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The Global Alliance for TB Drug Development

TB Alliance

TB Alliance is a not-for-profit organization dedicated to the discovery, development and delivery of better, faster-acting and affordable tuberculosis drugs that are available to those who need them.

Lobbying Activity

Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

TB Alliance welcomes the European Commissions proposed pharmaceutical package, especially with regards to: 1) addressing unmet medical needs, 2) proposing incentives to tackle antimicrobial resistance, 3) regulatory support, and 4) reporting on publicly funded financial support. TB Alliance is a not-for-profit organisation dedicated to the discovery, development, delivery, and availability of better, faster-acting, and affordable tuberculosis (TB) drugs. We are part of a group of Product Development Partnerships (PDPs), aiming to address existing market failures by linking the public, private, academic and philanthropic sectors. First, on addressing unmet medical needs (UMN), we welcome the pharmaceutical packages ambition to ensure available, accessible, and affordable medicines. We believe it is important for the definition of UMN to capture global health threats. The proposed definition of UMN includes diseases with high mortality, which is the case for many poverty-related and neglected diseases, such as TB the leading infectious disease killer in the world today. Considering that one of the objectives of the pharmaceutical package is to ensure access to treatments in disease areas where no treatments are currently available, we would like to highlight that for some poverty-related diseases such as TB, treatments may be available, but these are often older drugs that are burdensome for patients. Therefore, we urge that patient adherence is considered an important parameter, to be included in the new concept of UMN. Second, on antimicrobial resistance (AMR), we support the Commissions proposal to establish a strong incentive against the rise of AMR in Europe and around the globe. Each year, drug-resistant (DR) and multi-drug-resistant (MDR) TB are responsible for about 1 in 3 deaths caused by AMR infections. Research into innovative medicines for DR TB suffers from market failures that a streamlined EU incentive approach could address. As per the recent DG HERA study on bringing AMR medical countermeasures to the market, TB has been used as an example in the interim study to showcase the urgent need for the development of new and improved TB treatments. Therefore, we support the Commissions dedication to proposing an ambitious incentive to encourage the development of innovative medicines to counter AMR, such as the transferrable exclusivity vouchers (TEVs) or the priority review voucher (PRV), which TB Alliance has benefited from in the United States. Third, we encourage the Commission to consider that future innovative TB medicines should be considered eligible for early scientific support and faster marketing authorisation through existing procedures. The proposals on regulatory support from the European Medicines Agency are of interest, such as Article 60 of the Regulation on Enhanced scientific and regulatory support for priority medicinal products. Finally, on reporting publicly funded financial support, we welcome the Commissions ambition for more transparency in public funding. Unlike for-profit companies, TB Alliance relies on public and private sector funding for the research and development of innovative medicines, something which we share transparently. Our PDP model ensures that profits made are being re-invested in the core business of research and innovation. To conclude, we would like to emphasise the need for collaborative R&I models to achieve research excellence in innovative countermeasures for AMR and DR TB. One major example is the BPaL regimen, which is a new treatment for highly drug-resistant TB patients, that has been shown to cure approximately 90% of patients in only 6 months. BPaL received EU marketing authorization in 2020 and entered the WHO recommendations for treating TB, highlighting the importance of PDP model in driving innovation. As TB Alliance, we would like to thank the Commission for its work. We remain available to provide feedback on our experience to date.
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Meeting with Renaud Savignat (Cabinet of Commissioner Jutta Urpilainen)

