Memorandum by Glaxo Wellcome|
Genetic research is the study of inherited DNA
variation. This research has the potential to generate unsolicited,
predictive information about individuals and family members and
therefore raises a number of ethical, legal and social concerns.
Genetic research requires DNA information (genotypes) and clinical
information (phenotypes) from large, extensively and consistently
characterised populations. This differs from genomic research
which uses DNA based technologies to study genes (eg the genes
that are switched "on" or "off" in certain
tissues) and does not require detailed phenotype information from
populations. The information generated from genomic research is
not related to inherited DNA variation and has a lower potential
impact for individuals. This research therefore has different
ethical, legal and social concerns. This submission provides information
specifically relating to genetic research and genetic databases.
Genetic research, with the establishment, maintenance
and use of genetic databases, is required to maximise the value
of genomic information (eg the human DNA sequence and high-density
maps of genetic markers), in the treatment, cure and prevention
The UK has an opportunity through the National
Health Service (NHS) system of "tracking" patients and
using electronic medical records to establish a valuable genetic
research database. This would capitalise on advances in genetic
science and technology and has the potential to attract investment
in supporting and sustaining the UK's pharmaceutical and life
It is of vital importance that genetic research
databases are established, maintained and used in an ethically
responsible manner and that participants' privacy and confidentiality
are protected. Consistent terminology and agreed guidelines for
genetic research across the UK and internationally will facilitate
the delivery of significant public health benefits, providing
they are compatible with effective research utilising new technologies.
To maintain public confidence in genetic research
and its ability to deliver healthcare benefits, Glaxo Wellcome
believes that the Human Genetics Commission (HGC) should consider
government sponsored (or partly sponsored) public, physician and
healthcare provider education initiatives to increase awareness
and understanding of genetics-related technologies. This will
promote informed public debate, greater appreciation of the risks
and benefits of different DNA based applications, and enable genetic
technology to be applied to the optimal delivery of healthcare
as rapidly as possible.
Public healthcare benefits to come from advances
in genomic and genetic science will be delivered by the biotechnology
and pharmaceutical industries. It is therefore important that
these industries continue to be involved in the substantive debates
relating to the ethical establishment, maintenance and use of
1. Glaxo Wellcome is a research-based company
whose people are committed to fighting disease by bringing innovative
medicines and services to patients throughout the world and to
the healthcare providers who serve them.
2. In 1999, Glaxo Wellcome invested £1.269
billion in research and development, of which £507 million
was in the UK. Currently, Glaxo Wellcome employs 9,270 staff in
its research and development organisation, with 4,500 based in
the UK and 2,700 in the USA.
3. Glaxo Wellcome is at the forefront of
genetic research to deliver significant healthcare benefits to
patients and healthcare providers, and to build on its success
as one of the world's leading pharmaceutical companies. This research
requires the establishment, maintenance and use of genetic databases
that can be divided into two broad areas: disease genetics and
(a) Disease Genetics
4. The objectives of disease genetic research
at Glaxo Wellcome are to identify genes (called susceptibility
genes) which alter the risk of developing common diseases with
unmet medical needs including asthma, early onset heart disease,
osteoarthritis, depression, chronic obstructive pulmonary disease
(COPD), migraine, diabetes, Alzheimer disease and Parkinson's
5. Understanding the function of the different
forms of these genes in disease pathways will enable and facilitate
a better understanding of disease and the identification of valid
targets for medicine discovery programmes. These medicines are
likely to act at the underlying causes of disease and it is anticipated
that they will provide significant advances in the treatment,
cure or prevention of these illnesses. The discovery and development
of medicines is a long process and it is likely to take 10 to
15 years from the identification of a disease susceptibility gene
to the availability of a new medicine.
6. To identify disease susceptibility genes,
DNA samples from large, extensively and consistently characterised
populations are required. Glaxo Wellcome has therefore established
seven international collaborative family-based studies with academe
(called Genetics Networks) to collect this information for asthma,
early onset heart disease, metabolic syndrome (a constellation
of risk factors for cardiovascular disease), COPD, osteoarthritis,
depression and Parkinson's disease. For each network, these studies
bring together expert clinicians from approximately 10 different
clinical sites around the world and leading scientists in genetics.
