Saturday, February 8, 2025

Health Technology Authority’s Independence at Risk Due to Political Interference in Slovakia

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Political interference is threatening the independence of Slovakia’s leading health technology institute, the National Institute for Value and Technologies in Healthcare (NIHO). Recently, without formal discussion, the Slovak parliament hurriedly passed an amendment altering the leadership and funding criteria of the institute. As a result, NIHO’s future now hangs in the balance, awaiting a Constitutional Court ruling.

NIHO was established as an independent body tasked with ensuring cost-effective reimbursement prices for medicines and medical devices. The institute evaluates and reviews medicines, assessing their added value, but does not have decision-making power. Instead, it advises the Ministry of Health to ensure efficient spending on effective treatments. However, significant changes are on the horizon for the institute. NIHO director Michal Staňák expressed concerns about the parliamentary decision to Euractiv. MP Zdenko Svoboda, from the coalition party Hlas, introduced an addendum altering the rules governing the institute’s operations. The amendment claims that the current legislation fails to meet the requirements for proper, qualified, and efficient management of NIHO, necessitating a change.

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The primary change concerns the eligibility criteria for the director position, now restricted to medical doctors and pharmacists. This change risks excluding individuals with specialized education or experience in health technology assessment (HTA) structures. “Loss of expertise could be a risk,” Staňák told Euractiv. “Such a forceful change has the potential to damage the good reputation that NIHO has built internationally in recent years. Currently, we are seen as a stable partner in European cooperation, but that perception could change,” he continued.

Political Controversy Surrounds Amendments to Slovak Health Technology Authority

The amendment has faced criticism from opposition parties, particularly regarding the rushed manner in which it was introduced. The Christian Democrats have called on the president to veto the amendment, which they describe as a “last-minute patch.” Despite these appeals, President Peter Pellegrini signed the legislative change, set to take effect on August 1. In response, the Christian Democrats have turned to the Constitutional Court, arguing that the president’s approval of the amendment represents a severe interference in NIHO’s independence by enabling the removal of the director without providing any reason. They claim this violates the constitutional rights of Slovak citizens and have filed a complaint with the Constitutional Court.

Under the old law, the director of NIHO had to undergo a ‘cooling period’ and could not have been employed by a health technology registration holder or a health insurance company with less than 100% state ownership in the previous three years. Additionally, the director was required to hold a second degree in fields such as medicine, pharmacy, public health, natural sciences, mathematics, economics, law, ethics, or social sciences. The new amendment removes the cooling period and imposes stricter education requirements, allowing only doctors and pharmacists to hold the director position.

Staňák, who currently serves as NIHO’s director, does not meet these new requirements and will be unable to apply for the position again, despite his expertise and contributions to establishing NIHO in 2022. Furthermore, the new provision allows the Minister of Health to dismiss the director without providing a reason. The legislative change also poses potential implications for NIHO’s role in the Joint Clinical Assessment and the new HTA Regulation. These assessments provide scientific evidence and information to EU member states during the early stages of medicines’ marketing authorization.

Health Technology

Recent Amendments Threaten NIHO’s Role in European Evaluations and Introduce Potential Conflicts of Interest

Staňák expressed concern that the planned involvement of NIHO in joint European evaluations could be jeopardized by the recent amendments. Additionally, the amendment permits NIHO to receive funding from private companies, which could introduce conflicts of interest. Currently, NIHO is restricted to accepting funding solely from public actors, such as the European Commission for joint evaluation. However, starting August 1, NIHO will be allowed to conduct analyses and evaluations for private pharmaceutical companies as well.

Despite the challenges, NIHO has been instrumental in saving the Slovak health system €110 million last year by negotiating better prices for medicines. NIHO’s evaluations ensure that the prices of medicines and medical devices meet the cost-effectiveness criteria defined by Slovak legislation, providing assessments to the Health Ministry, which then negotiates with pharmaceutical companies.

The recent amendment does not affect the availability of medicines, which remains under the jurisdiction of the Health Ministry. Medicines’ categorization is recommended by the categorization committee and decided by the Minister, as has always been the case. As NIHO’s future remains uncertain, stakeholders are closely watching the Constitutional Court’s ruling. The outcome will determine whether the institute can maintain its independence and continue its crucial role in ensuring cost-effective and efficient healthcare spending in Slovakia.

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Resource: Euractiv, July 15, 2024


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