Key Benefits:
Decision of the Minister for Foreign Trade and Development Cooperation of 13 June 2014, No MinBuza-2014.313907 establishing policy rules and a subsidy ceiling for grant granting under the 2006 SubsidierScheme Ministry of Foreign Affairs (Fund Life Sciences & Health for Development)
The Minister for Foreign Trade and Development Cooperation,
Having regard to the Articles 6 and 7 of the Subsidy Decision Ministry of Foreign Affairs ;
Having regard to Article 10.2 of the Ministry for Foreign Affairs 2006 ;
Decision:
For grant-to-loan on the basis of Article 10.2 of the Ministry for Foreign Affairs 2006 within the framework of the Life Sciences & Health for Development Fund to finance activities in the field of developing innovative health technologies for disease control and health care. 1 related to poverty and sexual and reproductive health are the same as Annex policy rules attached to this Decision.
For the purposes of the grant of grants under the Life Sciences & Health for Development Fund, a subsidy ceiling of € 2,700,000 shall apply for the period from the date of entry into force of this Decision until 31 December 2016.
The distribution of the subsidy ceiling takes place on the basis of an assessment carried out in accordance with the criteria laid down in the policy rules, it being understood that from all the applications which meet the criteria, the applications which are the best in the case of the aid the first eligibility of the grant of the grant is met.
Applications for a grant under the Life Sciences & Health for Development Fund shall be submitted from the date of entry into force of this Decision until 1 October 2014, 15:00 Dutch time on hand from the Minister. established application form and provided with reference to the application form 2 requested documents.
This Decision shall enter into force from the day following the day on the day of the State Official Gazette, in which it is placed and expires with effect from 1 January 2017, except that the decision shall continue to apply to grants which are before that date ed.
This Decision will be Annex is placed in the State Official Gazette.
TheMinister
for Foreign Trade and Development Cooperation, on behalf of these,the Director-General for International Cooperation,
R. Swartbol
1.1 Introduction
A large proportion of the population in developing countries is not or not sufficiently achieved by health technologies that provide an effective and affordable solution to many common diseases and health problems. According to the World Bank and WHO, this lack of effective and affordable means for diagnostics, treatment and prevention is the primary problem for the control of poverty-related health problems in developing countries. Particularly poorer sections of the population, the so-called 'Bottom of the Pyramid' (BoP), which are disproportionately affected by simple preventative or treatable health problems, are able to benefit from innovative health technologies. It is precisely these groups which, in many countries, are the driving force of the national economy and are therefore of interest to the economic growth of the country. The still common diseases such as AIDS, tuberculosis, malaria and other poverty-related health problems, as well as sexual and reproductive health related diseases have a significant negative impact on the disease. labor productivity. And in addition, pregnancy and childbirth in developing countries (too) often result in disease and mortality of the (expeciated) mothers. In this way, the spil in the family is also temporarily or permanently away with all the consequences that would have.
The Netherlands has unique and high-quality expertise in the area of 'Life Sciences and Health'. The sector has been designated by the Cabinet as a top sector, which means that the government is investing in the sector together with companies and science. Through cooperation between enterprises, knowledge institutes and public sector organisations, Dutch expertise can be used to develop innovative solutions to the health problems in developing countries. Better health is beneficial for economic development, while a better economic situation is also beneficial to people's health. This offers opportunities for Dutch and local enterprises to come up with innovative solutions and implement them.
In addition, the Netherlands is also taking on a major international position when it comes to Sexual and Reproductive Health and Rights (SRGR). The Netherlands is seen as an international leader in this field, among other things, due to the good results on home soil. For example, the number of teenage pregnancies and abortions in the Netherlands is among the lowest in the world. Investing in sexual health is very important. This leads to smaller, healthier and better educated families, contributing to the so-called 'demographic dividend'. This is an increase in productivity among the population of a country, which leads to long-term economic growth. That is why the Netherlands continues to invest strongly in SRGR and is one of the priorities of Dutch development cooperation.
The Minister has therefore decided to finance projects to ensure that innovative health technologies are available for populations in the BoP that fight poverty-related diseases and diseases related to SRGR. Until December 31, 2016, Fund Life Sciences & Health for Development (hereinafter Fund LS&H4D) has € 2,700,000 available to support collaborative relationships that focus on developing such a research project. health technologies.