(b) Pharmacogenetics (the right medicine for
the right patient)
7. The objective of pharmacogenetic research
at Glaxo Wellcome is to correlate information from patients' DNA
with their responses to medicines. Samples for pharmacogenetic
research are being collected from clinical programmes on marketed
medicines and development compounds in over 15 different disease
areas, conducted in 40 countries around the world.
8. Over the next three to five years this
research may lead to the development of medicine response profiles
which would be undertaken, using a small blood or tissue sample
from patients, before a particular medicine is prescribed. This
profile will determine if the patient is likely to benefit and/or
not experience serious side effects from the medicine.
9. This technology has the potential to:
(i) optimise the utilisation of medicines
as physicians will be able to prescribe medicines more accurately
based on a predetermined efficacy and safety profile. This will
increase the likelihood of successful treatment and may save costs
for the NHS through more efficient use of medicines;
(ii) enhance post marketing medicine surveillance
systems by identifying genetic markers that could be used to determine
those patients at risk of a particular side effect;
(iii) streamline drug development by enabling
more efficient phase III clinical trials to be conducted through
the ability to apply greater focus to these studies and recruit
patients likely to respond into these traditionally large studies.
These concepts are outlined in a review published
by Dr Allen Roses.
10. Glaxo Wellcome has adopted a pro-active
approach to its genetic research policies (Appendix 1). We endeavour
to conduct genetic research to high ethical standards and have
put in place mechanisms to review our policies in the light of
recommendations from policy guidance groups.
RESPONSES TO QUESTIONS
What current projects involve collecting
genetic information on people in the UK? What other projects are
about to start? Are there collections of material (eg tissue samples)
that could be used to generate databases of DNA profiles?
(a) Disease Genetics (see paragraphs 4 to
11. Five international collaborative studies
in asthma, depression, osteoarthritis, COPD and early onset heart
disease involve clinical sites in the UK (Aberdeen, Birmingham,
Cambridge, Cardiff, Leicester, Liverpool, London, Nottingham,
Sheffield and Stoke-on-Trent). For each study, each clinical site
plans to recruit approximately 200 to 400 patients and family
members. Glaxo Wellcome plans to initiate further international
genetic studies in disease areas with unmet medical needs.
(b) Pharmacogenetics (see paragraphs 7 to
12. Twenty-one pharmacogenetic studies involve
approximately 60 clinical sites in the UK. This research is planned
to continue and expand to include more development compounds in
additional disease areas.
(c) Collections of Material that could be
used to Generate Genetic Databases
13. Glaxo Wellcome conducts genetic research
according to the policies provided in Appendix 1. These policies
are consistent with international principles for the ethical conduct
of research involving human subjects. There are no other collections
of biological material within Glaxo Wellcome with the appropriate
phenotype information and the necessary informed consents to allow
genetic databases to be generated to meet our objectives.
UK (IE NON-GLAXO
14. There are a number of academic centres, not
related to Glaxo Wellcome or our genetic research initiatives,
that have established genetic research databases with clinical
information and biological tissues (or DNA samples) from patients
with particular diseases and their family members. However, due
to the rapid evolution of ethics guidelines, Glaxo Wellcome believes
that there are sometimes shortfalls in the informed consents for
these studies, particularly for consents obtained prior to relatively
recent evolutions in recommendations from policy guidance groups.
15. For example, the original informed consents
may not adequately disclose possible collaboration with a commercial
third party, possibly leading to commercialisation of the study
results (as recommended by the Directive of the European Parliament
and of the European Council of 6 July 1998 on the legal protection
of biotechnological inventions). The consequences are two-fold:
first the potential value of these databases for medicine discovery
cannot be realised as it is not appropriate for Glaxo Wellcome
to gain access to such databases; and second, an avenue of funding
for further academic research is closed. The continual development
and communication of informed consent principles based on best
practice would help alleviate these problems.
