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European Society for Medical Oncology (ESMO)

ESMO

ESMO represents 40,000 oncology professionals across 179 countries, working to improve cancer care quality, education, and equal access to optimal treatment for all patients.

Lobbying Activity

Response to EU’s next long-term budget (MFF) – EU funding for competitiveness

3 Nov 2025

The European Society for Medical Oncology (ESMO), representing more than 45,000 members globally, welcomes the opportunity to provide feedback on the proposal for the Regulation establishing Horizon Europe (10th EU Framework Programme) as part of the larger consultation exercise on the post-2027 Multiannual Financial Framework (EU funding for competitiveness). The 2028-2034 EU Research & Innovation Framework Programme can become an even more important funding instrument for supporting cancer research, driving therapeutic innovation in oncology, and boosting the development of novel cancer treatments. To effectively address the increasing number of cancer cases in Europe, set to grow from over 4.47 million in 2022 to 5.48 million in 2045 , ESMO considers it crucial that cancer research becomes a main priority of the Horizon Europe programme - aiming to deliver tangible benefits for patients with cancer. ESMO considers it especially important that the cancer-workstreams of Horizon Europe focus on the following areas: Support research on personalised therapies for molecularly defined tumour subsets Enhance cancer prevention research Artificial Intelligence (AI) solutions for clinical decision-support, personalised prevention and precision diagnosis/therapy of patients with cancer Drive research towards meeting the unmet medical needs of patients with rare & very rare cancers Boost investigations into the multidimensional causes of cancer Addressing the needs of ageing populations Improve the length and quality of survival of everyone diagnosed with cancer ESMO's key recommendations are further developed in the document attached.
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Oncology professionals urge EU to protect cancer care during crises

28 Oct 2025
Topic — European Commission initiative for a coordinated response plan to cross-border health threats.
Message — ESMO demands oncology be protected as an essential service during health emergencies. They call for specific safeguards for medicine supplies and protected cross-border care access.12
Why — This ensures cancer treatment remains prioritized and funded during future health emergencies.3
Impact — Member States would lose sovereign control over their oncology medicine stockpiles during crises.4
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ESMO warns EU diagnostic rules threaten vital cancer research

6 Oct 2025
Topic — The European Commission is revising rules for medical devices and in vitro diagnostics.
Message — ESMO requests a mandatory, single-entry application system to reduce regulatory fragmentation across Member States. They also seek exemptions for lower-risk trials and a formalised scientific advice process.123
Why — Streamlining rules helps maintain Europe’s research base and prevents clinical trial relocation.45
Impact — European patients face delayed access to innovative and life-saving cancer treatments.67
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Meeting with Michalis Hadjipantela (Member of the European Parliament) and Bahá'í International Community

2 Oct 2025 · Introductory Meeting

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur) and European Federation of Pharmaceutical Industries and Associations and Standing Committee of European Doctors

25 Sept 2025 · Health policy

ESMO Urges Integration of Cancer Care in EU Heart Plan

15 Sept 2025
Topic — The EU is developing a comprehensive plan to tackle cardiovascular diseases.
Message — ESMO demands tougher tobacco controls and inclusion of rare cardiovascular cancers. They also advocate for streamlined diagnostic rules and harmonized health data sharing.123
Why — This integration would secure new EU funding and elevate ESMO's medical specialty.4
Impact — Tobacco and alcohol industries would face stricter tax rules and profit caps.5
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Oncology professionals urge EU directive on workplace mental health

8 Sept 2025
Topic — This consultation seeks to deepen the implementation of European social and working standards.
Message — ESMO supports a new EU Directive on Psychosocial Risks and Wellbeing at work. They recommend legislation focusing on primary prevention and collective organisational measures for workers. Recommendations include sufficient staffing levels, flexible hours, and control over high workloads.123
Why — These measures would help prevent oncologist burnout and improve staff retention in hospitals.45
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Meeting with Tiemo Wölken (Member of the European Parliament, Shadow rapporteur) and France Assos Santé

15 Jul 2025 · Critical Medicines Act

Response to Health technology assessment - Joint clinical assessments of medical devices and in vitro diagnostic medical devices

