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.
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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.
I once heard Rachel Kiddell-Monroe (the former president of UAEM) give a talk about her time working in a MSF hospital in Rwanda during the genocide. Upon arrival, she was being given a tour around the various units when she encountered a door that was completely shut. When she looked inside, she saw a room full of patients with HIV, all very close to death, and nothing being done to improve their health. The response she received from the MSF headquarters was simple: “Do you know how much it costs to treat a single patient with HIV? There’s nothing we can do for these people.”
As an international organization, UAEM aims to collaborate with universities to develop licensing policies that promote access to medicines in developing nations. Considering that universities develop one-third of all new medicines annually, this approach is justified. A clear example of a policy that would increase access to medicines is the use of non-exclusive rather than exclusive licensing in agreements with pharmaceutical companies. Exclusive licensing would give a single pharmaceutical company rights over the manufacturing, distribution, and importantly the price of the drug. On the other hand, non-exclusive licensing would allow multiple companies to produce and sell the drug, introducing generic competition and driving the price down.
Real-life examples of how these policies help address this global health crisis are abundant. In 2007, the University of British Columbia (UBC) licensed their first medical innovation under a global access licensing policy. The drug was a low-cost oral formulation of Amphotericin B, a novel agent with improved ease of administration and reduced toxicity, which could potentially treat 12 million individuals (nearly all of whom were in developing nations). It was only because these socially responsible licensing policies had been put in place that UBC was able to reach an agreement with iCo Therapeutics to ensure that the drug would be sold at-cost (with no profit gain) in developing nations. Considering that 0.8% of revenues generated yearly by US pharmaceutical companies come from Africa, India, and China, I believe that the marginal decrease in profits would be well worth saving the lives of millions in the developing world.
Regarding Western, our UAEM student group is leading a campaign to advocate for our university to form its own global access licensing policy using measures outlined in existing frameworks, such as the Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies (SPS) and the Global Access Licensing Framework (GALF). Through formal communication and collaboration with university administration and relevant policy makers, it is our hope that Western recognizes the importance of these policies and takes steps to adopt them, so that if any medicines are discovered by Western researchers in the future, we’ll be able to say that we certainly can do something for these people.
Written by: Michael Lee
Michael is currently in his third year of undergraduate studies at Western University and serves as UAEM Western's VP Access.