European Public Private Partnership Research Articles

Off-balance-sheet policies to the rescue: The role of statistical expertise for European public–private partnerships

Off-balance-sheet policies are an important but understudied phenomenon that emerged from a technical subtlety in the calculation of public debt statistics. Taking the case of an exemplary European off-balance-sheet policy, public–private partnerships (PPPs), this paper analyzes the technocratic processes that allow the emergence of such debt-neutral instruments. In the aftermath of the sovereign debt crisis, off-balance-sheet policies have become an important policy tool for Member States in the European Economic and Monetary Union, enabling them to strike a balance between the perceived ‘public investment gap’ and the mantra of fiscal consolidation. The case study shows how the lack of political solutions to Europe’s investment-consolidation conundrum leaves it to technical experts to find workable solutions within the existing rules. The off-balance-sheet status of PPPs came under threat in 2014 but was reaffirmed through a coordinated effort by two strange bedfellows: the European Investment Bank (EIB), a promoter of PPPs, and Eurostat, the European authority responsible for public debt and deficit indicators. I argue that Eurostat and the EIB have entered into strategic cooperation to increase each other’s room for manoeuvre, diffuse political pressure and avoid bureaucratic overload. This paper contributes to a better understanding of the role of technocrats and their expertise, which shape the mutual relations between fiscal constraints and financialized investment policies in the European investor states.

RESCEU and PROMISE: The Success of 8 Years of European Public-Private Partnership to Prevent RSV.

RESCEU and PROMISE: The Success of 8 Years of European Public-Private Partnership to Prevent RSV.

How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action.

Objective: Patients have unique insights and are (in-)directly affected by each decision taken throughout the life cycle of medicinal products. Patient preference studies (PPS) assess what matters most to patients, how much, and what trade-offs patients are willing to make. IMI PREFER was a six-year European public-private partnership under the Innovative Medicines Initiative that developed recommendations on how to assess and use PPS in medical product decision-making, including in the regulatory evaluation of medicinal products. This paper aims to summarize findings and recommendations from IMI PREFER regarding i) PPS applications in regulatory evaluation, ii) when and how to consult with regulators on PPS, iii) how to reflect PPS in regulatory communication and iv) barriers and open questions for PPS in regulatory decision-making. Methods: PREFER performed six literature reviews, 143 interviews and eight focus group discussions with regulators, patient representatives, industry representatives, Health Technology Assessment bodies, payers, academics, and clincians between October 2016 and May 2022. Results: i) With respect to PPS applications, prior to the conduct of clinical trials of medicinal products, PPS could inform regulators' understanding of patients' unmet needs and relevant endpoints during horizon scanning activities and scientific advice. During the evaluation of a marketing authorization application, PPS could inform: a) the assessment of whether a product meets an unmet need, b) whether patient-relevant clinical trial endpoints and outcomes were studied, c) the understanding of patient-relevant effect sizes and acceptable trade-offs, and d) the identification of key (un-)favorable effects and uncertainties. ii) With respect to consulting with regulators on PPS, PPS researchers should ideally have early discussions with regulators (e.g., during scientific advice) on the PPS design and research questions. iii) Regarding external PPS communication, PPS could be reflected in the assessment report and product information (e.g., the European Public Assessment Report and the Summary of Product Characteristics). iv) Barriers relevant to the use of PPS in regulatory evaluation include a lack of PPS use cases and demonstrated impact on regulatory decision-making, and need for (financial) incentives, guidance and quality criteria for implementing PPS results in regulatory decision-making. Open questions concerning regulatory PPS use include: a) should a product independent broad approach to the design of PPS be taken and/or a product-specific one, b) who should optimally be financing, designing, conducting, and coordinating PPS, c) when (within and/or outside clinical trials) to perform PPS, and d) how can PPS use best be operationalized in regulatory decisions. Conclusion: PPS have high potential to inform regulators on key unmet needs, endpoints, benefits, and risks that matter most to patients and their acceptable trade-offs. Regulatory guidelines, templates and checklists, together with incentives are needed to foster structural and transparent PPS submission and evaluation in regulatory decision-making. More PPS case studies should be conducted and submitted for regulatory assessment to enable regulatory discussion and increase regulators' experience with PPS implementation and communication in regulatory evaluations.

