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Baraldi, Enrico, ProfessorORCID iD iconorcid.org/0000-0003-1618-701x
Publications (10 of 85) Show all publications
Brantnell, A. & Baraldi, E. (2020). The roles of academic inventors in medical innovation processes: Exploring the influence of IPR ownership and IP nature. International Journal of Innovation Management, Article ID 2050045.
Open this publication in new window or tab >>The roles of academic inventors in medical innovation processes: Exploring the influence of IPR ownership and IP nature
2020 (English)In: International Journal of Innovation Management, ISSN 1363-9196, E-ISSN 1757-5877, article id 2050045Article in journal (Refereed) Published
Abstract [en]

This paper analyses four medical innovation processes originating from Stanford and Uppsala universities with the purpose of understanding how intellectual property rights (IPR) ownership and intellectual property (IP) nature influence the behaviour of academic inventors. We analyse this behaviour through the roles enacted and evaluate the requirements the roles pose by developing a method to assess the requirements of individual roles, which we label as role intensity. We find that both IPR ownership and IP nature can influence the academic inventors’ roles and role intensities. In contrast to assumptions in research and policy, we find that IPR ownership does not influence the roles and role intensities in a remarkable way. We also find support that research and policy should distinguish between patentable and non-patentable inventions in the field of medical invention as these two types of IP nature are associated with different roles and role intensities. These findings contribute to the literature on commercialisation of science and innovation management by demonstrating the importance of IP nature in influencing the roles of inventors. Managerial and policy implications are provided.

Place, publisher, year, edition, pages
World Scientific, 2020
Keywords
Science commercialisation, intellectual property rights, university ownership, inventor ownership, patent, medical innovation
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-262346 (URN)10.1142/S1363919620500450 (DOI)
Available from: 2015-09-14 Created: 2015-09-14 Last updated: 2020-03-03Bibliographically approved
Brantnell, A., Baraldi, E. & van Achterberg, T. (2019). An inductive exploration of the implementation knowledge of research funders. Health Research Policy and Systems, 17, Article ID 67.
Open this publication in new window or tab >>An inductive exploration of the implementation knowledge of research funders
2019 (English)In: Health Research Policy and Systems, ISSN 1478-4505, E-ISSN 1478-4505, Vol. 17, article id 67Article in journal (Refereed) Published
Abstract [en]

Background: Healthcare research funders may undertake various roles to facilitate implementation of research findings. Their ability to enact such roles depends on several factors, knowledge of implementation being one essential requirement. However, previous studies do not assess the type or level of knowledge about implementation that research funders possess. This paper therefore presents findings from a qualitative, inductive study of the implementation knowledge of research funders. Three aspects of this knowledge are explored, namely how research funders define implementation, their level of self-assessed implementation knowledge and the factors influencing their self-assessment of implementation knowledge.

Methods: Research funders (n = 18) were purposefully selected from a sample of research funding organisations in Sweden (n = 10). In-depth semi-structured interviews were conducted, recorded and transcribed verbatim. An inductive method using a systematic coding procedure was employed to derive the findings.

Results: The research funders defined implementation as either an outcome or a process, with the majority believing that implementation of healthcare research results demands a process, although its complexity varied in the research funders’ view. They perceived their own level of implementation knowledge as either limited or substantial, with a majority regarding it as limited. Clinical research experience, clinical experience and task relevance were singled out as the clearest factors affecting the self-assessment of their own implementation knowledge.

Conclusions: This study, the first to focus on implementation knowledge of research funders, demonstrates that they are a category of policy-makers who may possess knowledge, based on their previous professional experience, that is comparable to some important findings from implementation research. Consequently, the findings not only pinpoint the relevance of professional experience, but also reveal a lack of awareness and knowledge of the results of implementation research among research funders in charge of healthcare research.

