MEXICO - Health & Education
Director General, RM Pharma
Before founding and directing RM Pharma, Melissa Rosales worked at Pfizer for over eight years as manager of clinical investigation. She studied chemical pharmacology at UNAM and has a master’s degree in organizational psychology.
In 2019, we entered new therapeutic areas, where for example we are set to start an interesting new psychiatric protocol. We are close to starting with vaccines as well. The vaccine protocols are different from what we usually do. Normally, there is phase one with volunteers, phase two with a small number of ill patients with low doses, and phase three with more patients to measure security and efficacy, and phase four for pharmacovigilance. Vaccines have different phases as with all clinical trials, but for phase four of a vaccine trial you need a high volume of patients for testing. There are three studies in the pipeline and it is an area in which we will strengthen out presence going forward. We are working on a vaccine for syncytial virus (RSV) in seniors and children, and we are also working on a vaccine for pregnant women.
2019 was full of uncertainty, and slower performance than in 2018. The new administration changed many things, for example requiring a whole three-month period to issue medicine permits, where the previous administration had delivered in half that time. In fact, in 2019 pharmaceutical companies actually decided to work abroad given the approval time in Mexico.
The issue is implementation. It looks great on paper, but in reality, you do not know how it is going to work. The public health system was already chaotic and problematic. In my opinion, it is a great proposal, but we have to see if it will work in practice. There is a shortage of specialist physicians as it is, and doctors do not want to work in the public system.
It is good that the government is trying to reduce monopolies in the health care industry, although I do not think they should use generic medicines brought from India and China. We know within the industry that these medicines do not undergo the same quality processes as in Mexico. This is an ongoing issue that yet to be solved. I agree that costs should decline, just not at the cost of quality, efficacy, and safety.
There are great opportunities, but these have always stalled due to regulatory obstacles. What we have, similar to Brazil, is a situation where it takes around three to six months to start a project. Yet, when we need to recruit patients, we do so better than other countries, thereby mitigating this with high turnout rates; however, companies would prefer a more stable regulatory setting. The government is also changing the customs regime, and we have to import medicines and supplies, which today requires a different process. In terms of global ranking, Mexico has not advanced.
Permit approval times are rather similar. Colombia is undergoing some reforms in terms of clinical research, but not everybody there wants to undertake research. The main players are Mexico, Brazil and Argentina. Chile and Peru are also players, but not as notable.
Growth will be at around 20% for most projects, and the number of specialists will also rise. And meanwhile, we are undergoing an internal restructuring, and will focus on quality control. 2020 looks like a promising year, where we have been nominated for an international business award for reliability. There are many clinical research centers in operation, but they do not operate as companies, but rather as small clinics that provide consultations. We are one of the few that has a control board and strategic planning. Of those businesses 80% are run by doctors, who have very different visions. You need to set up your locations in close proximity to patients, and we have many in Estado de Mexico, were we have located close by. There are also plans to use telemedicine in conjunction with actual patient visits. We will also open for business in Querétaro around June where we will focus on training and patient consultation.
MEXICO - Agriculture
General Secretary, National Food and Commerce Union (SNAC)