Protection against COVID-19 hospitalisation conferred by primary-series vaccination with AZD1222 in non-boosted individuals: first vaccine effectiveness results of the European COVIDRIVE study and meta-regression analysis.

Vaccine effectiveness (VE) studies with long-term follow-up are needed to understand durability of protection against severe COVID-19 outcomes conferred by primary-series vaccination in individuals not receiving boosters. COVIDRIVE is a European public-private partnership evaluating brand-specific vaccine effectiveness (VE). We report a prespecified interim analysis of primary-series AZD1222 (ChAdOx1 nCoV-19) VE. Seven Study Contributors in Europe collected data on individuals aged ≥18 years who were hospitalised with severe acute respiratory infection (June 1st, 2021-September 5th, 2022) and eligible for COVID-19 vaccination prior to hospitalisation. In this test-negative case-control study, individuals were defined as test-positive cases or test-negative controls (SARS-CoV-2 RT-PCR) and were either fully vaccinated (two AZD1222 doses, 4-12 weeks apart, completed ≥14 days prior to symptom onset; no booster doses) or unvaccinated (no COVID-19 vaccine prior to hospitalisation). The primary objective was to estimate AZD1222 VE against COVID-19 hospitalisation. A literature review and meta-regression were conducted to contextualise findings on durability of protection. 761 individuals were included during the 15-month analysis period. Overall AZD1222 VE estimate was 72.8% (95% CI, 53.4-84.1). VE was 93.8% (48.6-99.3) in participants who received second AZD1222 doses ≤8 weeks prior to hospitalisation, with spline-based VE estimates demonstrating protection (VE≥50%) 30 weeks post-second dose. Meta-regression analysis (data from seven publications) showed consistent results, with ≥80% protection against COVID-19 hospitalisation through ∼43 weeks post-second dose, with some degree of waning. Primary-series AZD1222 vaccination confers protection against COVID-19 hospitalisation with enduring levels of VE through ≥6 months. AstraZeneca.

Models and methods: a perspective of the impact of six IMI translational data-centric initiatives for Alzheimer's disease and other neuropsychiatric disorders.

The Innovative Medicines Initiative (IMI), was a European public-private partnership (PPP) undertaking intended to improve the drug development process, facilitate biomarker development, accelerate clinical trial timelines, improve success rates, and generally increase the competitiveness of European pharmaceutical sector research. Through the IMI, pharmaceutical research interests and the research agenda of the EU are supported by academic partnership and financed by both the pharmaceutical companies and public funds. Since its inception, the IMI has funded dozens of research partnerships focused on solving the core problems that have consistently obstructed the translation of research into clinical success. In this post-mortem review paper, we focus on six research initiatives that tackled foundational challenges of this nature: Aetionomy, EMIF, EPAD, EQIPD, eTRIKS, and PRISM. Several of these initiatives focused on neurodegenerative diseases; we therefore discuss the state of neurodegenerative research both at the start of the IMI and now, and the contributions that IMI partnerships made to progress in the field. Many of the initiatives we review had goals including, but not limited to, the establishment of translational, data-centric initiatives and the implementation of trans-diagnostic approaches that move beyond the candidate disease approach to assess symptom etiology without bias, challenging the construct of disease diagnosis. We discuss the successes of these initiatives, the challenges faced, and the merits and shortcomings of the IMI approach with participating senior scientists for each. Here, we distill their perspectives on the lessons learned, with an aim to positively impact funding policy and approaches in the future.

Legal Challenges in Securing Critical Information Infrastructure Protection (CIIP): An American Empathy

Among the main achievements of the CIIP policy are establishment of the European Forum for Member States and of the European Public-Private Partnership for Resilience; carrying out of pan-European exercises (Cyber Europe 2010 and 2012); adoption, by ENISA, of a minimum set of baseline capabilities and services and related policy recommendations for National/Governmental Computer Emergency Response Teams (CERTs) to function effectively. In some cases, the Cybersecurity strategy is taking forward such actions (for example, in carrying out pan-European exercises). In other cases, the voluntary approach of the CIIP policy would be strengthened by the proposal for a Directive on network and information security, which would require the Member States to put in place a minimum level of capabilities at national level and to co-operate cross-border. This paper alludes to the legal challenges confronted by the authorities’ in implementing them.

