Association of European Cancer Leagues
ECL
The Association of European Cancer Leagues is a non-profit umbrella organization advocating for cancer prevention and patient support.
Lobbying Activity
European Cancer Leagues demand stricter bans on harmful media marketing
20 Dec 2025
Message — The organization urges a revision to prohibit marketing for novel nicotine products and alcoholic beverages. They demand mandatory, government-led rules to protect children from unhealthy food advertising across all platforms.123
Why — Stricter rules would support cancer prevention by reducing exposure to commercial drivers of noncommunicable diseases.45
Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)
19 Nov 2025 · Europesjki Plan Pokonania Raka
Meeting with Wopke Hoekstra (Commissioner) and
30 Sept 2025 · Public health and tobacco matetrs
Meeting with Olivér Várhelyi (Commissioner), Wopke Hoekstra (Commissioner) and
30 Sept 2025 · Public health and tobacco matters
Meeting with Teresa Ribera Rodríguez (Executive Vice-President) and
15 Sept 2025 · EU actions in fight against cancer
Response to Biotech Act
11 Jun 2025
Both medical and technological developments have led to the increased provision of cancer medicines on the market, making it possible for cancer patients to live longer with a better quality of life. However, currently, the only way to bring innovative cell and gene therapies to patients is via a commercial route, with extremely high prices. Also, given the reluctance of the pharmaceutical industry to invest in therapies that will not ensure a return on investment, academia has an important role to play in the development and availability of innovative therapies. To make this a reality, we suggest the following recommendations: There is a need for a non-commercial academic pathway to the patient, leading to an authorisation by the EMA. This is important to make advance therapy medicinal products (ATMPs) available to patient groups with high unmet needs. This includes an academic registration trajectory, with lower or no regulatory fees; some regulatory flexibility to take the very small patient populations and the intricate complexity of niche and personalised treatments into account, support to academics to fulfil the procedures and requirements. This process should lead to treatments that are as qualitative, safe and effective as treatments sprouting from the traditional commercial pathway. We highly encourage the development of the current EMA pilot for ATMP development further into a formal pathway. Limitations to implement a new ATMP in clinical practice by academia need to be alleviated to ensure access across the EU. Fees for marketing authorisation and reimbursement procedures need to be lowered or waived for academia. Academic authorisation licenses should be valid in all EU Member States without export issues. For personalised treatments or niche ATMPs for ultra-rare diseases and other exemption situations, the Hospital Exemption (HE) remains necessary. However, because there are countries which use it in different ways, there is need for some harmonisation of the adoption at a centralised level of some operational criteria that have proven to work at the national level. The treatment under HE should be accessible for every European patient in need of the product. Data should be collected to monitor outcomes, but not necessarily to build a dossier for marketing authorisation, as niche products are likely to fail in a commercial setting or meet the needs of only a few patients. An unlevel playing field can be avoided by using the commercial marketing authorisation pathway, the non-commercial academic authorisation pathway, and the HE in a complementary fashion. They should be parallel to each other without overlap, for the purposes of commercial development, non-commercial development, and exemption situations, respectively. Current HE licenses that exceed exemption situations should be offered a transition period to obtain an EMA authorisation. These adaptations to the HE would only benefit access if a non-commercial academic pathway is realised. European and national authorities should take the specificities of early phase research into account when authorising clinical trials. Discussions between researchers and regulators on new developments and how to embed them in the legislation can be very useful. These dialogues are also relevant to adjust the regulatory system to new technological developments, such as closed manufacturing systems and a shift from product regulation to process regulation in relation to clinical outcomes. Public funding for late phase clinical trials and regulatory procedures should be available for breakthrough ATMPs developed by academia. Collaboration among academic hospitals should be stimulated, so that knowledge on topics such as good manufacturing practice (GMP) and quality control, and GMP manufacturing capacity, may be shared. These academic networks are also vital in making treatments available across Europe and in setting up international clinical trials.
Read full responseResponse to EU rules on medical devices and in vitro diagnostics - targeted evaluation
21 Mar 2025
The introduction of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) was intended to strengthen patient safety and modernise the regulatory framework in Europe. However, several years into implementation, significant challenges have emerged. Particularly, Europes start-up and innovation ecosystem in medical technology is under strain, and concerns are growing that the current regulatory environment may inadvertently stifle innovation and competitiveness. In a nutshell: MDR is currently seen as a disincentive to launch new medical devices in Europe. Start-ups already in the EU face extended timelines and increased costs under MDR/IVDR, often requiring additional capital which diverts funds from R&D and product improvement. The prolonged period without market revenue makes early-stage companies less attractive to investors. Knowledge and capacity/resources gaps: The introduction of new requirements (e.g. rigorous clinical evidence, reclassification of software/diagnostics) necessitated expertise that was initially scarce. - Researchers and research organizations often lack the regulatory knowledge and expertise required for compliance with the MDR/IVDR. Since this expertise is not readily available in-house, they must rely on external regulatory and commercial consultants, leading to increased costs and delays. - Notified Bodies had to rapidly upskill, contributing to extended waiting times. The MDR/IVDR imposes stricter requirements for clinical evidence and evaluation studies, often necessitating the repetition of previously conducted research to align with the new standards. This not only leads to additional costs and delays but can also discourage further development and commercialisation of medical devices. The increased regulatory burden results in heavier workloads, longer timelines, and thus slower innovation then the timelines of the actual development, posing significant challenges to the advancement of medical technology. As a result, research institutes often opt not to launch a medical device or limit its use to in-house applications when no comparable device is available on the market. The limited capacity and slow throughput of Notified Bodies hinders timely market entry for new devices, prompting companies to choose the US first, given the clearer and more predictable FDA pathway. To conclude, the experience of the past few years clearly shows that certain aspects of these regulations and their implementation need adjustment. Unintended side-effects particularly the hurdles imposed on start-ups, the knowledge gaps, and the notified body bottlenecks must be addressed urgently. The EU should strive to create a regulatory environment where patients have early access to breakthrough medical technologies, and where medical device companies see Europe as a prime location to develop and launch new products. This will ensure that the MDR/IVDR framework truly delivers on its promise of protecting public health without placing a needless brake on innovation and competitiveness.
