Update from the EAU Policy Office Advocacy Success Story: Prostate Cancer in the EU's Beating Cancer Plan Mrs. Sarah Collen EAU Policy Coordinator Brussels (BE)
The report is from SAPEA, which is part of the European Commission’s Scientific Advice Mechanism.
s.collen@uroweb.org
The Scientific Opinion of the Group of Chief Scientific Advisors can be found at:
Since 2016 the EAU has been leading an advocacy campaign on early detection of Prostate Cancer, which has involved members of various scientific panels and committees in meetings and publications. Importantly, it has also involved national urological societies engaging with their national departments of health. One specific aim is that the European Commission should support EU governments with guidelines on risk stratified early detection of Prostate Cancer. This campaign was given a clear focus when the European Commission announced its Europe's Beating Cancer Plan, and as part of this, an update of the EU Recommendations on Cancer Screening. The update of the Recommendations included Prostate Cancer in the potential new cancers to benefit from EU-wide guidance, thanks to our joint advocacy. We are now closer to achieving this vision of EU-wide guidance as the EU’s scientific experts have also supported the EAU vision, and have called for the addition of “life-saving” prostate cancer early detection programmes. On 2 March, 2022 the Chief Scientific Advisors to the European Commission published a scientific opinion which is in favour of the development of EU-wide guidelines on risk stratified prostate specific antigen (PSA)-based prostate cancer screening, in combination with additional MRI scanning as a follow-up test.
European Urology Today Editor-in-Chief Prof. J.O.R. Sønksen, Herlev (DK) Section Editors Prof. T.E. Bjerklund Johansen, Oslo (NO) Prof. O. Hakenberg, Rostock (DE) Dr. D. Karsza, Budapest (HU) Prof. P. Meria, Paris (FR) Dr. G. Ploussard, Toulouse (FR) Prof. J. Rassweiler, Heilbronn (DE) Prof. O. Reich, Munich (DE) Assoc. Prof. F. Sanguedolce, Barcelona (ES) Prof. S. Tekgül, Ankara (TR) Special Guest Editor Mr. J. Catto, Sheffield (GB) Founding Editor Prof. F. Debruyne, Nijmegen (NL) Editorial Team E. De Groot-Rivera, Arnhem (NL) L. Keizer, Arnhem (NL) H. Lurvink, Arnhem (NL) J. Seesing, Arnhem (NL) EUT Editorial Office PO Box 30016 6803 AA Arnhem The Netherlands T +31 (0)26 389 0680 F +31 (0)26 389 0674 EUT@uroweb.org
The Chief Advisors followed the advise of a network of scientific experts. The experts issued a report concluding that there is a “strong scientific basis for introducing life-saving screening programmes in EU member states for both lung cancer and prostate cancer.”
European Parliament support early detection of Prostate Cancer Not only scientific advisors are calling for more efforts to beat prostate cancer, but thanks to our advocacy campaign, EU politicians are also calling for it. After a targeted campaign with Europa Uomo and researchers from the European Randomized Study of Screening for Prostate Cancer, we were able to secure changes to the European Parliament’s report on the EU’s Beating Cancer Plan. The Parliamentary report was voted on 16 February 2022, and included a call prostate cancer screening to be considered in the update of the Council recommendation in 2022. This recommendation is due to be published by the European Commission in the third quarter of 2022. Euro-MPs also called “for clear and tangible targets to be set for any new cancers that need to be tackled” which will help us in the implementation phase to ensure that any changes are time sensitive and measurable.
“The experts concluded that there is good scientific evidence for the benefit of risk stratified, organised, population-based PSAbased prostate cancer screening, particularly in combination with additional tests such as MRI scanning as a follow-up test.”
The EU takes steps to promote the use of Big Data and Real World Evidence in health At the EAU we have been at the forefront of a dynamic shift in use of evidence to include Real World Evidence (RWE) and Big Data to answer our urgent research questions where there is currently an unmet need. With our EU Innovative Medicines Initiative funded projects, PIONEER and now The experts highlighted that further research and ongoing monitoring are needed to identify the groups OPTIMA, we have been able to explore the that will most benefit from screening – particularly on possibilities offered by Big Data for prostate cancer, the ideal age range, and to ensure that an appropriate and we hope to extend that to other fields of urology in the future. balance of benefits and harms is maintained. The harms of ad hoc, opportunistic PSA testing for men were also noted in the report, and as something to be discouraged in order to reduce the risk of overdiagnosis and overtreatment, especially in older men. In response to the publication of the report, the Chair of the EAU Policy Office, Prof. Hendrik Van Poppel states: “We welcome the conclusions of the scientific experts, and we believe that if the European Commission and EU Member States act on this scientific advice, then it will help turn the tide on increasing mortality and ‘too late’ diagnosis of Prostate Cancer across the EU.”
