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The European Commission frequently invites citizens and stakeholders to express their views on EU actions around new initiatives, evaluations of existing policies, and laws through public consultations.

The results of these consultations feed into the decision-making process, and they can serve as a basis for future policy initiatives.

The input of Rare Cancers Europe (RCE) is therefore important in raising awareness on the particular specificities of rare cancers and the challenges faced by the rare cancers community. RCE therefore responds to consultations on topics that are relevant for rare cancers and our partners.

When creating RCE’s responses to public consultations, the RCE secretariat and leadership engage with the partners of our multi-stakeholder partnership. This means that the final responses bring together the priorities of scientific societies, patient and research organizations, healthcare and education providers, and the industry. Looking at this direction, the RCE Steering Committee is indeed composed of 5 elected members representing their related stakeholder group.

Please find below an overview of some of the most recent consultations that RCE has responded to:

Revision of the EU general pharmaceuticals legislation

As part of the European Commission’s Pharmaceutical Strategy for Europe, and drawing lessons from the COVID-19 crisis, the European Commission is currently evaluating its general legislation on medicines for human use, with the stated aim of ensuring a future-proof and crisis-resistant medicines regulatory system. The Commission is aiming to ensure better access to affordable medicines, while fostering innovation and improving the EU’s supply chain, as well as allowing the development and implementation of new technologies. A legislative proposal on this file is expected in Q4 2022.

RCE responded to both the Open Public Consultation (September-December 2021) and the Consultation on the Roadmap (April 2021) of the revision of the Pharmaceutical Strategy for Europe. In its responses, RCE highlighted the need for innovative approaches to enable the development and accessibility of medicines, notably by considering the enhanced use of artificial intelligence, Real-World Data (RWD), innovative clinical trials and digitalisation. RCE also underlined the vital need for new approaches for the scientific evaluation and authorisation of new treatments for rare and ultra-rare cancers. Finally, as unmet needs are high in the EU, RCE encouraged the Commission to promote dialogue, public-private partnerships, and HTA joint clinical assessment harmonization at national level. RCE also highlighted to the Commission that the COVID-19 pandemic revealed the lack of preparedness and resilience of EU health systems, which greatly impacted patients suffering from rare cancers. In its response to the consultation, RCE therefore asked that the unavailability and inaccessibility of certain medicines be tackled by improving, monitoring and tracing the security of the medicine supply chain.

Please find RCE’s full contribution to the consultation on the Roadmap here.

Revision of EU rules on medicines for children and rare diseases

The Commission is currently revising the EU rules to incentivise the development of medicines for children and people with rare diseases, to update the current legislation which has been in place for around 20 years. In this revision, the Commission has stated that it is looking to improve access to products for specific needs of children and people with rare diseases, as well as ensuring their development. The revision of the legislation also aims to ensure that the assessment and authorisation procedures for these medicines are efficient. The Commission’s legislative proposal on the file is expected in Q4 2022.

In January 2021, RCE responded to the Consultation on the Roadmap on medicines for children and rare disease, highlighting the need for harmonisation of HTA processes and clinical assessment as being vital to overcome disparities and accelerate access to rare cancer medicines. RCE’s response to the consultation on the roadmap also included a call for the EMA to include disease-based communities in its Scientific Advice processes, as well as highlighted the need for adaptive licensing approaches. In addition to the roadmap, RCE responded to the Open Public Consultation (May-July 2021) on the revision of the legislation, highlighting barriers to the current framework, such as regulatory processes, uncertainty and accessibility. In its response, RCE highlighted that these issues have resulted in insufficient development in areas of the greatest need for patients, as well as unequal availability, delayed access and often unaffordable treatment in the EU, all of which have a negative impact on the outcomes of patients with rare cancers. In its response to the consultation, RCE stressed the need for uniform implementation of the Cross-Border Healthcare Directive in all EU Member States, the use of telemedicine and national networks, as well as the importance of the European Reference Networks. Lastly, RCE also highlighted the need for improved disease awareness, the importance of collaboration with academia, and the need for improved access to clinical trials in Europe.

Please find RCE’s full contribution to the consultation on the Roadmap here.