Read full responseMeeting with Ricard Ramon I Sumoy (Acting Head of Unit Agriculture and Rural Development) and Bureau Européen des Unions de Consommateurs and
28 Jan 2025 · Exchange of views on issue considered relevant by the organisations on the Vision of agriculture and food, under preparation; in particular the food aspects.
Meeting with Victor Negrescu (Member of the European Parliament) and European Federation of Pharmaceutical Industries and Associations and
16 Oct 2024 · European Health Policies and their Impact on CEE Countries and Romania event
Meeting with Stella Kyriakides (Commissioner) and
9 Apr 2024 · Europe’s Beating Cancer Plan; quality of life
Meeting with Catherine Amalric (Member of the European Parliament) and European Brain Council and
18 Mar 2024 · Renew Europe Workshop on Healthcare in Europe and the patient-centric approach
Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur)
21 Feb 2024 · Pharmaceutical legislation
Response to Reducing human health risks associated with the use of sunbeds
19 Nov 2023
The Association of European Cancer Leagues (ECL), a network of cancer leagues at the national and regional level in Europe, welcomes this European Commissions call for evidence for an initiative to support their development on measures regarding ultraviolet radiation, including sunbeds. Our response draws on recent and past discussions with cancer leagues, as well as experience from ECLs Directors participation as Observer in the LVD Working Party of the European Commissions DG GROW, ECL calls for the following actions: - The Commission should coordinate official dialogues with concrete aims with policymakers, EU directorates, and pro-health stakeholders on policy solutions at both the European and national levels to halt and prevent the harmful use of sunbeds, especially by the underaged. - Explore with relevant stakeholders on developing an EU initiative to prevent harmful exposure to UV radiation, especially related to the use of sunbeds. - Provide funding for awareness-raising initiatives at the European, national and regional levels, keeping in mind that cancer prevention is often the responsibility of sub-national regions. - Put in place European level legislations resulting in legal requirements for tanning facilities which must be met for them to stay in operation, including mandatory training for employees on the carcinogenic and other health risks associated with the use of sunbeds, especially by those under 18 years of age; health warnings to be placed outside and inside the facilities, as well as on the sunbeds. - It should no longer be allowed that sunbeds can be labelled as safe under the Low Voltage Directive (LVD) of DG GROW. An official link with, or transfer to DG SANTE must be established for this dossier. Sunbeds are classified a Group 1 carcinogen carcinogenic to humans by WHOs International Agency for Research on Cancer (IARC). Yet, sunbeds are considered safe for use by European citizens as long as they fall under the requirements of the European Low Voltage Directive (LVD) (2014/35/EU) for electrical equipment, in the European Commissions Directorate General for Internal Market, Industry, Entrepreneurship and SMEs. The LVD covers health and safety risks on electrical equipment considering only voltage limits. Sunbeds which operate within those accepted voltage limits are hence misled to be safe, since as long as it is under LVD, no consideration can be given to the evidence-based detrimental health risk of sunbeds as a Group 1 carcinogen, and allows the sunbed industry to continuously argue on the safety of sunbeds solely on claims that they are within electrical voltage limits. - Official Recommendations which arises from this consultation will need to have the flexibility to be amended, if required, to be aligned with the final findings of the 5th ECAC expected in 2025. This current initiative comes at a time when the European Code Against Cancers (ECAC) 5th edition is still being developed. - In addition to the groups mentioned in the Consultation Strategy (EU governments, Commission expert groups, EBCP Stakeholder Contact Group, etc), cancer leagues should be an especially targeted consultation group, as cancer leagues are the main source of cancer information for the general population. Giving leagues targeted attention is also directly relevant to Part B of this consultation which highlighted the importance of the EU mobile app being developed for the Code Against Cancer, as it is ECL who is coordinating this project involving its member leagues. Also, the initiative only mentioned that the European office of the WHO will be consulted, but of course the consultation should involve WHOs International Agency for Research on Cancer (IARC) which develops the European Code Against Cancer, in order that recommendations from this initiative will be aligned with the next edition of the Code.
