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Pharmaceutical Manufacturing and Packing Sourcer

All Together Now

At the Cool Chain Association’s (CCA’s) 2014 Pharmaceuticals in the Cool Chain conference – held in Milan on 17-18 September – a roundtable discussion took place to debate the need for greater integration of the pharma cool chain. Here, a transcript of the meeting reveals the group’s talking points, which included the potential of a new, independent CEIV certification programme – currently being developed by IATA – as a new global cool chain standard of excellence.

Alan Kennedy:
Supply chain integration is all about collaborative working: parties coming together to resolve issues, increase profitability and raise performance. With the entire industry facing a host of cost pressures, pharma needs to move towards greater levels of efficiency, particularly in the way it manages its supply chains. The question is one of how we can reconcile the conflicting demands of lower costs and higher performance.

Steven Polmans: I fully agree that more and better integration is the key to the industry’s future. When we first started talking about the possibility of what has now become the CEIV Pharma certification at Brussels Airport, we knew we needed to get everyone in the logistical chain actively involved if it was going to work. But at the same time, it looked like we were the only ones seeing this. It was really down to us to get the supply chain to understand the benefits of going down this route all together.

Tony Wright: In principle, everyone in the air cargo sector agrees that we all need to be working towards reversing any modal shift, particularly when it is based upon cost. This will support the entire industry in growing its market share, rather than competing for the same slice of the cake. Driving supply chain collaboration takes time, effort and courage, and there is frequently a lack of willingness to make the first move. The result is that sometimes companies focus only on driving potential cost savings, when they should be working together to design efficiencies into the system.

Stavros Evangelakakis: Yes, we faced the same barriers in Luxembourg when Cargolux was seeking Good Distribution Practice (GDP) certification. Stakeholders readily agreed to sit round the table, but were not prepared to share any data. It was not until the Luxembourg government jumped in to support and streamline the scheme that we started to make progress. And to start with, it was not about sharing anything – it was simply about working towards common GDP standards and procedures.

Edwin Kalischnig: Integration has to start with improved cooperation in order to generate trust. We cannot get to real integration without going through stages of gradually improving cooperation. It is a stepby- step progression that takes time. We need to determine how this progression is managed.

Steven Polmans: One of the problems we are facing is that we are operating in a highly competitive environment. We have not reached the stage of sharing costs, revenues and information. Many of the companies in Brussels Airport’s CEIV Pharma-certified BRUcargo community, for example, have joined for their own competitive reasons, and I believe this is their entitlement. However, whatever the reasons for their participation, the end result is nonetheless an integrated network – still competing for business, but from a level playing field.

Tony Wright:
If compliance with the CEIV Pharma integration standard becomes a mandatory pre-qualification when bidding for contracts, then the result will be a streamlined supply pool offering not only higher standards but also a commitment to working in a more collaborative way.

Stavros Evangelakakis: Pharma shippers must understand that to enjoy these benefits they should be prepared to move away from putting every job out to multiple suppliers and lowestbid tender. Ultimately, we need to be able to discuss and share risk with the shippers. They must be prepared to reward innovation and investment, and we need to be able to work to agreed solutions – not just resort to passing blame between the parties whenever a problem arises.

Steven Polmans: You would be surprised how little the shippers really know about operations at the airport. At Brussels, we have been busy opening up communications with shippers, and we hope they will continue with this.

Malik Zeniti: The pharma shippers certainly have a lot to gain if they are willing to fully embrace the concept. If they can be convinced of the benefits for them, and how it can result in meaningful cost savings and assured consistency of quality and performance, then they will be happy, their insurers should be happy, and the whole collaborative concept should rapidly cascade down the cool chain.

Stavros Evangelakakis: At the end of the day, it is all about money. This is why people are unwilling to share information. They are scared of being taken advantage of. Shippers must work hard with their core group of supply partners to develop the necessary trust to overcome these fears. The goal must be to have an internationally recognised qualification from an independent body that means pharma shippers should not need to conduct routine audits. This will reduce their costs, but it will require a lot of trust.

Steven Polmans: We were really surprised by the positive reaction to the CEIV Pharma scheme from the shippers. While some of them said that they would probably continue to conduct full audits, others said that under a properly controlled certification framework, their inspections could possibly take the form of irregular facility spot-checks of a few hours, rather than the two- to three-day audit assessments that are typically conducted in every location.

Alan Kennedy: You can already start to see the scope for cost savings, because activities such as continuous highlevel inspections and the training of professional auditors cost huge amounts of money.