Public-Private Partnership in the Context of Sustainable Development on the Example of the Water and Wastewater Sector

The purpose of this paper is to analyze the implementation of investments in the water and sewage sector in Poland and other European countries using the Public-Private Partnership (PPP) formula. The paper identifies the strengths and weaknesses, opportunities and threats arising from the use of this formula for local government public tasks for the delivery and treatment of domestic wastewater, in the context of EU legislation. It also examines the validity of the use of PPP in the context of the implementation of the principle of sustainable development in water management. PPPs are commonly used to deliver strategic public services under financial limitations. Countries such as the United Kingdom and Ireland, based on years of experience and good practices, are effectively implementing PPP projects, including those in the water and sewerage sector. The provision of treated drinking water and the treatment of municipal wastewater is a fundamental task ensuring an adequate quality of life for people by maintaining public health at an appropriate level. The fact that water and sanitation infrastructure and service provision in this sector is expensive, both at the construction and operational stages, has led countries at different levels of development to turn to public-private partnerships. Properly managed PPP projects secure the interests of both the private and public partner and the end user of the services. The analysis of data and examples of European PPPs in the water and wastewater sector shows that PPPs have been successful for most public entities that have chosen them. Good practices from Scotland, Ireland and Poland, as well as projects that have experienced difficulties, show that stable and friendly legislation, thorough pre-feasibility studies and an appropriate allocation of risk make PPPs successful. In the context of the conducted analysis, PPP is a tool enabling the realization of tasks in the water and sewage sector, where the public party’s budget possibilities are limited. Moreover, PPP is a component of the realization of the sustainable development principle. The idea that the use of natural resources, including water, which is fundamental to the biological and cultural needs of humankind, should be met in such a way as to save them for future generations, is realized in PPP projects. This paper demonstrates that the use of financial assembly opportunities in PPPs makes it possible to significantly intensify the construction of new and upgrading of existing water and wastewater infrastructure. It contributes to the protection of aquatic ecosystems and securing public health associated with living in direct proximity to surface water and discharging wastewater without affecting the natural environment and human habitats.

A New Risk Stratification Model (R2-ISS) in Newly Diagnosed Multiple Myeloma: Analysis of Mature Data from 7077 Patients Collected By European Myeloma Network within Harmony Big Data Platform

A New Risk Stratification Model (R2-ISS) in Newly Diagnosed Multiple Myeloma: Analysis of Mature Data from 7077 Patients Collected By European Myeloma Network within Harmony Big Data Platform

Influenza vaccine effectiveness studies in Europe: SWOT analysis of DRIVE collaborating sites

Abstract Background DRIVE is a European public-private partnership that aims at creating a network that works on high quality, brand-specific effectiveness estimates for all influenza vaccines used in the EU each season. The SWOT analysis aims at assessing the quality and feasibility of DRIVE operational model after its implementation, i.e. the operations of the study site network as applied in DRIVE. Methods The SWOT analysis was conducted through two meetings held among 2 of 14 partners participating in the DRIVE studies in the first season, with clinicians, nurses, data managers and lab technicians from the sites in the network. We collected data on two identified axes (1.organizational and 2.logistical, practical, and laboratory aspects), containing more than one SWOT objective. For each item classified under Strength (S), Weakness (W), Opportunity (O) or Threat (T), experts assigned a 1-5 score, meant to reflect the impact of each listed item on reaching the objectives. Results The most common topics, reported by both Italian and Finnish sites collaborators, were the opportunities related to the training and development of the network; funding concerns; opportunities and challenges in training the personnel; management issues due to the project practical organization (e.g. for lack of dedicated personnel, including administrative and for data entry). The scores attributed to the single items appeared skewed to the top, showing how the researchers perceived the majority of the topics as relevant for their day-to-day work. Conclusions The SWOT exercise was welcomed as a useful means to compare issues and practices among local study sites, but also as a chance for exchange with both peers and project lead. The results highlight the great value of communication and discussion between study groups, albeit the geographical distance. Such exercise should be included as a routine opportunity for discussion aiming at improving both collaboration and governance model in large projects. Key messages One of the main challenges of large public-private consortiums is building a shared governance model; opportunities for collective sharing and collaboration should be promoted in this setting. This SWOT analysis was a useful exercise that should inform the prosecution of the programming of DRIVE operational model, allowing a comparison of issues and practices among local study sites.

