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LIFESCIENCELEADER.COM JULY 2014 37 manufacturing, and distribution of medi- cines. It is designed to include pan-Euro- pean, harmonized safety-and-control measures to stop illegal drugs entering the supply chain. These measures begin with two key safety features — bar codes and tamperproof technologies. Under the directive, all legitimate product packs must include a unique 2D bar code that identifies the pack and that carries the manufacturer code, serialization number, national reimbursement number (if avail- able), batch number, and expiry date. This needs to link with a repository system that stores and validates the bar codes end to end, from manufacturer to the point that the drug is dispensed to patients. The pack also needs to include a tamper- verification feature. The directive also includes responsibili- ties for wholesalers and brokers, written confirmations for APIs manufactured out- side the EU, and logos for legally operating online pharmacies. In April 2014, the EU launched a three- year, approximately $5.3 million project targeted at developing strategies and legal frameworks and raising awareness of fal- sified medicines in developing countries. IMPACTS AND OPPORTUNITIES To comply with the directive, companies need to put a number of processes and protocols in place. They need to buy and install hardware and software that can generate and print unique bar codes or 2D codes. Then they need to be able to scan the codes and store and track the data. And all of this hardware and software will need to integrate with any existing enter- prise resource planning (ERP) software. Packaging designs may need to be rethought because they will have to include space for the bar codes. Furthermore, those bar codes need to be clear enough and contrast well enough against the background for easy scanning. That means companies will need to have quality control in place, and they will need to ensure the codes remain stable and leg- ible in storage throughout the product's lifetime. As Stobie explains, this is the big- gest change in the pharma industry in the last 40 years, and any system is only ever going to be as good as its worst part. Of course, compliance with the directive will come with a price tag. According to Maarten Van Baelen, medical affairs man- ager at the European Generics Association (EGA), he estimated the costs as: printing and serialization — around $331,000 to $397,000 per packaging line antitampering —around $199,000 to $265,000 per packaging line verification with repository systems — around $53 million/year. The EGA believes this will make medi- cines, particularly generics, unaffordable by increasing the production costs. Van Baelen also suggested that the verification system could limit the ability of pharma- cists to dispense medicines. His organiza- tion would like to see an optional applica- tion of the safety features, a waiver for the tamper-verification feature, and a phased- in approach of the implementation. Another area where the Falsified Medicines Directive will have an impact is parallel trade, where traders import drugs from lower-value markets into higher-value markets in the EU (see "An Introduction to Pharmaceutical Parallel Trade in Europe" in Life Science Leader, May 2014). Traders may replace the pack- aging completely, which could involve the loss of the unique codes and damage to the tamperproof seals. To comply with the Falsified Medicines Directive, parallel traders will have to put more of a packag- ing and IT infrastructure in place. "This raises the bar for the parallel traders, as they will also need to invest in data and artwork management," says Stobie. Implementation also will take time. As Stobie warns, "Compliance is likely to take longer and be much harder than people think. As the directive will be enforced in 2018, companies that have not yet begun the process may not have enough time, and it could have a knock-on effect on the drug supply." However, there is a positive side to the process, too. As well as the protection for consumers, there could be advantages for both manufacturers and consumers. The system allows manufacturers to treat each individual pack as a "batch of one," meaning they can access precise real-time data on the production process at every stage. And for consumers, the machine- printed codes could help those with vision, language, or cognition issues. People with a visual impairment or cog- nitive problems could scan the code with a smartphone and hear spoken instructions, the product name and dose, a reminder to take the drug, or instructions to replace the pack because it is near the use-by date. This also could be a way to access instruc- tions on-screen in simplified language or as a translation. "Including information for the patients via the codes could be a way to increase patient engagement and adherence," says Stobie. The Falsified Medicines Directive also could provide opportunities for contract packaging companies. These are amongst some of the earliest adopters of the direc- tive, and many are already seeing the ben- efits of early compliance. HOW WILL THIS AFFECT COUNTRIES OUTSIDE THE EU? Under the terms of the directive, every batch of APIs imported into the EU from outside will have to be accompanied by a written statement issued by the regula- tory authorities that confirms compliance to GMP standards equivalent to those in the EU. Alternatively, the manufacturing country will have to be "whitelisted" by the EU as a country that has GMP inspec- tions equivalent to those in the EU. L C R A I G S T O B I E Global Account Manager, Domino Printing Sciences Compliance is likely to take longer and be much harder than people think. 0 7 1 4 _ R e g u l a t o r y - 1 . i n d d 2 0714_Regulatory-1.indd 2 6 / 2 0 / 2 0 1 4 1 2 : 2 9 : 1 4 P M 6/20/2014 12:29:14 PM