Select Committee on Science and Technology Written Evidence


Memorandum by the Biolndustry Association (BIA)

INTRODUCTION

  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 base.

  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[26], 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 health threat.

  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 terrorist organisations.

What are the main problems facing the surveillance, treatment and prevention of human infectious diseases in the United Kingdom?

  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[27] (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 use.

  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 ineffective.

  10.  It has been estimated that hospital-acquired (nosocomial) infections cost the NHS almost an extra £1 billion per year.[28] 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 UK market.

  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?

SURVEILLANCE

  14.  The World Health Organisation (WHO) has recognised that there exists a "disparity among national surveillance systems"[29] 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.[30] 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.

DIAGNOSTICS

  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 resistance—many 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 diseases—developing 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 product candidates.

    —  Prevalence issues of target disease resulting in societal resistance to vaccination for less apparent disease states.

    —  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?

EMERGING DISEASES [31]

  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:

    —  HIV—tens of millions infected worldwide, with a high proportion dying of AIDS.

    —  Hepatitis C—the most common cause of post-transfusion hepatitis worldwide.

    —  Influenza A—first 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.

    —  Legionella pneumophilia—outbreaks have been associated with poorly maintained air conditioning units—recent weeks have seen several outbreaks in the UK.

    —  Eschericia coli 0157:H7—transmitted through contaminated food, this bacterium has caused outbreaks of haemolytic syndrome in North America, Japan and Western Europe.

    —  Borrelia burgdorferi—the 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 virus—first 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.

RE -EMERGING DISEASES [32]

  23.  The following leading re-emerging diseases have been re-introduced into countries where they had previously disappeared:

    —  Dengue fever—spread through south east Asia since the 1950s, with re-emergence in the Americas in the 1990s.

    —  Meningococcal meningitis—epidemics 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.

    —  Tuberculosis—now 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 response.

  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 upon.

CONCLUSION

  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.

October 2002









26   "Pharmageddon-The Infectious Diseases Threat", FBR International Ltd (2001). Back

27   Pharma. Back

28   "Pharmageddon-The Infectious Diseases Threat". Back

29   WHO Fact Sheet No. 200 (June 1998). Back

30   "Getting Ahead Of The Curve", Executive Summary. Back

31   "Pharmageddon-The Infectious Diseases Threat". Back

32   "Pharmageddon-The Infectious Diseases Threat". Back


 
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