Validation and Improvement Opportunities of the Revised International Staging System for Multiple Myeloma: An Analysis on Mature Data from European Clinical Trials within the Harmony Big Data Platform

Validation and Improvement Opportunities of the Revised International Staging System for Multiple Myeloma: An Analysis on Mature Data from European Clinical Trials within the Harmony Big Data Platform

Engineering innovations in Canada’s public–private partnerships

Public–private partnerships (PPPs) have long been touted as an innovative project delivery method that encourages technological innovation and chases delivery efficiency. However, literature based on European PPP practices seems to provide conflicting evidence. To help better understand and further improve this prevailing delivery method, this study collected and analysed empirical evidence of engineering innovations that have been successfully used in existing PPP projects in Canada. Drawing on literature review and an intensive interview programme involving 19 interviewees from 15 successful PPP projects, the study answered the what, who, when, why and how questions about innovation in PPPs. The study concluded that the PPP delivery system does provide unique innovation opportunities and scope that traditional delivery models cannot support. Performance-based output specifications, vertical integration and communication are the three key areas for improvements to enhance innovation in PPPs further.

Leveraging the EHR4CR platform to support patient inclusion in academic studies: challenges and lessons learned

BackgroundThe development of Electronic Health Records (EHRs) in hospitals offers the ability to reuse data from patient care activities for clinical research. EHR4CR is a European public-private partnership aiming to develop a computerized platform that enables the re-use of data collected from EHRs over its network. However, the reproducibility of queries may depend on attributes of the local data. Our objective was 1/ to describe the different steps that were achieved in order to use the EHR4CR platform and 2/ to identify the specific issues that could impact the final performance of the platform.MethodsWe selected three institutional studies covering various medical domains. The studies included a total of 67 inclusion and exclusion criteria and ran in two University Hospitals. We described the steps required to use the EHR4CR platform for a feasibility study. We also defined metrics to assess each of the steps (including criteria complexity, normalization quality, and data completeness of EHRs).ResultsWe identified 114 distinct medical concepts from a total of 67 eligibility criteria Among the 114 concepts: 23 (20.2%) corresponded to non-structured data (i.e. for which transformation is needed before analysis), 92 (81%) could be mapped to terminologies used in EHR4CR, and 86 (75%) could be mapped to local terminologies. We identified 51 computable criteria following the normalization process. The normalization was considered by experts to be satisfactory or higher for 64.2% (43/67) of the computable criteria. All of the computable criteria could be expressed using the EHR4CR platform.ConclusionsWe identified a set of issues that could affect the future results of the platform: (a) the normalization of free-text criteria, (b) the translation into computer-friendly criteria and (c) issues related to the execution of the query to clinical data warehouses. We developed and evaluated metrics to better describe the platforms and their result. These metrics could be used for future reports of Clinical Trial Recruitment Support Systems assessment studies, and provide experts and readers with tools to insure the quality of constructed dataset.

Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation.

After nearly a decade of discussion, analysis, and development, the Medicines Adaptive Pathways to Patients (MAPPs) initiative is beginning to see acceptance from regulators, industry, patients, and payers, with the first live pilot project initiated under the guidance of the European Medicines Agency in 2014. Although it is a significant achievement to see the first asset being placed into human trials under an adaptive pathway, there is much to be learned regarding the multinational and multi-stakeholder effort that has driven the growing acceptance of MAPPs as a methodology and concept, as well as the need for continued and increasing international collaboration to foster the wider adoption of MAPPs. Changes in available science and technology, as well as a number of challenges in the current system, outlined in this paper, are transforming approaches to medicines development and approval. It is these challenges that have led directly to the groundbreaking MAPPs collaboration between the Massachusetts Institute of Technology Center for Biomedical Innovation's New Drug Development Paradigms Initiative, the EMA, patient, payer and health technology assessment groups, the European Federation of Pharmaceutical Industries and Associations, and the Innovative Medicines Initiative-a European public-private partnership. This article examines the development of MAPPs, from inception of the concept, to the establishment of this trans-Atlantic initiative, and examines challenges for the future.