1.2 Objectives
The LS&H4D Fund shall contribute to the Sexual and Reproductive Health and Rights (including HIV/AIDS) spearheading, which is one of the four spearheads of current development policy. In addition, the Fund is in line with the policy of encouraging new coalitions between enterprises, non-governmental organisations and knowledge institutions, as expressed in the recent Notes Trade and OS notes. 3
The main objective of the Fund LS&H4D is:
Structural poverty reduction by increasing the health status of poorer populations in developing countries through innovative health technologies for prevention, diagnostics, and/or treatment of SRGR related health care. disorders and poverty related diseases. This will create opportunities for partnerships that contribute to economic growth in developing countries through the development of innovative health technologies.
More specific objectives of the Fund LS&H4D are as follows:
1. A growing number of people have access to antiretroviral drugs, contracepatives and other products for good sexual and reproductive health.
2. Public and private clinics deliver better sexual and reproductive care where more and more people use it.
3. Fighting poverty-related diseases as intended in UN Millennium Target Number 6.
The categories of health technology, which are expected to make the most direct contribution to the health status of the poorer groups in developing countries on the themes mentioned above, are:
a. medicinal products;
b. Bio-medical products such as vaccines;
c. Medical devices;
d. Supporting technologies and services to enable effective diagnostics, therapy or prevention.
1.3 Eligible Projects
Applications for grant relate to projects related to a particular stage of product innovation, where the innovation chain extends from technical economic feasibility study to the development of a 'proof of interest'. concept '. The applications relate to projects designed to investigate the introduction of products, processes or services in new markets, with the exception of their actual vermarkting. There shall be no more than one application per grouping for grant eligibility. If a grouping lodges several projects eligible for subsidy, only the application which best meets the criteria of the Fund LS&H4D shall be honoured. The projects for which grants may be awarded should lead to a business case which is appropriate to be presented to relevant financial institutions and/or for the purpose of call for proposals in the (inter) national context. This in order to encourage further product innovation or market introduction of a health technology.
Figure 1: schematic representation of the possible projects within the LS&H4D fund, which is covered by the eligible projects, is grey and blue-coloured.
1.4 Project result chain 4
The selected methodology for the type of projects under LS&H4D is the result chain. It shall also act as the basis for monitoring and evaluation. The result chain describes the logical steps between the project input and the short-and long-term effects that the LS&H4D projects are aiming at. The resulting chain consists of the following separate steps as described below.
Input
Input shall be understood as the financial, human, material, technological and information resources deployed for development intervention. So the input is for the resources required for the implementation of the project.
Activities
Activities are measures or work that mobilizes input, such as resources or technical assistance, to achieve a specific output. Under LS&H4D, five project types of which activities are eligible have been identified, see section 1.3.
Output
Output means products and services following the completion of operations in the context of development intervention. In the case of LS&H4D, output is defined specifically as the Business Case to be prepared for financing for the further development of the intended health technology as defined in the grant application.
Figure 2 Result-eating of LS&H4D Projects Inputs Activities Outputs Outcomes
Outcome
Outcome is the intended or accomplished short-term effect of the output of an intervention, which usually requires joint efforts by the partners. The outcome of the outcome is changes in the development situation that occur between the completion of the output and the achievement of the impact. In the case of LS&H4D, outcome specifically refers to the submission of the developed Business Case (the output) to relevant financial institutions and/or for call for proposals in the (inter) national context, see Section 1.3.
Impact
Long-term effects are identified as impact. The impact will be the positive and negative effects of a long-term development intervention on identifiable populations. These can be direct and indirect and intended and unintended effects. These effects may be economic, social-cultural, institutional or technical, or environmental or other sectors. At impact level, for LS&H4D three specific objectives (sub-themes) are defined, see section 1.2.
1.5 Commander
The Minister has entrusted the implementation of these policy rules to the State Department for the Netherlands (hereafter RVO.nl), agency of the Ministry of Economic Affairs. RVO.nl will implement these policy rules on behalf of the Minister on the basis of a mandate granted to RVO.nl.
