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The Legal and Ethical Challenges of a Coronavirus Vaccine

Writer's picture: maxalexanderjonesmaxalexanderjones

Upon the announcement that Pfizer and BioNTech had found a coronavirus vaccine with a 90% success rate, their share price rose from the closing value of $36.40 on Friday 6th November to $41.92 at the start of trading on the following Monday. To put this in perspective, Pfizer has never seen such an increase in their share price in such a short period of time. Upon the back of this vaccine news, the FTSE 100 registered its second highest daily rise since 2015 proving that a potential vaccine is about more than saving lives – it is about restarting economies.



 

Legal Issue: IP Rights


The legal issue of a vaccine comes when you consider how one firm having full IP rights to create a vaccine would negatively impact the global coronavirus battle. Pfizer currently has one hundred and thirty-seven approved drugs and is looking to add this new vaccine, called BNT162, to its arsenal, pending approval by the Food and Drug Administration (FDA). In response to a potential monopoly on the production, pharmaceutical campaigners for Global Justice Now have called for a suspension of patent rights for this vaccine to prevent genuine healthcare taking a backseat to profits. Currently, Pfizer and BioNTech can only produce 50 million doses for 2020 and, as it is a 2-dose vaccine, only 25 million people can be immunised. It is important to note that this production capacity is including the financial support lent by Operation Warp Speed (an American government initiative to facilitate and accelerate the provision of a vaccine). Advocates for lifting exclusive patent rights rest their argument on the idea that current production levels are not high enough to deal with global demand. The way things are heading, with only one candidate producing the vaccine, there will be artificial scarcity as the implementation of patents mean that resources that could be directed towards manufacturing more cures are prevented due to legal protection. The World Health Organisation (WHO) has created the COVID-19 Technology Access Pool (C-TAP) to try and prevent such artificial barriers being constructed. This pool calls for all parties involved in the research and administration of coronavirus vaccines to put any “technology related knowledge, intellectual property and data” they may have, into the pool. The lower production costs and increase in access to medical supplies that would result from the use of the C-TAP program would certainly decrease the time frame within which the global pandemic would be dealt with, but at the cost of profit.



Opposition to this pooling of resources comes, inevitably, from those who are bound to gain from the retainment of such information. Chief executive of Pfizer, Albert Bourla, stressed that the researching companies are pouring a nearly endless amount of resources into this project and that the risk of developing a working vaccine is relatively low. The chief executive of AstraZeneca echoed a similar sentiment, saying that IP rights were a fundamental part of the pharmaceutical business and that not protecting them would hamper incentives to innovate. Despite this clear opposition to a pooling programme, AstraZeneca has nonetheless taken government grants; thereby undermining their attitude that the risk bearer should have sovereignty over their product. Pfizer, on the other hand, has chosen not to take any government funding on the basis of reducing bureaucracy for their scientists. In their defence, and the defence of pharmaceutical giants as a whole, they have generally pledged, some better than others, towards efforts that would ensure the equitable distribution of a vaccine. It seems that many executive qualms are specifically focussed on the pooling of patents rather than the general idea of equity in provision of the vaccine – something which AstraZeneca has shown they believe in by promising not to include a profit margin for the company while the pandemic was still expanding. Ultimately, the legal issues of hoarding key IP rights are relevant in that they create artificial ceilings on production levels in the name of profit without giving back enough during the actual provision of the vaccine.



 

Ethical Issue: Vaccine Sovereignty



The second challenge of a coronavirus vaccine is more of an ethical one, most notably, the idea of vaccine sovereignty. Vaccine sovereignty is a criticism of some of the vaccine development partnerships concerning the idea that the results of the partnerships will not serve the countries who need them most, but instead, the countries who have made them, or the countries who have paid the most. For example, the United States has reached an agreement with the University of Oxford/AstraZeneca partnership to buy 300 million doses at the price of $1.2 billion even before their vaccine is proven safe or effective. There is a worry that some countries may introduce protectionist measures to inhibit other countries’ ability to purchase the vaccine and thereby increase the amount

available for the domestic population. This ultimately leaves lower income countries with very few options. Already less prepared than larger countries to deal with the fallout of coronavirus, they are unlikely to be able to fork out large amounts of money for vaccinations and as a result, they will suffer heavier casualties. To combat this problem, the Serum Institute of India acquired a licencing agreement with AstraZeneca within which one billion doses of a potential vaccine would be made available for low and middle income countries, with half a billion of them going to India. China has pledged even more generously, saying that a successful Chinese vaccine would become a global, public good, implying that enough doses would be produced for international and national demand. Dr Tedros, director-general of the WHO, has said that tools to deal with the coronavirus crisis are global public goods and that for the solutions to this problem to work for everyone, there must be “solidarity” between countries rather than a hunt for profit. To prevent an ethical challenge from overwhelming us, companies must put prioritise lives and distribute the available vaccines equitably, rather than simply providing them to the most affluent countries.



 

Conclusion


Ultimately, the broad economic challenge that has resulted from coronavirus has proven to everyone that this has evolved far beyond a simple public health crisis. Economies and the prevalence of COVID-19 are inextricably linked, and governments, through initiatives such as Operation Warp Speed, have shown how committed they are to finding a way out of this crisis – even if that way out involves acting unethically by letting nationalist notion and corporate greed blind what the right thing to do is.


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A legal outlook by students, for students.

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