Ten years of PPP: An initial assessment

A public-private partnership (PPP) is a long-term contractual arrangement whereby the government calls on a company or a consortium formed for the purpose to design, build, finance and maintain a structure or facility necessary for its public-service mission. The company or consortium is subsequently remunerated according to the availability and performance of the structure or facility. The remuneration must enable the company or consortium to repay its initial investment and cover the financing costs and the services it provides. In a broad sense PPPs have long existed in France under various names and in various forms, marking the history of the development of the country’s infrastructure networks. In the modern sense, corresponding to the partnership contract (contrat de now renamed maches de partenariat since 2015) created in 2004 and covering all-inclusive government-pay contracts, PPPs have made significant inroads in certain sectors of public management such as social infrastructure (schools, hospitals, prisons, etc.). As a result France topped the European PPP league table in 2011-12, though PPPs remain a niche market overall in relation to the total amount of public procurement. Now, ten years later, it is possible to take stock, in both qualitative and quantitative terms, of projects initiated and carried out. This report aims to show the impact and effects of this new public procurement resource, sector by sector, in facts and figures, and to illustrate the contributions it has made and the feedback it has generated by major type of project and by public-sector initiator, from municipalities to central government agencies. JEL classification: H40, H5, H83 Keywords: Infrastructure, partnership contracts, public private partnerships, public procurement

The Innovative Medicines Initiative's New Drugs for Bad Bugs programme: European public-private partnerships for the development of new strategies to tackle antibiotic resistance.

Antibiotic resistance (ABR) is a global public health threat. Despite the emergence of highly resistant organisms and the huge medical need for new drugs, the development of antibacterials has slowed to an unacceptable level worldwide. Numerous government and non-government agencies have called for public-private partnerships and innovative funding mechanisms to address this problem. To respond to this public health crisis, the Innovative Medicines Initiative Joint Undertaking programme has invested more than €660 million, with a goal of matched contributions from the European Commission and the European Federation of Pharmaceutical Industries and Associations, in the development of new antibacterial strategies. The New Drugs for Bad Bugs (ND4BB) programme, an Innovative Medicines Initiative, has the ultimate goal to boost the fight against ABR at every level from basic science and drug discovery, through clinical development to new business models and responsible use of antibiotics. Seven projects have been launched within the ND4BB programme to achieve this goal. Four of them will include clinical trials of new anti-infective compounds, as well as epidemiological studies on an unprecedented scale, which will increase our knowledge of ABR and specific pathogens, and improve the designs of the clinical trials with new investigational drugs. The need for rapid concerted action has driven the funding of seven topics, each of which should add significantly to progress in the fight against ABR. ND4BB unites expertise and provides a platform where the commitment and resources required by all parties are streamlined into a joint public-private partnership initiative of unprecedented scale.

Las alianzas público privadas y su rol en la modernización de la infraestructura costarricense

