Feasibility of conducting brand-specific influenza vaccine effectiveness studies in three Nordic countries, Denmark, Finland, Sweden.

Introduction: The European Medicines Agency (EMA) has updated its Reflection Paper on the use of Real-WorldData (RWD) in Observational Studies (OS), emphasizing the regulatory importance of Real-World Evidence (RWE).Objectives: Summarize the main methodological recommendations of the EMA’s 2025 guidance, highlightchallenges and opportunities for the use of RWD in regulatory contexts, and discuss implications for clinicalresearchers, with particular attention to the role of pharmacists.Discussion: The new guidance distinguishes descriptive from causal OS and endorses Target Trial Emulation (TTE)to improve causal inference in observational research. It stresses transparency, reproducibility, and rigorous datagovernance, while calling for robust strategies to manage bias and confounding. Pharmacists are recognized askey contributors to drug utilization research and post-marketing surveillance, ensuring data quality and interoperability and supporting the integration of RWE into regulatory decision-making.Conclusions: EMA’s roadmap affirms the value of RWE in strengthening regulatory science. Its implementationwill require cultural change, technical expertise, and resource allocation, offering both challenges and opportunitiesfor healthcare researchers, particularly pharmacists, to transform RWD into trusted evidence.

Weighing the benefits and risks of diabetes drugs: a call for a unified global approach.

SummaryBackgroundSeasonal influenza causes substantial morbidity and mortality in older adults. While vaccination is recommended in Nordic countries for individuals aged ≥65 years, brand-specific effectiveness estimates are scarce but essential for regulatory decision-making. We evaluated brand-specific effectiveness of seasonal influenza vaccines against laboratory-confirmed influenza-related outcomes in Denmark, Finland, and one Swedish region during the 2024/2025 season.MethodsWe conducted a nationwide cohort study using target trial emulation and linked health registries. Individuals aged ≥65 years were matched 1:1, comparing seasonal influenza vaccine recipients to non-recipients. Cumulative incidences of laboratory-confirmed influenza A and B, influenza-related hospitalisation, and death were assessed at 18 weeks post-immunisation. Vaccine effectiveness (VE) was calculated as 1 minus the risk ratio.FindingsA total of 1,164,686 matched pairs were included (mean age 75.4 years, standard deviation 7.3). Overall VE against influenza-related hospitalisation was 46.8% (95% CI 40.8–52.9), with risk differences of −21.3 (−28.9 to −13.8) and −99.3 (−119.6 to −79.1) in Finland and Denmark, respectively, per 100,000 vaccinated individuals. Brand-specific VE was 63.4% (38.1–88.7) for Efluelda Tetra (split virion-high dose), 48.2% (40.8–55.6) for Fluad Tetra (subunit standard-dose adjuvanted), 43.6% (23.7–63.6) for Vaxigrip Tetra (split virion standard-dose), and 30.6% (−7.8 to 69.1) for Influvac Tetra (subunit standard-dose). VE waned by −6.5 percentage points (−10.5 to −2.5) every 3 weeks.InterpretationSeasonal influenza vaccines moderately reduced the risk of severe outcomes in older adults. Efluelda Tetra and Fluad Tetra appeared to offer favourable protection in their respective target groups, supporting their use in the 2025/2026 season. Annual monitoring using Nordic registries is crucial for informing evidence-based vaccination strategies and regulatory decisions.Funding10.13039/501100013120European Medicines Agency.

