Voices: Kuehn

Pharma’s Global Climate Change

Manufacturing pharmaceuticals is not for the faint of heart, no matter where you’re from

It’s proving to be a tough winter, especially for our colleagues in New England, as yet another polar vortex imposes Mother Nature’s will on us all. As I was preparing this month’s cover story “State of the Union,”  which encompasses three related narratives and includes our 2014 Annual Reader Survey results and analyst firm BMI’s assessment of India’s pharmaceutical industry and market, I began to realize the myriad ways in which Pharma’s current global “climate change” is affecting the industry and the committed professionals battling the market’s “elements” as they see to the day-to-day priorities of their operations.

More than 400 professionals responded to Pharmaceutical Manufacturing’s 2014 Reader Survey. What struck home for me most, upon seeing the results, was how much commonality there was in our respondents’ attitudes and opinions. And it was far from negative. Further, there was a shifting in the number of responses coming from the world’s major regions — that is more of Pharmaceutical Manufacturing’s readers responding from countries like India and China, and I do believe we had at least three readers from Australia chime in. Further, a strong majority came from the operational ranks at their pharmaceutical production facilities. In many ways, the diversity and geography of respondents reflected the globalization of the Pharma supply chain and the growing demand for drugs and therapies from countries and cultures that traditionally did not ascribe to Western-style healthcare modalities.

The point I’m trying to make here is that in spite of geographic differences, you hold similar opinions on organizational life and share similar attitudes when it comes to managing the role you play as an operations oriented professional. Heartening and impressive was the fact that, for those tasked with making drugs, most agreed that the best part of their job was the “challenging work environment” and doing “meaningful work that saves lives.” What did respondents like least about their jobs? Many commented that it was the oppressiveness of internal organizational bureaucracies, as well as a pervasive bean-counting mentality that was stymieing their passion to improve operations — in pursuit of the quality and efficiency they know regulators are demanding and that as professionals understand their operations are capable of, but something the “powers that be” seemingly refuse to promote or invest in. In my overview of the “State of the Union,” I offer what analyst Girish Malhotra thinks is at the root of this malaise: That as long as a firm can meet shareholder’s profit expectations — in spite of poor process and quality procedures and obsolete manufacturing and information systems — then there is little incentive to provide what their operational professionals are, in some cases, literally begging for.

What became clear from the snapshot readers’ responses provide, was that in spite of extreme pressures — many of them internal — most, if not all, retain the motivation and desire to meet the challenges they present and to meet the expectations of regulators and the consuming public.

The world’s prominent economies and their regulators are pursuing global standards of drug quality and safety through process and manufacturing excellence. Western regulators are intent on imposing cGMP-based standards on any company that seeks to sell its wares in their lucrative markets. This is the global climate change I’m talking about. And not everyone is up to dealing with the rain this climate change is producing. Case in point is the scrutiny and pressure India’s pharmaceutical industry is under recently. Oh, and let’s not just single out our brothers on the subcontinent either.

Yes, global market and competitive forces are changing the climate pharmaceutical manufacturers exist in. There are those, it seems, who are the “deniers” unwilling to understand the difference between short-term gains earned at quality’s expense and the long-term and profitable business sustainability cGMP operations can support. But yet, as the 2014 Reader Survey results reveal, there are plenty of true believers out there.

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