MSF Access Campaign March 2018
MSF Access Campaign Submission Public consultation on EU funds in the area of investment, research & innovation, SMEs and single market Every day, MSF medical teams are confronted with gaps in the availability and accessibility of the health tools we need to provide lifesaving medical care. Medicines, vaccines and diagnostics are often ill adapted to our patients’ needs and the conditions and settings we work in – or priced so high that patients and healthcare systems cannot afford them. For some diseases, the tools simply do not exist at all.
I. Targeting public health needs in FP9 As the second largest funder of biomedical research, the EU has a critical role to play in ensuring that publicly funded research investments serve patients’ needs and address unmet global health challenges. To do so, the EU must make research in underserved disease areas a priority. The European Commission has already acknowledged that medical research must prioritise interventions with the “the biggest impact on public health.” 1 This aligns with the European Commission ‘High Level Group’ recommendation that EU research programmes adopt a “missionoriented, impact-focused approach to address global challenges.” 2 To achieve these ambitions, public funding must target the unmet needs of people and healthcare systems in Europe and beyond. The development of safe, effective treatments for tuberculosis (TB) and vaccines adapted for use in low-resource settings are two areas where innovation and research investment are severely lacking. Delivering new TB treatment regimens Tuberculosis killed 1.7 million people in 2016. It is now the world’s deadliest infectious disease. Drug-resistant forms of the disease are difficult or impossible to cure with existing treatments. The way we organise, finance and conduct medical research today is simply not conducive to the development and testing of new treatment regimens, which must contain multiple drugs to be effective. Under current profit-driven approaches to R&D, competing companies seek to develop and sell proprietary compounds. This hampers much-needed efficiency, coordination, collaboration and open sharing of knowledge and results, which are all prerequisites for the development of effective TB treatment regimens. The newer drugs bedaquiline and delamanid first entered the market in 2012 and 2014, respectively, each developed by different pharmaceutical corporations. Years later, we still lack the evidence we need on how to use the drugs together to provide shorter, safer, more effective treatment regimen for drug-resistant TB. Meanwhile, due to lack of industry interest, promising compounds that could improve TB treatment such as sutezolid linger in development for years, unavailable to those who wish to develop them as part of a new treatment regimen. Concerted effort and mission-oriented public investment are urgently needed to overcome these hurdles and to rapidly deliver improved combination treatment regimens for drug-resistant TB. Thermostable vaccines for low-resource settings The limited thermostability of many vaccines requires them to be kept between 2 and 8 degrees Celsius, a tremendous challenge for their deployment and major contributor to poor immunisation coverage rates in developing countries. The ‘controlled temperature chain’ (CTC) – or a ‘flexible cold chain’ – is an innovative approach to vaccine management that allows vaccines to be kept at ambient temperatures for a specific number of
days just prior to administration. While the approach could be extremely beneficial to improving vaccine coverage in remote settings, it requires specific R&D efforts that are not currently prioritised or funded.
II. Using target product profiles (TPPs) to increase FP9’s societal impact TPPs are an important strategy for ensuring that people’s needs drive every step of the R&D process – including early, ‘upstream’ R&D – and that R&D results in affordable, accessible biomedical innovations. Based on a deep understanding of the unmet medical need in priority therapeutic areas, TPPs define the desired characteristics of a new product or treatment that would adequately address that need, including specific parameters such as target population, target price, administration form, minimal clinical effectiveness and stability. TPPs help to ensure that public funding targets the development of products with distinct therapeutic value that are appropriate for the contexts where they are needed most. The societal impact of FP9 could be significantly increased by employing TPPs in European Commission biomedical research funding programmes. Antimicrobial resistance (AMR): No stewardship without diagnostics and effective drugs New drugs, and new diagnostics to guide appropriate use of antibiotics, form an essential part of the WHO’s Global Plan of Action on AMR. The crux of implementing a successful stewardship programme is appropriate treatment: prescribing the right antibiotics for the right durations, according to the susceptibility profile of the bacteria causing the infection. In 2015, a consensus target product profile was developed 3 to steer diagnostics developers towards designing the most useful biomarker tests to distinguish bacterial from non-bacterial infections in low-resource settings to prevent the unnecessary use of antibiotics. However, none of the newer biomarker combination tests have been validated in low- and middle-income countries and issues such as affordability remain unresolved. Investments in R&D must ensure that new diagnostics and drugs meet the needs of people in all countries – not just wealthy ones. Affordability as a key criterion in TPPs WHO Member States have passed several resolutions on public R&D funding that endorse the principles of equitability, affordability and availability.” 