Italian Medical Device Industry Faces Existential Threat from "Health Payment" Law
Italy’s healthcare system, already struggling with lengthy waiting lists and chronic underfunding, is facing a new crisis. A controversial law, dubbed "health payment," is forcing medical device suppliers to retroactively reimburse a portion of the money provided to regional health authorities between 2015 and 2018. This "loyalty" contribution, enacted by Renzi’s government in 2015 as a concession to the European Union’s spending review, is proving to be a ticking time bomb, potentially crippling the very industry it relies on.
The law, which has thus far flown under the radar, came into sharp focus in October 2022 when companies were suddenly demanded to repay millions. The amount is staggering, with reimbursements for 2022 alone estimated at over €1 billion, a significant blow for a sector already struggling with rising costs and dwindling profits.
Italy’s small to medium-sized enterprises (SMEs), the backbone of the medical device industry, are particularly vulnerable. Vanda Mulliri, commercial director of Sanifarm, a Sardinian company specializing in supplying operating room and endoscopy equipment, voiced her despair:
"If this rule remains in place, we will have to close after almost 50 years and go into debt. We will have to pay more than a million euros, and we have no other option."
Sanifarm is not alone. More than 2,000 companies across Italy are embroiled in legal battles, appealing the retroactive nature of the law and its lack of transparency.
"We received almost a million euros in refunds, but we don’t know the basis of which invoices. Others have been hit much worse. If we had known immediately, we would have acted differently, or we would have closed in 2015," Mulliri added.
Adding insult to injury, companies are left in the dark about their debt. Many expressed bewilderment at the invoices they received, questioning the calculations and demanding clarity from the authorities.
Adding to the sense of chaos, regional authorities respond differently to the law. Some, like Sardinia, have halted payments by law, while others, particularly multinationals, comply readily. Smaller companies, trapped in between legal battles and mounting debts, are desperately hoping for a resolution.
The "health payment" law raises unsettling questions about Italy’s commitment to its healthcare system. While the Patients for an Italian Healthcare System (PUCS) campaign has highlighted the impact of government cuts on access to care and patient safety, this new threat could lead to a domino effect, compromising access to essential medical equipment.
Paradoxically, regions like Tuscany and Emilia Romagna, known for their highly effective and centralized purchasing systems, face the highest reimbursements. These regions prioritize public healthcare and minimize reliance on the private sector. Analysts suggest that this highlights a structural issue within the Italian healthcare system, where decades of underfunding have left public funding insufficient to meet the needs of a nation grappling with an aging population.
Political action to address the crisis is slowly gaining momentum. The PD, in collaboration with lawmakers Stefano Vaccari and Andrea De Maria, have proposed legislation to abolish the "health payment" and increase national health funding.
"The risk is twofold," Vaccari emphasizes. "On the one hand, the introduction of substandard products from other countries into public healthcare. On the other hand, a devastating impact on employment."
The stakes are high. Italy’s medical device industry employs 120,000 people and contributes significantly to the national economy, generating almost 1% of the GDP. But beyond economic ramifications, the potential consequences for healthcare access are dire. If the industry collapses, hospitals risk facing shortages of vital equipment, jeopardizing patient care and threatening the foundation of Italy’s already fragile public health system.
2024-11-30 04:00:00
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## The “Loyalty Tax” Threatens to Dismantle Italy’s Medical Device Industry: An Expert Interview
**World Today News Exclusive**
Italy’s medical device industry, a vital cog in the country’s healthcare system, is facing an unprecedented crisis. The controversial “health payment” law, a vestige of austerity measures imposed in 2015, is forcing suppliers to retroactively reimburse substantial sums to regional health authorities. This ”loyalty” contribution, initially seen as a concession to the european Union’s spending review, is now threatening to dismantle the industry it relies on.
To shed light on the situation’s severity adn its potential consequences, we interviewed **Dr. Marco Rossi, Professor of healthcare Economics at Bocconi University in Milan**, a leading expert in the Italian healthcare system.
**WTN:** Dr. Rossi, the “health payment” law has been criticized for its retroactive nature and potentially crippling impact on the medical device industry. Could you elaborate on the situation?
**Dr. rossi:** Absolutely. This law, colloquially known as the “loyalty tax,” mandates that medical device suppliers reimburse a portion of payments received from regional health authorities between 2015 and 2018. These reimbursements, amounting to over €1 billion for 2022 alone, are hitting an already vulnerable sector grappling with rising production costs and stagnant profits.
**WTN:** Who are the most affected by this law?
**Dr. Rossi:** the impact is felt across the board, but smaller and medium-sized enterprises (SMEs), which constitute the backbone of Italy’s medical device industry, are especially vulnerable. They often lack the financial reserves to absorb such sudden,large-scale financial burdens. Many SMEs have been forced to lay off employees,postpone investments in research and progress,and even consider shutting down operations altogether.
**WTN:** What are the wider implications of this crisis for the Italian healthcare system?
**Dr. Rossi:** This situation presents a grave threat to the already fragile Italian healthcare system. The medical device industry plays a crucial role in providing essential equipment and technologies for diagnosis, treatment, and patient care. Crippling this industry through retroactive payments will inevitably lead to shortages of crucial medical devices, longer waiting times for diagnostic procedures and treatments, and ultimately, compromised patient care.
**WTN:** What are the potential solutions to this crisis?
**Dr. Rossi:** The Italian government urgently needs to reconsider the applicability and feasibility of the “health payment” law.
Firstly, the retroactive nature of the payments must be addressed. It is unjust to burden companies with financial obligations for transactions made years ago.
Secondly, a comprehensive review of the law’s impact on the medical device industry is crucial. The government must ensure that the law does not inadvertently undermine a sector crucial for the functioning of the Italian healthcare system.
Thirdly, dialog and collaboration between the government, industry representatives, and healthcare professionals are essential to find enduring solutions that safeguard the future of the medical device sector and ensure the provision of quality healthcare for all Italians.
**WTN:** Dr. Rossi, thank you for sharing your insights on this critical issue.
The “health payment” law presents a daunting challenge for Italy’s medical device industry and the broader healthcare system. Addressing this crisis requires urgent action from the government, a willingness to compromise, and a commitment to finding solutions that prioritize the well-being of patients and the sustainability of the sector.