El término Alianzas Público Privadas (APP) es definido por las NacionesUnidas (2008) en su publicación “Guide book on Promoting GoodGovernance in Public-Private Partnerships”, como aquellos mecanismosinnovadores utilizados por el sector público con el objetivo de financiar,diseñar, implementar y operar obras y servicios públicos. El EuropeanPPP Expertise Centre (2011) señala además que las APP son contratos: i)basados en la provisión de servicios(1), considerando todo el ciclo de vidadel proyecto, ii) bajo los cuales se transfiere riesgos al sector privado yiii) donde el pago recibido por el sector privado -sea por medio del cobrode tarifas, pago directo del gobierno o combinación de ambos- estádirectamente ligado a los servicios prestados.Con una brecha anual de inversión en el sector transportes superior a losUS$1,000 millones y una situación fiscal restrictiva, la figura de las AlianzasPúblico Privadas (APP) se posiciona como una herramienta fundamentalpara que el Estado Costarricense brinde a ciudadanos y sector productivola plataforma de servicios de infraestructura que permita acabar con unrezago de décadas. Sin embargo, a la fecha la experiencia ha sido limitadaen cuanto al alcance y cantidad de proyectos, dada la carencia de unsistema concesional que incorpore el establecimiento de metodologíastécnicamente sustentadas para la selección del modelo de provisión-en cada proyecto- que garantice la maximización de la relación costobeneficiopara usuarios y/o contribuyentes.

Renegotiating PPP Contracts: Reinforcing the ‘P' in Partnership

The issue of renegotiation is becoming increasingly important as a tool to address uncertainty of public private partnership (PPP) projects and as a mechanism to restore its economic and financial equilibrium. This paper aims to understand how and why renegotiations occur in long-lasting PPP projects and what are the pros and cons of the renegotiation. We depart from a literature review on contract incompleteness and on the determinant factors for the renegotiation of infrastructure concessions. To illustrate the discussion, the case studies of nine European PPP projects are analysed by examining the specific exogenous and endogenous determinant factors that conduce to renegotiating contracts. The implications of contractual renegotiations are explained and summarized through a comparison of our case studies with literature. Although renegotiation, per se, is not a solution for the successful implementation of PPP projects, our findings reinforce the idea of contractual flexibility as a tool that allows adapting to uncertainty. Moreover, effective communication mechanisms allow a better response to unforeseen events, reinforcing the partners’ commitment to deliver a win–win project.

Stand der Technik und Trends bei der Erzeugung von Strom und Treibstoffen aus Holz

State of the art and trends in generation of electricity and fuels from wood Advanced conversion processes such as gasification technology for biomass have been under development for the last 30 years. First commercial plants went into operation. Over this period, motivation for biomass gasification has changed repeatedly. At first, production of high-temperature heat was the major motivation, later generation of electricity or combined heat and power (CHP). During the last ten years production of liquid and gaseous biofuels via gasification has been intensely studied and developed, which has increased the demands on the quality of syngas. This paper focuses on gasification development within Europe. Selected examples give an impression of current status and expected developments of gasification technologies for the production of electricity, liquid or gaseous biofuels. The examples make clear that there is still a considerable potential for innovation. Therefore, in coming years further technological breakthroughs can be expected. This development is expected to be supported by the implementation of the European Industrial Bioenergy Initiative (EIBI) and the planned European Public Private Partnership of bio-based industries (“Bridge”). It will be necessary to simultaneously advance fundamentally different technological options (e.g. enzyme- and thermochemical-based processes) and to perform intensive broad-based research to increase the efficiency of processes and to optimize the yields. For the market introduction of large-scale biomass gasification plants, i.e. of at least 50 MWWood power production, framework conditions have to be adapted in order to reduce commercial risk for investors. Biomass gasification can make a significant contribution for reduction of CO2 and the use of non renewable energy sources. It has to be understood as an integral part of an overall energy system.

Drug and Disease Model Resources: A Consortium to Create Standards and Tools to Enhance Model‐Based Drug Development

Model-based drug development (MBDD) is accepted as a vital approach in understanding patients' drug-related benefit and risk by integrating quantitative information integration from diverse sources collected throughout drug development.1 This perspective introduces the activities of the Drug and Disease Model Resources (DDMoRe) consortium, founded in 2011 through the Innovative Medicines Initiative Joint Undertaking (IMI-JU)2 as a European public–private partnership to address a lack of common tools, languages, and standards for modeling and simulation (M&S) to improve model-based knowledge integration.

The European Innovative Medicines Initiative

The Innovative Medicines Initiative is a unique and novel long term european public-private partnership designed by the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The initiative was promoted to accelerate the discovery and development of better medicines by removing bottlenecks in the drug development process. It focuses on creating better methods and tools that improve and enhance the drug development process, rather than on developing specific, new medicines.