Federal Ministry of Education and Research

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1 Federal Ministry of Education and Research Announcement Regulations for funding of products for the prevention, diagnosis and treatment of neglected and poverty-related diseases 1 Funding purpose Poor living conditions, insufficient access to adequate and healthy food, clean drinking water, medical care and education: These are circumstances which promote the spread of infections known as poverty-related diseases (PRDs). PRDs include infections which can be cured or at least controlled in industrialized countries, for example the "big three": HIV/AIDS, tuberculosis and malaria. They also include neglected tropical diseases (NTDs) which mainly pose a great problem for the population in poor countries in tropical regions. The highest numbers of victims of PRDs continue to be in poor regions of the world, more than e.g. cardio-vascular diseases, diabetes or cancer. For some of these diseases there is no treatment or adequate vaccine protection. Some of the drugs which are available have strong side effects or cannot be administered adequately because of the special conditions in tropical regions where infrastructure is usually poor. Because there are virtually no economic incentives, pharmaceutical companies put forth very little effort to research and develop new products to fight these diseases. The new and further development of the drugs, vaccines, and diagnostic agents that are so urgently needed to improve global health must therefore be supported with public funds and through joint action by the international community. The G7 heads of state and government who met in June 2015 under the German presidency committed to this in their summit declaration. The Federal Ministry of Education and Research (BMBF) is funding "product development partnerships", or PDPs, since 2011 and plans to continue funding on the basis of this call. PDPs are non-profit organizations which develop drugs, vaccines, and diagnostic agents to treat PRDs and bring these solutions to the market cost-effectively. These partnerships coordinate collaboration between partners from academic institutes, public research institutions, non-governmental organizations, and pharmaceutical companies engaged in research. PDPs are financed mainly by public and private donors. The BMBF's funding for PDPs is a valuable complement to its existing funding activities devoted to the fight against neglected and poverty-related diseases. Please note: This is not an official version of the call text. The official published call in German can be found under: https://www.bmbf.de/foerderungen/bekanntmachung.php?b=1093

2 - 2 - This BMBF funding measure is part of field of action 6 "International cooperation in health research" under the Federal Government's Health Research Framework Programme. 2 Object of funding Funding is provided for the development of methods and products that help to prevent, diagnose or treat neglected and poverty-related diseases. 1 In order to receive funding, the research must focus on health problems for which there is no suitable prevention, diagnosis or treatment method. Prevention methods may include vaccines, insecticides or other agents whose development requires scientific research. 3 Applicants Product development partnerships (PDPs) eligible for funding are those that pursue the goal of developing prevention methods, drugs or diagnostic agents to fight neglected and povertyrelated diseases and of bringing these solutions to the market cost-effectively. Such PDPs should be structured as networks which promote the cooperation of various players (academic institutes, public research institutions, pharmaceutical companies, biotechnology companies, and NGOs (not-for-profit organization). Eligible PDPs must fulfil the following minimum requirements, and items a) to d) to the full extent, prior to submission of an application: a. The focus of the PDP's activities is on one or more neglected and poverty-related diseases. b. The products are specifically tailored to the needs of people in developing countries. c. The main aim of the PDP is to improve public health, not to make a profit (not-for-profit organization). d. The PDP adopts private sector management strategies (pharmaceutical industry) such as portfolio management and industrial project and process management. In addition, evaluation of the application takes the following criteria into consideration: e. The PDP engages in lobbying to its own interests and makes efforts to raise awareness of the target disease in question. f. The PDP engages in capacity building in the low- and medium-income countries in which the majority of clinical product development occurs. 1 HIV, tuberculosis, malaria, the WHO's 17 prioritized neglected tropical diseases (http://www.who.int/neglected_diseases/diseases/en) as well as new or recurrent infectious diseases of particular relevance to low- and medium-income countries (e.g. Ebola).

3 - 3-4 Prerequisites of BMBF funding In addition to items a-d in section 3, the following conditions apply: PDPs eligible for funding must be organized as a legal person able to enter into contracts, a business partnership or alliance. Alliances must appoint a partner of the PDP as its coordinator who is capable of entering into contracts under civil law. When submitting an application, PDPs must have been active in their current organizational form for at least two years and have achieved their first operative successes. PDPs submitting an application must be able to ensure that the funds will only be used for work on the diseases and products set out in section 2 of the call (Object of funding). At least 50% of the funds needed for product development must be obtained from other sources (also own funds, proof to be furnished as part of the application). If the PDP is organized as an alliance, the relations among its partners must be laid down in a written cooperation agreement. The PDP must set itself guidelines on how to deal with partners in research and development and, in particular, how to handle intellectual property and exploitation rights and the management of patent rights. The aim is to keep the product price as low as possible in the target country. Wherever possible, the PDP s patent policies should allow for market competition through the production of generic drugs, which has been shown to lead to low market prices. Applications must therefore include innovative proposals for settling or handling patent law issues. The PDP needs to have established mechanisms for identifying and solving conflicts of interests. An appropriate technology and knowledge transfer is required. If possible, local producers should be given priority. Priority must be given to the development of sustainable cooperation with researchers and industry in the target countries over the short-term hiring of contractors. This also has the aim of strengthening local institutions.

