Harmonization of Albanian Legislation with the European Union Tobacco Regulatory Framework

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The regulation of tobacco products constitutes one of the most integrated policy frameworks within the European Union, combining public health protection, internal market regulation and fiscal harmonization. Candidate countries aspiring to EU membership are required to progressively align their legal and institutional frameworks with the EU tobacco acquis, primarily under Chapter 28 (Consumer and Health Protection) and Chapter 16 (Taxation).

This paper analyses the level of alignment between Albanian legislation and the EU Tobacco Package, focusing on the Tobacco Products Directive (2014/40/EU – TPD), the Excise Directive on tobacco products (2011/64/EU, recast proposal COM(2025) 580 of July 2025), and the WHO Protocol to Eliminate Illicit Trade in Tobacco Products. The study examines the current Albanian legal framework governing tobacco control and tobacco taxation, evaluates the compliance gaps with EU requirements, and assesses the fiscal and regulatory implications of incomplete harmonization.

Using legal analysis, comparative regulatory assessment and fiscal trend evaluation based on national revenue data from 2012–2025 (verified at approximately 226.3 billion ALL total tobacco excise revenues, with 24.9 billion ALL in 2024), the study identifies three structural gaps in the Albanian regulatory framework: the absence of a mixed excise taxation structure, incomplete alignment with the full EU tobacco control acquis (including packaging, labeling, flavor bans, reporting and novel products), and the lack of an integrated tobacco product tracking-and-trace system compatible with EU standards, together with non-accession to the WHO Protocol.

The analysis, cross-verified with the European Commission’s Albania 2025 Report (SWD(2025) 750), Albanian Medium-Term Revenue Strategy 2024–2027, parliamentary post-legislative reviews and Customs data, confirms that without full regulatory harmonization Albania risks ongoing inefficiencies and foregone revenues from suboptimal taxation and illicit trade dynamics. Conversely, full alignment with EU tobacco legislation (including the planned introduction of a mixed structure post-2026) could increase fiscal revenues by 15–20% in the medium term while strengthening public health protection and market transparency.

The paper concludes by proposing a policy roadmap for legislative transposition, fiscal reform and institutional coordination aimed at accelerating Albania’s alignment with EU tobacco acquis, drawing directly on Albanian government commitments in the Medium-Term Revenue Strategy.

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Description

The regulation of tobacco products represents one of the most comprehensive policy domains within the European Union, integrating public health objectives with fiscal policy and market regulation. Over the past two decades, the EU has developed a complex legal framework governing tobacco production, packaging, taxation, and distribution in order to reduce tobacco consumption, limit cross-border distortions in tobacco markets and ensure stable public revenues from tobacco excise duties.

For candidate countries seeking EU membership, the alignment of national legislation with the EU tobacco acquis constitutes a crucial step within the accession process. The relevant provisions are primarily embedded within two negotiation chapters: Chapter 28 (Consumer and Health Protection) and Chapter 16 (Taxation). Compliance with these provisions requires the transposition of the Tobacco Products Directive, the alignment of excise taxation structures with EU requirements, and the adoption of enforcement mechanisms addressing illicit tobacco trade.

Albania has undertaken several reforms in this area over the past decade, including amendments to tobacco control legislation (Law No. 9636/2006) and gradual increases in tobacco excise duties under Law No. 61/2012. Nevertheless, progress toward full harmonization with EU legislation remains partial and fragmented. The European Commission’s 2025 Progress Report (SWD(2025) 750) states explicitly in Chapter 28: “On tobacco control, Albania still needs to accede to the World Health Organisation’s framework Convention Protocol to eliminate the illicit trade in tobacco products, and to further align with the rest of the EU tobacco control acquis (See also Chapter 16 – Taxation).” In Chapter 16, Albania is moderately prepared, with ongoing alignment on EU excise minima through scheduled increases from 2025 to 2033, but “Albania still needs to move to a mixed excise duty structure (ad valorem and specific) for cigarettes.” No progress was registered on full TPD alignment or Protocol accession.

This study provides a comprehensive assessment of Albania’s current legal and fiscal framework governing tobacco products, evaluating its level of compatibility with EU legislation and identifying the structural reforms required to achieve full alignment. Data are drawn exclusively from 2024–2026 official sources, including Albanian government strategies and parliamentary reviews.

The paper addresses three main research questions:

  1. To what extent does the Albanian legal framework align with EU tobacco legislation?
  2. What are the fiscal and regulatory implications of incomplete harmonization?

What policy measures are required to ensure effective alignment with EU tobacco acquis?

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