Read full responseMeeting with Tilly Metz (Member of the European Parliament) and European Patients' Forum (EPF) and
10 Oct 2023 · Pharma Package
Cancer Leagues demand drug cost transparency to lower medicine prices
18 Sept 2023
Message — The organization calls for mandatory disclosure of research costs and tax breaks. They urge for harmonized hospital exemptions to improve access to advanced therapies. They also oppose data exclusivity vouchers for antimicrobials to prevent treatment barriers.123
Why — Lower medicine prices would help member cancer societies improve patient access to treatment.4
Impact — Pharmaceutical firms would lose lucrative exclusivity vouchers and face intense price scrutiny.5
Meeting with Sylvie Brunet (Member of the European Parliament)
6 Sept 2023 · Lutte contre le cancer au travail
Meeting with Sirpa Pietikäinen (Member of the European Parliament)
1 Jun 2023 · EU Pharmaceutical Legislation
Meeting with Tilly Metz (Member of the European Parliament) and Anticancer Fund
2 May 2023 · Revision of the Pharma Package
Meeting with Sara Cerdas (Member of the European Parliament)
19 Apr 2023 · Evento acerca do Espaço Europeu de Dados de Saúde e cancro
Response to Vaccine-Preventable Cancers
6 Feb 2023
Please find in attachment the feedback from the Association of European Cancer Leagues - ECL to the call for evidence for a Proposal for a Council Recommendation on Cancer prevention - action to promote vaccination against cancer-causing viruses. For more information, please contact us at ECL@cancer.eu.
Read full responseMeeting with Sara Cerdas (Member of the European Parliament)
25 Jan 2023 · European Cancer League 2023 Program
Response to Targeted revision of the EU system of tobacco traceability
30 Nov 2022
The Association of European Cancer Leagues - ECL welcomes the European Commissions intention to amend the current EU tracking and tracing system for tobacco products, which was put in place through Articles 15 and 16 of the Tobacco Products Directive (2014/40/EU), applicable in the EU Member States as of 20 May 2016. While welcoming the commitment to tailor the tracing system to reflect the real-world datasets produced by the system itself, ECL calls on the Commission to increase the overall transparency and independence of the system. A first step in this direction should be to make publicly available all assessments of the functioning and results of the track and tracing system. Despite the system having been running for over three years, this information is not yet available. Reversing this reality would allow for greater public trust in the system, as well as for more accurate involvement and scrutiny by the part of civil society organisations acting to protect the health of citizens from tobacco harms. Tobacco industry has an established track record in undermining health policies aimed at restricting (illicit) trade in tobacco products. To avoid industry interference in the system for tobacco product traceability, ECL further calls to limit the involvement of the tobacco industry to only what is absolutely necessary, addressing some key weaknesses that could hamper the transparency and independence of the system. In particular, the current process for nomination of data repositories and auditors seem to remain industry-led. The Commission or Member States could take the lead in this endeavour with full transparency. The names of auditors and the reports that these have produced should be made publicly available, to ensure that public interests are prioritised over commercial ones. Lastly, the scope of duties for auditing should be broadened to account not only for irregularities in relation to access of data storage facilities, but also for companies potential debatable choices of software generating unique identifiers.
Read full responseEuropean Cancer Leagues urge 80% pesticide reduction by 2030
19 Sept 2022
Message — ECL requests legally binding targets for an 80% reduction by 2030. They demand a total phase-out of synthetic pesticides by 2035. They also call for larger buffer zones to protect citizens.12
Why — These measures would directly help the organization's mission to eliminate occupational cancers.3
Impact — The agrochemical industry would lose the market for synthetic pesticides by 2035.4
Cancer leagues demand patient-centered European health data framework
26 Jul 2022
European Cancer Leagues urge tougher EU smoke-free rules
19 Jul 2022
Message — ECL wants the EU to include e-cigarettes and heated tobacco in smoking bans to protect public health. They also advocate for banning smoking in outdoor areas like playgrounds, parks, and beaches frequented by children.12
Why — These measures help the association progress toward its primary objective of a tobacco-free Europe.3
Impact — The tobacco industry would face stricter limits on marketing and selling their novel products.4
Meeting with Stella Kyriakides (Commissioner)
27 May 2022 · Visit to the Arodapnhousa Palliative Care Centre
Response to Cancer Screening Recommendation
22 Feb 2022
The 2003 Council Recommendation was vital in promoting the shift from opportunistic approaches towards population-based screening following evidence-based, quality assurance guidelines. For its revision, the challenge is to be forward-looking by motivating member states to prepare for the inevitable changes in early detection of cancer taking shape over the next decade. This is likely to be influenced by, amongst others, a shift from one-size-fits-all approaches towards addressing categories of people according to their level of risk. This presents technical challenges that will need to be addressed by screening programmes to assure quality and deliver value for money. Whilst the Recommendation cannot prejudge the evidence, it can anticipate the implications and requirements for good governance, data protection, workforce and appropriate communication to end-users. Clarifying and communicating effectively the terminology of the new paradigm (i.e. personalised, targeted, risk-based, etc.) will also be of value.
