MMD NEWSLETTER

Diabetes is a complex and progressive condition that affects more than 32 million people (one in ten adults) in the European Union. Turning the tide on the diabetes epidemic and improving the lives of people living with diabetes (PwD), their families and care teams requires systemic and innovative changes. The diabetes community needs changes in care delivery approaches but also policy changes that will promote enabling and equitable environments for health and ensure fairer and more affordable access to medicines, technologies, digital health and education.

Through the MMD newsletter, diabetes stakeholders aim to present a unified stance on a range of policy areas, raise awareness about the complexity of the condition and advocate for meaningful policy action on diabetes in Europe. We hope the newsletter will serve as a useful tool to help strengthen the voice of diabetes in the EU and advance prevention, treatment and care.

Below you will find an overview of all upcoming diabetes-related events, updates on the legislative landscape in the area of health as well as actions undertaken by diabetes stakeholders to make sure the voice of PwD is represented in all policy initiatives.

For any inquiries / suggestions, contact us at MMD@idf-europe.org

SAVE THE DATE

EUDF / EFPIA webinar for World Diabetes Day: Towards a more integrated care model for people living with NCDs, 9 November, 10:00 - 11:30 CET

Managing a public health crisis effectively is not simply about controlling the spread of a virus. For people living with one or multiple chronic diseases, pandemics such as COVID-19 bring severe synergistic impacts, which require a more nuanced and comprehensive approach to how we manage diseases, particularly in times of crises. The webinar will dive into integrated care models and how they can help Member States better protect the health of vulnerable communities – such as people living with diabetes – both in crises and beyond.

Click here to register!

Dedoc / IDF Europe event for World Diabetes Day, 14 November, 12.00 CET

#dedoc°, Diabetes Online Community, will host an international #docday on World Diabetes Day! In collaboration with IDF Europe, #dedoc° voices from several European capitals and IDF Europe's Young Advocates will tell how they celebrate World Diabetes Day on this special year of the Centenary of Insulin.

You can register here for the Facebook Live Stream.

IDF Europe event on World Diabetes Day, 16 November, 12.00-13.15 CET

IDF Europe will hold its World Diabetes Day (WDD) symposium on November 16, at 12.00-13.15 CET.  This year’s WDD theme is Access to Diabetes Care. The campaign aims to underline that millions of people living with diabetes around the world do not have access to diabetes care. The webinar will be hosted by MEP Sirpa Pietikäinen, MMD Co-Chair, and MEP Marisa Matias. Aligned with the global WDD theme, IDF Europe’s webinar – “Access to diabetes care – If not now, when? How are digital technologies and AI improving access to diabetes care?” will explore how digital technologies and artificial intelligence support equitable and sustainable access to quality diabetes care. Guest speakers will examine the need to rethink how care is delivered, moving from reactive to proactive care delivery, and towards more individualised care.

Click here to register!

Influenza Diabetes Community event on World Diabetes Day, 16 November, 14:30-16:00 CET

JDRF / EUDF / INNODIA webinar: Screening for Type 1 Diabetes: Why Is It Needed?

JDRF / EUDF / INNODIA webinar: Screening for Type 1 Diabetes: Why Is It Needed? will focus at engaging world leading experts of T1D screening, as well as people living with diabetes, policy makers and other stakeholders to help discuss the inclusion of screenings for pre-symptomatic Type 1 diabetes into the standard care service catalogue. The webinar will highlight the importance of national screenings for Type 1 diabetes, the health economic benefits of screening and the perspective of people living with diabetes.

More details on time and registration will follow soon.

NEWS

IDF Europe takes part in the targeted stakeholder consultation on EU4Health

On September 10, 2021, DG SANTE convened a workshop to present the results of the targeted stakeholder consultation on the EU4Health Work Programme 2022 and to get further insights from the participants. The unit presented the state of affairs on the ongoing implementation of the Work Programme 2021 (WP2021) and gave an overview of the priorities, strategic orientations and budget of the Work Programme 2022 (WP2022). 

With an estimated budget of €764 million, the WP2022 will focus on disease prevention and health promotion as the most urgent needs to be addressed in 2022 and beyond. The stakeholders emphasised the need to promote life-long health by putting in place healthy and safe urban, work and social environments, enabling healthy life choices and taking into account the needs of vulnerable groups at every stage of their life.

Digital transformation of healthcare was another crucial priority for the stakeholder pool. The discussion focused on strengthening health data collection, digital tools and services, including through benchmarking and capacity budling.

Stakeholders also underlined the need to enhance access to healthcare by strengthening primary care and reinforcing integrated care models.

The WP2022 is expected to be adopted at the end of 2021/beginning of 2022.

To read more about WP2022 relevance for the diabetes community and IDF Europe’s recommendations, go here.

