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Euractiv
6 days ago
- Health
- Euractiv
Last-resort antibiotic excluded from Belgian system, testing EU pharma reforms
A critical antibiotic designed to treat infections caused by multidrug-resistant bacteria will remain unavailable through Belgium's reimbursement system after negotiations between the government and the manufacturer failed. The problem goes far beyond Belgium. The inability to secure access to cefiderocol reflects a broader European market failure in valuing and funding last-resort antibiotics. 'The fight against antimicrobial resistance (AMR) is a spearhead of your policy and was a priority during the recent Belgian EU presidency,' MP Irina De Knop (Open VLD) told Health Minister Frank Vandenbroucke in the Belgian Parliament on 15 July, addressing the issue. 'The challenge lies not only in preventing resistance but also in ensuring access to scarce, new antibiotics that serve as last-resort treatments.' First-in-class antibiotic Cefiderocol is not a generic antibiotic. It is a first-in-class, patented siderophore cephalosporin developed by Shionogi, approved in the EU in 2020 under the name Fetcroja®. Specifically engineered to treat carbapenem-resistant Gram-negative bacteria such as Acinetobacter baumannii and Pseudomonas aeruginosa , it penetrates bacterial defences by hijacking iron uptake pathways. Its novel mechanism and limited target population make it difficult to assess using traditional volume-based pricing and reimbursement models designed for high-volume generics. Cefiderocol targets 'superbugs' identified by the World Health Organisation (WHO) as priority pathogens and is intended for an estimated 200 patients per year in Belgium, typically those with no remaining treatment options. 'Precisely because of this limited target group, it is hardly commercially viable,' said De Knop. 'The societal value of reserve antibiotics lies not in frequent use, but in their availability. This leads to a 'broken market' that threatens innovation and sustainable access.' Cost and safety criteria Minister Vandenbroucke confirmed that Belgium's reimbursement process for cefiderocol ended without a deal. 'We went far to reach an agreement, especially for those 55 patients,' he said. 'But apparently, even with far-reaching proposals, we could not meet the company's demands. The requested price is more than double that of the most expensive reimbursed late-line antibiotic.' Citing limited clinical evidence and safety concerns from one comparative trial, the minister explained that the antibiotic is classified as a true last-line option and must be kept outside the hospital's regular reimbursement system due to its high cost. 'In the absence of strict prescription controls, there's a risk it would be used too broadly, potentially accelerating resistance to this last-resort treatment,' he warned. While Belgium is monitoring EU-level initiatives, including push and pull incentives and alternative financing mechanisms, the minister acknowledged: 'There are currently no concrete plans to introduce a subscription financing model like in the United Kingdom.' Company calls for pan-European rethink The product's manufacturer, Shionogi, told Euractiv that Belgium's decision reflects a systemic issue across Europe. 'Reserve antibiotics play a vital role in treating infections caused by multidrug-resistant (MDR) pathogens, often when no other options remain,' the company said. 'Although used in very small patient populations, these antibiotics offer immense public health value, yet current reimbursement systems are not designed for low-volume, high-importance medicines.' The company cited remarks made by Minister Vandenbroucke during an AMR conference held under the Belgian Presidency of the Council in June 2024: 'Look at antibiotics: they should not be used too much. However, some of them have to be ready as soon as you need them. For that, you need a different kind of financing, almost like a subscription to a streaming service.' 'These initiatives, including the 'streaming service' model referenced by Minister Vandenbroucke, are aligned with G7 health priorities and show how sustainable innovation and access can go hand in hand,' the company said. Shionogi confirmed participation in delinked funding pilots: 'Yes. Shionogi is actively participating in the UK's NHS AMR Subscription Model, which pays for antibiotics based on their value to the health system, not the volume used. We were also involved in Sweden's national pilot and are engaged in discussions with HERA on similar approaches.' 'We recognise that European countries have unique needs. In Belgium, as across Europe, we're always open to solutions that deliver timely access for patients, reward responsible use, and make continued innovation in antibiotics possible,' the company's CEO Huw Tippett told Euractiv. A test case for the EU's Pharmaceutical Package Despite Belgium's efforts to strike a deal, MP De Knop warned that the lack of reimbursement leaves patients at risk. 'The result remains that this antibiotic, which is particularly important for a small group of people, is currently not reimbursed,' she said. 