Pharma community must work closely with regulators

The global pharmaceuticals market, estimated to be worth USD1.1 trillion a year globally, will surely benefit more from harmonized regulations reveals the Cool Chain Association (CCA)

The cool chain community must work closely with regulators to ensure the global pharma market, estimated to be worth USD1.1 trillion a year globally, benefits from harmonized regulations, delegates at the Cool Chain Association (CCA)’s Pharma and Biosciences Conference 2016 heard in Dubai, UAE.

A more unified approach is needed by pharma supply chain providers to address the evolving needs of the cool chain shipper and help to combat annual losses of up to USD35 billion resulting from wasted pharmaceutical product temperature excursions.

“Temperature controlled logistics is expected to grow by nine percent every year, leading to a global cool chain industry worth around USD16.7 billion by 2020,” said Sebastian Scholte, Chairman, CCA.

“However, the patchwork of regulations around the world, as well as the huge amount of data being collected as we process pharma goods, means we have to navigate a highly complex system.

“Open dialogue between industry and regulators is vital to ensure every voice in the cool chain is heard to help us achieve a slicker, more transparent supply chain that meets the evolving needs of the pharmaceutical marketplace.”

Significant changes in the industry

Delegates at the two-day CCA event, which brought together over 140 experts from all sectors of the global pharma supply chain, heard that the industry had seen significant changes over the last decade.

A wave of new regulations has spurred the launch of initiatives such as the International Air Transport Association’s (IATA)’s Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) accreditation scheme, and focused the attention of airports on building specialised pharma zones.

Therese Puetz, Chief Executive Officer, Karavan Management Consulting, told the conference the cool chain “toolbox” had also seen great advancements, such as unit load devices (ULD)s with rechargeable batteries, improved covers for protecting temperature- sensitive cargo, and real-time global tracking, as well as the use of nearfield comm-unications (NFC) to better monitor and protect pharmaceutical products.

She also pointed to halal pharma as a growing and important market. The smart cool chain is the next innovation and this is where the tailoring will happen, she said. “It is about making use of this enriched tool box, which has really grown over the years, driven by regulations and competition,” said Puetz.

Edwin Kalischnig, Secretary General, Cool Chain Association said that shippers should be more active in supporting companies that make the right choices and do the right investment

But better communication is needed with the shipper, including ensuring a clearer understanding of the implication of initiatives such as the Good Distribution Practice (GDP) guidelines and IATA’s CEIV programme, which are a “step in the right direction” towards global harmony, Bert Allard Jorritsma, Manager Special Cargo & Services Delivery, Emirates SkyCargo, told delegates.

“Good pharma logistics is more than just specialist handling equipment and warehousing – we as an industry need to align,” he said.

“We have so many handover points for the GDP, for example, and a large amount of complex data created from these handovers, but we have no clear solution as to how this data is able to help us and help the customer get what they need. The industry must work closely with regulators to ensure that any new legislation does not elongate the time- critical cool chain process.”

“The CCA could work together with The International Air Cargo Association (TIACA) to hold closed door sessions with regulators to address supply chain issues. One solution they could consider is the creation of a database that includes a quality trademark that rates all air cargo services at airports, to help shippers gain full visibility.”

Sebastian Scholte, Chairman of the Cool Chain Association, said the industry must work closely with regulators to ensure that any new legislation does not elongate the time-critical cool chain process

Emirates SkyCargo’s new facility

Delegates at the CCA event were also invited by Emirates SkyCargo to a tour of their new SkyPharma cool storage facility at Dubai International Airport, which opened for business recently.

The 11,000-sqm facility is run in conjunction with Emirates SkyCentral Dubai World Central (DWC), the carrier’s freighter hub in DWC, which offers 4,600 sq m of area dedicated for pharmaceutical cargo.

“The CCA holds at least two events each year and is the perfect opportunity for all segments of the cool chain industry to come together and debate the issues that matter,” said Edwin Kalischnig, Secretary General, CCA.

“With so many new regulations coming into force, as well as advancements in technology and changing market demands, we are living in a period of great change and it is more important now than ever before that all voices of the cool chain community are heard.

“Parties should embrace and introduce technology to create real transparency. Shippers should be more active in supporting companies that make the right choices and do the right investment. That is the only way to show that these investments pay off, which is not clear today.”

The next CCA event is the Cool Chain Association Pharma and Perishables Event in Dallas, Texas, USA from 5-6 December 2016.

The cool chain “toolbox” had also seen great advancements, such as unit load devices (ULD)s with rechargeable batteries, improved covers for protecting temp- erature-sensitive cargo, and real- time global tracking, as well as the use of nearfield comm- unications (NFC) to better monitor and protect pharmaceutical products