The process for drug approval is something that varies between different countries and continents. From the United States’ FDA (Food and Drug Administration) to Europe’s EMA (European Medicines Agency), as well as other agencies across the world, such as Japan’s NIHS (National Institute of Health Sciences) and the United Kingdom’s MHRA (Medicines & Healthcare Products Regulatory Agency), procedures, requirements and efficiency are all different. As different locations around the world have diverse laws and regulations, this certainly makes sense. However, the effect that this has on those who need different medications is profound yet often forgotten.
On a more personal note, this is an issue that I had been relatively unaware of until it began to affect me personally. Recently, the FDA approved a medication, called Skyclarys, for Friedreich’s Ataxia, a genetic disorder I have. This medication has shown incredibly positive results and may have the potential to halt the progression of a degenerative and life-shortening disease. While this is fantastic for the 4,000 patients in the United States who have Friedreich’s Ataxia, the remaining 11,000 individuals afflicted with this disorder across the world do not have access to this potentially life-saving medication. This is not to say that this medication is not making its way through other pipelines, and is currently seeking approval by the EMA, but it is something that will take time. In this case, and in many similar diseases with much shorter life expectancies, time is not a luxury that those affected have.
There are certainly flaws in all of these organizations, but there are also areas in which some supersede others. For example, the FDA is known to be faster than other agencies, such as the EMA, due to policies and procedures including fast-tracking, a designation that is given to medications that may affect particularly vulnerable populations. The EMA does have similar designations in place, but they do not seem to move as quickly as comparable programs within the United States. In addition to the EMA, medications must go through the European Commission, which considers the EMA’s recommendations and makes a final decision on whether or not a drug will become available to the public.
However, this is not to say that the EMA does not have benefits. While drugs may not be introduced into European populations as quickly, they do frequently benefit from more extensive research into efficacy and safety. Additionally, in countries with nationalized healthcare, it often takes longer for a drug to go through insurance processes. So, even though a drug may be available within the United States, it can take months for insurance approval to be completed and allow the average American to access the medications that they need.
While different agencies can vary procedurally, this is not to say that they do not work with one another. The FDA and EMA, for example, have near-daily communication and discuss the drug developments that they are making progress on. Sometimes, such as with the COVID-19 vaccine, different regions will work together to devise a solution to a global crisis. While this is great, it is just one step in the right direction.
It is difficult to say what the best approach to drug approval is — is the FDA’s focus on efficiency more useful, or is it better to follow the EMA and be more cautious, potentially losing lives as a result? While we may have our own opinions, nations must have the autonomy to make these decisions for themselves. Although decisions regarding drug approval have every right to vary across the world, it is crucial to look at the repercussions that this has on patients. It seems that the more collaboration that agencies have with one another, the more is accomplished and is therefore done so much more efficiently.
With the current state of the world, there is not a single perfect solution to reaching a globalized drug approval process. However, one way to approach this problem is by looking at collaborative efforts within drug development, such as those employed during the COVID-19 pandemic.
Firstly, this would allow for drugs to be developed more quickly. It seems relatively obvious, but the more people that contribute ideas, the faster that solutions will be reached. The biggest obstacle in accomplishing this is drug companies, which often compete with one another to create medications for the same condition. However, there does not seem to be a good reason that different companies and nations cannot collaborate and split profits. The only argument against this is the pure greed of drug companies and their desire to make as much money as possible. But, if collaboration were to become more common, companies would be splitting profits for a larger number of drugs, making this completely inconsequential.
Additionally, if countries were to work together in developing a drug, the process of approval would be inevitably sped up. One reason that agencies take different amounts of time is the varied requirements for what a drug needs to be approved. If drug development begins to take a more global approach, then the standards and goals that clinical trials and other studies need to take would be more standardized. Rather than conforming to the country that a pharmaceutical company is based in, studies would be more inclined to cover all of their bases. While this may add some time in the short-term, long-term effects would certainly outweigh this as agencies would not need pharmaceutical companies to return to the drug and enroll in more trials to do small amounts of additional testing.
Drug approval is only one of many obstacles in the process of taking a drug, though, as receiving a prescription, insurance approval and availability of medication are all extremely common barriers to face. Creating a more unified and streamlined process for global drug approval would certainly be a step in the right direction, but there are so many different steps, such as making medicines affordable and globalizing production, that must be taken in order for people to access the medications that can allow them to live long and healthy lives.