Keywords
Research policy, implementation, quality improvement, healthcare research, research funder, policy-maker, knowledge use
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
urn:nbn:se:uu:diva-317932 (URN)10.1186/s12961-019-0472-8 (DOI)000476498200001 ()31319867 (PubMedID)
Available from: 2017-03-22 Created: 2017-03-22 Last updated: 2019-08-29Bibliographically approved
Baraldi, E., Ciabuschi, F., Callegari, S. & Lindahl, O. (2019). Economic incentives for the development of new antibiotics: Report commissioned by the Public Health Agency of Sweden. Uppsala universitet
Open this publication in new window or tab >>Economic incentives for the development of new antibiotics: Report commissioned by the Public Health Agency of Sweden
2019 (English)Report (Other academic)
Abstract [en]

This report responds to a request by the Public Health Agency of Sweden (Folkhälsomyndigheten) concerning which incentives for antibiotics research and development (R&D) Sweden should take into consideration for potential public investments. Based on discussions and interviews with experts, feedback from stakeholders (i.e. potential recipients of Swedish incentives), company case studies and computer-based Monte Carlo simulations, this report provides a set of recommendations about the economic incentives that can be relevant for Sweden.

The incentives identified for Sweden’s portfolio meet the following criteria: improving Sweden’s visibility in the antibiotics field, reinforcing Sweden’s national R&D infrastructure in this area, leveraging Sweden’s strengths and traditions, limiting the public expenditure per incentive, permitting rapid implementation and effects, providing highly needed support to the antibiotic pipeline in unique ways, and granting Sweden a key contribution and thus influence on the design and direction of each incentive.

Based on these criteria, a Market Entry Reward (MER) was not considered a viable alternative for Sweden if implemented by Sweden alone, especially because of its demanding financial engagement (close to 1 B USD), which is necessary for this incentive to produce relevant effects on the antibiotics R&D pipeline. However, if Sweden were to decide to pilot an MER, it should focus on a fully delinked MER, which entirely substitutes market sales with lump sums paid on a yearly basis. An MER should moreover be financed primarily from the healthcare budget to avoid crowding out other incentives. A fully delinked MER would allow testing several features of this incentive model, such as the evaluation procedures to set the overall amount of the MER, the definition of the unit prizes to be paid by local healthcare facilities to the central government, and periodic reviews to reassess the amount of yearly lump-sum payments according to the confirmed therapeutic efficacy of the antibiotic.

If Sweden were to collaborate with other countries, such as the G20 group or the 28 EU members, a reasonable amount for its share is 6 or 23 M USD, respectively, for a partially delinked MER and 9 or 34 M USD, respectively, for a fully delinked MER. There are, however, ways to combine push and pull incentives, which are quicker and more efficient than an MER, namely combinations of grants with milestone prizes, which are rewards paid to developers upon the successful completion of key R&D steps (e.g. Phase 1 clinical studies). In addition to producing better effects for the money spent, a combination of milestone prizes and grants also prevents large MERs from crowding out push investments as well as recipients such as small- and medium-sized firms (SMEs), who usually cannot wait for a reward that is delayed until the final approval of an antibiotic.

The recommended portfolio of incentives for Sweden includes three incentives: grants, milestone prizes and Pipeline Coordinators, to be used in combination with each other as a way to cover the antibiotics R&D pipeline and achieve important synergies. The following features should be considered when implementing and funding the three selected incentives:

1) Grants should be dedicated to early R&D projects (no later than Phase 2) and to reinforcing the national R&D infrastructure, with a longer-term perspective than the current 3-year timeframe. In this regard, Sweden should maintain and possibly increase its current yearly investments in antibiotics R&D grants of approximately 7 M USD/year (60 M SEK) over several years. These investments will pay off in the long run, both in terms of molecules that will enter the future R&D pipeline; and as a stock of competencies spread over an infrastructure of specialised R&D centres that can be leveraged

for future antibiotics research. These competences must be built up immediately and the seeds for future R&D projects need to be planted as soon as possible.

