Key Stakeholder Organizations Research Articles

Developing a New, National Approach to Surveillance for Ventilator-Associated Events: Executive Summary

In September 2011, the Centers for Disease Control and Prevention (CDC) convened a Ventilator-Associated Pneumonia (VAP) Surveillance Definition Working Group to organize a formal process for leaders and experts of key stakeholder organizations to discuss the challenges of VAP surveillance

The clinical and strategic impact of generic documentation for end of life anticipatory prescribing

BackgroundThe End of Life (EoL) Care Strategy (2008) recommends that consistent ‘co-ordination of care’ and ‘delivery of high quality services in all locations’ is essential across a healthcare economy. Due...

Uptake and implementation of Advance Care Planning in Australia: findings of key informant interviews

Advance Care Planning (ACP) has an important role in enhancing patient autonomy and guiding end-of-life care. However, there is low uptake of ACP and evidence that advance care plans are often not implemented. We explored these issues in interviews with expert clinicians and representatives of key stakeholder organisations with interest in end-of-life care. Qualitative descriptive study of semi-structured telephone interviews with 23 participants. Participants thought that the low uptake of ACP in Australia is a result of inadequate awareness, societal reluctance to discuss end-of-life issues, and lack of health professionals' involvement in ACP. Problems in implementation of advance care plans were thought to be a result of problems in accessing ACP documents; interpreting written documents; making binding decisions for future unpredictable situations; and paternalistic attitudes of health professionals and families. Participants had different perspectives on how advance care plans should be implemented, with some believing in strict implementation, whereas others believed in a more flexible approach. Low uptake and poor implementation of advance care plans may be addressed by (1) increasing community awareness; (2) encouraging health professional involvement; and (3) system-wide implementation of multi-faceted interventions. A patient-centred approach to ACP is required to resolve the differences in views on how advance care plans should be implemented.

Primary maternity care reform: Whose influence is driving the change?

Backgroundin 2009 the Australian government announced a programme of reform that will change the way maternity services have traditionally been delivered. A shift to a primary maternity care model has occurred despite strong challenges from medicine and a general public that has embraced high technology in all aspects of life including childbirth. Aima critical analysis was undertaken for the purpose of identifying discourses that have influenced the direction of the Australian maternity care reform agenda. Methodwithin a critical discourse analysis framework data were collected from state, territory and commonwealth government policy documents, and selected written submissions from national key stakeholder organisations to the National Review of Maternity Services 2008. Findingsthree discourses influencing the direction of the reform are described, these include the following: ‘Australia is one of the safest place to give birth or to be born, but not for everyone’; ‘maternity care is primarily about mothers and babies, not about the service or the health professionals’ and ‘government must ensure provision of safe and sustainable maternity services’. Conclusionthe Australian government has strong support for the primary maternity care reform backed by a strong key stakeholder alliance involving consumers, midwives and rural doctors. On the contrary to the position of the key stakeholder alliance, the obstetric position has been unable to provide government with solutions to escalating costs and workforce deficits in the delivery of safe and sustainable maternity services. Consumers, rural doctors, midwives and government all agree on the need to safeguard excellent safety and quality standards whilst at the same time reducing high levels of medical intervention and providing options for care in a reformed maternity service designed to meet the needs of all Australian women.

The Dublin Consensus Statement 2011 on vital issues relating to the collection and provision of blood components and plasma‐derived medicinal products

