Political interference risks Slovak health technology authority’s independence [Advocacy Lab Content]

Political interference risks the independence of a leading Slovak health institute. Without formal discussion, the Slovak parliament rushed through an amendment changing leadership and funding criteria – the institute’s future now depends on a Constitutional Court ruling.

The National Institute for Value and Technologies in Healthcare (NIHO) was established as an independent authority to ensure cost-effective reimbursement prices for medicines and medical devices. It reviews medicines and assesses the added value of incoming medicines and therapies. It has no decision-making power but advises the Ministry of Health to ensure money is spent efficiently and on effective treatments.

Now, change is imminent at the Institute.

NIHO director Michal Staňák explained to Euractiv the implications of the parliament’s decision. MP Zdenko Svoboda, from the coalition party Hlas, presented an addendum changing the rules of the Institute’s operations. According to the new amendment, the current legislation does not correspond to the needs of ensuring the proper, qualified, and efficient management of the Institute, and a change is therefore necessary.

Eligibility criteria

The main section changes the eligibility criteria for the director position, which now limits applications to medical doctors and pharmacists and could potentially exclude those with specialised education or experience in health technology assessment (HTA) structures.

“Loss of expertise could be a risk,” NIHO director Michal 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.

The opposition parties criticised the amendment and the method it was introduced, as it was rushed through without any debate or discussion. The Christian Democrats urged the president to use his veto right and not to sign “the last-minute patch.”

President Peter Pellegrini signed the legislative change, which is due to take effect on 1 August.

The Christian Democrats now turn to the Constitutional Court.

“We believe that by signing this amendment, the President has enabled a gross interference in the NIHO’s independence by removing the director without giving any reason. This violates the constitutional rights of Slovak citizens, and we will therefore file a complaint with the Constitutional Court,” the statement read.

New requirements for director

The old law defines that the Institute’s director has to undergo a ‘cooling period’ and could not have been in an employment relationship with a health technology registration holder or with a health insurance company with less than 100% state ownership in the last three years. Additionally, the director should hold a second degree in medicine, pharmacy, public health, natural sciences, mathematics, economics, law, ethics, or social sciences.

The amendment removes the cooling period and introduces stricter education requirements.

Starting 1 August, the director can be a doctor or a pharmacist exclusively because, as the addendum states, medicine and pharmacy are prerequisites for achieving efficient pharmacoeconomic activities and evaluating the cost-effectiveness of medicines.

NIHO mainly evaluates the prices of medicines and medical devices for reimbursement; it does not prescribe them.

Current director Staňák does not fulfil this requirement and will not be able to apply for the new selection procedure despite being an expert in his field, having worked at the Austrian HTA and having played a significant role in establishing the independent Institute in 2022.

The new provision also allows the Minister to dismiss the director without providing a reason. 

NIHO and HTA Regulation

Legislative change can also impact NIHO’s role in the Joint Clinical Assessment and the new HTA Regulation. The common assessment reports will provide scientific evidence and information to member states at the early stages of medicines’ marketing authorisation.

“Prior to the changes proposed by the current coalition, the plan was for NIHO to be an active part of the joint European evaluations. Whether it will happen is questionable at the moment,” said Staňák.

The amendment does not touch upon the availability of medicines as that continues to be decided by the Health Ministry. The medicines’ categorisation is recommended by the categorisation committee and decided by the Minister, as has been the case so far.

“If marketing authorisation holders submit their applications for categorisation without undue delay (compared to more developed EU countries), joint European assessments can shorten the evaluation process. Value for money analyses remain in the hands of member states,” Staňák continued. 

More private influence, funding?

The amendment now allows funding from private companies.

“It is my understanding that the current legislation restricts NIHO to accepting funding solely from public actors to avoid any conflict of interest. For instance, NIHO can currently receive funding from the European Commission for joint evaluation. However, the new amendment will permit NIHO to accept private funding as well. Starting 1 August, NIHO will likely be allowed to conduct analyses and evaluations for private pharmaceutical companies as well,” Staňák concluded.

€110 million saved last year

At the beginning of the process, the pharmaceutical company introduces a drug to the market and sets a certain price. NIHO analyses the medicine, particularly in terms of its benefit to patients, and calculates at what price the medicine meets cost-effectiveness criteria as defined by Slovak legislation.

NIHO provides the assessment to the Health Ministry, which then negotiates with pharmaceutical companies regarding the results, the medicine’s potential categorisation, and the product’s final price. Afterwards, the medicine can be prescribed to patients, but oftentimes at a lower price than the pharmaceutical company’s original proposal.

Because NIHO reviewed pharmaceutical companies’ bids for medicines prices and managed to reduce them significantly, these additional “discounts” saved the Slovak health system €110 million last year alone.

[By Filip Áč, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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