Robert Jan van der Horst, CIO, DSM Sinochem Pharmaceuticals

Serialisation: In full compliance or a race against the clock?

What is Serialisation in the Pharma Industry?

Pharmaceutical Serialisation is the tracking and tracing of the passage of prescription drugs through the supply chain from manufacturing to dispensing to the patient. A unique serial number to each medicinal pack is assigned, which is linked to information about the product’s origin, batch number and expiration date.

With less than 10 months to go to the moment that the EU Falsified Medicines Directive (FMD) comes into force (09-02-2019), the serialisation journey shows all signs of a race against the clock.

A significant number of businesses (estimated 25 percent) have not yet started the journey and/or are not yet on full swing. A typical serialisation project easily takes around 6 to 9 months. Considering the duration of the project, the entire industry, including the pharmacies, should have been started now the serialisation project. Complicating factors as of today is that lack of expert resources in the industry as well as with service providers, the lack of available equipment in the market and time consuming validation activities of systems can easily double the project throughput time.

A large part of the industry (mainly the market authorisation holders and logistic service providers) also needs to connect to the European Medicines Verification System (EMVS). The setup of this EVMS connection also takes time and should be properly planned for. Meanwhile, the onboarding fees are already increased and expected to increase further. So it is attractive to onboard early rather than late.

 The implementation of serialisation is a major operation adapting software systems, manufacturing equipment, inspection equipment, communication networks, and messaging with government bodies or endpoint devices at the pharmacist 

Looking at the national Medicines Verification Organisations in each EU member state and some associated countries, the situation is not much better. The so-called national hubs will be the future platforms where the pharmacies need to be onboard. It is a million dollar question whether all national hubs & Pharmacies will be ready on time system wise.

Recent Personal experience: I recently bought some medicines in 5 different pharmacies in my neighbourhood where I live in Barcelona. None of the pharmacies were aware of Serialisation and had no clue that that they will have to scan and verify every single pack in less than 10 months from now before it is dispensed to the patient. Ultimately this will control the dispension to the patient as a last step in the total chain and is the proof of the pudding of serialisation.

On the other hand, good things also happened in the Market, such as, the majority of the industry will be ready in time. Especially this part of the industry should already be compliant for non-EU markets where serialisation became in force earlier than in the EU. The experience gained in these regions/industries can be of well use for EU FMD compliance.

DSM Sinochem Pharmaceuticals (DSP) is fully convinced that serialisation will bring benefits to the Pharma Industry. It will deliver brand protection and it will help combat against counterfeiting. Next to that, the entire supply chain (from manufacturer to pharmacist) will become fully tracked and traceable so that pharmacists can always verify the authenticity of the product before it is dispensed to end-consumers. And in addition, DSP’s “Sustainable Antibiotics Program” fits perfectly with the objectives of serialisation. This program aims to have sustainable manufacturing and to ensure sustainable use. As such DSP combats here primarily the unsustainable/ irresponsible manufacturing while serialisation will help the Industry/patients.

But the implementation of serialisation is not a simple software update; it will be a major operation in the adaptation of software systems, manufacturing equipment, inspection equipment, communication networks, messaging with government bodies, endpoint devices at the pharmacist etc. Therefore DSP started early its serialisation project. A few deductions from the DSP’s serialisation project are summarised:

The end-markets drive the speed:

• Depending on the end markets where the company is active, serialisation is already or will be soon a legal requirement;

• New markets come up as Saudi Arabia, Ukraine, Russia and Brazil although not always with clear requirements and moving targets in terms of deadlines.

Engage your customers and CMO’s in time:

• As your own customers and CMO’s are simply struggling with the same, it is highly recommended to take the lead in serialisation and demonstrate leadership as a competitive advantage.

Building sufficient time for setbacks:

• As this is a new for most companies something new, it is evitable that there will be technical setbacks in the solution and you need to overcome these challenges.

• It is hard to predict availability and level of readiness of on boarding partners. Therefore have a flexible plan that can cope with priority changes.

Preparing for success:

• Start on time and as early as possible.
• Get your best resources in the project.
• Select a proper vendor that has proven capabilities

The success of serialisation for your company is in the simplicity and practicality in which the recommendations as above can be applied.

Conclusion:

Coming back to the challenge in the title of this article, the entire industry (from manufacturer till pharmacist) should strive for full compliance as there is too much at stake: the responsible supply of medicines to patients, including lifesaving medicines and reinforcing that it is a race against the clock. It is right time to push the accelerator button at all levels.