A new approach to NCD control in Europe

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Interview with Marianne Takki, Policy Coordinator, DG Sante, European Commission

“I’m here to tell everyone about the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases, and explain to organisations and other health stakeholders how the approach works.”

At the European Health Forum Gastein 2018, Marianne Takki was present to discuss the activities and role of the European Commission in non-communicable diseases (NCDs) prevention and control.

MD: You mentioned that the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases[i], which the European Commission established this summer (2018), is a totally new approach. What is so different about this approach compared to how the Commission worked on NCDs earlier?

MT: Previously, there were several disease-specific expert groups at the Commission, such as on rare diseases, cancer control, and mental health. The outputs of these groups were not effectively taken forward. We [the Commission] realised that, for plans and recommendations to be useful to someone, implementation needs to be the focus of all planning. Now, with the new steering group that officially started in July 2018, the member states are involved from the beginning. The aim of the steering group is not to create aspirational statements, nor develop new policies: instead, the steering group will address what we already have. This approach puts health in all policies into practice.

“The Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases, which is established by the European Commission in July 2018, is a new approach to non-communicable disease control in Europe. This approach is about health in all policies being integrated into practice.”

Through the best-practices portal – which is a part of this new approach – we make sure that the member states know which NCD interventions are available and which can be implemented. Preferably, these practices are already implemented in a country or region and, with some adaptation, can be implemented in other places. The best practice portal is more than just a collection of best practices, it also includes an evaluation, for which the assessment criteria are established by the steering group. Finally, the Commission provides funding to member states for the implementation of best practices

MD: NCDs are now on the political agenda, but winds might change. How can we keep NCDs on the national and European agendas?

MT: Commitment of member states is realised by having regular prioritisation exercises, where member states prioritise their own needs. There are already many agendas out there, such as the sustainable development goals (SDGs), so the steering group aims to support member states in achieving the targets and goals that are most challenging for them.

MD: What can we expect from the steering group in the future?

MT: Until today, the Health Programme was the main funding for health projects. But now, while we are moving towards the next multi-annual financial framework of the EU (2021-2027), this will change. The steering group will be the main mechanism. I’m here [at the European Health Forum Gastein] to tell everyone about the steering group and to bring forward our approach, so that it becomes clearer to organisations and other health stakeholders. It is a new approach and we are taking baby steps in the beginning. The positive feedback that we have received from the member states since the launch of the steering group is a clear indicator that we are using the right approach.

In the next multi-annual financial framework, health is incorporated in the ESF+ programme, within the so-called health ‘strand’ or ‘cluster’. As stated in the proposal for the ESF + programme, article 29 in particular, the steering group would mainly be responsible for the health strand, including the work plans, prioritisation, strategy and implementation of the public health activities in the EU.[i] We are aiming for a more upstream decision-making process in the future. This would mean that the steering group can steer financial resources based on member states’ health objectives.

By the way, 7.7 billion euros are set for health research in Horizon Europe [the new research cluster]. I don’t think people see the opportunities here.

The first formal meeting of the steering group – chaired by Martin Seychell – was held on 6th of November 2018. We also plan a joint meeting between the steering group and the current Horizon 2020 research programme committee in Brussels in early spring 2019. This is to facilitate discussions between the stakeholders from research and health on ministerial level and the different Commission services on where the synergies are. This is one concrete future step in making sure that our policies are aligned, and our objectives are in synergy.

This interview was conducted by a Young Gasteiner Maaike Droogers

[i] Article 29 of ‘Proposal for a Regulation of the European Parliament and of the Council on the European Social Fund Plus (ESF+) COM/2018/382’ suggests that the steering group could have an important role in the future ESF+ health strand. Available here, https://eur-lex.europa.eu/resource.html?uri=cellar:a39e5630-640f-11e8-ab9c-01aa75ed71a1.0003.02/DOC_1&format=PDF.  

[i] Webpage of the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases is available here: https://ec.europa.eu/health/non_communicable_diseases/steeringgroup_promotionprevention_en

It is clear that something needs to change

Hans Kluge, Director of the Division of Health Systems and Public Health at the World Health Organization Regional Office for Europe, in an interview for the magazine “Healthy Europe” on how the economy affects our health. A short version of the interview is part of an article on page 12 of the print magazine “Healthy Europe”.


