Pharmaceuticals should heal society. But instead when most hear the term ‘Pharmaceuticals,’ they think of the opiates that should be relieving pain, not causing overdoses; and telemarketed drugs that have enough side-effects to cause anxiety with the ever-present phrase “do not take this if you have experienced...” Then, there are also life-saving vaccines. Some people have even lost trust in vaccines, shown by the anti-vaccination movement which sprung up in the late 1900s. The world is currently waiting for a vaccine for COVID-19, not to mention tests. The disease that has already killed more U.S. citizens than the Vietnam War is on everyone’s mind, yet the industry can’t seem to provide the answers everyone is craving. Where does this powerful industry fall short? What can be done to improve the pharmaceutical industry and save lives? Blockchain technology is a revolutionary solution. Executing blockchain technology in the pharmaceutical industry (the vaccine sector specifically) will aid in the regulatory process the drugs/vaccines go through to become approved for consumption, build rapport with the public, and decrease the falsification of data.

What is Blockchain?

To understand the power of blockchain in the pharmaceutical industry, one must understand the concept first. The term was first popularized by the cryptocurrency, Bitcoin, that took off in 2016. A blockchain is a “record-keeping technology” that enables industries to become completely transparent in their operations (Reiff.) Think of blockchain technology like evidence logs used in law enforcement. Everyone who has had contact with the evidence (the product) must write their name down, that way if anything were to happen to the evidence, there would be a record to find out who tampered with the evidence quicker. Another part of blockchain technology is the ‘decentralized administrative body,’ where a consensus of the network majority is needed to change one block. When there are changes, the block records the updates and who made them as well as notifying all other recipients up and down the chain. This increases transparency and efficiency as there is no middle man.

One of the first major non-cryptocurrency to implement blockchain in their everyday business was the diamond industry. The diamond industry has been criticized for lacking ethically sourced diamonds for years when Zimbabwe and parts Eastern Africa were a warzone. By implementing blockchain technology, everybody (from the shipping company to the appraiser to the customer buying the diamond) has access to the records of where the diamonds came from and each step they took to get to the piece of jewelry that was purchased. This enhances the value of the diamond as they are certifiably ethically sourced. This also increases companies’ rapport with customers and makes business processes more efficient. Efficiency is money saved; so by adding blockchain technology to their business, I believe the diamond industry increased their earnings and their marketability. The same can be done for the vaccine sector.

Current Condition of the Vaccine Sector

To people solely following the media during any health crisis, the vaccine research sector of the pharmaceutical industry must appear like a traveling circus. It pops up when something is going on, always seems to have a problem, and doesn’t fulfill the fantasy of the viewers. Also like a circus, there are multiple acts all going on at once, and not necessarily synchronously. The major concern right now in the vaccine research sector is COVID-19. The Centers for Disease Control (CDC,) The Army, the MayoClinic, and countless other universities are all simultaneously working on a vaccine for the disease. Researchers also need to be working on the Flu shot for fall 2020, as well as a vaccine for the new Measles outbreak in the North Eastern United States. That is just in the U.S. There is also a new outbreak of Ebola in the Democratic Republic of Congo, which could easily spread to the neighboring countries. New vaccines are being developed in virtually every country, for a whole plethora of diseases, with seemingly no organization or efficiency.

Needless to say, the vaccine research sector appears very overworked and overwhelmed. Technology like blockchain has the potential to completely rework the method of vaccine development, distribution, efficiency, and allocation of resources of labs locally as well as globally.

Government Regulation

Once a vaccine for a disease is discovered, it must jump through multiple hoops designed by the Food and Drug Administration (FDA) and other governmental organizations to be sold and administered to the waiting populace. Blockchain technology can simplify the process of approval for the FDA by creating transparency in the process of designing and testing a vaccine. This can aid with international drug exchanges and support the global community when there is a pandemic or other global health crisis.

