While revenue forecasts for the pharmaceutical sector in 2013-14 have fluctuated, the industry is poised to maintain significant growth. The logistical problems inherent in supplying essential drugs to users across borders and oceans continue to challenge us. Will this year’s new EU guidelines on Good Distribution Practice (GDP) bring greater clarity? Just how are we taking our medicine?
Three months ago, on March 7th, the European Union issued long-awaited new guidelines on storage and transportation of pharmaceutical products. Three months from now, on September 7th, they will come into effect. After a period in which the industry has had no universally accepted GDP standard and no recognisable mark of compliance, it will require a major overhaul to bring the multiple versions of good distribution practice in current usage under one umbrella. And as sector growth accelerates in emerging markets, what will the new guidelines do for trade?
Healthcare spending in the Middle East and North Africa (MENA) amounts to less than 2% of the global pharma market, but the region has seen an increase averaging 15% per annum over the past decade. With no mechanism in place for drug distribution, and often no transport infrastructure in place to support it, a number of innovative suppliers have leaned towards ad-hoc shipments. One client has described these shipments as “parachute drops”, meeting the critical short term needs of a community as quickly and effectively as possible. Perhaps more than any other sector, EVS Translations pharmaceutical clients understand that speed cannot also mean haste. Good Distribution Practice holds suppliers accountable for consistent storage, transportation and handling of life saving products, and the new guidelines promise a tightening of controls in areas including premises and equipment, complaint procedures, documented risk assessments and the suspected falsification of products. All perfectly sensible. But all perfectly clear? One of the grey areas that needs to be shaded black or white is the role of handling companies taking receipt of products at airports. These companies have operated until now without warehouse storage facilities, and have had supervisory responsibility for imported drugs for anything up to 48 hours. Would these companies now be accountable under the new EU Good Distribution Practice guidelines? Would the airlines?
This summer, workshops throughout Europe will seek to prepare the industry for its September 7th deadline date. Key questions loom large.
What will be the immediate consequences for those who fail an inspection?
Will there be fines for non-compliance? Will products be suspended or withdrawn from distribution?
What will this mean for Europe’s pharmaceutical export trade, and for the wider industry?
Companies that stand or fall on absolute precision will surely not be tardy in providing the answers. And EVS Translations will be there to support them, in any language.