HEALTHY EUROPE

Mr Kluge, are health and economy in opposition to one another and do the two sectors collide? If yes, how can we make them dovetail?

Hans Kluge:

  • I’m not sure that they collide per se, but it is clear that many in finance circles view health as a ‘black hole’; where money is poured in but with little in the way of return on investment.
  • We know, however, that this is something of a simplistic caricature of the situation.
  • There is an increasing body of evidence, building already on the compelling work profiled at the 2008 Tallinn Ministerial Conference which led to the Tallinn Charter on Health and Wealth, that the health system contributes economically, and that healthy populations provide a boost to the economy.
  • It is precisely for this reason that, along with the European Observatoryon Health Systems and Policies, my division at the World Health Organization (WHO) Europe has developed a workstream to firstly strengthen the evidence base, and secondly to explore how best to get these important messages across.
  • Messages such as the fact that health systems contribute to human capital at all ages; that the health system is an industry in its own right and major source of employment; and that, as we learned from the initial and spin-off work of the Commission on Macroeconomics and health, good population health allows for more people in employment, greater individual and collective productivity in employment, and more people investing in education, retirement and the economy itself.
  • Nonetheless, we often hear financial decision-makers talk about waste and inefficiency in the health sector as a reason for not investing in health, and it is important to not simply dismiss these accusations but to engage with them – for it is only by doing so that we can better understand why they are made and what type of information is needed to counter them.
  • In this regard, we are working to examine ways to improve the dialogue between health and finance decision-makers and to see how best they can work together when it comes to budget and spending decisions around health.
  • In saying this, I must admit that while I understand that we in the health community need to do better in speaking the language of the economists – they are after all the ones holding the purse-strings – I nonetheless would argue that as health has an intrinsic value of its own and should not necessarily be defined economically.
  • And I do think that other sectors are wasteful, perhaps in some cases more so, and we should not always be as defensive as we are here.

HEALTHY EUROPE

What is the impact of economic development on health?

Hans Kluge:

  • We know that people who are employed and earn more are in the main healthier than those who do not.
  • The reasons for this are many, some relating to socio-economic factors and the social determinants of health – so difficult for individuals to change themselves – some to education and access to information, and some to ability to pay for health services or health insurance etc.
  • So at a micro- or individual level, a better economic standing has a positive impact on health.
  • At a more macro-level, however, the picture is less clear.
  • Economic development and growth would suggest benefits across the population such that everyone’s standard of living is raised and that households have more disposal income, ideally to be spent on health.
  • But individuals may choose to spend any additional income or wealth on non-health related commodities; some of which might even worsen their health status beyond what being poorer might have done.
  • Economic development would also suggest that the social safety net can be drawn wider and strengthened, providing greater health coverage and health for more people.
  • But again, it depends where any additional money is spent – we know that even in richer countries, the amount spent on public health is far lower than it ought to be.
  • So while economic development should suggest greater health, it always comes down to choices and where resources are distributed.

HEALTHY EUROPE

Do we need a different, new form of economic development to get more health for all?

Hans Kluge:

  • This is of course a more philosophical issue than I am usually asked in my capacity as Director of Health Systems and Public Health at WHO Europe.
  • And I’m not sure that I am qualified to answer this!
  • What I can say is that with the Sustainable Development Goals (SDGs) of United Nations and the growing attention given to economic and social disparities worldwide, including in Europe, thinking about people’s access and right to health is coming to the forefront of discussions even those about the economy.
  • The push for sustainable development suggests an alternative to current models of economic development, re-emphasising the need for solidarity and looking out for the needs of the many rather than the few.
  • It is difficult to understand how we can be generating so much wealth across the globe, and yet in many cases we see inequality rising rather than falling.
  • It is clear that something needs to change, and a clear focus on redistributive models under the SDGs is a step in this direction, and with a positive effect on our pursuit of health for all.

HEALTHY EUROPE

What has to be done to ensure good health of the workforce?

