Aussendung der Stellungnahme des BMGF zum Thesis Paper über das 9. EU-RTD- Rahmenprogramm

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1 Frau Mag. Andrea Höglinger Organisationseinheit: BMGF - I/FXEL (Fachexpertin DI Dr. Eva Lang) Sachbearbeiter/in: DI Dr. Eva-Claudia Lang eva-claudia.lang@bmgf.gv.at Telefon: +43 (1) Fax: +43 (1) Geschäftszahl: BMGF-70422/0007-I/FXEL/2016 Datum: Ihr Zeichen: Aussendung der Stellungnahme des BMGF zum Thesis Paper über das 9. EU-RTD- Rahmenprogramm Sehr geehrte Frau Mag. Höglinger! Das Bundesministerium für Gesundheit und Frauen beehrt sich, eine Stellungnahme zum Thesis Paper über das 9. EU-RTD-Rahmenprogramm abzugeben. Die Stellungnahme setzt sich aus Beiträgen mehrerer Fachabteilungen des Ressorts und der GÖG zusammen. Da das Thesis Paper in englischer Sprache verfasst wurde, ist auch die Antwort des BMGF in dieser Sprache gehalten. Das Ressort ersucht Sie um Berücksichtigung der nachstehenden Kommentare zu den einzelnen Thesen: General Comments Thank you very much for giving us the opportunity to comment on this very important and well drafted thesis paper. The methods and procedures chosen to collect the joint Austrian recommendation seem well thought through. In general, the authors of the theses paper should clarify all abbreviations used in the document, or they even might want to include a list of terms. Additionally we would like to specifically emphasize that theses no. 4, 5, and 6 should be listed first to stress their importance. One concern from our end is that currently there is no sufficient policy framework in which the Research Program is embedded, for instance we see a lack of connection (missing interfaces) with other policy fields. We think this is one of the priorities that needs to be tackled if we want to come to a New Deal. The Austrian Public Health Institute Gesundheit Österreich GmbH (GÖG), appreciates all attempts to make the strategic outline of the Research Program more explicit, and to clearly focus on a few thematic pillars. Furthermore the application and management of such projects is a challenge. So any down-sizing of its complexity is favour- Bundesministerium für Gesundheit und Frauen Radetzkystraße 2, 1031 Wien post@bmgf.gv.at DVR: UID: ATU

2 able. Thus, the GÖG endorses Theme 6) in the provided Thesis-Document of the Austrian FP9 Think Tank. Especially we would welcome if the focus of the topics would be a bit less technology-driven and would rather consider socio-economic and public health topics, i.e. well-being and societal challenges as well. From the technology field, Big Data in Public Health, including the potential added value is a priority topic in our opinion. In this contextual regard we especially endorse the Themes 4) and 5) in the provided Thesis-Document. Also some research topics should be directed at the less-privileged parts of our community: the poor, the sick, the elderly and last but not least our children and especially those with special needs. And, yet another comment: Due to the high international competition, the chances to get European funding for a research project are very low. The tremendous amount of human resources that need to be invested to prepare a funding proposal that can compete with other proposals represents a big burden especially to small and privately funded research institutions. In order to support freedom of research, and give equal chances to different types of research organizations to successfully apply for European funding, the application procedures should be modified (more two- or three-step application), and clear guidance on the criteria a successful application needs to fulfill should be provided. Finally it has to be stated that the protection of the Austrian high social and ethical standards, e.g. with respect to embryo research, as well as concerning environmental and consumer protection is regarded as essential. Regarding the 10 theses in detail, we would like to suggest additional discussion on the following topics: Thesis 1: it should be emphasized that duplication of any work must be avoided, i.e. the EC (European Commission) is requested to take strong leadership and to avoid duplication between different EU instruments (DGs, institutions and agencies) and/or between Member States (MS); for example in our field (medical issues) make sure that no duplication of work is done between CHAFEA, SANTE, ECDC, EMA, EFSA and the MS. Work and research findings of one body should support and influence the work of the others, and within a joint strategy (led by the EC), the roles and responsibilities as well as the support should be clearly defined. Concerning thesis 1 and 3: Pleading for innovation-friendly environmental and safety regulations (p. 15) as well as a supportive policy and business ecosystem for RTI, particularly with respect to regulation enforcing fitness for global competition (e.g. green regulation (p.18) is regarded as one important aspect. Nevertheless it has to be stated that all theses efforts can only be made keeping up the high Austrian- and EU-standards on environmental-, food- and consumer-protection and respective national- and EU-regulations. Thesis 2: Any funding should clearly have the goal of sustainability this could be highlighted more in the document; when designing and implementing FP9, the need Seite 2 von 4

