Hospitals’ next cyber risk? The fridge.

SNEAK PEEK

The cyber resilience of Europe’s health systems is under the spotlight after an attack on French refrigerators raises concern about vaccine vulnerabilities.

Health payers and patient groups want a new EU-funded tool to ensure innovative medicines remain affordable amid U.S. pricing pressures.

The European Parliament is calling for a strong 2027 EU budget, increasing the funding for EU4Health.

DRIVING THE DAY

WARNING SIGNS: Europe needs to step up cyber resilience to protect critical health infrastructure as a cyberattack that knocked out hundreds of French fridges serves as a warning of worst-case scenarios. Hackers remotely heated up supermarket refrigerators earlier this month, spoiling food and in some cases sparking small fires. Now imagine it’s not food, it’s vaccines, antivirals, samples or blood products ahead of an attack.

No time to chill: Fridges are used throughout health care, “ranging from research laboratories to pharmacies that store vaccines, ” Vincent Strubel, director general of France’s cybersecurity agency ANSSI, told the French Senate Wednesday. ANSSI carried out “an extremely intensive, rapid, and effective effort” to investigate if health facilities were impacted, he said.

Canary in the coalmine: ‘Ethical hacker’ Ken Munro illustrated the breadth of threat in health systems at a Brussels conference on Wednesday. He warned of robot vacuums that can map hospitals and spy on computer screens. And he also revealed finding an open test on insulin pumps online, meaning hackers could have remotely increased the dose to a deadly level for 3,000 patients. He alerted the manufacturer.

Meanwhile: Smart kettles could be hacked from the street and details about a household’s — or hospital’s — internet connection could be retrieved. People could also be remotely locked out of various digital systems, he said, giving the example of a cheap thermostat. “But what if this is a very expensive medical scanner?”

Urgent call: Munro warned preparation was key to ensure any risks were mapped and mitigated, like if vaccine fridges were knocked out. “At the very least, we should make sure we’ve got a backup process and a backup plan to make sure if it does stop working, we can keep services moving,” Munro said. “Role play that now, don’t wait till the fridges stop working.”

The good news: Work is already underway to develop critical medicines and vaccines that don’t require refrigeration. Stablepharma, a U.K. -based biotech company, is working to turn existing vaccines into fridge-free versions that do not need cold storage for the entirety of their shelf lives.

“Our mission is basically to make life-saving medicines fridge-free, to have much better access in many parts of the world, to provide expanded access to people, and to have health equity,” Stablepharma CEO Özgür Tuncer told Morning Health Care.

One example: The company is moving a fridge-free tetanus-diphtheria vaccine into Phase IIb clinical trials after positive results in Phase I. They’re also working on fridge-free hepatitis B vaccines and looking to expand to more products.

Bonus: Fridge-free vaccines can also contribute to reducing waste and its environmental impact, “because a lot of vaccines and other pharmaceutical products get wasted if they deviate from the temperatures they need to be kept at,” he added.

Addressing a growing fragility: The cyberattack in France showed that “cold-chain dependence is not just a logistical challenge but a resilience challenge,” Tuncer said.“As health care systems become increasingly digital and interconnected, cyberattacks on refrigeration infrastructure represent another potential risk and point of failure.”

Strengthening Europe’s resilience: “Fridge-free vaccines, and other temperature sensitive medicines, can help reduce that vulnerability by enabling stockpiling without continuous refrigeration, strengthening preparedness during cyber incidents, natural disasters and war zones,” he added.

For example: The technology could extend the shelf life and storage flexibility of products like anthrax vaccines, which are stockpiled for biological defense. It would also make transporting medicines and vaccines easier in crisis situations, such as natural disasters or war zones.

DRUG PRICING

HOW MUCH TO PAY: Health payers and patient groups are calling for the adoption of a new EU-funded tool to maintain affordability of innovative medicines amid significant pricing pressure from the U.S. — but its survival hinges on industry and countries’ interest.