The regulations of health officials differ for each country, making the process of developing and distributing vaccines more complicated. A product used in France is not necessarily FDA approved and can therefore not be distributed to all clinics in the United States. This is the case with the Yellow Fever vaccine. In 2019 the sole supplier of the Yellow Fever vaccine for that is FDA approved underwent a “transition to a new production facility” causing a total depletion of all vaccines that can be distributed to all U.S. clinics (CDC). The supplier, Sanofi Pasteur, makes another vaccine in France that is distributed to over 70 other countries. The Stamaril vaccine was allowed into the U.S. by the FDA’s Investigational New Drug (IND) program. This allows the drug to be distributed to specific clinics but is nowhere near as available as the actual FDA approved Yellow Fever Vaccine. Even though the Yellow Fever vaccine is only recommended to those who are traveling to South America or Africa, the complete wipeout of all of the vaccine raises the ‘what if’ questions. What if it was a more important vaccine like the flu or measles? Or What if the replacement vaccine was not immediately approved by the IND program? This is one instance where blockchain technology can help simplify the process of determining approvals for experimental drugs.

The time it takes for a drug to be approved by the health administrations of countries would be shortened by a significant amount because one of the key aspects of blockchain technologies is transparency. All parts that go into making a vaccine could be put on a block, which would immediately be communicated to the FDA via a node (a computer that immediately receives an update when a block is updated.) All aspects of the production of the vaccine can be vetted by the FDA efficiently, getting the vaccine to the American people sooner and preventing the spread of disease. Suppliers would have their production environment considered and tested for alignment with government regulation. The chemicals in the vaccine can be put in a block, and the ingredients can be made available quickly to the FDA who can then determine if the chemicals are concurrent with health and safety guidelines. Dr. Smith of Sanofi Pasteur and his colleagues, in “Vaccine production, distribution, and uptake,” point out that improvements to the global infrastructure of the pharmaceutical industry could be made via “Harmonisation of regulatory and quality requirements to allow simplified and simultaneous licensure across the globe”(15.) By putting all of the ingredients and processes in blockchain technologies, not only would vaccines be distributed more quickly across the world, but the infrastructure could improve as regulations can become more compatible with increased access to the developmental process of vaccines.

If blockchain technology were to be implemented to the pharmaceutical industry, the time it takes for a government health organization to approve a new or temporary replacement vaccine would be shortened by a large amount, quelling concerns of shortages while ensuring the competence of the international or new vaccine.

Rapport with the Public

Even if the vaccine makes it through research, development, and approval by government agencies, there is the public that needs to take the vaccine. There has always been a distrust of what is new and discovered by science, especially with vaccines in certain groups of people.

If the vaccine sector of the pharmaceutical industry wants to continue to grow, there needs to be an increased rapport with the public. In the 1900’s it was believed that Autism was caused by vaccines, and that belief has yet to be completely dispelled. The “anti-vaccine propaganda” and rhetoric found in the 20th and 21st century causes even more skepticism with the vaccines developed (Smith et. al. 15) This subgroup dubbed ‘anti-vaxxers’ are refusing to vaccinate their children because they believe the health risks of vaccination are greater than that of the diseases. The opposite is true. As found in the Northeast U.S., there is a new outbreak of measles because the kids are not being vaccinated and are transmitting the disease to their classmates and friends. If the anti-vax movement continues, it could result in an increased rate of disease and an increased risk of epidemics and even pandemics. The relationship of trust between vaccine researchers and the populace must be rekindled; blockchain technology can do this.

Because the blockchain technology allows for increased transparency of business operations and the products themselves, it can be harnessed to rebuild the relationship between researchers and the public. Similarly to how a client buying a diamond can see what their diamond went through to get to their jewelry, a parent who is nervous about vaccinating their child can see the process of developing the vaccine. The uncertainty among the skeptical public will diminish when the parent sees the months, if not years, that went into developing the vaccine, and each step taken in production. This shows the parents the importance of vaccines; a product will not go through months of development and testing and given to the public if it wants to fail. The blockchain doesn’t have to stop with the ‘sale’ of the product when it comes to vaccines, it can be continued to increase support. There can be an additional block added to report the number of children who have taken a certain vaccine, and their condition afterward. The probability of developing side effects because of vaccines without an allergy to a medication is very rare. If parents can see the percentages and how they change with each administration, they are more likely to believe the statistics that are thrown around in the media. Implementing blockchain technology can only increase the understanding of the amount of effort put into immunizations, increasing public rapport, and decreasing the risk of another resurgence of other diseases.