Following a conference in Dublin in 2010, a consensus statement was published in this journal (1). In January 2011, a follow-up conference was convened in Dublin under the auspices of the plasma users coalition (PLUS) to further consider the statement produced in Dublin in 2010. The goal was to negotiate a revised set of principles which could be potentially accepted by most stakeholders including global patient, donors, manufacturing and provider organisations. PLUS was eager to continue the constructive dialogue that commenced between key stakeholders in 2010. PLUS represents the concerted views of seven patient organisations, whose members are dependent on products manufactured from plasma. The goal of PLUS in this work is to help encourage the production of a sufficient supply of safe and effective plasma-derived medicinal products (PDMPs) to meet the global needs of patients. By recognising that the collection systems for blood components and PDMPs are interrelated in a number of countries, this meeting considered the collection of both blood and plasma and the manufacture of PDMPs from both the industry and not for profit sectors, and the views of national blood authorities, patient and donor organisations. The meeting was attended by the following persons representing organisations as follows: PLUS members: Brian O’Mahony (Convenor) -European Haemophilia Consortium (EHC) and Irish Haemophilia Society, David Watters-IPOPI, Larry Warren, Johan Prevot-IPOPI, Uwe Schlenkrich-EHC, David Page-WFH, Other participants: Mark Skinner-A-PLUS and World Federation of Hemophilia(WFH), Charles Waller and Albert Farrugia Plasma Proteins Therapeutics Association, Bob Perry and Theo EversInternational Plasma Fractionation Association (IPFA), Roger Dodd-International Society of Blood Transfusion, Niels MikkelsenInternational Federation of Blood Donor Organizations (IFBDO), Jim MacPherson-America’s Blood Centers, Alison Turner-National Blood Authority Australia, Patrick Robert-Marketing Research Bureau Cees van der Poel EDQM, Paul Strengers -ISBT ⁄ Sanquin, Gilles FolleaEuropean Blood Alliance (EBA). A number of other organisations were invited to send representatives, including WHO, Thalassemia International Federation and the International Federation of Red Cross and Red Crescent Societies but were unable to attend because of other commitments. The statement produced in 2010 had been fully endorsed by 22 patient organisations and was endorsed with qualification by a number of other key stakeholder organisations. The most consistent qualification raised by organisations related to the previous clause 2.11 which was interpreted by some as providing endorsement for paid donations. Organisations that operate within a framework that only supports unpaid donors were therefore unwilling to fully endorse the 2010 statement. Not unexpectedly, this issue occupied a significant amount of time at the 2011 meeting. The final wording agreed recognises that different organisations will operate within different policy and regulatory frameworks, but acknowledges that both systems are needed at the current time. Encouragingly, there has emerged an improved understanding and dialogue between paid and non paid system advocates of the need for both Correspondence: Brian O’Mahony, Irish Haemophilia Society, Steering Group PLUS, Cathedral Court, New Street South, Dublin 8, Ireland E-mail: brian@haemophilia.ie Vox Sanguinis (2011)

How is advance care planning conceptualised in Australia? Findings from key informant interviews

Advance Care Planning (ACP) has been gaining prominence as an important component of good end-of-life care. This study explored how ACP is conceptualised by stakeholder organisations and clinicians involved in aged care and end-of-life care in Australia, in particular their views on the aim, appropriate context and settings for ACP, and how ACP should be facilitated. Twenty-three participants including expert clinicians and representatives of government organisations, professional societies, consumer groups and other organisations involved in aged care and end-of-life care. Qualitative descriptive analysis of semi-structured telephone interviews. Most participants viewed ACP as an ongoing process aimed at enhancing an individual's autonomy and ensuring good end-of-life care. However, there were significant differences in how this process was conceptualised. Some viewed ACP as a process undertaken by patients to define and communicate their treatment preferences. Others viewed ACP as discussions undertaken by health professionals to gain a better understanding of the patient's values and goals in order to provide good care. Our findings highlight significant differences in how ACP is conceptualised in Australia. A shared conceptualisation and agreement on purpose is needed to ensure a successful implementation of ACP in Australia.

Medicine in the 21st century: recommended essential geriatrics competencies for internal medicine and family medicine residents.

Physician workforce projections by the Institute of Medicine require enhanced training in geriatrics for all primary care and subspecialty physicians. Defining essential geriatrics competencies for internal medicine and family medicine residents would improve training for primary care and subspecialty physicians. The objectives of this study were to (1) define essential geriatrics competencies common to internal medicine and family medicine residents that build on established national geriatrics competencies for medical students, are feasible within current residency programs, are assessable, and address the Accreditation Council for Graduate Medical Education competencies; and (2) involve key stakeholder organizations in their development and implementation. Initial candidate competencies were defined through small group meetings and a survey of more than 100 experts, followed by detailed item review by 26 program directors and residency clinical educators from key professional organizations. Throughout, an 8-member working group made revisions to maintain consistency and compatibility among the competencies. Support and participation by key stakeholder organizations were secured throughout the project. The process identified 26 competencies in 7 domains: Medication Management; Cognitive, Affective, and Behavioral Health; Complex or Chronic Illness(es) in Older Adults; Palliative and End-of-Life Care; Hospital Patient Safety; Transitions of Care; and Ambulatory Care. The competencies map directly onto the medical student geriatric competencies and the 6 Accreditation Council for Graduate Medical Education Competencies. Through a consensus-building process that included leadership and members of key stakeholder organizations, a concise set of essential geriatrics competencies for internal medicine and family medicine residencies has been developed. These competencies are well aligned with concerns for residency training raised in a recent Medicare Payment Advisory Commission report to Congress. Work is underway through stakeholder organizations to disseminate and assess the competencies among internal medicine and family medicine residency programs.

