Concern expressed on pharma’s serialization progress

Last week, provider of versatile serialization and traceability solutions – Adents gathered worldwide professionals and experts, which included the likes of Microsoft and Siemens, to discuss the road ahead for pharma.

Behind schedule in the EU

Johan Verhaeghe, National Policy Liaison Manager at Medicines for Europe provided a sobering update on the industry’s serialization progress.

As part of EU FMD regulation, to handle the serialization data used to verify medicine authenticity, National Medicines Verification Systems (NMVS) need to be implemented by every European country via a National Medicines Verification Organisations (NMVO).  Johan noted that the financial burden of implementing these EMVS is estimated to stand at around 90 mn euros.

Giving a breakdown of the state of play, Johan noted that around 23 countries have entered the implementation phase, with 19 of those countries starting technical implementation.

He added, approximately 50% of the countries seem to be too late for the February 2019 deadline.

Germany is a well-advanced player in this landscape, but experts wanted the final steps of implementation will be challenging.

Marketing Authorization Holder (MAH) contractual on-boarding to the EU hub is far behind schedule.

This state raises concerns that bottlenecks could emerge, which could evolve into reduced access to medicines.

A lot of work needs to happen to prevent threatening the lines that supply EU citizens.

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Europe’s medicine supply

Adents calculates that Europe is fitted with around 1500 drug production sites, these are generating approximately 10,000 lines that need to be equipped. There is less than a year to implement the EU FMD changes, which is a short amount of time considering the volume of lines that need revising.

Counterfeit medicines

Not to lose sight of the motivations behind these regulations, experts at the event reminded attendees that billions of euros are lost in annual revenue due to counterfeit medicines. Counterfeiters are handed ample opportunity due to the complexity of healthcare supply chains and the lack of patient awareness.

Developing countries have a higher proportion of counterfeit medicines circulating according to industry calculations.

Alongside the implementation of serialization projects and track and trace regulations, open investigations by authorities are working to stop and penalize counterfeiters.

Want more? MHRA makes 40 arrests in medicine diversion investigations

Over the next few years, more than 80% of the Rx drugs marketed worldwide will be serialized.

Global serialization progress

The lack of harmonization between country-specific regulatory requirements across the world greatly complicates product distribution for global pharmaceutical companies. Sophie Mollie from GS1 noted that more than 65 legislations for pharmaceutical companies are either in place or have approaching deadlines regarding counterfeit medicines and traceability.

GS1 is working to smoothen this patchwork set up.

•  Africa has an interagency supply chain group working to implement Gs1 standards.
•  Turkey, a traceability trailblazer, recommend the use of Gs1 standards claiming they can lead to significant annual financial savings.
•  Latin America is instilling the use of the ANMAT programme for drug identification.
•  China is moving very fast with its GTIN use.

However, in the Q&A section of Sophie’s session an audience member noted they were struggling to engage with Morocco regarding serialization requirements.

GS1 educates stakeholders and kick-starts collaboration efforts to support global harmonization and also helps to ensure these standards are followed by professionals at the point of care.

US

The United States has been given a total of ten years to implement serialization, fully track and trace procedures are due to be completed by 2023.

Some requirements will be enforced this November. Originally these were supposed to be enforced in 2017.

The results of the HDA 2017 Manufacturer Readiness Survey go along way to illustrate that very few in the industry were prepared for last year’s deadline.  Back when the survey was conducted it appeared that around 70% of the generic base was lined up to be ready for November 2018.

Want more? Serialized guide to serialization.

Looking ahead, Perry Fri, Executive VP of Industry Relations, Membership & Education and Chief Operating Officer of the Healthcare Distribution Alliance (HDA) noted in his talk that by 2019 wholesalers need to verify serial numbers from manufacturers.

Questions were raised by some at the conference as to whether dispensers will be ready for their deadline ahead in 2020 or indeed may have to request for enforcement discretions. Especially smaller operations functioning at a local level.

“The first step is to acknowledge the problem, and then you can move on to risk management and analysis”

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Pharmacies and hospitals

Two sessions looked at the reality of serialization execution for hospital pharmacies and those who dispense medicines.

Patrick Mazaud procurement and purchasing manager of the Institute of Pharmacy, Pole Public Health Pharmacy of the Regional University Hospital of Lille discussed the good authentication practices required to protect against falsified medicines and that each hospital must decide on the optimum point of medicine authentication.

These procedures should check the medicine’s tamper evident seal prior to administration.

In order to be compliant, hospital pharmacies must identify operators and these operators must be trained to meet the expected performance levels.

Hospitals need to select the location of decommissioning, for example, whether it is on the arrival of supply that would require a quarantine area.

Patrick Mazaud estimated in his hospital, which hosts around 3000 beds and a high rate of pharmaceutical activities, around 1.3 million medicine packs per year would need to be decommissioned. Leading to the conclusion that decommissioning on arrival would be nearly impossible by pack. Only bulk or aggregation mode would allow the hospital to be ready and compliant by February 2019.

Serialization’s Implications on productivity and data

Manufacturers were advised not to underestimate how disruptive serialization implementation can be to efficiency. Surprisingly, warehouses were highlighted as sometimes more problematic than packaging lines.

Many make the mistake of assuming that serialization only impacts packaging lines. Serialization impacts manufacturers at a range of levels. Indeed, it demands equipment moderations to packaging lines, but also integration of automation and the adoption of new software for data handling. Therefore, most departments within the company can expect to be effected: production, engineering, quality, logistics, IT and information security.

The software which generates the serial code will need to operate simultaneously on several production lines at several sites while adjusting to the required country-specific regulations.  A huge volume of data needs to be processed and archived in regards to storing the codes.

Looking ahead

Evren Ozkaya CEO and Founder of Supply Chain Wizard noted that pharma needs to look to peer industries for supply chain inspiration.

Pharma certainly has a lot of ground to cover to achieve complete serialization and not much time. Nevertheless, in meeting the requirements, it should also prime itself for the days of value beyond compliance with serialization.

Want more? Printable worldmap: Serialization track and trace deadlines