Industry ‘Deeply Concerned’ Over Slow Progress With EU Drug Authentication System
Executive Summary
Pharmaceutical industry stakeholders are “deeply concerned” about the slow rate of sign-ups to the future European medicines authentication system, according to the industry federation EFPIA. To encourage more companies to connect as early as possible, the joining fee is to increase this month. There are also wider worries about EU member state implementation of the system.
The fee for joining the future European Medicines Verification System is to be raised by 50% again this month in another effort to hurry recalcitrant pharmaceutical companies into connecting to the system, which is due to go live on Feb. 9, 2019. The fee was first increased by 50% in January.
The consortium developing the EMVS, the European Medicines Verification Organization, says it is concerned that not enough companies have registered to connect to the EMVS, and that a bottleneck of applications could develop later on, pushing up connection and support costs as the go-live date approaches. The two fee rises are intended to jolt more companies into signing up as early as possible.
Under the EMVS, manufacturers need to establish a legal entity known as an “on-boarding partner” (OBP) that will be responsible for connecting to the system and uploading the relevant product information. About 2,200 OBPs in total are expected to connect, but as of May 21, only 794 had registered their intention to do so, and only 45 had actually connected, according to the European Federation of Pharmaceutical Industries and Associations, one of the EMVO’s member bodies.
“The EU stakeholder associations such as EFPIA are deeply concerned,” the federation told the Pink Sheet. “We believe that a lot of the OBPs who have yet to start their connection process (the remaining 1,400) are small manufacturers operating only in a small number of markets or even in single national markets.”
The concerns over companies’ hesitation will add to those already expressed about the rate of progress in setting up the national registry systems that will feed into the EMVS, with many countries still said to be behind schedule.
The EMVS is intended to authenticate product packs entering and leaving the European supply chain – mainly prescription drugs but some non-prescription products too. As required under the EU Falsified Medicines Directive (FMD) and a subsequent “delegated regulation,” these packs will have to carry a 2D barcode containing a “unique identifier” (UI) with the product code, a randomized serial number, the batch number, expiry date, and a national reimbursement number where required by member states. A total of 10.5 billion product packs will be affected, according to EMVO.
The UIs will be stored in a European repositories system to be managed by EMVO, with national databases linking to an “EU Hub” – the central element of the EMVS. The UI information will be uploaded by the OBPs.
OBPs act as the legal representative of marketing authorization holders (MAH) – whether original pack manufacturers or parallel traders – and are authorized to sign up to the EMVS on their behalf. An OBP can represent just one MAH or several – for example a company holding manufacturing and/or marketing authorizations in multiple EU countries.
“An important shortage can be noticed with respect to the number of OBPs going through the on-boarding process and getting connected to the EU Hub” – EMVO
EMVO has for some time been urging companies to begin the on-boarding process so as to allow the exchange of information between the OBP and EMVO, but many have been slow to do so. In December last year, EMVO said that “an important shortage can be noticed with respect to the number of OBPs going through the on-boarding process and getting connected to the EU Hub.”
Because of the small number of connections to date, it said, “we will most probably be ending up in a bottleneck situation which will cause [a] significant increase in on-boarding connection and support costs.”
In order to mitigate this risk, EMVO said it had decided to apply “a stepwise rise in the on-boarding fee for late followers” in order to “create a positive dynamic among the industry towards every party’s compliance, on time, and to give the impulse to the companies to start the onboarding to the EU Hub as soon as possible.”
The first 50% increase was applied on Jan. 15, 2018, and affected all OBPs that had not signed a valid EMVO participation agreement by that date. The second 50% increase will take effect from June 15.
The original on-boarding fee for an OPB representing one MAH was €3,000, rising in increments to €20,000 for those acting on behalf of more than 12 MAHs. With the Jan. 15 increase, those fees rose to €4,500 and €30,000 respectively. From June 15 they will increase to €6,750 and €45,000.
Companies therefore have just over a week to get signed up if they want to avoid the second fee hike. EMVO says that if OBPs have uploaded a valid participating agreement signed by their named authorized representative, provided a valid copy of proof, and submitted a filled-in invoicing information form by that date, they will benefit from the current rate.
According to EFPIA, of the 794 OBPs that have registered so far, 668 have signed up and paid the invoice. Some 477 have passed the legitimacy check, and just 45 have reached step six – connection to the system.
More Problems At Member State Level
Company sluggishness is not the only issue facing the new product authentication system. In February this year it was reported that delays were being experienced, partly because of divergences in national approaches to implementing the safety features.
EFPIA and the generics and biosimilars body Medicines for Europe complained that the implementation plan drafted in 2016 was being interpreted differently by the member states, and that only a limited number of IT contracts for the setting up of national repositories had been signed, according to a report of the meeting of the EU’s Pharmaceutical Committee held in October 2017, which was published in February. (Also see "EU’s Medicines Authentication System Hits Implementation Problems At National Level" - Pink Sheet, 1 Feb, 2018.)
The delays were confirmed at the committee's latest meeting in March. “Concerning progress, the overall setting up of the repositories system is currently behind schedule, with approximately half the repositories” being late, the committee’s meeting report said.
Some 27 National Medicines Verification Organisations have been established (out of a total of 31 – the EU plus the three EEA member states), while 21 IT contracts have been signed (67% of the total). The report said that in a number of NMVOs, wholesalers, pharmacies or hospitals had not been integrated into the system, and that “preparedness of hospitals is still a concern.”
It noted that the European Commission had sent letters to European stakeholder associations and member states “encouraging a stepping up of efforts to ensure a timely implementation of the safety features.”
Stakeholders, it said, had “been invited to renew efforts and encourage their members to (1) progress more rapidly in setting up and on-boarding the European/national databases and (2) budget for and acquire the necessary equipment, software and personnel to perform the verification/decommissioning tasks as of February 2019.”
EFPIA believes, though, that the EU and national authorities have a role to play in chivvying recalcitrant firms along. It said it had made “repeated requests to the [European] Commission and Member States to reach out to these companies and make sure that they understand their responsibilities with regards to FMD implementation.”
The Pharmaceutical Committee’s report added that member states “have been reminded of their responsibilities for implementation and enforcement at national level, in particular ensuring that the necessary infrastructure is in place and hospitals have sufficient assistance and resources to perform their tasks as of February 2019.”
From the editors of Scrip Regulatory Affairs.