Jeffrey Kemprecos, director of communications, government affairs, and market access at GSK-Gulf, and a biopharmaceutical-industry expert with more than twenty-five years of international experience, talked with GEN’s Mike May, PhD, about the do’s and don’ts of working with foreign governments on biopharma projects.
GEN: In the biopharma industry, how important is it for a company to work with foreign governments?
Kemprecos: In any country where the biopharmaceutical industry operates, government policies and practices shape prospects in three fundamental areas: taxation, the regulatory and legal framework, and as a major customer. In the pharmaceutical industry, the government’s regulatory and procurement roles tend to be larger than in other sectors. Innovative biopharmaceutical companies, including global leaders such as GSK, tend to invest heavily in the communications, government affairs, and market access functions to navigate these waters.
GEN: What are the top challenges that you’ve seen, especially anything related to bioprocessing?
Kemprecos: The general trend is that over time regulations tend to get more complicated and detailed, and bioprocessing is not immune to this trend. While regulations governing bioprocessing and other areas involving research, development or manufacturing continue to evolve and expand, we note that there is also a helpful convergence in some areas. GSK supports efforts to rationalize and harmonize standards at the international, regional, and national levels. The goal is to strike the right balance between the immutable goals of achieving high quality and safety of product and operating an efficient, transparent, and predictable regulatory system. In the Gulf region, we advocate for systems that are flexible, take on board the industry perspective and are capable of evolution as the science advances.
GEN: From your experience working with so many governments, what are your top tips?
Kemprecos: My current focus at GSK is the Gulf region, but I’ve led policy advocacy in up to 140 emerging-market and developing countries during my career. I like to think that my advocacy approach is very much grounded in the human experience. Policymakers and officials find our arguments more compelling when they are anchored in solid data, so evidence generation is very important to our work. They want us to be up front about how policy recommendations would benefit the company or sector commercially, so we need to be very transparent about that.
But my experience is that policymakers and officials in emerging markets are very supportive of enterprise. They are keenly interested in how they can partner with global leaders like GSK and the innovative biopharmaceutical sector to put policies in place to strengthen their competitiveness in the life sciences and biopharmaceutical sectors. As policy professionals, today we need to prepare for much broader discussions on policies that drive investment, grow employment and stimulate innovation in the sector. As is the case with most of us, policymakers want to understand how it benefits the country, or “what’s in it for them.”
GEN: Conversely, what are the top things to never do?
Kemprecos: Like most people, policymakers and officials want to engage with genuine, earnest people. Take time to do your homework, including developing data to support your analysis and policy proposals. Understand the policymaker’s perspective and the constraints they face. And be consistent—deliver on your promises and don’t tell one group of stakeholders something different from what you’d tell someone else. It’s an interconnected world and everyone deserves to be treated respectfully. Prepare for a negotiation—policy discussions are rarely “one and done.” Finally, listen to the locals. We may command broad international experience, but the rubber hits the road locally. Your local affiliate is an invaluable source of insights, networks, and experience in the market.