Increasing community capacity to prevent childhood obesity: challenges, lessons learned and results from the Romp & Chomp intervention

BackgroundObesity is a major public health issue; however, only limited evidence is available about effective ways to prevent obesity, particularly in early childhood. Romp & Chomp was a community-wide obesity prevention intervention conducted in Geelong Australia with a target group of 12,000 children aged 0-5 years. The intervention had an environmental and capacity building focus and we have recently demonstrated that the prevalence of overweight/obesity was lower in intervention children, post-intervention. Capacity building is defined as the development of knowledge, skills, commitment, structures, systems and leadership to enable effective health promotion and the aim of this study was to determine if the capacity of the Geelong community, represented by key stakeholder organisations, to support healthy eating and physical activity for young children was increased after Romp & Chomp.MethodsA mixed methods evaluation with three data sources was utilised. 1) Document analysis comprised assessment of the documented formative and intervention activities against a capacity building framework (five domains: Partnerships, Leadership, Resource Allocation, Workforce Development, and Organisational Development); 2) Thematic analysis of key informant interviews (n = 16); and 3) the quantitative Community Capacity Index Survey.ResultsDocument analysis showed that the majority of the capacity building activities addressed the Partnerships, Resource Allocation and Organisational Development domains of capacity building, with a lack of activity in the Leadership and Workforce Development domains. The thematic analysis revealed the establishment of sustainable partnerships, use of specialist advice, and integration of activities into ongoing formal training for early childhood workers. Complex issues also emerged from the key informant interviews regarding the challenges of limited funding, high staff turnover, changing governance structures, lack of high level leadership and unclear communication strategies. The Community Capacity Index provided further evidence that the project implementation network achieved a moderate level of capacity.ConclusionsRomp & Chomp increased the capacity of organisations, settings and services in the Geelong community to support healthy eating and physical activity for young children. Despite this success there are important learnings from this mixed methods evaluation that should inform current and future community-based public health and health promotion initiatives.Trial Registration NumberANZCTRN12607000374460

Public participation in practice — Assessing public participation in the preparation of regional forest programs in Northern Finland

The paper analyses stakeholder involvement and public participation in preparing Regional Forest Programmes (RFP) in Finland. Such programmes establish the outlines for regional forest management, setting targets and action plans for industrial timber use, non-wood production, recreational activities, and nature conservation in each region. Our analysis suggests that the RFP process has brought together a significant cross-section of actors who meet on a regular basis. Hence, it has become an institutionalised cooperation between key stakeholder organisations. It has facilitated information exchange and learning about issues pertaining to forest management practices, timber markets, and protection of biodiversity. Engaging the general public in the RFP process has, however, been mostly ineffectual. The process has also fallen short of the expectations to reconcile different perspectives and produce jointly accepted strategies. The biggest challenges lie in finding approaches to address conflicts constructively and to draw up a RFP that will contribute to actual changes in forest management activities.

Private Health Facilities in Saskatchewan: Marginalization through Legalization

This paper explores how the passage of Saskatchewan’s Health Facilities Licensing Act in 1996 created both a legal framework for private health facilities in the province as well as erecting significant barriers to virtually insure that no such facilities could effectively operate. This is done within the context of discovering how placing barriers to privatization has contributed to reform of the health care system and the conditions in which reform will be permitted. Data for the study were collected from a series of eleven key informant interviews including elected officials, civil servants, health care professionals, academics, members of key stakeholder organizations which both supported and opposed the legislation.

The Impact of Regulatory Fitness Requirements on Disabled Social Work Students

The Disability Commission of Great Britain conducted a Formal Investigation into the impact of regulatory fitness requirements on disabled people in three public sector professions, including social work. This article reports on the types of fitness requirements that have an impact on disabled social work students, and how these are interpreted and implemented in practice. IN terms of the regulatory framework, there is a requirement for mental and physical fitness in England and Wales, but not in Scotland. These requirements appear more stringent for social work students than for qualified social workers. There is no explicit mention of the Disability Discrimination Act in the regulatory framework. Key stakeholder organisations find fitness requirements unclear and articulated the need for clearer guidance for practice purposes. Different challenges present at different stages of social work education and there is a variety of ad hoc management strategies leading to the potential for discrimination against disabled people.