25 Jun 2025

The European Society for Medical Oncology (ESMO) - a professional society representing over 40,000 members from 179 countries and territories - welcomes the opportunity to contribute to this consultation on the draft Implementing Regulation laying down procedural rules for joint clinical assessments (JCAs) of medical devices and in vitro diagnostics (IVDs) at EU level. ESMO recognises the potential of JCAs to streamline access to high-quality technologies and reduce duplication across Member States. However, we urge the Commission and the HTA Coordination Group to ensure that implementation reflects the complexities of oncology diagnostics and therapies. Our response highlights four key priorities: 1. Oncology Expertise - Oncology-specific input must be systematically embedded in expert selection processes to ensure clinical relevance of JCAs. 2. Stakeholder Involvement - The role of clinical and learned societies must be formalised, enabling meaningful, timely input beyond ad hoc consultations. 3. Proportional Evidence Requirements - Clinical evidence expectations for oncology diagnostics must remain feasible, especially for niche or innovative biomarkers with limited data, especially in the context of rare tumours. 4. Comparator and Outcome Clarity - JCAs must provide consistent guidance on comparator choice and outcome selection in oncology, to reduce fragmentation and uncertainty for developers. The full feedback, which expands on these positions is attached for consideration. For additional queries, please, contact us on: publicpolicy@esmo.org
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Meeting with Aurelijus Veryga (Member of the European Parliament)

18 Jun 2025 · Making Cancer Treatments More Reliable in Europe

Response to Critical Medicines Act

11 Jun 2025

The European Society for Medical Oncology (ESMO) - a professional society representing over 40,000 members from 179 countries and territories - welcomes the European Commissions (EC) proposal for a Critical Medicines Act (CMA) and strongly supports its objective to enhance the resilience and security of supply for critical medicinal products in the EU. As a leading professional organisation for medical oncology in Europe, ESMO emphasises that patients with cancer are particularly vulnerable to medicine shortages - especially of off-patent, mature cancer therapies that are central to standard care protocols. These shortages increasingly jeopardise patient outcomes, delay treatments, raise system-wide costs and create additional anxiety and financial toxicity for patients particularly where individuals are forced to secure treatment themselves. While ESMO broadly supports the proposed regulatory and structural pillars of the CMA, we call for more explicit recognition of the unique challenges and clinical consequences related to oncology. To address medicine withdrawal risks, ESMO also encourages the EC to explore regulatory mechanisms that ensure continuity of supply for essential off-patent oncology medicines e.g. by linking marketing authorisation renewals or label expansions to clear supply obligations. Specifically, we urge the Commission to: Integrate oncology-specific vulnerability assessments into the Unions methodology for prioritising critical medicines. Shortages of oncology drugs including those used to manage treatment-related side effects often result in worsened morbidity and mortality, and these outcome-based risks must guide prioritisation and strategic planning. Ensure balanced investment incentives that include dedicated support for essential mature cancer medicines. The current commercial model insufficiently supports the production of these high-value, low-margin therapies, which are nonetheless indispensable for patient care. Strengthen and formalise joint procurement mechanisms for oncology and rare disease medicines. Fragmented demand and market failures for these therapies frequently leave Member States unable to secure timely and equitable access. ESMO strongly supports the use of the CMA to enable EU-level joint tenders for these products, including voluntary participation mechanisms and clear eligibility under the Act. Mandate the use of non-price criteria in public procurement, such as supply reliability, EU-based production, and environmental and social standards. These criteria should be mandatory in tenders for oncology medicines listed as critical or vulnerable, complemented by appropriate contingency planning measures moving away from the lowest-price-only model that exacerbates supply fragility. Create a dedicated EU funding stream for medicines security in the next Multiannual Financial Framework (MFF), including manufacturing and supply chain resilience for essential cancer medicines. ESMO recommends that these investments be treated as a strategic health security priority, aligned with energy and defence resilience. As such, the Critical Medicines Act represents a landmark opportunity to address one of the most urgent and under-recognised threats to cancer care in Europe. We urge the European Commission, Parliament and Council to adopt and implement this regulation in a way that explicitly safeguards oncology treatments, promotes equitable access, and embeds long-term resilience in the pharmaceutical ecosystem. The full feedback, which expands on these positions is attached for consideration. For additional queries, please, contact us on: publicpolicy@esmo.org
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Oncology society urges putting cancer at heart of Biotech Act

10 Jun 2025
Topic — The European Commission's Biotech Act aims to accelerate laboratory research toward the market.
Message — ESMO recommends placing cancer at the core of the legislation to accelerate drug development. They call for reduced regulatory complexity to make Europe more attractive for clinical trials.12
Why — Simpler rules would help resource-limited researchers transfer innovative cancer treatments to clinics faster.34
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ESMO urges EU to prioritize oncology in AI strategy

3 Jun 2025
Topic — A consultation on an initiative to boost industrial AI use and public services.
Message — ESMO wants cancer research to be a "strategic vertical" to advance personalized patient care. They advocate for oncologists to be involved in tool development from their inception.12
Why — This would secure EU funding for professional training and protect the doctor-patient relationship.34
Impact — Tech developers might face more scrutiny as algorithms must be open for review.5
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Meeting with Annukka Ojala (Cabinet of Executive Vice-President Roxana Mînzatu)

