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Good morning, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – in the weeks, months and years ahead, EAPM will be placing a lot of focus on the issues arising from the EU Health Data Space legislative proposal, which was launched in the past few days, until the end of this legislative mandate, пише извршни директор ЕАПМ-а др Денис Хорган.

The European Health Data Space proposal has finally landed. While the text outlining the plan has been significantly developed since it was first leaked in March, the proposal itself is broadly the same. Under the plan, the Commission wants to take a “quantum leap forward” in the way health care is provided to Europeans.

As discussed in various EAPM multistakeholder expert meetings as well as with the European Parliament, data can be the interface between an individual patient and a professionalised and regulated system, and is pre-eminently a nexus between private and public interests. 

And as a major area of continual research and technological development, it produces a constant stream of innovations – and consequently becomes a classic battleground on which conflicting views on the merits of innovation are played out. 

The specific field of medical innovation linked to data offers a rich display of such conflicts – with controversies over high-profile issues such as the direction of research and how to incentivise it, the morality of medicine pricing systems and practices, the ever-multiplying options for gathering and exploiting health-related data, or the adequacy of regulatory controls.  

In the proposal, the Commission wants to develop a single market for digital health services and products. Practically, that means expanding MyHealth@EU so that all EU countries can share e-prescriptions and patient summaries as well as other forms of health data such as lab reports.   It also means that there will be a new decentralized EU infrastructure called HealthData@EU that will enable the cross-border sharing of health data for research, regulation and policymaking.

Individual Agency

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The engagement of the individual too is a point of potential dissension, since for innovations to take effect, they must be accepted. 

As such, the system may be in place, and society may encourage the citizen to take advantage of an opportunity, but at the end of the day, the citizen must take the responsibility. The controversy sweeping across Europe about rights and duties in respect of vaccination offers a compelling example: many parents, unconvinced of the merits of vaccination for their child, are withholding permission for the conduct of immunisation procedures. Here the contrast between private and public interests is also clear, as an individual's insistence on refusing vaccination clashes with the public benefit of herd protection that vaccination affords.

Significant shake-up

The European Health Data Space proposal sets out the Commission’s vision for how the bloc’s health data should be managed, shared and used. The proposal paves the way for a significant shake-up in an area where progress across the EU isn’t consistent. In some countries paper is still king, while in others, accessing electronic prescriptions has been the norm for years. 

Those who value innovation as a potential benefactor of society – or who value it in more personal terms as an expression of human assiduity and imagination – naturally seek maximum liberty to pursue it. Those who are cautious about it because of the possible perils or practical problems it may engender naturally seek to monitor its progress and assert controls and impose constraints. 

МЕЂУТИМ between these two tendencies, it is necessary to strike a balance in the policy world that will allow innovation to take place while providing appropriate reassurances to sceptics. 

That can be done optimally only if the inevitable debates are informed by quality of reflection and soundness of evidence – on both sides. If either side feels it can arrogate on the basis of some presumed authority without taking due account of the issues or in disregard of other points of view, the outcome will be severely sub-optimal.

So in discussions of innovation relating to health data, meticulous navigation is needed to chart the best path through a multitude of variables so as to ensure public trust and to keep the personalised in personalised healthcare as EAPM has advocated. 

And amid all the consequent discussion of the technology and its implications, the central element should be – in line with the logic of the subject – the person. More than just a patient, more than a member of a category or of a stratified group. The person, the citizen, who merits attention as such and it is their health data. 

A potential patient, of course, as we all are fated to be at some stage or another. And to that extent, therefore, the person, the citizen, in general – that is to say, all persons, all citizens. For irrespective of any other definition or criterion or quality or characteristic, that is what we all are. A person, people. No amount of subsequent categorisation changes that: in the same way that you cannot salt salt to make it saltier, no additional epithets make a person anything other than what he or she fundamentally is – a person. And that is what the discussions should revolve around and which EAPM will put a focus on in the EU Health Data Space.

Patients, Citizens, Public trust

More involvement of the patient, the person, the citizen, also permits a new dimension to assessment of therapies.  

