ReportWire

Tag: health systems

  • Virtua Health, ChristianaCare decide not to merge operations

    Virtua Health and ChristianaCare have abandoned a planned $6 billion merger, the health systems announced Thursday.

    The health systems – two of the largest in the area – signed a letter of intent in July to explore the possibility of joining forces. The plan would have merged 600 health care sites in New Jersey, Pennsylvania, Delaware and Maryland into one system and would have affected about 30,000 employees. Merging would have generated an estimated $6 billion in annual revenue.


    MORE: Drinking tea instead of coffee may be better for your bones


    But the health systems “have mutually agreed to terminate the Letter of Intent,” they said in a statement. “After thoughtful evaluation, both organizations have determined that they can best fulfill their missions to serve their communities by continuing to operate independently.”

    The health systems did not detail why they decided against merging, but their statement said they are “committed to providing high quality, compassionate care and advancing the health and well-being of the patients and communities they serve.”

    Virtua Health, based in Marlton, has five hospitals in South Jersey. The health system operates two satellite emergency departments, 42 ambulatory surgery centers and 400 other sites. It has a cancer care affiliation with Penn Medicine and a pediatric partnership with Children’s Hospital of Philadelphia. In 2019, Virtua took over Lourdes Health System, including its hospitals in Willingboro and Camden.

    ChristianaCare is the largest health system in Delaware with four hospitals, a Level I trauma center and a freestanding emergency department.

    Courtenay Harris Bond

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  • Health Systems Race to Secure Expert Guidance as Medicaid Budget Cuts Loom – Black Book Flash Poll

    Responding to escalating fiscal pressures resulting from anticipated Medicaid reimbursement cuts, Black Book Research today released a flash poll reaffirming its 2025 rankings of healthcare advisory firms most capable of guiding hospitals reliant on Medicaid through strategic planning and critical operational adjustments.

    Given the heightened vulnerability of providers which derive considerable revenue from Medicaid, identifying the five most impactful advisory firm engagements has become crucial. “Without proactive strategic support, these hospitals face a substantial risk of severe financial distress or closure, significantly impacting community health services and the patients who rely on them,” said Doug Brown, Founder of Black Book.

    Approximately 300 U.S. hospitals, primarily safety-net, rural, children’s, and specialty facilities, are estimated to derive 30% or more of their revenue from Medicaid in 2025. These providers are particularly vulnerable to Medicaid reimbursement cuts.

    All US hospitals already rely significantly on Medicaid funds, averaging about 14.6% of revenue nationwide. Given the scale of potential impact, these institutions urgently require focused strategic support to manage anticipated financial disruptions and continue serving vulnerable populations effectively.

    A recent targeted Black Book flash survey of 40 hospital administrators identified five essential strategic priorities for health systems deriving 15% or more of their revenue from Medicaid, pairing each priority with top-rated advisory firms based on client satisfaction, proven outcomes, and effectiveness in Medicaid-driven engagements.

    The advisory firm rankings are based on extensive surveys involving more than 4,000 healthcare executives, CFOs, and strategic planners from Q4 2024 to Q2 2025 and have been available to view and download the complete report at the Black Book website for no charge to industry stakeholders since March 2025.

    5 Essential Strategies for Medicaid-Dependent Health Systems and Their Top-Rated 2025 Advisory Firms:

    1. Financial Vulnerability Assessment & Resiliency Planning

    Top-Rated Consultant: Kaufman Hall

    Hospitals must prepare rigorously for Medicaid funding reductions through detailed financial scenario modeling, proactive cost containment strategies, and reevaluation of service-line profitability. Kaufman Hall emerged as the highest-rated firm, recognized for its expertise in providing swift, actionable insights, precise risk forecasting, and tailored financial recovery strategies that align effectively with the unique fiscal demands of safety-net institutions.

    2. Operational Efficiency & Cost Structure Transformation

    Top-Rated Consultant: Huron Consulting Group

    Hospitals facing significant reimbursement reductions must optimize their operational efficiencies and cost structures. Huron Consulting Group was recognized for its success in reshaping operations, identifying significant cost-saving opportunities, streamlining clinical workflows, and implementing sustainable productivity improvements to effectively absorb Medicaid revenue reductions.

    3. Medicaid Policy, Advocacy & Stakeholder Engagement

    Top-Rated Consultant: Leavitt Partners

    Proactive engagement with Medicaid agencies, managed care organizations, and legislative stakeholders is vital to sustaining stable reimbursement streams. Leavitt Partners earned top honors due to their extensive network of policy experts, robust relationships within state governments, and proven capability in forming provider coalitions. Clients highly praised Leavitt Partners’ strategic guidance in interpreting regulatory developments and effectively influencing policy outcomes favorable to hospitals.