14 Oct 2022 · Global Gateway Strategy and Global Health Strategy

Response to EU strategic Framework for Global Health

19 Sept 2022

TB Alliance welcomes the opportunity to provide feedback on the EU’s 2010 Communication and believes an updated EU Global Health Strategy is needed. TB Alliance is a Product Development Partnership (PDP) dedicated to the discovery, development and delivery of better, faster-acting and affordable drugs for tuberculosis (TB) and multidrug-resistant TB (MDR-TB). PDPs are not-for-profits committed to developing health technologies via partnerships between the public, private, academic and philanthropic sectors, to tackle infectious diseases or poverty-related and neglected diseases (PRNDs) in underserved markets. In 2019, TB Alliance became the first not-for-profit to develop and register an anti-TB drug: Pretomanid. With our expertise on TB and our experience as a PDP in mind, in our response we look back on existing initiatives, how they relate to TB, and identify three aspects that should be prioritised: (i) funding; (ii) effective multilateralism; (iii) health objectives. In 2010, the EU’s Communication was a first recognition of the need for a more impactful global health framework. In 2015, the EU helped with the establishment of the 17 United Nations (UN) Sustainable Development Goals (SDGs) for 2030. Since then, EU strategies have aligned with the SDGs’ targets. In the past two years, due to the COVID-19 pandemic, the EU has continuously increased its focus on health threats and advocated for stronger multilateral collaboration. With a new Strategy, the EU can take a leading role on global health action and set out more ambitious objectives—including on TB. While TB is referenced in the EU’s 2010 Communication—which mentions the EU’s 2007-2011 programme against TB, noting how PRNDs require special attention—and the SDGs set targets to put an end to the epidemic, TB continues to impact and kill millions of people. According to the World Health Organization (WHO), in 2020 1.5 million people died from TB globally, and in 2022 the number of deaths was reported as rising. At the same time, data indicates that funding for TB has been decreasing. A new Strategy would be an opportunity to re-prioritise TB, and more generally PRNDs, which are serious health threats with worldwide impact. With this aim, TB Alliance is sharing recommendations on three priority areas. • Funding: o Targets—Financing should be directed to investments in: (i) R&D for innovative medical countermeasures to treat infectious diseases and PRNDs; (ii) global, cross-sectoral partnerships, especially models such as PDPs; (iii) scale up of capabilities, from clinical laboratories to healthcare workforce o Recipients—The eligibility criteria for EU funds should be more flexible, to ensure accessibility of funds for entities that are not based in the EU or its Associated Countries, but are dedicated to address PRNDs in underserved markets o Allocation—The amount allocated to the Strategy and its implementation should be clearly stated. A clarification on the allocation of funds among funding frameworks and projects (e.g., the Global Gateway, the Africa-Europe Investment Package, a new Strategy) is also needed. • Effective multilateralism: o Inclusion of all stakeholders—Beyond states and multilateral international organisations, a strengthened global health structure needs to involve a wide range of stakeholders, including industry, academia, civil societies, and innovative partnerships such as PDPs o Implementation and enforcement—Goals established at global health fora, such as WHO, G20, G7, need better implementation. Internationally agreed resolutions and conventions should, where and when possible, introduce binding measures. • Health objectives: TB and antimicrobial resistance (AMR) should be explicitly referenced on a new Strategy. Concrete goals and measures to address both need to be introduced and aligned to international action. TB Alliance would like to note its availability to take part in the targeted stakeholder consultations.
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Response to Recommendation for strengthened actions against antimicrobial resistance