The individual receiving treatment is best positioned to know if a certain treatment is working or not.  The person understands his or her body, so can work with health care professionals to devise adaptations to treatment cycles. The growing range of apps will also make it easier for the individual to understand at an earlier stage if a treatment is needed or not, which will also boost the chances for cost savings on unnecessary treatments – and will also provide a psychological boost for the individual, a reassurance that he or she retains some control of their own lives.

Образовање plays an important role here as well as the governance structures. This will save time in dealing with concerns on many of the issues that occur now with low participation in clinical trials, concerns regarding consent, sharing of tissue samples for further research, screening and so on.The plans for a health data space will also give birth to a new kind of data watchdog — so-called health data access bodies. These authorities will become key players in making sure that health data are up for reuse in research and policy.

Some countries have already set up something that resembles such a health data access authority, the Commission said in its Q&A-sheet — referring to Finnish Findata, the French Health Data Hub and the German Forshungsdatenzentrum. Some of these authorities were included in a consortium that launched a bid in early March to build a test version of the health data space for data reuse for research and policy.

For EAPM, the central issues in the weeks, months and years ahead will of course be about public trust and keeping the citizen/patient in the centre of proceedings – and naturally, EAPM will be placing a lot of focus on the health data space until the end of this legislative mandate.

The issue therefore becomes how best to enable and empower the person, the citizen with respect to their data, so that the individual's identity and role are at the centre of care. 

This is where personalised care and precision medicine find their place in these debates.

The advances in medical innovation and ICT tools can then enable the person to have a constructive interaction with the healthcare system – on condition that the healthcare system is adjusted accordingly. 

And on to non data related subjects..

Inequality in treatment

In comments reminiscent of mid-2021 when the global response to coronavirus was characterized by stark vaccine inequity, World Health Organization chief Tedros Adhanom Ghebreyesus spoke on Wednesday (4 May) of people in poorer countries being unable to access lifesaving COVID-19 tools. Except this time, instead of vaccines being out of reach, it is treatments. 

“Low availability and high prices” have led some countries to rule out buying highly effective antivirals, said Tedros. “It is simply not acceptable that in the worst pandemic in a century, innovative treatments that can save lives are not reaching those that need them.” 

WHO prepares for next pandemic

Pandemics and large-scale outbreaks can claim millions of lives, disrupt societies and devastate economies. WHO’s Health Emergencies Programme (WHE) is working with member states to help countries to prepare for large-scale outbreaks and pandemics. Through the Asia Pacific Strategy for Emerging Diseases and Public Health Emergencies (APSED III), core capacities required by the International Health Regulations (2005), or IHR, are being advanced, providing an important foundation for pandemic preparedness. 

This is complemented by efforts to strengthen disease-specific systems and capacities, including for vaccines, pharmaceuticals and other public health interventions. Countries are also encouraged to engage the whole of society for effective pandemic preparedness and response. As the next pandemic is most likely to be caused by influenza, the disease continues to be the priority public health threat in the Region. 

Obesity - Europe’s other health crisis

The new WHO European Regional Obesity Report 2022, published on 3 May by the WHO Regional Office for Europe, reveals that overweight and obesity rates have reached epidemic proportions across the region and are still escalating, with none of the 53 Member States of the Region currently on track to meet the WHO Global Noncommunicable Disease (NCD) target of halting the rise of obesity by 2025. The report reveals that in the European Region, 59% of adults and almost 1 in 3 children (29% of boys and 27% of girls) are overweight or living with obesity. Obesity prevalence for adults in the European Region is higher than in any other WHO region except for the Americas. 

Overweight and obesity are among the leading causes of death and disability in the European Region, with recent estimates suggesting they cause more than 1.2 million deaths annually, corresponding to more than 13% of total mortality in the Region. 

Obesity increases the risk for many NCDs, including cancers, cardiovascular diseases, type 2 diabetes mellitus and chronic respiratory diseases. For example, obesity is considered a cause of at least 13 different types of cancer, and is likely to be directly responsible for at least 200,000 new cancer cases annually across the Region, with this figure set to rise further in the coming years. Overweight and obesity are also the leading risk factor for disability, causing 7% of total years lived with disability in the Region. Overweight people and those living with obesity have been disproportionately affected by the consequences of the COVID-19 pandemic. 

