Putting patient safety first | How the Excellis Health Check and Brand Risk Assessment programme is helping pharma firms minimise security challenges

In an age where the protection, security and traceability of medicines is constantly under the spotlight, pharma companies of all sizes must rise to the challenge of developing watertight systems and processes across their entire operation.

This case study explores how a comprehensive risk assessment service from Excellis Health Solutions has enabled Jazz Pharmaceuticals’ supply chain teams to assess their traceability compliance readiness, strengthen their brand protection programme and identify opportunities to exemplify industry best practice.

With patient safety a critical concern, complying with global track and trace mandates and managing and mitigating risk is an essential component of safe and effective pharmaceutical supply management.

A growing concern

Counterfeiting methods are becoming ever more sophisticated as counterfeiters seek to exploit products entering new markets with fewer controls. Serialisation / Track and Trace mandates are part of the external response, but compliance and brand security remain an ongoing challenge and the strength of pharmaceutical supply chains is frequently tested.

Aware of these risks, Ireland-based biopharmaceuticals firm Jazz, which manufactures a diverse portfolio of products for patients with complex conditions, sought to test the robustness of their compliance readiness and brand security approach with the support of compliance specialists Excellis Health Solutions.

The company had worked with Excellis Health Solutions previously and recently commissioned a comprehensive assessment of their serialisation programme with particular focus on the EU-FMD and DSCSA requirements.

Enterprise Serialization Health-Check: Strengthening serialisation

“With a growing global business, we recognised the need to assess the strength of our serialisation programme, so we sought the support of Excellis to identify and quantify our strengths and examine areas for improvement,” said Lorraine Guildea, Senior Manager of Supply Chain and Serialisation at Jazz.

“They were able to conduct a detailed review and make recommendations for strengthening our supply chain in the immediate and long-term, but they also identified improvements which could enhance our ability to scale. We were then able to cascade mission-critical serialisation knowledge throughout our wider team to minimise any future risk.”

Based on the success and value of this Health Check assessment, Jazz again sought the expertise of Excellis to assess the brand security situation.

“There are elements of this assessment we could have done in-house, but we really wanted the independent input and experience of a consultancy who works extensively with all types of pharmaceutical business globally,” said Philip Lavelle, Global Head of Supply Chain at Jazz.

Brand Protection Risk Assessment: Developing brand-wide protection preparedness

The brand protection risk assessment aimed to give Jazz a better understanding of their current level of preparedness and potential exposure to risks around counterfeit and illicit products bearing the Jazz name, as well as identifying opportunities to optimise their systems and supply chain security, and evaluating their programmes based on industry best practices.

In essence, it would provide a blueprint for brand protection, examining Jazz’s capabilities, processes, technologies, controls and governance.

“It was reassuring to confirm that we are very well protected from a regulatory and legal standpoint since these areas have always been very tightly controlled,” said Philip. “However, some recommendations were for protection optimisation opportunities we hadn’t previously considered, including partnering with Customs Authorities to identify potential trademark infringements on importation for example.”

Achieving industry best practice

Excellis also made recommendations around getting structured access to robust intelligence via key information networks that would prepare Jazz for entering new markets.

“These are all exercises we would never have considered by Jazz without Excellis guidance and are examples of industry best practice that some of our peers are successfully using. It’s vital for us to stay abreast of these practices,” said Philip.

The value of brand security

Quantifying the value of this assessment is complex because the true benefit is around value recovery, reputation management and damage control, but Jazz view the exercise as an optimisation assessment measure that will equip them to identify and manage brand-related risks in future.

“One of the biggest benefits for us of having an external review was the level of expertise and objectivity, as well as accurate peer referencing, packaged up with a clear methodology and robust reporting dashboard which we could confidently present to our stakeholders,” said Philip.

“Internally, we’re often asked where we rank in terms of similar organisations, and whether we’re ahead of or behind the curve,” added Lorraine.

“With the information from our assessment, we can present a solid rationale for our programme that’s based on clear evidence – and we would have no hesitation in commissioning Excellis Health for similar assessments in the future.”

Ahead of the curve: Industry benchmarking and preparation is key

Excellis reckons that protecting the integrity of brands will become even more critical as counterfeiting methods progress.

Greg Cathcart, CEO Excellis Health Solutions says: “We recently saw with the seizure of the first counterfeited COVID-19 vaccines in Poland, the “hot” zones are not only in far-east countries and in Africa but here at our doorstep. This is what we anticipated and what we are leveraging with our extended team all other the world.

“Comprehensive assessments with realistic recommendations and industry benchmarking are really helping our clients to strengthen and supplement their initial efforts. From new markets in developing countries to assessing the established supply chain vulnerabilities, the risk assessment is a must in today’s world.

“Counterfeiters have a greater incentive to produce products of a reasonable quality because they want to ensure their products are undetectable as fake – but for pharma companies, if a counterfeit then causes patient harm, that has serious implications in terms of their products and income.

“Therefore, we strongly advise pharma companies of all sizes and in all product areas to ensure they’re regularly auditing and evaluating the security of their brand.”

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