Factors affecting citizen trust and public engagement and use of real-world evidence in health care

Welcome, health colleagues, to the European Alliance for Personalised Medicine (EAPM) update – this week, we are firstly detailing a major work that EAPM members conducted relating to citizens’ trust and public engagement in the health-care arena, writes EAPM Executive Director Dr. Denis Horgan.

Factors affecting citizen trust and public engagement and use of real-world evidence in health care

This relates to our latest academic publication where we have tackled this topic.  It is the result of series multistakeholder expert panels where EAPM discussed a number of challenges facing the implementation of RWE across Europe, including methodological and data-quality issues, lack of harmonization between RWE data collection systems, data-access and data-sharing limitations, limitations of regulatory agencies or HTAs/payers, and lack of citizen trust in data sharing.

Our recommendations to address these challenges should aid the routine European- wide implementation of RWE into health systems and health policy decision-making, and help physicians to realize the potential opportunities concerning the use of RWE in areas such as rare diseases and oncology. In addition, the EU 1+ Million Genomes/MEGA Initiative could offer a useful model for advances toward healthcare system cooperation.

The necessary changes recommended in this article will not occur of their own volition; it will require strategic reflection and deliberate action to form the relevant connec- tions. Focused efforts in EU policy making by those who recognize the need for change are a precondition to persuade those who have not identified the same requirements, particularly when they are gatekeepers within the health policy framework.

To access the academic publication, please click here.   

Cancer

Health and Food Safety Commissioner Stella Kyriakides, said: "When we launched the 'Europe against Cancer' Plan a year ago, we committed to devote significant resources to addressing the worrying inequalities that people face in terms of access to prevention, treatment and care across the EU. In 2020 alone, over 550,000 women died from cancer and over 1.2 million women were diagnosed with the disease in the EU. 

Flurry of action on EU Cancer Plan: The Commission is launching four new actions under the EU Cancer Plan. The Cancer Inequality Registry will quantify divergences in care and help guide EU interventions. The “Cancer screening call for evidence” updates Council Recommendations on screening dating back to 2003. Today (2 February) will also see the launch of the HPV action on vaccination, which aims to offer 90 percent of girls in the EU a vaccine against the cancer-causing human papillomavirus by 2030. The final action is the launch of the EU Network of Youth Cancer Survivors. In terms of screening, this is a key issue that EAPM has been engaging on for the last five years related to lung cancer and prostate cancer. 

EU clinical trials get long-awaited boost with single-application launch

It’s all systems go: EU’s Clinical Trials Regulation (Regulation (EU) No 536/2014) launched on Monday (31 January). Its underlying clinical portal and database – Clinical Trials Information System (CTIS) – went live on the same day. Both are envisioned to streamline clinical trial application, review, and supervision, and bolster transparency. 

With CTIS, clinical trial sponsors can submit all regulatory and ethics assessments under a single application instead of applying to each EU member state individually. Industry and academic sponsors will have a one-year grace period before they must submit all new clinical trial applications through this system. 

Initially intended to launch in May 2016, the European Medicines Agency is glad to finally get this up and running. “It’s truly a collective achievement,” Emer Cooke, head of the EMA, told a press briefing this week.

In the meantime, the global landscape for clinical trials has changed. China now takes a significant share of studies — a position it didn’t hold when the European Commission carried out its impact assessment on the proposed EU changes in 2010, Andrzej Rys, director for health systems at products at DG SANTE, told the briefing.“So, in 11 years … the global picture of conducting clinical trials is also changing,” he said. With global study numbers increasing every year, keeping numbers in Europe stable would in effect mean taking an increasingly smaller share globally.

“But we still believe these initiatives will … open the door also for more clinical trials in Europe,” Rys said.

Cross-border health threats 

On 11 November 2020, the European Commission adopted a proposal for a regulation on serious cross-border threats to health, repealing Decision No 1082/2013/EU (the 'Cross-border Health Threats Decision'). 

The initiative is among the first steps towards building the European health union announced by President Ursula von der Leyen in her State of the Union address. The proposals put forward aim to strengthen the EU's health security framework, and to reinforce the crisis preparedness and response role of key EU agencies. As the Commission points out, the coronavirus pandemic has demonstrated that the EU needs to improve preparedness and response to manage serious cross-border health threats more effectively at both EU and Member State level. 

According to the Commission, the upgraded EU framework for cross border health threats would: strengthen preparedness and response planning. An EU health crisis and pandemic preparedness plan and recommendations for the plans at national levels would be developed, coupled with comprehensive and transparent frameworks for reporting and auditing. The preparation of national plans would be supported by the European Centre for Disease Prevention and Control (ECDC) and other EU agencies. The plans would be audited and stress tested by the Commission and EU agencies. 

Africa-Europe Alliance 

Expectations are high for the EU-Africa summit on 17-18 February. French president Emmanuel Macron is leading efforts to revitalise the EU's "tired" relationship with African states and - so far - hard-to-get African leaders seem ready to play ball.

A sombre past and persistent present-day irritants weigh heavy on relations between the two continents of Europe and Africa A sombre past and persistent present-day irritants weigh heavy on relations between the two continents, however. 

With France in the EU presidency over the next six months, Macron will seek to thrash out an economic and financial "New Deal with Africa". Vying for the spotlight in Brussels is EU Council president Charles Michel who has waxed lyrical about establishing a New Africa-Europe Alliance which is "freed from the demons of the past". Meanwhile, the European Commission has its own army of senior officials tasked with promoting a "comprehensive strategy" for Africa. 

And that is everything from EAPM for today – stay safe and well, enjoy the rest of the week.

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