Ireland is one of the leading international locations for the Life Science industry. The industry which spans pharmaceuticals, chemicals, diagnostics, medical devices and biotechnology generates over 50% of our exports making Ireland the largest net exporter of medicines globally. Ireland is home to 13 of the top 15 companies in the world and manufactures 9 of the world’s top 15 medicines. In 2008 there were over 24,500 people employed in the sector producing exports of over €44 billion. Globally the sector has been expanding by 5-6% per annum since the turn of the decade, and last year recorded global sales of US $745 billion. By comparison exports of Life Sciences products from Ireland have more than doubled in the same time frame and now account for 9% of global sales.

For any Life Science (Pharmaceutical, Medical Device, Biologic and Diagnostic) manufacturing and supply chain companies, the safe and effective distribution of their products to the ultimate patient is crucial. This represents a significant challenge since the Life Science Sector also has to operate in a highly regulated environment, not least of which is the increasing compliance requirements for an international temperature controlled supply chain. The industry has indicated that in the EU over the next 2 to 3 years up to 50% of all newly approved medicines will be temperature-sensitive biopharmaceutical products.

At the beginning of 2008, the World Health Organisation (WHO) published a document titled “Good Distribution Practices (GDP) for Pharmaceutical Products” for commenting on by end of March of this year. This guidance is the counterpart of the document “Good Trade and Distribution Practices for Pharmaceutical Starting Material”, which was published by the WHO in 2003. At European level, the EU published its “Guidelines of Good Distribution Practice of Medicine Products for Human Use” (94/063/3) dating back to 1992.The International Air Transport Association (IATA) introduced a new set of regulations for airlines and ground handlers on the 1^st July 2009 to counter a pharmaceutical industry report that suggested that 50% of temperature deviations occur when the consignments are in the hands of the airlines and their facilities.

All of these international bodies have indicated the need for guidance on a range of distribution practices for the Life Sciences industry. These can generally be summarised as laying down requirements for the supply chain service providers to improve the management of the following:

·         Quality systems, organisations and personnel, in the supply chain.

·         Premises and storage areas

·         Transport vehicles, external packaging and shipping practices

·         Temperature controlled transport handling and dispatch areas, as well as temperature mappings to verify compliance

·         Counterfeit identification

·         Exports/imports and sub-supply routings

Life Sciences Ireland was established by the Irish Exporters Association (IEA) two years ago to address these issues and to develop and deliver training for the logistics, transport and storage industry; In the process ensuring that the manufacturers in the sector in Ireland could lead the way by ensuring a regulated, safe and efficient supply chain system for getting their products delivered to international markets and the consumer in those markets.

Life Sciences Ireland is an industry grouping within the Irish Exporters Association. The broad focus of the grouping is to support multinational and indigenous life sciences companies in their international trade and supply chain activities and to preserve the sector’s status as Ireland’s fastest growing export grouping.

Specifically, the Life Sciences Ireland grouping is focused on driving export excellence in life sciences by supporting the following critical business areas:

1. Logistical Efficiency - promoting and providing access to the latest cost reduction and supply chain efficiency improvement techniques and opportunities. 
2. Material Quality Control – assisting life sciences companies and those serving the industry to keep up to speed in the latest material handling and environmental control methods and standards.
3. Good Distribution Practices – Benchmarking the standard for the industry and promoting its use by all service providers regionally and internationally. 
4. Regulatory Response – providing training and support to enhance the sector’s ‘rapid response’ capability to changing regulations and standards.

For more information contact Patrick O'Loughlin; Life Science Division Director at (01) 6612182; Mobile: 086 2600227                                        or by email:loughin@eircom.net

A wide range of Life Sciences courses are available- please contact Raul Molina or Pat O'Loughlin for more information or send an email to lifesciences@irishexporters.org

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