1.6 Administrative charges
A test is carried out in accordance with a standard cost model in order to account for the administrative burden on applications and, where appropriate, of a grant under the LS4H&D Fund. The submission of an application, the management phase, the completion of the project, after which a request for the determination of the subsidy, and any objection and appeal procedures, has been taken into account. The calculation shows that the total percentage of administrative burden compared to the total available grant budget is around. 4.5%. The foregoing does not determine what is, and is not, eligible on the basis of these policy rules, but this is included in paragraph 6.
For a good understanding of the terminology used in these policy rules, the following principles apply:
1. Poverty related diseases: Poverty related diseases, as defined by the World Health Organisation (2014).
2. Bottom of the Pyramid: people with an average income of under $4,000 a year.
3. Business case: a trade-off between budgeting costs and the expected benefits of activities to be undertaken in order to achieve a product. A business case maps what the problem, the intended change, or identified opportunity is, what the intended results are, and what gives it. A business case can be associated with a project, a task, or a (strategic) business plan.
4. Health technology: development of new products, processes and services for prevention, diagnosis and/or treatment for health promotion purposes.
5. Knowledge setting: education and research institution as intended in the Law on higher education and scientific research and the Law on education and vocational education , and other institutions, which may be classified as knowledge or research institutions for the purposes of these policy rules. A knowledge institution from abroad should be registered as such to the Ministry of Education or a similar body in the country concerned.
6. Minister: the Minister for Foreign Trade and Development Cooperation.
7. Company: an entity with legal personality, regardless of the way in which it is financed, which carries out an economic activity. The Company must be registered with the Chamber of Commerce or a comparable local authority.
8. Pener: the participant of the grouping applying for the subsidy on behalf of the grouping. The pilot shall have legal personality, shall not be a public body, and shall be composed of at least two years at the time of submission of the application. If the application is honoured, the grant shall be granted to the pilot.
9. Project: a project a, b, c, d or e (see Section 1.2) that makes a significant contribution to one of the objectives of these policy rules, resulting in a business case, with at least one submission of request for funding to a relevant Financing institution and/or ' call for proposals in the (inter) national context, which has a positive impact on the health status of poorer populations in developing countries, can be realised. The duration of the project is not less than three months and up to two years. Projects may relate, on the one hand, to a particular stage of product innovation, where the innovation chain will extend from technical economic feasibility studies to the development of a 'proof of concept'. On the other hand, projects may be aimed at investigating the introduction of products into new markets, with the exception of the actual market vermarkting. Each individual project shall not comprise activities of another project.
10. Project a: a feasibility study which leads to an assessment of technical innovation and economic potential of planned industrial research or experimental development and the intended end result. A feasibility study consists mainly of desk research. This can be his literature review, patent search, inventory of available technology and potential partners, market exploration and competition analysis.
11. Project b: development of a proof of principle through industrial research involving activities related to planning or critical research aimed at establishing new knowledge and skills with a view to the development of the new knowledge and skills of the Member States. of innovative products, processes or services. It includes the manufacture of, for example, parts of complex systems, with the exception of prototypes.
12. Project c: development of a 'proof of concept' through experimental development involving, among other things, the acquisition and use of existing scientific, technical and other relevant knowledge and skills for plans, or designing and then testing innovative products, processes or services up to and including a working prototype.
13. Project d: a feasibility study to examine, within the framework of an investment decision to be taken on a health technology, whether it is technically or commercially feasible to implement a specific project, process or service in the developing country - Before the start of the study, there is sufficient clarity as to the size of the market, the intended design of the investment, the location, the operation and the financing.
14. Project e: a demonstration project in which health technology is demonstrated in a real field of practice, with the aim of introducing the technology concerned in the developing country, among a broad group of interested parties. The project is no greater in size and duration than strictly necessary to demonstrate that the technology has added value and is applicable under specific local conditions. During or after the demonstration project, no sale of hardware to any party in the target country can be involved. At the end of the demonstration project, the hardware 'not to be transferred to a local party', or when this is not desirable or possible, will be retrieved back to the Netherlands. A statement shall indicate what has happened to the demonstrated hardware. Where appropriate, the information provided in this declaration may be verified, for example by an on-the-spot inspection.
