RESEARCH PAPER 04/47 The Health Protection 17 JUNE 2004 Agency Bill [HL]
Bill 99 2003-04
The Health Protection Agency was established on 1 April 2003, as a Special Health Authority under the NHS Act 1977. The aim of the Health Protection Agency Bill is to establish the Agency as a non- departmental public body, incorporating the National Radiological Protection Board and thereby formally bring together all the elements of health protection and emergency planning to provide a comprehensive health protection system.
The Health Protection Agency Bill would provide the Agency with a wider range of functions than those presently available to a Special Health Authority.
Kate Haire
SCIENCE AND ENVIRONMENT SECTION
HOUSE OF COMMONS LIBRARY
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ISSN 1368-8456
Summary of main points
The Health Protection Agency was established on 1 April 2003. It was created under the National Health Service Act 1977 as a Special Health Authority, to provide an improved response to the threat from infectious diseases, and chemical biological and radiological hazards. It brought together a number of organisations, and works in partnership with the National Radiological Protection Board
The Health Protection Agency Bill will establish the Health Protection Agency as a non- departmental public body, incorporating the National Radiological Protection Board, which will allow a wider range of functions to be undertaken. The devolved administrations are to decide the exact function of the agency in Scotland, Wales and Northern Ireland.
The HPA will work with Primary Care Trusts, NHS trusts, and local authorities. There are also plans to strengthen international cooperation with the World Health Organisation and other international bodies, especially in reference to surveillance of emerging diseases. It has been created in two stages to prevent any delay that may have resulted from a lack of legislative time.
The Health Protection Agency published a five year corporate plan on 5 August 2003. This listed twelve strategic goals to deal with the perceived major health protection threats, and to improve the state of health emergency planning.
The Bill was introduced in the House of Lords in November 2003 and brought to the House of Commons on 29 April 2004.
CONTENTS
I Background to the Health Protection Agency 9
A. Getting Ahead of the Curve 9
B. Health Protection: a consultation document on creating a health protection agency 10
II Setting up of the Health Protection Agency as a Special Health Authority 10
A. Functions of the Health Protection Agency 11
B. Structure of the Health Protection Agency 12
1. General structure 12 2. Divisions of the Health Protection Agency 12 3. Partner organisations 16 C. Comments on the Health Protection Agency 16
1. Faculty of Public Health 16 2. The Chartered Institute of Environmental Health 17 3. Public Health Laboratory Service 18 D. Reports published after HPA created 19
1. Fighting Infection 19 2. Government Response 19 E. Health Protection Agency Corporate Plan 2003-2008 20
F. Present situation 21
III Proposals to establish the Health Protection Agency as a Non- Departmental Public Body 24
A. Background to proposed legislative changes 24
1. Health Protection: A consultation document on creating a health protection agency 24 2. Consultation on proposals for a Health Protection Agency 24
3. Comments on proposals 26 IV The Bill 26
A. House of Lords Second Reading Debate 27
1. Clauses 27 2. Main points of debate 29 B. House of Lords Grand Committee 31
1. Agreed amendments 31 2. Amendments not accepted 33 C. Health Protection Agency Report Stage 38
1. Main Amendments 39 2. Amendments not accepted 42 D. House of Lords Third Reading 43
1. Agreed amendments 43 2. Amendments not accepted 44 E. Views on the Bill 45
1. The Conservative Party 45 2. The Liberal Democrat Party 45
RESEARCH PAPER 04/47
I Background to the Health Protection Agency
Over the past few years there has been increasing concern over the threat presented by infectious diseases and acute or chronic exposure to chemical and radiological hazards. Infectious diseases still represent a significant health burden, with the infection rate of some diseases including HIV and tuberculosis rising. New diseases such as SARS have emerged and demonstrate the need for close vigilance, and the importance of an integrated approach to fight these diseases.
Concern has also been mounting over the adequacy of service provision in the event of a health emergency, including those that could result from deliberate release of a biological, radiological or chemical agent by a terrorist organisation.
Prior to the establishment of the Health Protection Agency a number of different organisations were responsible for providing services in their individual field of expertise. The aim of the HPA is to provide a more systematic and effective approach to managing the risks poised by infectious, chemical and radiological threats.
The reports that proposed the setting up of the agency are discussed below.
A. Getting Ahead of the Curve
The Chief Medical Officer’s strategy for combating infectious diseases, and other aspects of health protection, Getting Ahead of the Curve, was published in January 2002. The report addresses issues related to health protection beyond just examining the control of infectious diseases. The report contained the first proposal for the establishment of the Health Protection Agency.
The Report concluded that it was necessary to:1
• To recognise the scope and nature of the threat poised to the public by infectious diseases.
• To take a broad approach to health protection so that the risks of chemical, radiation and infectious hazards are considered as an entirety.
• To stress the scale of the emergence of new infectious diseases, and the global nature of this problem.
• To combat the resurgence of health care associated infection.2
1 Getting Ahead of the Curve, Chief Medical Officer, January 2002 http://www.publications.doh.gov.uk/cmo/idstrategy/idstrategy2002.pdf
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• To ensure that co-ordinated health emergency plans exist to deal with the threat from the deliberate release of biological or chemical agents.
The Report therefore proposed to create a new national agency, the Health Protection Agency (HPA), by reducing the national bodies involved in provision of services from four to one. The aim was to achieve a cohesive modernised service to manage health protection and emergency planning from national to local level.
B. Health Protection: a consultation document on creating a health protection agency
From June to September 2002 the Department of Health undertook an extensive consultation exercise on the creation of the agency, which received more than 200 responses.3 In November 2002 the decision to create the agency through a two tier system was announced. The proposed stages were:
1. The Health Protection Agency would initially be created as a Special Heath Authority in England and Wales, under the National Health Service Act 1977.
2. The Health Protection Agency would subsequently be established under legislation as a non-departmental public body, and would include the National Radiological Protection Board.
II Setting up of the Health Protection Agency as a Special Health Authority
The Health Protection Agency was established as a Special Health Authority for England and Wales on 1 April 2003.4 This created a single organisation which brought together the expertise and skills from different bodies, to provide a comprehensive health protection system. The HPA took on responsibility for providing or commissioning the functions that had been the responsibility of the following bodies:
• The Public Health Laboratory Service (PHLS), including the Communicable Disease Surveillance Centre (CDSC) and Central Public Health Laboratory
• The Centre for Applied Microbiology and Research (CAMR), which was part of PHLS. CAMR is responsible for the research and development of microbiological services and products.
2 This is the term now used to describe ‘hospital acquired’ infection and refers to infections transmitted to patients during their care in either hospitals or primary care settings. 3 http://www.dh.gov.uk/assetRoot/04/06/83/86/04068386.pdf 4 A Special Health Authority is a body created by statutory instrument under the NHS Act 1977
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• Functions related to protection from chemicals and poisons including: - The National Focus for Chemical Incidents (NFCI) - The Regional Service Provider Units that support the management of chemical incidents - The National Poisons Information Service
• NHS public health staff responsible for infectious disease control, emergency planning, and other protection support
It currently works in partnership with the National Radiological Protection Board (NRPB). This legislation would incorporate the NRPB into the Health Protection Agency.5
A. Functions of the Health Protection Agency
The purpose of the HPA is to prevent and reduce the dangers presented by infections, chemicals, poisons and radiation hazards. In April 2003 the HPA set out the principal functions designed to fulfil this remit.
