The Groundwork Framework

The Groundwork Framework Seven Steps to Successful Healthcare Priority-Setting The Roles of Government and the Pharmaceutical Industry

Executive Summary: The Groundwork Framework Introduction

This Framework is the outcome of the Groundwork Dialogue.

Groundwork was a twelve month engagement between senior individuals and advisors from Ghana, Philippines, and Vietnam; executives from Eli Lilly, GlaxoSmithKline and Janssen Pharmaceuticals (Johnson & Johnson); and priority-setting experts from NICE International and the Center for Global Development (CGD). It also benefited from inputs from health technology assessment experts from Thailand and Colombia, who participated as observers.i A list of Core Group Members can be found in Appendix One. The dialogue ran from March 2014 to April 2015 and was fully funded by the UK’s Department for International Development (DfID).

Groundwork was created to identify an appropriate role for the pharmaceutical industry in

support of government efforts to introduce healthcare prioritysetting. The introduction of predictable, evidence-based processes for priority-setting provides governments with the opportunity to signal their commitment to a stable system with which stakeholders can confidently and transparently engage. The resulting efficiency and predictability are of benefit both to health systems and the pharmaceutical industry.

The pharmaceutical industry is not the only important government stakeholder in this process – the many others include civil society organisations, health insurers, medical professionals and patient groups. Groundwork focused specifically on government/ industry dialogue because of the potential for improved channels of communication between these parties. Governments remain concerned that industry’s commercial interests could distort their efforts to set

healthcare priorities. And while industry welcomes priority-setting, it fears that it may be used to restrict access to its innovative products on national formularies, favour local industry, and that decisionmaking processes may be insufficiently transparent.

Groundwork draws on the experience of practitioners in government and industry to explore the political and technical pitfalls that may hinder healthcare prioritysetting, and how to improve communication channels between the interested parties. It seeks to set a tone and approach for collaborative problemsolving that can be replicated.

The Groundwork findings are intended as guidelines for both governments and pharmaceutical companies engaged in evidence-based decision-making processes.

i. The Groundwork Dialogue benefited from inputs of senior individuals from countries which have already established national plans and mechanisms for priority-setting embedded in their health systems. These participants offered their insights and experience to the dialogue as observers.

Disclaimer Groundwork was a multi-stakeholder and collaborative process which sought the views of all members of the Core Group, some of whom took part in their personal capacity. The Groundwork findings and interpretations do not necessarily reflect the views of all members of the Core Group, nor do they represent formal policy of the institutions involved.

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Seven Steps to Healthcare Priority-Setting Groundwork identified the following seven steps to ensure that the introduction of priority-setting results in people getting the medicines they need, at an affordable price:

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Strong Government Commitment

It requires strong government commitment and leadership to underline the value of effective priority-setting in health care to make clear political commitments and create institutions that make the connection between evidence and decisions on public spending. It means introducing legislation that defines the roles of government and quasi-government agencies in this process, as well as improving coordination and communication mechanisms. It also means investing sufficient resources to make priority-setting possible.

Government should be free to make clear commitments to evidence-based decision-making.

The Pharmaceutical Industry can explicitly recognise government sovereignty by supporting such commitments.

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Adoption of a Strategic Plan

Governments have responsibility for drawing up a strategic plan for priority-setting, which permits them to outline governance arrangements, provide a clear needs assessment, identify principles and standards, communicate how stakeholder consultation will be undertaken, and include an action plan with milestones to measure progress. The strategic plan is a first step, allowing governments to hold relevant Ministries and institutions to the commitments it contains and monitor progress towards them.

The creation of a strategic plan for priority-setting will include an assessment of health needs.

The industry can support governments in this by providing epidemiological information or input into pharmaceutical policy debates, as part of fair, transparent, timely and consultative processes.

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Creation/Strengthening of Priority-Setting Structures

Governments will determine the appropriate institutions (or departments within institutions) to ensure that structures for evidence-based decision-making are adequately-resourced, and have clearly defined responsibilities for collecting and evaluating the data necessary to make these decisions.

The pharmaceutical industry has an important role to play in recognising the authority of such bodies. For this to happen it will need to have confidence that priority-setting institutions will follow transparent processes for data collection, decision-making, monitoring and appeal, to which they are able to contribute.