23 Mar 2022

About TB Alliance: TB Alliance is a Product Development Partnership (PDP). PDPs are not-for-profits who develop drugs and technologies for people suffering from infectious diseases, poverty-related and neglected diseases in underserved markets, including new treatments for drug-resistant diseases. This is accomplished through partnerships between the public, private, academic, and philanthropic sectors. TB Alliance is dedicated to the discovery, development and delivery of faster-acting and affordable drugs for Tuberculosis (TB). As 1 in 4 deaths globally are due to drug-resistant TB, TB Alliance has a strong focus on AMR. In 2019, TB Alliance became the first not-for-profit to develop and register an anti-TB drug: Pretomanid. Evidence: As the European Union is revisiting actions to tackle AMR, TB Alliance would like to highlight five areas where inputs are needed: 1. Inclusion in emerging and existing global bioprepardness frameworks – While TB Alliance welcomes the funding allocated to AMR in DG HERA’s 2022 Work Plan and supports the call for AMR to be included in the WHO’s accord on pandemic prevention, more can be done in terms of ambition and funding. The importance of including AMR in existing and forthcoming frameworks is accentuated by the conflict in Ukraine. As Ukraine is among the WHO’s top 20 countries facing severe cases of multidrug-resistant TB, AMR will worsen as patients cannot access care and are dispersed. TB Alliance, for example, has had to stop its activities with drug resistant TB patients in Ukraine. 2. Promotion of stewardship – TB Alliance calls on the EU to increase its efforts to promote antimicrobial stewardship, which is critical to ensure appropriate prescription and assumption of antimicrobials. To support this, TB Alliance develops antibiotic regimens that are patient friendly, easier to tolerate and highly effective. Additionally, TB Alliance also carries out training activities with clinicians to educate on appropriate prescriptions – we would be happy to share this expertise. 3. Creation of incentives and support for PPPs – TB Alliance calls for: • Robust incentives: There is a need to review the current system and create novel incentives. In addition to ‘push’ incentives, there should be ‘pull’ incentives, such as transferable exclusivity extensions (TTEs) and market entry rewards (MERs). An effective push-pull system would ensure funding for R&D costs for antimicrobials, as well as reward the development of effective treatments. • Stronger PPPs: There is a need for funding for innovative public-private partnerships (PPPs). TB Alliance contributed to the Unite4TB and ERA4TB projects, under IMI’s AMR Accelerator. Building on this experience, TB Alliance calls for eligibility criteria to be made more flexible (e.g., to be extended to innovative PPP models and to have less strict geographical limitations). 4. Optimisation of the regulatory framework for fast-track approval – TB Alliance calls for the revision of the general pharmaceutical legislation to include provisions reducing regulatory burdens for the approval of antimicrobials. Adaptable, flexible, and more harmonised regulatory processes are needed to incentivise development, but also to accelerate availability and accessibility. 5. Optimisation of monitoring and surveillance systems – TB Alliance supports the monitoring and surveillance activities carried out by EU bodies (in particular, ECDC and EMA) and calls for efforts to be optimised, following the One Health approach. Monitoring and surveillance activities should be optimised by increasing surveillance activities, employing new monitoring technologies, co-ordinating and harmonising data collection across sectors, and providing support for monitoring to LMICs.
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Response to European Health Emergency Response Authority

23 Feb 2021

TB Alliance is a not-for-profit organization dedicated to the discovery and development of better, faster acting, and affordable tuberculosis drugs. It is part of a group of Product Development Partnerships (PDPs) which aim to address existing market failures by linking the public, private, and philanthropic sectors. The ongoing COVID-19 pandemic has highlighted the devastating consequences emerging health threats can have. To mitigate such threats, strong EU action is needed to bring early stage research through to market in areas with pandemic potential. Therefore, TB Alliance welcomes the European Commission’s ambition to create an EU Health Emergency Preparedness and Response Authority (HERA). TB Alliance supports the options within the Inception Impact Assessment, especially options 2 and 3, which include specific elements required for such an agency to be successful. TB Alliance urges the Commission to not follow option 1 as it lacks the necessary ambition and consequent funding for the HERA to be successful. While some valuable elements are contained within option 3, we believe that the existing research partnerships have their respective priorities should be kept separate whilst still collaborating with the HERA where appropriate. Therefore, TB Alliance advocates for an enhanced option 2.2. This augmented option 2.2 would entail two key amendments: broadening the scope to include poverty related and neglected diseases (PRNDs) and antimicrobial resistance (AMR) as well as a focus on public-private partnerships, specifically PDPs. TB Alliance calls for a widening of HERA’s scope to include PRNDs and AMR as key areas for EU level action. First, A holistic approach is needed regarding threat assessments, not focusing solely on the EU but reflecting the nature of health threats in a global perspective. COVID-19 has highlighted the interconnectedness of the planet and the ease at which biologic threats sweep across and between continents. Therefore, TB Alliance urges the Commission to include PRNDs, such as tuberculosis within the HERA’s scope. The second critical area to be included in the scope is AMR. Whilst the reference made to AMR is welcomed, TB Alliance calls for increased focus on the growing threat of AMR. The recent HERA Incubator announcement on COVID-19 variants is important, but it is important for the Commission to continue with the previously indicated pilot on AMR. The COVID pandemic has increased the threat of AMR as COVID patients are administered broad spectrum antibiotics which can lead to resistance. Furthermore, AMR currently takes 33,000 lives in Europe annually and could reverse decades of medical advances. TB contributes largely to AMR, with roughly 1 in 3 deaths from AMR globally being due to Drug-Resistant TB, which affects roughly 500,000 new patients each year. Finally, TB Alliance appreciates the reference to public-private partnerships to address critical needs in areas prone to market failures. In this view, we ask the Commission to consider the existing PDP model. Our Keeping The Promise Report (https://www.keepingthepromisereport.org/) outlines the impact 13 PDPs have had over the past decade, including the development of 66 new products and innovations that have improved health and saved lives by addressing unmet needs. One such example is TB Alliance’s Pretomanid, the first treatment for multi-drug resistant tuberculosis, which was brought from early stage research to market, and was recently approved by the EMA. PDPs have a proven track record of success in addressing areas where market failures exist, improving public health preparedness and being a cost-efficient investment. In conclusion, TB Alliance calls for more attention to PRNDs and AMR and for the Commission to look to the proven success of PDPs to support HERA in its goals. TB Alliance would welcome the opportunity to collaborate with the Commission on this important cause.
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Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