'You also did not present an immediate solution,' pointing to the minister. Belgium plans to introduce 'early and fast access' procedures by 2026, but currently lacks a dedicated funding stream for reserve antimicrobials. With no viable market and limited public procurement tools, cefiderocol has become a test case for Europe's broader pharmaceutical policy agenda. Antibiotic incentives are central to the EU's Pharmaceutical Package, currently under negotiation. The European Commission has proposed transferable exclusivity vouchers and pull incentives to stimulate antimicrobial innovation, though these remain politically contentious. Under the Belgian Council Presidency in June 2024, EU health ministers adopted Council conclusions calling on the European Commission and Member States to 'explore alternative reimbursement models, such as subscription-based schemes,' and to strengthen 'EU-level coordination to ensure sustainable access to critical antimicrobials.' These conclusions were part of the strategy paper 'The Future of the European Health Union: a Europe that cares, prepares and protects.' While often associated with generic shortages, the proposed Critical Medicines Act also introduces tools such as joint procurement, strategic stockpiling, and EU-wide demand coordination, all of which could be applicable to patented, last-resort antibiotics like cefiderocol. [Edited by Vasiliki Angouridi]
Euractiv
22-07-2025
- Health
- Euractiv
Belgian reform package targets excessive medical fees
Belgium's federal government has unveiled a socio-economic reform package after an all-night negotiating session among senior ministers. Among the agreement's most debated components is the proposed reform of the healthcare system. The so-called 'summer agreement', reached at 4 a.m. on 21st July - Belgium's National Day - marks a pivotal moment in Belgium's political trajectory, touching pensions, taxation, the labour market and healthcare. "What we have done in six months has not been seen in terms of reform impact in this century," Prime Minister Bart De Wever said. A key objective of the proposed healthcare system reform, led by Minister of Health Frank Vandenbroucke (Vooruit), is to make healthcare more affordable and transparent. Part of this involves limiting fee surcharges, the additional amounts some doctors charge patients above statutory tariffs. Shocked by the bill In a statement published on the social media platform Facebook, Vandenbroucke argued that "if you are ill, you should be taken care of, without being shocked by the bill afterwards simply because of the hospital you ended up in. We are removing excesses. This makes your bill fairer and more transparent. The right care should not depend on your wallet." According to an overview published by coalition partner Vooruit, the government is determined to rein in what it calls "excessive and unnecessary" fee surcharges. While most doctors do not charge extra fees, a minority continue to bill patients above the statutory tariffs, both in and outside of hospitals, leading to sharply unequal treatment and unpredictable medical bills. In some hospitals, patients may be charged over €2,000 in additional fees for procedures such as childbirth, while in others, no surcharges apply at all. "That's simply unfair," the party states. "And who ends up paying the price? Ordinary people." Vooruit party leader Conner Rousseau framed the reforms as a necessary intervention to preserve the sustainability of the system. "We are reforming healthcare to keep it affordable and to improve it for the future. Excessive and unnecessary surcharges that some specialists charge must be eliminated. Because if you need care tomorrow, you should still be able to get it," Rousseau said in a party communication following the agreement. The agreement confirms that limits on additional fees will apply across all medical sectors and disciplines. A negotiation period has now begun with representatives of the medical profession to set concrete ceilings on how much doctors can charge above the official rates. According to Vooruit, this moment represents a "historic turning point." If no consensus is reached, the government has reserved the right to impose limits. The agreement on surcharges follows a tense negotiation period that led to the first doctors' strike in decades. Balancing access and autonomy The reform package reflects a political compromise after weeks of mounting pressure from healthcare professionals. While Vooruit pushed to eliminate excessive billing practices, the New Flemish Alliance (N-VA) insisted that reforms be embedded in a broader structural agenda. "For N-VA, two principles were non-negotiable: high-quality care for patients and respect for caregivers," said MPs Frieda Gijbels and Kathleen Depoorter in a joint statement. "That's why we fought for a workable compromise that upholds both quality and professional independence." The agreement enshrines a coordinated approach to healthcare reform, covering not only fee supplements but also hospital financing and medical tariffs (the nomenclature). A revised framework law will be drawn up with a