The Protocol to Eliminate Illicit Trade in Tobacco Products: Questions and Answers

1. What is the objective of the Protocol and how will this be achieved?

The objective of the Protocol is the elimination of all forms of illicit trade in tobacco products. “Illicit trade” in tobacco products in this context means any practice or conduct related to producing, shipping, receiving, having possession of, distributing, selling or buying tobacco products which is prohibited by law.

In order to prevent this illegal trade, the Protocol aims to secure the supply chain of tobacco products through a series of government measures. It requires the establishment of a global tracking and tracing regime within five years of the Protocol’s entry into force, comprising national and regional tracking and tracing systems and a global information sharing point located within the Secretariat of the WHO Framework Convention on Tobacco Control (WHO FCTC). Other provisions to ensure control of the supply chain include licensing and record-keeping requirements, as well as regulation of Internet-sales, duty-free sales and international transit.

To address the illicit trade, the Protocol establishes offences and addresses liability and seizure payments, as well as the disposal of confiscated products. Other requirements aim to boost international cooperation, with measures on information sharing, technical and law enforcement cooperation, mutual legal and administrative assistance and extradition.

The Protocol’s obligations cover tobacco, tobacco products and manufacturing equipment (that is, machinery to make tobacco products), not all of which are covered by every provision of the Protocol.

2. What is the current status of the Protocol?

As of January 2016, 179 countries plus the European Union have become Parties to the FCTC. Of these 180 Parties, 54 signed the Protocol between 10 January 2013 and 9 January 2014, during which period the Protocol was open for signature. As of January 2016, 13 Parties to the Convention are Parties to the Protocol and many are about to become Parties. The Protocol requires 40 Parties to enter into force.

The WHO FCTC Convention Secretariat will be also the Secretariat to the Protocol once it enters into force, and will be responsible for supporting implementation and servicing the Meeting of the Parties.

3. What actions do countries need to take to become Parties to the Protocol?

Only countries that are Parties to the WHO FCTC can become Parties to the Protocol. The WHO FCTC Secretariat is currently promoting the entry into force of the Protocol, and can assist with further advice. The Secretariat has developed a number of detailed practical guidance documents on the process, which can be found in the Appendices. They are also available on the Secretariat website in the six UN languages.

There are essentially three main elements of the process of becoming a Party, two at the national and one at the international level.

  • National level: Enactment of national legislation and implementation of other administrative and institutional measures required to implement the Protocol.
  • National level: Approval of the Protocol for ratification or accession (usually by parliament or executive authority).
  • International Level: Deposit of the instrument of ratification (acceptance/approval)[1] or accession with the United Nations Treaty Section (usually by the ministry of foreign affairs).

The order in which these elements are completed depends on the constitutional system of the country. There are two main constitutional systems:

System 1

  • National approval of the Protocol
  • Ratification or accession by deposit of the relevant instrument in the Treaty section of the UN.
  • Enactment of national legislation and other measures

System 2

  • Enactment of national legislation and other measures
  • National approval of the Protocol
  • Ratification or accession by deposit of the relevant instrument in the Treaty section in the UN.

The ministry of foreign affairs of each country can advise which system the country adheres to.

3.1. What must be done at the international level?

To become Parties to the Protocol, Parties to the WHO FCTC that signed the Protocol are required to ratify the Protocol according to national requirements.

Parties that did not sign the Protocol may become Parties by means of accession, which has the same legal status as ratification. Appendix A provides details on the process of becoming a Party to the Protocol. Appendix B sets out model instruments of ratification and accession.

This process is determined by international law and is therefore the same for all countries. In most countries, the ministry of foreign affairs is in charge of the international process. Accordingly, the substantive lead ministry for the Protocol may wish to consult the ministry of foreign affairs, and also ensure its close involvement in the national-level process.

3.2. What must be done at the national level?

The relevant national processes are determined by national law, and are therefore different for each country. The lead ministry for the Protocol should liaise with all relevant national authorities on the steps to be followed. This should be done early in the process to avoid procedural confusion and unnecessary delays. In most countries, the multisectoral nature of the Protocol requires the involvement of the national authorities for health, customs, justice, trade, law enforcement and finance. To assist national authorities with this process, the Secretariat has developed a checklist of steps required at the national level, which appears in Appendix C

National approval of the Protocol

Prior to submitting the instrument of ratification (acceptance/approval) or accession, the Protocol must be approved by the competent political authority of the country. In many countries, this is the legislature or an equivalent national authority and/or the executive (head of government and/or head of state).

Enactment of national legislation and other measures

In order for a Party to fulfill its legal obligations under the Protocol, the necessary legislation and other measures must be enacted. Depending on the constitutional system of the country, this is done either before or after national approval of the Protocol and deposit of the instrument of ratification or accession (see above).