Hans Kluge:

  • I’m not sure that anything specific needs to be done for the workforce as opposed to those not working – at WHO Europe, we of course subscribe to the health for all view.
  • This is not intended to be reductionist or a lowest common denominator approach, rather it is the opposite.
  • It’s about everyone attaining their own highest possible level of health.
  • So everyone, not just those in the workforce or of working age, should benefit for universal health coverage and have affordable access to the highest quality care that they need.
  • Yes, of course, in different professions there are important occupational health guidelines which should be adhered to, and WHO has helped developed guidelines here.
  • But what is important is that workers have health coverage and financial protection – these are key issues particularly in the WHO European Region where access to care, and access to quality care is generally better for most people when compared to other regions; not everyone, of course, but our populations in Europe are generally better off than elsewhere.
  • Ensuring a strong people-centred health system will generate and maintain a healthy workforce, with a consequent benefit for the economy.

A Unique Momentum for Public Health

Zsuzsanna Jakab, WHO Regional Director for Europe, on the importance of the 17 Sustainable Development Goals for the health sector, why we are currently living at the expense of the present and future generations and for which reason health diplomacy is critical to lead us through a period of considerable uncertainty. A short version of the interview is part of an article on page 10 + 11 of the print magazine “Healthy Europe”.


HEALTHY EUROPE

Director Jakab, the 17 Sustainable Development Goals (SDGs)of the 2030 Agenda for Sustainable Developmentof United Nations are meant to end all forms of poverty, fight inequalities and tackle climate change over the next 15 years while ensuring that no one is left behind. What is the importance of the SDGs asa whole for the health sector?

Zsuzsanna Jakab:

The adoption of the 2030 Agenda and the universal commitment to the SDGscreateunique momentum for public health. The implementation of the SDGs will contribute to the full realization of human rights and fundamental freedoms for all, including the right of everyone to the highest attainable standard of physical and mental health.

Also, the adoption of the 2030 Agenda has clearly shown that the vision of the international community is converging, and that there are growing signs of solidarity in the world. We have unprecedented political determination to strengthen health systems towards universal health coverage, strengthen primary health care, combat major diseases and address the multiple determinants of health through the achievement of all SDGs. With these essential elements in place, we have an excellent opportunity to make major progress in achieving better health and well-being for all people at all ages. The point is that now we have to act together to live up to the pledges we all made in 2015.

HEALTHY EUROPE

What can the health sector contribute to reaching all the SDGs together?

Zsuzsanna Jakab:

Obviously,its main contribution is the implementation of SDG 3, the “health goal”, which is the most powerful tool for operationalizing health in all policies. This is underpinned by universal health coverage, which is the flagship of the new global vision for WHOapproved by Member States at the World Health Assembly in May this year.But health targets are not limited to SDG 3– almost all of the other 16 goals are directly related to health or contribute to health indirectly, reflecting the complex pattern of health contributions to SDG implementation.

If I have to pick a few key elements that have a strong impact on the implementation of the 2030 Agenda, I would like to highlight the main elements of the SDG roadmapendorsed by European Member States. The first is strengthening health systems towards universal health coverage. By building strong health systems we contribute to reducingpovertyand toincreasing social cohesion and inclusive economic growth.

Another isadvancing governance for health.Implementing the 2030 Agenda requires a high level of political commitment and a whole-of-government, whole-of-society approach. Health ministers and public health authorities play key roles in setting agendas, providing evidence and proposing policies. They can, for example, seek the commitment of heads of state and leaders of other sectors to improve population health and well-being by considering investments in public health, health in all policies and equity.

Ensuring that no one is left behindisanother major focus area.The health sector itself can ensure that everybody has access to quality care and that it does not discriminate against anybody, but it can also lobby for universal social protection, for example.

In addition, advocating forimproving the environmental, social, economic, commercial and cultural determinants of health through a health-in-all-policiesapproachandembedding health promotion and disease prevention in communitiescan probably reduce half of our burden of disease.It is particularly necessary, for example, to tackle the burden of disease from environmental exposures, climate change and unhealthy food systems; to address the risk factors for noncommunicable diseases; to meet the challenges of emergencies, communicable diseases and antimicrobial resistance; to strengthen the factors that promote social protection; and to empower people through education and training.

Plus, the health community can offer expertise, evidence and tools to assessthe effects of health and health equity policies, programmes and processes.