71st session of the WHO Regional Committee for Europe sets direction for the region post-COVID

The 71st session of the WHO Regional Committee for Europe (RC71) took place virtually during 13-15 September 2021 and consisted of week-long briefings and side events. Health ministers and high-level representatives of the 53 Member States of the WHO European Region together with partner organisations and civil society discussed the current health challenges and set the direction for future actions. The pan-European health community adopted new regional frameworks for primary healthcare, immunization and mental health as well as a measurement framework for the European Programme of Work, 2020-2025 - “United Action for Better Health in Europe”. Additional side events discussed the efforts required to tackle alcohol consumption, invest in healthcare workforce and act on the health effects of climate change. 

To read more about the perspectives of the diabetes community and IDF Europe’s full statements during the RC71, go here.

LEGISLATIVE UPDATES

European Health Data Space

The European Health Data Space (EHDS) is a Commission priority that aims to leverage the potential of digital health to provide high-quality healthcare and reduce inequalities. It seeks to promote better exchange and access to different types of health data (electronic health records, genomics data, data from patient registries etc.), to support healthcare delivery (primary use of data) and health research/health policy making (secondary use of data). A legislative proposal is expected to be adopted in Q1 2022.

The diabetes community welcomes the proposal to create sectoral and horizontal legislative frameworks to unlock the value of data, support the use, re-use and exchange of health data at the EU level.

In the context of diabetes care, it is critical to ensure that the ever-increasing quantity of health data (including data collected though diabetes devices, apps, etc.) and the adoption of new digital solutions be leveraged not only to improve health outcomes for PwD but also to inform policy makers of the actions required to improve diabetes management and prevention, to allow for more research and innovation, and ultimately to build more resilient healthcare systems.

Pursuant to the objectives stated above:

• Harmonised, Europe-wide data frameworks have the potential to bring about significant improvements in the prevention, management and care of diabetes and other non-communicable diseases as well as a reduction in health inequalities.
• The EHDS regulation must have a clear governance framework built on transparent foundations that fully protect citizens’ data in accordance with GDPR rules and promotes inclusiveness. Data protection and ethical and responsible use of data must be non-negotiable notions.
• Investment in an interoperable data infrastructure is required to allowing processing and analysis of different data sources. Data should not have to be physically pooled into one repository in a single format, but instead can sit as distributed data networks provided appropriate safeguarding mechanisms are in place.
• PwD must be included and treated as equal stakeholders (no tokenism) in the design of the EHDS as they are best placed to determine which care and outcomes matter most to them, how they wish to gain access to their own and others’ data and how they wish their data to be used.
• Tackling the digital divide and digital literacy needs of PwD, healthcare professionals and regulators is a pre-requisite to guaranteeing equal access to health and a reduction in health inequalities within and among Member States.
• The increased use of digital tools and systems as well as artificial intelligence (AI) for the management of people living with diabetes and other conditions must not supersede the role played by face-to-face interactions with the healthcare team, and/or the need for human oversight to remain pre-eminent.

IDF Europe’s response to the public consultation here.

EFPIA’s response to the inception impact assessment here.

A Pharmaceutical Strategy for Europe

Adopted on 25 November 2020, the Pharmaceutical Strategy for Europe aims to create a future-proof regulatory framework and to support industry in promoting research and technologies that actually reach patients in order to fulfil their therapeutic needs while addressing market failures. It will also take into account the weaknesses exposed by the COVID-19 pandemic and take appropriate actions to strengthen the system.

Objectives:

• Ensuring access to affordable medicines for patients, and addressing unmet medical needs (e.g., in the areas of antimicrobial resistance, cancer, rare diseases);
• Supporting competitiveness, innovation and sustainability of the EU's pharmaceutical industry and the development of high-quality, safe, effective and greener medicines;
• Enhancing crisis preparedness and response mechanisms and addressing security of supply;
• Ensuring a strong EU voice in the world by promoting a high level of quality, efficacy and safety standards.

The diabetes community welcomes an integrated approach to policy-making that addresses challenges and breaks down silos by working together across disciplines and regulatory competencies throughout the lifecycle of medicines and medical technologies.

To make Europe a world leader in medical innovation and build back better from the COVID-19 crisis the focus must be on creating a framework that embraces and encourages advances in science, technology and medicines. To achieve these goals, the new legislation must reinforce expertise-driven assessment and enable a more agile centralised authorisation framework. We support policies that encourage innovation in the management of care, foster health system resilience and implement value-based healthcare.

We also support the objectives of reducing inequalities in access to affordable medicines for people across the EU and within Member States which have become even more apparent during the COVID-19 crisis. For many of the 32 million PwD in the European Union (one in 10 adults) access to care and medicines often only comes at a cost, or is a function of where they live.