• Provide impartial authoritative information and advice to professionals and the public, and independent advice to the Government on public health protection policies and programmes
• Deliver services and support the NHS and other organisations to protect people’s health from infectious diseases, chemical hazards, poisons, and radiation hazards
• Monitor and respond to new threats to public health, and provide a rapid response to health protection emergencies, including the deliberate release of poisons, chemicals, or microbiological substances
• Improve knowledge about health protection through research, development, education and training. 6
The Health Protection Agency has a special working partnership with the National Radiological Protection Board and also works alongside the NHS, and has links with other national and international organisations. 7
5 http://www.hpa.org.uk/hpa/faqs.htm#top at 7 April 2004 6 http://www.hpa.org.uk/hpa/faqs.htm#q1 at 7 April 2004 7 http://www.hpa.org.uk/hpa/faqs.htm#q1 at 7 April 2004
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B. Structure of the Health Protection Agency
1. General structure
At present the Health Protection Agency is organised into the following divisions: 8
• Communicable Disease Surveillance
• Specialist and Reference Microbiology Service
• Chemical Hazards and Poisons
• Emergency Response
• Local and Regional Services
• National Radiological Protection Board (working in close partnership until legislation)
• Business
2. Divisions of the Health Protection Agency a. Communicable Disease Surveillance
The duties of this division relate to the control and surveillance of infectious diseases. The HPA summarizes the functions of the division:
• Leads at a national level on the surveillance, alerting and response functions for infectious disease
• Responds to, and co-ordinates control measures in, an infectious disease outbreak, incident or issue that is national (or of national significance) or involves a number of regions
• Provides a comprehensive authoritative public health information and news service for infectious diseases, including publishing the Communicable Disease Report and the relevant portions of the HPA web-site
• Provides authoritative, expert public health advice for those responsible for controlling infectious disease
8 http://www.hpa.org.uk/hpa/about_us/ourstructure.htm at 7 April 2004
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• Participates in training programmes for those involved in the surveillance and control of infectious diseases
• Supports national policy development by the Department of Health and other Government bodies, for example on vaccines and vaccine preventable diseases
• Undertakes research and development to support the above public health responsibilities
• Works with other national bodies to deliver UK wide protection against infectious diseases and provides the public health point of contact in the UK for those working to control infection across Europe (the European Commission and WHO-Europe) and the rest of the World (WHO-CSR) 9 b. Specialist and Reference Microbiology Service
The Specialist and Reference Microbiology Division (SRMD) is a network of reference laboratories providing specialist information and advice to other Health Protection Agency laboratories and NHS laboratories. The specialised knowledge is also available to consultants in communicable disease control, community and hospital doctors, environmental health officers, government and industry.
They undertake specialist tests, which are not usually carried out in other laboratories. Major centres include Colindale and Porton Down. The SRMD replaces the service previously provided by the Public Health Laboratory Service. c. Poisons and Chemical Hazards
This division provides detailed advice and support for chemical incidents across England and Wales. Possible risks may arise from chemical fires, chemical contamination of the environment, or the deliberate release of chemicals and poisons. It also provides information and support to the NHS and health professionals on toxicology, through the National Poisons Information Service.
The main activities are:
• To improve NHS preparedness with respect to chemical incident management.
• To facilitate the response to chemical incident management and to advise government of the potential public health impact of chemical incidents.
9 http://www.hpa.org.uk/infections/about/about.htm at 7 April 2004
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• To undertake public health surveillance of the impact of environmental chemicals. 10 d. Regional and local services
Local and Regional Health Protection Agency services work alongside the NHS providing specialist support in communicable disease and infection control, emergency planning and oversee some laboratory services. There are nine Regional Health Protection Teams, which cover the same areas as the regional government offices in England, with each Region divided into a number of local units.11
Regional Health Protection Teams: Each regional team consists of a regional epidemiologist, a microbiologist, emergency planners and information staff. Their role is to:
• Support the regional director of public health in managing the response to major incidents.
• Organise the Local Health Protection Teams.
• Integrate the surveillance and commissioning of microbiology services from the Health Protection Agency and NHS laboratories.
Local Health Protection Teams: There are a total of 42 Local Health Protection Teams. Each team comprises a leader, consultants in communicable disease, nurses, and other staff with specialist health protection skills. Teams also have access to expert advice on chemical and radiological issues, health emergency planning, and communications.
The role of the team is to:
• Provide specialist advice and support locally to primary care trusts, hospitals, and authorities and to reach joint decisions on how health protection should be delivered locally.
• Investigate and manage a full range of health protection incidents, involving surveillance, support and monitoring
• To be responsible for dealing with some chemical incidents.
10 http://www.hpa.org.uk/hpa/right_nav/emergency.htm at 7 April 2004 11 http://www.hpa.org.uk/hpa/right_nav/localregional.htm at 7 April 2004
14 RESEARCH PAPER 04/47 e. Emergencies
The Agency incorporates an emergency response division to provide an effective response to events including outbreaks of infectious diseases, chemical incidents and the threat of global terrorism. Major incident planning and training are of primary concern. The functions of the emergency division are:
• Improving the speed and effectiveness of our overall response, both locally and nationally, in the event of any future incident or threat. This includes providing positive and authoritative messages about health protection measures in order to reduce public anxiety.
• Providing a central source of authoritative scientific/medical information and other specialist advice on both the planning and operational responses to major incidents and wider public health or other emergencies. 12
Two exercises based on the release of smallpox have already been conducted to assess the effectiveness of the major incident plans.13 More recently a field exercise based on the deliberate release of sarin, involving more than 200 volunteer casualties, was conducted in Newcastle. The exercise also included a desktop training exercise, where members of the health and emergency services planned a response to additional major emergency incidents.
Dr Nigel Lightfoot, Director of the Emergency Response Division at the Health Protection Agency, said:
“We are very pleased with the way in which the day has gone. The procedures involved in the field exercise went so well that we finished an hour ahead of schedule.
“However, the point of exercises is to learn from them and improve upon existing plans. Both the field and desktop exercises were monitored by observers and umpires and we will take on board their observations and recommendations. We will also be studying film footage we have recorded of the day. Together they will help us to identify ways in which we can improve the health response to emergencies.”14
12 http://www.hpa.org.uk/hpa/right_nav/emergency.htm at 13 April 2004 13 “New public health agency sets out it’s stall”, British Medical Journal, 9 August 2003 14 http://www.hpa.org.uk/hpa/news/articles/press_releases/2004/040729_exercise_magpie.htm at 13 April 2004
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3. Partner organisations
The Health Protection Agency works in close partnership with the National Radiological Board (NRPB). The Health Protection Agency Bill would incorporate the NRPB into the HPA.
The statutory functions of NRPB, which were established under the Radiological Protection Act 1970 are:
• by means of research and otherwise, to advance the acquisition of knowledge about the protection of mankind from radiation hazards.
• to provide information and advice to persons (including Government Departments) with responsibilities in the United Kingdom in relation to the protection from radiation hazards either of the community as a whole or of particular sections of the community. 15
Since the establishment of the partnership with the HPA, both bodies have worked closely with other agencies to provide plans to deal with deliberate release of radioactive material. On 23rd January 2004, a one-day exercise was held in Cambridge to provide a training exercise and explore the planning issues related to the response to a radiological “dirty bomb”. In addition, the HPA, NRPB and the Department of Health have collaborated to provide updated guidance on emergency planning for incidents involving radioactivity.
The NRPB expressed some initial concern that incorporation into the Health Protection Agency might compromise their international reputation for independence and impartial advice. A Standard Note SN/SC/3036, The National Radiological Protection Board and the Health Protection Agency Bill [HL] Bill 99 2003-2004, has been produced to provide further information on this subject.
C. Comments on the Health Protection Agency
Several of the major organisations that have been closely involved in the Health Protection Agency commented on the creation of the HPA.
1. Faculty of Public Health
The Faculty of Public Health of the Royal College of Physicians broadly welcomes the proposals for the HPA. The Faculty states:
Starting with ‘Getting Ahead of the Curve’, the Faculty welcomes and indeed it admires the thoroughness with which background information has been
15 http://www.nrpb.org/about_us/index.htm at 7 April 2004
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assembled and analysed. However, the focus of this response is upon the proposed actions as detailed in this document and as then refined and explained in the later consultation document.