(NHS), MEDICAL RESEARCH
COUNCIL (MRC) AND
(WT) PILOT PROJECT
16. The NHS, MRC and WT are planning a pilot
study to establish a genetic "Databank" in the UK using
the well developed NHS infrastructure for "tracking"
patients and using electronic medical records. The MRC/WT are
in the initial stages of determining the feasibility and structure
of a large national sample of patients (500,000 to 1 million)
identified from general practice. If initiated this would be a
valuable resource for the UK and has the potential to attract
investment in supporting and sustaining the UK's pharmaceutical
and life science sector. If this were realised, the UK would also
become a more attractive place in which to introduce innovative
medicines and interventions.
17. Previously conducted epidemiology studies
have not collected information to adequately phenotype subjects
for multiple diseases; they have focused on one or a few diseases
or have relied on physician reporting and patient self assessment.
In addition the statistical power of these previous studies is
often limited by sample sizes. Traditional genetic studies have
collected extensively phenotyped patients but ascertainment has
been based on the presence of the disease and extensive data on
environmental factors are not usually collected.
18. This proposal for a genetic "Databank"
in the UK has the potential to enable extensive longitudinal epidemiology
studies of subjects prospectively and consistently phenotyped
for the presence or absence of major complex diseases and for
which DNA is available to classify subjects' disease on the basis
of genotype. These studies would be used to better understand:
the natural history of diseases including
onset and severity in multiple populations;
how multiple susceptibility genes
interact with each other and environmental factors;
how various health interventions
would impact the onset and course of disease;
the effectiveness of preventative
therapies for disease; and
whether markers for rare serious
side effects could be identified, thereby allowing medicines to
be prescribed for those patients most likely to respond positively.
19. The pharmaceutical industry, including
Glaxo Wellcome, has participated in discussions about this project
and Glaxo Wellcome is keen to work with the NHS/MRC/WT on this
initiative, to help ensure:
(a) the "Databank" is established
and maintained using ethical principles based on current best
(b) the information collected is optimised
for the delivery of healthcare benefits; and
(c) appropriate informed consents are obtained
to enable researchers from public and commercial entities to access
20. This important genetic research resource
should be made widely available to scientists in academic and
commercial organisations so that healthcare benefits are delivered
to patients as rapidly as possible. A research review committee
would need to be established to review protocols in a similar
way that ethics committees review protocols for clinical trials.
Several different mechanisms for funding the ongoing data collection
and infrastructure costs would need to be evaluated to ensure
the longevity of the resource.
Why are these genetic databases being assembled?
How are these activities funded? What practical considerations
will constrain developments? Are there alternative ways of fulfilling
21. Glaxo Wellcome is conducting genetic
research to build on its success as one of the world's leading
pharmaceutical companies and to deliver the significant public
healthcare benefits that will accrue from the rapid advances in
DNA science and technology (as outlined in paragraphs four to
nine). This research is an important component of our strategy
to discover new medicines and provide medicines of value to patients
and healthcare providers. Genetic research undertaken by Glaxo
Wellcome is funded entirely through the investments of Glaxo Wellcome
in research and development.
22. Practical considerations which will
constrain developments include:
(a) slower than expected technological advances,
their implementation or application;
(b) negative public perceptions and little
public understanding relating to genetic research;
(c) national/regional legislation, regulations,
policy guidance or terminology which differs substantively.
(a) Technological Advances
23. Completion of the sequence of the human
genome and advances in single nucleotide polymorphism (SNP) map
technology (including statistical analysis and rapid read out
technology) will drive many of the healthcare benefits to come
from genetic science. The widespread application of SNP map technology
requires the development of inexpensive, high-throughput methods
for scoring large numbers of SNPs from hundreds of patients and
controls. Considerable efforts are now underway within the biotechnology
research community to establish low-cost, high-throughput and
accurate SNP scoring technologies. There is therefore a need for
continued research and investment in this area to prevent technological
hurdles from impeding scientific developments.
(b) Public Perceptions and Knowledge
24. Although issues relating to public attitudes
to human genetic databases are outside the terms of reference
for this inquiry, it is of note that genetic databases are collections
of biological tissue (or DNA samples) and clinical data from individuals.