3 for legal/administrative resources to support researchers should be made clear (in the application and development process as well as the implementation and monitoring process) could these tasks be pooled somehow? Or processes be facilitated? Thesis 3 and 4: Concerning stronger involvement of civil society users and stakeholders : in our field, implementation science would support innovative concepts on how to better implement vaccination programs, hence we fully support the bottomup approach on this; involvement of NGOs, open consultation processes; support in developing platforms in this; the question is however, who is defined as stakeholder and how they should be involved in setting the research agenda the envisioned methods could be explained better in the document. Public-private partnerships: this should state clearly the aim and roles though, as involvement of industry might have stronger market ideas than true concern of public health; i.e. how can independence in recommendations be ensured and public money spent in an equal and independent way, if some parts of the industry benefit from public money (through FP-funding) in their research and development. Smart regulation : we support the development towards a joint strategy on licensing and distribution of vaccines, as well as the linguistic support in the whole process, and monitoring of implementation and safety. Digitalisation : international cooperation on this is important, which then later also allows sharing of data (electronic documentation of data on vaccination status, which could, in the future work all across Europe); use of digital data for various fields of relevance (i.e. to share vaccination data with healthcare providers in other countries); for this topic and the Austrian strategy however, General Directorate I of the Ministry of Health and Women`s Affairs should be consulted. Thesis 4: It would be important to point out in more clarity hat only projects that are supposed to provide solutions for societal challenges of our times are to be funded. Innvoation alone is not enough. The societal challenges that are prioritized should be specified in FP9. Thesis 5: Selection of criteria based on societal/economic relevance for Europe: we fully support the development of easy applicable health economic and costeffectiveness tools to support decision making; further, the prevention of disease needs to be highlighted and in focus, rather than (costly and long-term) treatment of disease; vaccines in this case have been shown to be one of the most effective interventions (apart from hand washing) in the history of public health. Additionally the paper says that the number of priority areas should be limited. The Austrian FP9 Think Tank should therefore suggest some priority areas. Thesis 6: Although the Think Tank recommends having few and clear objectives, the main objectives they list are all quite general and comprehensive. Thesis 7: Monitoring should not only target the (economic) implementation of the planned activities, but should integrate the quality of the content, as well as an im- Seite 3 von 4

4 pact evaluation; long-term effects should be measured (or predicted/modelled), as correctly suggested by introducing sustainable and harmonized outcome indicators. For process monitoring, harmonized internal and external evaluation schemes and methods are recommended. Stakeholder analyses should precede any funding, in order to measure the impact in the correct target group. Thesis 9: Third countries : this term needs to be revised or explained; do the authors mean Member States? Enlargement countries? Third world countries? Further, as mentioned above, the roles and responsibilities between the leading EU bodies and the implementing bodies needs to be clearly defined. Europe should take the lead in global initiatives : this should be merged with the aim and objective of the EC and its agencies overall; i.e. who is the target audience/beneficiaries? For example, should we focus on Zika/Ebola vaccine development, if we most likely will not have such epidemics in Europe? A strategy paper should make this clear for a pan-european approach. Support in application processes should be considered, or made easier, to allow fair competition for all MS. A general comment regarding thesis 9 concerns the fact, that the thesis paper should take into consideration the UN 2030 Agenda for Sustainable Development focusing on goal 3 Ensure healthy lives and promote well-being for all at all ages especially on goal 3b: Support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all. Mit freundlichen Grüßen Für die Bundesministerin: DI Dr. Eva-Claudia Lang Beilage/n: Seite 4 von 4

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