15. Collaborative: A non-incorporated contractual partnership consisting of a minimum of one non-profit-making company, a non-profit participant, representing a social organisation, and one party originating from the circle from the government. The latter may be a Ministry, an independent administrative body, county or municipality, or if it is a non-Dutch public participant, a part of the general government organisation in the country concerned. Knowledge settings can also be a partnership participant. At least one participant is established in the Netherlands and at least one participant in a developing country. The participants are not interlinked by majority ownership and do not have control in each other's organisation. Participants from the government may not receive a grant. The costs incurred by these participants are therefore not part of the budget of the project. The involvement of the ultimate target group is ensured through the social organisation in the partnership.
1. The application for grant relates to a project targeting a developing country as included on the LS&H4D country list, to be found on english.rvo.nl/lsh4d and www.rvo.nl/lsh4d and whose activities will take place after submission of the application.
2. The project concerns activities that benefit at least one of the three sub-themes of LS&H4D:
a. A growing number of people have access to antiretroviral drugs, contracepatives and other products for good sexual and reproductive health;
b. public and private clinics provide better sexual and reproductive care where more and more people use it;
c. Fight against poverty related diseases, as envisaged in UN millennium target number 6.
3. The project aims at effecting innovative health technologies in at least one of the following categories:
a. Medicinal products;
b. Bio-medical products;
c. Medical devices;
d. Supporting technologies to enable effective diagnostics, therapy or prevention.
(4) The costs of the project shall be as follows:
(a) at least 25% of the total eligible project costs shall be financed by the participation of the members of the grouping who are already directly or indirectly acquired from the budget of the Ministry of the European Communities. Foreign Affairs (for example, a grant or contribution from a Dutch embassy) may not be used to achieve the necessary own contribution.
(b) at least half of the own financial contribution shall be made up of funds from the profit-making undertakings;
c. A minimum of € 67,000 of eligible costs is involved.
5. In any event, no grant is granted for a project aimed at:
a. basic (scientific) research;
b. financing of commercial activities;
c. Activities included on the exclusion list of FMO, posted on http://www.fmo.nl/exclusion-list;
d. Loans or revolving financing, for example micro-credit, which are given to third parties respectively.
1. Subsidie requested by the manager of a grouping. Applications from individual companies and organisations shall not be eligible for a grant.
2. All members of the grouping shall have legal personality.
3. The pen-holding is open to all participants of the grouping, except for public parties.
(4) If the application is honoured, the holder shall be the recipient of the subsidy and as such responsible for the execution of the project, any participant of the grouping shall assume the execution of the activities.
(5) The person responsible for the grant shall be the recipient of all the obligations attached to the grant, irrespective which of the participants of the grouping is in fact entrusted with the execution of the work for the purpose of the project; whether the grant is intended to finance the activities of the participants of the grouping or the activities (partly) carried out by (a) participant (s).
6. In so far as the grant is intended to finance activities of participants of a grouping other than the pener, it appears that the application is based on the application. The application provides an insight into everyone's share in the implementation of the project and the costs involved.
(7) The decision to grant the grant of grants shall provide that the person responsible for the charge must be made available to the other participants of the grouping. That makes those participants in economic terms until grant recipients-even though they are in the relationship with the Minister not-and not 'subcontractors'.
8. The participants of the grouping shall cooperate on the basis of a cooperation agreement signed by all participants. The agreement shall contain agreements on, in each case, the manner in which each party contributes to the work of the grouping, the way in which decision-making in the grouping takes place, the manner in which the costs and the costs and costs incurred by the joint venture. risks are spread among the participants, intellectual property rights (dissemination and use), as well as the manner in which compliance with the obligations to the Minister is ensured against the Minister.
9. In the case of changes to the cooperation, such as accessions, breakout events or the entirety of a participant, for the Minister the leader is always the contact point and the responsible person. The pilot shall be required to submit amendments to the grouping for approval to the Minister.
10. The Minister shall reserve the right to recover funds from all or part of the grants to the person in charge of the pilot. Any recovery decision shall be addressed to the pilot. Or, and how the manager can tell the other participants of the partnership is a matter for which the Minister has no interference.