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European Urology Today
https://ec.europa.eu/info/sites/default/files/ research_and_innovation/groups/sam/ec_rtd_samcancer-screening-opinion.pdf (PDF)
It was found that there is good scientific evidence for the benefit of risk stratified, organised, populationbased PSA-based prostate cancer screening, particularly in combination with additional tests such as MRI scanning as a follow-up test. The use of active surveillance was noted as a helpful strategy for combating overtreatment.
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Together with the Group of Chief Scientific Advisors, they provide independent scientific advice to European Commissioners to support their decisionmaking. The full report can be downloaded at: www.sapea.info/topic/cancer-screening/
The European Union too is embracing these new tools for the benefit of health. The much anticipated legislation on the European Health Data Space (EHDS) is due to be published by the European Commission in April. The publication of this legislation will give much clarity on sharing of health data for medical use (primary purposes) while living abroad or travelling in other EU member states, and for research, policy making and regulatory purposes (secondary use). The European Medicines Agency (EMA), the EU’s joint regulator for medicines, has already initiated a pilot project of the EHDS, called DARWIN – Data Analysis and Real World Interrogation Network. In February it established the coordination centre of this network to develop and manage a network of real world data sources across the EU. In February too, Prof. James N’Dow from the EAU Executive Committee met with the EMA Big Data Taskforce to explain the work of the EAU on OPTIMA and PIONEER. Colleagues will also participate in upcoming workshops with stakeholders on issues such as Data Quality. The EAU also significantly contributed to the BioMed Alliance statement in December 2021 on the EHDS. The BioMed Alliance Task Force on Health Data Sharing proposed a set of recommendations for the governance, implementation and incentivisation of adoption of the EHDS. The statement particularly highlights the need to involve a broad range of
stakeholders and to align different legislative approaches with a clear and enabling EU legal framework. Read the full statement here. Biomed_ Alliance_EHDS_Statement.pdf (biomedeurope.org) The EAU is at the forefront of programmes and policies on use of health data to answer our unmet research needs to better the lives of our patients. The war in Ukraine and access to health care The war in Ukraine has caused much devastation in many cities across the country. War is devastating for health, and has led to many refugees leaving their homes and finding refuge in other European countries. The EAU has issued its own updated statement (https://uroweb.org/news/updated-statement-onthe-war-in-ukraine), and we have received many moving messages from Ukrainian colleagues, including a video message (https://youtu.be/ wM__3Im_DQo) from Prof. V. M. Lisovyi, the President of the Ukrainian Urological Association. One of our European network associations, the European Cancer Organisation, has established the ECO-ASCO Special Network on the Impact of the War in Ukraine on Cancer www.europeancancer.org and the EAU has joined this important network to represent the challenges and needs faced by the onco-urology healthcare professionals and patients. We have also connected this network to our national societies and patient organisations who are at the forefront of this response. On Wednesday, 23 March senior representatives of the WHO and EU Commission met with executive members of the associations involved, including Prof. Arnulf Stenzl who represented the urological community. The purpose of the meeting is to share the latest information from the WHO and EU, to exchange on the current challenges facing cancer centres, hospital networks and hospitals in the Ukraine and neighbouring countries, and the capacity to support Ukrainian cancer patient refugees in other countries. If you are working in a cancer centre that is delivering care to Ukrainian refugees, we would be happy to connect your centre to this network to facilitate good co-ordination between all of the relevant organisations and to help ensure that you are in the best place to receive any additional support your centre may need. The following website www.onco-help.org already contains many related resources and signposts to initiatives which are ongoing. If you have any web-based resources you think could be relevant, please do let s.collen@uroweb.org know.
Europe's Beating Cancer Plan Communication from the commission to the European Parliament and the Council
March/May 2022