The Faculty welcomes the creation of the new National Health Protection Agency. The Faculty welcomes the simplification of its name and believes that the four nominated organisations, namely PHLS, CAMR, NRPB and NFCI 16 all form logical component parts of the new body. The Faculty welcomes the plan that CDSC and NRPB in particular will maintain a distinct identity within this larger body given their internationally acknowledged expertise. The Faculty endorses the main functions of the National Health Protection Agency as laid out on pages 134 and 135 of the 'Getting Ahead of the Curve' document. The Faculty welcomes the call for a renewed focus upon R&D in this area but suggests that there are risks associated with changes. We would wish to be reassured that research capacity currently in the PHLS will be protected once transferred to the NHS as well as training opportunities. It will also be essential for the HPA and colleagues working in Health Protection in Primary Care Trusts to have the opportunity to influence the priorities of the NHS R&D Directors research programme and to ensure training opportunities are provided. 17
2. The Chartered Institute of Environmental Health
The Institute broadly supported the creation of the HPA, but also had some significant concerns. In summary the Institute stated:
Overall the CIEH supports the general principles of the Chief Medical Officer’s proposals. However, there are considerable concerns as to the effectiveness of the methods proposed to achieve the stated objectives, which have been detailed within the body of this response.
The CIEH believes that there is room for improvement in the arrangements for health protection and wishes, together with its members, to play a key role in this process. 18
Some of the main concerns expressed were centred on the level of provision of health protection services at a local level, and whether the role of the local authorities in health protection was sufficiently recognised.
• The division of responsibilities, and indeed the different arrangements, between individual regions and devolved areas of government are a matter of concern. Health emergency incidents will not respect “artificial” boundaries and it would be more effective to have a single set
16 See page 10 for full names. 17 http://www.fphm.org.uk/policy_and_consultations/Responses_to_consultations/2002/Sep/proposal_to _establlish_a_health_protection_agency0902.pdf 18 http://www.cieh.org/about/policy/responses/healthPro_creatingAgency.htm
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of arrangements for the whole of the United Kingdom. However, it is accepted that this would be politically difficult and there must therefore be compatible systems and effective partnership working.
• The consultation document proposes to move specialisms into the HPA and into the regions, which is likely to cause gaps at local level. Centralisation can create accessibility problems whereas local organisations, by their nature, are more accessible and as such responsibility for delivery of the majority of health protection services should rest at local level.
• It will be essential to ensure effective and efficient liaison between the different groupings involved in this area of work, in which the key importance of local authorities must be fully recognised. Local authorities must be fully involved in the determination of priorities for surveillance, given their local knowledge and expertise. Considerable expertise in this field rests within local environmental health departments and partnership working must ensure that this resource is fully utilised. 19
3. Public Health Laboratory Service
The Public Health Laboratory Service (PHLS) provided diagnostic microbiology services and specialist investigations. They liaised with the Communicable Disease Centre Colindale and the Central Public Health Laboratory to provide surveillance of infectious diseases and management of infection outbreaks. With the creation of the HPA the relevant specialist and epidemiological services were transferred to the Specialist and Reference Microbiology Service Division of the HPA, whilst the majority of the diagnostic laboratories were transferred to the NHS. The Communicable Disease Surveillance Centre Colindale is incorporated into the Communicable Disease Surveillance division of the Health Protection Agency.
The PHLS Board’s formal response welcomed proposals to strengthen public health protection. However, some disquiet was expressed about the effectiveness of the rearrangement of services and stressed the importance of maintaining integration of microbiological and epidemiological services at a local, regional, and national and level. The main concerns were that the fragmentation of the service would lead to a loss of an efficient coordinated response to the detection and control of infectious diseases. The importance of sufficient funding for research and development was also emphasised.20
19 http://www.cieh.org/about/policy/responses/healthPro_creatingAgency.htm 20 Public Health Laboratory Service Board’s Formal Response to the Consultation Document on creating a Health Protection Agency, 31 July 2002 (Held in the HC Library)
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D. Reports published after HPA created
1. Fighting Infection
The House of Lords Select Committee on Science and Technology published the report, Fighting Infection in July 2003. 21 The remit of the inquiry was to examine the diagnosis, treatment, prevention and control of infectious diseases. The Health Protection Agency was established during the course of the inquiry, and a number of recommendations were made concerning the new body:
• The HPA should develop collaborative relationships with other organisations, both local and international, which are involved in health protection.
• The HPA should improve information exchange, in particular to ensure integration of the exchange of electronic information.
• The HPA must be seen to act independently from the government.
2. Government Response
The Government response22 to “Fighting Infection” was published in November 2003. The key points relating to the Health Protection Agency are:
• The Government broadly agrees that the HPA should develop collaborative relationships with other organisations. Model agreements are already in place with the Primary Care Trusts, and the HPA Corporate Plan provides details of the proposed regional, national and international coordination.
• The planned implementation of the National Programme for information technology for the NHS will support implementation of an integrated system of electronic communication.
• The Government will protect the right of the HPA to publish independent advice and information in the legislation establishing the HPA as a Non-Departmental Public Body.
The Government also proposed that:
• The HPA establish a strengthened integrated system of surveillance of infection by the creation of a Health Protection Agency Surveillance Group.
21 Select Committee on Science and Technology, Fighting Infection, 2 July 2003 HL 138 2002-3 22 The Government Response to ‘Fighting Infection’, Cm 6012, 2003
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• A programme of new vaccine development should be set up.
• There would be a rationalisation of microbiology laboratories.
• There must be increased awareness, and a co-ordinated response to the increasingly complex problems of childhood infections.
E. Health Protection Agency Corporate Plan 2003-2008
The Health Protection Agency published a 5 year Corporate Plan on 5 August 2003, a document jointly published with the National Radiological Protection Board, whose functions will transfer to the HPA, subject to the Health Protection Agency Bill.
The Corporate Plan identifies 12 strategic goals for the HPA:23
1. To prevent and reduce the impact and consequences of infectious diseases.
2. To anticipate and prevent the adverse health effects of acute and chronic exposure to hazardous chemicals.
3. To reduce the adverse effects of exposure to radiation.
4. To identify, prepare and respond to new and emerging diseases and threats to health
5. To improve health service preparedness to health protection emergencies, including those caused by deliberate release.
6. To investigate childhood diseases associated with infection, chemical and radiation hazards
7. Too strengthen information and communications systems for identifying and tracking diseases and exposure to chemical or radiological hazards.
8. To establish a comprehensive research programme.
9. To develop a skilled and motivated workforce.
10. To share expertise and skills with international organisations.
23 Health Protection Agency Corporate Plan, 5 August 2003
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11. To develop the intellectual assets of the organisation in partnership with industry.
12. To provide the public with authoritative and impartial information and advice
At the launch of the Corporate Plan Dr Pat Troop, Chief Executive, said:
“Integrating the knowledge and skills from these established organisations is a huge gain for public health in this country.
But the Agency is more than a simple merger of expertise. There is a whole raft of new work we are embarking on, from establishing a network of local health protection teams around England, through to taking international collaboration to another level.
No other developed country has brought together this range of skills and expertise into one organisation. It gives us a powerhouse of scientific knowledge which we can focus on new targets, such as childhood diseases, illness caused by long-term exposure to chemicals, and predicting and preparing for new diseases, like SARS.”24
F. Present situation
The Health Protection Agency reached its first anniversary on 1 April 2004. In a press release Pat Troop, the Agency’s Chief Executive said:
“We have maintained the quality and range of services provided by the Agency at the same time as we were undergoing a major reconfiguration of services to create a new, fully integrated organisation. This will provide an extended range of benefits to public health protection and we are already beginning to see these delivered on the ground.
We should be pleased that we have succeeded in keeping the show on the road, especially as we were faced with major challenges from day one with the sudden emergence of SARS and, most recently, Avian ‘flu.
There is no doubt that our success in delivering continuity of service whilst accommodating huge changes has been due to the dedication and hard work of all our staff at local, regional and national level.
There is a great deal of work still to be done but we are steadily building on our foundations to ensure that people do receive the full benefit of integrated health protection.” 25
24 http://www.hpa.org.uk/hpa/news/articles/press_releases/2003/030805_corplan.htm 25 http://www.hpa.org.uk/hpa/news/articles/press_releases/2004/040401_hpa_oneyearon.htm
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The Health Protection Agency has already had to respond to:
• The threats from SARS and avian influenza.
• A significant increase in the number of sexually transmitted diseases.
• Highest rate of tuberculosis in Europe.
• Increasing concerns on bioterrorism treats of anthrax and smallpox.
• Emergence of new disease, with specific concerns centring on the threat from zoonoses (human diseases transmitted from animals).