‘Do no harm’? Professional regulation of disabled nursing students and nurses in Great Britain

This paper is a report of the findings of a General Formal Investigation launched by the Disability Rights Commission, Great Britain into the impact of regulatory fitness standards on disabled people, and on nursing students and nurses in particular. The potential for systemic discrimination against disabled nursing professionals lies in the existence and nature of regulatory fitness standards, as well as in how these are interpreted and implemented in practice. A review of relevant legislation, regulation and guidance was conducted to explore the interaction of the regulatory framework with the Disability Discrimination Act. A formal call to key national stakeholder organizations solicited information on perceptions of the regulatory framework and the adequacy of guidance issued. Independent research was commissioned on disabled people's disclosure of disability, informal and formal decision-making around fitness within the educational, and employment contexts. An Inquiry Panel examined all evidence sources, solicited further oral evidence from key organizations, and developed recommendations. No mention was found of the Disability Discrimination Act in any regulation and guidance governing nursing prior to 2006. There are particular requirements for 'good health and good character'. Respondents from key national stakeholder organizations, higher educational institutions and employers struggle to interpret the fitness requirements consistently. Implementation is variable, with reliance on ad hoc self-initiated strategies. The variability of interpretation and implementation can lead to discrimination against disabled people. The imprecision of fitness requirements and variability of implementation raise serious doubts about their utility in managing risk.

Ottawa Panel Evidence-Based Clinical Practice Guidelines for Aerobic Fitness Exercises in the Management of Fibromyalgia: Part 1

The objective of this study was to create guidelines for the use of aerobic fitness exercises in the management of adult patients (>18 years of age) with fibromyalgia, as defined by the 1990 American College of Rheumatology criteria. Following Cochrane Collaboration methods, the Ottawa Methods Group found and synthesized evidence from comparative controlled trials and formed the Ottawa Panel, with nominated experts from key stakeholder organizations. The Ottawa Panel then developed criteria for grading the recommendations based on experimental design (I for randomized controlled trials, II for nonrandomized studies) and strength of evidence (A, B, C+, C, D+, D, or D-). From the rigorous literature search, 13 randomized control trials and 3 controlled clinical trials were selected. Statistical analysis was based on Cochrane Collaboration methods. Continuous data were calculated with weighted mean differences between the intervention and control groups, and dichotomous data were analyzed with relative risks. Clinical improvement was calculated using absolute benefit and relative difference in change from baseline. Clinical significance was attained when an improvement of 15% relative to a control was found. There were 24 positive recommendations: 10 grade A, 1 grade B, and 13 grade C+. Of these 24 positive recommendations, only 5 were of clinical benefit. The Ottawa Panel recommends aerobic fitness exercises for the management of fibromyalgia as a result of the emerging evidence (grades A, B, and C+, although most trials were rated low quality) shown in the literature.

Ottawa Panel Evidence-Based Clinical Practice Guidelines for Strengthening Exercises in the Management of Fibromyalgia: Part 2

The objective of this study was to create guidelines for the use of strengthening exercises in the management of adult patients (>18 years of age) with fibromyalgia (FM), as defined by the 1990 American College of Rheumatology criteria. Following Cochrane Collaboration methods, the Ottawa Methods Group found and synthesized evidence from comparative controlled trials and formed the Ottawa Panel, with nominated experts from key stakeholder organizations. The Ottawa Panel then developed criteria for grading the recommendations based on experimental design (I for randomized controlled trials, II for nonrandomized studies) and strength of evidence (A, B, C+, C, D+, D, or D-). From the rigorous literature search, 5 randomized controlled trials were selected. Statistical analysis was based on Cochrane Collaboration methods. Continuous data were calculated with weighted mean differences between the intervention and control groups, and dichotomous data were analyzed with relative risks. Clinical improvement was calculated using absolute benefit and relative difference in change from baseline. Clinical significance was attained when an improvement of 15% relative to a control was found. There were 5 positive recommendations: 2 grade A and 3 grade C+. All 5 were of clinical benefit. The Ottawa Panel recommends strengthening exercises for the management of fibromyalgia as a result of the emerging evidence (grades A, B, and C+, although most trials were rated low quality) shown in the literature.

