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Development Of Immunization Policy And Its Implementation In The United Kingdom
The U.K. immunization program is managed through a tightly connected process that links the ways policy is developed, submitted to independent expert review and recommendation, adopted into strategy, and implemented into practice. There is one advisory body for immunization. Its recommendations, once accepted by government, are centrally funded, and vaccines are provided at no cost to recipients. Although the present system has worked well, changes in health care management at the peripheral level mean that the immunization program will need to adapt to retain the health gains achieved. Rates of vaccine-preventable disease are at historically low levels, although challenges related to costs and effectiveness remain.
The development and implementation of immunization policy in the United Kingdom is a seamless process, coordinated by the Department of Health (DH) in London, England, leading on behalf of Wales, Scotland, and Northern Ireland. One single policy is developed for all four countries, which may undergo minor adaptation for local implementation by each country’s relevant government departments. Major decisions on new policies are mutually agreed upon, and there has been no need for any one country to consider veto or refusal to implement a recommendation. The existence of a National Health Service (NHS) facilitates this unified process, from development of policy through to its implementation, simultaneously throughout the whole country. There is only one body that gives advice on immunization, one policy development process, and one implementation activity, delivered through one public-sector immunization service. Private-sector immunizations are numerically insignificant compared with the NHS program. Also, there is no legal compulsion for immunization, nor is there a school entry requirement for completion of immunization.
Joint Committee on Vaccination and Immunisation. The Joint Committee on Vaccination and Immunisation (JCVI) is an independent expert advisory committee established in 1963. It is a statutory expert committee, established in England and Wales under the NHS Act 1977 and the NHS (Standing Advisory Committees) Order 1981 as the Standing Advisory Committee on Vaccination and Immunisation. It is also a subcommittee of the National Professional Advisory Council covering Scotland. Included in its Terms of Reference is "to advise the Secretaries of State for Health, Scotland, Wales and Northern Ireland on matters relating to communicable diseases, preventable and potentially preventable through immunisation."1 The committee has around eighteen members representing all of the disciplines involved in immunization, including public health, child health, primary care, nursing, microbiology, immunology, and infectious disease, and there is one lay representative. Ex officio members represent agencies with essential contributions to immunization such as the Communicable Disease Surveillance Centre (CDSC) of the Health Protection Agency (HPA) and the National Institute for Biological Standards and Control (NIBSC). The main committee meets three times a year, and the meetings are not open to the public; subcommittees meet as needed. In recent years, much has been done to move to greater openness of the JCVI with a lay member and publication of the meeting minutes and agenda. The committee discussed public meetings and concluded that the disadvantages were possibly greater than the benefits, especially because the full minutes were being published. Concerns were focused on research confidentiality, commercial confidentiality, and the development of advice given to government on biosecurity; the latter is available to the public after agreement from the ministers involved. The committee agreed to revisit the subject of public meetings in the future. The JCVI minutes, its annual report, explanations for its recommendations, the interests of its members, and its Code of Practice are publicly available online.2 The obligations of the JCVI members include playing a critical role in ensuring the committee’s continued standing as an internationally recognized leading body in the field of immunization. Its members will (1) be committed to the continued development and improvement of this important area of public health; (2) bring relevant experience to the committee; (3) contribute to the provision of high-quality and thoughtful advice to U.K. ministers of health; (4) be expected to make an expert contribution to the work of the committee and to contribute fully to the committee’s debate and decision-making processes; (5) take into account the need for and impact of vaccines, the quality of vaccines and their safety, and the strategies to ensure that the greatest benefit can be obtained from the most appropriate use of vaccines; (6) be prepared, as requested by the Secretariat, to provide expert advice on relevant issues outside of committee meetings; and (7) be prepared, as requested by the Secretariat, to occasionally attend and contribute to the deliberations of one or more of the committee’s panels (or subgroups) that report to the main committee. The committee has no executive function. Its role is purely to provide advice and recommendations to the secretaries of state on the matters listed in its Terms of Reference. The secretaries of state are accountable to the U.K. Parliament for the performance of the JCVI and for ensuring that it continues to observe the highest standards of propriety, including impartiality, integrity, and objectivity in the execution of its role and responsibilities. Some of the papers presented to the JCVI—which often include prepublication copies of research or documents of commercial or clinical significance—are treated as confidential. Members meet and report as one committee usually three times a year. The DH, London, provides the secretariat for the JCVI. The committee publishes an annual report, available on the JCVI Web site. Immunisation Unit. In addition to providing the Secretariat for the JCVI, the DH (London) has the responsibility for immunization