Health & Community Law Alert: COVID-19 vaccines – the role of government for community access, equity of access and waivers

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.

Issues with equity of access

The legal and ethics issues include:

1. 1. 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:
      1. 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.^[1]
      2. Poverty in developing nations has driven hardship, for example in countries such as Papua New Guinea.
      3. 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.
      4. 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.^[2]
      5. 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.^[3]
      6. Intellectual property rights. International treaties concerning intellectual property rights and the rights of governments to require mandatory licences in patents.
   2. Current situation in Australia on the COVID-19 vaccine

   3. 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^[6]:

      1. 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).
      2. 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.
   4. Government indemnities

   5. 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.

      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.^[10] 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.

   6. Intellectual property

   7. 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.

      Soumya Swaminathan, chief scientist at the World Health Organization (WHO), in response to a question from Research Professional News.
   8. Commentary

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.

[1] Biden Administration purchases additional doses of COVID-19 vaccines from Pfizer and Moderna
[2] Coronavirus: EU stops short of vaccine export ban
[3] Call to action: Vaccine Equity
[4] Australia’s vaccine agreements
[5] Australian COVID-19 Vaccination Policy
[6] Budget documents
[7] Archive of Budgets
[8] Archive of Budgets
[9] Curevac redacted advance purchase agreement
[10] Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19