USA IRAC METHOD TO ANSWER

For the past year, a deadly virus, SARS-CoV-2, has been ravaging the globe. The illness it causes, COVID-19, has led to millions of premature deaths and irreparably impacted countless lives. Luckily, in record speed, numerous pharmaceutical companies spanning the globe have independently created successful vaccines to combat COVID-19, and help the world get back to some semblance of normalcy.

As can be expected with any undertaking of such urgency, vaccine rollout has been inconsistent globally. Some countries, primarily wealthy, have safely and efficiently vaccinated large swaths of their populations, while others have yet to

administer a single dose. This is a story about one such country in a race to save its citizens, all while navigating the pitfalls of a world order turned upside down by a pandemic.

Britannia, an island nation in northern Europe, was one of the first countries to provide emergency authorization to a vaccine, Zenon-1, which is produced by a Britannia-based pharmaceutical company named Robinson & Robinson (R&R). This was quickly followed by emergency authorization of a second vaccine, AniVax, which is produced by AniPharm, a company headquartered in the Peoples Republic of Nicha. Early in the vaccine regulatory approval process, Britannias Health Minister, Dr. Antonio Faucet, negotiated separate purchase agreements with both R&R and AniPharm.

Deal minted with Britannia, R&R went on to choose BioBharat Inc., located in the Republic of Bharat, a large and quickly developing nation located roughly 6,000 miles from Britannia, as the prime location for quickly and cheaply manufacturing the medicinal contents of each R&R vaccine vial. The agreement between BioBharat and R&R noted that BioBharat shall use its best reasonable efforts to manufacture all that is required of R&R to deliver finished vaccines directly from Britannia-based fill and finish distribution hubs, following emergency use authorization. R&R then opened numerous fill and finish distribution hubs across Britannia. In the pharmaceutical industry, fill and finish is the process of filling vials with vaccine and finishing the process of packaging the medicine for distribution.

While the relationship between R&R and BioBharat started off on a good foot, recent developments caused a strain in the relationship and a political headache for Britannia. A recent shipment of five-million Zenon-1 doses was sent by BioBharat via TransOcean Liners Ltd., a cargo ship carrier company. One day before the carrier was due to cross through the Suez Canal, a massive container ship, the Ever Given, ran aground in the canal and blocked trans-canal passage for six days. As the carrier vessel waited days to cross, the freezers in the cargo hold specially designed to maintain recommended vaccine temperature conditions were turned off to conserve fuel. As a result, the doses eventually delivered to R&R were both late and rendered useless.

Prior to this, alongside signing off on the agreements with R&R and AniPharm, Britannias Prime Minister, Doris Johanssen, convinced the Britannian Department for International Trade to set new tariff rates for imported vaccines and vaccine componentswith a rate of 15% for complete and

ready-to-use vaccine doses, and 0% for vaccine components. As AniVax is produced entirely in Nicha, and then shipped within filled vials ready for immediate use in patients, AniPharm has been hit with a 15% tariff at Britannias border. However, Zenon-1 is filled and finished in Britannia from both domestic and foreign component parts imported from Bharat, and thus, no duties have been levied on the Bharati-produced Zenon-1 components upon import.

The two approved vaccines use different technologies, or platforms. AniVax utilizes the most conventional methodan inactivated vaccine. This means it contains dead virus. Because the virus is still whole, it has all the parts, in the correct shape, that can stimulate a response from the immune system to destroy any SARS-CoV-2 virus that enters the body. Zenon-1 is a nucleic acid vaccine. This means it is a sequence of messenger RNA wrapped up in a lipid droplet to stop it being degraded in the body and help it get inside a cell. RNA is a sensitive molecule and is chopped up very easily and quickly if not protected by cold temperatures. Once the RNA gets into a cell, it instructs the cell to make the SARS-CoV-2 spike protein to which the immune system then responds.

Zenon-1 has been proven to be up to 95% more effective than a placebo at preventing symptomatic disease, while AniVax has a 72% overall efficacy with 86% efficacy against severe disease. AniVax is easier to store, as it requires storage at only refrigerator temperatures, while Zenon-1 requires standard freezer temperatures. AniVax requires only a single shot, while Zenon-1 requires a booster shot twenty-eight days after the first dose. Both vaccines have similar side effects, including, chills, headache, pain, tiredness, and/or redness and swelling at the injection site, all of which generally resolve within a day or two. While the vaccines have different active ingredients, they both contain similar inactive ingredients, such as lipids, tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose. Rumors abound related to both vaccines, with many Britannians believing the Nichan vaccine was rushed, failed to meet high scientific safety standards, and given the rocky political relationship between Britannia and Nicha, many believe it is subpar, its efficacy overinflated by the Nichan government, or could even be dangerous. Overall, roughly 73% of Britannians said they would get vaccinated, though a global poll found people are generally less likely to say yes to getting a COVID-19 vaccine made in Nicha.

To win back some public favor after the Suez vaccines scandal, Britannias government recently began enforcing a policy that prioritized shipments of vaccines from Britannia-based fill and finish distribution hubs straight to publicly funded hospitals, which are the main locations for vaccinations in Britannia. Any and all other vaccines filled and finished fully abroad have been designated as secondary gap-fillers used only in the event of a shortage of supply so as to consistently meet the governments commitment to inoculate one-million people per day. Domestic distribution hubs tapped to fill and finish are now, by law, required to use 50% domestically produced component partsresulting in the glass vials, seals, and sterile syringes used by R&R being produced solely by Britannian-based companies in Britannia.

Discuss any and all issues you spot from the above hypothetical using the IRAC method. Assume all countries discussed are member states of the WTO and have ratified the CISG.