The Companion Pandemic to COVID-19: The Use of Informal Practices to Access Public Healthcare Services in the European Union.

Objectives: The objective of this paper is to evaluate the use of informal payments and personal connections to gain preferential access to public health services during the COVID-19 pandemic and to propose effective policy measures for tackling this phenomenon. Methods: Using data from 25,744 patients in the European Union, six different scenarios are analyzed in relation to making informal payments and/or relying on personal connections to access public healthcare services. To evaluate the propensity to engage in informal practices in healthcare, probit regressions with sample selection and predicted probabilities are used. Robustness checks are also performed to test the reliability of the findings. Results: For each scenario, a statistically significant association is revealed between the propensity to make informal payments and/or rely on personal connections and the asymmetry between the formal rules and the patients' personal norms and trust in public authorities. Conclusion: To tackle informal practices in healthcare, policy measures are required to reduce the asymmetry between the formal rules and personal norms by raising trust in public authorities.

A European arena for joint innovation in healthcare: The Platform for Innovation of Procurement and Procurement of Innovation (PiPPi).

By 2000 the European Union (EU) had recognized that its innovation capacity was underperforming in comparison to similar competitors and trading partners. Although the EU has made an effort to stimulate public research and development (R&D) through policy tools like Pre-Commercial Procurement (PCP) and Public Procurement of Innovation (PPI), starting with the 2000 Lisbon strategy and continuing through the 2021 updated Guidance on Innovation Procurement, there has remained a gap in knowledge of and use of these tools, in particular within healthcare. The past decades have seen an explosion in the number and use of digital technologies across the entire spectrum of healthcare. Demand-driven R&D has lagged here, while new digital health R&D has largely been driven by the supply side in a linear fashion, which can have disappointing results. PCP and PPI could have big impacts on the development and uptake of innovative health technology. The Platform for Innovation of Procurement and Procurement of Innovation (PiPPi) project was a Horizon 2020-funded project that ran from December 2018 to May 2022 with a consortium including seven of Europe's premier research hospitals and the Catalan Agency for Health Information. To promote PCP and PPI, PiPPi established a virtual Community of Practice (CoP) that brings together all stakeholder groups to share and innovate around unmet healthcare needs. This perspective presents a brief history of PCP and PPI in Europe with a focus on digital innovation in healthcare before introducing the PiPPi project and its value proposition.

Clinical and Regulatory Challenges and Opportunities for Monoclonal Antibodies in Low- and Middle-Income Countries: Lessons from COVID-19 and Beyond.

Monoclonal antibodies are an effective and growing class of pharmaceuticals for the treatment and prevention of a broad range of non-communicable and infectious diseases; however, most low- and middle-income countries have limited access to these innovative products. Many factors contribute to the global inequity of access to these products; however, in this report, we focus on clinical and regulatory complexities as further highlighted by the coronavirus disease 2019 pandemic. Despite a higher prevalence of many diseases in low- and middle-income countries, only 12% of clinical trials for monoclonal antibodies are conducted in these countries. Additionally, only a fraction of the available monoclonal antibodies in the USA and European Union are authorized for use in low- and middle-income countries. Through learnings from desk research and global symposia with international partners, we present recommendations to harmonize processes and facilitate regional and international collaborations for more rapid approval of fit-for-purpose innovative monoclonal antibodies and biosimilars in low- and middle-income countries.

The dental workforce recruitment and retention crisis in the UK.

The precarious state of NHS dentistry is widely acknowledged, yet there is limited progress in addressing the underlying issues. Further delays will undoubtedly impact patient care, leading to oral health deterioration and unnecessary suffering. This will predominantly affect the most vulnerable in society, resulting in greater oral health inequalities.The underlying issues contributing to the current NHS dental crisis are many, and they include: prolonged delays in contract reform; long-term underinvestment; private sector growth; and fewer dentists working full-time and/or in the NHS. In England, an NHS dental contract that fails to promote prevention or equality of access continues to have a deep and pernicious impact on the future of NHS dentistry. The devastating impact of the COVID-19 pandemic on access cannot be underestimated and neither should the effect of Brexit on the availability of workforce.The recruitment and retention of dentists, and other members of the dental team, is undoubtedly a major issue in terms of capacity and access to NHS dental care. These problems, seen across the UK, are a particular issue in England, with acute challenges within rural and coastal areas.There is an urgent necessity to develop coherent, multifaceted strategies, aided by the collection of clear and accurate workforce data, to tackle these issues.

