The debate on the quality of healthcare in the European Union has made some new advancement, with the question for written answer posed last August by the Bulgarian member of the Parliament Ilhan Kyuchyuk and the publication of the report on the workshop held in May by the ENIVI Committee of the Parliament.

The tools to overcome fragmentation and inequalities

Mr Kyuchyuk was interested in knowing the means eventually available to the European Commission in order to establish differences in the quality of healthcare in the EU, and the measures proposed for countries with inferior quality healthcare, to help them catch up with Member States with high standards in health services. His question was based on the consideration of the existing fragmentation between European countries in the possibility to access quality healthcare. Inequalities arise most often from the differing quality of medical services — diagnostics, medicines, medical equipment and hospital infrastructure, wrote Mr Kyuchyuk in his question.

The answer by the EU Commissioner for Health and Food Safety, Vytenis Andriukaitis, came on 30 October.
According to Mr Andriukaitis, the Commission is responsible only to provide guidance and support to Member States, which remain in charge of the provision of their internal healthcare systems. The Commissioner recalled in his answer the twelve Member States that have received in 2018 a country specific recommendation regarding their healthcare system, and the fact the European Semester is the operative tool the Commission use to analyse the economic and social developments in the Member States, monitor relevant reforms and propose every year country-specific recommendations. The process of the European Semester also include the evaluation of access to timely, high-quality and affordable healthcare, one of the principles of the European Pillar of Social Rights, said Mr Andriukaitis.

The Commissioner also recalled in his answer several other instruments available to support the quality of healthcare, among which is the priority of knowledge-building. Member States also agreed a set of indicators that are now part of the Joint Assessment Framework (JAF) for Health, covering four dimensions: health outcomes, access, quality and non-health determinants. “The reading of these indicators is meant to provide a first-step quantitative screening to detect possible major challenges in each Member State’s health systems in the context of the Social Open Method of Coordination. Complementarily, the ‘State of Health in the EU’ cycle produced country profiles for all Member States in 2017”, said the Commissioner in his reply.
The Organisation for Economic Co-operation and Development (OECD) Patient-Reported Indicators Survey is also funded by the European Commission, and presents data useful to fill the knowledge gap on the quality of healthcare from the patients’ perspective. Finally, Mr Andriukaitis remembered the Commission’s Structural Reform Support Service, that can be activated on demand to provide technical support in order to raise the quality of healthcare.

The sustainability of health systems

A deep analysis and some examples of the sustainability of health systems has been been published by the Environment, Public health and Food safety (ENVI) Committee of the European Parliament, based upon the outcomes of a workshop held in May 2018 and intended to share the views of the Committee with those of representatives from the academia, international and national health organisations.

Among the main challenges to the sustainability of health systems, according to Dr Clare Bambra (Newcastle University), are the pervasiveness of inequalities in health and ageing. Death rate and life expectancy, for example, varies significantly between countries of East and West of Europe, or of the North and South of the continent. Not only: differences are also identifiable between neighbouring areas in the same city, e.g. Berlin, London and Paris, said the expert. Unemployment, healthcare services and housing, education, work, environment and health behavioural factors, such as smoking or drinking alcohol, are among the main factors determining the observed differences, together with politics and public policy.
According to Prof. Bambra, health inequalities have an estimated cost for the EU of € 980 billion per year, which is the equivalent of 9.4% of GDP. Health policies are also an important tool that may help influencing and reverting these inequalities; the European Social Charter, for example, can support issues related to the aging of the population. Reduction of the inequalities, said Mrs Bambra, requires policy cohesion across different sectors.

The access to new medical technologies is challenged by the the principle of universal healthcare, faced by the growing public spending and the consideration of the socio-economic costs of limiting access to health, said the co-chair of the workshop, MEP Mrs Cabezón Ruiz, being also the Rapporteur of the EP Report on EU options for improving access to medicines in the EU.
She said health expenditure represents the 15% of total public expenditure in OECD countries, with an increase of more than 70% since 1990. Projections show health expenditure might reach 9% of GDP by 2030 and 14% by 2060, compared to the 6% of 2014. This trend is supported by the ageing of the European population and the need of long-term care for chronic diseases, coupled to the raising costs of innovation and the high prices of pharmaceutical products. Only 3% of current health expenditure is currently being invested in health prevention and promotion in Europe, said Mrs Cabezón Ruiz. On the other hand, around 17% of health expenditure (approx. 1.41% of GDP) is due to pharmaceuticals, with expectations of growth by up to 7% in the next five years. The absence of new antibiotics is among the more urgent needs to be addressed.
The fundamental question, said Mrs Cabezón Ruiz, should be not why we need to reform health systems, but why we need to maintain the health systems of European member states. Quality and efficiency are characteristics typical of European healthcare systems, said the co-chair, and a return of about € 4.30 is estimated for each euro invested in health. Universality, equity and quality are also principles to be safeguarded, avoiding focusing the political debate only on controlling health expenditures. Education and socio-economic status also contribute to the observed health outcomes.
Access to medicines is another point of concern to be addressed. Mrs Cabezón Ruiz closed her presentation by illustrating several measures useful to support sustainability of health systems, as fiscal and budgetary-control measures at a national level, and reforms modelled on the example of Japan, that for example invested on primary care and prevention. Unmet needs remain also a central point of attention. Clinical trials, health prevention and promotion, intellectual property policy, research and innovation, and the concept of one-health are other important areas of intervention at the European level, according to the MEP.

