Thinking | 2 June 2021
Health & Community Law Alert: COVID-19 vaccines – the role of government for community access, equity of access and waivers
By Alison Choy Flannigan and Lauren Krejci
The COVID-19 pandemic has highlighted ethical and moral failures to protect the most vulnerable of the world’s population in what will be remembered as one of the greatest human tragedies of this century. What has been the role of governments and pharmaceutical companies and what lessons can we learn for future generations? We examine the legal and ethical issues in this article recently published by the IBA Healthcare and Life Sciences Law Committee.
‘The world is on the brink of a catastrophic moral failure – and the price of this failure will be paid with lives and livelihoods in the world’s poorest countries.’
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, 18 January 2021
Issues with equity of access
The legal and ethics issues include:
- The role of governments in negotiating contractual deals with vaccine companies, such as Pfizer and AstraZeneca, in both purchasing vaccines and entering into licencing deals to manufacture the vaccines within their own countries. Unfortunately, as we have seen:
- Wealth has driven supply. In February 2021, the US Department of Health and Human Services (HHS) and Department of Defense (DOD) purchased an additional 100 million doses of COVID-19 vaccines from both Pfizer and Moderna to help meet demand for COVID-19 vaccines in the United States. The orders placed bring the vaccine purchased by the US government from these two companies to a total of 600 million doses, enough to vaccinate 300 million people. Each company is delivering 300 million doses in regular increments through to the end of July 2021. Each company will leverage US-based manufacturing capacity to fill, finish and ship vials as the bulk material is produced.
- Poverty in developing nations has driven hardship, for example in countries such as Papua New Guinea.
- The pandemic crisis in India (which is one of the world’s largest manufacturers of vaccines), has proven that the reliance on sourcing vaccines from overseas is no longer an option.
- The role of governments in blocking vaccines from leaving their countries. In March 2021, the Economic Union blockaded the export of vaccines to Australia. The EU was accused, primarily by the UK and the World Health Organization (WHO), of so-called vaccine nationalism after it introduced export controls on jabs produced within the bloc.
- The WHO issued its Vaccine Equity Declaration in January 2021, which urged all countries to work together in solidarity to accelerate vaccine equity for health workers.
- Intellectual property rights. International treaties concerning intellectual property rights and the rights of governments to require mandatory licences in patents.
- Current situation in Australia on the COVID-19 vaccine
- The Government will provide $1.9 billion over five years from 2020-21 to distribute and administer COVID-19 vaccines to residents of Australia (free of charge to Australian residents).
- The Government will provide funding to the Department of Industry, Science, Energy and Resources to work with the Department of Health to develop an onshore mRNA vaccine manufacturing capacity in Australia.
- Government indemnities
- Intellectual property
The Australian Government has entered into three separate agreements for the supply of COVID-19 vaccines with Oxford University/AstraZeneca, Novavax and Pfizer/BioNTech. The Australian Government has also joined the COVAX Facility, which will allow for the purchase of vaccine doses as they become available. The Facility is investing in a diverse portfolio of potential COVID-19 vaccines. To date, more than $4 billion has been invested through these agreements.
The Pfizer/BioNTech vaccine has been provisionally approved by the Therapeutic Goods Administration (TGA) for people aged 16 years and over. As per the Australian COVID-19 Vaccination Policy, those who are at increased risk of exposure, developing severe outcomes from COVID-19 or working in services critical to societal functioning have been given priority.
The AstraZeneca vaccine also received provisional approval by the TGA in February 2021 for people aged 18 years and over. However, the Australian Technical Advisory Group on Immunisation (ATAGI) has since recommended the AstraZeneca vaccine for persons aged 50 years and over.
Currently the AstraZeneca vaccine is being manufactured by CSL in Australia.
The Australian Government announced in its Federal Budget on 11 May 2021:
Further, the provision of Government immunities provided in order to secure supply and the ability of vaccine manufacturers to procure waives also raises a number of ethical issues in the event that a patient suffers an adverse event.
In the 2020-21 budget papers, the Australian Government announced that it has provided an indemnity to Oxford University/AstraZeneca, 'covering certain liabilities that could result from the use of the vaccine'. However, it is unclear what this indemnity deal means in practice. The Government has provided similar deals to certain pharmaceutical companies that manufacture smallpox and influenza vaccines for Australia.