2 Feb 2021

TB Alliance is a not-for-profit organization dedicated to the discovery and development of better, faster acting, and affordable tuberculosis (TB) drugs. It is part of a group of Product Development Partnerships (PDPs), which aim to address existing market failures by linking the public, private, and philanthropic sectors. The ongoing COVID-19 pandemic has highlighted the devastating consequences emerging health threats can have, as well as the need for the European Commission to prioritize health and take appropriate action. Therefore, TB Alliance welcomes the European Commission’s proposal to reinforce the mandate of the European Centre for Disease Prevention and Control (ECDC). More specifically, there are three issues that TB Alliance would like to highlight: Antimicrobial resistance (AMR), health system resilience, and innovative models. First, AMR is a serious threat, to which TB contributes substantially. 1 in 3 deaths from AMR globally are due to Drug-Resistant TB (DR-TB), which affects roughly 500,000 new patients each year. Without new cures, deaths related to DR-TB could amount to 75 million by 2050, with a financial toll of 16.7 trillion USD globally . Therefore, TB Alliance warmly welcomes the Commission’s ambition under Recital 13 to “expand work and develop frameworks for the prevention of communicable diseases including antimicrobial resistance, develop specific preparedness activities and improve the surveillance of AMR.” That said, TB Alliance urges the Commission to heed the warnings and amplify the focus on AMR, as it poses one of the greatest global threats to health. Second, the COVID-19 pandemic has exposed the urgent need to establish resilient health systems in Europe. TB Alliance commends the Commission for placing emphasis on “identifying the existing gaps and strengthening health systems to improve their capacity to detect, prevent, respond to and recover from outbreaks of communicable diseases” under Article 4. These are necessary to ensure that adequate preparations, surveillance, risk assessment, and early warning measures are in place. TB Alliance urges the Commission to strive for closer cooperation with the non-profit industry, in particular PDPs, to build sustainable platforms for research through partnerships, training and infrastructure developments that better prepare health systems for diagnosis, prevention and treatment of communicable diseases in both Europe and beyond. Third, TB Alliance calls the Commission’s attention to the benefits of PDP involvement in the support of epidemic and outbreak response in Member States and third countries. PDPs have had essential roles in the global response against the COVID-19 pandemic and have contributed to develop infrastructure in many LMICs to operationalize local efforts, to connect scientists across continents to therapeutic testing, and convene novel partnerships to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. The pandemic has revealed that the world is becoming increasingly interconnected, stressing the vital importance of international cooperation to achieve global health. Therefore, TB Alliance welcomes the Commission’s commitment to cooperation with Member States, third countries and international organisations within the proposal, notably with the World Health Organisation, under Articles 8b and 11a. Additionally, TB Alliance calls for greater consideration of the needs of resource-limited countries and closer collaboration with PDPs to tackle future health crises. In conclusion, TB Alliance stands ready and willing to engage with and support the Commission’s ambition to better prepare Europe for future health threats, drawing particular attention to the looming threat of AMR.
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Response to Proposal for a Regulation on serious cross-border threats to health