    4. Payer Mix Diversification & Revenue Optimization

    Top-Rated Consultant: Deloitte

    Reducing Medicaid dependence requires strategic diversification into services and market segments with higher commercial reimbursement potential. Deloitte was recognized for excellence by hospitals aiming to expand outpatient capacity, introduce commercially successful specialty services, and modernize payer engagement strategies. Deloitte’s data-driven methodologies and strong implementation capabilities received particular commendation from clients.

    5. Community-Based Coverage Expansion & Medicaid Redetermination Preparedness

    Top-Rated Consultant: Chartis Group

    With millions of patients facing Medicaid eligibility redetermination and potential disenrollment, hospitals must secure continuous coverage within their communities. Chartis Group received the highest client recognition for successfully assisting hospitals in developing scalable coverage retention programs, forging partnerships with Federally Qualified Health Centers (FQHCs) and Community-Based Organizations (CBOs), and deploying digital outreach solutions. Chartis was particularly noted for its integration of community-centric strategies with sophisticated analytics to minimize coverage disruptions.

    __________

    These strategic frameworks and advisory rankings are featured in the 2025 Black Book of Healthcare IT Consultants and Advisory Firms, providing in-depth data and insights on 260 HIT management consulting organizations. This resource is available free to hospitals, health systems, and healthcare providers impacted by Medicaid policy shifts. Download the full report at https://blackbookmarketresearch.com/2025-black-book-of-healthcare-it-consultants-and-advisory-firms Black Book maintains a rigorous, independent methodology, strictly prohibiting vendor sponsorships or advertisements to ensure unbiased, credible client experiences.

    “Hospitals reliant on Medicaid are entering an era marked by unprecedented financial challenges, including impending reimbursement cuts, complex patient churn due to redetermination processes, and inflexible managed care rates,” said Brown. “The advisory firms highlighted in this report are not merely supportive resources; they represent essential partnerships. Their proven strategies, measurable outcomes, and deep Medicaid policy expertise are indispensable for hospitals aiming to navigate this turbulent landscape successfully.”

    About Black Book Research

    Black Book™ is a leading independent source for peer-validated performance rankings of consulting, advisory, and IT vendor organizations since 2004. Utilizing robust internal, partner-based panels, and extensive crowdsourced polling, Black Book has engaged, in particular, more than 3.3 million healthcare professionals since 2011, maintaining steadfast dedication to transparency, accuracy, and independence without vendor or advisory firm influence. Black Book maintains a rigorous, independent methodology, strictly prohibiting vendor sponsorships or association partnerships to ensure unbiased, credible client experiences. For more information, contact research@blackbookmarketresearch.com or visit www.blackbookmarketresearch.com.

    Source: Black Book Research

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  • Double-Digit Tariffs Disrupt U.S. Healthcare Costs and Supply Chain Stability, Industry Leaders Warn in Black Book Poll

    New Black Book Research survey reveals industry-wide concerns as tariffs on imports from Mexico, Canada, and China threaten to escalate healthcare costs, disrupt supply chains, and create affordability challenges for patients.

    A new survey conducted by Black Book Research has illuminated significant concerns among healthcare supply chain professionals, pharmaceutical executives, distributors, and medical equipment manufacturers about the financial and operational disruptions caused by recently imposed tariffs on imported goods from Mexico, Canada, and China.

    Leveraging Black Book’s advanced surveying technologies, the panel poll conducted over the past week gathered responses from 160 industry professionals spanning key stakeholder segments, including hospital finance and supply chain executives, payers, patients, health market customers, pharmaceutical and medical equipment manufacturers, and physicians and ancillary practice administrators. The survey aimed to assess the anticipated consequences of the 25% tariff on goods from Mexico and Canada, along with the 10% tariff on goods from China. The findings underscore widespread apprehension about escalating costs for hospitals, physicians, payers, and patients.

    Survey Findings:

    1. How significantly will the tariffs increase the cost of medical equipment and pharmaceuticals?

    164 of the 200 survey respondents predict that costs for hospitals and health systems will surge by at least 15% in the next six months due to increased import expenses.

    69% estimate pharmaceutical costs will rise by at least 10% as a result of the China tariff on active pharmaceutical ingredients (APIs).

    2. What impact will the tariffs have on medical supply chain operations?

    90% of healthcare supply chain professionals responding foresee major disruptions in procurement processes and contract negotiations with suppliers due to increased costs and pricing volatility.

