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Navigating the legislative labyrinth for EU health care 

Greetings colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – we hope you have all enjoyed a good week. There’s news below of a key EAPM event that arrives half-way through November, writes EAPM Executive Director Dr. Denis Horgan.

Taking stock of EU health care

On 15 November, EAPM will be hosting a keynote event, entitled Taking Stock: Navigating the Legislative Labyrinth for EU Healthcare that promotes the European Way of Life, in the European Parliament.

Recent advances in biomedicine are opening the door to new approaches – particularly for diseases such as cancer and rare diseases, where limited or no alternative treatment options exist and unmet need remains high. But despite the unique possibilities of these technologies, there are some outstanding challenges across regulatory, scientific, manufacturing, and market access fields that still hamper the ability to deliver the potential.

The event will focus on two legislative files which includes the EU’s general pharmaceuticals legislation and In Vitro Diagnostic Medical Devices Regulation. Attendees will be drawn from key stakeholders whose interaction will create a cross-sectoral, highly relevant and dynamic discussion forum. These participants will include public health decision makers, representatives from the Commission, Members of the European Parliament, patient organisations, and European umbrella 2 organizations. Registration is now open – click here to book your place.

European Health Data Space

Regarding this dossier, it is no surprise that Europe has decided to take further steps towards a more digitised and connected healthcare system between member states. The European Health Data Space (EHDS) is possibly one of the European Union’s most ambitious projects ever undertaken, and it could be transformative for EU healthcare as we know it.

The project was first presented in March 2022 and it will take a number of years before all of its functionalities are put in place. The road will be long and full of challenges, but it could put the European Union at the forefront of big data and reshape the way patients approach their health

There are many things to be decided yet, but this is what we know already.

The EHDS will be an ecosystem combining rules, standards, practices and infrastructures, under a common governance framework.

It will rely on two different pillars: MyHealth@EU and HealthData@EU. MyHealth@EU is focused on health data exchange between patients and health professionals across member states. The aim is to give European citizens, travelling or living abroad, access to the same healthcare as they would have in their home country. Some of its services are already operational in some places – we will come back to this later – and the rest will be implemented progressively across member states until the end of 2025.

HealthData@EU will be focused on what experts term the secondary use of data. Researchers, policy-makers and companies will be able to use and study patients’ medical records if they receive a permit from a health data access body that will be set up in each.

Global health care plan
The EU plan aims to outline how the region will respond to future pandemics and health threats, and reflect a policy vision that embodies the bloc’s values. In light of the COVID-19 pandemic, EU officials hope to impress upon member states that ensuring more equitable global access to health products worldwide will safeguard global health. “It is clear that no single government or institution can address this threat of future pandemics alone,” said Paul Zubeil, deputy director-general for European and International Health Politics at the German Ministry of Health.

While the draft strategy to be delivered later this year is sure to be ambitious, its  proposals will be at the mercy of the EU’s deliberative processes, and the final plan – expected sometime in the first half of next year – will reflect the views and priorities of its 27 member states. “You will need to be very lucid that what will come out of the global health strategy will also be a composition of geopolitical agendas,” said Sandra Gallina, Director-General of DG SANTE. “My heart is with Africa, but our member states have many different geopolitical priorities.”

Nevertheless, the inclusive approach to consultation undertaken by the EU has raised hopes that the final plan will ensure that the region retains the role it assumed during the pandemic as a global health leader.

“Global leadership by the EU starts at home,” said Perez-Cañado. “The global health strategy must no longer be only about development, but a truly holistic health approach.”

AI and product-liability laws
Katie Hancock of Pinsent Masons said the UK risks being left behind unless reforms are implemented soon, with the European Commission expected to put forward proposals for new EU legislation on AI liability.  Hancock was commenting after a study commissioned by the Office for Product Safety and Standards (OPSS) found that the use of AI in consumer products can “challenge the regulatory framework for both product safety and liability”.  Hancock said: “The publication by the OPSS of this report serves to highlight the fact that legislation is struggling to keep pace with technological development. The General Product Safety Regulations are now 17 years old, and the Product Liability Act is 35 years old. Neither was developed with modern smart or digital products in mind.” 

Czechs’ new text on Commission’s mandate for Council of Europe AI treaty

In revising the mandate for the European Commission to negotiate an international convention on AI, the Czech Presidency of the EU Council raised the question of whether the treaty should cover matters related to national security.

The Council of Europe, a human rights organisation that gathers 46 countries, is currently negotiating a Convention on Artificial Intelligence, human rights, the rule of law and democracy.

Due to the considerable crossover with the EU’s AI Act, the European Commission asked the member states for a mandate to negotiate on behalf of the EU.

Until 15 September, member states could provide written comments based on the European Commission’s recommendation, shared in August. Putting together this commentary and working closely with the Council’s legal service, the Czech Presidency put forth two proposals.

“During the WP TELECOM meeting on 13 October 2022, the Czech Presidency intends to discuss the two options mentioned above, and invites the delegations to indicate their preferred option and any other remaining points to be addressed in the text of the decision and the negotiating directives,” the document reads.

Council adopts three laws to boost EU health emergency response capacities
EU ministers adopted a new EU law which facilitates the timely purchase of and access to medicines, vaccines and raw materials, activates emergency funding and enables the monitoring of production facilities when another health crisis hits.

In case of a health emergency, the Commission will be tasked to draw up a list of crisis-relevant medical countermeasures and raw materials and to monitor their supply and demand. The Commission, who will also receive support from the European Medicines Agency, will set up a system to monitor relevant information concerning the supply and demand of crisis-relevant medical countermeasures and raw materials within and outside the Union.

This exercise will help the EU to better assess the needs for producing and purchasing such countermeasures and raw materials.
Ageing Europe

The share of people aged 55 years or more in the total number of persons employed in the EU-27 increased from 12 % to 20 % between 2004 and 2019.  In 2019, 48 % of all working men aged 65 years or more in the EU-27 were employed on a part-time basis compared with 60 % of women aged 65 years or more.  Agriculture, forestry and fishing was the largest employer of people aged 65 years or more in the EU-27, employing 14.9 % of the workforce for this age group in 2019. 

Usual weekly hours in main job, by sex and age class, EU-27, 2019 (hours) Source: Eurostat (EU labour force survey)  Ageing Europe — looking at the lives of older people in the EU is a Eurostat publication providing a broad range of statistics that describe the everyday lives of the European Union’s (EU) older generations.  Some older people face a balancing act between their work and family commitments, while financial considerations and health status often play a role when older people consider the optimal date for their retirement.  

Many of the EU Member States are increasing their state pension age, with the goal of keeping older people in the workforce for longer and thereby moderating the growth in the overall financial burden of state pensions. The success of such attempts depends, to some degree, on having an appropriate supply of jobs. This may partly help offset the impact of population ageing, while improving the financial well-being of some older people who might not otherwise have an adequate income for their retirement.

Source: Eureporter