Zentiva Group a.s.
Zentiva
Zentiva is a pharmaceutical company committed to ensuring the availability of high-quality and affordable medicines for patients around the EU.
ID: 888725551808-41
Lobbying Activity
Meeting with Maroš Šefčovič (Commissioner) and
28 Oct 2025 · Priorities of the EU’s trade agenda
Meeting with Jana Nagyová (Member of the European Parliament)
24 Sept 2025 · Urban Wastewater Treatment Directive
Response to Critical Medicines Act
4 Jul 2025
Zentiva is a major European manufacturer of affordable, high-quality medicines, with EU production sites in Prague and Bucharest. We produce around 600 million packs annually and serve 100 million patients across Europe. As a company integrated into EU supply chains, we are directly affected by the Critical Medicines Act (CMA) in both positive and challenging ways. While we welcome measures supporting critical medicine production, the long-term goal must be an economically viable and competitive production environment that attracts investment and secures access for all. We support the CMAs ambition, but reform must not stop with the 276 selected active ingredients. Without a sustainable framework for the off-patent industry - which supplies 70% of dispensed medicines and 9 out of 10 critical ones - we risk failing both the CMAs objectives and the people who rely on these medicines every day. Narrow focus can divert resources from essential medicines that may become critical tomorrow. The biggest barrier to the CMAs success is the insufficient EU State Aid framework. Without urgent revision of state aid rules - such as General Block Exemption Regulation (GBER) - many manufacturers (as big companies), particularly in developed regions, cannot access support. This limits their ability to compete for funding in decarbonisation, digitalisation, or energy efficiency. Strategic pharmaceutical production must be eligible for these EU funds. Dedicated rules should include simplified procedures, higher aid ceilings, and both CAPEX and OPEX support - regardless of region or company size. On procurement, we support the shift to non-price criteria and inclusion of supply security, environmental, and sustainability factors. These must be enforceable and harmonised across Member States. Predictable volumes, minimum guarantees, multi-winner tenders, and lead times are essential. Award criteria must not default to local production, which could harm competition and fragment the Single Market. Price revision mechanisms should apply to long-term or inflation-sensitive contracts. We talk of a Single Market - we should act accordingly. Stockpiling, as currently structured, remains disruptive. Managed nationally, it limits flexibility, creates waste, and blocks timely responses to shortages. The CMA must enable a coordinated EU approach with centralised, neutral mechanisms. Obligations must be proportionate, transparent, and fairly compensated - including storage, expiry, and logistics. Bulk API stockpiling for key molecules, co-financed by Member States, allows maximum flexibility, reduces environmental harm, and avoids wasteful overstocking. Collaborative procurement must remain voluntary and avoid duplicating national efforts. To work, it needs permanent regulatory flexibilities - like harmonised packaging, e-leaflets, and simplified labelling - to enable cross-border supply and responsiveness. While the CMA is a first step, it cannot stand alone. Other EU laws, such as the revision of the Urban Waste Water Treatment Directive (UWWTD), pose serious risks due to complex and unworkable implementation. Without impact assessments and coherence, such laws could undermine access to affordable medicines. The CMA shows we must rethink the broader regulatory and industrial framework - and move beyond fragmented, siloed policymaking. In conclusion, Zentiva is committed to strengthening Europes pharmaceutical resilience. But ambition must be matched by action. The CMA needs reformed state aid, fair procurement, and coordinated Member State commitment. Get the CMA right - and broaden the approach to ensure a sustainable healthcare system that delivers for all Europeans.
Read full responseResponse to Critical Medicines Act
27 Feb 2025
The European Commissions efforts to reinforce pharmaceutical manufacturing in the EU and strengthen supply chains are a welcome step. However, achieving true resilience requires a well-coordinated approach among EU and national authorities. A lack of alignment between policies, fragmented responsibilities, and insufficient cooperation pose significant risks to the success of these initiatives. A unified and strategic approach is essential to ensure that Europe remains self-sufficient and competitive in pharmaceutical production. Scope of the Future Legislative Act: - The Critical Medicines Act should not be limited to medicines on the EUs critical medicines list but should include all essential medicines. Key Policy Considerations: - A unified EU strategy is needed to support the pharmaceutical industry comprehensively, covering not only SMEs but also large pharmaceutical companies across the entire supply chain. - Financial incentives should support EU-based production (with primary focus on off-patent medicines), ensuring fair pricing mechanisms that reflect the cost of producing medicines in Europe. - State aid rules must be revised to allow fair access to incentives for all pharmaceutical companies, regardless of their size or location in economically strong regions. - Decarbonization efforts should be financially supported or at least rewarded to ensure the pharmaceutical industry can transition towards sustainable production without compromising competitiveness. Competitiveness: - Regulatory burdens on EU pharmaceutical manufacturers should be reduced. - The existence of 27 different national regulations creates inefficiencies; harmonization is needed to enable a truly unified pharmaceutical market. Ensuring Access to Sustainable Healthcare: - The systemic framework should be reviewed to ensure long-term access to sustainable healthcare in Europe, balancing affordability with incentives for manufacturers to maintain and expand production. Race to the Bottom & Sustainable Pricing: - Price pressure is a key driver of production shifts outside Europe (off-patent medicines). The EU must support sustainable pricing and reimbursement policies for key medicines. - The framework must ensure that pricing and reimbursement policies support stable supply chains rather than driving unsustainable cost-cutting measures.
Read full responseMeeting with Věra Jourová (Vice-President) and Svaz průmyslu a dopravy ČR
23 Nov 2023 · Competitiveness, green and digital transition