2) Two types of milestone prizes should be in focus for Sweden: first, a prize awarding a sum between 10 and 20 M USD at the end of Clinical Phase 1 to highly innovative molecules addressing specific pathogens and, second, a prize for projects successfully completing preclinical steps. Establishing a prize at the end of Clinical Phase 1 is a much needed and unique initiative, with significant effects on the early R&D pipeline, granting also strong international visibility to Sweden. Sweden could also take major responsibility for such a milestone prize by covering a relatively large share. The other recommended milestone prize, awarded at the end of the preclinical steps, would help refill the clinical pipeline and would therefore have more of a long-term effect.

3) Pipeline Coordinators, that is, organizations that take an active role in selecting and supporting a portfolio of antibiotics R&D projects in various ways, are the last recommended incentive. Selecting among currently existing Pipeline Coordinators rather than creating a new one, Sweden should fund two types of such organizations: R&D Collaborations, which create collaboration platforms to perform early development activities for the antibiotic projects they support, and Non-Profit Developers, who conduct their own antibiotic projects with the aim of bringing antibiotics to market but without pursuing profit goals. The first type of Pipeline Coordinator, R&D Collaborations, is relevant for a Swedish public investment because they are potentially the most efficient incentive in making R&D projects profitable. However, to fully exploit this potential, R&D Collaborations must be refined to become more flexible, reduce bureaucratic burden and avoid conflicts between participants.

Non-Profit Developers provide the most extensive support to selected products by intervening across the entire antibiotic pipeline to ensure products reach the market. Moreover, this model strongly promotes both global availability and responsible use (stewardship). Therefore, Sweden may fund Non-Profit Developers through its international aid budget and in this way make important contributions to global health.

Both types of Pipeline Coordinators also offer the advantage that they can help connect Swedish antibiotics R&D centres to international platforms, which reinforce the effects of infrastructure-related grants. Moreover, all forms of Pipeline Coordinators are incentive models that can be used as tools to manage the other two incentives (grants and milestone prizes). In this capacity, they can, for instance, evaluate grant applications and the antibiotic projects eligible for milestone prizes, which require a deep insight into the details of a drug development project.

A fourth model, regulatory simplifications, which radically cut costs and times for Clinical Phase 3, can also be relevant for Sweden due to its contained costs, rapid implementation and effects and connection with Sweden’s expertise. However, this incentive requires further analysis to fully grasp its implications for regulators and patient safety before being recommended for implementation.

The three incentives recommended by this report – grants, milestone prizes and Pipeline Coordinators – should be used in combination to exploit the synergies between them and their ability to push and pull molecules in different phases of the R&D pipeline. For instance, when grants and milestones are used together, the public investment per approved new antibiotic is lower than the combined spending if the two incentives were used in isolation. If it is not possible to introduce and use the three incentives simultaneously, the following priorities should be applied: first of all, grants need to be kept at current levels and possibly increased to fund both single antibiotic projects and competence development in the R&D infrastructure, while starting to invest in a Non-Profit Developer and a milestone prize at the end of Phase 1, followed by the development and funding of R&D Collaborations and, finally, a preclinical milestone prize.

Place, publisher, year, edition, pages
Uppsala universitet, 2019. p. 43
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
urn:nbn:se:uu:diva-375258 (URN)
Funder
Public Health Agency of Sweden
Available from: 2019-01-28 Created: 2019-01-28 Last updated: 2019-01-31Bibliographically approved
Baraldi, E. & Ratajczak-Mrozek, M. (2019). From supplier to center of excellence and beyond: The network position development of a business unit within "IKEA Industry". Journal of Business Research, 100, 1-15
Open this publication in new window or tab >>From supplier to center of excellence and beyond: The network position development of a business unit within "IKEA Industry"
2019 (English)In: Journal of Business Research, ISSN 0148-2963, E-ISSN 1873-7978, Vol. 100, p. 1-15Article in journal (Refereed) Published
Abstract [en]

This study aims to develop a more dynamic and relational view of centers of excellence (CoE) within multinational enterprises (MNEs), that is, business units with specific and highly valuable competencies and knowledge, which are transferred and leveraged by other units of the MNE. We employ a longitudinal case study to analyze how, between 1986 and 2014, an external supplier progressively became a CoE within IKEA and even improved this role, thereby becoming increasingly important for the MNE. Particularly, we develop a model linking internal (resources, competencies, and structure) and external factors (exchange volumes, interorganizational routines, mutual dependence, trust and commitment, and identities) with changed network positions, which, in turn, define the intensity and importance of a CoE's role. Thus, the elements required to establish a CoE may not originate from the MNE's core competencies, but may be extracted, recombined, and integrated externally from the MNE's global supply network.