14 May 2025 · Shortages of healthcare workers

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

13 May 2025 · EU Health Policy

ESMO Urges Placing Cancer at Center of EU Strategy

15 Apr 2025
Topic — The EU is developing a strategy to boost global competitiveness in life sciences.
Message — ESMO requests placing cancer at the center of the life sciences strategy. They want the EU to prioritize therapeutic innovation and medical breakthroughs. The strategy should also support translating research into novel treatments.12
Why — This would improve funding for professional education and training in oncology disciplines.3
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

18 Mar 2025

The European Society for Medical Oncology (ESMO) - a professional society representing over 40,000 members from 179 countries and territories - welcomed the EUs revision of its laws governing medical devices and in vitro diagnostics as, given the developments of the sector over the last 20 years, this was required to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of patient safety, while supporting innovation. However, the implementation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has been challenged by a lack of infrastructure, guidance, and coordination, triggering a series of unintended consequences that actually hinder clinical trial development. Our members have alerted to us emerging challenges with the implementation of IVDR that have the potential in the short term to delay, or even reduce, access to clinical trials for European patients, thereby causing delays in initiating clinical research in Europe and preventing access to new cancer treatments. In the longer term, if these challenges are not resolved then we fear that the continued application of the IVDR poses a genuinely existential threat to the future of oncological research in Europe. Researchers, like companies, are mobile and are increasingly choosing to conduct their studies in Asia or North America where the regulatory burdens are much less onerous. Whilst ESMO is a global society which seeks to improve the quality of oncological research across the world through a range of initiatives, we believe that this would not be best served by the weakening of existing centres of excellence in EU that continued application of the IVDR will occasion. Instead, we believe that the long-term future of oncological research would be more fruitfully advanced through the parallel reinforcement of Europes research base and the requisite investment in research ecosystems in other key regional hubs. Further details about our position are available in the attached submission.
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Meeting with Stine Bosse (Member of the European Parliament)

17 Mar 2025 · European health policy

Meeting with Fulvia Raffaelli (Head of Unit Health and Food Safety)

30 Jan 2025 · To discuss the European Health Data Space (EHDS)

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

18 Dec 2024 · Rare cancers

Meeting with András Tivadar Kulja (Member of the European Parliament)

14 Nov 2024 · European cancer health policy

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

11 Nov 2024 · EU health policy

Meeting with Tomislav Sokol (Member of the European Parliament)

7 Nov 2024 · Health policy

Response to Health technology assessment – Joint scientific consultations on medicinal products for human use

28 Oct 2024

The European Society for Medical Oncology (ESMO), representing more than 40,000 oncology professionals from over 177 countries, welcomes the consultation on the draft Implementing Act laying down the procedural rules for Joint Scientific Consultations on medicinal products. Please find the full feedback from ESMO in the attached document.
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Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

25 Sept 2024 · Wyzwania chorób rzadkich w tym rzadkich typów nowotworów

Response to Health technology assessment – Cooperation with the European Medicines Agency

22 Jul 2024

The European Society for Medical Oncology (ESMO) welcomes the draft Implementing Act setting out the procedural rules for cooperation, in the form of exchange of information, with the European Medicines Agency (EMA) in the context of the joint work under the EU Health Technology Assessment (HTA) Regulation. Please find the full feedback from ESMO in the attached document.
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Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

26 Jun 2024

The European Society for Medical Oncology (ESMO), representing more than 35,000 oncology professionals from over 172 countries, welcomes the consultation on the draft Implementing Act on the Management of Conflicts of Interest. Please find the full feedback from ESMO in the attached document.
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Meeting with Stella Kyriakides (Commissioner) and

9 Apr 2024 · Europe’s Beating Cancer Plan; quality of life

ESMO urges use of oncology tools in EU clinical assessments

2 Apr 2024
Topic — This consultation concerns rules for joint clinical assessments of new medicinal products.
Message — ESMO wants its clinical benefit scale and guidelines used to evaluate treatments. They also demand that medical oncologists are formally consulted during assessments.123
Why — This would solidify ESMO's influence over European drug reimbursement and clinical standards.45
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Response to Evaluation of the Regulation on serious cross-border threats to health

9 Feb 2024

The European Society for Medical Oncology (ESMO) welcomes the upcoming evaluation of the EU Regulation on serious cross-border threats to health. Please find the feedback from ESMO in the attached document.
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Response to Joint European degree

6 Feb 2024

The European Society for Medical Oncology (ESMO) welcomes the EU initiative to establish a joint European Degree. Please find the feedback from ESMO in the attached document.
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ESMO calls for harmonised data rules to boost cancer research