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Introduction of Processes for Priority-setting, Decision-making, Review and Appeals

To overcome the co-existence in many countries of formal and informal decision-making systems, procedural clarity about how and when decisions are made is vital. Government needs to provide information about who will be involved in such decisions, and under what circumstances. The process for each step from priority-setting, decision-making, to review and appeal requires:

Priority-Setting • Clear policy intentions on approaches to macro, meso and micro priority-setting • The issuance of clear process guidelines on how healthcare priorities are defined • The introduction of processes to manage the tension between stakeholder perspectives • Explicit reference to the links between priority-setting and reimbursement policies • The introduction of clear process for topic selection • The introduction of early mini appeal process • The introduction of stakeholder consultation guidelines

Decision-Making and Review • Clear processes for timely, speedy decision-making • Transparent processes for information input, review and commentary • Specific guidelines for data submissions based on health priorities and treatment pathways • Engagement with industry on deliberative appraisals • Iterative processes of data collection and review • The introduction of review meetings following controversial decisions

Appeal • Appeal processes that distinguish between process and content appeals • Clear criteria to identify which appeals go to an independent review panel • Clear timelines for consideration and decision on appeal • Commitment to revert to judiciary only as absolute and exceptional last resort The industry can play a positive role by making high-quality data submissions through appropriate channels and actively engaging in the formal consultation processes for prioritysetting, decision-making, review and appeal set up by government. In addition, the industry should be transparent about its support for other stakeholders engaged in the process.

Industry will eschew informal processes if it feels confident that the processes are fair and that government decisions result from them. Formal consultation processes should therefore allow industry to provide comment on policy and on the interpretation of technical and policy submissions. Processes should enable government and industry to engage iteratively on data collection, review and appraisals. Formal processes should also allow appropriate management of conflicts of interest. If these processes are followed industry will be able to respect the resulting decisions and commit to resort to appeals only in highly exceptional circumstances.

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Allocation of Resources for Data Collection and Monitoring

Effective priority-setting requires good data management and analysis, which in turn requires effective data collection and monitoring. There is a need for improvements in the quality, quantity, reliability and timeliness of data collected, including from the informal sector.

It is important to be able to link data sets and improve data-sharing across government departments. More investment is needed to build the capacity of staff and data management mechanisms should match or enhance system capabilities.

There is considerable potential for the industry to support governments to enhance their data capabilities, while managing conflicts of interest. The most important commitment governments seek from industry is to provide full and transparent data sets. Industry can also support technical capacity- building and provide on-the-ground support for data collection and analysis.

The industry could also provide governments with support for research and the development of IT infrastructure.

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Commitment to Stakeholder Consultation

Stakeholder perspectives are important to the viability of evidence-based approaches to decision-making. There is therefore a need to introduce clear processes, standards and guidelines for stakeholder engagement and clarity about how stakeholder views are taken into consideration.

The pharmaceutical industry, as other stakeholders, can engage in a timely manner throughout government consultation processes, support decisions made, and go to appeal only as a last resort. In addition, industry should declare any sponsorship or support for patient organisations or professional bodies that are part of the consultation process.

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Introduction: The Groundwork Framework Groundwork was created in response to the growing developing country government interest in priority-setting as a way of supporting their commitments to universal health coverage (UHC). The majority of these governments still have to manage competing claims on limited public budgets and spend a relatively low percentage of GDP on healthcare (5% to 9.5% OECD average). This means that the application of rational mechanisms to ensure the efficient, equitable and ethical allocation of finite resources is particularly important.

The introduction of predictable, evidence-based processes for priority-setting provides governments with the opportunity to signal their commitment to a stable system in which stakeholders can confidently and transparently engage. The Dialogue was designed to support governments in these efforts to make wise decisions about health expenditure, including on innovative medicines for their populations. Introducing priority-setting is not easy. All countries face challenges to implementing evidence-based decisions efficiently. These challenges include resource constraints, weak links between

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government departments, poor legislative underpinning, and the politicisation of healthcare.

