Memorandum by the Biolndustry Association
1. The BioIndustry Association (BIA) is
the trade association for innovative enterprises in the UK's bioscience
sector. Established in 1989, our mission is to encourage and promote
a thriving, financially sound sector of the UK economy, built
upon developments across the biosciences. We seek to create economic
growth, increase employment opportunities, and expand the skills
2. In all there are more than 550 bioscience
companies operating in the UK, employing over 40,000 people. From
this growing base, we have attracted over 350 members, the majority
of which are involved in realising the human health benefits that
bioscience promises. Our UK headquarters are in central London
but we also have an office in Edinburgh serving the interests
of our 85 Scottish members.
3. The BIA congratulates the Sub-Committee
on this important Inquiry. Infectious diseases kill approximately
15 million people per year throughout the world,
with the result that the control of infectious diseases features
prominently on the political agenda of many governments throughout
the world. In particular, emerging and re-emerging infectious
diseases, many originating in the developing world, pose a global
4. The bioscience industry has an important
role to play in helping to address this threat. Bioscience has
the potential to revolutionise the development of new therapies,
for example producing both new and improved vaccines and novel
treatments through advances in molecular genetics and using genomics
to find more effective targets and therapies for diseases. Governments
have also begun to look to bioscience companies for ways to protect
populations against the possible use of biological weapons by
What are the main problems facing the surveillance,
treatment and prevention of human infectious diseases in the United
5. Obstacles to the process of preventing
human infectious diseases include the costs and opportunities
for developing new drugs and vaccines and translating these into
consumer costs. The development time from concept to product can
be up to 10 years or more and can exceed $800 million
(fully loaded to include the costs of failed drugs en route),
so it important that there are incentives for drug and vaccine
manufacturers to develop products faster and cheaper. This would
also enable infectious diseases to be tackled more effectively.
6. A lack of funding at the early stage
also makes it imperative for the Government to invest more in
basic research and development into infectious diseases.
7. Issues such as the increasing regulatory
burden on companies and shortage of manufacturing facilities are
also obstacles that have been cited by BIA member companies as
matters of concern.
8. Advances in medical technology in vaccine
development are felt to be unnecessarily delayed by institutional
processes that do not necessarily exist in North America, such
as the development of genetically modified organisms for human
9. The ability of pathogens to develop new
ways of resisting antibiotics means that in some cases drugs which
have previously been used to treat infectious diseases have become
10. It has been estimated that hospital-acquired
(nosocomial) infections cost the NHS almost an extra £1 billion
The bioscience industry has the ability to discover and develop
innovative new treatments, for example using functional genomics
and bacterial genome data, and therefore has a major role to play
in helping to remedy this situation.
11. The incidence of small-scale anthrax
attacks in the US has made it imperative for the UK to consider
its preparedness for attacks of this type. The UK bioscience industry
occupies a position of world leadership and it is important that
we harness this expertise in coordinated efforts to detect, prevent
and manage any potential attack. The BIA established the BioDefence
TaskForce in November 2001, which has the specific remit of liaising
with the Government on biodefence issues on behalf of the industry.
Will these problems be adequately addressed by
the Government's recent infectious diseases strategy, "Getting
Ahead of the Curve"?
12. The BIA welcomes the actions proposed
in the strategy, which has the potential to address issues such
as those raised in this paper. In particular, it is positive that
the strategy features initiatives and attitudinal support for
development of capacity to bring new drugs and vaccines to the
13. The BIA calls on the Government to ensure
that the bioscience industry is involved in or consulted on processes
where appropriate, such as the national expert panel to assess
the threat from new and emerging infectious diseases, drawing
up action plans to address infectious disease priorities and putting
together a programme of new drug and vaccine development. Communicating
between Government and industry will help to move the UK towards
a partnership approach to improve the development and consequently
the availability of treatments for infectious diseases.
Is the United Kingdom benefiting from advances
in surveillance and diagnostic technologies; if not, what are
the obstacles to its doing so?
14. The World Health Organisation (WHO)
has recognised that there exists a "disparity among national
Although the UK has won international respect for its work on
infectious disease surveillance, the BIA notes the Government's
view that more needs to be done to ensure that the present system
is able fully to protect public health.
The UK already has what is arguably the best microbial surveillance
system in the world. At the very least this needs to be maintained
as it generates exceptionally valuable data. The strengthening
and expansion of the surveillance system in the UK, proposed in
Getting Ahead Of The Curve, is to be applauded as problems
such as drug resistance will then be even more effectively tracked.
Co-ordination of the currently separate infectious disease surveillance
systems would greatly assist this. Tracking disease trends and
identifying new disease threats in a timely manner in turn enables
effective treatments to be designed and produced.
15. The UK has also benefited from the WHO's
main means of creating a global surveillance system, namely through
the development of a "network of networks", linking
existing local, regional, national and international networks
of laboratories and medical centres into one surveillance network.
This covers the 191 WHO Member States and partners such as the
European Union-United States Task Force on Emerging Communicable
Diseases. The network has also addressed requirements for monitoring
the intentional use of pathogenic microbes.
16. In addition, the UK Public Health Laboratory
Service contributes to the Eurosurveillance Project, a European
tribune funded by the European Commission to promote the diffusion
and exchange of information on communicable diseases. This is
a step in the right direction, and it is important that the UK
continues to be involved in EU-wide surveillance initiatives;
after all, a disease that becomes a problem for one EU member
state is likely to become a problem for others. However, to ensure
the efficacy of such surveillance networks, better communication
and integration needs to be encouraged.
17. The UK bioscience sector has contributed
much to innovation in developing new diagnostic methods and is
a promising source of new tests for human disease. For example,
new DNA-based detection assays provide a sensitive means to test
for the presence of infectious pathogens. Similarly, the field
of proteomics focuses on detecting proteins that are associated
with a disease, with the aim of discovering new protein markers
for diagnostic purposes.