e13731 Background: Drug approval processes by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) often shape regulatory decisions globally. This study describes the particularities of drug approval of systemic therapies for sarcomas by the FDA and EMA and compares them with those of three Latin American regulatory authorities: Brazil's ANVISA, Argentina's ANMAT, and Mexico's COFEPRIS. The aim is to elucidate the similarities and differences in approval practices, which may inform future regulatory strategies in these regions. Methods: We conducted a comprehensive review of all cancer drugs approved by the FDA and EMA for the treatment of sarcoma over the past 15 years and matched to approvals in Brazil, Argentina, and Mexico. These countries were chosen due to their population size and the accessibility of their health agencies’ databases. The regulatory agencies’ websites were consulted for the registration of drugs approved between January 1st, 2009, and January 1st, 2024. We analyzed the characteristics of studies, availability of approvals based on randomized controlled trials (RCTs), overall survival (OS), and the interval between FDA and EMA approvals compared to each of the three assessed Latin American regulatory agencies. Additionally, we included drugs granted tissue-agnostic approval, recognizing the potential necessity for sarcoma treatments to be guided by biomarker-driven decisions. Results: Over the past 15 years, 19 drugs have been approved for by the FDA to treat sarcomas, and 13 by the EMA. The FDA led the approvals, granting authorization to 18 of these treatments first, with Trabectedin being the sole exception, approved earlier by the EMA and COFEPRIS. Mifamurtide is the only new drug against sarcoma licensed by the EMA but not by the FDA. During this period Argentina approved 8 of these drugs, Mexico 7, and Brazil 6. When comparing the median approval times, there was a 3.03-year interval from the FDA to the Latin American agencies (range: -6 to 5.7 years) and a 3.22-year interval from the EMA (range: -0.2 to 11.8 years). Phase 3 trial-based approvals constituted 83.3% for COFEPRIS, 75% for ANMAT, 66.7% for ANVISA, 61.5% for EMA, and 36.8% for FDA. Regarding approvals contingent on OS data, ANMAT had 37.5%, ANVISA: 33.3%, COFEPRIS 28.5%, compared to EMA 23%, and FDA 10.5%. Additionally, within this timeframe, 52.3% of FDA approvals were contingent on biomarkers, compared to 50% for EMA, 10.5% for ANVISA, and 5.2% for both ANMAT and COFEPRIS. Conclusions: The observed discrepancies in drug approval timelines and the lower number of drug approvals in Latin American countries, as compared to those by the FDA and EMA, may exacerbate disparities in treatment accessibility for sarcoma patients in these regions. Approvals of sarcoma drugs by regulatory agencies of Latin American countries were more frequently conditioned to phase 3 trials and overall survival benefit.

We assessed vaccine effectiveness (VE) against medically attended, laboratory-confirmed influenza in children 6 months to 15 years of age in 22 hospitals in Japan during the 2013–14 season. Our study was conducted according to a test-negative case-control design based on influenza rapid diagnostic test (IRDT) results. Outpatients who came to our clinics with a fever of 38°C or over and had undergone an IRDT were enrolled in this study. Patients with positive IRDT results were recorded as cases, and patients with negative results were recorded as controls. Between November 2013 and March 2014, a total of 4727 pediatric patients (6 months to 15 years of age) were enrolled: 876 were positive for influenza A, 66 for A(H1N1)pdm09 and in the other 810 the subtype was unknown; 1405 were positive for influenza B; and 2445 were negative for influenza. Overall VE was 46% (95% confidence interval [CI], 39–52). Adjusted VE against influenza A, influenza A(H1N1)pdm09, and influenza B was 63% (95% CI, 56–69), 77% (95% CI, 59–87), and 26% (95% CI, 14–36), respectively. Influenza vaccine was not effective against either influenza A or influenza B in infants 6 to 11 months of age. Two doses of influenza vaccine provided better protection against influenza A infection than a single dose did. VE against hospitalization influenza A infection was 76%. Influenza vaccine was effective against influenza A, especially against influenza A(H1N1)pdm09, but was much less effective against influenza B.

Target Trial Emulation Using Cohort Studies: Estimating the Effect of Antihypertensive Medication Initiation on Incident Dementia.

Safety of influenza vaccines in pregnant women

Introduction: Regulatory agencies encourage the incorporation of the patient voices throughout clinical drug development. Patient-Reported Outcomes (PROs) offer one way of doing this and their use has markedly increased in many therapeutic areas, particularly oncology, in recent years. However, few oncology drug labels include PRO data and those which do, offer little consistency.Objective: To provide multidisciplinary perspectives (patient, pharmaceutical industry, PRO researcher, regulatory expert) on PRO data in oncology drug labels.Methods: PRO data in the labels of drugs approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for oncology indications between 2010 and 2020 were critically reviewed by authors who provided their insights on the advantages and disadvantages/gaps.Results: Forty-six oncology drugs included PRO data in their labels. Differences were observed between FDA and EMA PRO labeling (e.g., PRO concept, use of tables and graphs to display PROs or reference to clinical meaningfulness). In providing their perspectives on the number and nature of PROs in labels, authors noted limitations including: the low proportion of oncology drugs with PRO labeling, limited PRO information in labels, lack of patient-friendly language, and potential bias towards positive outcomes. Lack of consistency within- and between-agencies was noted.Conclusion: Despite regulatory agencies’ commitment to incorporate patient voices in regulatory decisions, availability of PRO information is limited in oncology drug labels. While several PRO guidance documents are available from regulatory and Health Technology Assessment agencies, harmonization of PRO guidance for labeling inclusion around the world is needed to better inform prescribers and consequently their patients in the process of shared medical decisions.