In this context the relationship between health systems and the pharmaceutical industry is extremely important. The industry welcomes prioritysetting, but it fears that it may be used to restrict access to its innovative products on national formularies, favour local industry, or that decisionmaking may be insufficiently transparent. In addition, variations in how, when and what mechanisms are being introduced are creating additional layers of complexity for companies seeking to access these markets. This is significant because they are considered by many industry analysts as providing the biggest growth opportunity for the sector, as well at the greatest potential health gains.

A positive relationship between government and industry holds the promise of enabling the smooth introduction of new processes to set priorities and take evidence-based decisions. A more conflictive relationship can hinder these goals. Groundwork focused specifically on government/ industry dialogue because of the potential to improve communication between these

parties. The pharmaceutical industry is not, of course, the only important government stakeholder in this process – the many others include civil society organisations, health insurers, medical professionals and patient groups.

Priority-setting provides an opportunity to make health systems more efficient and more predictable in ways that benefit both health systems and the pharmaceutical industry, but this is not a foregone conclusion. For some time to come, even as the foundations of the system for rational, evidence-based decision-making are being put in place, they will operate side by side with the existing systems, often characterised by inconsistency, informality and sometimes corruption.

This means that those committed to priority-setting – companies and government personnel alike – will need to demonstrate leadership in defence of the behaviours that a more rational system needs: setting clear goals; outlining and sticking to clear decision-making procedures based on health outcomes; and introducing transparent, iterative and consultative technology assessment processes, as well as formal appeals processes.

The Groundwork Process

Department for International Development (DfID).

This Framework is the outcome of the Groundwork Dialogue.

Groundwork was a twelve month engagement between senior individuals and advisors from Ghana, Philippines, and Vietnam; executives from Eli Lilly, GlaxoSmithKline and Janssen Pharmaceuticals (Johnson & Johnson); and priority-setting experts from NICE International and the Center for Global Development (CGD). It also benefited from inputs from health technology assessment experts from Thailand and Colombia, who participated as observers.ii A list of Core Group Members can be found in Appendix One. The dialogue ran from March 2014 to April 2015 and was fully funded by the UK’s

Groundwork’s high-level, cross-country, and cross-sector leadership explored what this would mean in practice. The Groundwork group met twice for two, two-day workshops in the period March 2014 to April 2015 during which the group constructed a framework for collaborative evidence-based decision-making. Following this process Meteos produced a number of drafts of the Groundwork Framework for comment by the Group. A final revised version was launched at the High-Level Meeting in Hanoi in April 2015.

The resulting Groundwork Framework identified what industry and government could do to navigate – together –

seven critical steps in the introduction of priority-setting, which would allow governments to achieve improved healthcare outcomes on limited budgets and meet the pharmaceutical industry’s desire to expand access to appropriate medicines in these markets. Specifically, it examined how to address the political and technical pitfalls that may hinder healthcare prioritysetting, and how to improve communication channels between the interested parties.

It also sought to set a tone and approach for collaborative problem-solving that can be replicated. Its findings are intended as guidelines that can be used by both governments and pharmaceutical companies engaged in evidence-based decision-making processes to improve communications and build trust.

ii. The Groundwork Dialogue benefited from inputs of senior individuals from countries which have already established national plans and mechanisms for priority-setting embedded in their health systems. These participants offered their insights and experience to the dialogue as observers.

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The Groundwork Framework: Seven Steps to Healthcare Priority-Setting The Groundwork group explored what both government and industry might do to ensure that the introduction of priority-setting results in people obtaining the medicines they need, at an affordable price.

The following seven steps outline how this might work:

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The steps can be seen in three sub-sections: Steps one to three focus on the role of government leadership.

Although the industry can play a collaborative role in, for example, the provision of information to help with priority setting, these steps describe

what governments can do to lead the process and ensure it is adequately resourced and run. Steps four to six are those processes which require more detailed negotiation and resolution between industry and government. Step seven applies to all stakeholders, throughout the process.