6 Feb 2024
Topic — The European Commission is reviewing the application of data protection rules six years later.
Message — ESMO calls for uniform rules to facilitate oncology research and international collaboration. They propose 'one-time consent' for future studies and 'no-consent' for disease registries.123
Why — Standardised procedures would reduce administrative burdens and financial costs for multi-national projects.45
Impact — Current data restrictions harm minority groups by delaying identification of specific health problems.6
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Response to Reducing human health risks associated with the use of sunbeds

17 Nov 2023

The European Society for Medical Oncology (ESMO) is one of the leading professional organisations for medical oncology, with more than 34,000 members from over 170 countries. ESMO is committed to preventing new cancer cases, improving the quality of cancer care and promoting equal access to optimal treatments for all cancer patients. In line with its mission to alleviate the societal burden of cancer and advance cancer prevention and control globally, ESMO welcomes the European Commission's (EC) efforts to mitigate the negative health effects associated with the use of sunbeds, including the risk of melanoma, among other types of skin cancer. Moreover, ESMO recognizes that this effort is an important step towards delivering Europe's Beating Cancer Plan and the BECA Report on Strengthening Europe in Fight Against Cancer, concerning the exposure to ultraviolet radiation (UVR) as an important contributor to melanoma risk. Accordingly, ESMO urges the EU institutions to adopt stricter legislative measures on the use of sunbeds for cosmetic purposes by adults, and totally prohibit their use by minors. ESMO stands ready to support the EC throughout the process and offers to mobilise its network of medical oncologists, health professionals and researchers to foster the development of robust measures for addressing the impact of artificial ultraviolet radiation. You can read the full feedback in the attached document. For further information, please contact: publicpolicy@esmo.org
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ESMO Urges Tailored EU Rules for Rare Cancer Medicines

8 Nov 2023
Topic — The EU is revising its pharmaceutical legislation to improve medicine accessibility and affordability.
Message — ESMO calls for mandatory consultations with expert disease communities. They request defining rare cancers by annual incidence rather than prevalence.12
Why — These reforms would strengthen the group's regulatory influence and speed up drug designations.34
Impact — Lowering statistical evidence requirements might increase uncertainty regarding the effectiveness of new treatments.5
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ESMO Urges Stricter Air Quality Limits to Prevent Lung Cancer

15 Feb 2023
Topic — Revision of EU air quality standards to better align with health recommendations.
Message — ESMO recommends lowering the annual limit for fine particulate matter to 5 μg/m³ by 2030. This would align EU policy with current international health guidelines.1
Why — Stricter limits would reduce lung cancer rates and healthcare costs across the EU.2
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Response to Vaccine-Preventable Cancers

3 Feb 2023

The European Society for Medical Oncology (ESMO) welcomes the intent of the European Commission to put forward a proposal for a Council Recommendation on vaccine-preventable cancers. Please find the feedback from ESMO in the attached document.
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Meeting with Véronique Trillet-Lenoir (Member of the European Parliament, Rapporteur)

24 Jan 2023 · Asbestos at work directive - Health Data Space - Air pollution

Medical oncologists urge EU to adopt stricter asbestos limits

29 Nov 2022
Topic — The Commission is revising rules to protect workers from carcinogenic asbestos exposure.
Message — ESMO requests setting the exposure limit at 0.001 fibres per cubic centimetre to better protect workers. They argue this is necessary to meet the goals of Europe’s Beating Cancer Plan.12
Why — This move would fulfill their core objective of improving cancer control across Europe.3
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Meeting with Véronique Trillet-Lenoir (Member of the European Parliament)

11 Sept 2022 · Participation à un débat de l'institut Curie "Cancer in Europe: notice of storm" à l'occasion du congrès de l'ESMO

