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The European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.
The European Commission (EC) has finally published a regulation on mandatory safety features for medicines packaging to combat counterfeiting of pharmaceuticals. Publication of the regulation means that a deadline of 9 Feb., 2019 has been set for implementation of European Union (EU) rules on unique identifier barcodes and anti-tamper devices for single-pack medicines, many years after the rules were first suggested. The three-year transition period, however, has already been questioned by information technology (IT) specialists as to whether it will be long enough to allow time for the proper testing of systems for authentication of the unique identification data.
The packaging safety features scheme will be an end-to-end system under which the serialization and other data on each pack will be fed by packaging units into a repositories network so that it can be verified by a pharmacist with a scanner at the dispensing point.
The EC, the Brussels-based EU executive, formally approved the regulation in October 2015, after the European Parliament and the European Council, representing the EU’s 28 member states, delegated it with the task of drawing up detailed rules on the single-pack serialization codes and their verification. The packaging regulation is one part of the 2011 Falsified Medicines Directive (FMD) of the EU, which was based on legislative proposals first made by the EC in 2008. Sections of the FMD, including those covering packaging, were drawn up to strengthen rules first outlined in a 2001 directive on medicines.
The regulation, which mostly applies to prescription medicines, has taken so long to work out after many years of consultation and bring to the stage of implementation because of the complexity of serialization systems. Of the many pieces of EU legislation on medicines, the packaging regulation could turn out to be the one with the biggest impact on the European pharmaceutical sector because of the broad range of groups that it affects.
Medicine manufacturers and packaging contractors, wholesalers and other distributors, and hospital and community pharmacists all have to be linked to a new digitalized supply-chain system based on a network of data repositories containing the serialization and other data on each individual pack. In Germany alone, Europe’s largest pharmaceuticals market, there are approximately 20,000 pharmacists to be connected to the system.
The difficulties of setting up the safety features scheme within three years stem from the necessity to establish it on two levels-one on the manufacturing side and the other within a repositories network.
Implications for manufacturers
The manufacturers or their packaging contractors are having to reorganize and upgrade their packaging lines for the production of packs which, under the regulation, will be required to have a 2D matrix serialization barcode containing a product code, serial and batch numbers, and expiry date. The pack will also have to have an anti-tamper device (ATD), the specifications for which are not laid down by the regulation, except that it should not interfere with the verification process at the dispensing point. In most cases, manufacturers and packaging companies will have to rely on the outside expertise of software and equipment vendors, the most efficient of which already have full order books.
A survey in 2015 by Domino Printing Sciences, Cambridge, England, a specialist in packaging coding systems, found that approximately 35% of companies investing in packaging improvements to comply with the regulation were upgrading 100 or more packaging lines. Another 15% were converting between 50 and 99 lines (1).
Around two-thirds of companies had allocated serialization budgets of more than £2 million (US$3 million). However, 25% had not fixed a budget, while around a quarter were also expecting that preparation for serialization would taken them longer than three years, according to the survey.
“A high number of smaller companies are still not even aware of the regulation so it is likely a lot of them will not make the deadline,” says Craig Stobie, head of Domino’s global life-sciences team. “On the other hand many of the larger and more proactive companies have been preparing for the regulation for some time.”
Creating a repositories network
Parallel with the preparation work being carried out by the manufacturers and their packaging partners is the creation of a repositories network. This network will be run by National Medicines Verification Organizations (NMVOs) in each of the EU’s 28 member states and a central European Medicines Verification Organization (EMVO) with a European Hub connecting all the national systems to ensure their interoperability. The Hub will link the pharmacists authenticating the data on packs with the national schemes.
Under the regulation, authentication is the responsibility of manufacturers, distributors, and pharmacists so the verification organizations are being formed by the stakeholders, with much of the funding being provided by the manufacturers. The NMVOs will be supervised by national medicines authorities.
The EMVO and the Hub has already been set up. Of the EU member states, only Germany has so far established an NMVO, but its authentication system is still in the pilot stage. Most of the rest are well advanced in the process of creating verification organizations so that they should be ready to sign contracts with authentication software providers later this year.
“It will be challenging (setting up NMVOs on time), and for some countries it will be more challenging than others,” says Anci Kvarnstroem, a consultant at PhQConsulting in Sweden. “But they will all be able to meet the deadline. A lot of countries had already started preparing to implement the regulation even before it was finally published.”
Testing the system
“The most challenging task will not be the establishment of the NMVOs but putting in place and testing the actual authentication systems in each country,” she continued. “[These will have to have] secure connections to the European Hub and to all stakeholders that are obliged to verify and decommission the individual packs by the deadline in February 2019.”
There is a growing view among IT experts and groups involved in the creation of the NMVOs that a key issue is the time needed to test new systems. Thus both the manufacturers and packaging companies and the NMVOs will have to allow for a sufficiently long testing period before the deadline of February 2019.
“This is a huge change-management project,” said Graham Smith, commercial director at Aegate, a UK-based authentication services provider. “Before the regulation comes into effect in February 2019, we need to make sure everything works properly. Manufacturers need not only to serialize medicines, but also to test that these codes can be loaded into the database and that the codes can be read by wholesalers and pharmacists. It seems to make sense that once an authentication system is in place there should be sufficient time allowed for testing.”
Some stakeholder groups are aiming to leave as long as 18 months for testing by setting up NMVOs as quickly as possible and appointing authentication service providers to establish verification systems by the end of 2016. In the UK, for example, stakeholders are expecting to have a verification system at least at the pilot stage by mid-2017 so that manufacturers will then be able to start testing their serialization systems on it.
“We believe that the testing period needs to be a lengthy one,” says Rick Greville, responsible for the implementation of FMD legislation at the Association of the British Pharmaceutical Industry (ABPI), representing UK manufacturers. “We are advising manufacturers that they should allow a minimum of six months before the February 2019 deadline for testing,” he says.
Experts have warned that manufacturers need to ensure that all their lines upgraded for serialization are properly tested. “The temptation is to concentrate on testing the better equipped lines while it is the lines held in reserve which will be causing problems,” says Stobie.
Opinion is nonetheless divided about the amount and application of the data provided by the new safety features system. The Brussels-based Medicines for Europe-formerly European Generic and Biosimilar medicines Association (EGA)-is, for example, urging medicines agencies to allow the application of the unique identifier data to be broadened to applications like pharmacovigilance. “The FMD legislation allows national competent authorities to extend the scope of the safety features,” says Maarten Van Baelen, the association’s market access director.
However, others believe that the priority should be ensuring that the serialization system as laid down by the regulation is operating by the February 2019 deadline. “The potential for other data management schemes is very alluring,” says Kvarnstroem. “We must remain focused on the implementation of the serialization system to comply with the regulation. If we start to widen the scope of the project, we won’t be able to get it ready on time.”
1. C. Stobie. “Compliance Waits for No One!,” presentation at Pharmapack conference (Paris, February 2016).
Article DetailsPharmaceutical Technology Europe
Vol. 28, No. 4
Citation: When referring to this article, please cite as S. Milmo, "Europe Moves Forward on Anticounterfeiting Measures," Pharmaceutical Technology Europe 28 (4).