clear timeline to synchronise all three elements. Gijbels, a practising periodontist, said: "From the very beginning, we advocated for an integrated reform. The sector itself called for reforms to be considered together, and we ensured the voice of doctors was heard, even directly to the minister. These changes must never become a blank cheque." Depoorter added: "We're pleased that the final law leaves room for dialogue, entrepreneurship, and safeguards the liberal profession. Reforms must benefit both the patient and the care provider." As part of the broader package, the agreement also scraps the so-called 25% rule, ensuring patients receive equal reimbursement whether they visit a contractual or non-contractual provider. The option of partial contract remains, while mutual health insurers will take on increased responsibility for budget management, rising to €100 million annually by 2029. Curbing pharma overspending To rein in the projected 25% growth in pharmaceutical spending, the government will introduce a flat €2 co-payment for certain overprescribed drugs like statins and antacids, while promoting more selective prescribing and stricter fraud controls. The pharmaceutical industry is expected to contribute half of the required savings, which will be reinvested in underfunded areas such as mental health, dental care, staffing and innovative treatments. [Edited by Vasiliki Angouridi, Brian Maguire]
Telegraph
21-06-2025
- Health
- Telegraph
‘Super sperm donors' could be stopped by EU over ethical concerns
'Super sperm donors' who father hundreds of children could be stopped by the EU over ethical concerns, amid calls for international limits to curb cross-border donations. Six EU countries called for the cap, with some suggesting a bloc-wide register of sperm donors at a meeting of health ministers in Luxembourg. The boom in donor-assisted reproduction is driven by falling fertility rates and increasing demand by single-sex couples and single women. It has increased the risk of accidental incest, the spread of hereditary diseases, and psychological damage to people when they realise how many half-siblings they have. While many countries have national limits on sperm and egg donations from a single donor, there is no cross-border cap, which means the limits can be dodged by donating abroad. Some commercial sperm and egg banks have voluntary limits, while others in Europe have no restrictions at all. Attention has been drawn to the issue by a number of high-profile cases, such as Pavel Durov, Telegram founder, who said he had fathered more than 100 children in 12 counties. 'We badly need a Europe-wide quota supported by an EU register to ensure proper implementation,' said Frank Vandenbroucke, Belgian health minister. 'It is unacceptable that children or parents have to discover through genetic testing that they could have 70 or more half-siblings across Europe or even globally. That is unethical and a risk factor.' Last year, a Dutch court banned Jonathan Jacob Meijer from donating any more sperm. He fathered at least 550 children in the Netherlands and other countries, in a case that inspired a Netflix documentary. Another Dutch donor whose sperm carried a rare cancer-related genetic variant fathered at least 52 children, some of whom were later diagnosed with cancer. Donor-conceived individuals can discover they have more than 100 half-siblings. Swedish, Danish, Finnish and Norwegian ethical boards warned of the psychological effects that can have. 'There is a distinction between having half-siblings across six families versus 75, or having 12 versus 100 offspring seeking contact over the course of a donor's lifetime,' they said in a joint statement. Donor anonymity rules also vary from EU member state to member state. Some allow children to know the donor's identity from a certain age, while others allow the donor to choose to be anonymous. No legal limit in UK Belgium wants the European central donor register and anonymity to be removed so children can find their fathers. Sweden and Belgium raised the idea of the cross-border cap at a meeting of EU health ministers on Friday. France, the Netherlands, Hungary and Spain back the plan. In the UK, one person's sperm donation can be used in a maximum of 10 families but there is no legal limit on the number of children that can be conceived within those 10 families. Before April 1 2005, sperm donors were automatically anonymous but could choose to remove anonymity. Children can request information about their donor at the age of 18 if donations were made after that date. The data includes the full name, date of birth and last-known address. Donors cannot be anonymous but they choose to share additional information such as a goodwill message. Any EU law on sperm donation must first be proposed by the European Commission but regulating donation limits is mainly a national power. Supporters of the cap have suggested updating the EU regulation on substances of human origin but that legislation was only reviewed last year. Brussels is more likely to try and raise awareness of the issue, and plans a meeting of national authorities to discuss the problem.