The interpretation and implementation of regulatory fitness requirements

The Disability Rights Commission launched a general formal investigation (FI) into the impact of fitness standards on disabled people studying, qualifying, registering and working in three public sector professions, including nursing. The FI's review of statutory and regulatory frameworks identified a significant amount of primary and secondary legislation and guidance, with an array of fitness requirements of statutory basis. There is, however, scant reference to the Disability Discrimination Act. The FI additionally issued a forma call for evidence targeting key stakeholder organizations, exploring how these interpret and implement regulations and guidances. Responding organizations acknowledge that the potential for, and reality of, discrimination exists and stems from highly variable and subjective interpretations and implementation of the regulatory fitness requirements. There is a widely perceived lack of adequate and clear guidance for practice purposes. Fitness requirements can discourage disabled people from attempting entry into the profession. A risk-averse culture discourages disclosure, and can affect the types and timeliness of support being provided to disabled students and professionals.

A survey of midwives’ views on providing aspects of antenatal care in Estonia

Objective to survey the views of midwives in Estonia about who they considered should have responsibility for carrying out certain aspects of antenatal care (ANC) in Estonia. Design, setting and study population in collaboration with key stakeholder organisations, the authors developed eight statements on aspects of ANC and five combinations of possible professionals (including midwives obstetrician-gynaecologists and various combinations of the two) who could have responsibility for carrying out those aspects of ANC and included them in a self-administered questionnaire. The questionnaire was sent with a covering letter and stamped addressed return envelope to all 366 midwives in Estonia. Two postal reminders were sent to non-responders. Results the response rate was 73.5%. There was no consensus among respondents about whose responsibility it was to diagnose pregnancy, carry out the risk assessment of a pregnancy, or carry out fetal monitoring during pregnancy. There was consensus among respondents that either midwives or obstetrician-gynaecologists could have responsibility for referring for further tests and examinations if a pregnancy was thought to be at risk. There was also consensus that counselling, biometry and blood pressure monitoring should be the sole responsibility of midwives. Key conclusions despite national policy to shift ANC towards being midwifery-led and despite provisions in a European Directive permitting most roles in ANC to be performed autonomously by trained midwives, there is no consensus among Estonian midwives that all aspects of ANC should be their responsibility at present. Thorough research is required to establish which specific ANC roles Estonian midwives are not willing to take responsibility for, and to examine why they are not willing to take on such roles.

Community Action—Challenges and Constraints—Implementing Evidence-Based Approaches Within a Context of Reorienting Services

Community action on alcohol use-related projects face significant challenges in focusing efforts where they are most likely to be effective—on environmental strategies for optimum impact and sustainable institutional change. Reorienting and enhancing the efforts of existing services is a crucial issue for all countries with limited resources. This paper evaluates the use of a public health partnerships model to reorient resources and enhance cross sector collaboration to reduce alcohol consumption-related harm in a large New Zealand city from 2001–2004. The evaluation assessed changes in the management practices of participating health provider organisations, the reorientation of activities and the redeployment of provider resources, in light of evaluation evidence from collaborative initiatives undertaken by key stakeholder organisations. Despite the considerable challenges inherent in reorienting existing health sector resource and encouraging more evidence-based practice, this evaluation found encouraging signs of positive systemic changes, both within the health sector and with external stakeholders, in the redirection of priorities and resources. The focus on collaborative environmental strategies has also contributed to some limited, but promising structural changes to reduce harm in the licensed alcohol availability, accessibility and promotion environment.

Improving the use of research evidence in guideline development: 3. Group composition and consultation process