2 Feb 2021

TB Alliance is a not-for-profit organization dedicated to the discovery and development of better, faster acting, and affordable tuberculosis (TB) drugs. It is part of a group of Product Development Partnerships (PDPs), which aim to address existing market failures by linking the public, private, and philanthropic sectors. TB Alliance commends the European Commission on its proposal for a Regulation on Serious Cross-Border Threats to Health. The challenges posed by the COVID-19 pandemic have brought an unprecedented focus on the pivotal role of adequate preparedness, coordination, and response measures to combat cross-border health threats. In light of this, we highlight three areas in which the proposal can be further improved: antimicrobial resistance (AMR), international cooperation, and biomedical research and development. First, TB Alliance commends the attention drawn to the AMR under Recital 11 of the proposal. However, we urge the Commission to not group AMR under the term ‘related special health issues’. This categorisation may lead to an underestimation of the seriousness of the threat posed by AMR. Currently, AMR takes 33,000 lives in Europe annually. About 1 in 3 deaths from AMR globally are due to Drug-Resistant TB (DR-TB), which affects roughly 500,000 new patients each year. More than 50% of DR-TB cases are caused by direct transmission. A single case can take between 9 months to more than 2 years to treat, using about 14,000 pills. Without new cures, deaths related to DR-TB are expected to mount to 75 million by 2050, with a financial toll of 16.7 trillion USD globally. Second, TB Alliance welcomes the Commission’s commitment to international cooperation within the proposal, notably with the World Health Organisation (WHO). More specifically, TB Alliance endorses Articles 7, 10, 19 and 21 on implementing mechanisms to ensure cooperation between the European Union, Member States, and the WHO in the context of the International Health Regulations. Yet, TB Alliance urges the Commission to expand this cooperative and collaborative approach beyond the identification of and response to health threats, to other activities to combat future health threats. This would include basic research, development of treatments and vaccines, and equipment and methods for containing outbreaks. Whilst working to tackle health threats beyond the boundaries of the European Union may not appear to have direct benefits to Europe and its citizens, such actions can certainly have many far reaching, indirect consequences, as shown by the current circumstances we are experiencing due to SARS-CoV-2. The COVID-19 pandemic has shown how flexible cooperation can facilitate an agile response across the planet, this lesson must be remembered when addressing the global challenges of health security and AMR for which we must ensure expansive cooperation. Third, TB Alliance supports the Commission’s ambition in the explanatory memorandum to ensure that the Regulation on Cross-Border Health Threats complements other EU health initiatives, notably those supporting biomedical research and development. In this context, TB Alliance urges the Commission to be agile and open to novel technologies and products which can contribute to the fight against future health threats. More cooperation with the not-for-profit industry at the European level, drawing particular attention to new and innovative partnerships models such as PDPs, is needed. The recent EMA approval of TB Alliance’s Pretomanid is an example of how alternative models are proven to be effective and impactful in addressing global health issues. In conclusion, we believe that global health issues call for international cooperation to counter their serious impact on societies and economies. In the context of research and development, TB Alliance is eager to collaborate with the Commission and other stakeholders to create innovative partnerships, like PDPs, and expand existing ones.
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Response to EU-Africa Global Health Partnership