AimThis article presents the study protocol of a retrospective cohort study designed to compare the effectiveness of herpes zoster, and influenza vaccines in individuals with multiple sclerosis (MS), chronic inflammatory bowel diseases (IBD), or chronic inflammatory rheumatic diseases (CIRD) to individuals without these diseases, using claims data of one of the largest population based health insurances in Germany.BackgroundIndividuals with autoimmune diseases such as MS, IBD, and CIRD are more susceptible to vaccine preventable infectious diseases such as influenza and herpes zoster, due to the autoimmune disease itself, the presence of comorbidities and immunosuppressive therapies. Vaccines are the primary means to prevent such diseases. The efficacy of these vaccines is usually estimated using large randomized controlled trials, from which patients with MS, IBD, and CIRD are often excluded. It is therefore unclear whether these vaccines are also effective for these patients.DesignA target trial emulation based on observational claims data of a statutory health insurance company is proposed.MethodsThis study will aim to emulate multiple target trials to compare the effectiveness of herpes zoster and influenza vaccines in patients with and without MS, IBD and CIRD using data from a large German statutory health insurance provider (BARMER). The primary outcome for each vaccine effectiveness analysis is the disease itself. The analysis will be carried out using both time-dependent matching and a multivariable Cox proportional hazards model in conjunction with g-computation. Additionally, the moderating effect of immunosuppressive therapies on the vaccine effectiveness will be estimated using a stratified secondary analysis.DiscussionThis study will estimate and compare the effectiveness of influenza and herpes zoster vaccines in individuals with and without MS, IBD, and CIRD. Because of the large amount of data, this study will also be able to investigate the role of the immunosuppressive medication on vaccine effectiveness, which may provide guidance for vaccine administration guidelines.

This research explores the growing importance of qualitative in-trial research (ITR) in regulatory and health technology assessment (HTA) decision making. Since 2020, the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have emphasized incorporating patient experience data into drug development and approval. We reviewed regulatory guidance documents, drug approval records, and HTA reports from January 2017 to March 2025. This included labels and reviews for new drug applications from the FDA and EMA, the Patient-Focused Drug Development guidance series, guidance on rare diseases, oncology, and gene therapy, and methodological guidance from HTA bodies in Scotland, the UK, France, Germany, Italy, and Spain. From more than 1000 drug applications assessed by both regulatory agencies, only ten and eight products (from the FDA and EMA, respectively) included ITR, with 55% of these for rare diseases. Both agencies used ITR data to gain insights into symptoms and patient experiences, the relevance of patient-reported outcome concepts, and meaningful changes in symptoms or treatment benefits; and to support the interpretation of meaningful score or endpoint changes. Two products included ITR data in both FDA and EMA reviews/labels. Three HTA bodies published guidance documents on qualitative research, with only two products out of eight reviewed including qualitative data in HTA reports.Despite increasing use, ITR in regulatory submissions and HTA reviews remains limited. Early planning and alignment of ITR objectives with regulatory and HTA requirements are needed to enhance the relevance and impact of qualitative evidence in drug development and healthcare decision making.