Medical Device Regulations and custom-made device documentation: A further ten frequently asked questions and their answers.

During the 1990s, three Directives were enacted that aimed to harmonise the regulation of medical devices within the European Union (EU). Custom-made devices (CMDs) were subject to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive [MDD]), which was given effect in the UK by the Medical Devices Regulations 2002 (UK MDR 2002). Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR]) replaced the MDD and was transposed into the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 in the UK. The UK left the EU on 31 January 2020 and entered an 11-month implementation period (IP), during which any new EU legislation that was enacted also took effect in the UK. The EU MDR was scheduled to be fully implemented on 26 May 2020 (during the IP) but this was deferred for one year, until 26 May 2021 (after the IP had concluded), as a result of the coronavirus disease 2019 (COVID-19) pandemic. Consequently, the EU MDR was removed from the UK statute book by a further amendment to the UK MDR 2002, the Medical Devices (Amendment etc.) (EU Exit) Regulations 2020. Since 1 January 2021, CMDs manufactured in Great Britain can conform to either the UK MDR 2002 (as amended) or the EU MDR (until 30 June 2023) while devices manufactured in Northern Ireland are subject to the EU MDR alone. CMDs must be supplied with a statement, a label and, depending on the risk class, instructions for use; this paper answers ten questions regarding this documentation following these legislative changes.

The association between the proportion of Brexiters and COVID-19 death rates in England.

RATIONALE: A cultural divide may exist between a set of people who accept and a set of people who reject the advice of experts. This cultural divide may have important consequences and policy implications, especially in times of severe crisis. OBJECTIVE: Ecological study of whether there exists a significant conditional correlation between two variables that appear unrelated except for attitude towards experts: (1) Proportion of people voting in favour of remaining in the European Union in 2016 and (2) COVID-19 outcomes measured by death rates and vaccination rates. A significant conditional correlation would indicate that polarized beliefs have important consequences across a broad spectrum of societal challenges. METHODS: This study uses simple descriptive statistics and multiple linear regression, considering confounders suggested in the related literature, with data at the District level in England. RESULTS: Districts where people voted most heavily in favour of remaining in the EU (top quintile) had nearly half the death rate of districts in the bottom quintile. This relationship was stronger after the first wave, which was a time when protective measures were communicated to the public by experts. A similar relationship was observed with the decision to get vaccinated, and results were strongest for the booster dose, which was the dose that was not mandatory, but highly advised by experts. The Brexit vote is the variable most correlated with COVID-19 outcomes among many variables including common proxies for trust and civic capital or differences in industry composition across Districts. CONCLUSIONS: Our results suggest a need for designing incentive schemes that take into consideration different belief systems. Scientific prowess - such as finding effective vaccines - may not be sufficient to solve crises.

European cancer mortality predictions for the year 2023 with focus on lung cancer.

BACKGROUND: We predicted cancer mortality figures for 2023 for the European Union (EU-27), its five most populous countries, and the UK. We also focused on mortality from lung cancer. MATERIALS AND METHODS: Using cancer death certification and population data from the World Health Organization and Eurostat databases for 1970-2018, we predicted numbers of deaths and age-standardized rates (ASRs) for 2023 for all cancers combined and the 10 most common cancer sites. We investigated the changes in trends over the observed period. The number of avoided deaths over the period 1989-2023 were estimated for all cancers as well as lung cancer. RESULTS: We predicted 1 261 990 cancer deaths for 2023 in the EU-27, corresponding to ASRs of 123.8/100 000 men (-6.5% versus 2018) and 79.3 for women (-3.7%). Over 1989-2023, ∼5 862 600 cancer deaths were avoided in the EU-27 compared with peak rates in 1988. Most cancers displayed favorable predicted rates, with the exceptions of pancreatic cancer, which was stable in EU men (8.2/100 000) and rose by 3.4% in EU women (5.9/100 000), and female lung cancer, which, however, tends to level off (13.6/100 000). Steady declines are predicted for colorectal, breast, prostate, leukemia, stomach in both sexes, and male bladder cancers. The focus on lung cancer showed falls in mortality for all age groups in men. Female lung cancer mortality declined in the young (-35.8%, ASR: 0.8/100 000) and middle-aged (-7%, ASR: 31.2/100 000) but still increased by 10% in the elderly (age 65+ years). CONCLUSIONS: The advancements in tobacco control are reflected in favorable lung cancer trends, and should be pushed further. Greater efforts on the control of overweight and obesity, alcohol consumption, infection and related neoplasms, together with improvements in screening, early diagnosis, and treatments may achieve a further 35% reduction in cancer mortality in the EU by 2035.