Keywords
Center of excellence, IKEA, International business, Multinational enterprise, Network position, Poland
National Category
Business Administration
Identifiers
urn:nbn:se:uu:diva-388765 (URN)10.1016/j.jbusres.2019.03.008 (DOI)000470942500001 ()
Available from: 2019-08-12 Created: 2019-08-12 Last updated: 2019-08-12Bibliographically approved
Baraldi, E., Ingemansson Havenvid, M., Linné, Å. & Öberg, C. (2019). Start-ups and networks: Interactive perspectives and a research agenda. Industrial Marketing Management, 80, 58-67
Open this publication in new window or tab >>Start-ups and networks: Interactive perspectives and a research agenda
2019 (English)In: Industrial Marketing Management, ISSN 0019-8501, E-ISSN 1873-2062, Vol. 80, p. 58-67Article in journal, Editorial material (Other academic) Published
Abstract [en]

This article introduces Industrial Marketing Management's special issue on start-ups and networks. To begin with, we stress the relevance of understanding the context wherein entrepreneurship unfolds – a context filled with social, technical and economic connections to which the start-up needs to relate. We also present and confront three network perspectives which bring different insights to the interplay between start-ups and networks: Social Network (SN) theory, the Industrial Marketing & Purchasing (IMP) view, and Actor-Network Theory (ANT). Next, we introduce the 12 papers of this special issue and place them on a continuum covering a start-up's process of network embedding and including the three periods of establishment, consolidation and stabilization. We conclude with a research agenda suggesting five avenues for further research: (1) tracing start-ups' process of network embedding, (2) mapping the connections between the different networks affecting a start-up, (3) grasping the negative effects of networks on start-ups, (4) making longitudinal case studies on start-ups and networks more comparable via common analytical tools, and (5) investigating how policy influences the complex interplay between start-ups and networks.

National Category
Applied Psychology Interaction Technologies Business Administration
Identifiers
urn:nbn:se:uu:diva-341953 (URN)10.1016/j.indmarman.2018.02.002 (DOI)000480512000007 ()
Available from: 2018-02-16 Created: 2018-02-16 Last updated: 2019-09-30Bibliographically approved
La Rocca, A., Perna, A., Sabatini, A. & Baraldi, E. (2019). The emergence of the customer relationship portfolio of a new venture: a networking process. Journal of business & industrial marketing, 34(5), 1066-1078
Open this publication in new window or tab >>The emergence of the customer relationship portfolio of a new venture: a networking process
2019 (English)In: Journal of business & industrial marketing, ISSN 0885-8624, E-ISSN 2052-1189, Vol. 34, no 5, p. 1066-1078Article in journal (Refereed) Published
Abstract [en]

Purpose While several studies have focused on the initial phases of new ventures and their first customer and supplier relationships, we have a limited understanding of how the new venture's portfolio of customer relationships emerges. This paper aims to explore the emergence of the customer relationship portfolio of a new venture and to investigate the effects of early relationships on subsequent ones. Design/methodology/approach Methodologically, the authors rely on a longitudinal single case study of a new venture which develops, implements and sells customized cost-management software. The study is exploratory and based on 24 in-depth interviews. Findings The findings show that the development of a customer portfolio depends on the cumulative effect of heterogeneous elements and network connections. These include the initial link between the new venture and the first customer and a subsequent series of interconnections that develop with the emerging network capability of the new venture. Originality/value As one of the few studies that explore the emergence of new ventures' customer relationship portfolio, this study demonstrates the value of applying a relational/network approach for studying relationship portfolio dynamics.