Public perceptions of "genetics" that are often fuelled
by sensational media coverage of unrelated DNA related applications
such as genetically modified foods can adversely affect participation
in genetic research.
25. It is important that there is increased
public awareness, education and understanding of genetics and
genetics-related technologies so that there is informed public
debate and greater appreciation of the risks and benefits of different
DNA based applications. This will help potential participants
in genetic research to make a balanced judgement regarding their
26. Over the next 10 years there is likely
to be increased use of pharmacogenetic information prior to the
prescription of medicines. Ongoing physician and healthcare provider
education is therefore required for the full value of this technology
to be realised in the provision of cost-effective healthcare in
27. Glaxo Wellcome believes that the HGC
should therefore consider government sponsored (or partly sponsored)
public, physician and healthcare provider education initiatives
to meet the needs outlined in paragraphs 25 and 26.
(c) National/regional Legislation, Regulations,
Policy Guidance and Terminology
28. To clarify and harmonise European Union (EU)
law and practice in relation to the patent protection of biological
inventions, the European Parliament approved the European Union
Biotechnology Directive (98/44/EC) which came into force in July
1998. This Directive was substantially implemented into UK law
by the July 2000 deadline.
29. Under this Directive, human DNA sequence
in isolated form or otherwise obtained by a technical process
with an associated industrial application is patentable. This
clarification and harmonisation of the law provides an incentive
for the investment in genetic research and biotechnology across
the whole of the EU. For Glaxo Wellcome, it provides the basis
for the large investments in research and development that are
needed to turn DNA based inventions into medicines to treat, cure
or prevent disease.
30. The Netherlands, supported by Italy,
has filed a nullity action against the EU Biotechnology Directive
and many countries including Germany have failed to implement
the Directive into national law by the required deadline. Some
of these countries may implement the Directive at a later stage
(possibly with restrictive conditions on patenting) and some may
wait for the outcome of the nullity action. If the nullity action
is successful or a number of Member States fail to implement the
Directive or implement it subject to restrictive conditions, investment
in biotechnology within the EU could be adversely affected. In
addition, academic institutions that license biotechnology intellectual
property to supplement government grants may be denied a source
Regulatory Guidelines for Medicines
31. Over the next three to five years Glaxo
Wellcome anticipates that through pharmacogenetic research it
will be possible to provide medicine response profiles with some
of our medicines (see paragraphs seven to nine). For these benefits
to be realised it is important that the pharmaceutical industry
and drug regulatory authorities, including the Medicines Control
Agency and the Medicines Devices Agency, work together to develop
regulatory guidance on:
the use of pharmacogenetics in drug
the introduction of medicine response
the application of pharmacogenetics
to post-marketing surveillance.
Informal dialogue between the pharmaceutical
industry and the European Agency for the Evaluation of Medicinal
Products (EMEA) has begun and Glaxo Wellcome is keen to continue
this dialogue so that the pharmaceutical industry and the regulatory
authorities work together to ensure that patients can benefit
from this new technology.
32. International (eg United Nations' Educational,
Scientific and Cultural Organisation (UNESCO) International Bioethics
Committee, World Health Organisation (WHO), Human Genome Organization
(HUGO) Ethics Committee) and National groups (eg UK Medical Research
Council) have issued, or are issuing, policy guidance on the use
of biological samples in genetic research.
33. The guidance of the various groups is
not always consistent. Inconsistent guidance at regional and national
levels related to:
requirements for sample identification;
disclosure of information; and
may adversely impact genetic research, which
is conducted on an international basis.
34. Groups that issue policy guidance on
genetic research and genetic databases often distinguish different
types of databases according to the degree to which sample/data
can be traced to an individual subject. However, these groups
use different terminology that can make interpretation for practical
35. The terminology provided in Appendix
2 is that proposed by an Industry Pharmacogenetics Working Group
including representatives from Abbott, AstraZeneca, Bristol-Myers
Squibb, Glaxo Wellcome, Janssen, Merck, Pfizer, Pharmacia, Roche,
Schering AG, Schering-Plough and SmithKline Beecham. This industry
group was established to advance the understanding and development
of pharmacogenetics by addressing non-competitive ethical, regulatory
and legal issues. One of the issues being addressed is inconsistent
terminology which can provide process difficulties for ethics
review boards and regulatory authorities in the evaluation of
research protocols and consent forms, and in the regulatory review
of market applications for medicines and medicine response profiles.