Nevertheless, a future-oriented approach is not a signal to pursue innovation at all costs. We are concerned that the interest generated by exploring potential new sites for screening and developing new modalities may overshadow the necessity of a sustained focus on quality that ensures the benefits of screening with minimised harms. The update should clearly address and renew the essential principles for quality improvement in cancer screening across its entire pathway. To this end, we endorse and promote the recommendations of the WHO Short Guide on Cancer Screening (https://bit.ly/3IdDai8).
Large differences persist in Europe regarding the coverage of cancer screening. Other indicators of quality suggest wide variation in the performance of screening within and between member states. In 2017, the second implementation report of the Recommendation suggested that appropriate monitoring of screening activities was not yet in place in many member states. The monitoring actions are necessary not only for the accountability of cancer screening but also for evaluating the screening outcomes. Therefore, the update of the Recommendation must be coupled with long-term investment from the EU to support member states with these activities as the ability to evaluate the quality and coverage of the existing screening programmes is a prerequisite for member states to make an informed choice about the introduction of screening for new cancer sites or not.
Most affected by variation in screening quality are socially disadvantaged populations who face barriers to access and often inadequate communication thereby exacerbating existing inequalities. Communication to all possible end-users of cancer screening requires regular refreshing to ensure it is clear, honest and faithful to the evidence, and supports people to make an informed choice about screening. Improving equity within cancer screening programmes has gained major importance since the publication of the Recommendation and must have a prominent and central place in its update. Once again, this refers back to the previous points of establishing and implementing robust monitoring and reporting systems to inform policy decisions that can lead to action to reduce inequality in access to cancer screening.
When considering variation, we also stress the importance of acknowledging the heterogeneity of health systems in Europe and the context in which they operate, namely: financial resources, workforce and technical capacity, etc. For this reason, we urge that the Recommendation implores member states to follow a stepwise approach to implementing, evaluating and expanding screening, based upon localised needs and cost-effectiveness analysis. Moreover, we suggest that the update of the Recommendation enables the establishment of a permanent platform supporting member states to implement quality assurance and continuous quality improvement of organised cancer screening.
Read full responseResponse to Evaluation and revision of the general pharmaceutical legislation
27 Apr 2021
ECL welcomes the opportunity to contribute to the revision of the general pharmaceutical legislation.
Across the legislative changes in the health space, it is essential to remember that health is a public good and should not be discussed as a marketing item.
ECL’s keywords: conditionalities, transparency, and cross-border collaborations.
Firstly, to address unmet medical need (UMN), gaps in science need to be filled as essential research questions are not investigated. Patients play a pivotal role in steering non-commercial and commercial R&D towards those areas that need new health technologies to prevent, detect, cure, or stabilise a disease. It should be logical to include patients’ voice in the discussions on defining criteria to assess UMN.
Public, academic and non-profit research should be supported with HORIZON Europe and the EU4Health Programme to address UMN, with the objective of extending their role from basic research to market-ready products. This would ultimately increase competition for commercial developments.
Simplification: It does not mean cutting corners in scientific assessments. Simplification should mean making communication channels more transparent and avoid duplications. This should apply also in the monitoring of medicine and medical device supplies, making use of existing tools such as the i-SPOC systems to firstly prevent shortages and then minimise the disruption should a shortage occur.
Incentives: These should be accompanied by conditionalities and within a system of rewards & sanctions to cover scientific gaps, drive research in areas that currently do not have treatments, guarantee the provision of medicines, foster transparency on R&D costs and the costs required to put a medicine on the market. Public funds for research should come with conditions to make drugs affordable and available, for example by making use of socially responsible licensing and periodically assessing if targets are reached. Personalised treatments should not lead to proliferation of orphan designations that may not bring real added value. To address affordability, revoking market exclusivity when a medicine has generated sufficient RoI should be explored.
Future-proofed legislation: It is essential to establish a sustainable system that can still be in place in the next years. Personalised medicine is a vital area for patients, but EU legislation cannot establish an unsustainable ecosystem for governments, otherwise personalised medicine would only be accessible to some, widening inequalities among the EU Member States. The introduction of generics and biosimilar needs to be fostered to increase competition and minimise monopolies.
Skyrocketing prices create an unsustainable system. Even if the new therapies might bring added value to patients (which should be assessed with joint clinical assessment to identify real innovation in treatment of complex diseases, such as cancer) these need to be affordable or they will never reach patients. There should be a clear justification behind a price: besides bringing added value for patients, there should be a reasonable relationship between the cost of bringing the product to market and the price, price should be predictable and cost-effective. In addition, a fair pricing process should be created together with other stakeholders. By echoing the response of EFPN, the Commission should investigate the (marketing) tactic of withdrawing off-patent drugs and reintroduction of similar medicines with a new indication and much higher price.
Collaboration: EU Member States face common challenges (e.g. aging population, economic distress, new unaffordable medicines coming into the market, Covid-19). It comes naturally to strive for cross-border collaboration and perform horizon scanning when assessing and negotiating medicines. Healthcare systems are under the competence of national governments, but the EU should take the lead and support regional initiatives, like BeNeLuxA.