    81% of medical equipment manufacturers predict longer lead times and supply shortages stemming from increased production costs and import restrictions.

    3. How will hospitals and physicians manage the higher costs?

    90% of the twenty-one hospital finance executives surveyed report they will need to shift increased costs onto insurers and patients in the form of higher service charges.

    94% of healthcare administrators anticipate reducing procurement volumes or delaying equipment upgrades to mitigate financial strain.

    4. What effect will the tariffs have on payers and patient affordability?

    84% of payers expect to see higher claims costs due to increased pricing on medical treatments and drugs.

    48% of payer executives believe that insurance premiums will rise within the next 12 months as a direct consequence of increased supply chain expenses.

    5. Will alternative sourcing strategies mitigate tariff impacts?

    27% of respondents report that they are actively seeking domestic or alternative international suppliers to offset higher costs from Mexico, Canada, and China.

    However, 92% of pharmaceutical manufacturers caution that switching suppliers could result in regulatory delays and supply inconsistencies, particularly for critical medications.

    6. How will the tariffs impact healthcare IT vendors, software, and managed services?

    39% of healthcare IT executives foresee increased costs for software licensing, cloud computing, and managed services due to higher prices for imported technology components and IT infrastructure.

    91% of provider IT leaders anticipate delays in planned digital transformation projects as budgets shift to cover increased operational costs.

    16% of healthcare IT vendors predict that tariffs will increase the cost of essential hardware, including servers, networking equipment, and medical IT devices, impacting service delivery timelines and pricing for clients.

    Industry Response & Outlook

    “Healthcare providers, payers, and patients will all experience the financial ramifications of these tariffs,” said Doug Brown, Founder of Black Book. “As medical supply costs escalate, hospitals and insurers will be forced to make difficult financial decisions, inevitably passing increased expenses down to patients through higher out-of-pocket costs.” With the healthcare sector bracing for the full impact of these tariffs, Black Book Research remains committed to tracking and analyzing emerging supply chain trends, cost containment strategies, and industry-wide adaptations to mitigate risks and sustain affordability.

    About Black Book Research: Black Book Research is a premier source for unbiased, comprehensive market research and customer satisfaction surveys in the healthcare IT and services industries. Our independent methodologies provide real-time, actionable insights that inform strategic decision-making across the healthcare ecosystem. Black Book’s surveying technologies and industry outreach capabilities ensure timely, high-impact polling results, enabling healthcare organizations to respond effectively to market dynamics. Learn more at www.blackbookmarketresearch.com.

    Source: Black Book Research

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  • Why dengue in Europe could spell disaster for the rest of the world 

    Why dengue in Europe could spell disaster for the rest of the world 

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    In the early morning of the last day of August, Parisians experienced for the first time a practice normally confined to tropical regions — authorities fumigating the city against the tiger mosquito. The event was a tangible confirmation of what public health stats already showed: Dengue, the deadly mosquito-borne disease, had well and truly arrived in Europe. 

    In 2022, Europe saw more cases of locally acquired dengue than in the whole of the previous decade. The rise marks both a public health threat and a corresponding market opportunity for dengue vaccines and treatments; news that should spur the pharma industry to boost investment into the neglected disease. 

    On the face of it, this shift would appear to benefit not only countries like France but also nations like Bangladesh and the Philippines that have long battled dengue.

    But that assumption could be fatally flawed, experts told POLITICO. 

    People working in the field say the rise of dengue in the West could, in fact, make it harder to get lifesaving drugs to those who need them most, because pharma companies develop tools that are less effective in countries where the dengue burden is the highest or because wealthy nations end up hoarding these medicines and vaccines. 

    “It might look like a good thing — and it is a good thing — that we’re getting more products developed, but does it then create a two-tier system where high-income populations get access to it and then we still have the access gap for low- and middle- income countries?” asked Lindsay Keir, director of the science and policy advisory team at think tank Policy Cures Research.

    Killer invading mosquitoes

    Climate change and migration mean the mosquitoes that transmit dengue, as well as other diseases such as chikungunya and Zika, are setting up shop in Europe. The most recent annual data from the European Centre for Disease Prevention and Control shows that, in 2022, Europe saw 71 cases of locally acquired dengue: 65 in France and six in Spain.

    While dengue usually results in mild or no symptoms, it can also lead to high fever, severe headache and vomiting. Severe dengue can cause bleeding from the gums, abdominal pain and, in some cases, death.

    So far, the mosquito has mostly been confined to Southern Europe but it’s a worry across the Continent. In Belgium, the national public health research institute Sciensano has even launched an app where members of the public can submit photos of any Asian tiger mosquitos they spot.