What’s this? Researcher have developed an open-source digital tool dubbed ‘ASCERTAIN, ’ aimed at helping payers and pharmaceutical companies during complex pricing and reimbursement discussions. That includes determining how much a new therapy should cost, its added value for patients, and its potential impact on national budgets. It adapts to national circumstances and takes into account clinical outcomes, failure rates, public and private research funding and profit, the researchers from Erasmus University Rotterdam told an event on Wednesday.

Remember: The EU has already pushed for more coordinated uptake between national drug value assessments (via EU Health Technology Assessment). As countries face drug value assessments (via EU Health Technology Assessment). As countries face significant pressure from the U.S. to increase drug prices under its ‘most-favored-nation’ policy, some are pushing for more collaboration on HTA and pricing. The tool is designed to complement existing HTA processes.

Patients say it’s a way out: “We are under huge pressure from industry on prices and access. This is a situation of blackmail,” explained Charlotte Roffiaen, an EU adviser at France Assos Santé. “The only way out is to join forces. And I think it [the model] could be a starting point,” she added.

Industry’s response: Sara Marques, an oncology official from AstraZeneca, said that patients and industry are concerned about the same thing — lack of medicine access resulting from MFN — but argued that “on the other end, we have the pharmaceutical industry that needs an environment that incentivizes the continuation of this innovation cycle.”

Sticking together: Wim van Harten, a member of the Netherlands Cancer Institute said the tool could be useful for the EU to come up with a more uniform response to MFN, since countries which are most impacted such as France, Germany and Italy are already splitting off in their own directions. “Otherwise, we will be played with,” van Harten warned.

But: Three health payer officials, granted anonymity to speak freely, told Morning Health Care that the tool is a step in the right direction, but could fail to land without further EU financial support.

Some ways forward: The ASCERTAIN project is looking for future funding through the EU’s research budget, Horizon Europe, said Carin Uyl-de Groot, the tool’s lead researcher. “We would like to reach out to other countries and companies as well,” to adapt it to different use cases, she added.

More MFN moves: Meanwhile, eight ministers will meet today on the sidelines of an EU Competitiveness Council meeting to further discuss a potential MFN response.

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CANCER

LET’S COLLABORATE: The European Cancer Organisation (ECO) is calling for a dedicated institute to bring cancer research and investment under one roof. In a new report out today, the organization argues that a dedicated European Cancer Institute would help counter fragmentation and uncertain funding arrangements, strengthening and complementing countries’ policies. “The problem is not a lack of ambition. It is a lack of coordination,” it said.“Across Europe, promising cancer initiatives often operate separately, depend on short-term funding and struggle to turn research breakthroughs into better care.”

The proposal: The institute would operate at an EU level as a decentralized agency, similar to how the European Centre for Disease Prevention and Control operates, and coordinate existing cancer initiatives. It would also invest in and maintain shared infrastructure and be able to direct funding towards initiatives with measurable results.

Why now? While the idea isn’t new, it was important in the context of ongoing negotiations of the EU’s next long term budget, the report says, as there’s uncertainty about the future of health policies.

EBOLA

DEADLY EBOLA OUTBREAK TRAVELS WEST: The outbreak in the Democratic Republic of Congo is continuing to spread, with Nigeria reporting its first case while those in Kenya climb to nine. Read more about the latest cases here.

Emergency meetings: “Ebola is now affecting three regions of Africa,” said Jean Kaseya, director-general of Africa Centres for Disease Control and Prevention, on Wednesday. “The situation demands urgent action and political leadership at the highest level.” He said he invited African Ministers of Health to an extraordinary virtual meeting on Oct. 28 to “strengthen our collective response.”

WHAT WE’RE READING

Australian biotechnology company CSL has appointed Deborah Waterhouse, president of GSK Global Health, as its next chief executive and managing director, Reuters reports.

Global health might be seeing a new era of philanthropy, driven by A.I. companies, write The New York Times.