Have Health Inequalities Increased during the COVID-19 Pandemic? Evidence from Recent Years for Older European Union Citizens.

Reducing inequality is one of the current challenges that most societies are facing. Our aim was to analyze the evolution of inequalities in self-assessed health among older Europeans in a time period spanning the 2008 economic crisis and the COVID-19 health crisis. We used data from Waves 2, 4 and 8 of the Survey of Health, Ageing and Retirement in Europe. We used inequality indices that accept ordinal variables. Our empirical results suggest that average inequality declines over time. Gender significantly influences the results. Some of the countries with the highest level of inequality are Denmark and Sweden, and some with the lowest are Estonia and the Netherlands. Our results may be of interest for the development of public policies to reduce inequalities. Special attention should be paid to vulnerable groups, such as the elderly.

Reply to Davison, G. Comment on "Huijghebaert et al. Does Trypsin Oral Spray (Viruprotect®/ColdZyme®) Protect against COVID-19 and Common Colds or Induce Mutation? Caveats in Medical Device Regulations in the European Union. Int. J. Environ. Res. Public Health 2021, 18, 5066".

We have read the comment from Davison with great interest [...].

Drivers and barriers of international migration of doctors to and from the United Kingdom: a scoping review.

BACKGROUND: Many high-income countries are heavily dependent on internationally trained doctors to staff their healthcare workforce. Over one-third of doctors practising in the UK received their primary medical qualification abroad. Simultaneously, an average of around 2.1% of doctors leave the UK medical workforce annually to go overseas. The aim of this study was to identify the drivers and barriers of international migration of doctors to and from the UK. METHODS: A scoping review was conducted. We searched EMBASE, MEDLINE, CINAHL, ERIC and BEI in January 2020 (updated October 2021). Grey literature and citation searching were also carried out. Empirical studies reporting on the drivers and barriers to the international migration of doctors to and from the UK published in the English language from 2009 to present were included. The drivers and barriers were coded in NVivo 12 building on an existing framework. RESULTS: 40 studies were included. 62% were quantitative, 18% were qualitative, 15% were mixed-methods and 5% were literature reviews. Migration into and out of the UK is determined by a variety of macro- (global and national factors), meso- (profession led factors) and micro-level (personal factors). Interestingly, many of the key drivers of migration to the UK were also factors driving migration from the UK, including: poor working conditions, employment opportunities, better training and development opportunities, better quality of life, desire for a life change and financial reasons. The barriers included stricter immigration policies, the registration process and short-term job contracts. CONCLUSIONS: Our research contributes to the literature by providing a comprehensive up-to-date review of the drivers and barriers of migration to and from the UK. The decision for a doctor to migrate is multi-layered and is a complex balance between push/pull at macro-/meso-/micro-levels. To sustain the UK's supply of overseas doctors, it is vital that migration policies take account of the drivers of migration particularly working conditions and active recruitment while addressing any potential barriers. Immigration policies to address the impact of Brexit and the COVID-19 pandemic on the migration of doctors to and from the UK will be particularly important in the immediate future. Trial registration PROSPERO CRD42020165748.

Comment on Huijghebaert et al. Does Trypsin Oral Spray (Viruprotect®/ColdZyme®) Protect against COVID-19 and Common Colds or Induce Mutation? Caveats in Medical Device Regulations in the European Union. Int. J. Environ. Res. Public Health 2021, 18, 5066.

I read with interest the recent paper of Huijghebaert et al. published recently in this journal [...].

Cancer patient management: Current use of next-generation sequencing in the EU TOP4.