policy development and strategy implementation.3 Its Immunisation Unit has approximately twenty-five members working as five interconnected groups: Policy, Strategy, and Science; Administration and Finance; Vaccine Purchase and Distribution; Immunisation Information; and Immunisation Informatics. The groups work in a seamless way, with individuals working on multiple cross-cutting projects that encompass the management and development of the national immunization program. Scotland, Wales, and Northern Ireland typically have one health professional and a small number of administrators working on immunization. The Immunisation Unit works on horizon scanning for new vaccines or emerging problems in close partnership with the Health Protection Agency (HPA), an independent nongovernmental organization (NGO) that undertakes vaccine research, epidemiology, and surveillance on the immunization program and on vaccine-preventable diseases. The HPA is an "arm’s length body" created in April 2003 to provide better protection against infectious diseases and other dangers to health, including chemical hazards, poisons, and radiation. It serves the populations of England and Wales and was to have become a United Kingdom–wide body in April 2005. Its core functions are to identify and respond to health hazards and emergencies; anticipate and prepare for emerging and future threats; alert and advise the public and government on health protection; provide specialist health protection services; and support others in their health protection roles. The HPA provides much of the scientific advice that underpins the development of U.K. immunization policy. This information is shared with the DH in advance of presentation to the JCVI or publication. For example, the DH may fund research studies on new vaccines, which are coordinated by the HPA and undertaken by the Vaccine Evaluation Consortium.4 The results of this background work will culminate in a paper or papers for the JCVI. In some circumstances, an expert subgroup may be convened to assist the Immunisation Unit in reviewing and advising on research, bringing together available evidence, and making recommendations that will, in turn, be provided to the main committee. The DH works closely with the HPA in the development of study protocols and preparation of analyses that will be provided to the JCVI. The JCVI receives papers and hears presentations that will support the justification for a new or changed policy.5 After debate, the committee may make recommendations. It is often invited to consider cost-benefit analysis that is undertaken by the HPA on behalf of the DH.6 Although the JCVI’s recommendations are not constrained or facilitated by cost-benefit results, the committee is keen to see the resource implications of policies it is considering.7 Once the JCVI makes a new recommendation, it is the responsibility of the DH to convey that recommendation to the chief medical officer and health ministers. At this stage, the new policy will be considered fully in the light of available resources and the cost-benefit results. "New money," as opposed to adaptation of existing resources for new purposes, will become available only if it has been bid for successfully in the Comprehensive Spending Review, a three-year cyclical process through which new and existing programs are funded. The Immunisation Unit may have to bid for, and establish, multiple new funding streams for a single new vaccine policy in order to cover costs of vaccine purchase, payment to health professionals, local campaign costs, promotion, and advertising.8 Once central funds have been secured for a new policy, implementation can proceed without any requirement for additional funds to be sought at the local level. Translating policy into strategy. Following ministers’ acceptance in all four countries of any new recommendations from the JCVI, and after resources have been identified and confirmed, it then falls to the Immunisation Unit to translate the new policy into an effective strategy. This requires different actions depending on the new policy, ranging from simple modification of existing activities to a major campaign for introduction of a new vaccine.9 A strategic plan is developed with activities, timelines, agencies, and tasks to manage the implementation of the new policy. This way of working was reviewed in 2001 by the National Audit Office (equivalent of the U.S. Government Accountability Office) as part of a project on effective policy making. The DH work on introduction of new vaccines received commendation that its policy design and implementation had followed good practice.10 In some instances, U.K. policy development may appear slower than that of some other industrialized countries. For example, the change from whole-cell pertussis vaccine to acellular pertussis vaccine was not made until 2004. However, this was a deliberate decision since protection from the whole-cell vaccine was excellent, and reactions when the vaccine was given at two, three, and four months of age are fewer than when the vaccine is given later, as in the United States.11 In 2004, a "five-component" acellular pertussis vaccine became available with efficacy shown to at least equal that of the previously used whole-cell vaccine.12 Those circumstances did not apply in the United States when the decision was made there to make such a change. As a second example, varicella vaccine is not now routinely recommended for the U.K. childhood program.13 This recommendation awaits confirmation that its introduction in childhood will not increase the burden of varicella zoster in older age groups.14 Third, pneumococcal conjugate vaccine (PCV), in routine use in the United States, has been recommended for introduction into the childhood program, subject to resolution of the most effective use of the vaccine, in the most cost-effective manner.15 On other occasions, the United Kingdom may lead the world in new vaccine introduction. Meningococcal C conjugate vaccine was introduced in 1999, into the routine infant schedule and in a catch-up program for all people under age twenty-five.16 The United Kingdom was the first country to use this vaccine.