• A rising incidence of hospital acquired infections, especially the emergence of multi-resistant staphylococcus aureus (MRSA), including an increasing rate amongst children.
Important developments by the Health Protection Agency have been announced recently including the establishment of a new vaccine development facility. The Times reported:
BRITAIN is to develop the world’s first “rapid response” vaccine factory, designed to identify and mass produce emergency antidotes for the most virulent diseases.
Plans for the facility have been submitted to the Government by experts at Porton Down, the microbiological research centre, amid growing concerns that the country is ill-equipped to deal with the outbreak of a new disease such as Sars or a bioterrorist incident.
The Times has learnt that the proposals are advanced, with weekly discussions about detailed modifications to the £50 million facility.
Among its most important functions will be the ability to cope with the most lethal “category three” and “category four” pathogens — such as the Ebola virus, Lassa fever, anthrax and plague, and any new diseases. It is hoped that the facility, which will be permanently staffed by up to 20 scientists, will be able to identify diseases and produce candidate vaccines in a matter of months after an outbreak anywhere in the world.26
Research links with the biotechnology industry are also being strengthened. The Health Protection Agency Porton Down has recently announced the development of a designer protein to inactivate the BSE prion molecule. The Daily Telegraph reported:
26 “Vaccine plant to fight bioterrorism threat” The Times May 8 2004
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A designer protein that "eats" the abnormal prions that cause mad cow disease and variant CJD has been developed at Porton Down which can clean instruments and also offers a new way to dispose of contaminated tissue.
Because abnormal prions, themselves proteins, can withstand heat and many standard sterilisation methods, the health service has launched a pounds 200 million programme to update sterilisation equipment and use more throwaway instruments, and has spent pounds 6 million on decontamination research.
But reusable instruments are inferior and an attempt to replace cold steel with one alternative, diathermy, in which a high frequency electrical field is used to remove tonsils, was ended recently after two patients died because of bleeding.
The designer protein offers a powerful new way to decontaminate instruments which may also be used to clean up abattoirs and help dispose of potentially BSE- contaminated material from cattle by digesting it in tanks.
Developed by the Health Protection Agency, Porton Down, in conjunction with the protein manufacturer Genencor International, the protein has worked so well that commercialisation is now being discussed, said an HPA spokesman.
The second stage of the proposal is to establish the Health Protection Agency as a non-departmental public body. This legislation will provide the Agency with an extended range of functions than are presently not available to a special health authority.27
27 “The designer protein that could destroy ‘human BSE’ – and keep our hospitals clean” The Daily Telegraph April 28 2004
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III Proposals to establish the Health Protection Agency as a Non-Departmental Public Body
A. Background to proposed legislative changes
1. Health Protection: A consultation document on creating a health protection agency
The Government published the consultation document, Health Protection: A consultation document on creating a health protection agency, in December 2002.28 This contained proposals on the status of the Agency.
In response to a question requesting information on the consultation exercise Ms Blears said:
Ms Blears: We received over 200 written responses to the consultation paper on the Health Protection Agency (HPA). Our decision to proceed with the HPA's creation, first as a special health authority and subsequently as a non- departmental public body, takes account of the widespread support for establishing the HPA.
Because the consultation paper set out proposals for creating the HPA by Regulatory Reform Order, it did not simply invite views on general principles but made relatively detailed proposals about the nature of the legislation needed. Many of the responses similarly made detailed points. We are continuing to consider these points in deciding on the details of the legislation to establish the agency. We aim to publish a report on the consultation exercise at the same time as our proposals for changes to primary legislation, since at that stage we shall best be able to show how we have taken into account the detailed points made.29
2. Consultation on proposals for a Health Protection Agency
The outcome of the consultation on the proposals for a Health Protection Agency was published on 4 December 2003; six months after the HPA had been set up as a Special Health Authority.30 a. Status of the Agency
The consultation proposed that primary legislation should establish the HPA as an executive non-departmental public body.31 This would allow the HPA to be given
28 http://www.dh.gov.uk/assetRoot/04/06/83/86/04068386.pdf 29 HC Deb 6 February 2003 c442W 30 Consultation on Proposals for a Health Protection Agency, 4 December 2003: HC Library Deposited Paper 03/2631
24 RESEARCH PAPER 04/47 responsibilities in each part of the UK as well as nationwide reasonability in the case of the National Radiological Protection Board. This would provide the HPA with a wider range of functions than are presently available to a Special Health Authority which only has responsibilities in relation to England and Wales. b. Main proposals on legislation
The consultation report provided details on the legislative proposals for the functions and duties of the HPA. The report concluded that the main aims of legislation should be to provide the HPA with:32
• The authority to obtain and analyse data and other information, to enable the surveillance of infectious diseases and chemical and radiation hazards.
• The ability to carry out functions for each of the devolved administrations.
• A different role in Wales from that which it will have in England.
• The function of providing health protection services at a national, regional and local level.
• The duty to cooperate with other organisations performing similar functions.
• The power to provide and to commission services to discharge its functions.
• The right to publish independent advice and information.
In addition recommendations were made that:
• All the functions of the National Radiological Protection Board should be transferred to the HPA.
• The public functions of the HPA should reviewed by the Commission for Healthcare Audit and Inspection.
• Funding could be received from the Secretary of State and any of the devolved administrations.
31 This is a body which has a role in the processes of national government, but is not a Government department or part of one. Such public bodies are generally created by primary legislation 32 Consultation on Proposals for a Health Protection Agency, 4 December 2003: HC Library Deposited Paper 03/2631
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3. Comments on proposals
Sir William Stewart, who is Chairman of both the Health Protection Agency and the National Radiological Protection Board, welcomed this move:
“I very much welcome this news on behalf of the Agency and the NRPB. This is an important milestone in the establishment of the Health Protection Agency as the UK’s leading authority on public health protection issues.
The Bill would formally and finally bring together the key elements in public health protection – emergency preparedness, biological, chemical and radiological expertise – within a regional, national and international network of scientific excellence. I have always believed this would offer the best and most effective means of protecting people’s health.
The world has changed and we need new systems and solutions if we are to ensure that the UK retains and extends its capacity to deal with new and rapidly emerging threats to public health such as SARS.
We are all global citizens – we can no longer afford to think of this country as a small island perched off the coast of continental Europe because an emerging disease can race around the world within 24 hours or less. It is therefore essential that we have the best possible health protection systems in place and remain at the forefront of scientific developments in the field.
The bold and innovative step in creating the Health Protection Agency will enable us to provide an improved, more comprehensive health protection system for the people of this country.”33
We encourage the ability of the HPA to act independently in setting priorities for health protection, and we hope that scientific evidence and advice set forth by the HPA will form the basis for swift policy responses. With the high potential of the Agency to use its combined expertise in addressing some of the most pressing issues affecting the country’s health, it is important that the Government and the relevant departments take the Agency’s recommendations into serious consideration and develop appropriate responses to that advice.
IV The Bill
The Health Protection Agency Bill had its first reading in the House of Lords on 27 November 2003.
33 http://www.hpa.org.uk/hpa/news/articles/press_releases/2003/281103_hpa_bill.htm
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A. House of Lords Second Reading Debate
The Health Protection Agency Bill had its second reading on 5 January 2004. 34
Lord Warner of Brockley, the Parliamentary Under-Secretary of State Department of Health, began the debate on the second reading of the Bill. He set out the background to the establishment of the Health Protection Agency and the reasons for legislation.
Our key aim in creating the agency is to strengthen and co-ordinate the arrangements for specialist support for health protection on which local NHS bodies and local authorities rely. In the past, a considerable number of different bodies and interests have provided support for health protection issues. Advice on infectious disease generally came from the Public Health Laboratory Service, including the Communicable Disease Surveillance Centre. The National Focus for Chemical Incidents and various regional service provider units provided support on chemical hazards.
Regional advisers supported the health contribution to emergency planning, and consultants in communicable disease control took responsibility for much of the action at local level, in relation to both infectious disease and other hazards. Advice on radiological hazards is currently provided by the National Radiological Protection Board. There was also the National Poisons Information Service and the Centre for Applied Microbiology and Research. The Health Protection Agency will combine all those functions in one organisation for the Secretary of State for Health, with the devolved administrations deciding the precise role that the agency will play in Scotland, Wales and Northern Ireland.