CTV News
30-05-2025
- Health
- CTV News
Belgium says 52 babies born from sperm donor with cancer-linked gene
A sperm is shown as it fertilizes an egg, leading to reproduction in the human body. (Sashkin/ Brussels, Belgium — A Danish sperm donor with a potentially cancer-causing gene fathered 52 children in Belgium between 2008 and 2017, the country's health ministry revealed Friday, in a case potentially involving several other children across Europe. According to a recent investigation by The Guardian, at least 10 cases of cancer have been identified among the 67 children born from his donations between 2008 and 2017. The man was reportedly in good health with no known family history of cancer, and had been tested in line with regulations in place at the time of the donations. But he was later found to carry a mutation of the TP53 gene that causes Li-Fraumeni syndrome (LFS), a rare hereditary disorder that significantly increases cancer risks, including for breast cancer or leukaemia. An alert was issued in 2023 after cancers were identified in some children conceived from his donations at a clinic in Denmark, and Belgium's Federal Agency for Medicines and Health Products was notified that year. But Health Minister Frank Vandenbroucke has said he learned about the case on Monday, and the government has declined to say how many Belgian cases involve confirmed cancer diagnoses. The scandal has exposed apparent breaches of Belgian law, which since 2007 has limited a single donor's sperm to no more than six women. 'That rule was exceeded nationally and within individual centres,' the health ministry said. An internal review has identified 37 affected families in Belgium, leading to 52 births. Authorities noted that not all children necessarily reside in Belgium. The donor's sperm was also reportedly used in at least nine other countries - Bulgaria, Cyprus, Germany, Spain, Hungary, Ireland, Greece, the Netherlands and Poland.
Straits Times
30-05-2025
- Health
- Straits Times
Belgium says 52 babies born from sperm donor with cancer-linked gene
At least 10 cases of cancer have reportedly been identified among the 67 children born from a Danish man's sperm donations between 2008 and 2017. PHOTO: ISTOCKPHOTO BRUSSELS - A Danish sperm donor with a potentially cancer-causing gene fathered 52 children in Belgium between 2008 and 2017, the country's health ministry revealed on May 30, in a case potentially involving several other children across Europe. According to a recent investigation by The Guardian, at least 10 cases of cancer have been identified among the 67 children born from his donations between 2008 and 2017. The man was reportedly in good health with no known family history of cancer, and had been tested in line with regulations in place at the time of the donations. But he was later found to carry a mutation of the TP53 gene that causes Li-Fraumeni syndrome (LFS), a rare hereditary disorder that significantly increases cancer risks, including for breast cancer or leukaemia. An alert was issued in 2023 after cancers were identified in some children conceived from his donations at a clinic in Denmark, and Belgium's Federal Agency for Medicines and Health Products was notified that year. But Health Minister Frank Vandenbroucke has said he learned about the case on May 26, and the government has declined to say how many Belgian cases involve confirmed cancer diagnoses. The scandal has exposed apparent breaches of Belgian law, which since 2007 has limited a single donor's sperm to no more than six women. 'That rule was exceeded nationally and within individual centres,' the health ministry said. An internal review has identified 37 affected families in Belgium, leading to 52 births. Authorities noted that not all children necessarily reside in Belgium. The donor's sperm was also reportedly used in at least nine other countries – Bulgaria, Cyprus, Germany, Spain, Hungary, Ireland, Greece, the Netherlands and Poland. AFP Join ST's Telegram channel and get the latest breaking news delivered to you.
