved diagnostics
3.10.5 Against this background of openness
of purpose, all participation in the Roche Sample Repository is
entirely voluntary in nature. Roche policy dictates and guarantees
independence of individual choice as to participation in DNA collection
for the Roche Sample Repository with respect to choice as to participation
in any Roche sponsored clinical trial. Practicable control of
collected samples, including the right to withdraw samples from
the Repository at any time whilst participating in the associated
clinical trial, remains with the participant. Subsequent anonymisation
of the sample renders reliable identification for withdrawal impossible.
3.10.5A Roche recognises the legitimate
interest of society in applying the aggregate results of genetic
studies to the improvement of the human condition. It perceives
a universal recognition that identification of the best potential
candidate genes for pharmacogenetic investigation is not always
possible at this stage of our understanding of genetics.
3.10.6 As such Roche appreciates the value
of using genetic resources within the Roche Sample Repository
for future as yet unforeseen investigation. This intent is made
entirely transparent to participants prior to establishing their
consent for DNA collection. In addition, the maximal time the
sample will be retained to allow for such investigation is strictly
prescribed by Roche Sample Repository policy at 15 years. All
genetic investigational strategies, not made absolutely explicit
at the time of collection and institutional ethical review, will
only be undertaken in accordance with guidance and counsel actively
sought from an independent scientific and ethics advisory group.
This group consists of acknowledged experts, from outside of Roche,
representing the fields of biology, ethics, sociology, law as
well as the community.
3.10.7 Roche recognises a duty to integrate
the principles enumerated above into a programme of scientifically
and socially responsible, accountable, and transparent use of
genetic information for the development of new diagnostics and
therapeutics. As such, Roche is actively engaged in a programme
of communication and education with all stakeholder communities,
to build understanding of Roche's position in genetic research
and promote ongoing debate as to best practice in maintaining
optimal ethical and social accountability. In particular, Roche
has adopted, and actively promotes to other participants in the
field of pharmacogenetics, a rigorous policy ensuring the obligatory
timely public communication of research results to the scientific
community. Such open communication is a pre-requisite of accountability.
Intellectual Property Rights
3.10.8 Roche's purpose in supporting pharmacogenetics,
within the UK and elsewhere, is as an adjunct to their traditional
drug development activities. It is thereby hoped to realise the
promise of using genetic information for the discovery and development
of new and improved diagnostics and therapeutics. Consequently,
Roche has a requirement for adequate protection of its intellectual
property, to allow subsequent investment in the delivery of such
advances. Adequate protection of intellectual property is particularly
important in the light of Roche's stance on timely public communication
of the results of genetic analysis.
3.10.9 In keeping with the transparency
of the protocols underlying the Roche Sample Repository, the intent
of Roche to acquire and maintain intellectual property rights
pertaining to therapeutic and diagnostic advances is made explicit
during the process of establishing subject consent for DNA collection,
as is the intent of Roche to actively pursue therapeutic and diagnostic
3.11 How do you see Roche's activities in
the area of genetic databases developing in the future?
Roche's commitment to pharmacogenetics, and
vision of the resultant benefits of its application, is both strategic
and long term. As such, future clinical development within Roche
will include systematic and comprehensive assessment of the potential
benefits of introducing genetic analyses. These analyses will
be prioritised where it is believed they will provide greater
aetiological understanding of disease or enhanced therapeutic
efficiency/safety. Inevitably, this activity will translate into
an increase in the level of DNA collection sought within the UK
and elsewhere in the world, in association with traditional drug
3.12 What lessons, if any, should be learnt
from genetic database initiatives in other countries?
Roche's commitment to the use of genetic analysis
is global in nature and scope. Inherent in such an approach, is
the assumption that the very highest standards of ethical and
scientific research will be universally adhered to and actively
Retrospective analysis of the limited examples
of successful prosecution of DNA data-banking in other countries
would suggest such success to stem from:
Establishing a clear sense of scientific
Building effective methods for sample
de-identification and protection of individual genetic privacy.
Ensuring transparency of policy and
The progress of the DeCODE initiative in Iceland,
in rapidly discovering novel candidate loci for such major public
health problems as stroke and late onset Alzheimer's disease,
has been widely reported. This would seem to entirely underscore
the faith of Roche and other investigators in the ability of genomic
and genetic analysis utilising human genetic databases to help
provide more effective and safer pharmaceuticals in the near future.
3 October 2000