    The diseases spread by these mosquitoes have traditionally fallen under the umbrella of neglected tropical diseases, a group of infections that affect mainly low-income countries and struggle to attract research and development investment. But this is changing.

    Policy Cures Research, which publishes an annual report on R&D investment into neglected diseases, removed dengue vaccines from their assessment in 2013. Dengue was no longer seen as an area where there was market failure, due to the emergence of a market that the private sector could tap into. 

    The organization is still tracking dengue drugs and biologics and their 2022 analysis showed a 33 percent increase in funding for research into non-vaccine products compared to the previous year, with industry investment reaching a record high of $28 million. 

    Climate change and migration mean the mosquitoes that transmit dengue, as well as other diseases such as chikungunya and Zika, are setting up shop in Europe | Lukas Schulze/Getty Images

    Sibilia Quilici, executive director of the vaccine maker lobby group Vaccines Europe, said the most recent pipeline review of members found that roughly 10 percent were targeting neglected diseases. There is more R&D happening in this area, said Quilici.

    Across the major drugmakers, J&J is working on a dengue antiviral treatment and MSD has a dengue vaccine in their pipeline, while Sanofi has a second yellow fever jab in development. Two dengue vaccines are already approved in the EU — one from Sanofi and another from Takeda. Moderna recently told POLITICO that it is looking closely at a dengue vaccine candidate and it already has a Zika candidate in the works. 

    For the few, not the many

    But just because there might soon be larger markets for Big Pharma doesn’t mean the products will be suitable for the populations that have been waiting years for these tools. 

    Rachael Crockett, senior policy advocacy manager at the non-profit Drugs for Neglected Diseases initiative (DNDi), said increased pharma investment in a particular disease won’t necessarily lead to products developed that are globally relevant. “Industry will — and governments are also more likely to — focus on prevention,” she said.

    That means tools such as vaccines will be prioritized; but in countries where dengue is endemic, the rainy season completely overburdens their health systems and what they desperately need are treatments, said Crockett.  

    She also said a massive increase in investment without a structure to ensure access to resulting products means “we have absolutely no guarantee that there isn’t going to be hoarding, [that] there isn’t going to be high prices.” Case in point: The U.S. national stockpile of Ebola vaccines, which exists despite there never having been an Ebola outbreak in the country.

    But just because there might soon be larger markets for Big Pharma doesn’t mean the products will be suitable for the populations that have been waiting years for these tools | Noel Celis/AFP via Getty Images

    Underlying many of these fears are the mistakes of the COVID-19 pandemic, which saw countries with less cash and political heft at the back of the queue when it came to vaccines.

    Lisa Goerlitz, head of German charity Deutsche Stiftung Weltbevölkerung (DSW)’s Brussels office, warned if drug development picks up because of a growing market in high-income countries, then accessibility, affordability and other criteria that make it suitable for low resource settings might not be prioritized.

    Vaccines Europe’s Quilici sought to allay these concerns, pointing to the pharma industry’s Berlin Declaration, a proposal to reserve an allocation of real-time production of vaccines in a health crisis. Quilici said this was a “really strong commitment …which comes right from the lessons learnt from COVID-19 and which could definitely overcome the challenges we had during the pandemic, if it is taken seriously.”

    CORRECTION: This article has been updated to correct the spelling of Lisa Goerlitz.

    Ashleigh Furlong

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  • How countries are throwing away their best chance to prevent the next pandemic 

    How countries are throwing away their best chance to prevent the next pandemic 

    It’s meant to be a legally binding deal that could prevent the next pandemic.

    Originally proposed by European Council President Charles Michel in the worst days of the COVID-19 pandemic, the aim is to create a new set of rules to guide countries on pandemic preparedness and response. 

    But with countries fiercely divided on key issues and just 12 months left to agree, it’s looking increasingly likely that the text will end up as a damp squib.

    As the who’s who of global health descends on Geneva in the coming days for the World Health Assembly — the annual meeting of the decision-making body of the World Health Organization — the fate of the treaty will be the main topic of discussion over glasses of champagne at swanky receptions. 

    The behemoth draft version of the text was ambitious, covering everything from access to vaccines to strengthening health systems so they can respond to health crises.

    But with countries facing off over intellectual property rights and the rules around sharing medical products developed during a pandemic, a compromise with any substance looks increasingly difficult to reach. 

    “If the groups can give up a little bit and try to compromise, I think that in the middle, we might have something left … we might have something that is useful for the future,” said a Geneva-based diplomat, who requested anonymity to talk about confidential negotiations. However, they added that the “fallback position might be a treaty with a little bit of content — just a little bit.”