To determine the measures required, a gaps analysis between the existing measures, including the legal, regulatory and policy frameworks, and the different provisions of the Protocol is recommended. This allows an action plan for the implementation of the Protocol to be established. The detailed self-assessment checklist developed by the Secretariat, set out in Appendix D, is intended to assist Parties in this respect. A document compiled by WHO, “Steps to eliminate illicit trade factsheet”, can also support this assessment as shown in Appendix E . These two documents may serve as useful tools for Parties in conducting the gap analysis.

It is worth noting that according to the information obtained from Parties’ reports submitted to the Conference of the Parties through the Convention Secretariat on their implementation of the WHO FCTC, many Parties have already instituted some measures to combat illicit trade in accordance with their legal obligations under Article 15 of the WHO FCTC. Therefore, to a certain extent, many Parties to the WHO FCTC may have already taken steps to implement the Protocol.

After the existing measures are considered and gaps are identified, Parties may rely on best practices and examples from other governments on the different approaches to combat the illicit trade.

Several mechanisms and tools are available to assist Parties in the process of enacting and implementing national legislation and other measures. Firstly, the Convention Secretariat, WHO FCTC is in the process of establishing Knowledge Hubs (KHs) in all WHO Regions to generate and share expertise, information and knowledge and provide training, regionally and globally, to strengthen the capacity of Parties to meet their obligations under the WHO FCTC, including the Protocol. The KH based at the University of Cape Town (South Africa) provides assistance to Parties on matters related to the illicit trade, in particular in measuring the magnitude of the illicit market. Parties wishing to receive such assistance may contact the Convention Secretariat at protocolfctc@who.int.

Secondly, as requested by COP 6, a panel of experts on the different aspects of the Protocol is being established by the Convention Secretariat; its members will be available upon request to support the implementation of the Protocol, including governance aspects. Parties interested in receiving such advice may wish to contact the Convention Secretariat at protocolfctc@who.int.

4. What are the possible roles and responsibilities of government agencies in implementing the Protocol?

The Protocol comprises 47 Articles; the substantive key provisions in Part III (Articles 6-13) deal with supply chain control. Click here to read an overview of the Protocol.

Based on the above outline of the key provisions of the Protocol, it becomes clear that fulfilling these obligations requires the involvement of several government agencies. Governing systems may vary widely between Parties. In order to determine the roles and responsibilities of different government agencies, it may be useful to establish a multi-sectoral mechanism, composed of potentially relevant government sectors, to review the existing mandate of each sector and determine the roles and responsibilities under the obligations prescribed in the Protocol. As an alternative to establishing a new mechanism, a practical approach could be to assign this task to the national coordinating mechanism established under Article 5.2(a) of the WHO FCTC. According to the report submitted to the Conference of the Parties, many Parties reported that supply-chain control is a responsibility of the finance, customs and/or trade sectors.

Controlling the supply chain serves to prevent illicit trade. The Protocol also contains provisions regarding unlawful conduct including criminal offences, international cooperation, and finances. Sectors taking a leading roles in these provisions may therefore include foreign affairs, finance, the police or other enforcement authorities.

5. What are the benefits for Parties to the WHO FCTC in becoming a Party to the Protocol?

The illicit trade in tobacco products has become a pervasive problem reaching all corners of the globe. It threatens the health of the population, causing as many as 6 million deaths annually, as well as fostering criminality and reducing tax revenues. Parties to the Protocol enjoy a wide spectrum of benefits extending from the maintenance of national security, to increasing fiscal revenues and most importantly protecting the health of the population, particularly vulnerable groups.[2]

It is well recognized that the prevalence of smoking is price sensitive, making illicit products particularly attractive to lower income and younger segments of the population, who constitute most tobacco-product consumers. Eliminating illicit trade in tobacco products ensures the market is composed of taxed tobacco products subject to health regulations and thus reduces tobacco consumption and smoking prevalence, as lower income and younger people find tobacco more expensive and less attractive. The public health implications are immense, ranging from lowering the rates of chronic diseases to saving considerable funds that would otherwise have been spent on health care, as well as maintaining health equalities.

Moreover, eliminating the illicit trade in tobacco products generates higher revenues from the increase of taxable tobacco products, while upholding and strengthening national tax policies. This fosters improved national security through the eventual destruction of criminal organizations and other criminal activities resulting from the illicit trade, as well as a decline in corruption.

According to the World Customs Organization, the growth in the illicit trade in tobacco remains a worrying worldwide phenomenon and an enduring source of funding for other illicit activities that undermine social order, good governance and the rule of law.[3]


1.Ratification, acceptance and approval are equivalent in substance. The difference is in the legal requirements at the national level. The ministry of foreign affairs can advise on this. For simplicity, the term “ratification” will be used in this document

2.World Health Organization, Illegal Trade of Tobacco Products. What you should know to stop it, World No Tobacco Day 2015, Geneva, 2015.

3.World Customs Organization, The illicit trade report 2013, Brussels, 2014.

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