22 Aug 2019

As a leading R&D organisation, dedicated to the discovery and development of better, faster acting and affordable drugs for tuberculosis (TB), TB Alliance welcomes the EC’s commitment to reducing global social and economic burden of infectious diseases, including TB, through the EU-Africa Global Health Partnership. TB is a leading infectious disease killer globally. While much of the global TB burden exists in low and middle-income countries, Europe and high-income countries face serious risks of drug resistant TB, which represents one third of the world’s social and economic burden of antimicrobial resistance (AMR). As such, we share the view that lack of technologies to address this challenge is conditioned by fragmentation in research, lack of adequate research capacity in developing countries and insufficient industry investment. The EU-Africa Global Health Partnership predecessor, EDCTP2, has demonstrated tangible impact by boosting scientific excellence, strengthening clinical research capacity across the EU and Sub-Saharan Africa (SSA), advancing tools against poverty related and neglected diseases (PRNDs) and enhancing the safety and quality of clinical research and products. The new partnership within Horizon Europe will be the opportunity to build further on these achievements. With regards to the partnership’s mission, we urge the Commission to retain the focus on TB, HIV/AIDS and Malaria. We believe that diverting funding to other infectious disease areas which do not suffer from lack of funding and/or market failure can diminish the impact of an EU R&D partnership in the field of global health and fail to address the most pressing challenges. Funding priorities should be based on a strategic research agenda, driven by global health needs. EDCTP has proven that R&D investments to combat PRNDs represent a great return of investment for Europe, boosts its research capacity and global competitiveness, and makes a critical contribution toward the Sustainable Development Goals (SDGs). We call on the Commission to ensure an ambitious doubling of funding to €1.36 billion, as well as increasing contributions from the EU and SSA participating states. This would represent a true investment as the innovative treatments, diagnostics and vaccines maintain the enormous return on investment for the European and African tax-payers as they will contribute to greater health security, prevention and faster, more effective diagnosis and treatment. The UN high level meeting on TB predicted a need to spend US$ 13 billion per year on TB alone showing the financial impact successful R&D can have. Current restrictions around EDCTP, and particularly strict geographic ones, limit the scientific expertise that this partnership could benefit from. We recommend a more inclusive partnership model, involving relevant actors, which may not be based in Europe or SSA and avoid undue organisational and financial hurdles that delay and increase the costs of product development. In order to maximise impact, increased investment should be accompanied with more opportunities to leverage funding from new sources and allow partners greater flexibility to invest in a portfolio of products, especially in Phase 1 and 2 trials. This will allow for shifts in funding priorities between products showing diminishing promise to those with increasing promise. We call for an institutionalised partnership, that supports a long-term sustained approach. Particularly, we believe that Article 187 partnerships would grant greater flexibility to attract both private and public stakeholders for cooperation in global health R&I. Lastly, SSA Participating States' contributions need to be encouraged and safeguarding their equality improves implementation and uptake, especially on network strengthening and capacity building. SSA Participating States need to have more say in decision-making and scientific advisory bodies must include African experts.
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Meeting with Giulia Del Brenna (Cabinet of Commissioner Carlos Moedas)

10 Oct 2018 · Global Health in Horizon Europe

Response to MFF: 9th Framework Programme for Research and Innovation and Rules for Participation and Dissemination

20 Aug 2018

Horizon Europe (HE) as a public programme must generate tangible societal benefits and public returns, focusing on areas where there is a clear lack of commercial markets to drive innovation, such as in the field of poverty-related and neglected diseases (PRNDs). While we welcome that the proposal acknowledges Research and Innovation (R&I) as key instrument to tackle global societal challenges as per the Sustainable Development Goals (SDGs) it is regrettable that it does not explain how the programme will deliver on the SDGs, with the exception of a budget target for climate-related R&I. We are also concerned about the merging of industrial competitiveness and societal challenges in Pillar 2 -questioned both by the ex-ante impact assessment and the opinion of the regulatory scrutiny board. The capacity to address societal challenges should also be an essential criteria to define R&I missions, regardless of any economic consideration. HE should focus investments in global strategic areas where societal impact can be maximised such as health, climate change/environment or food security and nutrition. And in order to ensure that societal needs and the SDGs are sufficiently addressed, HE needs to include adequate safeguards that prioritise societal impact, mainstream sustainable development, and better define and monitor societal impact. The need to deliver accessible, suitable, safe, effective and affordable products and innovations should be at the core of Pillar 2 and a requirement for the entire framework programme. Although the EU is strongly committed to promoting R&I across its borders, international cooperation and in particular, third country participation has dwindled in the last decade, currently representing only around 3% of Horizon 2020 projects. EU R&I framework programmes have fallen short of becoming effective science diplomacy tools or of complementing EU’s development and cooperation programmes, through R&I collaboration with Low and Middle-Income Countries (LMICs). Existing R&I cooperation platforms such as the Africa-EU high level policy dialogue on science, technology and innovation or the European and Developing Countries Clinical Trials Partnership (EDCTP) are key cooperation schemes that should be preserved and enhanced. For that, LMICs need to continue to be automatically eligible for funding, not depending on the call text or whether the Commission considers their participation necessary. Similarly, in the interest of international collaboration for global health innovation, US entities should continue to be considered eligible for funding under the Health Cluster of Horizon Europe. Civil society organisations (CSOs) are key stakeholders in R&I. CSOs can contribute to identifying, and co-creating solutions to addressing societal challenges, improving public accountability and ensuring that work programmes are needs-based and fit-for-purpose to address societal needs. We recommend that stakeholders focusing on societal impact, such as CSOs, are consulted throughout the programming cycle: from priority setting including on R&I missions and partnerships and the Strategic Planning Process implementation, to the monitoring and evaluation. We noted with particular concern that the proposed budget dedicated to health has not increased compared to H2020 in terms of percentage of the total budget,and remains considerably lower than most of other clusters. Recent evidence shows that we will not reach the ambitious SDGs health targets without new and improved health technologies. To ensure the EU continues to play a leading role in this area, HE should maximise the EU’s contribution to eradicating PRNDs through increased funding and an ambitious R&I mission, with a portfolio of projects and follow-up funding mechanisms based on the attainment of scientific criteria.
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Response to Protecting citizens against health threats

