Regulation Awareness Key to Extending Regenerative Medicine ReachThu, 01/17/2019 - 18:11
Q: How are BioCenter and regenerative medicine in general positioned in Mexico?
A: BioCenter is still in its initial stage, especially considering that regenerative medicine remains in the development phase. Our role at the moment is to understand how this branch of medicine will impact the Mexican market, since the topic is fairly new and accessible only to a certain population segment. Even treatment efficacy depends on each person; all solutions are personalized and making statistical projections becomes difficult.
Adoption has also been slow among the medical and pharmaceutical industries because most professionals do not know much about the subject. Traditional medicine is highly methodical and there is considerable skepticism when it comes to new treatments. Furthermore, the medical industry is dependent on pharmaceutical companies that have built truly hegemonic practices. It is difficult to break such an ingrained paradigm. Lastly, regenerative medicine faces issues related to regulation and general understanding of the concept because the science does not refer only to stem cell therapy.
Q: What role can regenerative medicine play in generating a patient-centric culture?
A: People are increasingly willing to invest to stay healthy rather than face the need to combat a disease. Overall, medicine should focus on the patient, not on the disease. Regenerative medicine, like its functional and integrative counterparts, is considered a patient-driven industry, especially as patients are the ones demanding personalized solutions and innovative treatments that focus on maintaining health rather than just acting when the problem appears. These are all different branches but they all share a patient-centric vision focused on medicine being predictive, personalized, participatory and preventive, what we now call “P4 Medicine.”
Access to information has made patients much more participatory in the treatments they get and the practices they adopt, which is key to the patient-centric approach medicine should take. Similarly, patients are increasingly asking doctors to make recommendations based on nutrition and socio-cultural factors to achieve better treatment results.
Q: What alliances have you established to promote the adoption of regenerative medicine?
A: Government participation in regenerative medicine is still limited and it will take time before these treatments become the new normal in that market. However, we have established alliances with different clinics to create panels that can collaboratively participate in developing research and regulatory frameworks.
At the moment, we are lobbying for clear and integral regulations so companies wanting to participate in regenerative medicine can play according to fair and adequate rules. Efficacy tests, for example, must evolve to adapt to the reality of new treatments. Right now, Mexican law demands that companies present statistical data regarding the efficacy of any solution, which would equate to presenting phases I through IV of a medical trial. However, given the nature of regenerative medicine, no two patients receive the same treatment or dose, so it is impossible to provide such data.
Q: What are the main trends impacting regenerative medicine?
A: There is a legal dispute regarding the differences between hematopoietic and mesenchymal stem cells, which is why we are pushing for different regulation relating to each type of cell. We are also trying to define marketing guidelines so companies looking to enter the market can understand how to promote their products while avoiding false promises from less serious players.
Medical tourism is also a hot topic in regenerative medicine, especially considering Mexico’s attractiveness to US patients in terms of price and quality and due to the legal limitations regarding these treatments in their home country.