BRUSSELS, 8 Feb (APM) - The 9 February scheduled start for Europe's new system to protect patients from falsified medicines has slipped into just "a significant milestone" along the way, admitted the European Medicines Verification Organisation (EMVO) at a launch event in Brussels on Friday.
The scale and complexity of the system has defeated efforts by EMVO - the players in Europe's drug supply chain - to have everything ready in time, and although legal liability for non-compliance with the EU's 2011 legislation exists as from Saturday, a stay of execution until at least September is being requested,
"It has been suggested that some national competent authorities will not enforce fines for a specific period of time from February 2019 in order to provide end-users with a grace period", according to an EMVO document seen by APM.
Andreas Walter, the EMVO director, told the launch audience that the system had "a lot of late starters" and would "need time to warm up".
European Commission officials present at the launch declined, however, to offer any view on the feasibility of an extension. "We are in listening mode", said Anna-Eva Ampelas, a head of unit in the health department.
The system will connect around 2,000 pharmaceutical companies, around 6,000 wholesale distribution authorisation holders, 140,000 pharmacies, 5,000 hospital pharmacies and around 2000 dispensing doctors in 28 EEA countries
So far, 1800 companies that are manufacturing authorisation holders are on-board, covering 90% of packs on the market, said Hugh Pullen, the president of EMVO.
Data from 20 EFPIA member companies shows that in December 2018 they had duly modified packs for nearly 85% of their 51,000 product lines, and pack changes were underway for most of the remainder.
Around €1 billion has been invested in the new system - mainly by drug manufacturers - and wholesalers, pharmacists, hospitals and parallel traders are also carrying costs.
A further €100-200 million annually is estimated to be the ongoing costs to maintain the IT infrastructure.
The challenges of bringing the system into operation range from the political to the technical.
At political level, the impending withdrawal of the UK presents perhaps the major uncertainty (APMHE 61760
). But extended transition periods for some member states - and reported delays in engagement by national authorities in others - also leave open questions about the scheme's operation and integrity.
Within EMVO itself, there are still evident tensions over the costs, and about the cost-allocations among manufacturers. Medicines for Europe's executive director, Adrian Van Den Hoven, made public his members' insistence on greater recognition of the problems faced by firms making low-cost products, and Pullen acknowledged that financing was a subject still under review.
At a more technical level, an obvious complication is that non-compliant packs already in the system will still be legally in circulation for up to five years.
The availability of IT service suppliers is a concern in some countries, and pharmacies in hospitals face particular difficulties in organising and financing their engagement because they are frequently obliged to operate through the hospitals' own IT systems.
The management of recalls and alerts is a headache for everyone in the chain, and EMVO admits that it still has to establish an effective alert handling mechanism. Error messages can be triggered by minor inconsistencies between date formats, missing or incorrectly uploaded data, or procedural mistakes at the wholesale or pharmacy level .
There are even a number of packs in circulation manufactured in India that carry codes according to the Indian export serialization requirements using a similar 2D data matrix code, which inevitably generate an error message.
These should not be considered as indicative of a potential falsification until the system is properly stabilised, says EMVO, "in order to avoid unnecessary disruption to the supply chain."
The deluge of data uploads expected to the system from 9 February onwards, when the legal obligation comes in, is also generating anxieties over possibility strains on its capacity.
Pullen said: “EMVO will ensure that the system remains technically stable, secure and that any issues are ironed out without any disruption for patients or the pharmaceutical supply chain."