Communication. Once a new policy has been accepted and the strategic plan developed, multiple routes are employed so that health professionals and the public understand the change and the actions that they need to take to facilitate its implementation. The most common vehicle will be a Chief Medical Officer/Chief Nursing Officer/Chief Pharmacist Letter to all registered medical practitioners, irrespective of specialty; all nurses involved in immunization; and all pharmacists. The Immunisation Unit does further targeting of information to other health professionals who may be missed through these formal processes. Materials appropriate to the new policy are placed prominently on relevant Web sites, especially the two main DH Web sites on immunization (www.immunisation.nhs.uk and www.mmrthefacts.nhs.uk) and on the DH’s main Web site, www.dh.gov.uk. The chief medical officer (England) sends quarterly updates to all registered doctors, providing a further opportunity to reinforce messages about new immunization policies. The DH publishes a book on immunization—Immunisation against Infectious Disease—which describes all vaccines and vaccination procedures. This is sent through a similar distribution as the Chief Medical Officer Letter and provides definitive guidance on immunization. There may be occasions when the guidance in this manual differs from the "Summaries of Product Characteristics" of particular vaccines, but the DH advice, agreed to by the JCVI, is seen as the version that health professionals should follow. The DH manages a network of "Immunisation Coordinators" who have local responsibility for implementation of new policies and effective delivery of the immunization program. Before recent changes in the structure and management of the NHS, Immunisation Coordinators were either consultants in communicable disease control (public health specialists), pediatricians working in community child health, or (rarely) other health professional staff. With the recent devolvement of local management to Primary Care Trusts (PCTs), the role and identity of Immunisation Coordinators in this new structure is being actively redefined. The coordinators are brought to meetings in advance of new policies’ being implemented, briefed on the scientific and practical issues, and provided with training materials so that they can implement local training of primary care and school health service staff. This process ensures that the same training materials are used in all localities for all health staff. The Immunisation Coordinators also provide essential services in the supply of information to the DH. For example, if a school-based campaign is being planned, the coordinators provide the DH with details of all children within their schools, by age band, which allows the quantities of vaccine provided from the central authority to be matched against the local requirements. Once the coordinators are advised of their vaccine allocations, they can plan the roll-out into schools either school by school (as in the measles-rubella [MR] campaign in 1994), or by age cohort basis (as in the meningococcal C conjugate vaccine campaign 1999/2000 or the annual bacille Calmette-Guérin [BCG, for tuberculosis] vaccination). They also provide the DH with information that is used to ensure that each school will have consent and information forms in advance of an immunization activity. The coordinators also provide the focal point for performance management between the DH and local services. A similar coordination role exists for the annual influenza vaccination campaign as for the routine and campaign childhood programs. Vaccine supplies. The Immunisation Unit has the lead for vaccine supply to prepare for implementation of a new policy. After resources have been secured, the group will identify the supply requirements and then place invitations for vaccine manufacturers to submit bids through a competitive procedure, as specified in European Union (EU) Directives on government procurement. The processes for purchase of routine (and emergency) vaccines was reviewed in detail by the National Audit Office in 2003, and it was concluded that procurement had followed EU regulations, had encouraged competition, and had been adjudicated and awarded fairly.17 Following public advertisement of invitations for bids to supply new vaccines, applicants are given identical briefing on the DH requirements for volumes of new vaccines, time of commencement of availability of product, and the quantities required through the period of a contract. With a new vaccine, it is typical to insist that deliveries from the manufacturers are "front loaded" so that the first supplies of vaccine are sufficient to fill the supply chain and provide stock for all users with sufficient vaccine to match all of their requirements. An adjudication meeting is held, attended by representatives from England, Wales, Scotland, and Northern Ireland, and the bids from all applicants are compared. Criteria for successful bidding are safety, efficacy, availability, price, and record of the company against previous contracts. Wherever possible, more than one supplier is chosen.