4 - 4 - It must be ensured that newly introduced drugs and vaccines are monitored on a long-term basis (pharmacovigilance), if necessary by investing in laboratory capacities and conducting training measures for an improved local quality infrastructure. In addition to the safety and effectiveness of the new products, the local conditions and the impact on the target country need to be taken into account the aim of market introduction must always be to reduce the burden of disease in the target countries. Ideally, data collected by the PDPs in the target country should be analysed locally with the help of local experts. At the very least, the data and results should be made available to the local health systems. 5 Type, scope and rates of funding The requested grant volume can amount to up to 2 million per year and PDP for the entire project period. Grants are calculated on the basis of project-related costs or expenditure incurred by each product development, up to 50% of which can be covered by government grants. The remaining funding must come from other sources (proof to be furnished as part of the application). The maximum funding period is five years. Funding is granted on the basis of funding contracts under civil law between the selected PDPs and an intermediary organization. 6 Legal basis These funding regulations are valid in conjunction with the health research framework programme, Project grants will be awarded in accordance with the present funding regulations and in analogous application of section 44 of the Federal Budget Code (BHO). There is no legal entitlement to a grant. A decision on the award of funding will be made after due assessment of the circumstances and within the limits of the budget funds available. On this basis, a funding contract under civil law will be concluded between an intermediary organization and each PDP which has been awarded funding. This funding contract contains the terms and conditions of the payment and accounting for budget items, proof and examination of proper use and, if necessary, the termination of said contract and reclaiming of the funds awarded.

5 - 5-7 Funding procedure 7.1 Involvement of an intermediary organization The Federal Ministry of Education and Research will entrust an intermediary organization with the implementation of this funding measure. Advisory services for applicants are provided by the DLR Project Management Agency. Contact: Deutsches Zentrum für Luft- und Raumfahrt e. V. (DLR) DLR Project Management Agency Health Research Dr. Isabella Napoli Heinrich-Konen-Straße Bonn, Germany Tel The guidelines provide the structure for applications. The evaluation criteria under section must be taken into consideration when drafting an application. Applicants may direct enquiries concerning the application to until 5 th February Answers to enquiries will be posted at 7.2 Funding procedure Deadlines Applications must be submitted to the DLR Project Management Agency by 29 th February 2016 at midnight. Deutsches Zentrum für Luft- und Raumfahrt e.v. Projektträger Gesundheitsforschung Keyword: PDP Heinrich-Konen-Strasse Bonn, Germany

6 - 6 - The applicant PDP must put a legal signature on the submitted application. The submission deadline is not a cut-off deadline. However, it may not be possible to consider applications received after this date. Applicants who intend to submit applications after the above date are advised to contact the DLR Project Management Agency before doing so Application procedure See application guidelines (http://www.dlr.de/pt/portaldata/45/resources/dokumente/leitfaden/pdp_guidelines.pdf) Required documents All of the documents named in the application guidelines must be submitted to the BMBF in the original and two copies as well as in electronic form (pdf file on CD). In light of the international dimension of the funding measure and the international evaluation procedure, all documents must be submitted in English Selection procedure Independent experts will be involved in the evaluation of the submitted applications on the basis of the following criteria: 2 PDP: Organization and management (max. 30 points) Efficiency and effectiveness of organizational structures Track record of organization's performance Quality of steering mechanisms - monitoring and controlling Quality management and quality policies (clinical trials, ethics, publication of results) Portfolio management Risk management within the PDP Protection of intellectual property (WTO/TRIPS) Qualifications/experience of managing director and scientific profile Qualifications of scientific advisors PDP's experience in the development of products to prevent, diagnose and treat neglected and poverty-related diseases Non-profit organization, public image (social responsibility) 2 Applications must score at least two-thirds of the maximum number of points possible in each evaluation category.

7 - 7 - PDP's operational objective and expected output in the next 5 years Previous achievements of the PDP Evaluation methods (internal and external) PDP: Cooperation with partners (max. 20 points) Cooperation with partners in industrial countries and with partners from developing countries on the basis of equality Existing and proposed networking with international initiatives in the field of neglected and poverty-related diseases Willingness and ability for capacity building Balanced sharing of risks and costs between the PDP and its partners Sustainability of the projects with regard to the transfer of research results to the health systems of the developing countries (technology and knowledge transfer, local production, distribution systems, etc.) Mechanisms to identify and solve conflicts of interest Joint use of research infrastructure Application: Formal and scientific criteria (max. 10 points) Scientific and methodological quality of the proposal and of the analysis of the current situation concerning existing methods to fight disease Distinctness from similar initiatives Logic and consistency of application with regard to objectives and results, strategies, activities and ways of achieving them Degree to which the goals stated in the application are SMART (specific, measurable, achievable, relevant and time-bound) Application: Product development(s) encouraged by funding (max. 40 points) Vision, strategy and added value of product development Effect of BMBF funding on the PDP Need for the developed product and expected demand and potential impact, also compared to other similar initiatives Potential use and impact on poverty among the population in developing countries Existing supply/need for research in this area Cost-benefit ratio of the BMBF investment

8 - 8 - Project plan, budget plan Implementation strategy (support for registration and/or pre-qualification) for market launch The BMBF/intermediary organization will evaluate the proposals in terms of compliance with formal and operational requirements. An international group of independent experts will evaluate the scientific quality of the proposals. The results of this evaluation will be forwarded to the BMBF in the form of a recommendation for funding. The BMBF will subsequently take a final funding decision. 8 Entry into force These funding regulations will enter into force on the day of their publication in the Federal Gazette (Bundesanzeiger). Berlin, 19 October 2015 Federal Ministry of Education and Research On behalf Dr. Renate Loskill

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