Past consultations
EU4Health 2022 - Stakeholder consultation on priorities, strategy & needs
EU4Health is the EU’s response to the COVID-19 pandemic, which is having a major impact on the patient community. The new EU4Health programme aims to go beyond crisis response to address healthcare systems’ resilience. The European Commission sought input via a targeted stakeholders’ consultation, to which we responded. This consultation sought input from stakeholders on the priorities and strategic orientations and on the needs to be addressed through EU4Health annual work programmes, focusing in particular on input that could facilitate reflection for the 2022 EU4Health Work Programme and beyond.
More information
EPF Accompanying Statement to the Public Consultation response
Revision of EU rules on medicines for children and rare diseases
The EU rules on medicines for rare diseases and medicines for children were adopted in 2000 and 2006, respectively. The rules were designed to improve the treatment options available to 30 million European patients affected by one of over 6000 rare diseases, as well as for 100 million European children affected by paediatric diseases. At the time, there were limited or no medicinal products available for treatment of both groups. We responded to the European Commission's Public Consultation on the revision of EU rules on medicines for children and rare diseases - however, we only responded to the paediatric-related questions. We drafted our response in cooperation with EPF's Youth Group. In our response, we advocated for increased access of young and paediatric patients to medicines and treatments, as well as encouraged the European Commission to foster research in those areas.
EPF Response
European Health Data Space
Health is an area where Europe can undoubtedly benefit from the data revolution. Proper use of health data can improve health systems’ sustainability, foster disease prevention, increase the quality, safety and patient centredness of healthcare, decrease costs and transform care into a more participatory process. Nevertheless, the road to fully exploit the potential benefits of data in health is only partially built, still extremely fragmented and undeveloped with and for patients. In its response to this public consultation, EPF called for the creation of a patient-centred European Health Data Space.
EPF Response to the Roadmap
EPF Accompanying Statement to the Public Consultation response
3rd health programme (2014-2020) – final evaluation
The final evaluation of the 3rd health programme that ran from 2014 to 2020 will assess: - its results and the impact of those results, - its effectiveness, cost-efficiency and EU-added value, - what worked well and what did not. The lessons learnt from the evaluation will be used to improve the implementation of the 4th health programme that will run from 2021 to 2027.
More information
Evaluation of the cross-border healthcare directive
EPF has worked extensively on the Cross-border healthcare Directive (2011/24/EU). Building on our previous work in this topic, we have engaged on the recent public consultation on the evaluation of this Directive by the European Commission. Our response has identified the following priorities: 1) patient’s rights, 2) information for patients, 3) equity of access, and 4) patient’s involvement in assessing the Directive.
More information
EPF Response to the Roadmap
A European approach for trustworthy artificial intelligence
In its Communication “Artificial Intelligence for Europe”, the Commission announced the drafting of ethics guidelines in the field, by an independent Expert Group representing various stakeholders. The group has published draft guidelines in December 2018 and, following stakeholder consultations, is revising the document. The Communication presented how the Commission will take this work forward, including key requirements for trustworthy Artificial Intelligence, and outline next steps.
More information
Blood, tissues and cells for medical treatments & therapies – revised EU rules
EU legislation provides high safety and quality standards for blood, tissues and cells used for medical treatments and therapies. This initiative will update the EU rules on scientific and technological developments in this field, including innovative therapies. It will also address the (re)emergence of communicable diseases, including lessons learnt from the COVID-19 pandemic, and the increasing commercialisation and globalisation of this sector, so contributing to the European Health Union.
Deadline: 15 April 2021
European Centre for Disease Prevention and Control – reinforced mandate
The ECDC will have its competences extended to improve preparedness, surveillance, risk assessment, and early warning and response to face future cross-border health threats, as well as smoothing cooperation between ECDC and other agencies, particularly the EMA. The EPF welcomes these changes, too. Nevertheless, in recognition of the important and growing health impact of chronic diseases, the mandate of the ECDC should be further extended to encompass chronic diseases.
European Medicines Agency – strengthened role to address public health emergencies
EPF welcomed the proposal to extend the EMA’s mandate and resources. The EMA plays an important role in protecting public health in the EU. We believe it does not go far enough and can be improved to address medicines and medical devices shortages, as well as to further support for patient and civil society engagement.
Data sharing in the EU – common European data spaces (new rules)
Given the upcoming proposal for a European Health Data Space, EPF welcomed the request for a regulation on European data governance (Data Governance Act), which will serve as a horizontal framework for data governance across the different sectoral data spaces. Focusing on the contents of the Data Governance Act, EPF highlighted in its public consultation that the European Commission should address a set of elements included in the current version of the proposal that we believe require further attention, especially considering their potential impact on the field of health data.
EU Beating Cancer Plan
Cancer is the second leading cause of death and disability in the EU - it carries with it a huge societal and personal burden due to premature deaths, loss of productivity and the costs associated with its treatment and care. The EU’s Beating Cancer Plan will be implemented using the whole range of Commission funding instruments, with a total of €4 billion being earmarked for actions addressing cancer, including from the EU4Health programme, Horizon Europe and the Digital Europe programme. In its response to it, the EPF highlighted several priorities that we wished to see as part of the Cancer Plan.
More information
EPF Press Release
EU Commission Pharmaceutical Strategy
The draft pharmaceutical strategy of the European Commission was out for public consultation. The consultation was open until 15 September 2020. Access to and affordability of medicines is one of the stated health policy priorities of the European Commission. EPF prepared a response, based on our previous policy work and our analysis of the Roadmap for the pharmaceutical strategy, on which we submitted initial comments in July.
More information
EPF Draft response
Digital Education Plan
The European Commission launched an EU-wide public consultation to gather the views of citizens and stakeholders on the future of digital education during the COVID-19 recovery period and beyond. The consultation contributed to the Commission’s proposal for a renewed Digital Education Action Plan, expected in September 2020. Digital transformation was one of the Commission’s priorities as set out in its flagship strategy, a Europe fit for the digital age. The new Digital Education Action Plan will form a key aspect of the Next Generation EU recovery instrument. The Action Plan will support Member States, education and training institutions and citizens in their efforts to adapt to the digital transition and help ensure a fair and inclusive recovery for all.
European Medicines Agencies’ Network Strategy to 2025
EMA and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years that was released for a two-month public consultation. The draft strategy detailed how the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.
More information
EPF Draft response