EU’s Medicines Authentication System Hits Implementation Problems At National Level
Executive Summary
The EU’s new medicines verification system, which is due to come into operation in February 2019, is experiencing delays, partly as a result of differences in member state approaches to the implementation of safety features on product packs. The European association representing generic and biosimilar firms has warned that any delays in setting up the system could lead to product shortages.
The establishment of a Europe-wide system for verifying the authenticity of medicinal products is being held up by problems at EU member state level, particularly differences in national requirements regarding the new safety features that manufacturers must place on product packs from February next year.
Medicines for Europe, which represents manufacturers of generic and biosimilar medicines and is one of the stakeholders in the system, said that an implementation plan for introducing the safety features had been agreed in 2016. However, member states have interpreted the plan in different ways, which the association said was “highly challenging” and could jeopardize the timely implementation of the system, potentially leading to product shortages.
There have also been issues with the “repositories system” – the linked databases that will store individual product data – although progress in this area seems to have picked up recently.
Under a “delegated regulation” which came into force on Feb. 9, 2016 and which complements the EU Falsified Medicines Directive, the European Medicines Verification System (EMVS) must be up and running by Feb. 9, 2019. From this date, all human-use prescription products, with a few exceptions, will only be allowed on the market if they have a “safety feature” comprising a 2D barcode (the “unique identifier”) allowing their authenticity to be verified, as well as an anti-tampering device. (Also see "EU Pharma Has Three Years To Comply With New Safety Feature Rules" - Pink Sheet, 10 Feb, 2016.)
Products will be “checked in” to the system when they are placed on the market, and “checked out” at the time of dispensing. Identification information from the barcodes will be entered into repositories to be set up by stakeholders via National Medicine Verification Organizations (NMVOs). National Medicine Verification Systems will be able to exchange this information through the EMVS, which will act as a central European “hub.” The EMVS itself is overseen by the European Medicines Verification Organisation (EMVO), an industry consortium comprising R&D and generics companies, parallel traders, pharmacists, and distributors.
“The timely setup of the repositories system is essential to be able to verify the authenticity of medicines as of February 2019” – European Commission
According to the European Commission, the “timely setup of the repositories system is essential to be able to verify the authenticity of medicines as of February 2019.” However, the commission told a meeting of the EU’s Pharmaceutical Committee in October last year that the project was behind schedule and there were “still some issues” with stakeholder integrations.
According to a report on the meeting published earlier this month, the commission noted that the European R&D-based industry federation EFPIA and Medicines for Europe had complained that the implementation plan drawn up by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for introducing safety features on nationally authorized medicine packs was “subject to divergent interpretation” by the different national competent authorities. This was causing issues for marketing authorization holders when introducing the necessary regulatory changes to the product information.
And while 25 NMVOs had been established (out of 31 EU + EEA member states), only 14 IT contracts for the setting up of national repositories had been signed to date, the commission told the most recent meeting of the EU’s Pharmaceutical Committee, in October 2017, the report said.
Implementing The Safety Features
Some progress has since been made on the issues outlined at the October meeting, but there are still problems regarding the safety features at national level, according to Medicines for Europe. “Our members are experiencing issues with the non-aligned regulatory implementation of the introduction of the 2D barcodes on packs in different member states,” for example regarding the requirements for notification and submission to regulators of the “mock-up” of new product packs carrying the bar code, it told the Pink Sheet.
Under the CMDh’s implementation plan, companies need only notify regulators that they intend to implement the safety features on their packs, and this is “regarded as a confirmation that they will be implemented in the legal timeframe.” The CMDh “therefore agreed that the implementation can take place before approval in line with the process for type IA variations, provided that no other changes are made on the mock-ups at the same time and it has no impact on the overall readability of the mock-up,” Medicines for Europe noted.
However, different national competent authorities have interpreted this implementation plan differently. For example, some require approval of the mock-up or just its submission while others do not require any mock-up at all, according to the association.
“The fact that member states have diversely interpreted the CMDh implementation plan is highly challenging and putting timely implementation at risk” – Medicines for Europe
The CMDh has also updated the product information template (the Quality Review of Documents Template) for nationally authorized medicines with the aim of facilitating implementation of the safety features on product packs. However, while “some NCAs request prior approval of the updated QRD template before technical implementation can be done, some don’t,” Medicines for Europe said.
“The fact that member states have diversely interpreted the CMDh implementation plan that was elaborated with the purpose of avoiding fragmented and non-harmonized approaches by NCAs is highly challenging and putting timely implementation at risk,” the generic trade association declared. It said it had been told that it was “difficult for CMDh to enforce the compliance of member states’ competent authorities with the CMDh implementation plan, specifically for products approved via national procedures.”
Medicines for Europe has therefore urged the commission and the HMA (heads of medicines agencies) to take the “necessary steps to assure an aligned regulatory implementation of 2D barcodes on the packs in accordance with the CMDh implementation plan” or risk “potential shortages in certain member states to the detriment of patients.”
Repositories Making Progress
On the positive side, progress has been made with setting up the repositories system over the past few months. “At our level, we have worked very hard to align cooperation between the originator and the generic/biosimilar associations across Europe and we believe we have been successful in achieving that. This is fundamental because companies are paying for the system and therefore hold bigger responsibilities in setting it up,” Medicines for Europe said.
The industry associations involved in the EMVO designed the “blueprint concept,” which offers a "standard" verification system allowing individual countries to join the EMVS without building their own system from scratch. (Also see "Ireland Chooses "Blueprint" System To Link Into Future EU Product Verification Network" - Pink Sheet, 18 Aug, 2016.)
Despite the initial delays noted by the commission last year, Medicines for Europe says implementation of the repositories is getting back on track. “We have noticed that during the ramp-up phase so far, stakeholders are coming together and are in the process of setting up the system. This situation evolves on a daily basis, which means that the European Commission overview of readiness is already outdated.”
A total of 27 NMVOs have now been set up and 16 contracts with system providers have been signed, the association said. If NMVOs follow the blueprint approach “and with the support of EMVO, country readiness is still possible to have a verification system in place in time to meet the 9 February 2019 deadline.”
While the majority of member states have until February 2019 to implement the new rules, Belgium, Italy and Greece – which already have identification systems in place – were given until Feb. 9, 2025 to comply. Belgium has since informed the commission that it will not apply this derogation and will comply by February next year.
Additional Costs Of FMD
Implementing the Falsified Medicines Directive will result in an estimated additional cost per package of generic medicines of between €0.12 and €1.77, according to figures presented at Medicines for Europe's 17th Regulatory and Scientific Affairs Conference, which took place in London last month. (Also see "Brexit, Mutual Recognition, Shortages: First Takes From Medicines For Europe" - Pink Sheet, 25 Jan, 2018.)
From the editors of Scrip Regulatory Affairs.