Read full responseMeeting with Stella Kyriakides (Commissioner)
15 Jan 2021 · Exchange of views on the EU Pharmaceutical Strategy
Response to Revision of the EU legislation on medicines for children and rare diseases
16 Dec 2020
The ECL Access to Medicines Task Force (A2M TF) welcomes the Commission’s initiative to seek a new legal framework to solve issues within current legislation on medicines for children and rare diseases. The A2M TF urges the Commission to prioritise the following problems:
There are no approved treatments for 95% of rare diseases. This must change. Therefore, the A2M TF strongly agrees with the Commission that medicines should be developed in areas of unmet medical needs. To encourage real innovation in areas with high unmet medical need, public and private investment in R&D should be steered towards clearly defined public health needs. This should include medicines for children and rare diseases. To achieve this, an improved coordination and priority-setting mechanism is needed at the EU and global level. The new legislative framework should provide incentives to stimulate developments for patients with so-called ultra-rare diseases and for children’s most pressing needs, such as medicines for children with rare diseases, with extra attention for children with cancer. For children, the ‘mechanism of action principle’ should be introduced. This prevents granting of PIP waivers when an adult cancer has no paediatric iteration but the drug’s mechanism of action is beneficial for pediatric cancers.
The incentives must reasonably reward the level of novelty of a product. The regulation should tackle threats to affordability and access, such as incentives leading to overcompensation, indication stacking, and high drug prices even when the R&D investment of a company was very low. At the same time, it should deter inappropriate use for so-called “artificially rare diseases” and multiplication of exclusivities in all forms.
The new regulation should introduce experiments with innovative incentives. An example is a system based on rewards or prizes. The reward compensates for the R&D cost, so that the drug can be distributed in every European country at the cost of production and distribution.
The EU faces huge inequity challenges. There exists too big of a difference between and within Member States when it comes to access to medicines. In some Member States, certain treatments are delayed or do no enter the market at all. Children and patients with rare diseases must have equitable access to affordable treatment. It should not matter where you live.
The A2M TF sees a problem with the lack of legal conditions connected to incentives (e.g. SPC’s) that could enhance wide market availability. EU wide access could be guaranteed by introducing an obligation for providers to introduce new orphan treatments in the entire European market. Dedicated funding to support development of orphan drugs by SMEs and academia should come with conditions leading to affordability. “Socially responsible licensing” is a guiding framework for these conditions. Transparency is fundamental. The fact that the Commission cannot reassess a provided designation on its effect for availability, affordability and accessibility might lead to problems connected to misuse of the regulation. To conclude: it lacks an intervening tool that keeps the paediatric and orphan pipeline healthy.
In addition, academia plays a vital role in developing treatments in the area of unmet medical need. The new legislative framework must value their efforts and ensure a level playing field for academic sponsors. Therefore, the regulations must extra support academic sponsors. To ensure that the pool of non -commercial sponsors enlarges, and thereby more new treatments for children and patients with rare diseases are developed.
The ECL A2M TF wishes to contribute to this stakeholder wide discussion on the matters as described above. If it would be the Commission’s preference, the ECL A2M TF welcomes any further dialogue and endorses the position submitted by the European Fair Pricing Network (EFPN). Please see p.15-17 of the attached position paper on the EU Pharma Strategy.
Read full responseResponse to Intellectual Property Action Plan
29 Jul 2020
The patent system and additional mechanisms (e.g., supplementary protection certificate - SPC) protect medicines from generic competition and incentivise companies to do research and development. In the EU, a new medicine is protected from competition by for 13 years on average. In this period, the absence of competition keeps the price at a high level and companies can gain high profit margins which recover their R&D costs. This further allows them to continue investing in R&D and discover new treatments.
Although this system undeniably stimulates R&D by companies, it also has disadvantages. Growing competition, particularly related to increased availability of generics and biosimilars, significantly contributes to savings in medicine's budget, allowing for both greater availability of off-patent medicines, but also greater investments in innovative treatment options. Patents and incentives such as data exclusivity can slow down research. Researchers and companies who intend to patent an invention are not inclined to share information about their work. But sharing early research results gives an impetus to further research.
ECL Recommends to:
1. Fund pilot studies to find alternative ways to incentivise and award medicines development and ensure R&D models result in affordable products. Research should not be driven by the chase after IP but rather by societal return where valuable solutions for patients are awarded. There is little evidence analysing alternative models which are designed to bring innovative medicines at reduced and affordable prices. This uncertainty should lead to a cautious approach, particularly regarding initiatives such as delinkage, which are highly disruptive and require legal change and/or substantial change in the practice of medicine development.
2. Conduct continuous review of the European IP system (including the application of patent protection, SPC and R&D incentives) to ensure an effective stimulus for further innovation, particularly in areas of high unmet medical need, while avoiding the current affordability issues and excessive pricing spiral caused by anti-competitive practices (including pay-for-delay deals and misuse of patent protection and incentives).