Unlike the U.S. situation, during the past five years there have been no shortages of routine childhood vaccines in the United Kingdom interrupting the program, apart from shortages of BCG and materials for skin testing prior to BCG administration.18 These products had come from one particular manufacturer. The key elements of the DH purchasing policy, which have been effective in preventing or minimizing the effects of vaccine shortages, are the avoidance of dependence on single suppliers (whenever possible); forecasting of stockholdings up to twelve months in advance; use of strategic reserves of vaccine to smooth out ebb and flow of supplies; and the ability to switch from unrestricted ordering of vaccines to managed allocation of supplies to physicians (see below). Exhibit 1
Normally, doctors can order their vaccines from a central distributor as needed. Delivery from the distributor can be weekly, or at whatever interval the physician wishes, or ad libitem. The average ordering is for delivery every two weeks. These arrangements provide a delivery service with a "cold chain" (a proven vaccine delivery mechanism used around the world) guaranteed to the end user, with complete traceability of all distributed doses of vaccine. This system is computerized so that a product, batch, or locality recall can be implemented within hours. For most new vaccine introductions, open or unrestricted ordering of vaccines by primary care providers is suspended in favor of supply by allocation. Here, the centrally located doses of a particular vaccine are issued, irrespective of the quantity requested locally. The DH Immunisation Unit holds information on the number of doses of vaccine routinely ordered by all primary care providers, from which the number of children of all ages cared for by each provider can be estimated. Weekly supplies are therefore issued to allow for the immunization of exactly the specified cohorts for the new policy, with allowance for "pump priming" of the distribution and supply network, and daily variation in the numbers of people seeking immunization. At the same time that the vaccine distribution is being organized, changes are made to the national computerized registry process so that children can be called for the specific new initiative—either as routine immunization program events or as part of a catch-up/call-back process.19 When Haemophilus influenzae type b (Hib) vaccine was introduced in 1992, with two producers, available supplies were rapidly outstripped as demand for vaccination against a publicly feared form of meningitis exceeded all expectations, despite the existence of a surplus of vaccine over calculated requirements. In 1999 meningococcal C conjugate vaccine was introduced in a complex program that provided vaccinations simultaneously through school health services and through primary care, with different age groups being prioritized for vaccination according to the manufacturers’ supply estimates. For this initiative, the "allocation" method was used for the first time; there were no supply problems throughout the whole campaign. Since then, it has become routine to switch to "allocation" in the run-down of a vaccine that is being discontinued (for example, oral [live] polio vaccine and whole-cell pertussis vaccine, in anticipation of introduction of inactivated polio vaccine and acellular pertussis vaccine) and similarly manage vaccine supply for an age-based campaign on the same basis. In 2004 a switch in national policy was implemented, with acellular pertussis vaccine replacing whole-cell pertussis vaccine and inactivated polio vaccine replacing oral polio vaccine.20 In advance of the switch, routine ordering was suspended and "allocation" supply instituted. National stocks were depleted of old vaccine; local "end-user" stocks were maintained at levels sufficient to maintain the program, without large stock holdings, until the new vaccine was delivered. Within three weeks, the whole country had been transferred to the new vaccine, seamlessly and with minimal wastage of old vaccine. Public promotion of policies. Whenever a new policy is implemented, a new promotion program is developed for the public. This includes any of the following: leaflets; fact sheets; press, television, and radio advertisements; videos; and Internet materials, including "Q and A" formats, frequently asked questions (FAQs), and mail-in facilities for Internet questions. All new materials are pretested with the appropriate target audience and amended in light of consumers’ comments, and their impact is monitored.21 The latter is done through biannual surveys of 1,000 mothers of young children that monitor their awareness of DH immunization promotion materials and the program’s impacts.22 More than 20,000 parents have been interviewed since this form of surveillance was introduced.23 The Information Group within the Immunisation Unit also provides training for health professionals at the local level, organizing multidisciplinary seminars for doctors, practice nurses, health visitors (visiting nurses), pharmacists, and any other health care staff involved in immunization. This group also undertakes focus groups with parents as part of the monitoring and evaluation of the impact of DH policies and as part of the testing of public acceptability of new policies. This research helps provide understanding