Response to Requirements for Artificial Intelligence

6 Aug 2021

The European Society for Medical Oncology (ESMO) welcomes the proposal for a Regulation laying down harmonised rules on Artificial Intelligence. While the intention of the Regulation is welcomed, ESMO is concerned regarding the potential impact of this Regulation on the usage of artificial intelligence technologies for the purposes of health research and healthcare practice. Currently in oncology, artificial intelligence is being used in the radiology setting (in terms of imaging) and we are in the nascent stages of AI applications in pathology, radiomics, genomics, proteomics and drug development, in addition to developing clinical decision-support tools that integrate clinical practice guidelines with new clinical data in the area of medical oncology, among others. It is thus crucial to ensure that if any regulations will be put in place to govern the safety of such systems they will aim to foster health research and optimal healthcare practice, rather than obstruct it. Additionally, EU rules on AI should be developed to serve the needs of healthcare professionals and patients, enable advancements in the AI field, and they should be made applicable in a consistent manner in all EU countries. Thus, any measures supporting the trustable development, deployment and use of AI in healthcare should address the following issues: 1. Enabling regulatory environment for AI: EU rules and legislation governing the use of AI as well as AI-related measures should be tailored to the needs of healthcare professionals and patients, and they should be developed and implemented in a manner that does not stifle the use of AI in medical research and clinical practice. The current proposal for a Regulation laying down harmonised rules on AI follows a risk-based approach that sets stricter rules for AI systems that are considered as ‘high-risk’ under the Regulation. ESMO believes that, even though robust requirements are needed for systems that pose potential threats to the safety of EU citizens, the risk-based approach should not unintentionally prevent the use of AI systems that could advance medical research and improve the treatment and care provided to patients with cancer. Moreover, legislation on AI should not impose additional administrative burdens to medical researchers that use AI-driven systems as part of their research. 2. GDPR: ESMO would like to underline the need for harmonising the implementation of EU data protection rules in all EU countries. In order to seize the full benefits of applying AI systems in oncology, we believe that it is crucial to ensure that the GDPR is interpreted in a consistent manner in all EU Member States. ESMO’s work on the GDPR: https://www.esmo.org/policy/eu-general-data-protection-regulation 3. Impact on healthcare professionals and regulating the ‘Black Box’ doctrine: Applying AI systems in medical research and healthcare may require specific knowledge and competences. It is important that measures are taken to ensure that healthcare professionals are involved in the development of these tools from their inception and they gain the skills needed to use AI systems, including by integrating this in educational and university curricula. Moreover, while respecting intellectual property rights, the principles of AI algorithms and logic should be understandable and open for review by experts and healthcare professionals. 4. Integration of future-proof scenarios: Ensure that new regulations governing the use of AI are created in a forward-looking manner that does not impede advances in scientific research, and allows for the use of health data for AI-applications supporting the medical field, e.g clinical decision-support systems et al., without making it cumbersome for healthcare professionals. ESMO welcomes the draft Artificial Intelligence Act, and would be glad to work with the European Commission to ensure that we create an AI Regulation that fosters research, especially in the healthcare setting.
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Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

Representing more than 25,000 oncology professionals from over 160 countries, ESMO welcomes this important consultation. In light of this, we recommend the following: 1. Ensure access: • HTA: ESMO believes that unifying HTA across Europe through joint clinical assessments will contribute to improving access to high quality medicines. ESMO recommends using cancer medicines as a pilot to jointly assess medicines under the draft HTA Regulation. • Biosimilars: With many expensive cancer medicines coming off patent, ESMO believes that biosimilars present a necessary and timely opportunity as they can positively impact the financial sustainability of healthcare systems while improving access to medicines for patients. • Prioritising cancer medicines: ESMO developed the ESMO-Magnitude of Clinical Benefit Scale which uses a rational and structured approach to score the Magnitude of Clinically Meaningful Benefit of EMA-approved medicines. The tool is used by various countries across the world to prioritise cancer medicines and is also used by the WHO to evaluate cancer medicines for the WHO Model List of Essential Medicines. With the incoming wave of high-cost treatments in similar settings for cancer, the ESMO-MCBS may be a tool to support the EU and its Member States to choose medicines appropriately. • Off-label use: Off-label use of old inexpensive medicines is crucial for the treatment of cancer patients. Currently, the existing framework at the EMA does not allow for approval of these already approved medicines for other indications, in a simple manner. ESMO recommends analysing the existing situation concerning off-label use of medicines and creating a framework that would be conducive to defining which currently used off-label medicines, supported by robust evidence, for other indications should be made available. • Collection of data: ESMO’s antineoplastic medicines survey (ANMS) is currently the most comprehensive assessment on the availability of cancer medicines globally. ESMO will be re-doing the ANMS survey and will be sharing the data with the European Commission. 2. Enable innovation: • Precision medicine: To contribute to the rapidly evolving field of precision medicine, ESMO created the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT). The tool aims to optimise patient care by making it easier to identify patients with cancer who are likely to respond to precision medicine. It also defines clinical evidence-based criteria to prioritise genomic alterations as markers to select patients for targeted therapies. ESMO is also conducting a survey to assess the availability of biomolecular technologies and would be sharing the data with the Commission. Thus, ESMO encourages the revision to take into account existing work done by scientific societies. • Academic research: ESMO would support the EMA in increasing its collaboration with academia to jointly discuss new scientific advances, knowledge, and potentially create solutions addressing the challenges within the field of innovation. • Bureaucracy in clinical trials: ESMO would suggest to review the framework associated with clinical trials with the aim of reducing the bureaucratic burden associated with clinical research. 3. Enhance the security of supply of medicines: • Shortages: Shortages of inexpensive, essential medicines are a growing public health emergency. ESMO believes that only a supranational EU solution can mitigate the inexpensive, essential medicines shortages and welcomes the forthcoming study on shortages. 4. Reduce regulatory burden: • GDPR and CTR: ESMO recommends the harmonised implementation of Recitals 33 & 157 of the GDPR, & Recital 29 and Article 28 (2) of the CTR across the EU to facilitate scientific research. • Resources: As the review will address legislation underpinning the role and functioning of the EMA, it is crucial that the strengthening of the EMA and its mandate is equally supported by adequate resources.
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Response to Evaluation of patient rights in cross-border healthcare