3. Ensure the right balance between awarding IP incentives in orphan medicine development, particularly where there exist no treatment alternatives, and preventing unintended effects on affordability (e.g., by revoking market exclusivity when a medicine has generated sufficient return on investment; or evaluating the benefit-risk ratio of extended market and data exclusivity).
4. Enforce compulsory licences for products in case of public health emergencies (including covid-19 pandemic). If European patents with unitary effects can be granted, granting European compulsory licences must also be enabled. The EU should be able to invoke this right in public health crises, including when unavailability or limited availability of medicine/vaccine occurs, e.g., due to excessive prices or manufacturing issues.
Read full responseResponse to Pharmaceutical Strategy - Timely patient access to affordable medicines
24 Jun 2020
ECL welcomes the initiative to build patient-centred Pharma Strategy with strong emphasis on addressing unmet need & achieving greater medicines access, availability, affordability and sustainability of health systems. For key policy recommendations, see page 12-18 of our BCP vision: https://bit.ly/3drdqPp
Strengths:
1.Ensure timely access to safe, quality and affordable medicines and financial sustainability of MS’ health systems.
ECL appreciates recognition of (i) high medicines prices and its negative impact on health systems and patients; (ii) need for enhanced cooperation in HS, HTA and P&R; (iii) need for increased transparency throughout the sector, including on costs and prices of medicines. ECL recommends to:
i. Prevent misuse and overuse of the orphan status and ensuring the right balance between investment in orphan medicines, particularly where there is no treatment alternative, and preventing unintended effects on affordability;
ii. Conduct a study on the role of price transparency, with attention to robust methods for the calculation of R&D and production costs, and suggesting ways toward EU-wide implementation of the WHO Transparency Resolution;
iii. Measure and disclosing the extent of public investment in R&D at both the EU and MS level and creating prerequisites for public investment to ensure publicly funded products are available at an affordable price;
iv. Establish High-Level multi-stakeholder WG to discuss a fair price definition and sustainable pricing models.
2.The need for new therapies to be clinically better than existing alternatives as well as cost-effective.
It is crucial to align patient and public health needs with development of new medicines. It is important to maintain high regulatory and HTA standards. ECL recommends:
i. Full implementation of the Clinical Trials Regulation as soon as possible;
ii. Close collaboration between public authorities, patients and HCPs to identify and financially support areas of unmet medical need and low financial interest;
iii. High quality benefit-risk assessment of patient-relevant endpoints before granting market access, stressing the need for surrogate endpoints in CTs to be accompanied by hard endpoints reflecting improvements in overall survival and quality-of-life measures;
iv. Systematic collection and submission of real-world evidence (including OS, adverse reactions and QoL improvements) once the medicine enters the market;
v. Pooling of resources and international cooperation between EU MS to prepare health systems for (i) the arrival of new medicines and technologies, (ii) conducting high quality HTA and (iii) sharing information about prices and pricing and reimbursement strategies, in order to enhance MS' ability to (a) prioritise medicines with higher clinical value, (b) review and adjust prices based on new evidence, and (c) effectively negotiate the prices of medicines.
3.Addressing and preventing medicine shortages.
One country cannot address this growing problem alone. Please see our recommendations on how to prevent and manage medicine shortages in Europe here: https://bit.ly/2YqgxCE
Shortcomings:
1.More attention should be given to the need to maintain a robust regulatory environment for medicines coming to the EU market. This includes new ways of collecting evidence on medicines efficacy and safety (also post approval - RWE) and data requirements for developers which include regulators/payers demands early in the medicines R&D process. Connecting this Strategy with the recently published EMA Regulatory Science strategy is crucial.
2.The negative impact of IP protection and incentives on the affordability of products should be elaborated.
3.Acknowledging public investment in medical R&D and attaching it to conditionalities related to open science and affordability is key, e.g., for products funded through EU4Health or HEU.
4.Role and responsibilities of the EMA in the development of the Strategy should be clarified and enhanced
Read full responseMeeting with Stella Kyriakides (Commissioner)
25 May 2020 · VC meeting with discussion on access to care for cancer patients, clinical trials and research, healthcare systems in Member States during COVID-19, data collection and future funding.
Response to Farm to Fork Strategy
16 Mar 2020
The Association of European Cancer Leagues (ECL) welcomes the Commission's proposal for a Farm to Fork strategy for sustainable food. As a network of 30 national and regional cancer societies in the European region, we are acutely aware of the association between nutrition, diet and body weight and cancer. The current edition of the European Code against Cancer (http://cancer-code-europe.iarc.fr/index.php/en/) advises individuals to maintain a healthy body weight and follow a diet that is rich in legumes, pulses and wholegrain foodstuffs, whilst limiting or avoiding processed meat, sugary drinks and foods high in salt and sugar.
Whilst individual knowledge and behaviour change is imperative to good health, in most circumstances, individual behaviour is greatly influenced and constrained by the environment in which they live and work. In this spirit, we are greatly encouraged that the Farm to Fork strategy will work hand-in-hand with the Beating Cancer Plan to foster supportive environments that allow individuals to make the choices to improve their health by maintaining a healthy, balanced diet. We are also conscious of the role food production has in addressing the climate emergency and, therefore, encourage the Farm to Fork strategy to heed the advice of the EAT Lancet commission to promote a planetary health diet. We are encouraged to see the potential of the Farm to Fork strategy to address environmental issues and believe that this will return multiple benefits for public health.