of the complex reasons that underpin parents’ approaches to the immunization of their children and influences the way in which the DH communicates back to parents and to health professionals. Other implementation activities. Arrangements are put into place to either anticipate or coincide with the introduction of a new policy to inform on its impact. These include new surveillance arrangements to fully measure the impact of a new policy—through laboratory-based data or disease notification data—and may also include sero-epidemiological surveillance for population impacts.24 Market testing is undertaken to evaluate the impacts of any advertising accompanying the introduction of new vaccines. New data collection arrangements are set up in advance so that the vaccine coverage of a new initiative can be monitored, usually through the computerized call/recall systems provided by the national immunization registry.25 All new pharmaceutical products, including vaccines, carry a black triangle symbol on their packaging and accompanying information. This is a standard symbol added to the product information of a vaccine during the early stages of marketing to encourage reporting of all suspected adverse reactions. In the case of recent new vaccine policies, expert groups have been set up in advance to monitor and investigate reports of serious adverse events. Special studies are also prepared that link hospital or primary care records of clinical events with immunization data so that risks of adverse outcomes can be assessed.26
With progressive transfer of responsibilities for health care provision to local levels, much central management of public health programs is now devolved to the approximately 300 PCTs expected to coordinate and deliver the immunization program. Previously, District Health Authorities (numbering around 100) provided these functions. One immediate change has been the trebling of the number of people acting as Immunisation Coordinators, who sometimes lack experience in immunization program management and influence within their primary care organizations. These changes could make implementation of immunization policy more challenging. In response, a review is in place to identify the most effective way to maintain the immunization management chain most effectively, harnessing the best local expertise that can influence local implementation and provide professional and technical leadership within the new framework. Although in recent years the United Kingdom has experienced vaccine shortages for only one line of products—those used in pretesting and provision of BCG immunization, such that the program had to be suspended—managing vaccine supplies remains a challenging task. Shortages of essential vaccines are minimized through a deliberate policy of obtaining vaccine from more than one supplier whenever possible, even if the consequence is higher prices than could be obtained from a single supplier. The active use of supply forecasting by the DH Immunisation Unit allows early identification of windows of vulnerability that can be managed by obtaining additional supplies from alternative producers, but this is effective only if the other suppliers have surplus stock that can be redirected to the U.K. market. The maintenance of national-level stockpiles also dulls the effects of interruptions in supplies. Especially effective in maintaining supplies, even during periods of shortage, has been the "allocation" method of distribution used in the United Kingdom. Maintaining continuous availability of all essential vaccines will likely be a demand on the program providers in the future, given the inherent difficulties in vaccine manufacturing. The costs of new vaccines have escalated enormously, with some new products, such as PCV, costing as much as all other routine childhood vaccines combined. Yet the cost-effectiveness of such products does not equate with that of all other recommended routine vaccines. These price increases could mean that some vaccines may not be introduced even into industrialized countries, if the cost-benefit calculus of such vaccinations compares unfavorably with that of introducing other health interventions. Alternatively, different criteria may have to be used as the yardsticks of cost-benefit calculi, which would allow new vaccines to become acceptable to those responsible for national funding priorities. The vaccine policy and implementation processes in the United Kingdom represent a single stream of government-led activities in a program that is entirely publicly funded. An integrated series of actions starts with policy development, independent expert review and endorsement (where appropriate), government acceptance, and then implementation within a managed system that provides vaccines free to all users. Challenges remain, however, especially from decentralization of management of public health to peripheral levels where the skill base may be suboptimal, and expected high prices of some forthcoming vaccines may fail to deliver the cost-benefit balances that have been associated with vaccination programs up until now.
David Salisbury (david.salisbury{at}dh.gsi.gov.uk) is head of immunization and infectious disease in the U.K. Department of Health, London.
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Developing New Immunization...
From Strategy To Implementation