17 Apr 2018

TB Alliance welcomes the initiative of the European Commission to devote increased attention to infectious diseases and enhance the EU’s role as a partner in global health security. We particularly welcome the effort to “strengthen the impact of research and innovation by embedding research gap analysis and priority setting together with the Member States under the Permanent Working Group of the Health Security Committee on Preparedness and Response Planning.” In this context, we would like to draw attention to areas that lack a lucrative commercial market and require public investments to accelerate the development of innovative medical countermeasures, most notably poverty-related and neglected infectious diseases (PRNDs). This should be central in the challenges addressed by the next EU Research Framework and the Communication should include clear actions related to FP9 investments towards infectious diseases. While PRNDs affect more than one billion people worldwide, major product- and research-gaps exist. Many PRNDs affect and increasingly threaten the health of EU citizens. Global R&I into new and improved tools to address PRNDs is chronically underfunded, and although the EU is among the top three funders of PRND R&I worldwide, a lot more needs to be done. The EU needs to increase its investment in PRND R&I to help fight the ongoing epidemics, save millions of lives, and prevent the spread of PRNDs into other parts of the world, including the EU. This is also essential to achieve the Sustainable Development Goals. Among PRNDs, an important health, security and economic burden to Europe is posed by tuberculosis (TB) and we recommend to include specific reference in the text. In 2015 alone, an estimated 323,000 new TB cases and relapses (incident cases) occurred in countries of the WHO European Region and there were an estimated 32,000 TB deaths from TB in the WHO European region, which also has the highest burden of multi-drug-resistant TB in the world. WHO’s 18 high-priority countries for TB in the European region include several EU member states as well as several neighboring countries. In 2014, a study by Diel et. al. on costs of TB disease in the European Union estimated that in the original EU-15 states plus Cyprus, Malta and Slovenia an average TB case cost €10,282 per patient, an average MDR-TB case cost €57,213 and an XDR-TB case costs as much as for €170,744. For the 70,340 susceptible TB cases, the 1,488 MDR-TB cases and 136 XDR-TB cases notified in 2011, costs of €536,890,315€ were estimated to be accumulated in the EU in 2012. In the same year, the 103,104 disability-adjusted life years caused by these cases, when stated in monetary terms, amounted to a total of €5,361,408,000. Analysis done by KPMG in the UK, and published by the Global TB Caucus in November 2017, estimates that during the period of 2000-2015, TB related mortality caused the loss of US$ 616 billion. If action is not taken, future TB related mortality may lead to a further loss of US$ 984 billion globally between 2015 and 2030—a figure equivalent to the size of the Netherlands’ economy in 2016. No country is exempt. While much of the TB burden globally exists in low and middle-income counties, Europe face serious risk from the threat of drug resistant TB. A multi-country cluster of MDR TB involving 28 migrants was delineated in 2017 by the ECDC in migrants recently having arrived from countries in the Horn of Africa. The ECDC warns that although the number of cases detected so far is small, there is a possibility that more cases associated with this cluster may still be identified. The Joint Riga Declaration on TB signed in 2015 by ministers and high level representatives from the ministries responsible for health of the EU Member States and Partner countries of the Eastern Partnership recognized that TB and MDR-TB are a cross-border health threat in the world where overall the mobility of the population is increasing.
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Meeting with Vytenis Andriukaitis (Commissioner) and

25 Jan 2018 · EU action to help reduce TB