European Health Data Space

This new EU initiative is aimed at promoting better exchange and access to different types of health data, with the objective of supporting healthcare delivery, health research and health policymaking. The European Commission has stated that the European Health Data Space (EHDS) will allow a clear governance framework with data-protecting rules to ensure safer exchange of patients’ data. The entire data system will be built on transparent foundations that fully protect citizens’ data and reinforce the portability of their health data, as stated in article 20 of the General Data Protection Regulation (GDPR). The EHDS will also aim to support digital health services and clarify the safety and liability of health artificial intelligence. The Commission has stated that the EHDS will therefore be built on 3 main pillars: a strong system of data governance and rules for data exchange, data quality, and strong infrastructure and interoperability.

RCE responded to the Open Public Consultation (May-July 2021) and the Consultation on the Roadmap (February 2021), and advocated for EU citizens to be able to better control access to their data and be able to share their heath data with healthcare professionals across the EU, while taking into account any potential pitfalls and drawbacks this could entail for the delivery of healthcare and medical research. In its responses to the consultations, RCE also stressed the need for harmonised interpretation of the General Data Protection Regulation (GDPR), and highlighted the need for investment in digital platforms, infrastructures and fora, in addition to the implementation of a federal learning system to address concerns linked to the GDPR and data sharing. 

Please find RCE’s full contribution to the consultation on the Roadmap here.

Cross-border healthcare – evaluation of patients’ rights

The Cross-border healthcare Directive gives patients the right to seek planned healthcare in another EU country and established European Reference Networks (ERNs) to facilitate discussion on rare cancers. The Directive is currently under evaluation, with the aim of encouraging cooperation between national healthcare providers, notably on rare diseases and European Reference Networks, and to give patients access to safe and high-quality healthcare when in another EU country.  

RCE responded to the Open Public Consultation (May-July 2021) and underlined the need for patients to receive timely and appropriate information on upfront costs, reimbursement rules, and the amount the respective national health system or private insurance will cover when accessing healthcare abroad. RCE also put forward the importance of harmonised interoperable digital platforms, as well as the need for increased awareness on healthcare access in another EU Member State. In its response, RCE identified barriers that are not addressed in the current legislation, such as administrative burdens and a lack of patient information and awareness, with RCE highlighting that addressing this issue could be supported by patient organisations. To improve the current legislation, RCE recommended the further integration of European Reference Networks (ERNs) into national healthcare systems, to improve access to planned healthcare in another EU country. Finally, RCE stressed the importance of the Cross-border Healthcare Directive’s role to limit any administrative and logistical burdens connected to follow-up care to the greatest possible extent, given the unique set of challenges faced by patients with rare cancers.

Europe’s Beating Cancer Plan: A new EU approach to prevention, treatment and care

Published by the European Commission in February 2021, Europe's Beating Cancer Plan (EBCP) sets out a new EU approach to cancer, with the European Commission stating that the EBCP will tackle the entire disease pathway. The EBCP is one of the European Commission’s key policy initiatives and its announcement, roll-out and implementation is highly relevant for RCE. Thus, RCE responded to the Consultation on the Roadmap (February-March 2020) for the EBCP. In its feedback, RCE requested that rare adult cancer component is included, as well as a component on paediatric cancers, in all national cancer plans. In addition, RCE advocated for the use and connection to national systems of the four European Reference Networks (ERNs) relevant to rare adult cancers. RCE also recommended increasing the financial resources of ERNs to ensure their sustainability, given their impact and importance for the rare cancers community. The importance of data protection and the need for a harmonised implementation of the GDPR were highlighted in RCE’s response to the consultation, which can contribute to improve the lives of rare cancers patients in the EU. In regard to cancer health, RCE insisted on the need for more prevention as well as for the setup of interoperable, population-based cancer registries. The suggestions put forward by RCE in its response aimed to improve early diagnosis, treatment and access to rare cancers care. To achieve improve access to rare cancers care, RCE recommended the adoption of the Health Technology Assessment Regulation at EU-level. Finally, RCE underlined the crucial positive role of medical education on rare cancers.

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