Professor Barbara Prainsack (Univeristy of Vienna and King’s College, London) commented the theme of precision medicine as a possible tool to support sustainability of healthcare, instead of being looked as a cost driving and technology driven practice that would increase health inequalities. A change of paradigm that would require to rethink the very term of personalization and precision medicine, said the expert. Precision medicine today represent something that “encompass the collection and use of and all the individual patient information (e.g. genome, microbiome, and information related to lifestyles) and integrate them to create a map that gives the possibility of predicting when people will have a health problem”, is the new definition proposed by Prof. Prainsack. A definition that brings as a consequence towards a more holistic approach to the patient, based not only on the specific organ affected by the diseases: a shift would be need from symptomatic and ‘episodic’ medicine to continuous and pre-symptomatic medicine, said the expert.
A better data governance, and an increased attention to certain population groups and individuals, would be further outcomes of precision medicine, according to Mrs Prainsack. But a stronger framework for data protection and access would also be needed. Health in all policies is another measure strongly suggested by the expert, together with reducing harm and waste, for example through promoting low-cost interventions such as the ‘preventing over-diagnoses’ movement, or the realistic medicine initiative. Systematic exploration of low-tech and high-touch practices and their effects has been also suggested by Prof. Prainsack.

A direct comparison of the yet proposed Japanese model has been made by Dr Akiko Maeda, senior health economist at the Organisation of Economic Co-operation and Development (OECD). Life expectancy reached 83,9 years in Japan in 2015, paralleled by a very low incidence of obesity (3,7% vs 19.7% average OECD value) and a low ischemic mortality rate (34.1 for 100,000 people in 2015). On the other hand, dementia is raising in Japan (2,3% in 2017) due to the ageing of population. ‘Big items’ affecting the Japanese situation are, according to Mrs Maeda, the high per capita spending on health, high capital investment in the health sector, and a lack of efficiency in the use of hospitals. Japan is funding its healthcare expenditure through debt, thus greatly contributing the first global position of the country as for total debt (over 200% od GDP).
The new Vision 2035 indicates as priorities the tackling of fiscal deficits and ensuring economic stability. Healthy longevity is a field Japan wishes to act in as an authority at the global level. A complete new vision of the urban infrastructure is also envisaged, allowing for multi-generational living, a better social connectivity and improved coordination of medical care services, social services and long-term care. Healthcare, long term care and social services, housing and preventative care, and design of a system to promote wellbeing are the five step the Japanese government is planning in this direction, said Dr Maeda. An horizontal model for the healthcare system is the final goal, with engagement of all sectors through a shared vision and values. Investments in traditional high-knowledge fields of excellence of the Japanese industry is also being pursued, including stem cell research, cancer research, internet of things and robotics, this last one requiring also a deeper debate to solve ethical issues.

The final objective of a person-led heal-deal health support system that complements the professional-led cure-care system has been at the center of the intervention made by Dr Thomas Plochg, director of the Netherlands Public Health Federation. The Netherlands too are experiencing a transformative phase of their healthcare system. According to Dr Plochg, the current Dutch system is very successful at treating acute, single diseases, but it results unsustainable by design due to the high number of specialists and 70% of staff costs to treat a single patient. And all this different expertise are not of help to reach a coherent diagnosis and treatment, he added.
The values of the Dutch population and a more pro-active approach based on prevention is the picture envisaged by Thomas Plochg for the future of the Dutch healthcare system, based on a ‘zoom out’ vision in order to have a more holistic, integrative view of health. The idea of positive health might be part of this switching of perspective from the ‘care and cure’ to ‘the ability to adapt and self-manage in the face of social, physical and emotional challenges’. Health, and not diseases, should be the core interest of healthcare business models, added the Dutch expert, in a sort of business-to-consumer health relationship (e.g on the model of Spotify services). An approach that is not free from very dangerous aspects, especially for personal data protection.

The last intervention to the debate contributed the example of the Andalusian healthcare system. Dr Natividad Cuende, executive director of the Andalusian Initiative for Advanced Therapies, said the pharmaceutical and biotechnological sector should not be defended at the expense of health system sustainability. A balance between both interests must be found, she added, which protects health systems from the costs arising from monopolies on certain innovative drugs.
Dr Cuende illustrated the example of Andalusia healthcare system, that is the only one in Europe acting as ATMP manufacturer, clinical trial sponsor, healthcare provider and funding entity. According to the Spanish representative, the very high prices of advanced therapies – reaching a mean value of € 500,000 per treatment – are due to the complexity of the legislation governing this class of medicinal products. Member States may exert a hospital exemption clause to regulate non-industrially manufactured ATMPs. Public health systems, is the opinion of the expert, have already experience of several procedures used for cell and tissue donation and transplantation, and which are also used for ATMP manufacturing.

Dr Cuende also remembered that Spain is the leader in Europe of clinical trials in ATMP.
Andalusia is among the European regions with the lowest GDP per inhabitant and with the lowest number of hospital beds, but with a very high life expectancy. Andalusia spent a higher than average percentage of GDP on healthcare compared to other Spanish regions, but with the lowest healthcare expenditure per capita, she added. The rational use of medicines is promoted through the appropriate medicine prescription and competitiveness among pharmaceutical companies. This second objective is achieved through prescribing by active substance (rather than brand), the use of more efficient therapeutic alternatives, and public bids for the selection of the brand of medicines that pharmacists will use when dispensing by active substance. According to Dr Cuende, these measures allowed for 93.4% of medicines being prescribed by active substance in 2017, and to the lower hospital pharmaceutical spending in Spain.

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