4 Affordability should be a critical target characteristic for medical innovation. Even when early-stage R&D is taxpayer-funded, 5 patients, medical providers and governments are facing increasingly and unsustainably high prices for medicines, including in Europe and the United States. High prices led, for example, to rationing of sofosbuvir for the treatment of hepatitis C in European Member States, including France and Italy. In 2016, exorbitant prices for pneumonia vaccines jeopardized MSF’s ability to provide medical assistance to migrants arriving in Greece.6 Academics and civil society organisations have repeatedly demonstrated that drug pricing is primarily determined by what the market will bear, not by pharmaceutical corporations’ R&D costs. After several years of negotiation with manufacturers, MSF now buys generic hepatitis C treatment for US$120 per treatment7 in almost all of the countries where we treat the disease, a sea change from the treatment’s initial launch price of US$142,000. However, the vast majority of people living with hepatitis C live in middle- and high-income countries that cannot access generic treatment at this low price. In many of these countries, exorbitant drug prices remain the major barrier to treatment. This begs the question: what is the value of a medical product when the people who need it cannot afford it? There should be an essential condition for European taxpayer funding for medical innovation: products that emerge from development with public support must be affordable for people and healthcare systems, in Europe and elsewhere. The European Commission should ensure that affordability is enshrined as a key eligibility criterion for all TPPs. Any recipient of EU funds should commit to affordability, for instance by meeting a target price or price ceiling. Affordability commitments should be assessed as a required component of proposals for funding and included as binding provisions in project contracts. All contracts should be made publicly accessible to ensure transparency and traceability between public funding for R&D and the end product it enables, and to ensure accountability for public return on public investment. Page 2 of 3
Recommendations To enable maximal public health impact, projects funded under FP9 must address unmet public health needs and ensure affordable access to the fruits of publicly funded research. We urge the European Commission to ensure that: • •
Medical innovation projects funded under FP9 (i) meet pre-specified TPPs that address priority unmet health needs, and (ii) are consistent with globally agreed4 access principles to ensure the delivery effective end products, including products for use in low-resource settings. Affordability is a key outcome parameter in the TPPs, including commitments form funding recipients to deliver end products at or below a target price or price ceiling. The target price or price ceiling should be assessed as a required component of funding proposals and included as binding provisions in project contracts. Contracts for all medical innovation projects funded under FP9 are made publicly accessible to ensure transparency and traceability between public funding for R&D and the end product it enables, and to ensure accountability for public return on public investment.
References 1 European Commission. Commission Communication on the EU Role in Global Health. [Online]. 2010 [Cited 2018 Feb 27]. Available from: https://ec.europa.eu/europeaid/sites/devco/files/communication-eu-role-in-global-health-com2010128-20100331_en.pdf. The need to prioritize R&D funding according to health needs is also clearly acknowledged in: Council of the European Union. Council Conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States. [Online]. 2016 [Cited 2018 Feb 27]. Available from: http://www.consilium.europa.eu/en/press/press-releases/2016/06/17/epsco-conclusions-balance-pharmaceutical-system 2 European Commission. LAB – FAB – APP. Investing in the European future we want. Report of the independent High Level Group on maximising the impact of EU Research & Innovation Programmes. [Online]. July 2017 [Cited 2018 Feb 27]. Available from: http://ec.europa.eu/research/evaluations/pdf/archive/other_reports_studies_and_documents/hlg_2017_report.pdf 3 Dittrich S, Tadesse BT, Moussy F et al. Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus. PLoS ONE 11(8): e0161721. [Online]. 2016 [Cited 2018 Feb 27]. Available from: https://doi.org/10.1371/journal.pone.0161721 4 WHO. Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination. [Online]. 2012 [Cited 2018 Feb 27]. Available from http://www.who.int/phi/CEWG_Report_5_April_2012.pdf 5 Ekaterina GC, Beierlein JM, Khanuja NS et al. Contribution of NIH funding to new drug approvals 2010–2016. [Online.] 2017 [Cited 2018 Feb 27]. Available from: http://www.pnas.org/content/early/2018/02/06/1715368115 6 MSF. Expensive pneumonia vaccine key barrier to vaccinating refugee children. [Online]. 2016 [Cited 2018 Feb 27]. Available from: http://www.msf.org/en/article/greece-expensive-pneumonia-vaccine-key-barrier-vaccinating-refugee-children 7 MSF. MSF secures generic hepatitis C treatment at $120 compared to $147,000 launch price tag. [Online]. October 2017 [Cited 2018 Feb 27]. Available from: https://www.msfaccess.org/about-us/media-room/press-releases/msf-secures-generic-hepatitis-c-treatment-120-compared-147000
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