As a long-standing member of the European Public Health Alliance (EPHA) we endorse their contribution to the consultation process. We are proud to refer you to our recent contribution to Europe's Beating Cancer Plan and its section on diet and nutrition, which directly addresses the proposed Farm to Fork strategy. Our contribution can be downloaded at: https://www.europeancancerleagues.org/wp-content/uploads/ECL-vision-EU-Beating-Cancer-Plan_final.pdf
Read full responseResponse to Europe’s Beating Cancer Plan
3 Mar 2020
Europe's Beating Cancer Plan (BCP) should aim to organise our society and economy to benefit EU citizens, cancer patients and survivors. The goal should be to close the inequalities gaps between and within MS, focusing on key areas where Europe should work together to improve cancer control and care. BCP should complement and amplify the impact of national and regional cancer control plans.
PREVENTION
Tackling modifiable risk factors have additional benefits for all NCDs. Priority should be given to translating messages of the European Code Against Cancer into policy action, incl. re environmental and workplace carcinogens, and immunisation against HPV and hepatitis B. BCP should take the lead to regulate artificial tanning devices as a public health problem and not as a commercial device. BCP must focus intensely on early detection of cancer as timely diagnosis greatly increases chances for successful treatment and increased understanding of possible warning signs of cancer, among HCPs and the public. Support is required to establish a permanent platform for competent authorities and independent experts to monitor, evaluate and propose evidence-based recommendations to improve population-based cancer screening programmes. Lack of clarity on or commitment to the implementation of optimal strategies to bring about improvements in public health through behavioural change or policy and regulatory measures should be addressed.
RESEARCH
R&I investments should be driven by public health and patients’ needs, abiding to the highest transparency standards and involving patients and civil society. Public R&I should be accountable and result in health technologies that are available in a timely manner to those who need them and at a price that individuals, health systems and providers can afford. Focus should be given to behavioural research underpinning lifestyle patterns that increase cancer risk and management of long-term side-effects of treatments and interventions improving the quality of life of survivors. Effective research efforts are conditioned by the possibility of sharing high-quality individual health data across the EU, EEA and as part of global collaborations. BCP should support such collaborations and address challenges posed by heterogeneous interpretation of GDPR across MS.
TREATMENTS
The Roadmap rightly identifies that treatment costs for many cancer therapies are high, with often limited analysis of the overall social and economic benefit of such treatments, there are large inequalities in terms of patient access to treatments and that innovation may further increase those gaps. BCP should include concrete measures to safeguard the sustainability of healthcare systems and patient access to treatment such as ensuring robust regulatory framework to avoid its misuse (incl. accelerated approvals where sufficient evidence on safety and efficacy is missing; patent protection and IP incentives - e.g., orphanisation of cancer treatments) and support MS in their cooperation in horizon scanning, HTA and information sharing on pricing. BCP should include measuring the extent and causes of medicines shortages and suggest coordinated approach among MS.
CARE & SURVIVORSHIP
BCP should provide funds to build capacity in MS, particularly in the CEE region, to ensure structural investment in workforce, technologies and specialised centres of excellence. BCP should be patient-centred with overall focus on quality of life of patients and survivors. Best practices, particularly in terms of full integration of supportive care and psycho-social services in cancer care and protection against financial toxicity of cancer for both patients and carers shall be promoted.
For more detailed information about our priorities for effective cancer control, please consult our full position paper, available at: https://www.europeancancerleagues.org/wp-content/uploads/ECL-vision-EU-Beating-Cancer-Plan_final.pdf
Read full responseMeeting with Stella Kyriakides (Commissioner) and
20 Jan 2020 · Discussion on cancer
Meeting with Vytenis Andriukaitis (Commissioner) and
5 Jun 2018 · HTA
Response to Implementing act under Article 15(11) of the Tobacco Products Directive 2014/40/EU
29 Sept 2017
Comments of the Association of European Cancer Leagues on the traceability system and security features.
1. We welcome that unique identifiers are generated by an independent third party at the request of the Member States.
2. We are worried about the definition of independent third party as the tobacco industry has a long history of working with many third parties which they describe as “independent”, but serve their interest. We strongly support the proposals submitted by Smoke Free Partnership to deal with the independence issue. If a fifth of the income of a third party is generated by the tobacco industry, the company is or becomes dependent from the tobacco industry.
3. We regret that the unique identifiers are not secure, an obligation of the WHO FCTC illicit trade protocol, which the EU has ratified. Data carriers are not protected against cloning or copying. It is a myth to believe that the EU repository system will automatically alert the Member States when codes are copied. For instance, when products are exported outside the EU, those products will not contain a security feature and will not be registered in the EU system as illegal, only as exported. Copied codes could be applied on packs and transported illegally in the EU without registration. When those products are seized, authenticity can’t be checked (no security feature) and verification in the EU repository system will reveal that they are legal (exported, but no further info).