    And then there’s the all-important question: How to ensure that countries actually comply with what’s agreed.  “A treaty with no compliance mechanism is just a piece of paper,” warned Nina Schwalbe, founder of the public health think tank Spark Street Advisers and former senior official at UNICEF and Gavi, the Vaccine Alliance.

    POLITICO walks you through the biggest sticking points:

    Face-off with Big Pharma

    There are two highly contentious proposals in the draft text. One calls on countries to take measures to support time-bound waivers of IP rights so that companies other than patent holders could make vaccines or treatments — an issue that countries never truly succeeded in solving during the COVID-19 pandemic. The second is to ensure that countries that share information about dangerous pathogens can access any resulting treatments and vaccines developed using this data.

    Developing countries see these as central to ensuring equity in the next pandemic. But both are fiercely opposed by Big Pharma, which has the backing of some wealthy Western nations.

    On intellectual property rights, the U.S. has taken a big red pen to the draft text, stripping out mention of waivers of intellectual property rights. It also wants to weaken provisions that would require pharmaceutical companies to license other manufacturers to produce their products.

    The U.S. wants to weaken provisions that would require pharmaceutical companies to license other manufacturers to produce their products | Thibaud Moritz/AFP via Getty Images

    For the debate over whether sharing information regarding new pathogens should be linked to some kind of benefit — potentially monetary — the line is less clear. The Global South, which is pushing to include the benefits link, has the biggest ask, said a second Geneva-based diplomat who also requested anonymity to talk about confidential negotiations. But a flat no from the Global North could see them lose timely access to those pathogens — something that could delay the development of pathogen-specific vaccines or treatments, and cost lives.

    Too many cooks, too little time

    When WHO members agreed in December 2021 to negotiate a pandemic treaty by May 2024, the deadline seemed a lifetime away. But a lot of time was lost at the start of the process on procedural matters, said the first diplomat. That delay was likely “strategic at some point also for some groups,” they said, without specifying who they were referring to.

    There’s no denying that the text tries to cover a lot of ground, much of it highly controversial. Given that, the deadline of May 2024 is “an extreme challenge,” said the second diplomat. What may be necessary is a streamlining of sorts. “It’s not about lowering the ambition but maybe lowering the level of detail,” they said.

    Ambassador Nora Kronig, head of the international affairs division in the Swiss Federal Office of Public Health, told POLITICO that there is still uncertainty about the scope and content of the treaty. “There’s still a lot of work ahead of us to make it tangible and realistic and implementable,” she said. 

    ‘Just a piece of paper’ 

    Perhaps the biggest question is how the treaty will actually be enforced. 

    “There hasn’t been a lot of discussion about this because it touches on the difficult issue about sovereignty and about having an international organization or other countries, [having] a look on what you do, [and] on how you prepare,” said the second diplomat. 

    In a draft text, countries including China, Russia, Iran, Namibia and Egypt express strong reservations about monitoring mechanisms such as a peer review process, where countries would carry out regular reviews of each others’ pandemic preparedness. Meanwhile, the EU, Canada and Switzerland have put forward proposals for stronger language on monitoring how ready a country is for a health crisis.

    Some countries fear a naming and shaming process, but it doesn’t matter how well-prepared one country is, if another isn’t, said the first diplomat. “I think that we should be accountable to each other, and we should be transparent, and we should try our best to allocate resources and also to make the necessary changes to improve, and also to help others to improve,” they said.

    Some observers want to go even further. Schwalbe would like to see a committee of independent people reporting on the treaty. “Whatever’s in it, we need to hold states accountable for what they’ve agreed to,” she said. 

    Ultimately, the outcome will be “the fruit of international negotiations,” said the second diplomat. “Of course, it will be the [lowest] common denominator.”

    But their view is that if it binds countries on anything new then it’s worth something. “One could see anything that those countries agree upon [as] progress, even if it is watered down and it is incremental or iterative,” they said.

    Ashleigh Furlong

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  • Beyond the pale? Why the EU is regulating breast milk

    Beyond the pale? Why the EU is regulating breast milk

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    The European Union regulates all sorts of banks: money banks, blood banks, sperm banks

    Its next target? Breast milk banks.

    Brussels bureaucrats want to homogenize the rules overseeing the donation and use of donor breast milk across the bloc. 

    It’s part of the European Commission’s proposed revamp of the laws covering safety and quality standards for substances of human origin (SoHO) intended for human use. Currently, the laws cover blood, tissues and cells, but the EU wants to extend coverage to all SoHO — including donor breast milk.