11. In the case of the directors and/or one of the members of the grouping, they shall not be eligible for any subsidy if there is:
a. Conviction for an offence concerning his business conduct;
b. engaged in serious business misconduct or mismanagement;
c. has failed to fulfil the obligations relating to the payment of social security contributions and/or tax in accordance with the legal provisions in force in the Netherlands or in the developing country;
d. is convicted or prosecuted for criminal activity, including violation of internationally accepted human rights, or under strong suspicion of direct or indirect involvement in such activities; and/or
e. a blacklist of (a) international organisation (s).
The subsidy shall amount to a maximum of 75% of the eligible project costs per grouping up to a maximum of:
a. € 75,000,-for project a
b. $225,000,-for project b and c
c. € 150,000,-for project d
d. € 300,000,-for project e
A description of the project costs which can be taken into account in determining the size of the subsidy is set out in this section. No subsidy shall be granted for costs which cannot be regarded as necessary in reasonable terms. The internal costs incurred by both the pilot and the other participants in the grouping shall be taken into account without any profit margin. Costs of participants in developing countries shall be assessed by local standards.
The eligible costs relate only to the lodging of the application:
1. The number of hours the project staff involved in the project makes for the project, multiplied by a fixed hourly rate of € 87.50, in which both direct labour costs and imputed indirect costs are understood. These costs may be increased by:
a. Materials and/or equipment costs: the cost of the use of equipment and the cost of materials consumed if these are to be distinguished in the records;
b. Third party costs: the costs paid to third parties;
c. Travel expenses: international travel expenses and interlocal travel expenses outside the Netherlands based on economy class, up to a maximum of the business class rate for intercontinental flights;
d. Subsistence expenses: the maximum subsistence allowance is the number of overnight stays the lodging and other costs in accordance with the Daily Subsistance Allowance Rates (DSA lists) of the Ministry of the Interior, applicable at the start date of the project: Annex I belonging to Article 3, first paragraph of the Travel Arrangement abroad . 5
2. By way of derogation from the first paragraph, the hourly rate for personnel of the cooperative participation in the developing country shall be fixed by local units up to the maximum fixed hourly rate specified in the first paragraph.
3. By way of derogation from the first paragraph, a project shall include only labour costs and costs incurred by third parties other than project management or coordination costs for the grant.
(4) In any case, the following costs shall not be eligible:
a. The costs of applying for subsidy;
b. Financing costs and interest rate reductions;
c. Turnover taxes such as VAT and VAT (this also applies to BTW/VAT members of the grouping's exempted members);
d. cost of purchasing licenses (e.g. software licenses, patent licenses)
e. costs caused by inflation and exchange rate fluctuations.
f. cost of promotional material;
g. General translation costs;
h. costs of the establishment and maintenance of intellectual property rights;
i. Costs for the enhancement of health systems and health financing.
1. The application must be signed in writing and/or by e-mail, by application of grant application LS&H4D, legally valid, at the latest on 1 October 2014 at 15:00 in Dutch time at the Dutch National Service for Enterprise Netherlands: Postal address: PO Box 93144, 2509 AC The Hague, Netherlands; Visiting address: Princess Beatrixlaan 2, The Hague; by mail: LSH4D@rvo.nl.
(2) The application shall be drawn up in the English language and shall be made using a form established for that purpose by the Minister and bearing the Annexes referred to therein, which shall be made available to english.rvo.nl/lsh4d and www.rvo.nl/lsh4d
3. For the budget, use should be made of the project budget calculation tool, download via english.rvo.nl/lsh4d and www.rvo.nl/lsh4d
(4) The application shall be accompanied by a cooperation agreement signed by all participants in the grouping as referred to in paragraph 4.
5. The application includes a description of how the business case for financing is offered in one or more relevant funding institutions and/or 'call for proposals' in the (inter) national context related to the health status of the poorer population groups in developing countries.
6. Participants declare to be aware of the OECD Guidelines for Multinational Corporations on Corporate Social Responsibility, the UN Convention on Biological Diversity and the Objectives of the International Business. Work organization, and that they act hereafter; be aware of the FMO exclusion list and do not carry out any activities under the project named on this list; to actually deliver its own (financial) contribution.