11 Feb 2021

Representing more than 25,000 members from over 160 countries, the European Society for Medical Oncology (ESMO) welcomes the EU’s efforts to evaluate the transposition of the Directive on patients’ rights in cross-border healthcare. With an estimated 2.7 million new cases in the EU in 2020, cancer constitutes a growing threat that impacts the health and well-being of EU citizens. It is therefore crucial that robust policies for addressing the many challenges related to cancer are put in place at the EU level. We would like to emphasise the following: 1) Directive’s relevance: Many forms of cancer, including rare cancers, face challenges linked to late or incorrect diagnosis, lack of access to appropriate therapies and expertise, lack of commercial interest in developing new therapies, difficulties in conducting well-powered clinical studies, and few available registries and tissue banks. The Directive is indeed relevant for tackling cross-border challenges through the creation of interconnected European Reference Networks (ERNs) with national centres to improve early access to appropriate pathologic diagnoses, fast-track referral pathways, medical and professional expertise, and to guarantee patients’ rights in receiving care and reimbursement to treatments across Europe. The ERNs for rare cancers are a successful European example of cross-country cooperation and how to achieve an equitable access to care. 2) Directive’s effectiveness: Seven years after the transposition of the Directive, there are still significant gaps related to digitalisation of healthcare, lack of awareness regarding how patients can seek cross-border healthcare, among others. Digitalisation: The creation of user-friendly, interoperable and harmonised IT solutions to allow the easy exchange of cases, knowledge and discussion on complex cancer cases and treatment pathways is vital for cancer patients. The IT tool of the ERNs, the Clinical Patient Management System (CPMS), is cumbersome and does not allow for cases to be shared/discussed in a user-friendly manner. It would be crucial to create interconnected, collaborative EU/national networks on state-of-the-art definition, clinical research, medical education, highly challenging clinical cases, while reducing health migration especially for rare cancer patients. Moreover, creating digital fora for exchanges between experts and patients would be vital too. 3) Barriers faced by patients: Awareness: The Directive foresees the establishment of National Contact Points (NCPs) to inform patients, giving them the ability to make a freely informed decision regarding where to receive treatment. Sadly, patients are still unaware of their rights to receive treatment abroad and still encounter hurdles linked to logistic and linguistic barriers to receiving care in another Member State. Moreover, NCPs have little knowledge about rare cancers and should consult the relevant ERNs and patient groups while providing advice to cancer patients. Thus, there is a need to raise awareness and provide clear, accurate, and detailed information for patients, including rare cancer patients, and caregivers who may need access to a centre of expertise in another EU Member State. Reimbursement: One of the challenges regarding the implementation of the Directive is the lack of clear information regarding potential expenditures linked to seeking cross-border care. Thus, patients need to receive timely and appropriate information about the upfront costs, reimbursement rules, and the amount the national health system or private insurance will cover. Moreover, this responds to the need to improve EU’s efficiency to protect people affected by cancer. The COVID-19 pandemic has shown how important and life-saving cross-country health cooperation is, and how harmonisation of the Directive should be a policy priority to protect patients. ESMO will be glad to be consulted on this topic, as needed.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

