Collection of information on tracking and tracing systems Supplementary information for MOP2 provisional agenda item 4.1 Related document: FCTC/MOP/2/6 GENERAL INFORMATION In its first session in October 2018, the Meeting of the Parties decided to establish a Working Group for the development and implementation of tracking and tracing systems in accordance with Article 8, including the global information-sharing focal point (Article 8.1) and unique identification markings for cigarette packets and packages (Article 8.3) to further elaborate on the next steps. The first mandate was for the working group to compile an overview of good practices, employed by Parties willing to participate in the exercise, as regards the implementation of tracking and tracing systems as well as unique identification markings for cigarette packs and packages at the national or regional level The Working Group decided to develop a questionnaire in order to gather information on practices related to the establishment of a tracking and tracing system (national or regional) and the unique identification markings used. It was decided to send the questionnaire both to the Parties to the Protocol as well as to the Parties of the WHO FCTC and to publish the voluntary questionnaire on the website of the WHO FCTC Secretariat. A total of sixteen responses to the questionnaire were received from Parties to the WHO FCTC of which eleven are also Parties to the Protocol. Out of these, one response was received from a regional economic integration organization, representing 18 Parties to the Protocol that have implemented a single regional tracking and tracing system. In consideration of the number of responses received, the present report provides a preliminary overview of the general state of implementation of tracking and tracing systems currently in existence or in development in the jurisdictions of those Parties that participated in the exercise. ESTABLISHMENT OF A TRACKING AND TRACING SYSTEM Eight responses, representing twenty-three Parties and two non-Parties to the Protocol indicated having implemented a tracking and tracing system (‘system’) at the moment of submitting the questionnaire, whereas five responses reported being in the process of implementing a system within the next two Supplementary information years. Most Parties reported requiring or planning to require between two and five years to fully implement a tracking and tracing system. In terms of financing, experiences of Parties vary in that some Parties require the industry to bear the full costs of implementing the tracking and tracing system, while in other instances public resources are used. In at least one case licensing fees have been indicated as the main proposed source of financing for the system. Responsibility for implementation of the tracking and tracing system is in almost all instances distributed between the Ministry of Finance, the Customs authorities and the Ministry of Health. SCOPE OF APPLICATION The scope of application of the reported systems varies, ranging from only cigarettes to include in some instances all tobacco products. Most Parties have reported having planned an extension of the system to include all tobacco products. Most Parties with an established system have also indicated that tobacco products manufactured for export and duty-free tobacco products are covered within the scope of the system. UNIQUE IDENTIFICATION MARKINGS (UIMs) No pattern could be identified in relation to the use of unique identification markings (UIMs) for the purpose of tracking and tracing tobacco products. Some Parties reported having delegated the development of unique identifiers to a specific national entity, while in other cases the contractual partner engaged for the establishment and routine management of the system is responsible. Security features used to protect the integrity of the UIMs include, among others, number serialization, time stamps and QR codes. The validity of the issued UIMs in time ranges from six months to perpetuity. With regards to the visibility of UIMs, most Parties reported the UIMs are or will be made visible to law enforcement authorities from other jurisdictions. Nonetheless, some Parties reported that the system in place would not allow for recognition of the UIMs affixed in other jurisdictions. DATA STORAGE, CONTROL AND AUDIT In most instances Parties reported that data produced via the system is ready for export, but not in all cases ready to be accessed via the Global Information Sharing Focal Point platform. Data retention periods vary and range between two years and perpetuity. Generally, data is accessible for inspection by law enforcement agencies and regulatory bodies via online verification tools and audits. TOBACCO INDUSTRY INTERFERENCE Some Parties have indicated that financial requirements for the implementation of the system are or will be borne directly by the industry. Many Parties have reported having been approached by the tobacco industry during the development phase of the system. Vigilance in relation to interference from the industry remains needed. OTHER ASPECTS Supplementary information A number of challenges have been reported by Parties in the implementation of tracking and tracing systems, including the availability of resources, the lack of recognized standards for the development of the system, requirements for the drafting of tracking and tracing legislation and tobacco industry interference. Parties have also indicated technical areas for which support would be needed to ensure implementation of tracking and tracing systems at domestic level, including system financing, procurement practices, IT requirements and system design, financial and human resources for implementation and interagency cooperation. = = = Supplementary information Annex QUESTIONNAIRE ON TRACKING AND TRACING SYSTEMS Section 1. Introductory questions This section of the questionnaire is intended to contextualize the following sections by providing Parties with a possibility to describe their advancements towards the establishment of the tracking and tracing system. QUESTION COMMENT Introductory questions 1 Please briefly explain the state of play with regard to the establishment of a tracking and tracing system in your jurisdiction Please provide as much detail as possible on the current state of play, any potential steps accomplished so far and any other information you can share 2 If a tracking and system has been established, please provide its launch date Please provide a date 3 If the system has not been established yet, please indicate your best estimate as to its most likely launch date Please provide an approximate date 4 Please indicate whether the (intended/actual) system is national or regional For regional systems, please specify the concerned region. 