What formula is the pharmaceutical industry developing in the face of constantly increasing costs? How are companies coping with the growing regulatory pressure? What will production be like in tomorrow's world? There were serious topics on the agenda at the 20th anniversary of ISPE-DACH in Hamburg/Germany.
The world of the pharmaceutical industry has revolved faster in the last 20 years than the original protagonists were probably expecting when they became the founding members of ISPE-Dach (Germany, Austria, Switzerland Affiliate) in 1993. It is indeed so long ago that a few pharmaceutical engineers joined forces and set up a regional German-speaking branch of the ISPE. The aim then, as it is today, was to facilitate the sharing of experience and expertise among professionals working in the production of pharmaceuticals.
The little group has since grown to an organization with over 1000 members and has just celebrated its 20th anniversary in Hamburg—with speeches and a fitting program to mark the work of two decades.
It is not only the number of members that has increased, though: the demands on pharmaceutical production have also risen. The overarching theme, "Regulatory pressures and cost pressures in the pharmaceutical industry: Winds of change in production processes", was chosen for a reason and reflects a changing world with a bitter pill to swallow for the pharmaceutical sector which is more used to the sweet taste of success.
The substantial changes in the demands on the sector were underlined by Marcel Staudt of Novartis, the new chairman of ISPE-DACH, in his welcome address and backed up by way of three examples.
- Example 1—The patent gap: Patents which currently account for sales worth around 250 billion US dollars are due to expire between 2010 and 2015. For the companies concerned, said Staud, this will mean an abrupt drop in total sales of 75% and in sales of the original medicinal products of 90%.
- Example 2—Warning letters: The FDA has also tightened up procedures, and the number of warning letters has rocketed since 2009. The inspectors have become more critical in their assessments and are not shying away from taking drastic measures. Factories are also being closed if there are difficulties with the supply situation.
- Example 3—Patents and emerging markets: The pharmaceutical industry is seeing above-average growth in the emerging markets and patent protection is being undermined to some extent, as was the case recently in India. There is also increasing pressure from generic drugs and counterfeit products. An observation added by Ulf Schrader of McKinsey & Company was that 30% of all medicinal products in circulation in Africa are fake.
- Eight different trends were identified, with the speakers exploring the changes ahead for production in the next few years and the position to adopt in future.
Recognising these changes, all participants agreed that the pharmaceutical industry has to adopt to raise productivity and cost efficiency 0 But how? Discover some ideas of market insiders on the ext page!
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