BackgroundThe World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the third of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this.ObjectiveIn this review we address the composition of guideline development groups and consultation processes during guideline development.MethodsWe searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments.Key questions and answersWhat should be the composition of a WHO-panel that is set up to develop recommendations?The existing empirical evidence suggests that panel composition has an impact on the content of the recommendations that are made. There is limited research evidence to guide the exact composition of a panel. Based on logical arguments and the experience of other organisations we recommend the following:• Groups that develop guidelines or recommendations should be broadly composed and include important stakeholders such as consumers, health professionals that work within the relevant area, and managers or policy makers.• Groups should include or have access to individuals with the necessary technical skills, including information retrieval, systematic reviewing, health economics, group facilitation, project management, writing and editing.• Groups should include or have access to content experts.• To work well a group needs an effective leader, capable of guiding the group in terms of the task and process, and capable of facilitating collaboration and balanced contribution from all of the group members.• Because many group members will not be familiar with the methods and processes that are used in developing recommendations, groups should be offered training and support to help ensure understanding and facilitate active participation.What groups should be consulted when a panel is being set up?We did not identify methodological research that addressed this question, but based on logical arguments and the experience of other organisations we recommend that as many relevant stakeholder groups as practical should be consulted to identify suitable candidates with an appropriate mix of perspectives, technical skills and expertise, as well as to obtain a balanced representation with respect to regions and gender.What methods should WHO use to ensure appropriate consultations?We did not find any references that addressed issues related to this question. Based on logical arguments and the experience of other organisations we believe that consultations may be desirable at several stages in the process of developing guidelines or recommendations, including:• Identifying and setting priorities for guidelines and recommendations• Commenting on the scope of the guidelines or recommendations• Commenting on the evidence that is used to inform guidelines or recommendations• Commenting on drafts of the guidelines or recommendations• Commenting on plans for disseminating and supporting the adaptation and implementation of the guidelines or recommendations.• Key stakeholder organisations should be contacted directly whenever possible.• Consultation processes should be transparent and should encourage feedback from interested parties.

Assessing learning needs for breastfeeding: setting the scene.

Breastfeeding has a major contribution to make to public health, yet the UK, like many other developed countries, has low rates of breastfeeding. A contributing factor is that practitioners are ill-prepared to support breastfeeding women. There is a mismatch between the care professionals provide and the support women desire. A national breastfeeding learning needs assessment (LNA) was carried out in England to provide a comprehensive picture of professional and practitioner learning needs and existing training opportunities and resources. The LNA comprised five elements, and sought the views of service users through consumer organizations and voluntary breastfeeding supporters. Two elements of the LNA are reported here. A search of RDLearning, a web-based national resource, provided details of existing accredited courses in the UK for practitioners. Ten short courses provided by higher education institutions were identified, along with a range of courses offered by voluntary and other organizations, such as the National Childbirth Trust and UNICEF Baby Friendly Initiative. Second, an e-mail survey of 28 key stakeholder organizations was undertaken, with a response rate of 68% (n = 18). All but one acknowledged that their members could benefit from further breastfeeding knowledge and expertise and were supportive of a national breastfeeding education initiative. The most popular forms of education provision were workshops and seminars, online and written information. The topic considered most important for all practitioners was the health outcomes of breastfeeding. Other contributions which stakeholder organizations felt they could make were the provision of information resources and setting up specialist interest groups.

A Survey of Stakeholder Organisations on the Proposed New European Chemicals Policy

In February 2001, the European Commission published a White Paper proposing that a single new system of chemical regulation should be applied throughout the Member States of the European Union. The proposed Registration, Evaluation and Authorisation of Chemicals (REACH) system was to include both new and existing chemicals, with the aim of ensuring that sufficient pertinent data were made available to enable human health and the environment to be protected. The policy was founded on the principle of sustainable industrial development, and ambitiously attempted to incorporate the needs and views of key stakeholder organisations, such as industry, trade associations, consumer groups, environmentalists, animal welfarists and Member State governments. During the period between the publication of the White Paper and the on-line publication of consultation documents, as part of a public consultation exercise, in May 2003, many of these key stakeholder organisations produced material in support of or critical of the White Paper, either in part or as a whole. In this paper, we have attempted to review this extensive material and to present it in the context of the current chemical regulatory system that the REACH system will replace. Emphasis is placed on the impact of the new policy on the number of animals used in the testing regimes within the REACH system and the inclusion of alternative methods into the legislation. Although supportive of the overriding aims of the new policy, FRAME believes that the fundamental concept of a risk-free environment is flawed, and that the new REACH system will involve the unjustifiable use of millions of laboratory animals. The new policy does include alternative methods, particularly for base-set substances. Nevertheless, alternative testing methods that are already available have been excluded and replaced with outdated in vivo versions. There is also insufficient detail with regard to the further development and validation of alternative methods, particularly for substances of high concern, such as endocrine disrupters or reproductive toxins, for which no alternative testing methods currently exist.