As reported by in-pharmatechnologist.com, ePedigree has now been delayed twice, with the date moved back from the initial proposal of 2009 to give companies more time to prepare.

The delays will have been noted by companies and regulators around the world, who have been monitoring California’s pioneering implementation of an ePedigree system.

Universal adoption now seems many years away, with the Californian system suffering delays as interested parties try to ensure the regulatory and technological challenges are overcome. The concern is that if ePedigree is implemented in a rush it could lead to a disruption in the supply of medicines.

By delaying implementation until 2011 legislators had intended to give adequate preparation time but not all parties were convinced it would. In a statement following the previous delay the Pharmaceutical Research and Manufacturers of America (PhRMA) said: “it is possible that even by 2011, some of the key challenges will remain and still need to be resolved."

This has proven to be true resulting in revised legislation that states any manufacturer selling drugs in California must have an ePedigree for 50 per cent of its products by the start of 2015. The remaining 50 per cent must be designated an ePedigree before 1 January 2016.

Another wave of legislation comes into affect on 1 July 2016 prohibiting wholesalers or repackagers from selling, trading, or transferring a dangerous drug without a pedigree. Also they cannot acquire a dangerous drug without receiving a pedigree.

The complete legislation will finally be implemented on 1 July 2017, when the measures affecting pharmacies come into force. These will apply the wholesaler and repackager regulations implemented in 2016 to pharmacies.

IMS Health Inc., a healthcare industry analyst group located in Norwalk, CT, released its 2009 forecast for global pharmaceutical sales last week, stating that growth is expected to hold steady in2009 with anemic increases of 1% to 2% seen in the United Statesas generic competition,fewer new drug launches and an economic slowdown take their toll.

The worldwide market is expected to grow 4.5% to 5.5% in 2009with sales surpassing $820 billion. They predict double-digit growth in emerging markets to help offset the snail’s pace of growth in the world’s biggest market, The market will contend with a number of forces in 2009, such as multibillion-dollar drugs losing patent protection, the rising influence of
regulators and reimbursement on healthcare decisions and niche products playing a larger role.

The U.S. market is still expected to generate 2009 sales of $292 billion to $302 billion with the worsening economy and fewer new product launches making their impact. New productapprovals are at historically low levels, IMS said, with only 25 to 30 newchemical entities slated for launch in 2009, including potentially prominententries in the diabetes and rheumatoid arthritis arenas. But those numbersmay be optimistic given recent foot dragging by U.S. regulators, who havebeen letting action dates for approval decisions pass without rulings anddelays of three months or more becoming more common. 

The top five European markets--France, Germany, Italy, Spain and Britain--are forecast to grow 3% to 4% next year with sales reaching $162 billion to $172 billion, while the Japanese pharmaceutical market is seen growing 4% to 5% in 2009, reaching $84 billion to $88 billion.
Growth at a far higher rate is projected for the emerging markets of China, Brazil, India, South Korea, Mexico, Turkey and Russia. IMS sees combined growth from those nations of 14% to 15% with sales of $105 billion to $115 billion, helped by increased government healthcare spending.