Place, publisher, year, edition, pages
EMERALD GROUP PUBLISHING LTD, 2019
Keywords
Interaction, Networking, Customer relationships, New ventures, Customer portfolio
National Category
Business Administration
Identifiers
urn:nbn:se:uu:diva-393009 (URN)10.1108/JBIM-10-2018-0300 (DOI)000479264400012 ()
Available from: 2019-09-19 Created: 2019-09-19 Last updated: 2019-09-19Bibliographically approved
Wagrell, S. & Baraldi, E. (2019). The joys and sorrows of a start-up's interactions with the public sphere: a case from medical technology. Journal of business & industrial marketing, 34(1), 267-283
Open this publication in new window or tab >>The joys and sorrows of a start-up's interactions with the public sphere: a case from medical technology
2019 (English)In: Journal of business & industrial marketing, ISSN 0885-8624, E-ISSN 2052-1189, Vol. 34, no 1, p. 267-283Article in journal (Refereed) Published
Abstract [en]

Purpose: This paper aims to address the crucial interactions that a start-up enacts with actors from the public sphere in a context of medical technologies. The public actor commonly plays multiple roles, ranging from co-developers and financiers to large-scale users, which are all pivotal to the development and survival of the new venture. The paper investigates the possible “dark sides” of a start-up’s marriage with a public partner, departing from three specific roles the public sphere can assume in relation to a start-up: as a development partner, as a financer and as a customer.

Design/methodology/approach: The study builds on an in-depth empirical case study of a Swedish med-tech startup company.

Findings: The authors find the financing role to be least problematic, whereas the customer role is the most problematic in that it provides numerous barriers to the possible development and growth of a start-up firm striving to get new customers in a public setting. Examples of the most prominent barriers found are regulations, complex decision-making processes and assessment elements of med-tech products that are outside the control of the startup firm, hence issues that cannot be handled within inter-organizational relationships.

Originality/value: The study builds on 27 in-depth interviews, which were undertaken during 2005-2013, thus contributing detailed data about a start-up’s many and crucial interactions with different public actors. Departing from three different roles, a public partner can adopt in relation to a start-up, (development, co-financer and customer) provides results with managerial implications for start-up’s and policy implications for health-care policy.

Keywords
Start-ups, Inter-organizational interaction, Med-tech, Positive and negative effects, Public actors
National Category
Business Administration Engineering and Technology
Identifiers
urn:nbn:se:uu:diva-381391 (URN)10.1108/JBIM-11-2018-0326 (DOI)000461721700020 ()
Available from: 2019-04-09 Created: 2019-04-09 Last updated: 2019-04-09Bibliographically approved
Baraldi, E., Ciabuschi, F., Lindahl, O. & Fratocchi, L. (2018). A network perspective on the reshoring process: The relevance of the home- and the host-country contexts. Industrial Marketing Management, 70, 156-166
Open this publication in new window or tab >>A network perspective on the reshoring process: The relevance of the home- and the host-country contexts
2018 (English)In: Industrial Marketing Management, ISSN 0019-8501, E-ISSN 1873-2062, Vol. 70, p. 156-166Article in journal (Refereed) Published
Abstract [en]

While research on reshoring generally focuses on the host-country to explain why a company brings its previously offshored activities back home, this paper stresses the relevance also of the home-country context. Specifically, relying on the IMP (Industrial Marketing & Purchasing) perspective we show how offshoring and reshoring processes and decisions are both enabled and constrained by the micro-interactions and inter-dependencies in the industrial networks stretching over the home-country and the host-country. This work relies on a longitudinal case study about an Italian manufacturing firm to develop a model indicating how offshoring/reshoring is a long-term process which unfolds depending both on the focal firm's strategy and on its interplay with the embedding network. Next to this interactive process perspective, we contribute to the literature on reshoring and the global factory also the concept of "selective reshoring", whereby companies bring back a very specific sub-set of activities, which were previously fine-sliced and offshored, and re-embed these activities in their local home context. The more flexible and selective nature of this relocation of activities between different supply markets depends both on the firm's strategy and on the structure, overlap and evolution of the network elements located in the home- and host-country contexts.