HEALTHY EUROPE

The health sector and health promotion are connected to all other societal sectors, such as agriculture, infrastructure, education, city planning and landscape architecture. Should health therefore be an overarching goal in the context of the SDGs?

Zsuzsanna Jakab:

Health is an overarching goal. Without health we cannot achieve the SDGs, and to achieve health we need to accomplish all of the SDGs. The SDGs have strong interconnections that extend to all sectors. If properly implemented, actions to achieve the SDGs should span many spheres of governance (such as legal, institutional, technical and fiscal realms) and many sectors (such as those focused on agriculture, transport, energy, justice, welfare, education, security, industry and housing). Ultimately, this will improve people’s living conditions; increase capacity; improve social, environmental and financial protection; create a greener society; and increase security at all levels.

Yet, effective multisectoral action also requires policy coherence across sectors as well as effective multistakeholder governance for health. This means that actors across health and other areas must regularly engage with each other in structured dialogue and, where appropriate, plan and act jointly to maximize shared gains and minimize tradeoffs.

Let me offer an example to show that allSDGs are strongly interconnected and indivisible, meaning that each depends on the success of the others.Poverty (which SDG 1 specifically addresses) is linked to poor health, low salaries, unemployment and low educational outcomes. Without effective and universal education, health coverage and social protection, the risk of poverty is passed from one generation to the next. The implementation of social protection floors that provide universal access to basic social guarantees such as healthcare, disability benefits, unemployment benefits and old-age pensions reduces the risk of poverty and social exclusion.These are specific targets of SDG 1 and SDG 10, but strongly connected to target 3.8 of universal health coverage.

Similarly, out-of-pocket payments for health care(addressed in SDG 3) can have detrimental effects on families, individuals and society by contributing toimpoverishment. Out-of-pocket payments as a proportion of total health expenditure are still high in many countries of the WHO European Region, ranging from 11% to 49% (our benchmark goal is 15%). The outcome statement “Health systems for prosperity and solidarity: leaving no one behind”,adopted by all 53 Member States in Tallinn, Estonia, in June this year, stresses that in order to include everybody, we need to extend coverage to the whole population, improve access to medicines and carefully redesign policies on user charges to protect all households from financial hardship. This has to be addressed throughout a whole-of-the-government approach.

One more example of the interconnectivity of the SDGs involves preserving Earth’s ecosystems on which human societies depend. Climate change and environmental degradation are increasing the risk of extreme weather events and creating greater food and water insecurity, all of which contribute to a higher burden of disease. Approximately 16% of all deathsin the Regionare attributable to environmental factors that could have been prevented and/or eliminated. Much progress could be achieved by focusing on strengthening the implementation of the many national and international commitments that Member States have already made in these areas. In our Region, we have the Ostrava Declarationon environment and health, the implementationof which will contribute to achieving SDGs 3, 6, 7, 9, 11, 12, 13, 14 and 15.

HEALTHY EUROPE

Sustainability means not living at the expense of future generations. Is this currently the case – in Europe and globally?

Zsuzsanna Jakab:

Let me clarify: sustainability means not living at the expense of future or present generations. How societies live, consume and produce continues to be disconnected from natural environments as a result of long-standing patterns and practices in policies, institutions, technologies and lifestyles. Despite improvements in the last decades, Europe’s ecological footprint is large. If everyone on the planet had the same ecological footprint as the average resident of the European Union, we would need approximately 2.6 Earths to support our demands on nature.

We are living not only at the expense of future generations, but also at the expense of the present generation. Climate change already contributes significantly to the global burden of disease, and its health effects are projected to increase in all countries and regions. The rising numbers of deaths and losses from more frequent heat waves, floods and wildfires that we are already observing are related to our unsustainable lifestyles.

Every year, at least 1.4 million premature deaths in the Region are attributable to environmental risk factors – especially air pollution – and 14 people every day die from diarrhoeal disease due to inadequate water supplies, sanitation and hygiene. This situation is worrisome and the challenges are multifaceted, since the systems that account for a large proportion of our environmental pressures are also linked in complex ways to benefits and interests such as jobs, investments, lifestyles and values.