And that is everything from EAPM for now . Stay safe and well, and enjoy your weekend when it arrives...

коначно стиже

The European Health Data Space proposal has finally landed. While the text outlining the plan has been significantly developed since it was first leaked in March, the proposal itself is broadly the same. Under the plan, the Commission wants to take a “quantum leap forward” in the way health care is provided to Europeans.

As discussed in various EAPM multistakeholder expert meetings as well as with the European Parliament, data can be the interface between an individual patient and a professionalised and regulated system, and is pre-eminently a nexus between private and public interests. 

And as a major area of continual research and technological development, it produces a constant stream of innovations – and consequently becomes a classic battleground on which conflicting views on the merits of innovation are played out. 

The specific field of medical innovation linked to data offers a rich display of such conflicts – with controversies over high-profile issues such as the direction of research and how to incentivise it, the morality of medicine pricing systems and practices, the ever-multiplying options for gathering and exploiting health-related data, or the adequacy of regulatory controls.  

In the proposal, the Commission wants to develop a single market for digital health services and products. Practically, that means expanding MyHealth@EU so that all EU countries can share e-prescriptions and patient summaries as well as other forms of health data such as lab reports.   It also means that there will be a new decentralized EU infrastructure called HealthData@EU that will enable the cross-border sharing of health data for research, regulation and policymaking.

Individual Agency

The engagement of the individual too is a point of potential dissension, since for innovations to take effect, they must be accepted. 

As such, the system may be in place, and society may encourage the citizen to take advantage of an opportunity, but at the end of the day, the citizen must take the responsibility. The controversy sweeping across Europe about rights and duties in respect of vaccination offers a compelling example: many parents, unconvinced of the merits of vaccination for their child, are withholding permission for the conduct of immunisation procedures. Here the contrast between private and public interests is also clear, as an individual's insistence on refusing vaccination clashes with the public benefit of herd protection that vaccination affords.

Significant shake-up

The European Health Data Space proposal sets out the Commission’s vision for how the bloc’s health data should be managed, shared and used. The proposal paves the way for a significant shake-up in an area where progress across the EU isn’t consistent. In some countries paper is still king, while in others, accessing electronic prescriptions has been the norm for years. 

Those who value innovation as a potential benefactor of society – or who value it in more personal terms as an expression of human assiduity and imagination – naturally seek maximum liberty to pursue it. Those who are cautious about it because of the possible perils or practical problems it may engender naturally seek to monitor its progress and assert controls and impose constraints. 

МЕЂУТИМ between these two tendencies, it is necessary to strike a balance in the policy world that will allow innovation to take place while providing appropriate reassurances to sceptics. 

That can be done optimally only if the inevitable debates are informed by quality of reflection and soundness of evidence – on both sides. If either side feels it can arrogate on the basis of some presumed authority without taking due account of the issues or in disregard of other points of view, the outcome will be severely sub-optimal.

So in discussions of innovation relating to health data, meticulous navigation is needed to chart the best path through a multitude of variables so as to ensure public trust and to keep the personalised in personalised healthcare as EAPM has advocated. 

And amid all the consequent discussion of the technology and its implications, the central element should be – in line with the logic of the subject – the person. More than just a patient, more than a member of a category or of a stratified group. The person, the citizen, who merits attention as such and it is their health data. 

A potential patient, of course, as we all are fated to be at some stage or another. And to that extent, therefore, the person, the citizen, in general – that is to say, all persons, all citizens. For irrespective of any other definition or criterion or quality or characteristic, that is what we all are. A person, people. No amount of subsequent categorisation changes that: in the same way that you cannot salt salt to make it saltier, no additional epithets make a person anything other than what he or she fundamentally is – a person. And that is what the discussions should revolve around and which EAPM will put a focus on in the EU Health Data Space.

Patients, Citizens, Public trust

More involvement of the patient, the person, the citizen, also permits a new dimension to assessment of therapies.  

The individual receiving treatment is best positioned to know if a certain treatment is working or not.  The person understands his or her body, so can work with health care professionals to devise adaptations to treatment cycles. The growing range of apps will also make it easier for the individual to understand at an earlier stage if a treatment is needed or not, which will also boost the chances for cost savings on unnecessary treatments – and will also provide a psychological boost for the individual, a reassurance that he or she retains some control of their own lives.