Place, publisher, year, edition, pages
ELSEVIER SCIENCE INC, 2018
National Category
Business Administration Engineering and Technology
Identifiers
urn:nbn:se:uu:diva-357536 (URN)10.1016/j.indmarman.2017.08.016 (DOI)000433400700014 ()
Available from: 2018-08-24 Created: 2018-08-24 Last updated: 2018-08-31Bibliographically approved
Baraldi, E., Lindahl, O., Savic, M., Findlay, D. & Ardal, C. (2018). Antibiotic Pipeline Coordinators. Journal of Law, Medicine & Ethics, 46, 25-31
Open this publication in new window or tab >>Antibiotic Pipeline Coordinators
Show others...
2018 (English)In: Journal of Law, Medicine & Ethics, ISSN 1073-1105, E-ISSN 1748-720X, Vol. 46, p. 25-31Article in journal (Refereed) Published
Abstract [en]

The World Health Organization (WHO) has published a global priority list of antibiotic-resistant bacteria to guide research and development (R&D) of new antibiotics. Every pathogen on this list requires R&D activity, but some are more attractive for private sector investments, as evidenced by the current antibacterial pipeline. A pipeline coordinator is a governmental/non-profit organization that closely tracks the antibacterial pipeline and actively supports R&D across all priority pathogens employing new financing tools.

Place, publisher, year, edition, pages
SAGE PUBLICATIONS INC, 2018
National Category
Business Administration Engineering and Technology
Identifiers
urn:nbn:se:uu:diva-361903 (URN)10.1177/1073110518782912 (DOI)000439619700004 ()
Funder
EU, FP7, Seventh Framework Programme
Available from: 2018-10-01 Created: 2018-10-01 Last updated: 2018-10-09Bibliographically approved
Baraldi, E., Ciabuschi, F., Callegari, S. & Lindahl, O. (2018). Ekonomiska incitamentsmodeller för utveckling av nya antibiotika: Rapport på uppdrag av Folkhälsomyndigheten. Uppsala universitet
Open this publication in new window or tab >>Ekonomiska incitamentsmodeller för utveckling av nya antibiotika: Rapport på uppdrag av Folkhälsomyndigheten
2018 (Swedish)Report (Other academic)
Abstract [sv]