The current terminology being used by Glaxo Wellcome is likely
to be changed so that it is consistent with the terminology outlined
in Appendix 2.
What is the genetic information that is being
collected? How is it being stored and protected?
36. For the disease genetic studies that
Glaxo Wellcome has initiated (see paragraphs 4 to 6), clinicians
expert in the particular therapeutic area define the clinical
characteristics (phenotype) of the disease.
37. After patients and family members provide
signed informed consent, the clinicians:
obtain detailed medical histories
from the patient and family;
conduct a comprehensive clinical
examination and series of specific tests to confirm (or rule out)
the relevant diagnosis in the patient and family;
collect information about the precise
characteristics of the disease in each affected person; and
draw a single blood sample for DNA
analysis from each family member.
38. The patient/family data are coded (Appendix
2). The names that correspond to the codes can only be accessed
by the clinical investigator (or designee) at the clinical site
where the patients are recruited. These data are encrypted and
sent electronically to a genetic epidemiology centre (Duke University
North Carolina, Vanderbilt University or Boston University USA)
where they are stored in password protected computers and only
accessed by authorised personnel.
39. The coded blood samples are sent via
a secure carrier to a sample reception centre at Duke University
USA where they are kept in secure environments. Following sample
receipt and entry into a computerised sample tracking system,
samples are transferred to Glaxo Wellcome for ensuing genetic
analysis and storage. A portion of the DNA sample is sent to the
clinical site for research.
40. DNA is extracted from the samples and
genotyped at specified DNA markers by an academic screening centre
(eg Duke University USA, Queen Elizabeth Medical Centre, Perth,
Australia). This information is then sent to the epidemiology
centres where genetic epidemiologists look for associations between
defined disease characteristics and the genotyped DNA markers.
41. For the pharmacogenetic research undertaken
by Glaxo Wellcome (see paragraphs seven to nine), a healthcare
professional takes a blood sample for DNA analysis from patients
who provide signed informed consent.
42. The samples and medical information
are coded. The patient names that correspond to the codes can
only be accessed by the clinical investigator (or designee) at
the clinical site where the patients are recruited. The samples
are sent either directly to a third party for DNA extraction or
sent to Glaxo Wellcome (in the UK or USA) before being sent to
a third party for DNA extraction. The DNA samples may also be
genotyped by a third party at specified DNA markers.
43. Coded samples are stored and tracked
according to Good Laboratory Practice (GLP) procedures and coded
clinical data are handled according to Good Clinical Practice
(GCP) procedures. All samples (coded and anonymised) are stored
in secure environments and only accessed by authorised personnel.
44. After the samples from the study are
genotyped at specified DNA markers, the data are combined with
the clinical trial information in order to find associations.
These databases are password protected, only accessed by authorised
personnel and subject to computer validation compliance.
45. For most Glaxo Wellcome pharmacogenetic
research there are two research uses for the patient's sample
(reflected in the consent form completed by the patient):
(a) Coded samples/data (Appendix 2):
To study genes that may affect the patient's response to the study
medication. Genes related to the individual's disease or those
likely to affect response to the medication are studied. If signed
informed consent has not been provided for anonymised research
once the genetic analysis is complete and the study results are
reviewed the coded sample is destroyed. A coded sample can be
destroyed earlier at the request of the patient.
(b) Anonymised samples/data (Appendix
2): patients may give signed informed consent for their samples
to be stored indefinitely and used for future study. The sample
may be used for continued research into the patient's response
to the study medication and it may be used for genetic research
into other diseases and to study response to a range of medicines.
Under these circumstances, to provide additional protection of
patient privacy, these samples/data are anonymised. Glaxo Wellcome
replaces the original code numbers relating to the sample and
to the medical information with a random code number.
How do the organisations involved see their
responsibilities regarding privacy; consent; future use; public
accountability and intellectual property rights?
