The independent data storage is the cornerstone of the whole track and trace system as per the Tobacco Products Directive (TPD) Recital 31 and Article 15. It is the only role in the track and trace legislation that requires an “independent” provider, appointed by the tobacco manufacturer. This fact is critical because the existence of a Delegated Act (DA) to govern the key elements of the storage contracts between the manufacturer and the database provider is a perfect illustration that the legislators did not contemplate having “independent” providers for any other facet of the track and trace system. If they had, then there would be draft DAs for contracts with these providers (e.g., ID Issuers, Security Feature Providers, Anti-Tampering Device Providers, etc.).
The legislators, however, did not do this. Therefore, the inescapable conclusion is that the database supplier is the only supplier who needs to be “independent” from the manufacturer under the TPD. To read the legislation any other way would be disingenuous and would result in an unlawful amendment and supplement of the legislation. Of course, this, for now, ignores the fact that such an independence clause may itself violate the Charter of Fundamental Rights for commercial actors to conduct business. To the extent that requiring independence is permissible, it would have been particularly important to enlarge this independence criteria for the management of the new data storage repositories to all of the Commission’s consultants in the process of establishing these implementing and delegated acts.
Another issue raised by the DA is the unrealistic timing of the draft Implementing Act on track and trace Article 15 (IA). Several times, the DA refers back to the IA and the role the primary repository provider must play in implementing the terms of the IA. Therefore, it is important to identify the severe timing problems for the implementation of the IA and the DA in this section.
In particular, assuming the IAs and the DA are approved by December 31, 2017, and that the selection and appointment period for suppliers follows the timeline set out in the IAs and DA, the primary repository providers would only first sign agreements with the secondary repository provider around September 2018 (Draft IA, Annex 1, Part B). Moreover, the secondary repository will only first disclose the specifications for the data exchange to the economic operators (e.g., the primary repositories providers, ID Issuers and all economic operators) in October 2018 (Draft IA, Article 28). These facts mean that none of the economic operators will know what systems and processes they need to acquire, adopt and implement until only a few months before implementation is mandatory in May 2019. This timeline is simply impossible to meet and must be revisited by the Commission.
The cause of this impossible-to-meet timeline is clear, DG SANTE’s consultants did not work closely with the main stakeholders in this legislation – the manufacturers. Whether this was caused by inappropriate lobbying and the interests of commercial actors who have a great desire to secure lucrative contracts with the EU for track and trace, or whether this was based on a false interpretation of the Framework Convention on Tobacco Control, the failure to work closely with the only knowledgeable entities in the supply chain has once again resulted in a wildly inappropriate and unfeasible draft regulation that the Commission must now fix. This delay is certainly not the fault of the thousands of members of the EU-wide tobacco supply chain who should not now be forced to meet this punitive timeline.
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