BACKGROUND: Next-generation sequencing (NGS) is recognised by a growing audience of medical professionals as a functional diagnostic tool in oncology. However, adoption in clinical routine proceeds haphazardly in Europe. METHODS: A semi-structured interview survey was administered to 68 cancer care professionals in four EU countries between June-August and November-December 2021. Pre-screening questionnaires assessed sufficient NGS expertise, diverse geographical distribution, and professional roles. RESULTS: Our findings provide a better understanding of current clinical, regulatory, and reimbursement practices for NGS in four EU countries. CONCLUSIONS: Despite the impending European In-vitro Diagnostic Medical Devices Regulation (IVDR), tortuous national guidelines implementations and limping reimbursement policies are common traits across surveyed countries and produce disparity in access to advanced healthcare services amid regional distinctions. POLICY SUMMARY: The evident information gap between involved parties and demand for consistent national guidelines could be filled by health economics analyses tailored to local specifics to provide factual leverage for a structured adoption of NGS testing.

Health misinformation and freedom of expression: considerations for policymakers.

Health misinformation, most visibly following the COVID-19 infodemic, is an urgent threat that hinders the success of public health policies. It likely contributed, and will continue to contribute, to avoidable deaths. Policymakers around the world are being pushed to tackle this problem. Legislative acts have been rolled out or announced in many countries and at the European Union level. The goal of this paper is not to review particular legislative initiatives, or to assess the impact and efficacy of measures implemented by digital intermediaries, but to reflect on the high constitutional and ethical stakes involved in tackling health misinformation through speech regulation. Our findings suggest that solutions focused on regulating speech are likely to encounter significant constraints, as policymakers grasp with the limitations imposed by freedom of expression and ethical considerations. Solutions focused on empowering individuals - such as media literacy initiatives, fact-checking or credibility labels - are one way to avoid such hurdles.

SARS-CoV-2 Infection in San Patrignano, the Largest European Drug Rehabilitation Community.

BACKGROUND: Studies on SARS-CoV-2 conducted in confined settings for prolonged times allow researchers to assess how the coronavirus spreads. San Patrignano (SP), Italy, is the largest European drug rehabilitation facility. METHODS: Between 15 October and 31 December 2020, all SP residents were tested for SARS-CoV-2. We analyzed the relationships between individual characteristics and being SARS-CoV-2-positive. Three selected predictive models were used to calculate the number of expected hospitalizations. For each model, we summed the estimated individual risks to obtain the expected number of hospitalizations in our sample, and we tested whether the observed and expected numbers differed. RESULTS: Of 807 residents, 529 (65.6%) were SARS-CoV-2-positive. Of these 323 (61.1%) were symptomatic. A strong relationship was found between being positive and living connections (p-value < 0.001). No statistically significant relationship was found with age, sex, smoking history, or comorbidities. Although 9 to 17 hospitalizations were expected, no hospitalizations were observed (p-value < 0.001). No one died of COVID-19. CONCLUSIONS: The peculiar characteristics of SP residents or the SP environment might at least partially explain the null hospitalization rates. Despite the extreme uniqueness of our population and despite the protected environment and all precautions that were taken, the fact that the virus was able to circulate and infect a large portion of the population highlights the fundamental role of social interactions in the spread of the disease.

Precarious employment and workplace health outcomes in Britain.

RATIONALE: The world of work is changing rapidly, and precarious employment is becoming more prevalent in Britain and elsewhere, particularly since the 2008 financial crisis. This is despite the evidence linking employment precarity to adverse health outcomes, and the policy discourses advocating for high-quality jobs. OBJECTIVE: I seek to establish empirically the extent and nature of the potential link between employment precarity and health outcomes, which is done chiefly at the workplace level. The research can be vital from the perspective of informing policy, given that the workplace represents the level where key policy levers operate. METHODS: I use nationally representative data from the British Workplace Employment Relations Survey. Four workplace health outcomes (WHOs; viz., injuries, illnesses, job satisfaction, and job anxiety) have been used to examine if organizations with precarious employment arrangements are likely to experience adverse health outcomes. I use alternative econometric approaches to compare organizations that reported to have three types of precarious employment arrangements, viz., shift working, annualised hours, and zero-hours contracts (ZHCs), vis-à-vis their counterparts without such arrangements. RESULTS: The results obtained reveal that workplaces with precarious employment arrangements are significantly unhealthier, and those with the most insecure form of precarious employment perform particularly worst in this respect. CONCLUSIONS: Precarious employment may become ever more prevalent as organizations contend with economic fallouts from shocks such as Brexit or Covid-19. This may lead to sub-standard health outcomes. The positive influence of trade unions on working conditions has largely been decimated and the workforce in Britain is ageing. These combinations may pose significant challenges to public health including mental health crises. Public policy ought to help minimise adverse health outcomes linked to employment precarity.