Similarly, the European Commission has entered into Advanced Purchase Agreements (APAs) to secure supplies of COVID-19 vaccines. The EU Vaccine Strategy aims to ensure swift and equal access to vaccines for its Member States. To date, the Commission has entered into APAs for four different vaccines: BioNTech-Pzifer, Moderna, AstraZeneca and Johnson & Johnson. According to the EU Vaccine Strategy, the APAs have provided for Member States to indemnify vaccine manufacturers for liabilities incurred under ‘specific conditions’. However, the Commission has emphasised that the indemnity provisions do not affect ‘the regulatory burden of proof borne by the companies to demonstrate the safety and efficacy of their products’.
Further, the US government issued a declaration under the Public Health Services Act to ‘provide immunity for activities related to medical countermeasures against COVID-19’, such as vaccine manufacturers. This declaration was authorised under the Public Readiness and Emergency Preparedness Act (PREP Act). To date, the US government has also entered into several agreements with pharmaceutical companies to secure a COVID-19 vaccine supply, including Moderna and Pzifer.
Unlike the US and the UK, Australia does not have a no-fault vaccine compensation scheme or specific COVID-19 vaccine compensation scheme for rare side effects. Further, Australia’s National Disability Insurance Scheme does not compensate individuals for temporary vaccine-related injuries. However, the Australian Government may choose to introduce a no-fault compensation scheme as its COVID-19 vaccine rollout plan progresses.
As a WHO member, Australia is a party to the Agreement of Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement). TRIPS sets out a number of general principles, contains minimum standards on intellectual property and deals with enforcement procedures.
Most intellectual property treaties are developed through WIPO. Australia is a signatory to many of the 26 multilateral treaties that WIPO administers.
Further, as we have seen in the past with HIV medications, and the competition for scarce resources such as ventilators in the US, equity of access is also an issue, particularly as patents grant monopoly rights.
In the Australian Patent’s Act 1990 (Cth), the Federal Court may make an order requiring the grant of a compulsory licence to exploit a patented invention.
The court may order a compulsory licence to be granted if certain conditions are met, including that demand in Australia for the invention is not being met on reasonable terms, authorisation to exploit the invention is essential to meet that demand and it is in the public interest to grant the licence. If the person seeking the compulsory licence is the patentee of another invention and is seeking the licence to exploit that other invention, the court must also be satisfied that the other invention involves an important technical advance of considerable economic significance on the original invention.
The court may also order a compulsory licence to be granted if the patentee has engaged in restrictive trade practices in connection with the patent under the Competition and Consumer Act 2010 or under an application law (within the meaning of that Act).
The court may order a patent to be revoked after an order for a compulsory licence has been made (on the same grounds that apply to an order for a compulsory licence).
The patentee must be paid an agreed amount of remuneration, or an amount of remuneration determined by the court.
It will be interesting to see what governments will do in balancing the interest of the patent owner against public health and COVID-19.
'The tough question is going to be for the first tens of millions of doses, who should get it. Ideally it should not depend on the country that is manufacturing the vaccine,'
Soumya Swaminathan, chief scientist at the World Health Organization (WHO), in response to a question from Research Professional News.
Unfortunately, there are more questions than answers at this present time when the world is at the mercy of the pandemic. However, there is a role for responsible governments coming to an arrangement by international treaties to protect the most vulnerable of the world’s population and future generations.
This article first appeared on the website of the Healthcare and Life Sciences Law Committee of the Legal Practice Division of the International Bar Association, and is reproduced by kind permission of the International Bar Association, London, UK. © International Bar Association.
This article was written with the assistance of Lauren Krejci, Paralegal.
 Biden Administration purchases additional doses of COVID-19 vaccines from Pfizer and Moderna
 Coronavirus: EU stops short of vaccine export ban
 Call to action: Vaccine Equity
 Australia’s vaccine agreements
 Australian COVID-19 Vaccination Policy
 Budget documents
 Archive of Budgets
 Archive of Budgets
 Curevac redacted advance purchase agreement
 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19
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