That wide-ranging role for the agency is an important development, because when an incident occurs it is not always immediately clear whether it has a chemical, radiological or an infectious source. A single agency can provide quick access to all relevant expertise. We also expect to see benefits as all these different specialist areas learn from each other. By placing different responsibilities within a single unified agency we should see a greater degree of cross-fertilisation of good ideas and good practice than in the past.35
1. Clauses
All the clauses relate to the Health Protection Agency Bill, which had its Second Reading on 5 January 2004. a. Clauses related to Health Functions
Clause 2 specifies the function of the Health Protection Agency in each of the four parts of the United Kingdom. It will also provide the power for the Secretary of State, or the
34 The Health Protection Agency Bill [HL] Bill 3 2003-4 35 HL Deb 5 January 2004 c13
27 RESEARCH PAPER 04/47 devolved administrations, to give the agency additional functions in the future if circumstances make this necessary. The appropriate authority to direct the function of the agency in each area is specified in Clause 6.
Clause 2 of the Bill states:
2(1) The Agency has the following functions in relation to health— (a) the protection of the community (or any part of the community) against infectious disease and other dangers to health; (b) the prevention of the spread of infectious disease; (c) the provision of assistance to any other person who exercises functions in relation to the matters mentioned in paragraphs (a) and (b).36
Clause 4 details supplementary functions of the Health Protection Agency including provision for research, collection of data and the provision of information. b. Clause 3: Radiation Protection Functions
This clause provides the Health Protection Agency with the radiation protection functions that are presently the responsibility of the National Radiological Protection Board. Details are contained in Standard Note SN/SC/3036, The National Radiological Protection Board and the Health Protection Agency Bill [HL] Bill 99 2003-2004.37 c. Other clauses
The remainder of the Bill is primarily concerned with the practical issues of establishing and running the agency. Details are provided in the explanatory notes published alongside the Bill.38
• Clause 5 concerns co-operation with other bodies whose work relates to the functions of the Health Protection Agency.
• Clause 7 makes provision for the publication of information and advice within the constraints of the Data Protection Act 1998.
• Clause 8 details the transfer of property and staff of the incorporated bodies forming the agency.
• Schedule 1 concerns the organisation of the Health Protection Agency including the membership of the agency, details of finance and the annual reporting system.
36 Health Protection Agency Bill [HL] 3 March 2004 37 http://hcl1.hclibrary.parliament.uk/notes/ses/snsc-03036.pdf 38 http://pubs1.tso.parliament.uk/pa/cm200304/cmbills/099/en/04099x--.htm
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• Schedule 2 relates to the transfer of property and staff.
• Schedule 3 provides information on the amendments to other acts.
2. Main points of debate
A number of issues were raised in the Second Reading debate. a. Disease registration
Concern was expressed that without adequate collection of epidemiological date the HPA would be unable to operate efficiently. Baroness Finley said:
The Government need to engage the public in understanding why epidemiological data are so important. The public needs to understand why every citizen's disease data are important to contribute to the mosaic picture of health, so that policies can be scrutinised and early warning signs detected. Without addressing some of the broader aspects, I fear that the Health Protection Agency may find itself in shackles and unable to operate as effectively as one hopes it will.39 b. Consent and confidentiality
Lord Fowler emphasised the need for clarification of the issues relating to consent and confidentiality.
I believe that in Committee we shall need to consider Clause 7, which sets out when information will not be published. I assume that the provision on the Data Protection Act covers patient confidentiality. That is clearly a very important issue in this area. But I am always wary when I see that publication can be banned when it is "not in the public interest". We shall need to examine who judges what is in the public interest and what is not.40 c. Infection dangers
The continuing problem and increased prevalence of certain infectious diseases was highlighted. In particular, Lord Fowler drew attention to the rise in sexually transmitted diseases, tuberculosis and hospital acquired infections.
The report, (Health Protection Agency report on sexually transmitted diseases published to coincide with World AIDS Day ), presents a very grim picture. It shows that sexually transmitted infection generally has increased alarmingly; that in the past 12 months, for example, diagnoses of infectious syphilis in men
39 HL Deb 5 January 2004 c23 40 HL Deb 5 January 2004 c19
29 RESEARCH PAPER 04/47
increased by 73 per cent and in women by 33 per cent; that there have been significant increases in sexually transmitted infections among gay and bisexual men; that cases of gonorrhoea, again among gay men, have almost doubled since 1999; and that those same sexually transmitted infections may facilitate the transmission of HIV.
The report also reveals that there has been an increase in the number of heterosexual HIV diagnoses acquired in this country, and that over the past 12 months there has been a 20 per cent increase in the number of people living with HIV to an estimate today of about 50,000. 41 d. An effective information technology system:
Lord Turnberg stressed the importance of the need for a rapid integrated information system to allow accurate transfer of information, especially during outbreak of infection, or other emergency situations.
The HPA needs a first-rate IT system so that information about the nature of outbreaks—for example, where they are occurring or linking an unusual case in one part of a country with one in another—is transmitted rapidly to those in the field who have to trace sources of outbreaks and take action. An effective IT system is the vital nervous system for the HPA, which is so dependent on rapid information flows. Currently, its systems are nowhere near as good or as integrated as is necessary. That is despite repeated requests for funding by the HPA's predecessor. We must ensure that the HPA is not similarly deprived.42 e. Research and development:
The importance of maintaining investment in research and development of new technology needed to combat future infection, biological or chemical hazards was emphasised. Lord Soulsby mentioned a particular area of concern to be that of vaccine research, development and production.
One area of particular concern is that of vaccine research, development and production. The Government's response to the House of Lords inquiry agreed that there has been a significant deficit in the UK capacity for vaccine production. A secure supply of vaccines in the event of a national or global pandemic is essential. Previously, the HPA Porton Down facility was identified as an essential component of preparedness. Further, the HPA has commented that it would be imprudent not to have a vaccine capability there.43
41 HL Deb 5 January 2004 c19 42 HL Deb 5 January 2004 c35 43 HL Deb 5 January 2004 c38
30 RESEARCH PAPER 04/47 f. Role of primary care trusts
Lord Chan queried whether primary care trusts had the resources to be able to fully collaborate with the HPA in surveillance, management and control of infection at a local level.
Clearly, the Health Protection Agency is essential for the maintenance of the public's health. The HPA's efficiency is increased by its regional centres in England. The downside of the current arrangements, including the two-part implementation of the restructuring of the HPA, has been the upheaval of staff in its regional centres. In addition, the primary care trusts are expected to fund the work of the regional centres of the HPA, but many primary care trusts are struggling with debts. Further, public health units in primary care trusts are also small and fully stretched in coping with the issues of health inequalities. Therefore, there is an air of crisis management in public health in primary care trusts, especially in parts of the north west, where the HPA is expected to collaborate with the primary care trusts on issues such as surveillance, diagnosis, management and control of outbreaks.
With such a wide-ranging agenda, it is unlikely that the HPA can be expected to work well without the prospect of additional funding. If the HPA is to be independent and effective, the Bill is to be welcomed; but if it is to be involved in the community where protection is expected, it must be allowed to function with adequate resources. 44
B. House of Lords Grand Committee
The House of Lords Grand Committee stage was on 3 March 2004.
1. Agreed amendments
The main amendments that were agreed to and the reasons for the changes are given below. a. Clause 4 (5)
Amendment 19 was requested by Scottish Ministers, and adds details to the Scottish equivalents to the legislation. This enables the Agency, Scottish bodies and local authorities to enter into agreements with each other. The following text insertion was made.
Original text Amended text (d) for the purposes of sections 13 (payments by NHS bodies towards
44 HL Deb 5 January 2004 c42
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certain local authority expenditure) and 14 (payments by local authorities towards expenditure by NHS bodies on prescribed functions) of the Community Care and Health (Scotland) Act 2002 (asp 5) as if it is an NHS body within the meaning of that Act; (e) for the purposes of section 15 of that Act (delegation etc. between local authorities and NHS bodies) as if it is an NHS body within the meaning of that Act.
b. Clause 8(a)
Amendment 35 was to provide greater consistency of the word ‘enactment’ throughout the Bill.
