Code of Good Distribution Practice for Life Sciences Products Launched

-The first of its kind in Europe

Designed to Ensure Ireland Stays Preferred Location for Life Sciences Companies

The Code of Good Distribution Practice for Life Sciences Products was launched today (23.10.09) at a reception in Dublin. Launching this initiative of the Irish Exporters Association, Mr. John Whelan, the Association’s Chief Executive, said the World Health Organisation at the beginning of 2008 indicated that the internationalisation of pharmaceuticalproduction and the wide availability counterfeit drugs had created the need for good distribution practice, to ensure patient safety.

The IEA since 2007 has been working with the Irish Life Sciences manufacturers, the Irish Medicines Board and the logistics companiesservicing the market,to develop a voluntary Code of Good Distribution Practice for the sector. This GDP Code of practice with its compliance certified courses is the outcome of this collaborative work. It is the first of its kind in Europe and will help ensure that Ireland remains in the forefront of preferred locations for FDIin the pharmaceutical and medical devices sector.

He went on to say“Ireland is the largest net exporter of Life Sciences products worldwide with13 of the top 15 international companies having facilities in Ireland. Nine of the top 15 medicines in use worldwide are manufactured here in Ireland,” he added. There are 25,000 people employed in the sector in Ireland and exports for 2008 were over €44 billion. Internationally the sector has grown at the rate of 5 to 6% annually since 2000. The rate of growth during the same period in Ireland was double that. Irish-made Life Sciences products now account for 9% of the world total output.’’

The Life Sciences Sector has always operated in a highly regulated environment, but in recent times there has been an increase in counterfeit products entering the supply chain, and also new medicinal compounds increasing need a temperature control environment. Consequently there has arisen theneed forfurther regulatory requirementsin theinternational supply chain. “The industry has indicated that over the next two or three years that up to 50% of all newly approved medicines will be temperature-sensitive biopharmaceutical products,” said Mr. Whelan.

With these trendscoming to prominence, two years ago the Irish Exporters Association established Life Sciences Ireland to address solutions to theseissues. “We believed that these issues could best be resolved by developing a voluntary GDP Code with the support of the manufacturers and delivering training for the logistics, transport and storage industry to ensure compliance with this Code ,” said Mr. Whelan. He noted that by pursuing this course of action that Irish Life Sciences companies in Ireland would be well positioned to continue to lead the way internationally.

Mr. Whelan thankedthe Irish Medicine Board and noted that the assistance of Mr. Pat O’Mahony, CEO of the Irish Medicines Board was invaluable in developing the GDP Code He also thanked the Department of Enterprise, Trade and Employment for its support through the Accel funding scheme and the Life Sciences companies for their support during the early stages of the training development and pilot delivery.

“Logistics companies who comply with all of the criteria listed in the publication that we are launching today will be awarded the Life Sciences Ireland GDP Passport,” said Mr. Whelan. He then announced that Kuenhe and Nagel was the first company to complete all phases of training and to acquire the first Life Sciences Ireland GDP Passport. “We are confident that other logistics companies will be applying for their passport in the near future,” concluded Mr. Whelan.

Logistics companies who want to find out more about the Life Sciences Ireland GDP Passport should contact Life Sciences Ireland at the Irish Exporters Association in Dublin.

Full details are available at http://www.irishxporters.ie/ or e-mail lifesciences@irishexporters.org

(ENDS)

For further information contact: John Whelan

Telephone: 087 927 1243

Email: jfwhelan@irishexporters.ie