4. We regret that the anti-tampering devices are only verifying that the data carriers are readable, but not that they are applied on the right products (brand description mentioned in the unique identifier). In Brazil, for instance, a camera on the production line verifies that unique identifiers are applied on the right products. It is possible that, intentionally or not, data carriers are applied on the wrong products. This will hardly be noticed, if the products are exported outside the EU or only noticed in a later stage, at the retail level, when an inspection takes place.
5. Tobacco companies will choose providers for the primary repositories. Those primary repositories will appoint a secondary repository. Both choices will result in contracts and payments by the tobacco companies. The data storage providers will be monitored by auditors, paid and selected by the tobacco companies.
6. We believe that the control by the tobacco companies of the secondary or common data repository is extremely worrying for the following reasons:
• The tobacco industry has no incentive to select a common data provider who would do an excellent job and alert systematically all irregularities committed by them.
• The data service and auditors will have a financial relationship with those they should monitor. This may create a conflict of interest between the watchdog and the customer.
• The common data repository will not be managed by the Commission or the Member States. Both institutions can’t interfere in the daily work of the data provider, but can only request, in case of unsatisfactory performance, the end of the contract. For instance, when obligations on legal independence or irregularities in relation to access of the data are observed. However, an abrupt contract termination is difficult to justify and even undesirable as it might disrupt the data sharing and analysis. The data storage system is controlled by the industry which is conflict with recital 31 of the Tobacco Products Directive which stipulates that “the data related to the tracking and tracing system should be under the control of (..) the competent authorities from Member States and the Commission”.
• Art. 27 of the implementing act for the traceability system is a first step to resolve this problem. At a minimum, we would request a stronger rewording of article 27.10, which would give the control of the data to the Member States and Commission to obtain the analysis they need.
Read full responseResponse to Delegated act under Article 15(12) of the Tobacco Products Directive 2014/40/EU
28 Sept 2017
Comments of the Association of European Cancer Leagues (ECL) on the traceability system and security features:
1. We welcome that unique identifiers are generated by an independent third party at the request of the Member States.
2. We are worried about the definition of independent third party as the tobacco industry has a long history of working with many third parties which they describe as “independent”, but serve their interest. We strongly support the proposals submitted by Smoke Free Partnership to deal with the independence issue. If a fifth of the income of a third party is generated by the tobacco industry, the company is or becomes dependent from the tobacco industry.
3. We regret that the unique identifiers are not secure, an obligation of the WHO FCTC illicit trade protocol, which the EU has ratified. Data carriers are not protected against cloning or copying. It is a myth to believe that the EU repository system will automatically alert the Member States when codes are copied. For instance, when products are exported outside the EU, those products will not contain a security feature and will not be registered in the EU system as illegal, only as exported. Copied codes could be applied on packs and transported illegally in the EU without registration. When those products are seized, authenticity can’t be checked (no security feature) and verification in the EU repository system will reveal that they are legal (exported, but no further info).
4. We regret that the anti-tampering devices are only verifying that the data carriers are readable, but not that they are applied on the right products (brand description mentioned in the unique identifier). In Brazil, for instance, a camera on the production line verifies that unique identifiers are applied on the right products. It is possible that, intentionally or not, data carriers are applied on the wrong products. This will hardly be noticed, if the products are exported outside the EU or only noticed in a later stage, at the retail level, when an inspection takes place.
5. Tobacco companies will choose providers for the primary repositories. Those primary repositories will appoint a secondary repository. Both choices will result in contracts and payments by the tobacco companies. The data storage providers will be monitored by auditors, paid and selected by the tobacco companies.
6. We believe that the control by the tobacco companies of the secondary or common data repository is extremely worrying for the following reasons:
• The tobacco industry has no incentive to select a common data provider who would do an excellent job and alert systematically all irregularities committed by them.
• The data service and auditors will have a financial relationship with those they should monitor. This may create a conflict of interest between the watchdog and the customer.
• The common data repository will not be managed by the Commission or the Member States. Both institutions can’t interfere in the daily work of the data provider, but can only request, in case of unsatisfactory performance, the end of the contract. For instance, when obligations on legal independence or irregularities in relation to access of the data are observed. However, an abrupt contract termination is difficult to justify and even undesirable as it might disrupt the data sharing and analysis. The data storage system is controlled by the industry which is conflict with recital 31 of the Tobacco Products Directive which stipulates that “the data related to the tracking and tracing system should be under the control of (..) the competent authorities from Member States and the Commission”.
• Art. 27 of the implementing act for the traceability system is a first step to resolve this problem. At a minimum, we would request a stronger rewording of article 27.10, which would give the control of the data to the Member States and Commission to obtain the analysis they need.
Read full responseMeeting with Vytenis Andriukaitis (Commissioner) and
2 Mar 2017 · Towards a renewed EU Alcohol and Health Forum
Meeting with Vytenis Andriukaitis (Commissioner) and
6 Mar 2015 · EU ACTION ON CANCER INCLUDING INO ON ON-GOING JOINNT ACTIONS AND THE CANCER CODE, Possibilites of further co-operation & Tobacco