Representing over 25,000 members from over 160 countries, the European Society for Medical Oncology (ESMO) welcomes the consultation on the roadmap for a new Pharmaceutical Strategy. ESMO considers the following as priorities within the objectives: - Shortages: Shortages of inexpensive, essential medicines are a growing public health emergency that require concerted and collaborative action at the EU level. While there is a clear impact of medicines shortages on patient outcomes, their causes are complex and multifactorial and cannot be solved by any Member State alone. As the treatment of cancer patients is highly affected by these shortages, ESMO developed 6 reports on medicines shortages. The foundational report & 5 country profiles, done with the Economist Intelligence Unit, indicated that no country is left untouched by the issue of inexpensive, essential medicines shortages. Thus: 1) ESMO believes that only a supranational EU solution can mitigate the inexpensive, essential medicines shortages, which have been exacerbated by the COVID-19 pandemic. 2) ESMO believes that shortages of inexpensive, essential medicines are due to their unavailability, and the ‘shortages’ of expensive, innovative medicines are due to their inaccessibility. Thus, in order to ensure a continuous supply of both kinds of products, ESMO would recommend having tailored suggestions for both, especially as anti-cancer medicines are highly affected in both categories. - Off-label use of certain medicines for certain indications: Off-label use of certain medicines, including old inexpensive medicines as well medicines which may be used in specific situations, e.g. for rare and very rare cancers, are crucial for the treatment of cancer patients. Currently, the existing framework at the EMA does not allow for approval of these already approved medicines for other indications, in a simple manner. 3) ESMO recommends analyzing the existing situation concerning off-label use of medicines and creating a framework that would be conducive to defining which currently used off-label medicines, supported by robust evidence, for other indications should be made available. 4) ESMO recommends assessing the off-label use of medicines in rare and very rare cancers, through an EU-wide survey. - Collection of data: ESMO’s antineoplastic medicines survey (ANMS) is currently the most comprehensive assessment on the availability of cancer medicines globally, according to the WHO report on pricing of cancer medicines (2018). ESMO will be re-doing the ANMS survey and will be sharing the data with the European Commission. - Prioritizing cancer medicines: The ESMO-MCBS is a tool, assessing EMA-approved medicines, for a rational and structured approach to derive a relative ranking of the Magnitude of Clinically Meaningful Benefit of anti-cancer treatment. It is being used by various countries across the world to prioritize cancer medicines. With the incoming wave of high-cost treatments in similar settings for cancer, there is a need to allow EU Member States to choose medicines appropriately, including the use of biosimilars. A concrete example of countries using the ESMO-MCBS: WHO cancer report 2020 (p. 45 ). 5) ESMO recommends using cancer medicines as a pilot to jointly assess medicines under the draft HTA regulation (joint clinical assessments). The ESMO-MCBS may help facilitate the process, given that it is already being used by the WHO and various countries across the world. - Economic model: ESMO is working towards the development of a geographically-adapted value-based reimbursement model to tackle issues related to the reimbursement of expensive, innovative medicines. ESMO will share the details concerning the model with the EU institutions in due course. - GDPR & CTR: 6) ESMO recommends the harmonized implementation of Recitals 33 & 157 of the GDPR, & Recital 29 and Article 28 (2) of the CTR across the EU in order to facilitate scientific research. Attachment:1
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Meeting with Stella Kyriakides (Commissioner)

26 May 2020 · VC meeting to discuss the EU's Cancer Plan and its objectives, cancer care and treatment during the COVID-19 pandemic

Response to Report on the application of the General Data Protection Regulation

29 Apr 2020

Representing over 25,000 members from over 160 countries, the European Society for Medical Oncology (ESMO) welcomes the consultation on the roadmap paving the way for a report on the application of the GDPR. The GDPR is an important piece of legislation that was drafted to improve the harmonisation of data protection laws across the EU, affecting all sectors including health research. As cancer is a field heavily driven by research, ESMO recognised the potential impact the GDPR may have on health research and advocated for safeguarding the research community from its unintended implications. ESMO’s advocacy activities focused on raising awareness on the possible consequences of the GDPR on clinical, translational and epidemiological research in the EU: to ensure that the Regulation does not jeopardize health research (see attached: a paper on behalf of the European oncology community before the GDPR was adopted). Over the years, we strongly advocated for the inclusion of a withdrawable ‘one-time consent’ from patients, subject to strict safeguards, allowing their data and tissues to be used for future retrospective clinical research, which will also ensure the viability of biobanking (recital 33). Additionally, we supported the introduction of a ‘no-consent’ principle to allow research based on population-based disease registries in line with strict ethical standards (recital 157). We welcomed these recitals because they acknowledged our concerns. Since May 25, 2018, the applicability of the GDPR has been contingent upon the guidance emanating from the EDPB, and then subsequently national authorities. ESMO recognises that the Regulation allows Member States some scope to further specify its application in the processing of personal data in areas such as public health. However, the GDPR aims to improve the way data is protected and processed across the EU, not repeat the mistakes of its predecessor. The guidance provided by the EDPB is indeed crucial for the harmonised implementation of the GDPR. Therefore, it needs to be unambiguous and clear, especially for health research. Currently, the vagueness of the guidance regarding the interpretation of recitals 33 and 157, protecting health research, has led to strong inconsistencies in the way the GDPR is being applied at the national levels. ESMO & its members have witnessed concrete examples of these inconsistencies. In particular, ESMO is worried that such interpretations may disregard these two recitals, contrary to the initial intention of backing their approval within the final text of the GDPR. We do not believe that the EDPB and national authorities can over-interpret the said text to such an extent. ESMO is thus concerned regarding the fragmented application of the GDPR across the EU 27 & its implications on future research. Therefore, we request Member States, the EDPB, the European Commission and all relevant EU institutions to take the following into account, for a harmonised GDPR for health research: -GDPR Recital 33: If willing, patients should have the right to provide a withdrawable “one-time consent” to using their data and/or biological samples for future retrospective research, under the scrutiny of appropriate review bodies (institutional review boards and/or ethics committees); -GDPR Recital 157: population-based disease registries (including cancer registries), that are crucial for the creation of health policies, are allowed to operate with a “no-consent” policy under the supervision of relevant public health bodies. -CTR: Recital 29 and Art. 28 (2) of the CTR should be implemented across the EU 27 to give patients enrolled in a clinical trial the right to allow their data to be used retrospectively beyond the end and scope of the trial, for future research. ESMO recognises the EU’s achievements in this field and remains committed to helping EU institutions and Member States protect the future of both the privacy of patients and health research.
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Response to Europe’s Beating Cancer Plan