46. Glaxo Wellcome, as a research based
pharmaceutical company, conducts research that requires the collection
of information, and in some circumstances biological tissues from
groups of individuals and patients. Glaxo Wellcome seeks to conduct
its research, including genetic research, in an ethically responsible
manner. The rapid advances being made in genetic science and technology
give rise to a constantly changing ethical landscape for genetic
research. Glaxo Wellcome therefore diligently and actively tracks
ethics discussions and policy guidance, and reviews its current
procedures in the light of these developments.
47. To ensure Glaxo Wellcome actively contributes
to ethics debates and is aware of ethics policy guidance relevant
to genetic research, a Genetics Policy Adviser was appointed in
1998. This individual is responsible for ensuring appropriate
Glaxo Wellcome representation in ethics debates and for tracking
recommendations made by international, regional and national groups.
In addition, Glaxo Wellcome actively seeks advice from internationally
recognised independent ethicists on the procedures used in our
48. A Data Privacy Officer was appointed
in 1998 to help Glaxo Wellcome in the protection of patient privacy
and confidentiality in its research activities. In addition, this
minimises the risk that Glaxo Wellcome's research objectives will
be adversely affected by the impact that breaches of confidentiality
may have on patient participation in our research programmes.
In addition many of the procedures to protect patient privacy
and confidentiality in genetic research are standardised GLP and
GCP procedures that are subject to internal audit.
49. Research involving human subjects is
conducted under stringent conditions that protect subjects from
misuse of data. The process of informed consent is an important
component of patient protection in this regard. It is the means
by which potential participants make a judgement about the contribution
that their involvement can make, relative to the risk or benefit
to them as individuals. It is the policy of Glaxo Wellcome to
obtain appropriate signed informed consents before any genetic
research is conducted (Appendix 1) consistent with legislative
requirements and international agreements on research involving
50. New research uses for Glaxo Wellcome
genetic databases that were established using previous Glaxo Wellcome
policies are individually assessed in the light of recommendations
from policy guidance groups (eg WHO, HUGO Ethics Committee, UK
MRC). If necessary, subjects are re-consented for the new genetic
research. In addition, Glaxo Wellcome will only access genetic
information from third parties (eg academic institutions) if it
has been collected with acceptable informed consents.
51. To support informed consent, Glaxo Wellcome
has developed patient brochures and a videotape and offers them
to investigators to help explain to patients, before they give
signed informed consent, the objectives of pharmacogenetic research
and the safeguards in place to protect patient privacy and confidentiality.
52. The key difference between coded and
anonymised data/samples (Appendix 2) is that the latter samples/data
cannot be linked back to the individual donor whereas the link
between coded samples/data and the individual donor is maintained
(Appendix 2). Anonymised samples/data provide an additional degree
of confidentiality protection. This is often used in circumstances
where the samples/data are kept indefinitely for future research
purposes (see paragraph 45b).
53. Policy guidance groups, for example
the UK and Sweden MRCs, are beginning to recommend that coded
data/samples should be used rather than anonymised samples/data
(a) The scientific value of anonymised genetic
databases may be compromised if additional information from the
subjects is required, as this cannot be obtained for anonymised
samples/data. For example, genetic epidemiological research requires
phenotype information to be obtained from groups of individuals
at time points over a number of years. This therefore requires
that the link between the sample/data and the individual is maintained
over the period of the research.
(b) The non-specific nature of future research
detailed in the informed consent may be inadequate. Where a link
is maintained between the sample/data and the individual donor,
specific future uses can be re-consented. This raises practical
difficulties however, particularly if that research is planned
years after the samples were originally collected, there are a
large number of subjects to re-contact and/or there are multiple
ethics committees and countries involved.
(c) The results of genetic research may produce
information that is of value for the healthcare management of
the individual donor. Under these circumstances, where the information
is of recognised medical value, it may be ethically necessary
to provide information to the subject or their physician. Currently,
because of the early stage of Glaxo Wellcome's genetic research,
no results of the research are provided to anyone (unless legally
required). Once the significance of results have been confirmed,
the group results are published and shared widely within the medical
community in a timely and responsible manner.