18. In its Final Programme Document published
in November 2001, the National Measurement System Directorate
identified the central concern of the diagnostics sector as standards
of measurement. The validity of analyses and measurements is critical
for biotechnology R&D, especially in the post-genomic world
where discoveries have the potential to be translated into immensely
useful products and processes. The National Institute for Biological
Standards and Control plays an important role in monitoring and
validating these products to safeguard and enhance public health.
19. To transfer technology and to satisfy
the regulator, data must be accurate, precise and reproducible
by different organisations. For many years comparability has been
built into the physical sciences and the industries that use them,
but this has often not been the case in biology. The National
Measurement System programme is well placed to generate new approaches
in measurement in biotechnology which will lead to standardisation
and thus comparability, both nationally and internationally.
Should the United Kingdom make greater use of
vaccines to combat infection and what problems exist for developing
new, more effective or safer vaccines?
20. Yes, for the following reasons:
Viral disease prevalence is increasing,
with limited treatment options available; vaccines preventing
disease are therefore a logical and more effective approach.
Bacterial disease remains problematic
given the development of antibiotic resistancemany antibiotics
no longer work against bacteria that cause disease.
Parasitic disease remains an issue
for people in the UK.
Increased international travel and
migration has lead to an increase in the number of exotic and
re-emerging diseasesdeveloping world diseases are now more
of a threat to developed countries.
Threats from bioterrorism, such as
smallpox, are not amenable to approaches other than prevention
with vaccines and outbreak control with vaccination.
21. There are, however, some problems relating
the development of new vaccines. These are:
Infrastructure to develop candidates,
eg difficulties in translation of basic research findings into
Prevalence issues of target disease
resulting in societal resistance to vaccination for less apparent
Replacement of existing vaccines
requires larger studies with greater power.
Development time and cost from concept
to product (up to ten years or more).
Shortage of manufacturing capacity.
Lack of investment in early stage
research and development in the field of infectious diseases.
Which infectious diseases pose the biggest threats
in the foreseeable future?
22. These are new or drug-resistant infections
where we have seen an increase in incidence over the past 25 years,
or expect to see an increase in incidence in the near future:
HIVtens of millions infected
worldwide, with a high proportion dying of AIDS.
Hepatitis Cthe most common
cause of post-transfusion hepatitis worldwide.
Influenza Afirst isolated
in humans in 1997, it was initially feared that the H5N1 virus
could trigger a global influenza pandemic, but fortunately the
virus does not seem to transmit as well as first thought.
have been associated with poorly maintained air conditioning unitsrecent
weeks have seen several outbreaks in the UK.
Eschericia coli 0157:H7transmitted
through contaminated food, this bacterium has caused outbreaks
of haemolytic syndrome in North America, Japan and Western Europe.
Borrelia burgdorferithe cause
of Lyme disease, this bacterium, which is transmitted to humans
by ticks is now endemic in Europe and North America.
Nosocomial infections such as methicillin-resistant
S. aureus (MRSA) and Vancomycin-resistant entercocci.
West Nile virusfirst identified
in 1937 in the West Nile district of Uganda, this virus has since
been seen in Africa, Europe, the Middle East, west and central
Asia, Oceania and, most recently, North America.
23. The following leading re-emerging diseases
have been re-introduced into countries where they had previously
Dengue feverspread through
south east Asia since the 1950s, with re-emergence in the Americas
in the 1990s.
in sub-Saharan Africa since the mid-1990s. A new strain, first
recorded in China in the 1980s, has spread west and we are now
seeing outbreaks in Africa.
Tuberculosisnow on the rise
and spreading to Western Europe, with a major cause seen as being
the breakdown of the health infrastructure in the former USSR.
What policy interventions would have the greatest
impact on preventing outbreaks of and damage caused by infectious
disease in the United Kingdom?
24. Above all, it is important for the Government
to take a forward-looking, long-term approach to tackling infectious
diseases. Steps have been made in the right direction, notably
in Getting Ahead of the Curve, to determine the risks of
diseases for the UK and to set a realistic strategy for an effective
25. Greater Government investment in manufacturing
facilities and in basic research and development into infectious
diseases would also greatly assist the UK's ability to prevent
or respond to the risk of outbreaks.
26. Finally, as mentioned above, it can
take over ten years and up to $800 million to develop new drugs.
Expenditure of this magnitude means that it is necessary to provide
the bioscience industry with the necessary time and incentives
needed to develop new drugs and vaccines to tackle infectious
diseases. Protection of the resulting products by patents also
needs to be guaranteed for research of this type to be embarked
27. With the rise in drug resistance, which
is taking place faster than new drugs and vaccines can be developed,
and the spread of emerging and re-emerging diseases, the prospects
for controlling infectious diseases do not appear to be very positive
in the short term.
28. However, it is possible that infectious
diseases can be held in check in the medium to long term and the
bioscience industry has a key role to play in enabling this to
happen. By focusing on the underlying biology of infectious diseases,
it is expected that new approaches and products will be developed
to address both existing and emerging diseases. It is essential
that the bioscience industry's role is complemented by a political
will to enable the infectious diseases to be effectively tackled.
The Government's strategy and this inquiry are important steps
in this process.
26 "Pharmageddon-The Infectious Diseases Threat",
FBR International Ltd (2001). Back
"Pharmageddon-The Infectious Diseases Threat". Back
WHO Fact Sheet No. 200 (June 1998). Back
"Getting Ahead Of The Curve", Executive Summary. Back
"Pharmageddon-The Infectious Diseases Threat". Back
"Pharmageddon-The Infectious Diseases Threat". Back