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Strong government commitment to and leadership of the priority-setting process

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Adoption of a strategic plan for priority-setting, informed by health needs and priorities

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Creation of new governmental/public structures and/or strengthening of existing ones to manage and ensure quality in priority-setting processes

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Introduction of clear, transparent processes for priority-setting and decision-making

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Establishment of clear mechanisms for review, monitoring and appeal of allocation decisions

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Allocation of resources for data collection and analysis

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Commitment to ongoing stakeholder consultation throughout the process

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Strong Government Commitment The Challenge Priority-setting is being introduced into what are often weak and underresourced health systems, in which decision-making can be opaque and sometimes flawed. Even where health budgets are expanding, this is not keeping pace with intensifying demands on the resource-constrained public system. The extra upfront investment required to introduce prioritysetting therefore has to compete with many other government priorities. In addition, decisions about healthcare provision are highly politicised in these, as in all countries, while many health systems have little experience of priority-setting and little evidence upon which to base decisions.

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What Needs to Happen?

The move to an evidencebased system requires strong government commitment and leadership to garner support from government institutions, the private sector and the public. This requires enhanced government understanding of the value of priority-setting, leading to clear political commitments to the importance of fair process, and the creation of institutions (or departments within existing institutions) that make the connection between evidence and decisions on public spending. It means introducing legislation that defines the respective roles of government and quasigovernment agencies in this process, as well as

improving coordination and communication mechanisms between government departments. Finally, it means investing sufficient resources in new processes and institutions to make priority-setting possible.

These commitments should be sufficiently robust to ensure that decisions are based on national health priorities, clinical evidence and cost-effectiveness.

The Role of Industry Government should be free to make clear commitments to evidence-based decisionmaking. The pharmaceutical industry can explicitly recognise government sovereignty by supporting such commitments.

Adoption of a Strategic Plan The Challenge The process of healthcare priority-setting is complex, requiring governments to balance the demands of prevention, Public Health, primary, secondary and tertiary care. It may also be influenced by industrial policy. As currently practiced in many countries, planning around these competing priorities lacks coordination and can be subject to pressure from special interest groups. The absence of

strategic planning can result in a lack of consistency in the introduction and implementation of policies and in data collection. It can also lead to a lack of accountability and variable understanding and application of evidencebased decision-making among policy makers. Lack of coordinated planning is particularly problematic in countries where a high proportion of healthcare expenditure is dedicated to pharmaceuticals, as it can

lead to ad-hoc prioritisation of technologies that may be cost-effective, but unaffordable. Moreover, it can make governments vulnerable to inappropriate lobby and challenge by influential stakeholders in ways that are opaque and distort healthcare priorities.

What Needs to Happen?

The introduction of a strategic plan is an important step in strengthening government moves to evidence-based

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decision-making. Governments are responsible for drawing up a strategic plan for priority-setting, which permits them to outline governance arrangements for priority setting processes; provide a clear needs assessment, with related goals and outcomes; identify principles and standards and how conflicts of interest, for example, will be dealt with, and include an action plan with milestones to measure progress. As such, strategic planning can play a vital role in defining and operationalising healthcare priorities and in building buy-in across government departments. It provides an

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The development of a strategic plan is nevertheless only a first step. Governments must then hold relevant Ministries and institutions to the commitments they contain and monitor progress towards them.

The Role of Industry Strategic planning for healthcare priority-setting will include an assessment of health needs. Industry can support governments in this by, for example, providing epidemiological information and/or input into pharmaceutical policy debates, as part of fair, transparent and timely and consultative processes.

Creation/Strengthening of Priority-Setting Structures The Challenge Many countries lack specific institutions and structures for assessing the current state of health need and opportunities to inform priority-setting, yet severe constraints on budgets make it difficult to invest in new capacity and/or infrastructure. Furthermore, priority-setting has to compete with other frontline health services, such as hospitals and primary care.

It is also highly technical, requiring specialist skills, which can be challenging for resource-poor countries.

These restrictions mean that the process of reform may be funded in ways that gives rise to potential conflicts of interest, such as HTA being part-funded by the insurance

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opportunity to look at the needs of the health systems as a whole, as well as the ability to manage the resource implications of evaluating new technologies. It allows government to take into account implementation challenges, for example of how to link health technology assessment (HTA) and procurement decisions within the planning process. Finally, it provides an opportunity for government to outline clear processes for stakeholder consultation. Such procedures can ensure quality and transparency, and should harmonise political and technical decision-making.

providers or regulatory bodies receiving industry funding.

What Needs to Happen?

