by Peter O'Donnell
BRUSSELS, Feb 9 (APM) - Europe's plan to protect patients against falsified medicines is at risk from multiple delays in putting preparations in place in many member states and among many companies, according to Andreas Walter, the head of the organisation set up to coordinate the supply chain's role.
On the first anniversary of the publication of the key EU legislative text (APMMA 46301), Walter told APM that of the 2,500 drug firms obliged to upload their product data into the new system, only 100 have begun to do so.
With now only two years to go before the legislation enters into force, equally disturbing data are emerging on progress at national level. Only 14 countries have created the required national systems, and only two of them have actually signed contracts with the IT providers necessary to make systems functional, he said.
Walter is executive director of the European Medicines Verification Organisation (EMVO), set up in 2015 by Europe's drugmakers, wholesalers, pharmacists and parallel traders to oversee the Europe-wide organisation and infrastructure of interoperable systems to verify the authenticity of dispensed medicines.
Preparatory work is "behind schedule" in two-thirds of the countries involved (which include Switzerland, Norway, Iceland and Liechtenstein as well as the EU member states).
In four countries there has not even been a start to the necessary technical preparations, according to EMVO's end-January monitoring report.
EMVO's responsibilities including ensuring that all EU manufacturers upload data on their products into the IT system at the heart of the new pan-European verification infrastructure.
"We have a mandate for this," said Walter. "But we know there is a real lack of readiness, and particularly among smaller companies that do not belong to the major trade associations."
Part of the problem, he explained, is that companies need to invest in production line upgrading, to permit the incorporation of the new safety features and individual product identification data on packs.
The costs per product line are between 250,000 and 400,000 euros, with further costs for the data upload.
Many smaller firms encounter difficulties in meeting these costs, and Walter says EMVO is trying to make meeting the obligations as simple as possible.
"But if they are not on board by the deadline, then as from February 10 2019 they cannot sell their products," he pointed out.
EMVO is also responsible for creating the central hub of the IT system, into which the national systems will feed.
"We will meet our own deadline on this," said Walter. "The hub is ready. But not all countries are, so there is a risk that some will not be compliant by the deadline."
In each member state, consortia that bring together the national supply-chain organisations - mirroring EMVO - are responsible for creating the local hubs at the end of the spokes from the central system.
But in some countries the consortia remain incomplete, with pharmacies and wholesalers still not integrated.
He said EMVO is trying to push late-adopter countries to assume their responsibilities, and is now beginning to reach out to national regulatory authorities to urge local organisations to speed up.
The underlying concept of the new EU system is that seamless connections between manufacturers, distributors and pharmacies will permit verification of every pack at the point of dispense - thus protecting patients from any chance of receiving counterfeit or falsified medicines from the legal supply chain.
But Walter recognises that the integrity of the entire system depends on reliability throughout the system. "Any gaps will constitute a risk to patients," he admitted. "If we have holes and countries coming later we will have a problem, so we have to convince them."
The countries that are still notably lagging in their preparations include Cyprus, Denmark, Greece, Italy, Liechtenstein and Malta.
And in some countries, pharmacies are "further back along the adoption curve" in preparing for their verification responsibilities.
Walter is concerned that where preparations fall behind schedule, it will become impossible to catch up in time.
There is a long time-lag in completing many of the processes involved in compliance. Walter cites the example of one medium-sized multinational that has been working for two years to meet the requirements and is still not there.
"It found there was also a gap of months between uploading product data to the hub and getting production of the new packs carrying the data through the system so that they appeared in pharmacies and could therefore be subject to a dispensing check by the pharmacist," he said.
He worries that if everyone leaves their preparations too late, there will be bottlenecks in the final stages. "There are only so many providers that are capable of upgrading a production line," he cautioned.
EMVO processes have been designed to manage surges of activity, but any further delays - and especially a late rush - are a grave concern, he said.
The prospect of Brexit - due to occur in early 2019, only days away from the deadline for the falsified medicines legislation - is another potential problem, but he says this is not an issue right now.
"The UK stakeholders are going ahead and we hope for their system to be incorporated even if the UK is no longer a member state," said Walter, pointing to the example of Switzerland, which is a full member of the EMVO scheme.
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