    While, at first glance, it might seem like the EU is trying to milk its regulatory powers, experts are largely in favor of the plan to set EU-wide standards, saying it will improve its availability and safety.

    With lawmakers and EU countries debating the revamp, POLITICO walks you through the issue.

    What are breast milk banks?

    Women who make more breast milk than their babies need can donate it to a breast milk bank.

    These banks screen donors and collect, process and distribute the milk to infants in need — those whose mother’s own milk is not available or sufficient.

    While exclusive breastfeeding is recommended for all babies in the first six months of their life, it’s especially important for premature or sick newborns, experts say.

    Among many other benefits, breast milk contains antibodies that are important for newborns’ immune systems. Babies born before 30 weeks of pregnancy are especially susceptible to infections, particularly from necrotizing enterocolitis, a type of gut inflammation that can be fatal. Their survival rates improve when they get human milk as compared with formula, said Elien Rouw, a breastfeeding medicine specialist in Germany and president-elect of the Academy of Breastfeeding Medicine.

    There are currently 282 breast milk banks in Europe, including Turkey and Ukraine, according to the European Milk Bank Association.

    Aren’t they already regulated?

    Donor breast milk is regulated differently in different countries. For example, it’s considered a health product in France, a food in Germany, and is uncategorized and unregulated in Romania. And while the safety standards are set at the national level in France, for instance, they are set at the regional level in Belgium.

    The Commission wants to harmonize breast milk safety standards across the EU | Kenzo Tribouillard/AFP via Getty Images

    There is some level of convergence though. For example, most national guidelines in the world recommend donor breast milk should be pasteurized, according to the European Milk Bank Association.

    In France, for example, the milk is first tested for bacteria and highly contaminated milk is thrown out, explains Jean-Charles Picaud, professor of pediatrics specialized in neonatology at Hôpital de la Croix-Rousse in Lyon, and president of the French Human Milk Bank Association. The rest is then pasteurized at precisely 62.5 degrees Celsius for exactly 30 minutes and then retested before being made available for babies.

    What does the Commission want to do?

    The Commission wants to harmonize safety standards across the EU, not only to ensure the safety of the babies that consume breast milk, but also to make it easier for donor breast milk — and other SoHO — to cross borders. 

    Donor milk banks are unevenly spread out across the Continent. There are over 30 in France, for example, but only four in Belgium and one in Romania. And parts of Europe are facing a shortage of donor breast milk, while it remains in limited supply elsewhere. 

    “There are children dying in Germany because they didn’t have, or didn’t have enough, human milk,” Rouw, the breastfeeding medicine specialist in Germany, said. Centers in Germany caring for extremely premature babies without direct access to a milk bank are buying it in part from Belgium and the United States, she added.

    Experts agree that having harmonized safety standards would make the cross-border exchange of breast milk easier, improving babies’ access to it. These include things like donor selection criteria, maternal blood tests for infections, hygiene standards during collection, cold chain conditions during transport, and testing the milk for bacteria, said Picaud, president of the French Human Milk Bank Association.

    However, while the Commission is setting out the principle of bloc-wide standards in its regulation, it aims to leave it to expert bodies — the European Centre for Disease Prevention and Control (ECDC) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) — to hammer out the precise scientific and technical details so that these can be more easily updated should the need arise.

    Should donors get paid?

    The debate over paying for substances of human origin is a divisive one. Germany’s Human Milk Bank Initiative, a nongovernmental organization that promotes nonprofit donor milk banks, warned in a position statement to the Commission in 2020 that “ethically questionable approaches” have been used globally to acquire human milk from “lactating mothers in resource-limited regions or from socio-economically disadvantaged populations.”

    EU countries take varying approaches when it comes to donor compensation for breast milk. Donors in France, for instance, receive no financial compensation. In Sweden, donating mothers receive a nominal 250 Swedish krona (€22.56) per liter of donated milk.

    The Commission’s proposed revision includes guidance on compensation for all SoHO donors, to allow any financial losses to be covered — but leaves it to EU countries to determine whether to allow it and if so, the conditions for it, ensuring they remain “financially neutral.”

    As well as human milk banks, the new law would also apply to any company looking to commercialize breast milk as an ingredient.

    A nurse checks reserves of breast milk in the Sant’Anna hospital in Turin, Italy | Diana Bagnoli/Getty Images

    Given the growing body of research showing the clinical benefits of donor breast milk for premature babies, hospital-affiliated milk banks around the world are expanding their activities — and there’s also growing commercial interest, a Commission spokesperson told POLITICO.

