MALCOLM ZOPPI | LEGAL JARGON WRITER
Regulatory red-tape is being cut with the aim of releasing a Covid-19 vaccine on the market as soon as possible. A vaccine usually takes between six to ten years to reach the market. The European Commission deemed it not feasible to wait for this long, and decided to “use existing flexibilities in the EU's regulatory framework to accelerate the authorisation and availability of successful vaccines against Covid-19” (European Commission, 2020). This will likely entail not fully adhering to the security measures put in place to minimise possible side-effects that a vaccine may cause. The European Commission’s President Ursula von der Leyen stated that the vaccine will be available by fall, less than a year after the start of its research.
For this, Big Pharma has been asking the European Commission for product indemnity in the case that their vaccines cause side-effects on users. AstraZeneca, a British-Swedish pharmaceutical company headquartered in Cambridge, has been granted such immunity from claims against its Covid-19 vaccine. The European Commission justified this level of protection for the manufacturer by referring to the high levels of risks taken. The risks refer to the need to release a vaccine within a record-breaking time, sacrificing safety measures which have been put in place the safeguard the public’s health.
Possible Legal Implications:
Firstly, the possibility of claims arising from the use of the vaccine are probable. This can be inferred from the pharmaceutical’s worries of serious claims arising, which led to the companies to ask for indemnity. This could mean that a person who suffers a damage from the use of AstraZeneca’s vaccine will not be able to claim compensation. This goes against the common law principle of torts, as well as the rule of law’s fundamental principle of access to justice. Ultimately, people may find themselves in a worst position post-vaccine, without the possibility of seeking rectifying remedies.
Secondly, granting indemnity to large pharmaceutical companies will reinforce Big Pharma’s ability not to face accountability. In 1976, the U.S. Congress approved a request by four drug firms — Merck’s Sharp & Dohme, Merrell, Wyeth, and Parke- Davis — for a similar indemnity deal. They achieved this by “refus[ing] to sell to the government the 100 million doses they had manufactured until they got full liability indemnity and a guaranteed profit” (The New York Times, 2020). The EU Commission’s indemnity deal with AstraZeneca proves that economic lobbying by large organisations sacrifices consumer rights for the benefit of profits.
Possible Commercial Implications:
The possible commercial implications include a lack of confidence by the public towards vaccines. This would be a reasonable response, given that pharmaceutical companies recognised the high risks involved with cutting the red- tape safety measures.
Wider commercial implications of the arrival of a vaccine against Covid-19 could be extremely positive. If the vaccine is taken by the vast majority of people, life can resume as normal. Restaurants and bars will be open at full capacity. Further, people will gain confidence in their spending, allowing for a recovery from the economic downturn we have been experiencing. A rise in transactions between large businesses will occur, and unemployment rates will drop. Masks and hand-gel, on the other hand, will see a drop in sales.
Questions for Discussion:
Is it reasonable to put on the market a vaccine that was rushed to this extent?
Who should be held accountable if someone is negatively affected by the vaccine? The rushing governments, or the rushed manufacturer?
If the vaccine is used widespread, will we return to our usual ways? For example, will we abandon remote-working?
Born in Switzerland, grew up in the Bahamas, studying in England, completed an Erasmus year in Denmark, and now living in Spain.
Malcolm prides himself on his internationality and ability to analyse current affairs from different perspectives.
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