24 Feb 2020

Representing over 25,000 members from over 160 countries, the European Society for Medical Oncology (ESMO) welcomes the consultation on the roadmap paving the way for Europe’s Beating Cancer Plan. ESMO considers the following as priorities within the key pillars, as well as neglected areas we feel must be reflected in the Plan. - Prevention: 1) Cancer registries: Using interoperable, population-based registries effectively will be crucial for creating Member State-specific prevention policies. They should be appropriately funded and GDPR should not be an obstacle to their work (see below). 2) Awareness: ESMO will develop educational tools for patients & professionals, including teach the teacher initiatives; collaborate with IARC; work with disease-based societies & other organizations; and integrate prevention into ESMO’s annual, tumour-specific and regional congresses to collectively aim to achieve the 40% reduction. - Early diagnosis: ESMO supports the evidence-based development of screening programmes and provides guidance in its guidelines. - Treatment: 1) Harmonization of the standard of care: ESMO currently has over 80 clinical practice guidelines, updated in real-time, and used by most oncologists globally. Given that in most EU countries there is no measure of the implementation of standard of care, it would be important to invest in implementation of guidelines, to ensure that national and local care pathways are in line them. This assessment will reduce mortality and improve overall survival rates of cancer patients. It will also highlight the discrepancies in the availability of medicines, which also needs to be addressed. 2) Prioritizing cancer medicines: The ESMO-MCBS is a tool, assessing EMA-approved medicines, for a rational and structured approach to derive a relative ranking of the Magnitude of Clinically Meaningful Benefit of anti-cancer treatment. It is being used by various countries across the world to prioritize cancer medicines. With the incoming wave of high-cost treatments in similar settings for cancer, there is a need to allow EU Member States to choose medicines appropriately, including the use of biosimilars. A concrete example of countries using the ESMO-MCBS: WHO cancer report 2020 (p. 45 ). - QoL & survivors: Patient guides: The ESMO Patient Guides are designed to assist patients, often in their own language, to better understand the nature of different types of cancer and evaluate the best available treatment choices. Eg: Patient Guide on Survivorship et al. - Neglected areas: 1) Data Protection:The harmonized implementation of the GDPR is crucial for health research. It would be vital to implement the principle of a one-time consent for retrospective clinical research and biorepositories, & the derogation from the consent requirement for population-based cancer registries across the EU 27. 2) Workforce: ESMO provides recommendations for a global curriculum in medical oncology: a set of common guidelines to ensure that all patients have an equal chance of receiving treatment from well-trained physicians. ESMO is also collaborating with the WHO to develop a series of tools and resources including one on health workforce optimization for cancer care. 3) Rare cancers: As 20% of all cancers are rare, their specificities make them closer to common cancers. In order to improve the quality of diagnosis and the standard of care, it is vital to rely on the expertise of the European Reference Networks (e.g. EURACAN) as well as on the successful multi-stakeholder initiative, Rare Cancers Europe and the Joint Action on Rare Cancers’ overarching deliverable: the Rare Cancer Agenda 2030. Specific areas for EU cooperation: 1) Medicines shortages: Shortages of inexpensive, essential medicines are a growing public health emergency that require a concerted effort at EU level; 2) HTA: Please see ESMO-MCBS above, regarding the joint-clinical assessment of medicines. For best practices, please see attached.
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Meeting with Stella Kyriakides (Commissioner) and

21 Jan 2020 · Discussion on cancer

Meeting with Vytenis Andriukaitis (Commissioner) and

3 May 2018 · HTA