Governments will need to determine the appropriate institutions (or departments within institutions) for evidence-based decisionmaking, with clearly defined responsibilities for collecting and evaluating the data necessary to make these decisions. These bodies should be adequately resourced. Once established, government should be clear about how the new structures relate to other organisations making healthrelated decisions, such as health insurers, and invest in improved coordination

and communication between them. In addition, governments may choose to draw on the expertise of external advisers about priority-setting tools and methodologies. Where they do so, such arrangements should be transparent.

The Role of Industry The pharmaceutical industry has an important role to play in recognising the authority of such institutions. For this to happen it will need to have confidence that prioritysetting institutions will follow transparent processes for data collection, decisionmaking, monitoring and appeal, to which they are able to contribute.

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Introduction of Processes for Priority-setting, Decision-making, Review and Appeals

The Challenge The co-existence in many countries of formal and informal decision-making systems is problematic. Legislative frameworks, particularly the links between legislative and judicial processes, can be unclear. When formal decisionmaking structures are opaque, they may be susceptible to undue influence, inappropriate lobbying and even corruption.

The over-reliance on informal communication channels between individuals opens up potential bias, as well as contributing to further mistrust.

Groundwork uncovered much potential for improved relations here. Both sides need to manage the tension between a mechanism that needs to be both structured and flexible. From a government perspective, while interested in the knowledge that the pharmaceutical industry holds, there is considerable wariness on the part of officials who fear being manipulated by industry – directly or indirectly – at critical moments, such as the point of review of UHC benefits package. Government is also highly sensitive to the need to be accountable to other stakeholders, making it wary of face to face engagement with industry, which could be open to misinterpretation.

Consequently formal written submissions are often a preferred mode of engagement, which can be frustrating to the

pharmaceutical industry. The industry has clear appetite to engage more effectively with government in decisions about medicines coverage and prioritisation. The more knowledge a company has about specific country health priorities and pathways, the more it will want to offer relevant and needed products.

The industry is concerned about a perceived ‘antipharma’ bias preventing it from engaging with government about how medicines could help achieve health ambitions, particularly in relation to noncommunicable diseases.

The challenge is to ensure that governments are clear that pharmaceutical company representatives in country are not seeking to override due process in order to meet short-term business goals and targets for specific products/ technologies. Pharmaceutical companies, in turn, need to be confident that they will encounter a level playing field if they use formal channels, and that effective disincentives are in place to address infringement of these rules by their competitors.

What Needs to Happen?

To support evidence-based decision-making governments can introduce a strong and unambiguous legislative framework and procedural clarity about how and when decisions are made. There is

a need for transparent national (and regional) decision-making processes for the definition of healthcare priorities; choice of UHC benefits package/s; the processes for medicine review, and technology selection and procurement. Government needs to provide information about who will be involved in such decisions, and under what circumstances. In this way, informal avenues for influence can be replaced by clear, streamlined and formal processes, which give governments autonomy to take decisions, while providing stakeholders with confidence that their views will be heard and decisions made in a timely way. The processes for each step from priority-setting, decision-making, to review and appeal are:

Priority-Setting • Statement of clear policy intentions on approaches to macro (contribution to health system efficiency), meso (clinical pathways and guidelines) and micro (product-based health technology assessment) priority-setting • The issuance of clear process guidelines on how healthcare priorities are defined • The introduction of processes to help governments manage the tension between patient perspectives (individual) and the population perspective (public health)

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• Explicit reference to the links between priority-setting and reimbursement policies • The introduction of clear process for topic selection • Introduction of a mini appeal process, following initial topic selection, to avoid costly and damaging judicial review later in the process • The introduction of clear stakeholder consultation guidelines throughout the process

Decision-Making and Review • The introduction of clear deliberation processes that provide clear criteria for decision-making, clear timeframes and speedy process • The introduction of transparent processes for information input, review and commentary that permit industry and other stakeholders, subject to government guidelines, to provide support to the interpretation of technical and policy inputs and to submit high quality data in appropriate ways • The introduction of specific government guidelines for data submissions which reflect the health priority and treatment pathways of the country in question • Engagement with industry on deliberative appraisals, followed by well-defined government decision-making and clear communication about the thresholds being used and any scope for review