Yet,the future is hopeful. Europe has some of the world’s highest environmental standards and has set a vision to “live well, within the planet’s ecological limits” by 2050.Adequate investments in environmental and climate policies can generate innovations and sustainable solutions, which can be implemented and exported to help address international environmental and climate challenges more effectively.

Unsustainable lifestyles are damagingto health in various ways. For example, rising rates of obesity, physical inactivityand consequent noncommunicable diseases are results of these health-damaging lifestyles. More than 50% of adults (in 46 countries accounting for 87% of the Region) are overweight or obese, and in several of these countries the rate is close to 70%. Of particular concern are high rates of childhood obesity.Preliminary unpublished data from the WHO European Childhood Obesity Surveillance Initiative (COSI) reveals that in some countries almost 50% of 8-year-old boys were overweight and more than 25% were obese in 2016. Regional estimates for 2016 show that more than 40 million and 5 million of disability-adjusted lifeyears lost per year are attributable to dietary risks and low levels of physical activity, respectively. Based on trends from surveys of adolescents and adults, the Region is unlikely to achieve a 10% relative reduction in prevalence of insufficient physical activity.

HEALTHY EUROPE

Which aspects of sustainability should have priority? Where should we start?

Zsuzsanna Jakab:

The SDGs are indivisible. This makes prioritizinga single SDG difficult. But a range of so-called accelerators can help to achieveone SDG with multiple benefits for all other SDGs. I will mention just a few.

The first is collective action to achieve shared goals. The 2030Agenda provides the opportunity to strengthen intersectoral and multistakeholder cooperation. The good news is that extensive coordination efforts are scaling up to, for example: meet specific health priorities (such as disease outbreaks);ensure more effective emergency responses; standardize data collection; increase access to priority medicines through joint work on product development, registration, approval, prequalification and distribution; and support universal health coverage. 

At this early stage in the implementation of the SDGs, the health community faces a critical opportunity to capitalize on this growing momentum. Our United NationsIssue-based Coalition on Health and Well-being provides a good example: more than 20 United Nations agencies work together in European countries to implement country health priorities through multistakeholder action.

Also, to achieve long-term sustainability and address sustainability challenges, we need fundamental transformations in how we produce and consume; inthe commercial determinants of innovative health technologies andregulations;in ourpractices and behaviours; and in our beliefs and values. For example, addressing the consumption ofultra-processed foods, sugar-sweetened beverages and tobacco requires multisectoral responses involving a range of public- and private-sector actors working in health, industry, finance, environment, media and other areas.

From the health perspective, major investments in health promotion and early disease detection and prevention will allow countries to limit the rising costs of health systems and enable savings if disease can be avoided. Member States are called to place a spotlight on people-centred primary health care as the means to move towards universal health coverageand serve the most disadvantaged, marginalized, stigmatized and hard-to-reach populations. We must carefully considereffectiveness, safety and efficiency; ensurethe continuity, integration and coordination of care; and fosterrespectful and compassionate relations between people and their health-care workers.

We must also ensure that more people are better protected from emergencies. Every country is vulnerable to epidemics and emergencies – these threats are universal. Global and regional earlywarningand event-based surveillance systems are now in place. Early detection, risk assessment, information-sharing and rapid response are essential to avoid illness, injury, death and economic losses on a large scale. However, not all countries have the same risk-preparedness and -management capacities for health emergencies. The implementation of the International Health Regulationsand the Sendai Framework for Disaster Risk Reduction 2015–2030will address this.

HEALTHY EUROPE

The SDGs are not legally binding, but governments are expected to take ownership and establish national frameworks for their achievement. What importance do the SDGs have in the realpolitik, the practical policy of nations?

Zsuzsanna Jakab:

The fact that the 2030 Agenda is universal, for high- and low-income countries alike, provides an unprecedented opportunity for global governance. Although it is not legally binding, we see more and more countries, international actors and stakeholders engaged in implementing and contributing to the2030 Agenda and achieving the SDGs.

We can see this commitment in, for example, the annual reporting of more than 100 countries worldwide and 36 countries in the Region at the United Nations High-level Political Forum on Sustainable Development. TheForum isan important process for strengthening assessment, review, dialogue, mutual learning and the science–policy interface. Development partners are more engaged in financing solutions for sustainable development, and countries are more and more interestedin aligning national priorities with sustainability principles.