    At least one company is using breast milk to make fortifiers for sick and premature babies in the neonatal intensive care unit, which are then added to either a mother’s milk or donor milk.

    Sarah Taissir Bencharif

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  • World population at 8 billion — by the numbers

    World population at 8 billion — by the numbers

    It’s getting crowded in here.

    Last month, the global population reached 8 billion for the first time, according to the United Nations. While the number of humans on the planet is expected to keep growing — peaking at around 10.4 billion by the end of the century — its demographic profile is changing. Fertility rates are gradually decreasing and several countries — most of them in Europe and Southeast Asia — will experience population declines in the next 30 years.

    Thanks to better health care and improving economic conditions, people across the planet now live longer and healthier lives, though significant regional inequalities still exist.

    Greater life expectancy, combined with lower fertility rates, also means that the world’s population is aging. The old-age dependency ratio — the number of people over 65 as a share of the working-age population — is projected to double in the next 30 years. This means the working-age population will need to sustain a growing number of retired people — a big challenge for social security, pension and health care systems.

    Giovanna Coi

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  • When’s the Perfect Time to Get a Flu Shot?

    When’s the Perfect Time to Get a Flu Shot?

    For about 60 years, health authorities in the United States have been championing a routine for at least some sector of the public: a yearly flu shot. That recommendation now applies to every American over the age of six months, and for many of us, flu vaccines have become a fixture of fall.

    The logic of that timeline seems solid enough. A shot in the autumn preps the body for each winter’s circulating viral strains. But years into researching flu immunity, experts have yet to reach a consensus on the optimal time to receive the vaccine—or even the number of injections that should be doled out.

    Each year, a new flu shot recipe debuts in the U.S. sometime around July or August, and according to the CDC the best time for most people to show up for an injection is about now: preferably no sooner than September, ideally no later than the end of October. Many health-care systems require their employees to get the shot in this time frame as well. But those who opt to follow the CDC current guidelines, as I recently did, then mention that fact in a forum frequented by a bunch of experts, as I also recently did, might rapidly hear that they’ve made a terrible, terrible choice.

    “There’s no way I would do what you did,” one virologist texted me. “It’s poor advice to get the flu vaccine now.” Florian Krammer, a virologist at Mount Sinai’s Icahn School of Medicine, echoed that sentiment in a tweet: “I think it is too early to get a flu shot.” When I prodded other experts to share their scheduling preferences, I found that some are September shooters, but others won’t juice up till December or later. One vaccinologist I spoke with goes totally avant-garde, and nabs multiple doses a year.

    There is definitely such a thing as getting a flu shot too early, as Helen Branswell has reported for Stat. After people get their vaccine, levels of antibodies rocket up, buoying protection against both infection and disease. But after only weeks, the number of those molecules begins to steadily tick downward, raising people’s risk of developing a symptomatic case of flu by about 6 to 18 percent, various studies have found. On average, people can expect that a good portion of their anti-flu antibodies “are meaningfully gone by about three or so months” after a shot, says Lauren Rodda, an immunologist at the University of Washington.

    That decline is why some researchers, Krammer among them, think that September and even October shots could be premature, especially if flu activity peaks well after winter begins. In about three-quarters of the flu seasons from 1982 to 2020, the virus didn’t hit its apex until January or later. Krammer, for one, told me that he usually waits until at least late November to dose up. Stanley Plotkin, a 90-year-old vaccinologist and vaccine consultant, has a different solution. People in his age group—over 65—don’t respond as well to vaccines in general, and seem to lose protection more rapidly. So for the past several years, Plotkin has doubled up on flu shots, getting one sometime before Halloween and another in January, to ensure he’s chock-full of antibodies throughout the entire risky, wintry stretch. “The higher the titers,” or antibody levels, Plotkin told me, “the better the efficacy, so I’m trying to take advantage of that.” (He made clear to me that he wasn’t “making recommendations for the rest of the world”—just “playing the odds” given his age.)

    Data on doubling up is quite sparse. But Ben Cowling, an epidemiologist and flu researcher at Hong Kong University, has been running a years-long study to figure out whether offering two vaccines a year, separated by roughly six months, could keep vulnerable people safe for longer. His target population is Hong Kongers, who often experience multiple annual flu peaks, one seeded by the Northern Hemisphere’s winter wave and another by the Southern Hemisphere’s. So far, “getting that second dose seems to give you additional protection,” Cowling told me, “and it seems like there’s no harm of getting vaccinated twice a year,” apart from the financial and logistical cost of a double rollout.