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• The introduction of iterative processes of data collection and review, which permit industry to provide clinical and economic evidence on products that may lead to the addition of new technologies and removals of old ones from formularies • The introduction of light-touch review meetings following controversial decisions or immediately prior to a final decision, as a way of avoiding subsequent protracted challenges

Appeal • The introduction of appeal processes that make a clear distinction between processbased and content-based appeals • The use of clear criteria to identify which appeals go to an independent review panel • The introduction of clear timelines for consideration and decision on appeal • Commitment from industry and government to revert to judiciary only as absolute last resort

The Role of Industry The pharmaceutical industry can play a positive role by actively committing to engage in the formal consultation processes. This will happen if industry feels confident that government decisions are made as a result of formal processes.

During the priority-setting process industry can, transparently, provide epidemiological information to government about different

diseases, as well as putting forward its views about prioritysetting more broadly. It can also engage in mini-appeal processes in the early stages of topic selection to avoid costly and damaging judicial review later in the process.

During decision-making and review processes industry can provide support to the interpretation of technical and policy submissions and make high-quality data submissions in appropriate ways. It can also engage in iterative processes of data collection and review and deliberative appraisals. Finally, it can participate in meetings following controversial decisions or immediately prior to a final decision. In some countries the industry has a presence on Drug Pricing Committees, which gives rise to (perceived) conflicts of interest. To address this, clear and transparent processes that all parties uphold and mechanisms for active management of conflicts of interest, should be introduced.

If priority-setting and decisionmaking and review processes are working well, industry will be able to respect the resulting decisions. This will prevent the use of informal channels of influence and the use of procedures – such as the “tutela” system – or other forms of legal challenge, inappropriate for defining healthcare priorities.

A robust and trusted process will allow industry to make a commitment in principle to resort to appeals only as a last resort.

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Allocation of Resources for Data Collection and Monitoring The Challenge Evidence-based decisionmaking depends on reliable, timely and complete information.

Moreover, it is important that evidence is matched to decisions, i.e. macro-data for priority-setting and micro-data for HTA evaluations. Many government health systems require considerable investment to overcome poor quality data systems and weak data collection capabilities. They may also lack technicians and officials with the necessary skills to undertake evaluation for priority-setting, apply HTA to all the relevant technologies, manage budgets, improve efficiency and streamline procurement. In the absence of these skills evidence-based decision-making may be hampered by inconsistency of data input, inaccessible or fragmented data, a lack of reliable metrics against which the data will be evaluated and concerns about data bias.

This also affects the pace of decision-making and can lead to medicine approval being so slow that the delay results in decisions being made on old data. At the same time, government is not always confident that it is being presented with complete data sets.

What Needs to Happen?

Effective priority-setting requires good data management and analysis, which in turn requires effective data collection and monitoring. The benefits

of good data collection and monitoring also apply to financial management, system optimisation, quality measurement and improvement.

Governments need to be clear about what the data is to be used for and how it is connected to health priorities and government policies. It should provide officials with the information necessary to ask the right questions and to seek the appropriate data sets for the task in hand, e.g. the definition of broad health priorities or decisions about the use of particular treatment options and technologies. There is a need for improvements in the quality, quantity, reliability and timeliness of data collected, including provision for the difficulty of collecting data from the informal sector. Once collected, there is a need to be able to link data sets, e.g. diagnoses and outcomes data, and there is a need to improve data sharing across government departments. When introducing data management mechanisms care should be taken to ensure that they match or enhance system capabilities. This need highlights the advisability of cross-border data-sharing to avoid expensive duplication of research efforts. At the level of personnel, there is a need for more investment in IT capacity and training of technicians, both to improve the quality of data collection and to use the data to its full potential.

The Role of Industry Groundwork uncovered considerable potential for

the industry to support governments to enhance their data capabilities, though participants were careful to highlight the importance of carefully managing conflicts of interest in all instances. The most important commitment governments seek from industry is to provide full and transparent data sets. In addition, some government officials believe industry could play an important role in technical capacity building, by supporting training to improve data collection, e.g. epidemiological data, coding in hospitals, or developing a list of methodological best practices, e.g. to validate data. It could provide a clearly accessible, single list of available regional and international data resources, complete with evaluation of their limitations and strengths, and information about whether they can be borrowed. Industry could also provide on-the-ground support for data collection and analysis: including establishing minimum data-sets and levels of evidence required to address specific questions and for the development of expertise in evaluating clinical trial data and results, statistical modelling and technology assessment. This expertise could also extend to the analysis and interpretation of “real world� data, as industry has considerable experience in this area. Finally, the industry could also provide governments with financial and other types of support for research and the development of IT infrastructure.

