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Challenges in the distribution of Life Sciences products
Article published in the "Exporting Review", published with the Sunday Independent Newspaper on March 19th 2011Ireland is Home to 15 of the top 20 manufacturers of pharmaceutical products and medical devices in the world, and life sciences industry (incorporating pharma and medical devices) now accounts for over 63pc of Irish merchandise exports.
The life sciences sector in Ireland has been performing very well, despite the global economic recession, and has been one of the few industries to achieve continuous growth throughout the period 2008 to 2010.
There are over 350 companies employing about 17,000 people in a variety of activities, including active pharmaceutical ingredients (API) and devices manufacture, intellectual property (IP) management, diagnostics, research and development (R&D) and supply chain management.
“In Ireland we have gained tremendously from the globalisation of the manufacture of pharmaceutical products and medical devices,” explains Raul Molina, Life Sciences Ireland Administration Manager, Irish Exporters Association. “However, the global supply chain – from bulk manufacturing to sub supply and final packaging for safe patient use – brings a wide range of challenges such as the maintenance of appropriate transit conditions and final medicinal consumption.”
The current EU guidance on pharmaceutical transport (CPMP/QWP/609/96/Rev2) was written in 1996 and revised in 2003. During this time significant changes occurred in the globalisation of manufacture, with a consequent rise in the complexity and vulnerability in the supply chain.
“Because of the increasing complexity of the supply chain, serious practical questions are now being asked about where it starts and ends, and precisely where control must be focused to guarantee quality all the way from ingredients to the final consumed medicine,”says Molina.
“The more global and complex the distribution network, the more difficult it is to ensure that goods follow approved routes and are transported by approved and trained delivery drivers. For adequate monitoring of the supply chain it will be essential that transit records are properly maintained so quality is assured at every point along the pharmaceutical supply chain.”
Logistics and transport partners have been upgrading their systems to get pharmaceutical products and medical devices to the international markets safely, securely and efficiently.
However, the old guidelines are not meeting the current industry requirements. Hence, increasing efforts are being put in place by the EU and other international organisations to upgrade the procedures that ensure integrity and security throughout the whole supply chain. The EU has accepted that there is a lack of clear guidance on the regulatory expectations for ensuring that medicinal products and APIs are not damaged during transportation.
In a consultation paper it stated: “In order that products are fit for their intended purpose, including the ability to tolerate the range of expected storage conditions during use by patients or use in animals, simple and risk-based guidance is required for the transport. Such guidance needs to cover cold chain and non-cold chain products and all of the different stages of manufacture, importation and distribution.”
The EU is in the process of upgrading and aligning the text in its Good Distribution Practice (GDP) guidance(CPMP/QWP/609/96/Rev2) and its Good Manufacture Practice(GMP) - Chapters 5, 6 and 7, Annex15. The consultation period finished in January and the discussion process is expected to be completed by November of this year.
The life sciences sector in Ireland has been performing very well, despite the global economic recession, and has been one of the few industries to achieve continuous growth throughout the period 2008 to 2010.
There are over 350 companies employing about 17,000 people in a variety of activities, including active pharmaceutical ingredients (API) and devices manufacture, intellectual property (IP) management, diagnostics, research and development (R&D) and supply chain management.
“In Ireland we have gained tremendously from the globalisation of the manufacture of pharmaceutical products and medical devices,” explains Raul Molina, Life Sciences Ireland Administration Manager, Irish Exporters Association. “However, the global supply chain – from bulk manufacturing to sub supply and final packaging for safe patient use – brings a wide range of challenges such as the maintenance of appropriate transit conditions and final medicinal consumption.”
The current EU guidance on pharmaceutical transport (CPMP/QWP/609/96/Rev2) was written in 1996 and revised in 2003. During this time significant changes occurred in the globalisation of manufacture, with a consequent rise in the complexity and vulnerability in the supply chain.
“Because of the increasing complexity of the supply chain, serious practical questions are now being asked about where it starts and ends, and precisely where control must be focused to guarantee quality all the way from ingredients to the final consumed medicine,”says Molina.
“The more global and complex the distribution network, the more difficult it is to ensure that goods follow approved routes and are transported by approved and trained delivery drivers. For adequate monitoring of the supply chain it will be essential that transit records are properly maintained so quality is assured at every point along the pharmaceutical supply chain.”
Logistics and transport partners have been upgrading their systems to get pharmaceutical products and medical devices to the international markets safely, securely and efficiently.
However, the old guidelines are not meeting the current industry requirements. Hence, increasing efforts are being put in place by the EU and other international organisations to upgrade the procedures that ensure integrity and security throughout the whole supply chain. The EU has accepted that there is a lack of clear guidance on the regulatory expectations for ensuring that medicinal products and APIs are not damaged during transportation.
In a consultation paper it stated: “In order that products are fit for their intended purpose, including the ability to tolerate the range of expected storage conditions during use by patients or use in animals, simple and risk-based guidance is required for the transport. Such guidance needs to cover cold chain and non-cold chain products and all of the different stages of manufacture, importation and distribution.”
The EU is in the process of upgrading and aligning the text in its Good Distribution Practice (GDP) guidance(CPMP/QWP/609/96/Rev2) and its Good Manufacture Practice(GMP) - Chapters 5, 6 and 7, Annex15. The consultation period finished in January and the discussion process is expected to be completed by November of this year.
CONCERN OVER FAKE MEDICINES ONLINE
In tandem with the push for improved regulatory guidance on transit conditions is the increasing concern of counterfeit products entering the supply chain.
“The European counterfeit market is said to generate more than€10.5bn every year. Counterfeit medicines, which have been discovered at EU borders, increased seven-fold from ‘560,598 articles in 2005 to 4,081,056 in 2007’, and are expected to have continued this exponential growth in recent years,” says Molina.
He cites a Pfizer report, which showed how one in five people (out of the 14,000 surveyed) have admitted to buying prescription-only medicines online, which equates to 77 million of the overall EU population. “These are increasingly worrying numbers as it is estimated up to 90pc of the medicines sold online are in fact fake,”he says. A revised upgraded GDP guideline regime is now considered the key to keeping counterfeits out of the legitimate supply chain/distribution network.
GDP is about much more than just the distribution of products.The MHRA (the UK Authority) recently defined GDP as “the sum of all of the processes and activities designed and implemented to ensure that the quality of medicines is maintained throughout the distribution chain from manufacturer to patient, ensuring compliance with regulatory requirements at all relevant stages. It includes the storage and transportation of APIs, other ingredients and packaging components used in the production of the medicines”.
A step ahead internationally, the Irish Exporters Association has developed a GDP Passport Scheme – a voluntary Code of Practice for the distribution of pharmaceutical products and medical devices.
It was developed in close consultation with the Irish Medicines Board (IMB) and following the training and quality guidelines set out by the IMB, MRHA, EMA, etc. Since its launch, 10 international and indigenous logistics and transport companies have already been GDP-certified. GDP remains an essential aspect to ensure that Ireland remains as a preferred location for manufacturers in the life sciences industry.
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