Asia and the Medical Affairs Function
Yanis Saradjian,
Director of Consulting
Regardless of company size, establishing operations to support expansions in new territories has a big impact on existing organizational structures. The question often rests on how the subsidiary will be connected to the headquarters. Will it be a centralized or decentralized operation? How independent does this operation need to be based on distance, time zone, cultural aspects, size and/or budget? Mix these factors, in addition to regional capabilities, and headaches will result for even the most experienced executives.
Through our research on medical affairs operations, we found pharma companies to have gained ground in regions where the function wasn’t previously present, either because the environment didn’t call for it or because markets were not established.
Along with global expansions came the transformation of existing markets. This transformation involved the need for more formal medical affairs functions, whereas commercial and clinical operations had previously handled the few required medical affairs activities.
As happened in the United States 20 to 25 years ago and in Europe more recently, regulators are now mandating that Asian-based companies and subsidiaries separate their drug commercialization activities from scientific communication. Many of these organizations now find themselves following the general roadmap of the U.S. model.
Nonetheless, a company’s expansion in new markets means the creation of dedicated organizations within company-wide initiatives. But anytime companies grow functions in new regions, they face the challenges of various healthcare models and regulations. Some Asian countries may not yet be suited to accommodate the medical affairs model as it is known in the US, for example.
Research from Cutting Edge Information confirms that the medical affairs function is not yet fully functional in every Asian country. However, our recent discussions with medical affairs executives in Asia revealed that organizations are gradually implementing, shaping and adapting teams to meet local regulations and each country’s needs. Our data reveal the current status of medical affairs operations in this region. As Figure A shows, 84% of survey respondents indicated that their companies have some form of medical affairs operations in one or more Asian country.
Although this percentage is high, close to half of the respondents also indicated that the medical affairs function is housed under larger functional groups of clinical, commercial, business development or new product planning and is not a prominent function of the organization in these countries. When accounting for that factor, only 46% of surveyed companies can be considered having a stand-alone, dedicated and independent medical affairs operation in Asia.
Companies also recognized the need to establish medical information teams, with 73% of survey respondents reporting having medical information teams in place. For the medical science liaison function, which often follows the establishment of medical information teams, only 44% of survey respondents indicated having a deployed team. These teams vary in size from 1 to 45, depending on market size and how long the team has been in place. All the companies surveyed for this research have marketed products in some part of the world but not necessarily in the Asian regions.
Interviews with executives revealed that typical emerging markets medical affairs functions tends to be smaller, less organized and less procedural, with FTEs of 5 to 10 people. As country regulators begin to raise the bar in procedures and governance, companies respond by formalizing the medical affairs function and beefing up staffing numbers, mostly in the medical communications and MSL areas.
The country-level managers’ first and foremost responsibility is to identify opportunities to serve the medical community in that country and to develop a medical affairs plan for the region. A country-level medical affairs group’s core responsibility is to answer medical information requests and engage local healthcare professionals through MSLs for the most part. The resources needed to handle these core tasks correlate to the size of the country and products available in that market.
Interestingly enough, long-established companies with Asian-based headquarters, where the medical affairs functions were not needed just a few years ago, are learning from their Western counterparts on how to structure and establish the function.
The primary challenge falls entirely to the global and regional leadership to recognize the need for medical affairs functions, the appropriate time and the appropriate way to implement the change. To stay ahead of the curve and to operate at a pace that is adapted to the country, companies should understand they need to not change too quickly or too slowly and to manage that change effectively.
The other challenge is to find the required talent and to appropriately train new hires on medical affairs functions. Factors such as culture, knowledge of regulations, health systems and networks are mostly unfamiliar to companies establishing new operations and to new hires learning about the medical affairs role. It is a fundamental shift in the whole model by which the industry has worked, but companies need to recognize the increasing importance of the medical affairs role worldwide.
Medical Affairs executives will congregate and discuss their experience and the latest developments of this function at NextLevel Pharma’s Medical Affairs Leaders Forum Asia that will be held in Singapore on July 22-23, 2013. Secure your attendance to learn about the opportunities offered by this growing market.