Our short series of perspectives on the serialisation project from the OSMR Board Members comes to an end with the point of view of Mr. Dan Zaharescu – OSMR President and Executive Director for the Romanian Association of International Medicines Producers (ARPIM).

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1. What has been the biggest challenge that serialisation brought to the industry you are representing?

Implementing the Falsified Medicines Directive brought novelty elements to the medicines’ life cycle. All those involved in the legal supply chain acted in a dynamic and efficient way in order to make this project a reality.

The most visible changes implemented as of February 9th, 2019, are the Unique Identifier printed on the medicine pack and the anti-tempering device on the packaging of medicinal products, both elements for the purposes of allowing the identification and authentication of the respective medicines. In addition, the second element ensures that the patient is the first one to open the medicine pack.

However, the serialisation project is an extremely complex endeavour, much more than just printing a two-dimensional Data Matrix barcode on the medicines’ packs. Thus, the entire process of upgrading operational flows, software and production lines, in a timely manner, whilst ensuring a high-quality product standard is maintained, represented one of the biggest challenges that was successfully delivered by the innovative medicines industry.

Patient safety is of the utmost importance for all those representing this industry. Therefore, the great amount of effort placed into making the National Medicines Verification System a robust, fully operational, efficient system that enables patients to have access to authentic medicines, was done having as primary objective protecting public health.

2. What is in your opinion the biggest advantage that the Falsified Medicines Directive (FMD) has to offer?

Undeniably, the most important advantage the Falsified Medicines Directive has to offer is the high level of security ensured for patients across Europe.

Whenever purchasing a prescription-based medicine pack from a pharmacy, the patient has the certainty that the pack, based on the printed Unique Identifier, is verified in the National Medicines Verification System and thus, what he is given is an authentic medicine.

The immense effort that has been undertaken by all the relevant actors in this project had as its fundamental core value: protecting patients’ safety.

3. What have been the major concerns expressed by members within the industry you represent?

The cost entailed by all the changes that the serialisation project is conveying represents the major concern that has been formulated by representatives of the innovative medicines industry.

Upgrading production and packaging lines in manufacturing sites all across Europe, in a relatively short amount of time, came with a high financial burden. Nevertheless, everyone involved in this project soon understood that a swift mobilization is needed, as one cannot put a price on patients’ safety.

4. What are some of the dangers associated with medicines falsification?

Falsified Medicines pose a great threat to public health, and this is by far the biggest danger associated with these types of medicines.

Both the innovative and the generic medicines market are targeted by those manufacturing such products and endangering the stability of the entire legal supply chain.

As they lack active substances or contain these in the wrong dosage, falsified medicines can increase the patient’s resistance to genuine treatments and thus make the recovery process a long and assiduous one.

5. What are the most valuable lessons learned that can be taken by the industry from the serialisation experience so far?

Representatives of the innovative medicines industry have been early adopters of the new regulation on medicines’ serialisation. Having understood the importance of such a project not only at a national level, but also at a European level, innovative medicines manufacturers have proved a high adaptability to the novelty that was enfolding before them.

The human-centric feature of this project managed to develop a common understanding and a collaborative communication between all the key actors in the legal supply chain. I think most importantly, the main take-away of this project is that a common goal which undertakes a compelling feature, that of protecting patients’ safety, is a catalyst for change.