Original text Amended text (a) an enactment contained in or made (a) any provision of or instrument made under an Act of the Scottish under an Act of the Scottish Parliament; Parliament
c. Clause 9
Amendment 36 inserted two further sections into the clause in response to a recommendation from the Delegated Powers Committee.
Original text Amended text A direction— (1) A direction— (a) must be given in writing; (a) must be given in writing; (b) may be varied by a subsequent such (b) may be varied by a subsequent such direction. direction.
(2) A direction under section 2(2), (3) or (4) must be given in regulations made by statutory instrument.
(3) A statutory instrument making regulations giving a direction under section 2(2)(a) or (3) is subject to annulment in pursuance of a resolution of either House of Parliament.
32 RESEARCH PAPER 04/47 d. Clause 11
Amendment 37 inserted a further section to provide a consistent use of the word ‘enactment’.
Original text Amended text (10) Enactment includes— (a) any provision of or instrument made under an Act of the Scottish Parliament; (b) Northern Ireland legislation.
A number of amendments of Schedules 1, 2 and 3 were also accepted.
2. Amendments not accepted
Other amendments that were proposed, but either withdrawn or not agreed to in Grand Committee, raised some important points for debate. a. Local community services
Earl Howe expressed disquiet about the ability of the local services, at primary care trust level, to control communicable diseases.
Much will depend on PCTs, which, as we know, have their hands full in all sorts of ways unrelated to public health. Many—I am one—feel that PCTs are in any case too small, in terms of population, to have the full range of specialties needed to produce effective health gain and effective local control. Indeed, the consultants in communicable disease control—the very people who know most about the day-to-day business of health protection—have been removed from the PCTs and relocated into the Health Protection Agency. The direct involvement of those individuals with the local arms of the NHS and with environmental health departments of local authorities has thereby been done away with.45
He continued:
We are in danger now of making the system a good deal less joined-up than before at local level. It would be very helpful if the Minister could tell the Committee something about the day-to-day practical arrangements—the allocations of responsibilities for lines of command and so on—that will overcome the structural shortcomings to which I have referred. I beg to move. 46
45 HL Deb 3 March 2004 c250GC 46 HL Deb 3 March 2004 c251GC
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Lord Warner responded:
Historically, it would be fair to say that different PCTs and their predecessors have taken different decisions about the funding of health protection. The noble Earl expressed concerns about that at Second Reading. None of us would disagree that there have been variations around the country in that response. The HPA's existence, with the memoranda of understanding that I mentioned, offers the opportunity to work towards more uniformly high standards throughout the country. So what we have is a pragmatic solution in which there is a clear allocation of resources by the HPA to the work of local and regional services; a pretty standard memorandum of understanding, but one tweaked to take account of local circumstances, as is right; and a commitment by the agency as one of its key priorities to produce a more standardised response where there are local control or infection incidents, so that it can respond around the country in a consistent way. That strikes me as a considerable improvement on what existed previously. I do not underestimate the contribution made by consultants on communicable diseases, but we had a less consistent service. The existence of the agency offers improvements in that area. I hope that that provides some reassurance to the noble Earl. 47
The amendment was withdrawn b. Zoonoses
Some of the peers felt that a specific reference to diseases transmitted from animals (zoonoses), should be added to Clause 2 which outlines the function of the Health Protection Agency. The amendment was proposed by Lord Clement- Jones.
Because zoonoses can pose such serious public health threats, many of which are newly emerging diseases, the HPA certainly should have a responsibility for preventing their spread. That point was made strongly in the report entitled Getting Ahead of the Curve, in 2002. I shall not weary the Minister by repeating the words in that report, but it was a very interesting tour d'horizon on some aspects of public health. I think that the Minister might find paragraph 2.48 of the report quite helpful.
By including zoonoses in the Bill, we would ensure that the HPA can draw resources not only from agencies dealing solely with human health, but also from those with animal health and food safety concerns, such as Defra and the FSA. With the HPA, we have an excellent opportunity to bring together surveillance information and prevention approaches to infections that cross the borders of human, animal and food-borne disease.48
Lord Warner clarified the scope of the term ‘infectious diseases’:
47 HL Deb 3 March 2004 c252GC 48 HL Deb 3 March 2004 c253GC
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Zoonoses are already included in the term "infectious diseases". The HPA is already active in that area and the Bill places a duty on it to co-operate. As to the concerns expressed by the noble Lord, Lord Clement-Jones, about whether it will always do this work as part of its planned work programmes, the agency will have to agree its work plans in relation to its budget with the Department of Health. Therefore, we can formalise those arrangements in the work plans to be agreed with the HPA. There will be no problem in regard to a mechanism to ensure that it takes an active part in the area. Neither the chairman nor the chief executive, who have been listening to the debate from the end of the Room, will be in any doubt whatever of the Committee's views on the subject.
Against that background, the Bill already adequately meets the concerns expressed by Members of the Committee, and I am not sure whether the addition of the words would improve its provisions. When I consulted parliamentary counsel on the matter, he advised that the inclusion of a reference to a particular example of infectious disease could have the effect of casting doubt on the scope of the generality of "infectious disease". Unqualified, it is actually broader than qualified.49
The amendment was withdrawn. c. Devolution
Earl Howe queried why an agency that was created to address national problems could potentially have different remits in different parts of the United Kingdom, depending on what function are bestowed by the devolved assemblies.
Quite why we then have a situation in which a supposedly national agency—a UK-wide agency—will find itself performing potentially different roles under potentially different remits depending on which part of the country it operates in is something that only the Minister can tell us. At best, it is an arrangement that is bizarre as well as administratively difficult. At worst, it is positively dangerous. If the Scottish Parliament were to choose not to confer the same functions on the agency as those conferred under the Bill for England, questions arise on, first, whether the agency would be able to work satisfactorily with such a split personality, and secondly, whether the Scottish Parliament will have the capacity to perform by itself all the responsibilities that it chooses not to pass to the agency. We simply do not know the answer to either of these questions, and they are very important.50
Lord Warner stated that a feature of the devolution settlements was that the devolved authorities take their own decisions in certain areas, but the Bill will allow a coordinated approach to health protection across the UK. He said:
49 HL Deb 3 March 2004 c257GC 50 HL Deb 3 March 2004 c259GC
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Nevertheless, it must be recognised that, for the first time, we will have a body that has a legislative basis for exercising health protection functions in every part of the UK. It may not be in quite the legal format that the noble Earl would prefer, but it enables those functions to be co-ordinated by the HPA51
The amendment was withdrawn. d. Confidentiality of data
Concern was expressed that it might be made too easy to overrule the protection offered to a patient’s confidential information by the Data Protection Act 1998, by citing the need for disclosure in the public interest. Earl Howe said:
But there is clearly a balance to be struck between allowing the agency to pursue its active operational links with local authorities, as it must certainly do, and conferring carte blanche on the agency to disclose confidential patient data to anyone on a local authority's payroll.52
Lord Warner responded:
However, we have entered the complicated territory of the inter-relationship between the Data Protection Act and the Human Rights Act. At this point I am reluctant to go into a long dissertation on the subject, but I will say that, essentially, parliamentary counsel sees this as a matter where if the information was used against the authority in the Data Protection Act and it was not proportionate, this could bring it within the terms of the Human Rights Act. So the judgment would be concerned with the proportionality of dispensing with the safeguards of the Data Protection Act.
I am happy to write giving the legal opinion which underpins this argument rather than go into its lengthy detail now. I agree with noble Lords that it is an interesting issue, but it is probably not something for the delectation of the Committee at this hour. However, I shall write to noble Lords with the detail of parliamentary counsel's arguments on this issue.53
The amendment was withdrawn. e. Links with other organisations
It was recognised that in order to work effectively the agency would need close working relationships with other bodies. Earl Howe questioned whether more efficient co-
51 HL Deb 3 March 2004 c261GC 52 HL Deb 3 March 2004 c284GC 53 HL Deb 3 March 2004 c285GC
36 RESEARCH PAPER 04/47 ordination could be obtained if Clause 5 specifically listed the bodies that would be under a duty to co-operate with the Health Protection Agency.