Falsification of Data

The backbone of any scientific study is the data provided, so the data must be accurate and accountable. Without accountability in data, there would be no possibility of improving vaccines or developing responses for diseases. Panic is the most dangerous effect of any crisis, it often causes more problems than are necessary. Accurate and accountable data will prevent panic, saving the world from unnecessary pain and damage.

Finding reliable data seems like it would be easy to come across in the world of science, but current events prove otherwise. When COVID-19 was first appearing in Wuhan, China, it is now apparent that the initial numbers were not accurate. While this could have been done for a variety of reasons, the main point is that the data was falsified. A major concern for researchers when developing vaccines is inadequate and falsified data. Not having the correct data during a pandemic can cause governments to over or underestimate the amount of spread a disease could have, and then the policies that result will not be adequate for the true force of the pandemic. In the case of COVID-19, the data was underestimated so the government response was not as quick or intense as it needed to be earlier.

Because blockchain technology allows for the editing of data from only a consensus of a decentralized administrative source and records all of the changes, there would be increased accountability in health data, aiding in the control and response to global health crises. Currently, the World Health Organization (WHO) is the main organization holding accountability in the pharmaceutical industry. They are the central midpoint where data is processed and their analysis influences the epidemiological decisions for the rest of the world. They must rely on the information given by scientists alone. If blockchain technology were to be implemented in the pharmaceutical industry, the scientists reporting data would be checked by the system themselves. This allows the WHO and other international health organizations to process data quicker and formulate a plan for the global response quicker. The data would be better grounded in fact, and the response would be better catered to each specific outbreak zone.

Conclusion

Implementing blockchain technology to a non-financial sector of government and industry may appear confusing and far-fetched, but it can result in an incomparable improvement in the pharmaceutical industry. Like in the diamond industry, the goods are valuable. There also needs to be government regulation, but it can be more efficient and more harmonious with the rest of the world’s regulations by using blockchain technology. People want to know that their vaccines, as their diamonds, are safe and will not cause them to lose sleep over the safety of their investment. Vaccines are beneficial to everyone in society, and if the skeptical public who are concerned can see the refinement, testing, and care that went into making the vaccine, they may just start trusting science again. Blockchain technology most importantly prevents the falsification of data, which is crucial in situations similar to the current crisis of COVID-19. If health data is accurate and reliable, as it would be with blockchain technology in place, governments and organizations would be able to prepare accordingly for any health risk, reducing panic and saving lives. The pharmaceutical industry isn’t broken, just sick. The symptoms? A lack of transparency, accountability, and efficiency. The cure? Integrating blockchain technology into the vaccine sector of the pharmaceutical industry.

Citations

  • O'Neal, Stephen. “Diamonds Are Blockchain's Best Friend: How DLT Helps Tracking Gems and Prevents Fraud.” Cointelegraph, Cointelegraph, 6 Feb. 2019, cointelegraph.com/news/diamonds-are-blockchains-best-friend-how-dlt-helps-tracking-g ems-and-prevents-fraud.
  • Oyston, Petra, and Karen Robinson. “The Current Challenges for Vaccine Development.” Journal of Medical Microbiology, vol. 61, no. 7, 2012, pp. 889–894., doi:10.1099/jmm.0.039180-0.
  • Reiff, Nathan. “Blockchain Explained.” Investopedia, DotDash, 1 Feb. 2020, www.investopedia.com/terms/b/blockchain.asp.
  • Smith, J., Lipsitch, M., & Almond, J. W. (2011). Vaccine production, distribution, access, and uptake. Lancet (London, England), 378(9789), 428–438. https://doi.org/10.1016/S0140-6736(11)60478-9.
  • United States, Congress, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), and NCEZIC. “Clinical Update Announcement: Temporary Total Depletion of US Licensed Yellow Fever Vaccine Addressed by Availability of Stamaril Vaccine at Selected Clinics.” Clinical Update Announcement: Temporary Total Depletion of US Licensed Yellow Fever Vaccine Addressed by Availability of Stamaril Vaccine at Selected Clinics, CDC, 2019.

About the Author

Victoria Tholkes

University of Wisconsin-Madison

  • Field of Study:Biochemistry and Spanish
  • Expected Year of Graduation:2023
  • Chosen Prompt: Blockchain solutions for the pharmaceutical industry and how the technology will help solve problems and challenges in the next 3-5 years.