Our analysis of the voluntary national reviews published until 2017 shows that, generally, countries show a willingness to address challenges relating to governance, leadership and engagement. Many countries state commitments to improve energy efficiency, reduce emissions, improve air quality, support renewables, reduce waste, improve recycling, develop information technology, and develop knowledge-based or green economies. However, countries have struggled to apply the broad principles of intersectoral work and to integrate the three dimensions of sustainability – environmental, social and economic – and have engaged in even less discussion on the potential health benefits of wider action on sustainability.

HEALTHY EUROPE

In Europe and globally, we are currently experiencing a conflict between sociopolitical concepts of nationalism and national self-interest and concepts that attach more importance to solidarity within and between nations. Are we currently standing at a crossroads in this regard? What does that mean for the health sector? 

Zsuzsanna Jakab:

We are definitely in a time of emerging challenges, and these challenges are not unique to the health sector. We can be proud of the attributes we assign to European health systems: solidarity, equity and universalism – but, indeed, these are at risk.

The political and public debate is increasingly polarized on climate change, the globalization of hazardous products, terrorism, civil conflicts, vaccination, etc.These complex and sometimes interconnected problems require systemic approaches that involve a wide range of society and multiple levels of governance, from local to global – with recognition of the increasing relevance of regional and local levels.The biggest challenge in this context, however, is to nurture leaders with a strategic vision, technical knowledge, political skills, and an ethical orientation to lead the complex processes of policy formulation and implementation.

Health diplomacy is critical to lead us through this period of considerable uncertainty in Europe and the wider world. Meeting and working together to achieve the SDGs and the European policy framework for health and well-being Health 2020require more and more expertise from Member States and from many state and non-state actors. These efforts require close cooperation on health matters with the European Union and other European organizations. Public health professionals increasingly need a better understanding of the mechanisms of diplomacy, and diplomats engaged in health-related negotiations must be informed of the challenging dimensions of today’s public health.

WHO is committed tocontinue promoting the vital role of health in human development at all levels of government, as well as within the United Nations system and among a range of non-state actors and citizens. We must continue to use human rights-based principals to argue for public health measures to address issues ranging from climate change to tobacco control toadequate standards of living, and to ensurea wide range of civil, political, economic, social and cultural rights.

 

 

Data protection as an added value

Leonardo Cervera Navas, Director at the European Data Protection Supervisor (EDPS) in an interview for the magazine “Healthy Europe” on the protection of health data and the challenges of sharing them within and between countries. A short version of the interview is part of an article on page 8 of the print magazine “Healthy Europe”.

Director Cervera Navas, what has to be done generally to guarantee data security and ethical usage of data? How can the tasks of the European Data Protection Supervisor in that context be described shortly?

Leonardo Cervera Navas:

The fundamental rights to privacy and to the protection of personal data have become more important for the protection of human dignity than ever before. Such rights are enshrined in the EU Treaties and in the EU Charter of Fundamental Rights. The General Data Protection Regulation (GDPR), now applicable since two months, lays down, under its Article 5, the data protection principles(lawfulness, fairness and transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity and confidentiality)that apply to all processing of personal data.Indoing so, the GDPR expressly reinforces the data protection principles that guarantee, among others, data security.

However, in today’s digital environment, we also have to consider the ethical dimension of the processing of data. We should address deeper questions as to the impact of new technologies in data driven society on dignity, individual freedom and the functioning of democracy. The possible solutions relate tomanifold aspects and have engineering, philosophical, legal and moral implications.We needa collective effort, underpinned by ethical considerations in order to respond to these challenges.

In this context, in theEDPS Strategy 2015-2019, we have outlined as one of our priorities the assessment of an ethical dimension that, as said above, goes beyond the application of data protection rules and encourages a multi-stakeholders and informed conversation and knowledge-sharing on the impact ofbig data and the internet of things on digital rights.