    In the U.S., though, flu season is usually synonymous with winter. And the closer together two shots are given, the more blunted the effects of the second injection might be: People who are already bustling with antibodies may obliterate a second shot’s contents before the vaccine has a chance to teach immune cells anything new. That might be why several studies that have looked at double-dosing flu shots within weeks of each other “showed no benefit” in older people and certain immunocompromised groups, Poland told me. (One exception? Organtransplant recipients. Kids getting their very first flu shot are also supposed to get two of them, four weeks apart.)

    Even at the three-ish-month mark past vaccination, the body’s anti-flu defenses don’t reset to zero, Rodda told me. Shots shore up B cells and T cells, which can survive for many months or years in various anatomical nooks and crannies. Those arsenals are especially hefty in people who have banked a lifetime of exposures to flu viruses and vaccines, and they can guard people against severe disease, hospitalization, and death, even after an antibody surge has faded. A recent study found that vaccine protection against flu hospitalizations ebbed by less than 10 percent a month after people got their shot, though the rates among adults older than 65 were a smidge higher. Still other numbers barely noted any changes in post-vaccine safeguards against symptomatic flu cases of a range of severities, at least within the first few months. “I do think the best protection is within three months of vaccination,” Cowling told me. “But there’s still a good amount by six.”

    For some young, healthy adults, a decent number of flu antibodies may actually stick around for more than a year. “You can test my blood right now,” Rodda told me. “I haven’t gotten vaccinated just yet this year, and I have detectable titers.” Ali Ellebedy, an immunologist at Washington University in St. Louis, told me he has found that some people who have regularly received flu vaccines have almost no antibody bump when they get a fresh shot: Their blood is already hopping with the molecules. Preexisting immunity also seems to be a big reason that nasal-spray-based flu vaccines don’t work terribly well in adults, whose airways have hosted far more flu viruses than children’s.

    Getting a second flu shot in a single season is pretty unlikely to hurt. But Ellebedy compares it to taking out a second insurance policy on a car that’s rarely driven: likely of quite marginal benefit for most people. Plus, because it’s not a sanctioned flu-vaccine regimen, pharmacists might be reluctant to acquiesce, Poland pointed out. Double-dosing probably wouldn’t stand much of a chance as an official CDC recommendation, either. “We do a bad enough job,” Poland said, getting Americans to take even one dose a year.

    That’s why the push to vaccinate in late summer and early fall is so essential for the single shot we currently have, says Huong McLean, a vaccine researcher at the Marshfield Clinic Research Institute in Wisconsin. “People get busy, and health systems are making sure that most people can get protected before the season starts,” she told me. Ellebedy, who’s usually a September vaccinator, told me he “doesn’t see the point of delaying vaccination for fear of having a lower antibody level in February.” Flu seasons are unpredictable, with some starting as early as October, and the viruses aren’t usually keen on giving their hosts a heads-up. That makes dillydallying a risk: Put the shot off till November or December, and “you might get infected in between,” Ellebedy said—or simply forget to make an appointment at all, especially as the holidays draw near.

    In the future, improvements to flu-shot tech could help cleave off some of the ambiguity. Higher doses of vaccine, which are given to older people, could rile up the immune system to a greater degree; the same could be true for more provocative vaccines, made with ingredients called adjuvants that trip more of the body’s defensive sensors. Injections such as those seem to “maintain higher antibody titers year-round,” says Sophie Valkenburg, an immunologist at Hong Kong University and the University of Melbourne—a trend that Ellebedy attributes to the body investing more resources in training its fighters against what it perceives to be a larger threat. Such a switch would likely come with a cost, though, McLean said: Higher doses and adjuvants “also mean more adverse events, more reactions to the vaccine.”

    For now, the only obvious choice, Rodda told me, is to “definitely get vaccinated this year.” After the past two flu seasons, one essentially absent and one super light, and with flu-vaccination rates still lackluster, Americans are more likely than not in immunity deficit. Flu-vaccination rates have also ticked downward since the coronavirus pandemic began, which means there may be an argument for erring on the early side this season, if only to ensure that people reinforce their defenses against severe disease, Rodda said. Plus, Australia’s recent flu season, often a bellwether for ours, arrived ahead of schedule.

    Even so, people who vaccinate too early could end up sicker in late winter—in the same way that people who vaccinate too late could end up sicker now. Plotkin told me that staying apprised of the epidemiology helps: “If I heard influenza outbreaks were starting to occur now, I would go and get my first dose.” But timing remains a gamble, subject to the virus’s whims. Flu is ornery and unpredictable, and often unwilling to be forecasted at all.

    Katherine J. Wu

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