(d) Individuals are unable to withdraw from
the study if their samples/data are anonymised.
54. Glaxo Wellcome recognises the need to
maximise the scientific value of genetic databases in a way that
adequately safeguards the interests of those subjects who participate
in this research. Glaxo Wellcome is therefore actively monitoring
these developments and their implications for our genetic research.
55. Glaxo Wellcome actively communicates
the broad objectives of its genetic research in public meetings
and publications. In addition, Glaxo Wellcome actively provides
information to potential genetic research subjects, clinical investigators
and ethics committees on the procedures in place to protect patient
privacy and confidentiality (see paragraph 51).
56. Clinical development research programmes,
including those which incorporate pharmacogenetics, are reviewed
by regulatory authorities. In addition, individual genetic research
protocols and consent forms for both disease genetics and pharmacogenetics
are reviewed by ethics committees prior to study initiation. These
procedures and processes help to ensure that research activities
are conducted in an ethically responsible manner. In addition,
genetic research data are subject to scrutiny by regulatory authorities
where it forms part of an application to market a medicine.
57. For the discovery of a new medicine,
considerable investment (approximately £350 million over
12 years) in research and development is required. Without patent
protection there would be no incentive for making these large
investments to bring new medicines through to the market and make
them available for the benefit of patients. Where Glaxo Wellcome's
research leads to a valuable invention that is novel, non-obvious
and has utility, we seek full patent protection under the relevant
58. Glaxo Wellcome makes DNA-based discoveries
and inventions that can significantly improve public health. Many
of these inventions result from extensive genetic research using
DNA and clinical information supplied by groups of patients and
individuals. The invention may often arise only by analysis of
DNA and clinical data from statistically meaningful numbers of
patients and not those from just one individual. It is clearly
explained in the Glaxo Wellcome consent form that the genetic
research may lead to a significant improvement in patient health
of commercial value and that Glaxo Wellcome (in some instances
with collaborative researchers) intends to claim exclusive rights
to the results of that research.
59. In order to encourage and support the
development of new knowledge, Glaxo Wellcome may choose to allow
third parties, such as academic institutions, to use our patented
inventions through favourable licence agreements.
How do they see their activities in the area
of genetic databases developing in the future? What advances in
sequencing, screening and database technology are they anticipating?
60. It is anticipated that completion of
the sequence of the human genome and advances in SNP map technology
(see paragraph 23) will facilitate the identification of disease
susceptibility genes and genetic markers to predict responses
to medicines (this is outlined in a review published by Dr Allen
61. In order to optimise the pharmacogenetic
research and technology to enhance the prescription of well tolerated
medicines, it will be necessary to establish a regulated, secure
repository of blood samples for the first few hundred thousand
patients who receive a new medicine. If a serious adverse event
should occur in a few patients, it may then be possible to compare
the DNA of patients who experienced the side effect with the DNA
of matched patients who were free of the side effect. This would
enable the identification of genetic markers (eg SNPs) that could
be used to identify subsequent patients who are at risk of the
side effect and should be managed appropriately (eg different
medication, lower dose).
What lessons should be learnt from genetic
database initiatives in other countries?
62. Large State or partly State sponsored
genetic database initiatives in Iceland, Sweden and Estonia illustrate
the potential value for these countries that can be generated
by utilising healthcare infrastructures as a resource for genetic
research. The UK has a similar opportunity through the NHS/MRC/WT
initiative (see paragraphs 16 to 20).
63. The genetic database initiative in Iceland
was reported to involve informed consent procedures that would
not be regarded as "best practice" by many groups. This
has generated adverse publicity that may impact other genetic
research activities. In addition, investment and use of data from
this initiative may be compromised if the consent procedure makes
the data unacceptable to research organisations such as Glaxo
Wellcome. This illustrates the need for the UK initiative to be
established using ethical principles based on best practice and
for there to be informed public debate.
5 Roses AD (2000) Pharmacogenetics and the practice
of medicine. Nature 405: 857-865. Back
Roses AD (2000) Pharmacogenetics and the practice of medicine.
Nature 405: 857-865 Back