A Look into the R&D System

In a nutshell, the process for a drug to come to market is the following: discovery and development, pre-clinical trials, clinical trials, approval by the respective government health agency (ex. FDA or Health Canada), and then finally post-approval research. The patent holder may then license their product to other parties, such as pharmaceutical companies, giving them the rights to distribute and manufacture the medicine.
 
Due to the profit-driven nature of the R&D system, a lot of the incentive comes from return on investment. For example, antibiotic resistance is becoming an increasing issue due to excessive use, misuse, and lack of innovation—evident by only 5 out of the 150 major pharmaceutical companies even running active antibiotic development programs. Antibiotics, which are taken for a short period of time and generally cure the targeted disease, do not generate a lot of profit for a pharmaceutical company. In contrast, a medication for diabetes or hypertension which must be taken by a patient every day for the rest of their lives, generating large amounts of revenue.
 
Another example of the drive for profit can be seen with the Ebola virus. Ebola has been around for the last 40 years; however, it has traditionally been confined to poor African nations. Once the Ebola outbreak occurred in 2014, no one was prepared for it, as there was a serious lack of treatments available. Although deadly, Ebola had not been much of a research interest due to its lack of profitability for pharmaceutical companies. In addition, the World Health Organization (WHO) has compiled a list of neglected tropical diseases such as Dengue and Chagas Disease that affect more than a billion people worldwide. Again, there is little incentive in the pharmaceutical industry to innovate solutions for these diseases, since they mainly affect populations living in poverty.
 
The R&D system also fails to deliver affordable medications. Take the case of Martin Shkreli for example, the former of CEO of Turing Pharmaceuticals. He famously hiked up the price of the antiparasitic drug Daraprim from US $13.50 to $750 per pill, making the medication virtually unaffordable. Contrast that with the fact that Daraprim was recently recreated by high school students in Australia for a mere $2 per pill, clearly demonstrating that Turing’s price hike could in no way be justified. 
 
There are some serious flaws with the current R&D system. This is why UAEM is working with WHO to implement an alternative global R&D agreement. A global R&D agreement would ensure that WHO Member States provide appropriate funding centered around global health needs. It would also ensure WHO Member States commit to seek alternative mechanisms for innovation that are not backed by a financial incentive. Finally, this agreement would encourage collaboration among researchers all over the world to ensure that innovation is as fast and efficient as possible.
 
For more readings:
 
http://uaem.org/our-work/campaigns/the-alternative-biomedical-rd-system-campaign/
http://phrmacdn.connectionsmedia.com/sites/default/files/pdf/rd_brochure_022307.pdf
http://apps.who.int/medicinedocs/en/d/Js4907e/3.5.html#Js4907e.3.5
https://www.theguardian.com/science/2016/dec/01/australian-students-recreate-martin-shkreli-price-hike-drug-in-school-lab  

Written by: Christina Blagojevic
Christina is currently in her third year of undergraduate studies at Western University and serves as one of UAEM Western's Global Research and Development Leaders.