There are various initiatives ongoing to collect meaningful data on haemophilia A and B (HA and HB). At present, haemophilia medicinal products obtain marketing authorization (MA) after appropriate performance of clinical trials (CTs). However, the number of patients recruited for CTs, as required in the corresponding guidelines 1, 2, rarely reflects the number of patients needed to obtain statistical relevance. Additional data collection after MA is needed to complement the information on Safety and Efficacy (S&E). Registries might be a source to contribute to this information. For new and upcoming FVIII and FIX products, the Pharmacovigilance Risk Assessment Committee (PRAC) recommendations include enrolment in registries to obtain longitudinal real-life data. The collection of data in registries has the additional value of allowing comparison of products. It is of inherent importance to maximize the quality of registry data to improve the benefit to public health. Moreover, strengths and weaknesses of data collection systems such as regulatory CTs and registries need to be identified. Providing robust and sufficient clinical data on efficacy and safety to support MA for products used in rare diseases can be challenging. In general, the basic regulatory needs on the clinical trial concept for FVIII and FIX products are laid down in the corresponding European clinical guidelines 1, 2. The potential delay in market access for novel factor concentrates for the treatment of haemophilia patients in Europe has been criticized 3-8. Thus, in accordance with European Paediatric Regulation, timely access to novel products has to be balanced against the need to assess S&E of a product in previously treated patients (PTPs) below the age of 12 years. In addition, for novel factor concentrates, it is a requirement to investigate PUPs under controlled conditions in CTs. With the fast-growing number of novel factor concentrates that are applying for MA, it might be challenging to perform clinical trials in PUPs with HA and HB in countries where the products will be marketed. Data from registries might be able to complement information derived from CTs (Table 1). Standardized study conditions, including frequency and method of inhibitor testing and predefined case definitions Consistent with regulatory requirements Close monitoring of inhibitors High data quality Same parameters and data collected for all products All PUPs at participating centres included (no selection bias) Real-life data Large number of patients Long follow-up Comparison among products Exploration of treatment variations/differences in standard care that may influence outcome Selection of PUPs: only approximately 30–50% are able to enter CTs (inclusion and exclusion criteria, Good Clinical Practice criteria) Small sample size Open, uncontrolled study design No enrolment of patients with moderate or mild haemophilia Long duration of recruitment (no suitable PUPs if too many products entering market at same time) Limited value of single PUP study No direct comparison of products feasible Limited study period Unknown confounding factors Unknown confounding factors No standardized dataset yet No standardized time schedule for, e.g. inhibitor testing or blood sampling Missing data Changing treatment practice over time Parameters are defined now but must be able to answer questions in 10 years, including about unknown new side effects Switch to other FVIII products (challenging for statistical analysis) Frequently driven by independent investigators, and no direct access to data for regulators or industry For novel products, e.g. those developed for their long-acting properties, it is crucial to identify and mitigate new safety issues that might emerge once a product is extensively used postmarketing, and data from registries could be predestined to fill this gap. According to the European Commission expert group on rare diseases, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition or exposure, and serves one or more predetermined scientific, clinical or policy purposes 9. Independent haemophilia registries might be a potential source of S&E data for haemophilia products 10-14. Once a significant number of patients have been entered, registries are able to minimize selection bias and to collect long-term outcome data. A lack of transparency complicates the discussion on whether existing registries already provide the data that regulators are seeking 15. Even if the collected parameters are known, the quality of the data is often unknown. Educating and training patients and centres to improve compliance and adequate data monitoring, which should be determined in a harmonized international or at least European protocol, are needed to enhance data quality. Examples for information transparency of existing registries are the PedNet registry (pednet.nl), the FranceCoag registry (francecoag.org) and the UKHCDO registry (ukhcdo.org). Cohort studies are preferred above registries, optimization of patient numbers and preventing selection bias improves the quality of data. Harmonization of study protocols and CRF forms enables pooling of data from different registries. Therefore, it is necessary to obtain informed consent from patients and caregivers to share their data for specific requests on S&E. Patients might be anonymized using centre codes and unique identifiers that might be stored by an independent entity. Whether a legal European solution could be found in that respect should be investigated. National registries might be the starting points for a European collaboration, and in the future merged into a European umbrella registry. Collaboration of all stakeholders is needed and must be improved, and basic rules must be established for handling and analysing data. The definition of an adequate core dataset (an ‘interoperable model’) is seen as the way forward. The number of parameters must be balanced between the workload for the physician and the need for monitoring of confounders. Additionally, different datasets are required for PUPs and PTPs, and a method, such as use of unique identifiers, must be found to link the data of a PUP to the corresponding data when the PUP becomes a PTP. Collection of longitudinal data must be ensured so that each patient's status is adequately mirrored contributing to the knowledge on the demographic change in the haemophilia population. Furthermore, it should be possible to distinguish extended-half-life products from other products in registries, and therefore, a solution must be found to enter the type of product, even before a product receives MA. However, an adequate core dataset, adjustment for confounding factors and methods of analysis need to be established, harmonized and, finally, approved by regulators. Registries can contribute significantly to clinical knowledge and providing data on epidemiology, public health profiles, quality of life, consumption and pharmacoeconomic aspects. Specific, well-defined clinical, laboratory or genetic questions may be addressed providing guidance on future drug development. The data coming from registries and cohort studies should be robust and as complete as possible to allow for sound evaluation. Therefore, the objectives should be clear and established upfront. A strong argument for the additional effort needed for the establishment of a well-designed and well-managed registry is the possibility of increasing sample size and surveying an entire population to complement the information coming from regulatory CTs. In principle, registries can be an important source of data for the evaluation of inhibitor development in PUPs, allowing for comparison of different products. All patients who participate in CTs should be included in registries. How exactly this objective can be achieved and which legal avenues exist to do so must be discussed. Regarding the current paediatric investigation plans (PIPs) published on the European Medicines Agency (EMA) website, one might calculate that approximately 500 PUPs will be needed for CTs in the coming years. Data from those PUPs are invisible for the community as long as the CTs last. In addition, treatment information of PUPs which do not fit to CT inclusion criteria might also not become available. In this context, more collaboration and cooperation are urgently needed. The EMA organized a workshop on 01–02 July 2015, to investigate whether current European haemophilia registries can provide valuable data for regulatory purposes and to evaluate how to best capture data, building on existing expertise in this area. This workshop revealed that patient organizations support the inclusion of all haemophilia patients in a registry, despite the hurdles provided by data protection laws. Furthermore, the implementation of an international personal identifier system is encouraged, although establishing such a system would be challenging. During the EMA workshop, it was noted that financial and technical support is crucial, e.g. providing appropriate facilitation options, such as technical tools. However, this support needs to be balanced against the independence of registries. The accuracy and robustness of data entry requires a proactive review and control programme. A predefined adequate dataset might serve as a common denominator for existing or emerging registries and a funding system needs to be established to cover most important questions and financial hurdles, to comply with monitoring requirements and to assist in setting up centralized data entry processes. The following conclusions were, with regard to content, agreed upon by all stakeholders at the EMA workshop: The current regulatory and scientific situation regarding strategy and outcome of data collection is complex due to the legal background and different needs and interests of involved parties (Fig. 1). To obtain MA, the performance of CTs following a stepwise approach dedicated to pre- and postauthorization investigation is mandatory. The concept and conduct of CTs as well as data availability are tightly controlled via established procedures between applicants and regulatory authorities. The majority of haemophilia registries are run by physicians, consequently, outcome reporting and access to data vary depending on individual conditions. Based on European law, regulators do have access to the protocol, conduct and results of CTs but are not similarly involved in the structure, management, evaluation and data access of registries. To optimize and complement the information coming from regulatory CTs with longitudinal data coming from registries, a suitable strategy needs to be developed. Identification of, agreement on and approval of an adequate dataset serving as a common denominator for registries could be a starting point. Additionally, the possibility of anonymized data sharing with regulatory authorities upon request has to be established. The details of data sharing, access, timelines and reporting structures need to be developed in consultation with the involved parties and legal advisors. The way forward will be to develop a collaboration involving all stakeholders, in which regulators have a key role. The availability of data coming from CTs for a single product balanced with the accessibility of data derived from registries will have an impact on reconsideration of the EMA PUP approach. C.K., H.M.v d B., B. K-S. and A.H. wrote the paper. The authors stated that they had no interests which might be perceived as posing a conflict or bias.