Образовање plays an important role here as well as the governance structures. This will save time in dealing with concerns on many of the issues that occur now with low participation in clinical trials, concerns regarding consent, sharing of tissue samples for further research, screening and so on.The plans for a health data space will also give birth to a new kind of data watchdog — so-called health data access bodies. These authorities will become key players in making sure that health data are up for reuse in research and policy.

Some countries have already set up something that resembles such a health data access authority, the Commission said in its Q&A-sheet — referring to Finnish Findata, the French Health Data Hub and the German Forshungsdatenzentrum. Some of these authorities were included in a consortium that launched a bid in early March to build a test version of the health data space for data reuse for research and policy.

For EAPM, the central issues in the weeks, months and years ahead will of course be about public trust and keeping the citizen/patient in the centre of proceedings – and naturally, EAPM will be placing a lot of focus on the health data space until the end of this legislative mandate.

The issue therefore becomes how best to enable and empower the person, the citizen with respect to their data, so that the individual's identity and role are at the centre of care. 

This is where personalised care and precision medicine find their place in these debates.

The advances in medical innovation and ICT tools can then enable the person to have a constructive interaction with the healthcare system – on condition that the healthcare system is adjusted accordingly. 

And on to non data related subjects..

Inequality in treatment

In comments reminiscent of mid-2021 when the global response to coronavirus was characterized by stark vaccine inequity, World Health Organization chief Tedros Adhanom Ghebreyesus spoke on Wednesday (4 May) of people in poorer countries being unable to access lifesaving COVID-19 tools. Except this time, instead of vaccines being out of reach, it is treatments. 

“Low availability and high prices” have led some countries to rule out buying highly effective antivirals, said Tedros. “It is simply not acceptable that in the worst pandemic in a century, innovative treatments that can save lives are not reaching those that need them.” 

WHO prepares for next pandemic

Pandemics and large-scale outbreaks can claim millions of lives, disrupt societies and devastate economies. WHO’s Health Emergencies Programme (WHE) is working with member states to help countries to prepare for large-scale outbreaks and pandemics. Through the Asia Pacific Strategy for Emerging Diseases and Public Health Emergencies (APSED III), core capacities required by the International Health Regulations (2005), or IHR, are being advanced, providing an important foundation for pandemic preparedness. 

This is complemented by efforts to strengthen disease-specific systems and capacities, including for vaccines, pharmaceuticals and other public health interventions. Countries are also encouraged to engage the whole of society for effective pandemic preparedness and response. As the next pandemic is most likely to be caused by influenza, the disease continues to be the priority public health threat in the Region. 

Obesity - Europe’s other health crisis

The new WHO European Regional Obesity Report 2022, published on 3 May by the WHO Regional Office for Europe, reveals that overweight and obesity rates have reached epidemic proportions across the region and are still escalating, with none of the 53 Member States of the Region currently on track to meet the WHO Global Noncommunicable Disease (NCD) target of halting the rise of obesity by 2025. The report reveals that in the European Region, 59% of adults and almost 1 in 3 children (29% of boys and 27% of girls) are overweight or living with obesity. Obesity prevalence for adults in the European Region is higher than in any other WHO region except for the Americas. 

Overweight and obesity are among the leading causes of death and disability in the European Region, with recent estimates suggesting they cause more than 1.2 million deaths annually, corresponding to more than 13% of total mortality in the Region. 

Obesity increases the risk for many NCDs, including cancers, cardiovascular diseases, type 2 diabetes mellitus and chronic respiratory diseases. For example, obesity is considered a cause of at least 13 different types of cancer, and is likely to be directly responsible for at least 200,000 new cancer cases annually across the Region, with this figure set to rise further in the coming years. Overweight and obesity are also the leading risk factor for disability, causing 7% of total years lived with disability in the Region. Overweight people and those living with obesity have been disproportionately affected by the consequences of the COVID-19 pandemic. 

And that is everything from EAPM for now . Stay safe and well, and enjoy your weekend when it arrives...

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