The creation of the agency may prove to be a step towards creating that framework and single channel of communication. However, one need only look at my amendment and the multiplicity of bodies and individuals with responsibility for one aspect or another of public health protection to appreciate that there is still a very long way to go. Simply to say, as the Bill does, that these bodies, whoever they are, must all co-operate with each other ignores the need for there to be someone or some body with their hands on the key levers for maintaining standards of public health protection and driving them up.54
Baroness Andrew replied to the query, explaining why it would not be practical to list all the organisations that would be required to coordinate on health protection functions:
This list, however forbidding in length and complexity and however thoughtful in substance, is not complete. For example, no reference is made to the health and social services boards in Northern Ireland, or to the Northern Ireland health and safety bodies. Moreover, as new bodies are formed, the list would become even more incomplete. Were we to go down this road, how would we keep the list up to date? Who would we include and where are the boundaries of public health? The list would have to be amended by further primary legislation, a point noted by the noble Baroness, Lady Finlay.
I conclude by referring to the second point made by the noble Baroness. The amendment would not achieve what I take to be its aim; that is, by identifying by name all the specific bodies affected. I would challenge the notion of vagueness and unnecessarily robust generality here. That is how new international bodies should be able to be included, for example, as well as the WHO, obviously, with which we have worked and continue to work extremely closely.55
The amendment was withdrawn. f. Publication of information
The proposed amendment related to Clause 7 and aimed to clarify the circumstances under which the government could prevent disclosure of information. Lord Fowler requested details of when information, which could be in the public interest, might be withheld.
I want the Minister to give a clear explanation of the kind of information that, in the Government's view, contravenes the Data Protection Act, and that would not be published under this provision..
54 HL Deb 3 March 2004 c288GC 55 HL Deb 3 March 2004 c292GC
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Subsection (2)(c) provides that if the publication is not in the public interest, it can be withheld. I am concerned to know what information can be withheld on that basis. Is information gathered already that is withheld from publication? If so, what kind of information is that? If not, what information is it envisaged will be withheld that is already published? Above all, what I really want to know from the Minister is who actually decides what is in the public interest. Where is the decision made? How is it processed?
My belief is that, generally, publication is in the public interest for holding governments—any government—to account; informing the public of the dangers; and advising them on the action that they may take. In essence, I really want to know from the Government what kind of information can be banned on public interest grounds; by what process that decision is made; and how it can be challenged. How can it be challenged if information is withheld on public interest grounds? How are we to know and challenge the idea that it is not against the public interest?56
Lord Warner provided clarification on the Agency’s powers to publish information.
Let me say at the outset that we are absolutely at one with the noble Lord, Lord Fowler, on the importance of making information available to the public. There is no disagreement between us on that.
Clause 7(1) provides a clear path for the agency proactively to publish advice and information. As far as we have been able to establish, such a power does not exist in the founding legislation of any other body, apart from the Food Standards Agency and, to some extent but in more limited form, in the HPA as a Special Health Authority. That is the position from which we start. The agency's power to publish information is stronger under the Bill than it was as a strategic health authority. We have strengthened that power and, as the Bill is currently framed, the discretion of judgment in Clause 7(1) is left with the agency, subject to the caveat in Clause 7(2). So there is a clear responsibility on the agency to make that judgment. 57
The amendment was withdrawn.
C. Health Protection Agency Report Stage
The Report stage debate was in the House of Lords on 6 April 2004.58 A number of amendments were accepted.
56 HL Deb 3 March 2004 c295GC 57 HL Deb 3 March 2004 c298GC 58 HL Bill 37 2003-4
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1. Main Amendments a. Clause 4
Two amendments relating to clause 4 were agreed. The amendments were made in response to concerns raised during the Grand Committee stage, that under clause 4(7) the government would have too wide a remit in directing the functions of the HPA.59
Original text Amended text (7) The appropriate authority may (after (7) The appropriate authority may direct the relevant consultation) give the Agency Agency to have regard, in exercising directions as to the exercise of its functions. any of its functions, to such aspects of the policy of the authority as the authority directs.
(7A) The Agency must comply with any direction under subsection (7). (7B) If the appropriate authority thinks that the Agency is to a significant extent— (a) failing to discharge any of its functions, or (b) failing to discharge any of its functions properly, it may (after relevant consultation) give the Agency such a direction as it thinks appropriate for remedying that failure.
If the Agency fails to comply or unreasonably If the Agency fails to comply or unreasonably delays in complying with the delays in complying with a direction the appropriate authority may exercise direction under subsection (9) the appropriate the function to which the authority may, instead of the direction relates instead of the Agency. Agency, take such action as it thinks appropriate to remedy the failure.
b. Clause 5:
Clause 5 relates to the co-operation of the agency with other bodies. During the Grand Committee stage queries were made as to why a specific reference was made to local authorities, but not to any of the other bodies. The government recognised that it was unhelpful to single out local authorities and introduced this amendment.
Original text Amended text (1) In the exercise of its functions the Agency (1) In the exercise of its functions the Agency must co-operate with other bodies (including must co-operate with other bodies which local authorities) which exercise functions exercise functions relating to health or any relating to health or any other matter in relation other matter in relation to which the Agency to which the Agency also exercises functions. also exercises functions.
59 HL Deb 6 April 2004 c1745
39 RESEARCH PAPER 04/47 c. Clause 7
Questions were raised at the Grand Committee stage as to whether the Minister would be able to influence the Agency’s decisions on publication of information under the present wording of clause 7. The aim of the amendment was to make it clearer that the Agency had the freedom to publish the information they feel is appropriate, subject to restrictions in the public interest.
Original text Amended text (2) Subsection (1) does not permit the (2) But the Agency must not publish any publication of any matter— matter— (a) which contravenes the Data Protection Act (a) which contravenes the Data Protection Act 1998 (c. 29); 1998 (c. 29);
d. Clause 8
The amendment detailed subclauses to be inserted in order to comply with Cabinet Office guidance on the treatment of employees following the transfer of work.
Original text Amended text (6A) If the appropriate authority varies or revokes a direction or order under section 2 or 3, it may make a scheme for the transfer of the rights and liabilities of the Agency specified in subsection (8) to a relevant transferee. (6B) The rights and liabilities are the rights and liabilities relating to the contract of employment of any individual whose employment, in the opinion of the appropriate authority, relates wholly or principally to the Agency’s exercise of a removed function. (6C) A removed function is a function which is the subject of the direction or order which the appropriate authority varies or revokes. (6D) A relevant transferee is an entity which, following the variation or revocation of the direction or order, is to exercise the removed function. (6E) The appropriate authority must not make a scheme under subsection (7) unless it first consults, in respect of the scheme, each person or body that it must consult in respect of the variation or revocation of the direction or order under section 2 or 3.
40 RESEARCH PAPER 04/47 e. Clause 10
The amendment introduced a new clause to the Bill, “Health Care Provision: Standards”, to enable the Agency to be subject to review and inspection by Committee for Healthcare Audit and Inspection. The Agency, as a Special Health Authority is currently subject to inspection, but it was felt that the original provisions drafted in the Bill did not detail clearly that this process would continue.
Original text Amended text 10 Health care provision: standards (1) In so far as any health care is provided by or for the Agency it is to be treated for the purposes of the standards provisions as an English NHS body. (2) Health care must be construed in accordance with section 45 of the Health and Social Care (Community Health and Standards) Act 2003. (3) The standards provisions are Chapters 2, 3 and 10 of Part 2 of that Act. (4) The references in section 53 of that Act (failings of bodies) to special measures are, in relation to the Agency, references to anything that may be done by the appropriate authority in pursuance of section 4 above. (5) Section 57 of that Act (studies as to economy and efficiency, etc.) does not apply to the Agency. (6) This section does not extend to Scotland and Northern Ireland.
f. Schedule 3
Several amendments were made to enable the Agency to be placed in the jurisdiction of the Parliamentary Commissioner for Administration in relation to all its functions, except for Scotland which will come under the jurisdiction of the Scottish Public Services Ombudsman. A single ombudsman should simplify the overseeing of the Agency.
