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This year, experts took on topics ranging from innovation to market access and the impact of mega trade pacts.
At CPhI’s Global conference and exposition in Madrid, CPhI released Part 3 of its annual report, in which experts outline key trends and issues for the pharmaceutical industry. This year’s expert panelists are:
· Dilip Shah, CEO of Vision Consulting Group
· Vivek Sharma, CEO of Piramal Enterprise, Ltd.’s contract development and manufacturing organization (CDMO) division, Pharma Solutions
· Prabir Basu, manufacturing, operational excellence and cGMP consultant, and former head of the US National Institute for Pharmaceutical Training and Education (NIPTE)
· Alan Shepperd, IMS Health’s global generics thought leader principal
They tackled topics from macroeconomic trends and the impact of mega trade pacts on pharmaceutical markets to growth trends and consolidation in injectable drugs and contract services, to innovation in manufacturing and generics and their potential role in improving global access to medicine.
Piramal’s Sharma discussed market trends including growth in outsourcing, in generic injectables, and overall market consolidation, as compliance and quality demands may drive some smaller companies out of business. Recently, a number of major acquisitions have taken place in the space, including Pfizer’s buying Hospira and InnoPharma, Hikma buying Bedford Labs, Mylan buying Strides Arcolab, Sun Pharma buying Pharmalucense and Piramal buying Coldstream Laboratories. Companies with the ability to handle highly potent active pharmaceutical ingredients (HPAPI) safely, with strong compliance and efficiency records will have a distinct advantage in the market, he says.
Dilip Shah examined the potential impact of the U.S. Trade Promotion Authority Bill, TPA 2015, which would give the President the right to fast track huge trade deals. The bill calls for fast-track drug registration and harmonization, yet extends patent exclusivity to 23 years. Shah believes that it could reduce generic drug manufacturers’ ability to compete and reduce the public’s access to lower-cost drugs, not only in the US but in 11 Pacific Rim countries. It would also reduce US access to followon biologics and biosimilars, Shah said
Prabir Basu began his essay on innovation by asking a question posed seven years ago by IBM: what can pharma learn from the automotive industry? Basu sees many similarities between pharma’s situation today and where carmakers were back in 2008, with:
Inefficiencies in manufacturing
Older plants and infrastructure
Lack of innovation
Insufficient customer focus.
Originally, carmakers reacted to more challenging market conditions by outsourcing and offshoring operations to countries where labor costs are lower. This provide a short-sighted response, Basu said, and ultimately, investment in innovation allowed the industry to regain its stability. The same should hold for pharma, Basu says, and investment in education and innovation will be critical to reducing costs and improving efficiency in the future. He also called for sharing more best practices, as the semiconductor industry group, SEMATECH does.
IMS’ Shepperd began his op-ed by sketching a utopian world where there was total freedom of access to safe, effective and affordable medicines. That picture remains a dream, given a reality where Europe is mandating price cuts for pharmaceuticals across the board, both name-brand and generic drugs. In addition, more costs are shifting to the consumer.
The current economic climate in the EU makes generic medicines more important than ever, Shepperd wrote. “Positive measures and advancing the use of generic drugs can provide a far more sustained solution to cost containment than lowering prices for generics. Sustaining policies for pricing and reimbursement will be essential,” he wrote.
Download Part 3 of the report here.