Regulatory authorization of oncology drugs, including immune-checkpoint inhibitors, is often based on enhanced efficacy and acceptable toxicity profiles, investigated in randomized, open-label clinical trials. Regulatory approval decisions of the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are frequently compared and contrasted, specifically based on review requirements, and time to approval or refusal decisions. We reviewed databases of the US FDA, the EMA and Clinicaltrials.gov, from January 1, 2015 until December 31, 2021, and analyzed regulatory approvals for immune-checkpoint inhibitors in the treatment of non-small cell lung cancer (NSCLC). We specifically focused on time to approval duration of each immune-checkpoint inhibitor, and considerations of patient-reported outcomes (PROs) by each regulatory agency. Despite similarities in the regulatory pathways and methods used for immune-checkpoint inhibitor approvals, NSCLC indications that stood out in terms of outcome divergence were mainly first-line drugs for treatment naïve patients. The US FDA was quicker to reach approval decisions, when compared with the EMA. The US FDA and the EMA both recognize the value of PROs as important patient-centered endpoints. Policy statement: There are several regulatory structures in the US and Europe that aim to leverage the latest clinical trial evidence and speed up the regulatory approval processes. In our study, the preponderance of outcome differences in approvals were not influenced by the expedited drug development and access programs. Increased harmonization and collaboration on the PRO measurement and validation are encouraged among these agencies to improve the efficiency of regulatory decisions in the future.

