Patient Outcomes Measure the Value of Innovation: AMIIFBy Miriam Bello | Mon, 09/27/2021 - 12:30
Q: As a representative of the innovation industry, what are the non-COVID-19 epidemiological trends the sector is trying to address?
A: COVID-19 has been critical but we have neither forgotten nor left behind innovation in other fields. Mexico’s largest health challenge is non-transmissible diseases, which cause 80 percent of deaths in the country. This population was significantly more vulnerable to the pandemic. The innovative industry is developing gene therapies and personalized medicines to address numerous diseases. Many of our members are also endorsing regulations that would allow these two types of therapies to be introduced into the country.
Companies are also innovating on antimicrobial resistance (AMR). About 700,000 people die annually from AMR and it is estimated that if no innovations are made, over 10 million people could die from AMR by 2050. The industry is taking action internally but we are also approaching COFEPRIS and the General Health Council to build a joint response. Through the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), many pharmaceutical companies have provided millions of dollars to develop new treatments. Regardless of the company or country, anyone can join in the fight against AMR.
Q: How could Mexico enhance its investment in R&D and how would this impact its economic development?
A: Two years ago, global investment in innovation amounted to US$170 billion. This number has probably risen, considering the significant investment in R&D and infrastructure to fight COVID-19.
Mexico annually invests about US$250 million on innovation, which is significantly below global figures. We rank 29th in clinical research but we can improve by accelerating approval processes and making the market more competitive to increase investment in innovation. Early investment can greatly impact the development of therapies, making them more beneficial to patients.
Clinical research generates 4.4 direct jobs and every MX$1 (US$0.05) generates an economic impact of MX$1.64 (US$0.08). This dynamic sector is seeing the most investment globally. It would be strategic for Mexico to invest in the life sciences sector for its economic growth.
Q: How are AMIIF and its members developing pathways that accelerate access to innovation?
A: The alliances created to deliver the COVID-19 vaccine were outstanding because they were the result of many pharmaceutical companies sharing their library of active principles and research lines. This allowed the development of multiple vaccines, reflecting the innovation, collaboration, excellence in processes, clinical trials and close work with authorities that led to accelerating access to healthcare. It was a demonstration of what the industry can do when it works together.
Through the ACCESS study, we analyzed the timeline and speed of introducing innovation to the Mexican market, which is about 4.3 years on average and has not improved in recent years. We approached COFEPRIS to speed up the process, which we expect will accelerate with new Commissioner Alejandro Svarch. The organization has taken significant steps to reactivate the New Molecules Committee, which has started operating efficiently, successfully reviewing 99 drugs. However, there is a long way to go. AMIIF’s members have 20 drug registries waiting for COFEPRIS’ approval even though they have been greenlighted by the Committee and by other international agencies, such as the FDA or EMA.
Q: What other actions could government organizations take to increase access to innovative medicines?
A: The General Health Council has made numerous advances, such as the creation of the National Compendium, which will require that all medicines registered in its catalog be available to all public institutions. This is a significant step. Previously, companies had to submit each medicine for review at every single public institution. The General Health Council is also working on a census on orphan diseases, which will improve the treatment for these patients. Globally, there are about 7,000 orphan diseases.
We understand the government’s reasoning for changing the medicine purchasing schemes but the implementation has been difficult and can be improved. We are constantly working to build a collaborative dialogue between the industry, UNOPS and the government to develop better distribution processes because we have seen how delays have impacted patients.
Q: What how are innovative drug developers taking advantage of technological trends?
A: The pandemic accelerated trends that were already taking place. For example, AI integration improved disease detection and the development of new molecules, shortening the decade-long development process by almost half.
Moreover, companies have supplemented their treatments with digital tools so patients can track their adherence to treatment, which is one of the biggest problems in identifying the outcome of a new drug.
A large percentage of the global population has internet access, which is why telemedicine has been effective and encouraged. Telemedicine has also been effective in training doctors in remote or different regions and in helping them to reach patients. This tool can enhance access to health.
Q: What alliances is AMIIF seeking as part of its social responsibility strategy?
A: We have been working with Esquipulas for a long time, providing medical care to indigenous people. AMIIF also has strategic partners, such as Save the Children, Cruz Roja and Direct Relief. Through Direct Relief, we donated 145,000 units of methotrexate and cyclophosphamide in March 2020. We also donated masks. More recently, the organization financed the first arrival of Moderna’s COVID-19 vaccine to Mexico. Direct Relief has also financed vaccine donations from Mexico to other Central American countries.
Q: What new financing schemes for innovation could best fit Mexico’s health system?
A: The payment-by-result model has been pursued by AMIIF for years. In this model, companies do not charge for the drug but for the outcome it generates on a patient. For health systems, especially public health systems, this model could curb their spending and encourage treatment adherence among patients.
In the US, studies have shown that the payment-by-result model improves the use of resources by 28 percent. Results and patient outcomes are the true way to measure the effectiveness of a treatment.
The Mexican Association of Pharmaceutical Research Industries (AMIIF) represents more than 60 national and international pharmaceutical companies committed to the development of new medicines and therapeutic solutions.