På uppdrag av Folkhälsomyndigheten utreder vi i denna rapport en rad incitamentsmodeller för forskning och utveckling (FoU) av antibiotika som kan vara aktuella för en svensk offentlig investering. Baserat på diskussioner och intervjuer med experter, återkoppling från intressenter (d.v.s. potentiella mottagare av svenska incitament), företagsfallstudier och datorbaserade Monte Carlo-simuleringar lämnar rapporten rekommendationer kring de ekonomiska modeller som Sverige bör investera i. De incitamentsmodeller som valdes ut för den svenska portföljen uppfyller följande kriterier: de kan öka Sveriges visibilitet och förbättra den nationella FoU-infrastrukturen i antibiotikafältet, de bygger på Sveriges styrkor och tradition i detta fält, de innefattar begränsade investeringar, de kan införas och ge resultat relativt snabbt, de tillfredsställer på ett unikt sätt viktiga behov i antibiotikapipelinen, och de ger Sverige en möjlighet att spela en avgörande roll i själva skapandet och inriktningen av incitamentet. I enlighet med dessa kriterier, bedömdes att en ”Market Entry Reward” (MER) inte är genomförbar för Sverige ensamt. Det beror främst på att det krävs ett stort finansiellt åtagande (närmare 1 miljard USD) för att ett incitament som en MER ska kunna ge relevanta resultat på pipelinen. Om Sverige trots detta skulle välja att pilottesta en MER på egen hand, borde ett sådant försök fokusera på en s.k. ”totalt losskopplad” MER (Fully Delinked), vilket betyder att MER helt och hållet ersätter marknadsförsäljningen och istället ger fasta årliga utbetalningar till utvecklaren. En MER borde primärt finansieras via sjukvårdsbudgeten för att undvika undanträngningseffekter mot incitament i andra utgiftsområden. En totalt losskopplad MER skulle tillåta testning av flera olika aspekter såsom utvärderingsprocessen för att bestämma det totala värdet på en MER, internprissättning till sjukhus för att återfinansiera de statliga betalningarna, samt regelbundna mellanlägesrevideringar av årliga betalningar beroende på resistensläget. Om Sverige skulle samarbeta med andra länder, som exempelvis G20 eller EU:s medlemsländer, skulle en rimlig storlek på den svenska andelen vara 6 respektive 23 miljoner USD för en partiellt losskopplad MER, och 9 respektive 34 miljoner USD för en totalt losskopplad MER. Det finns dock andra sätt att kombinera push- och pull-incitament som är mer effektiva och snabbare än en MER, nämligen en rad kombinationer av ”grants” (forskningsanslag) och ”milestone prizes”, där det senare är belöningar som betalas ut till utvecklare när de framgångsrikt avslutar viktiga steg i sin FoU (t.ex. Fas 1 i kliniska studier). Förutom bättre effekter per investerat belopp, undviker en kombination av ”grants” och ”milestone prizes” dessutom att stora MER tränger undan push investeringar och mottagare såsom små- och medelstora företag (SMEs) som vanligtvis inte kan vänta på ett incitament ända tills det slutgiltiga godkännandet av ett antibiotikum. Den föreslagna incitamentportföljen för Sverige omfattar tre incitament: ”grants”, ”milestone prizes” och ”Pipeline Coordinators”. Dessa tre incitament skall användas tillsammans för att säkerställa att hela FoU-pipelinen för antibiotika stödjs och att viktiga synergier skapas. Följande aspekter borde tas i beaktning vid implementering och finansiering av de tre valda incitamenten: 1) ”Grants” borde riktas mot tidiga FoU-projekt (fram till Fas 2) och att förstärka den nationella FoUinfrastrukturen, med ett tidsperspektiv som ska vara längre än den nuvarande 3-åriga tidsramen. Det är viktigt att Sverige bibehåller och om möjligt höjer sina nuvarande årliga investeringar i ”grants” för FoU om antibiotika på cirka 60 miljoner SEK/år (7 M USD) och att dessa investeringar får fortsätta över många år i framtiden. Investeringarna kommer att ge långsiktiga effekter både i form av nya molekyler som kan fylla på den framtida FoU-pipelinen och genom fördjupade kompetenser, exempelvis i form av en nationell forskningsinfrastruktur bestående av specialiserade FoU-centra som kan utnyttjas i framtida antibiotikaforskning. Det bör understrykas att man inte kan fördröja dessa investeringar eftersom den här typen av kompetenser behöver byggas omedelbart och frön för framtida FoU-projekt behöver sås i detta nu. 2) Två typer av ”milestone prizes” borde implementeras av Sverige. Först och främst ett ”prize” som delar ut mellan 10 och 20 miljoner USD (bedömningar gjorda av de små företagen i fallstudien) vid slutet av klinisk Fas 1 som bör riktas mot höginnovativa molekyler mot specifika patogener. Därutöver bör ett ”prize” tilldelas projekt som framgångsrikt avslutar de prekliniska stegen. Att inrätta ett ”prize” vid slutet av klinisk Fas 1 skulle vara ett nödvändigt och unikt initiativ, som förutom starka effekter på den tidiga FoU-pipelinen dessutom skulle ge Sverige en stark internationell visibilitet. Genom att finansiera en större del av detta ”milestone prize” skulle Sverige ta ett stort ansvar för att aktivt skapa dessa mycket viktiga incitament. Det andra rekommenderade ”milestone prize”, som delas ut vid slutet av de prekliniska stegen, skulle bidra till att fylla på den kliniska pipelinen och skulle därmed ha mera långsiktiga effekter. 