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As 2023 drew to a close, the pharmaceutical sector in Slovakia saw a notably busy period due to a looming deadline for the conclusion of Managed Entry Agreements (MEAs). 

All medicinal products previously subject to conditional reimbursement were required to undergo resubmission, culminating in the conclusion of MEAs with the Ministry of Health by the 31st of December. Failure to comply would not only result in the delisting of these products, but also controversially, necessitate that Marketing Authorisation Holders (MAHs) bear the cost of treatment until patients could transition to a comparable therapy, although for a period no longer than 24 months.

The deadline for finalising these MEAs proved to be a formidable challenge. During the course of the year, the Ministry of Health was overwhelmed not only with resubmissions but also concurrent negotiations stemming from new pricing and reimbursement applications that mandated MEAs.

As a result of the unwavering efforts of the market access teams from pharmaceutical companies, and the dedication of the hardworking, albeit thinly-stretched, team at the Ministry of Health, the situation was effectively resolved. The majority of negotiations and agreements were successfully concluded just before the festive Christmas period.

Consequently, patients in Slovakia will continue to have access to a variety of innovative treatments, with the prospect of new ones being introduced in the near future.

24 January 2024

Life Sciences Bulletin: The managed entry agreements race in Slovakia

As 2023 drew to a close, the pharmaceutical sector in Slovakia saw a notably busy period due to a looming deadline for the conclusion of Managed Entry Agreements (MEAs).  All medicinal products previously subject to conditional reimbursement were required to undergo resubmission, culminating in the conclusion of MEAs with the Ministry of Health by the […]...

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19 January 2024

Office Talk – ESG, things are getting serious

The Green Deal as the new growth strategy of the European Union aiming to transform the Union into a resource-efficient and competitive economy with no net emissions of greenhouse gases (GHG) by 2050 has already started. As of 2024 the Corporate Sustainability Directive (CSDR) becomes applicable for large companies and listed SMEs as well as […]...

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ESG
18 January 2024

Employment Brief:  New rules on platform work in Croatia

Changes to the Croatian Labor Act, governing work for digital platforms, took effect on January 1, 2024. Croatia opted to regulate platform work before the formal adoption of the EU Platform Work Directive. What are the main novelties? Work organization Digital working platforms (e.g., companies offering services through mobile apps for transport or food delivery) […]...

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18 January 2024

Sozialversicherung und Steuer bei grenzüberschreitender Telearbeit

In dieser Folge spricht Anna Schwamberger mit Karin Spindler-Simader aus unserem Steuerrechtsteam über die neusten Änderungen hinsichtlich der Harmonisierung der Sozialversicherung auf EU-Ebene im Zusammenhang mit grenzüberschreitender Telearbeit und die steuerrechtlichen Fragestellungen, die sich daraus ergeben. Haben Sie Fragen zu dieser Episode oder generell zu unserem Arbeitsrecht-Podcast? Wir laden Sie herzlich ein, uns unter arbeitsrecht@wolftheiss.com zu kontaktieren. […]...

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17 January 2024

Future of construction: Digitalization, artificial intelligence and digital twins in focus

The construction industry is experiencing rapid transformation through the integration of digitalization, artificial intelligence and digital twins. These technologies play a crucial role in optimizing construction processes, increasing efficiency and ensuring the highest quality standards. This event, presented by Black Manta Capital, PropX and Wolf Theiss, promises insightful insights into current developments and challenges in […]...

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16 January 2024

Changes to Hungarian employment law in 2024

This article is available in both English and Hungarian. This year several employment law rules of practical relevance will change in Hungary. These changes will have different entry into force dates, and are all briefly summarised below. Child and parental leave allocation As of 1 January 2024, the conditions for granting child and parental leave […]...

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15 January 2024

Our Events & Webinars

Wolf Theiss offers a variety of in-person events and webinars, most of them free of charge. You are looking to expand your knowledge, network with peers, or stay up-to-date with legal developments in your field? Learn more about upcoming and recent events below. Our online and in-person events feature interactive sessions, engaging discussions, and valuable […]...

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15 January 2024

New opportunities for on-site electricity producers and suppliers in Hungary

*This article is available in both English and Hungarian. In the evolving landscape of the Hungarian energy market, there is a growing emphasis on transitioning to self-sufficiency and on-site energy which helps with substantial costs and energy losses associated with transmission. As a result, there is an increasing interest in the industrial sector and commercial […]...

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11 January 2024

Audit priorities of the Austrian Financial Market Authority for 2024

This article is also available in German below. In December, the FMA traditionally published its focus areas for supervisory audit activities in the new year. The selected focus areas reflect the authority’s broad supervisory spectrum and address the current challenges, in particular geopolitical risks, the economic framework conditions and the opportunities and risks arising from […]...

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11 January 2024

Wolf Theiss advises Symfonia sp. z o.o. on the acquisition of Softeh Plus, one of the first Romanian ERP companies

Bucharest, 11 January 2024 – Wolf Theiss acted as a legal advisor to Symfonia sp. z o.o., a portfolio company of MidEuropa Partners and Accel-KKR, in relation to their acquisition of Softeh Plus S.R.L. The deal was closed on 31 December 2023. Wolf Theiss assisted Symfonia in its successful acquisition of Softeh Plus S.R.L., a Romanian company specialized […]...

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10 January 2024

Current Enforcement Environment in Central and Eastern Europe: What to Anticipate in the Reconstruction of Ukraine

Key Takeaways: Overall, the webinar underscored the importance of proactively addressing compliance challenges, understanding regulatory nuances in Central and Eastern Europe, and the reconstruction efforts in Ukraine.The webinar concluded with a Q&A session, providing attendees with an opportunity to further explore the topics discussed and gain practical insights. Feel free to explore the complete webinar […]...

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8 January 2024

20th Capital Markets Forum

The board of the Forum Capital Market Instruments – Capital Market Financing e.V. and Wolf Theiss look forward to welcoming you to Vienna on January 24, 2024. The event focuses primarily on the area of ​​real estate and related issues. Following the event, the forum invites you to a get-together where there is an opportunity […]...

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