Finally, we commend the goals of addressing unmet medical needs, which are present across many conditions, and promoting the adoption of new innovative tools, treatments and technologies to reduce health expenditure and promote care.

Next steps:

The Commission has opened a public consultation on the revision of the general pharmaceutical legislation, 28 September 2021 - 21 December 2021.

The implementation of the strategy will span the mandate of this Commission and will notably see a proposal for revision of pharmaceutical legislation in 2022.

Read IDF Europe’s response here.

Read EFPIA’s response here.

Read MedTech Europe’s response here.

Health Technology Assessment

Health Technology Assessment (HTA) estimates the value of health technologies – medicines, medical devices and diagnostic tools, measures for disease prevention etc. – compared with other technologies. The regulation aims to strengthen EU-level collaboration for assessing health technologies, with a view to speeding up the adoption and deployment of new health technologies within healthcare systems.

The proposal envisages common work in four areas:

• Joint clinical assessments pertaining to the most innovative health technologies;
• Joint scientific consultations between health technology developers and HTA authorities;
• Identification of promising health technologies at an early stage;
• Voluntary cooperation in areas not covered by compulsory cooperation.

The diabetes community supports EU-level cooperation on assessing the effectiveness of new health technologies to enhance access to medicinal products and medical devices for people living with diabetes and simplifying the submission procedure for producers of health technologies. The EU needs to speak with one voice on clinical evidence: HTA should deliver a robust European capacity for clinical assessments and strengthen the function of the single market for various health technologies.

While we welcome the decision on the implementation period of five years, we regret that a stronger framework for the use of Joint Clinical Assessments could not be agreed upon. We maintain that the shape of the compromise risks introducing an unpredictable system whereby Member States decide on a case-by-case basis if and how they commit themselves to use jointly conducted clinical assessments. This will create unnecessary administrative and regulatory barriers to patients’ access to new medicines introduced in Europe. While we welcome the use of safeguards to ensure that joint assessments cannot simply be ignored, we believe that cooperation can be further strengthened to truly improve patient access across Europe, inform funding of innovation or resolve the challenges faced by social security systems across Europe.

We also believe that the HTA framework must enhance further the role of patient representatives and civil society at large in all decision-making processes and treat them as equal partners in the process. Inclusive and transparent joint consultations can only happen with the meaningful engagement of patients as they are best placed to make decisions concerning their care. Strengthened cooperation on HTA must guarantee a common approach at the EU level and shift away from national models of patient involvement, promote continuity of engagement and engage patients as early as possible, to let the patient community have the full picture and empowered to drive the innovation agenda.

Timeline:

On 22 June 2021, Parliament and Council reached a provisional agreement.

Coreper confirmed the provisional agreement from interinstitutional negotiations on 30 June 2021. ENVI voted on the provisional agreement on 13 July 2021 (58 votes in favour, 14 against and 6 abstentions). Parliament and Council are expected to formally adopt it in the coming months.

More on IDF Europe’s position here.

More on EFPIA’s position here.

More on MedTech Europe’s position here.

PUBLICATIONS

Living in COVID Times: Experiences from People living with Diabetes

In April 2021, IDF Europe released its report on Diabetes & COVID-19 survey which was conducted between August and October of 2020. The aim of the survey was to gather the perspectives from people with diabetes on their lives during the pandemic. The survey recorded responses from 3,480 people living with diabetes in 32 European countries. One of the key findings of the report was that the pandemic had a severe impact on the mental health of people living with diabetes, with over 50% of respondents reporting a deterioration in their mental health and over 40% indicating feeling very or extremely more anxious during this period than prior to the pandemic. The report also highlighted many geographical inequalities in access to diabetes care across Europe. Difficulties in access, as well as financial worries, were especially marked in central and eastern European countries as well as in the south of Europe. Download the report to read more about the findings and IDF Europe's recommendations for restructuring health systems post-pandemic.

IDF Diabetes Atlas 10th edition

The IDF Diabetes Atlas is the authoritative resource on the impact of diabetes across the world. First published in 2000, it is produced by the International Diabetes Federation (IDF) in collaboration with a committee of scientific experts from around the world. It contains key diabetes statistics and trends including prevalence, mortality and health expenditure. The 10th edition will include a specific section on COVID-19 as well as more information on type 2 diabetes incidence and prevalence in children and adolescents. The Atlas also aims to support the development of high quality-diabetes data in all countries and territories.

Data from the IDF Diabetes Atlas 10th edition reports a continued global increase in diabetes prevalence, confirming diabetes as a significant global challenge to the health and well-being of individuals, families and societies. Overall, it estimates that 537 million worldwide lived with diabetes in 2021, of whom 61 million in Europe. The global figure is predicted to rise to 643 million by 2030.

The IDF Diabetes Atlas 10th Edition and other resources will be available for download on December 6, 2021.