In September 2015, the EDPS issued an Opinion, Towards a New Digital Ethics, in which we urged the EU and the internationally responsible entities to promote an ethical dimension in future technologies to preserve the value of human dignity. The EDPS also created anEthics Advisory Group (EAG)with the aim of helping the EDPS to better assess the ethical implications of how personal information is defined and used in the digitalised world. As outcome of its work, the EAG issued a Final Report, which is available on our website.

This year the EDPS willbe hosting the International Data Protection and Privacy Commissioners Conference. The main theme of the Conference is:“Debating Ethics: Dignity and Respect in Data Driven Life”, focusing on the impact of digital technologies on our lives.

Let me recall that the European Data Protection Supervisor (EDPS) is the data protection authority for the European Union institutions, bodies and agencies. Among these institutions and bodies, the EDPS supervises the European Medicine Agencies (EMA)andclosely follows the work of EMA’s Technical Anonymisation group (TAG) with the key objective to further develop best practices for the anonymisation of clinical reports.The TAG group involves members from Europe and the US with significant experience in the area of anonymisation and clinical trials, coming from the academia, the public authorities – DPAs, the private sector, and other research institutions.

In addition to our supervision of the EU institutions, the EDPS also has a role as advisor on data protection issues in a wide range of policy areas and all matters concerning the processing of personal data, including health research policies.

HEALTHY EUROPE:

Standardized surveys and usage of health data could bring benefits for patients by improving treatments and enabling more personalized medicine. On the other hand health data are especially sensitive. What has to be done to guarantee data security and ethical usage of data especially regarding health data? What are the most important measures?

Leonardo Cervera Navas:

It is widely acknowledged that standardized surveys and use of health data can bring benefits for patients by improving their treatments. In this regard, I would like to underline that data protection shouldnot to be considered as an obstacle, but as an added valuein order to improve the usage of health data, while keeping it safe and respecting the ethical dimension.

As provided by EU legislation, certain categories of personal data, including health data, are considered as particularly sensitiveandcannot be processed unless the ‘controller’ can rely on a specific legal ground (as specified under Article 9 of the GDPR) and specific safeguards are applied to the processing.

One of the legal grounds for the processing of health data is the explicit consent of the data subject (the person that can be identified, directly or indirectly, via the personal data).  Consent is a key condition,also from the ethical viewpoint,for the processing of personal data in the context of health research projects.However, it should be considered that consentis not, in all circumstances, the appropriate legal basis for all the types of processing of personal data.In addition to allowing researchers to process sensitive data where the data subject explicitly consents or makes her data public, the GDPR also permits a controller to process sensitive data when processing is necessary for the purposes of “preventive or occupational medicine”; for reasons of public interest in the area of public health”; and for research purposes where “processing is necessary for [research] purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.”

We also note that it is often difficult to fully identify the purpose of personal data processing for scientific research purposes at the time of data collection. Therefore, data subjects should be allowed to give their consent to certain areas of scientific research.

Let me also flag that Article 89 of the GDPR allows the EU or Member States to limit certain individual rights, when necessary for scientific research. As an exception, it should however be strictly interpreted and applied.

The GDPR introduces safeguards which, even though also applying to ‘non-health data’, are particularly relevant to the processing of health data:

  • The principle of privacy by design and by default: this important principle, initially established only ‘in practice’, is now codified by the GDPR. Privacy shall be embedded in the design phase of the processing of data.
  • The principle of data minimisation and data quality: these are ‘sides of the same coin’. A large amount of data are available in the real world, but not all of them are of good quality. The GDPR introduces the concept of data minimisation (use just what you need). As minimisation is implemented, there is a greater incentive to select data of good quality. Data quality is crucial in healthcare (e.g. clinical trials, therapy evaluation, etc.).
  • The principle of accountability: the GDPR introduces a shift in paradigm about compliance. The controller has to adopt suitable measures to ensure and demonstrate compliance  and to continuously assess, manage and minimize risk associated to processing.

A non-exhaustive list of appropriate measures includes: documentation,implementing security requirements , Data Protection Impact Assessment (DPIA)  anddesignation of a Data Protection Officer (DPO).

HEALTHY EUROPE:

Should information sharing of health data within and between countries be enhanced, especially for the aim of improving diagnoses and treatments? What are the challenges doing this?