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Stakeholder Consultation The Challenge The need for governments to engage in transparent and ongoing stakeholder engagement on healthcare priority-setting was highlighted throughout the Groundwork process. Stakeholders in healthcare include patient groups, medical associations and the general public as well as industry. Patient organisations are often relatively new in developing countries and concern was expressed about the importance of ensuring that they are not manipulated by more powerful stakeholders.

What Needs to Happen?

Stakeholder perspectives are important to the viability of evidence-based approaches to decision making. Governments need to introduce clear standards and guidelines for stakeholder engagement along all steps – priority-setting, decision-making, review and appeals. The guidelines should highlight the precise nature of any engagement and the points at which stakeholder perspectives will be gathered.

Governments then need to make clear how they have taken these views into consideration.

The Role of Industry As outlined above, the pharmaceutical industry – as a key government stakeholder – can engage in a timely manner throughout government consultation processes, support decisions once made, and resort to appeal only as a last resort. In addition, industry should declare any sponsorship, educational or other types of support for patient organisations or professional bodies that are part of the consultation process.

Next steps The Groundwork Framework was launched at a High-Level Meeting in Hanoi on 22nd April and is now available for use as guidance by companies and governments wishing to benefit from the expertise and collective inputs of the Groundwork group. For further information please contact info@meteos.co.uk

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Appendix One: Groundwork Participants

Kalipso Chalkidou

Executive Director, NICE International

Edith Gavor

Programme Manager, Ghana National Drugs Programme, Ministry of Health, Ghana

Amanda Glassman

Director of Global Health Policy and Senior Fellow, Centre for Global Development

David Grainger

Senior Director, Global Public Policy, Eli Lilly

Martha Gyansa-Lutterodt

Director of Pharmaceutical Services, Ministry of Health, Ghana

Ha Anh Duc

Vice Chief of Cabinet and Secretary to Minister of Health, Ministry of Health, Vietnam

Kenneth Hartigan-Go

Academic Director and Faculty, Stephen Zuellig Graduate School of Development Management, Asian Institute of Management, Philippines

Dell Kingsford Smith

Vice President, Global Pharmaceutical Pricing, Johnson & Johnson

Sylvester Mensah

CEO, National Health Insurance Agency, Ghana

Nguyen Khanh Phuong

Head of Health Economics Department, Health Strategy and Policy Institute, Vietnam

Ong The Due

Researcher, Health Strategy and Policy Institute, Vietnam

Nathaniel Otoo

Vice Chief Executive, National Health Insurance Agency, Ghana

Reetan Patel

Programme Manager, NICE International

Anjali Radcliffe Director, Government Affairs, Europe, Middle East and Africa GlaxoSmithKline Madeleine de Rosas-Valera

Former Assistant Secretary of Health, Department of Health, Philippines

Chris Strutt Senior Vice President, Government Affairs, Public Policy & Patient Advocacy, GlaxoSmithKline Netnapis Suchonwanich*

Assistant Secretary General, National Health Security Office, Thailand

Peerapol Sutiwisesak*

Deputy Secretary General, National Health Security Office, Thailand

Yot Teerawattananon*

Program Leader and Senior Researcher, Health Intervention and Technology Assessment Program, Thailand

Jadej Thammatacharee*

Director of Policy and Planning, National Health Security Office National Health Security Office, Thailand

Koen Torfs

Tran Thi Mai Oanh

Vice President Health Economics, Market Access and Reimbursement, Europe, Middle East and Africa, Johnson & Johnson

Nattha Tritasavit*

International Coordinator, Health Intervention and Technology Assessment Program, Thailand

Director, Health Strategy and Policy Institute, Vietnam

Claudia Patricia Observer and Independent Consultant, Colombia Vaca Gonzalez* Steve Wooding Managing Director, Emerging Markets, Johnson & Johnson

* participated as observer (see page i)

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