Original text Amended text Parliamentary Commissioner Act 1967 (c. 13) Parliamentary Commissioner Act 1967 (c. 13) 1 In the Parliamentary Commissioner Act 1967, 1 (1) The Parliamentary Commissioner Act in Schedule 2 (departments 1967 is amended as follows. etc. subject to investigation) at the appropriate (2) In Schedule 2 (departments etc. subject to place there is inserted— investigation) at the appropriate “Health Protection Agency.” place there is inserted— “Health Protection Agency.” (3) In the Notes to Schedule 2, after paragraph 11 there is inserted the following paragraph—
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“12 (1) This paragraph applies in relation to the Health Protection Agency. (2) No investigation is to be conducted in relation to any action taken by or on behalf of the Agency in the exercise in or as regards Scotland of any function to the extent that the function is exercisable within devolved competence (within the meaning of section 54 of the Scotland Act 1998).”
2. Amendments not accepted
Several amendments although not accepted were recognised as raising issues that might require further consideration before third reading. a. Clause 4(8)
There was still some disquiet about whether clause 4(8) was proportionate in the powers it provides for the government to direct the function of the HPA. Lord Warner acknowledged these concerns:
Clause 4(8), as amended by the government amendment, would continue to provide a default power for an appropriate authority if the agency failed to comply with a direction about remedying a failure.
We consider that a default power is necessary where a body is providing front- line services, particularly where, as with the agency, it is the only body of its kind. Similarly, Section 24(7) of the Food Standards Act provides:
"If the Agency fails to comply with any directions under this section, the authority giving the directions may give effect to them (and for that purpose may exercise any power of the Agency)".
There is also a power in Section 84A of the National Health Service Act 1977 which allows for intervention orders to be made in relation to a failing NHS body. There is no default power for CHAI or CSCI, but those bodies carry out inspections and reviews. They are not in the front line of service provision in the way that the agency will be.
I have set out this context at some length because I am trying to show that, in framing these amendments, we have tried to take account of recent practice in circumscribing the Secretary of State's powers to issue directions in a meaningful way which does not go too far but preserves his right, in particular circumstances, to exercise a discretion. That is what we are trying to do in these amendments. The power to direct the agency to take account of policy, about which noble Lords have raised concerns, could not be used in that way. In the Bill Parliament
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entrusts the agency with functions without providing for it to be micromanaged by directions. These amendments are very circumscribed. I hope that noble Lords will accept that we have tried to respond to the concerns expressed in Committee.60 b. Clause 4(9)
Earl Howe expressed some of the concern felt over the issues related to confidentiality, and whether this clause would allow overruling of Data Protection Act 1998.
My only concern is that there is nothing in the subsection that pays even the smallest degree of lip service to the key principles of data protection, chief of which perhaps is proportionality. What it says is that:
"The disclosure of information to or by the Agency . . . does not breach any restriction on the disclosure of information (however imposed)".
That seems to me a very broad power, which could be interpreted as overriding common law duties of confidentiality. There is absolutely no mention of the public interest or of the kinds of circumstances in which disclosure might be allowable. Without a qualifier of this type, individuals may well start to wonder, when they go to see their doctor, whether and to what extent private information on their medical files might be revealed and to whom. Fears of that kind tend to undermine trust and confidence between doctor and patient. In Grand Committee, the Minister spoke about the interrelationship between the Data Protection Act and the Human Rights Act. I do not doubt that there is a balance between the two statutes; but as I understand the Data Protection Act, it already contains provisions that enable the free exchange of data where the public interest demands that such data should be disclosed. 61
D. House of Lords Third Reading
The Bill had its third reading on 29 April 2004.62
1. Agreed amendments a. Clause 4
This inserts a new sub-section to ensure that any information shared by the agency with other bodies complies with the Data Protection Act. This will only allow information to be disclosed in the public interest.63
60 HL Deb 6 April 2004 c 1745 61 HL Deb 6 April 2004 c1746 62 The Health Protection Agency Bill [HL] Bill 59 2003-4 63 HL Deb 29 April 2004 c939
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Original text Amended text But subsection (11) does not authorise a disclosure of information which contravenes the Data Protection Act 1998 (c. 29)." b. Clause 8
A technical amendment was made to clause 8 in the same way as other such references were amended at the Report stage.64
Original text Amended text (6) A relevant body is a body— (6) A relevant body is a body— (a) established otherwise than by or under any (a) established otherwise than by or under any enactment, enactment, (b) all of the functions of which are conferred (b) all of the functions of which are conferred on the Agency in pursuance on the Agency in pursuance of a direction or order under this Act, and of a direction or order under this Act, and (c) which is specified in one or more schemes (c) which is specified in a scheme.
2. Amendments not accepted
Lord Clement-Jones moved an amendment to remove Clause 4(7):
The appropriate authority may direct the Agency to have regard, in exercising any of its functions, to such aspects of the policy of the authority as the authority directs.
Concern was expressed that this clause could provide the Secretary of State with the authority to direct the functions of the HPA, whereas no such provision exists in the case of the Food Standards Agency. Lord Warner responded:
My Lords, I am sorry that the noble Lord, Lord Clement-Jones, has such difficulty with my extensive explanation of our thinking on Report. Clause 4(7) is part and parcel of the revised powers of direction as to the exercise of functions, which we agreed to incorporate in the Bill on Report. I would suggest that removing it would not improve the Bill. It particularly goes together with Clause 4(8). So, they are part and parcel of the same approach. I shall not go through the extensive explanations that I gave on Report, but I should like to focus on one particular point. I shall return to the point about the Food Standards Agency. I would remind the House that Clause 4(7) is virtually identical in terms to the wording in Section 131—subsection (1) in particular—of the Health and Social Care (Community Health and Standards) Act 2003. Whatever else we did in the Bill, we combed through it extensively and had extensive debates on whether
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those provisions would unreasonably fetter the independence of those bodies and on whether it would put the Secretary of State in a position rather whimsically to give directions to the Healthcare Commission and CSCI. After our debates, the Act on the statute book had virtually identical wording to that in Clause 4(7).
I reiterate to those who are concerned that Clause 4(7) will be used to prevent the agency carrying out an act that an appropriate authority did not believe to be appropriate, that that is not a backdoor way of maintaining the wider power of direction which we removed from the Bill on Report. 65
The Bill was passed and brought to the House of Commons.
E. Views on the Bill
The Health Protection Agency Bill was broadly welcomed by the opposition parties.
1. The Conservative Party
During the Second Reading of the Health Protection Agency Bill, Lord Fowler said:
Lord Fowler: My Lords, I welcome the Bill and agree with the noble Lord that it is an important measure. I also agree that we are fortunate in having in the agency some very skilled and dedicated staff who already have an international reputation. To place much of this on a United Kingdom basis obviously makes a great deal of sense.66
2. The Liberal Democrat Party
The Liberal Democrat Party contributed the following summary of the party view on the Health Protection Agency Bill.
The Liberal Democrats welcome the Health Protection Agency (HPA) Bill. We applaud the efforts of the Agency in carrying out its mission of “protecting people’s health and reducing the impact of infectious diseases, chemical hazards, poisons and radiation hazards,” and we support the HPA’s role in taking the lead to address threats to health in the UK, especially in an era where newspaper headlines warn of emerging health threats such as SARS, avian flu, and other zoonoses. The HPA brings together a wide range of experts that go beyond infectious disease researchers to include scientific leaders in areas such as chemical and radiological threats. Bringing these areas under the umbrella of one agency will help to set priorities and address threats swiftly and effectively.
The work of the HPA will be especially important at the local level, and the Government should ensure that all of the HPA’s specialist services at the local
65 HL Deb 29 April 2004 c938 66 HL Deb 5 January 2004 c18
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level will continue to receive adequate resources and support so that the Agency can carry out its functions appropriately. Health surveillance under the former Public Health Laboratory System reached a very high level of quality, and we are enthusiastic for this level of quality to be maintained, and indeed exceeded, by the continued work of the HPA. To maintain these high standards, the Agency therefore will require continuous support in terms of resources, not only for its central administration, but also for devolved administrations and representatives in the field, where much of the Agency’s daily work in surveillance will take place.67
67 Personal communication from Liberal Democrat Party
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