7. In the context of the application procedure, emphasis is placed on Article 7, third paragraph, of the Subsidy Decision Ministry of Foreign Affairs . Should an application be submitted incomplete, the Minister may ask for a supplement. The date of receipt of the application shall then be the date on which the application was completed. If an application is only submitted in the last two weeks before the expiry of the deadline, the manager will run the risk that the Minister will not apply his authority to ask for a supplement as the manager is not in charge. such an addition is no longer possible without exceeding the deadline. In such a case, the application will no longer be possible, but will be assessed as it was primarily submitted.
In addition to the Article 4:35 of the General Administrative Law Law An application for grant is rejected if it fails to comply with the provisions of these policy rules.
Applications which have not already been rejected on the basis of previous paragraphs shall be assessed in substance on the basis of the criteria set out below. In order to be eligible for a grant, the quality of the application must be of sufficient quality, i.e. the application must score a minimum of 73 points. Moreover, the technical and technical quality of the proposal, as well as the quality of the operator and of the grouping, must be sufficient. Only those applications that meet these minimum quality requirements are ranked on the basis of the scores obtained, and according to this rate of subsidy, will be provided until the subsidy ceiling has been reached.
Policy (up to 38 points to be obtained)
The degree of policy relevance of the project shall be assessed according to the following criteria:
-Relevance for health enhancement: the extent to which the project benefits the combating of diseases related to sexual and reproductive health and poverty related to the BoP population;
-Development relevance: the extent to which the project contributes to economic development and growth by creating market opportunities for enterprises in developing countries, in the field of health technology for poverty related health problems among the BoP population;
-Access: the manner in which and the degree to which the access of the BoP population to, and the use of, the health technology to be developed will be guaranteed in an affordable way by means of agreements on intellectual property rights on Framework of cooperative knowledge, process and products.
-Innovation: the extent to which the proposed solutions/technologies/approaches are innovative, supported by, for example, research (scientific and other relevant), problem-related, target-target and context analyses.
-Financing Business Case: the manner and extent of how the business case to be developed to promote the health status of the poorer population groups in developing countries in the project is financed by relevant funding institutions and/or 'call for proposals' in the (inter) national context.
Content and technical (maximum 31 points to be obtained)
With regard to the technical quality of the project, the following criteria are included in the assessment:
-Elaboration of Outputs, Activities, Resources and Risks: the degree to which the project is elaborated in outputs, intended activities, resources and risks and is provided with a clear link between these levels.
-Elaboration of intended outputs, intended activities, resources and risks in SMART systematics: the extent to which outcomes, outputs, resources and risks are elaborated specifically, Measured, Acceptable, Realistic and Time-bound.
-Risk, monitoring and guidance: the extent of adequate risk management, consisting of an adequate risk analysis, including corruption, and an adequate monitoring and mitigation system, including relevant cross-links between parallel activities, and guidance.
-The extent to which the project results from (scientific and other relevant) research, problem, target and context analyses and, on the other hand, focuses on the health issues of the BoP
-The extent to which the project focuses on innovation in the field of SRGR-and poverty-related diseases.
-the extent to which the proposed project is technically feasible and feasible in the period prescribed and has no negative implications for the environment or social conditions.
Organization (maximum 14 points to be obtained)
With respect to the quality of the pilot, the following criteria shall be used in the assessment:
-The extent to which the pilot has sufficient planning, monitoring and evaluation capacity to be accountable for the implementation of the project.
-the extent to which the pilot has sufficient financial and administrative management capacity in order to successfully carry out the project.
Grouping (up to 17 points to be obtained)
In relation to the grouping, the following criteria shall be used in the assessment:
-The quality of risk analysis of the grouping. In any case, attention has been paid to the success and risk factors, or to the cooperative strengths and strengths of the project, and to propose measures to be taken.
-The value added of the grouping: how and the degree to which the project of the grouping has added value in relation to activities of individual organisations.
-The extent to which the project is consistent with the current core activities and strategy of the cooperative participants.
In case grant is granted under these policy rules, the following applies:
1. For the modification of the project, the Minister may grant approval at the prior request of the holder. The approval may be subject to requirements.
2. The pilot shall cooperate in the disclosure of the data and the results of the project.
3. The pen-in-command shall cooperate with an evaluation survey or monitoring aimed at the application and effects of the policy rule.