Tony Wright: But how easy will it be to apply a model that works at Brussels to other, very different, airports?

Steven Polmans: The programme will certainly need to be adapted to each location, while at the same time guaranteeing the same standards and high quality levels. But with many organisations operating in multiple locations, it should be reasonable to expect a fairly high degree of standardisation in terms of the procedures and learnings that are transferred from one geographical location to another – for example, standardised and centralised training.

Alan Kennedy: How important is it that there is an ‘integration champion’ among the stakeholders in a particular supply chain: an organisation that coordinates and promotes the integration process? It needs a relatively impartial organisation to take the initiative.

Stavros Evangelakakis: You are absolutely right about this. At Luxembourg Findel Airport, when it came to the new GDP agenda, it happened because the Luxembourg government effectively brought the stakeholders together and said: “If you want to be part of this, you need to sign up to the agenda and participate in the training”. So they brought the people together. Now, if we are going to work towards more integrated supply cool chains, we must avoid all unnecessary duplication of effort and be prepared to be strict in interpreting and enforcing the rules.

Steven Polmans: I agree we must not create unnecessary and confusing duplication. We must closely align the new CEIV Pharma programme with the existing GDP requirements. We do not want to find ourselves in a position where we are competing – or perceived to be competing – on the name of the programme rather than on the quality of the programme. Global standards and transparency should be key. Therefore, we also want to avoid creating tiers of certification, at least at this stage.

Alan Kennedy: It would certainly be very counterproductive if the new CEIV Pharma scheme and the existing GDP were running in parallel as alternatives. The IATA’s CEIV Pharma programme is envisaged as a global standard, and as such, the various regional and national GDPs around the world should feed into it.

Malik Zeniti: That seems reasonable. By unifying the two platforms, existing GDP-certified players would not be disadvantaged or demoted in any way, and will be able to graduate to full CEIV Pharma compliance with minimal effort and expense.

Tony Wright: This flexibility might make it easier for the CEIV Pharma scheme to be adopted across the world where standards other that the EU GDP are in effect.

Malik Zeniti: We must also be careful not to lose sight of the fact that technology providers are an integral part of any integrated supply chain. These companies make a vital contribution to more costeffective cool chain solutions by bringing expertise and solutions in areas such as tracking technologies, temperature control equipment and specialised packaging.

Tony Wright: The starting point for creating awareness and moving this all forward is to decide which organisations are going to be responsible for driving it.

Alan Kennedy: In this case, it may be sensible to try and form a crosssector steering group to oversee and coordinate the initiative. By doing this, it will not be perceived as representing a particular vested-interest group, which would be counterproductive to uptake.

Steven Polmans: Then I think there may be a key role in this for the CCA, since it is an independent organisation representative of all supply chain parties, and the concept of greater supply chain integration is directly in line with its strategic mission of creating a seamless cool chain.

Alan Kennedy: On that note, we have come to the end of the available time. The outcome of this discussion is that the CCA will engage with the IATA-CEIV Pharma group and others, to discuss how we can work together to promote cool chain integration and set up the necessary management and coordination structure. Thanks to you all for participating.

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Steven Polmans boasts a long career in the airline handling industry at a number of airports and in a variety of sectors. Steven is currently Head of Cargo at Brussels Airport, where he is responsible for the implementation of the strategic plan for its cargo business unit.

Malik Zeniti is Treasurer of the CCA and Manager of Business Development at DuPont Protection Technologies in Luxembourg. Malik leads the market development and sales of the thermal air cargo covers business branded Tyvek® in Europe, the Middle East and Africa.

Tony Wright is the Chief Executive Officer (CEO) of Exelsius Cold Chain Management, a leading consultancy in GDP and air cargo temperature control. Tony has over 35 years of experience in healthcare logistics products, and advises many leading pharma and biopharma organisations.

Stavros Evangelakakis is a Board Member of the CCA and is currently the Head of Global Healthcare and Pharma Product Manager at Cargolux Airlines, where his responsibilities include the development of tailored cool chain solutions for the pharma sector.

Edwin Kalischnig is Secretary General of the CCA and CEO of Xtreme Technologies BV. Edwin is a specialist leader in the areas of radio frequency identification and sensor-based computing for cool chain applications.

Alan Kennedy is an independent consultant working in partnership with organisations in the public, private and not-for-profit sectors to foster collaborative working, as well as improve and promote supply chain efficiency and best practice. He is Director of PartnerSave Ltd.
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