5 Please indicate what advice you sought in the preparatory phases of establishing your system Please provide as much detail as possible (e.g. initial studies etc.) 6 Please indicate how the system has been/will be adapted to tackle the particularities of the illicit trade market faced in your jurisdiction? Please provide as much context as possible (e.g. no production etc.) 7 If you have an established tracking and tracing system, please indicate whether you foresee review of, or changes to, that system Please provide as much detail as possible (e.g. reasons for change, indicative timelines etc.) 8 If, as a Party to the Convention, you do not yet have a tracking and tracing system could you indicate what information you would require to assist you in your reflections in establishing a tracking and tracing system Please provide as much detail as possible Supplementary information QUESTION COMMENT 9 Please indicate whether you were approached by the tobacco industry, or other vested commercial interests, in relation to the tracking and tracing system Please provide as much detail as possible 1 0 Please indicate how transparency was ensured when consulting with stakeholders Please provide as much detail as possible Section 2. Establishment of a tracking and tracing system Article 8.2 of the Protocol states: Each Party shall establish, in accordance with this Article, a tracking and tracing system, controlled by the Party for all tobacco products that are manufactured in or imported onto its territory taking into account their own national or regional specific needs and available best practice. This section of the questionnaire focuses on the initial phase of establishing a tracking and tracing system, prior to its implementation. The below questions are aimed at collecting information on: (a) any legal act(s) enacted for the purpose of establishing the system; (b) specific needs of countries in establishing the system; (c) timeline for legal and technical implementation. QUESTION Y/ N COMMENT Establishment of the system 1 1 Please provide the legal act(s) establishing the system or describe the intended legislative actions required for providing the system with its legal basis. Please provide a link or electronic copy of the legal act(s) or any announcements relating to the intended legislative actions. 1 2 How long did it take (or do you estimate to take) to establish the system? Please provide as much detail as possible (e.g. the duration of different stages, preparation of legislation, technical-roll out, etc.) 1 2 a As a complement, please give an indication of the makeup of the tobacco market in your jurisdiction. Please provide as much detail as possible (e.g. number of actors, volume of product, distribution models, Supplementary information QUESTION Y/ N COMMENT size of the market etc) 1 3 How is / will the system be financed? Please provide as much detail as possible (e.g. publicly available information as to the systems costs and the (intended) methods of shifting the costs to the industry in line with Article 8.14 of the Protocol ) 1 4 Which authority(ies) is/are/will be responsible for the operation of the system? Please provide as much detail as possible 1 5 Is there a website, or other information that you can share, which authoritatively describes the main features of your system? Please provide a link/pdf etc. as applicable Supplementary information Section 3. Scope of the tracking and tracing system This section of the questionnaire focuses on the type of tobacco products and movements of tobacco products that are covered by tracking and tracing systems. QUESTION Y/ N COMMENT Scope of the system 1 6 What type of tobacco products are captured by the tracking and tracing system? Please provide as much detail as possible (e.g. what tobacco products, timeline etc.) 1 7 Will the scope of the tracking and tracing system be extended to other tobacco products, if not currently covered, and when? Please provide as much detail as possible (e.g. cigarette (incl. 'roll your own', other tobacco products etc.) 1 8 Does / will the tracking and tracing system capture all tobacco product manufacturing in, and tobacco product imports into, your jurisdiction? Please provide as much detail as possible (e.g. any exceptions, such as on products manufactured in your jurisdiction and destined for export) 1 8 a Does / will the tracking and tracing system capture tobacco products for export? Please provide as much detail as possible (e.g. any exceptions) 1 8 b Does / will the tracking and tracing system cover tobacco products destined for duty free sales? Please provide as much detail as possible 1 9 Which parts of the supply chain after manufacturing are / will be captured by the tracking and tracing system? Please provide as much detail as possible (e.g. production, first purchaser, subsequent purchaser, distribution, wholesale, retail, consumer, warehousing and shipping, point of departure etc.). Supplementary information 2 0 Which events within the supply chain trigger the reporting obligations? What is the timeframe for reporting individual events, e.g. product dispatches or arrivals. Please provide as much detail as possible Supplementary information Section 4. Unique identification markings Article 8. 3 states With a view to enabling effective tracking and tracing, each Party shall require that unique, secure and non-removable identification markings (hereafter called unique identification markings), such as codes or stamps, are affixed to or form part of all unit packets and packages and any outside packaging of cigarettes within a period of five years and other tobacco products within a period of ten years of entry into force of this Protocol for that Party. Article 8.4 requires that the following information form part of those unique identification markings (a) date and location of manufacture; (b) manufacturing facility (g) product description (f) intended market of retail sale (where available) This section of the questionnaire focuses on how unique identification markings are generated, applied, encoded and what information they contain. Parties are also asked to submit samples of unique identification markings and their encoding structures. QUESTION Y/N COMMENT Unique identification markings 21 How are / will be the unique identification markings for the tracking and tracing system generated? Please provide as much detail as possible (e.g. codes, stamps, both) 22 How is / will be the uniqueness of the identification markings achieved? Please provide as much detail as possible (e.g. if uniqueness is global and non-specific to the type of product) 23 How is / will be the security of traceability markings achieved? Please provide as much