506 Background: Targeted therapy has revolutionized the treatment of mRCC. However, cost has lead to variable regional approval and funding. Can such variation in funding of established drugs impede approval of newer agents? Methods: Regulatory agency decisions regarding axitinib, the most recently approved mRCC therapy in the U.S., were reviewed. Reports from the US Food and Drug administration (FDA), the European Medicines Agency (EMA), the pan-Canadian Oncology Drug Review (pCODR), UK's National Institute for Health and Care Excellence (NICE), and the Therapeutic Goods Administration (TGA) of Australia were included. Data abstracted included the date of report publication, basis for determination of clinical efficacy, determination of cost-effectiveness, theme of stakeholder submissions prior to and after the regulatory decision, final decision, and rational for approval/rejection. Results: At the time of analysis, all agency decisions had been finalized. All of the agencies based their assessment of clinical efficacy of primarily on the same phase III clinical trial: the AXIS trial, demonstrating a progression-free survival benefit of axitinib compared to sorafenib (6.7 versus 4.7 months, p<0.001). Cost-effectiveness data was considered by NICE and pCODR, but not the FDA, the EMA, or the TGA. Axitinib was recommended received approval by the FDA, the EMA, and the TGA for use in patients with mRCC who have failed prior treatment with sunitinib or cytokines. pCODR recommended axitinib for funding in the 2nd line setting only in patients unable to tolerate everolimus. And NICE recommended against the funding of axitinib. Both dissenting organizations cited concerns with the pivotal trial’s control arm, sorafenib, not representing their regional standards of care as primary reasons for restricted access and rejection. Cost considerations were also cited as factors in the rejections. Conclusions: Differing regulatory approvals and funding worldwide are creating regional standards of care that impeding the research, development, and approval of newer agents. Divergent standards of care before and after clinical trials may restrict their external validity and applicability.

Consensus of regulatory decisions on the same Marketing Authorization Application (MAA) are critical for stakeholders. In this context, regulatory decision patterns from the Swissmedic (SMC), the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) were analyzed for hemato‐oncology products (OP) and non‐oncology products (NOP). We compared 336 SMC regulatory decisions between 2009 and 2018 on new active substances with the EMA and the FDA for OP (n = 77) and NOP (n = 259) regarding approval rates, consensus, and divergent decisions. For OP MAA, we analyzed the underlying reasons for divergent decisions; for consensus decisions, the similarity and strictness of labeling. For OP, the approval rate for the SMC was 88.4%, the EMA 91.3%, and the FDA 95.7%. For NOP, the SMC had an approval rate of 86.2%, the EMA of 93.8%, and the FDA of 88.8%. The consensus decision rate among agencies was 88.4% for OP and 84.4% for NOP. The main clinical driver for divergent decisions for OP was nonrandomized trial design and low patient numbers. Comparing the approved indication wordings, the highest similarity was between the SMC and the EMA, and lowest for the FDA and the EMA. Investigating label strictness, the FDA numerically had the highest but not‐statistically significant number of strict labels. The approval rate stratified by disease area (OP and NOP) differed among the SMC, the EMA, and the FDA. High concordance in regulatory decisions was observed between agencies for OP as well as NOP. Reasons for divergent decisions regarding OP were mainly due to scientific uncertainties. Comparing strictness of indications, numerical but no statistically significant differences were observed between agencies.

Many states make use of personal identity numbers (PINs) to govern people living in their territory and jurisdiction, but only a few rely on an all-purpose PIN used throughout the public and private sectors. This article examines the all-purpose PIN in Finland as a political technology that brings people to the sphere of public welfare services and subjects them to governance by public authorities and expert institutions. Drawing on documentary materials and interviews, it unpacks the history and uses of the PIN as an elementary building block of the Nordic welfare state, and its emerging uses in the post-welfare data economy. The article suggests that, although the PIN is capable of individualizing, identifying, and addressing individuals, its most important and widely embraced feature is the extent to which it enables interoperability among public authorities, private businesses, and their data repositories. Interoperability, together with advances in computing and information technology, has made the PIN a facilitator of public administration, state knowledge production, and everyday life. More recently, in the post-welfare data economy, interoperability has rendered the PIN a national asset in all the Nordic countries, providing a great advantage to biomedical research, innovation business, and healthcare.