Leonardo Cervera Navas:

The increasingly international dimension of scientific research requires the sharing of health data at the EU and at the international level toenhance diagnoses and treatments.

At the same timethe sharing of information may bring to an increased risk for the protection of data subjects. For this reason, the GDPR lays down a number of grounds, subject to specific conditions, for the transfer of personal data to third countries and international organizations. Such ‘legal grounds’ include: transfers to Countries recognized by the European Commission as providing an adequate level of protection by so-called adequacy decisions and appropriate safeguards provided by the controller or processor (legally binding agreements between public authorities, binding corporate rules, standard data protection clauses, approved codes of conduct or certification mechanism).

We note that the GDPR, also referring to codes of conduct or certification mechanism, extends the possibility for data transfers, also having regard to the exchange of health data for research purposes.

HEALTHY EUROPE:

The General Data Protection Regulation, which has become law across the EU in May 2018, has been criticised as being over-regulative by health researchers and practitioners. Should it be attenuated regarding the purposes of health research and treatment?

Leonardo Cervera Navas:

As already mentioned, Article 9 of the GDPR provides for legal grounds other than consent allowing the processing of sensitive data in the context of research, in particular when necessary for reasons of public interest in the areas of public health, such as for public health surveillance activities and epidemiological studies.

The GDPR also offers new opportunities for standardizationof data protection practices in the field of scientific research, in particular with reference to codes of conduct, binding corporate rules and certification mechanisms. Such harmonisation (a ‘common playing field’) would facilitate the exchange of health related data (across health operators within EU Member States and with third countries) and hence the medical and scientific work.

As a general remark, let me stress that in the future, we expect that privacy is increasingly perceived as a quality feature of products and services lubricating the flow of information.

Let me finally add that the EDPS will soon publish a background paper on research and data protection in the European Union, as a first stage in stimulating an informed discussion on data protection law and related ethical issues in the field of research, having regard in particular to health research.

 

Include, invest, innovate – Health Systems for Prosperity and Solidarity: leaving no one behind

WHO high-level regional meeting, Tallinn 2018

In June 13th-14th three Young Gasteiners were dispatched to Tallinn to help disseminate outputs from the WHO high-level conference organised to reaffirm the principles signed by WHO members in the 2008 Tallinn Charter. It provided a forum to discuss challenges facing these principles of health for prosperity and solidarity: present and predicted political and financial headwinds.

The conference sought to reaffirm, through new evidence, that health systems based on solidarity are the most efficient means of facing these challenges.

It was split into three themes:

  • Include – The ethical arguments of improving coverage, access and financial protection for everyone (universal health coverage) are well trodden. However, the conference highlighted the economic case and the huge increases in expenditure amongst poorer WHO European region (+/-10% increase in annual expenditure) for these reasons.
  • Invest –the case for investing in health systems was further stressed for ensuring a productive workforce and longer labour-market participation, amongst other reasons. The importance of value-based healthcare in providing tangible economic evidence towards investing in health systems was provided. Communication on returns on investment over different timescales was also found to be key to persuading finance ministries.
  • Innovate – experience of harnessing and spreading innovations were elaborated. The conference converged on the need for multi-stakeholder visions for innovative healthcare systems. These visions must provide the pathway and incentives for scaling up and spreading innovation. Innovation should be a tool to shrink, not widen health differences between and within countries. Participants were honest and clear that health systems based on solidarity need to be efficient, responsive and require reform. Innovation was viewed as key to these requirements and thus key to safeguarding the solidarity underlying our systems of universal healthcare.

Conclusion: Currently expenditure in health systems is seen as a black hole. The forecasted growth in expenditures to around 14% GDP by 2060 requires a stronger case being made of this expenditure as an investment. Innovation in HTA/pharmaceuticals are a good example with their value-metrics. However, the low hanging fruit seems to reside in health services innovation and spread. It is here where the efforts of the WHO and OECD are focussed.

Check out the blogs on:

Include written by the Young Gasteiner Karolina Mackiewicz: here

Invest written by the Young Gasteiner Dimitra Panteli: here

Innovate written by the Young Gasteiner Philip Hines: here

The three Young Forum Gastein authors together with their fellow Young Gasteiner Gabriele Pastorino (left)