3) ”Pipeline Coordinators”, d.v.s. organisationer som på flera sätt tar en aktiv roll i att välja och stödja en portfölj av FoU-projekt om antibiotika, är det sista rekommenderade incitamentet. Snarare än att skapa en ny ”Pipeline Coordinator”, borde Sverige välja bland de som redan finns och finansiera följande två typer av sådana organisationer: ”R&D Collaborations”, som skapar samarbetsplattformar för att genomföra tidiga FoU aktiviteter för de projekten de stödjer, och ”Nonprofit Developers”, som genomför egna antibiotikaprojekt i syftet att föra nya antibiotika hela vägen till marknaden, dock utan vinstintressen. Den första typen av ”Pipeline Coordinator”, ”R&D Collaborations” är relevant för Sverige att investera i eftersom det handlar om den incitamentsmodell som potentiellt är mest effektiv i att skapa lönsamma FoU projekt. Men för att kunna utnyttja denna potential fullt ut behöver ”R&D Collaborations” vidareutvecklas för att bli mer flexibla samt minska byråkrati och konflikter mellan deltagarna. ”Non-profit Developers” är å andra sidan den modell som erbjuder det mest omfattande stödet till utvalda produkter genom att agera över hela antibiotikapipelinen för att se till att dessa produkter når marknadslansering. Dessutom, ger denna modell starkt stöd gällande global tillgång och ansvarsfull användning (”stewardship”). Därför, skulle Sverige kunna finansiera ”Non-profit Developers” via sin internationella biståndsbudget och därmed även ge ett viktigt bidrag till global hälsa. Båda typer av ”Pipeline Coordinators” har fördelen att de kan hjälpa att koppla svenska FoU-centra för antibiotika till internationella plattformar, vilket skulle förstärka effekterna av infrastrukturrelaterade ”grants”. Dessutom, är alla sorters ”Pipeline Coordinators” incitamentsmodeller som kan användas som verktyg för att styra övriga två incitament (”grants” och ”milestone prizes”). Tack vare denna förmåga, kan de utvärdera ansökningar till ”grants” och de antibiotikaprojekt som är berättigade till ”milestone prizes”, vilket kräver både djupa och detaljerade kunskaper i specifika antibiotikaprojekt. Utöver dessa tre incitamentsmodeller kan även en fjärde modell vara relevant: ”regulatory simplifications”. Denna modell innefattar regulatoriska förenklingar som radikalt sänker kostnader och tider för kliniska Fas 3-studier. Modellen kan vara relevant för Sverige tack vare att kostnaderna är begränsade, implementeringen och effekterna snabba samt att det finns en koppling till svensk expertis. Trots dessa fördelar, kräver detta incitament fortfarande vidare analyser för att fullt ut förstå dess implikationer för regelverket och patientsäkerhet innan den kan rekommenderas för implementering. De tre incitamenten som rekommenderas i denna rapport – ”grants”, ”milestone prizes” och ”Pipeline Coordinators” – bör användas tillsammans i särskilda kombinationer för att utnyttja synergierna mellan dem och deras förmåga att både trycka (”push”) och dra (”pull) molekylerna i olika faser i FoU-pipelinen. Dessa synergier innebär att när exempelvis ”grants” och ”milestone prizes” används samtidigt, blir den offentliga investeringen för varje nytt antibiotikum lägre än den sammanlagda investeringen om de två incitamenten används separat. Om det skulle vara omöjligt att införa och använda de tre incitamenten samtidigt, borde följande prioriteringsordning tillämpas: först och främst behöver nuvarande nivåer på ”grants” bibehållas och om möjligt höjas för att finansiera både enskilda projekt om FoU om antibiotika och för utveckling av kompetenser samt för FoU-infrastruktur, medan investeringar påbörjas i en ”Non-profit Developer” och i en ”milestone prize” vid slutet av Fas 1, följd av vidareutveckling och finansiering av ”R&D Collaborations” och slutligen av ett prekliniskt ”milestone prize”.

Place, publisher, year, edition, pages
Uppsala universitet, 2018. p. 69
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
urn:nbn:se:uu:diva-372650 (URN)
Funder
Public Health Agency of Sweden
Available from: 2019-01-08 Created: 2019-01-08 Last updated: 2019-01-17Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0003-1618-701x

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