It is well known that originally the role of the MSL is purely scientific, but with the development of various business models, it is forced to embrace new skills to generate value under a broader strategic perspective. This post is for those who aspire to be MSLs and those who, being MSLs, may wonder if it’s okay to take on some new role.
Doctors in Latin America are specially trained to care for patients, but due to different circumstances, some doctors make a career in health management, from coordination to medical management, to give examples, giving organizational and strategic support to health institutions. This is where the MSL is positioned to spread scientific information; however, the role has been acquiring new responsibilities, in some cases because a therapeutic area is so specialized that there is no sales force, local access areas, and reduced human resources, so the appropriate patient route must be efficiently unraveled to achieve market access.
We could think that we are treading on the gray area since many times the MSL finds itself facing a fine line between what to do and what not to do. However, there is nothing gray about market access, and I love that because in addition to its importance in the process, it is an area that forces you to face the problem from another angle, not purely scientific but more strategic.
In rare diseases, patients can be so poorly mapped (there is always a sub-diagnosis) that doctors do not know about the disease and hopefully have heard of it at some time, so the MSL becomes vitally important when transmitting knowledge. However, it is not only a matter of transmitting knowledge to the doctor but also gaining insight and even presenting studies on efficacy, safety, and pharmacoeconomics (HEOR) to decision-makers, who are not necessarily doctors, but who help this route for the patient to gain access to medication.
An important access barrier in LATAM is bureaucracy. I will not delve into the subject, and the legal/legislative framework that varies greatly in each country. In Peru, for rare diseases, there is a (reduced) list of rare and orphan diseases framed in the legislative field and that certainly does not cover all existing diseases because there is an under-registration or there are few or no local publications of patient cases. Furthermore, if a medicine is not locally authorized for commercialization (it does not have a sanitary registration), the state will not buy it despite it having approval for EMA/FDA, as it happens in other countries such as Argentina through compassionate use or Colombia through lawsuits where they can have access to high-cost medication for these diseases despite not necessarily having local registration and this does not happen in Peru because its legislation does not contemplate such legal concerns.
Peru is a market that continues to grow and every year there is a lot on offer; it is no wonder that health is a large growing market also because doctors are learning more about rare diseases in general. This is due to the work of multidisciplinary teams, the coordination of a very diverse human group, and the constant look that the pharmaceutical industry places on MSLs so that they take on the challenge of reinventing themselves in the field.
Carlos Manuel Romero Prieto, MD, MBA
MBA with a specialty in Health Services Management. A physician with experience assuming management positions, that began in the pharmaceutical industry as MSL in the iron line to dedicate later himself 100% to the therapeutic area of rare and high-cost diseases. He is currently assuming the position of MSL for PTC Therapeutics in Peru.