detail as possible 24 What tobacco product packaging are / will be unique identification markings affixed to? Please provide as much detail as possible (e.g. unit packets, cartons, master case, pallet) 25 What information forms / will form part of the unique identification marking? Please provide as much detail as possible with reference to Art 8 (4.1 (a) date and location of manufacture,(b) manufacturing facility, (f) intended market of retail sale and (g) product description) and whether Supplementary information QUESTION Y/N COMMENT additional information is contained within 25 a To what extent is the information forming part of the unique identification marking available to enforcement authorities outside your jurisdiction? Please provide as much detail as possible 25 b Is the unique identification marking visible to enforcement authorities outside your jurisdiction? Please provide as much detail as possible 26 Please explain the encoding structure of the unique identification markings along with an example of current unique identification markings Please provide as much detail as possible (e.g. any limitations on permitted character set(s), length, etc.) 27 Does / will the system recognise unique identification markings from other jurisdictions? Please provide as much detail as possible (e.g. which jurisdictions, unilateral or bilateral recognition) 28 Please explain what data carriers are / will be used to encode the traceability markings Please refer to international standards if applicable, and whether any types of data carriers are specifically prescribed? 29 Please provide an estimate on how many unique identification markings are / will be stored in your system on average, if available Please provide as much detail as possible (e.g. per year) - estimates can be approximated by the size of the market in terms of unit packs you may indicate how many UIMs are generated and applied 30 Please indicate for how long the unique identification markings are valid Please indicate whether the unique identification markings have an expiration date (e.g. the time between generating and applying the uim) Supplementary information Section 5. Control of the system Article 8.2 of the Protocol states: Each Party shall establish, in accordance with this Article, a tracking and tracing system, controlled by the Party for all tobacco products that are manufactured in or imported onto its territory taking into account their own national or regional specific needs and available best practice. This section of the questionnaire focuses on the control mechanisms in place to ensure the system is managed by the national authorities. N o QUESTION Y/ N COMMENT Control measures 3 1 How is / will be the non-removability of unique identification markings achieved? Please provide as much detail as possible 3 2 How is / will be the functioning of the system controlled by your authorities? Please provide as much detail as possible 3 3 Please explain which entities/authorities are / will be responsible for all stages of the traceability process Please provide as much detail as possible 3 4 Does / will the system include any measures to prevent the manufacture of tobacco products without traceability markings? Please provide as much detail as possible 3 5 What rules apply / will apply to the stored tracking and tracing information in terms of access and audit? Please provide as much detail as possible 3 6 Please indicate how the information from the system is used by your authorities for enforcement purposes Please provide as much detail as possible 3 7 Have you introduced any additional measures to secure the UIM? Please provide as much detail as possible 3 8 How is independence from the tobacco industry ensured? Please provide as much detail as possible 3 9 How is it ensured that obligations assigned to each Party in line with Article 8.12 are not performed by or delegated to the tobacco industry? Please provide as much detail as possible Supplementary information Section 6. Information storage and accessibility of information This section of the questionnaire focuses on the information stored by parties under Article 8.5, and the accessibility of that information under Article 8.6. N o QUESTION Y/ N COMMENT System design 4 0 Does the system’s design include a message dictionary or a data dictionary? 4 0 a If yes, please provide the data dictionary(ies) Please provide a link or electronic copy 4 1 Please provide current examples of the format and content of the information required under Article 8.4.1 (a-j) as reported and stored in the system Please provide a link or electronic copy 4 2 Is / will the format and content of information stored in the system ready for exporting via the non-proprietary and open standards of electronic data communication? Please provide as much detail as possible 4 3 How long is / will be tracking and tracing information stored in your tracking and tracing system? Please provide as much detail as possible (e.g. references to retention periods) 4 4 While a Global Information Sharing Focal Point has not yet been established, can you indicate the technical readiness of your system to interlink with a Global Information Sharing Focal Point? Please provide as much detail as possible 4 4 a Do you foresee at this stage any challenges in interlinking your system with a future Global Information Sharing Focal Point? Please provide as much detail as possible Supplementary information Section 7. Additional information (optional) This section of the questionnaire provides Parties an opportunity to complete their answers with further information concerning their efforts in establishing the tracking and tracing system. N o QUESTION COMMENT Additional information 4 5 Are there any particular areas in which you face a lack of expertise? Please name the areas of missing expertise (e.g. IT systems, supply chain management, tobacco control policies, etc.) 4 6 Are there any particular obstacles that you face in establishing the tracking and tracing system? Please explain the nature of obstacles (e.g. technical issues, conflicting legal provisions, etc.) 4 7 What are your needs in terms of technical support in order to advance the establishment of the traceability system? Please explain 4 8 Please explain your expectations in terms of the tracking and tracing system's impact on the fight against the illicit trade of tobacco products Please explain 4 9 Is there any other information / documents that you would like to share with other Parties Please explain
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Collection of information on tracking and tracing systems: supplementary information for MOP2 provisional agenda item 4.1: related document: FCTC/MOP/2/6
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