FMD Delegated Act - the letter of the law or the spirit?

EU medicineA recent article in this publication highlighted a potential log jam in the implication of the Falsified Medicines Directive. The article, authored by Tim Marsh, is a classic case of interpretation and how intent can mean different things to different people.

For those that did not see the piece the crux was this:

'The tamper evident packaging technology can be applied before the deadline of the FMD Delegated Act. However, the Unique Identifier should only be placed once there is an operational repository (EMVS) where the relevant identification data can be uploaded. Retroactive implementation of the Unique Identifier and uploading is not permitted.'

There is no doubting the accuracy of the article, it could not be clearer could it? There is a problem on the horizon. Except that this is not the Commission's intent. This provision has been made to encourage the setting up of an operational repository so as not to impede the work of pharmaceutical manufacturers and the wider supply chain as they progress towards meeting the requirements of the new legislation.

This makes sense as a repository clearly has to be in place and the EU Commission has recognised that this is an area where indirect pressure, or motivation, may need to be applied to speed up decision making.

In addition, the period required for integrating and testing the new authentication system will be extensive and the work intense. With all member states required to comply, the potential for a last minute rush to meet the deadline is real. The Commission understands this and has set this prohibition in to help and not hinder.

Perhaps they have been too subtle and more direct language would have helped understanding. It does not change the fact though that this is a joined up process. For the FMD to work manufacturers must work with others in the process to ensure the deployment of an effective authentication service. They need to use their influence positively to speed up the creation of operational repositories.

So what of the interpretation? The article referenced above rightly states that "manufacturers need a significant amount of time and planning to ensure compliance by the 2019 deadline" but it seems clear to us that the prohibition Issue is intended to motivate action to assist industry rather than hinder their progress. The EU Commission is undoubtedly committed to patient safety and we feel that the Commission has not been given enough credit in the framing of the law and the intended motivations and actions required from those involved in the process of implementing the Falsified Medicines Directive.

This leads us to our point of concern, which is ensuring that National Medicines Verification Organisations (NMVO's) are set up in each country promptly to facilitate the creation of national databases. This would seem to us to be a better use of resources than being worried about a situation which should not arise.

We are all in this together and we stand shoulder to shoulder with Tim Marsh in his advocacy of dialogue between all stakeholders in the process. We are equally delighted that he is using this platform to discuss possible issues with the roll out of the FMD and so perhaps we should summarise our differing interpretation as an instance where we see that as a glass half full and not a glass half empty.

Graham Smith is a director and chief sales officer of Aegate Ltd.

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