Alison Choy Flannigan
Hall & Wilcox, Sydney
alison.choyflannigan@hallandwilcox.com.au

It is clear that the Covid-19 pandemic has produced challenges for the global community and important lessons can be learnt to ensure that the international community is better prepared to ideally avert and, if not, identify, contain, and manage pandemics and reduce associated loss of life and social and economic damage. Covid-19 has also enhanced new and newly approved ways of providing healthcare and making laws, which should be further structured, developed and perpetuated. Health is intrinsically linked to people’s way of life and the protection of the environment. The Covid-19 pandemic has shown some deep interactions between these fields and a greater aspiration of people for healthier, reasonably connected, smarter and more sustainable cities.

This article expresses some concrete actionable recommendations to policy makers, legislatures and multinational organisations for reform.

With the pandemic, we have learnt that politics has been an inhibitor to ensuring the equitable distribution of information and resources (such as diagnostic tests, ventilators, PPE, vaccines and treatments) to the most vulnerable. Further, there is a balance to be achieved between:

1. protecting the public health of the community and the most vulnerable (including of patients with non--Covid-19 diseases); and
2. the fundamental civil rights of individuals, including the right of individuals to personal liberty, including the freedom to circulate and to consent to medical treatment.

One of the most important lessons to be learnt is that there needs to be a partnership between government, scientists and at-risk communities, as well as openness, honesty and transparency to build trust. Political decisions need be made on a scientific basis in a transparent way and not behind closed doors. So, how should the law respond to this? It would be impractical to expect countries to agree to international treaties to resolve all of the problems, such as the supply of vaccines, however, we are of the view that international treaties should be reviewed so that countries can better co-operate in the event of a pandemic.

What legal regimes, frameworks and subject matter areas (collectively, the ‘Applicable Laws’) have been implicated by Covid-19?

Constitutional Powers

​​​​​​​Several countries had existing constitutional powers to declare an emergency and grant powers to their government in the case of a public health emergency. For example, the Political Constitution of the United Mexican States provides for the declaration of an emergency, which grants broad and general authority to the General Sanitary Council and the Minister of Health to take executive actions. In other countries such as France, these emergency powers are counterbalanced by the obligation of the executive power to regularly consult the parliament while ministers may be asked to testify and justify their actions before special parliamentary commissions.

Various areas of law impacted by Covid-19 included:

• Public health legislation allowing for emergency health measures such as lockdowns, use of masks, use of tests, restricted access to aged care facilities or other collective areas, etc;
• The regulation of therapeutic goods including medical devices, medicines, laboratory tests and the governmental procurement process for urgent health supplies;
• The exemption or limitation of emergency health product manufacturers’ potential liability for damage caused to patients and the taking over of this liability by governmental funding;
• Intellectual property rights, including patents and sui generis rights of database producers;
• Social security and other financial support programmes;
• Privacy, personal data protection and electronic records;
• Employment including regulation of remote working, vaccinated or unvaccinated employees; and
• Electronic meetings and transactions, including court hearings and taking of affidavits via video conference.

Private law:

• A major contract law issue was the interpretation of force majeure clauses in contracts, including leases or the supply of energy or other goods or the provision of services possibly impacted by the pandemic (considering that in some countries such as France, the legal concept of force majeure is not of a public policy nature and may therefore be derogated from).
• Corporate law issues including use of electronic signatures and the use of virtual technology for meetings.
• Regulation and criminal liability issues linked to cybersecrity, while cyberattacks are constantly increasing.
• A positive consequence was the collaboration between public and private health sector, including in relation to hospital capacity and workforce shortages/surge agency staff. However, some private sector businesses were prematurely shut down which affected the supply of products which were essential to face the pandemic.
• Another positive consequence was the faster introduction and facilitation of e-health, and e-prescribing, as well as easier and quickier access to health personal data for secondary R&D purposes.

The Covid-19 pandemic also showed the capacity of government services and public bodies, as well as parliament members, to strongly accelerate their procedures for the sake of both fighting against the pandemic but also sustaining innovation.

What were the consequences and results of the applicable laws?

Overall, there was some consensus that the applicable laws did not provide a clear and solid framework that allowed the issues derived from the emergency to be tackled in the best possible way. Examples include:

• A lack of coordination between the government authorities and difficulty interpreting the legal authority to order lockdowns and other sanitary measures.
• Difficulty, including in the public communication field, with acquiring and distributing medical supplies such as facemasks or hydroalcoholic gel, resulting in shortages and confusion among the population. The most acute was the shortage of oxygen in India or in African countries such as Tunisia but also of some medical equipment, such as artificial respirators, intensive care beds, healthcare staff and professional protection equipement in the EU.
• Confusing and unclear regulations for the emergency approval of tests, medical devices and equipment. For example, in Mexico, it was reported that there was no clear emergency approval pathway for vaccines.
• Conditional approval of only briefly tested vaccines, as well as a lack of access to some sets of critical health data, creating vaccine scepticism among some people.
• Unclear regulation relating to triage, given a lack of hospital infrastructure to treat patients.

Nonetheless, some countries reported that healthcare and social security systems were effective during the pandemic:

• For example, in Turkey, the number of hospitals, ICU units and healthcare workers were sufficient for operating 24/7. As such, the pandemic did not overwhelm the healthcare system.
• In Australia, residents had free access to Covid-19 testing and vaccines.
• In France, the pandemic also accelerated the launching of a new healthcare system reform including to a certain extent a reorganisation of territorial healthcare services, reopening of beds in public hospitals or the enhancement of healhcare professionals’ status, called the ‘Ségur de la Santé’.

What were the implications of the applicable laws for international coordination and collaboration?

Overall, most countries reported a lack of connection and harmonisation between local applicable laws and international health measures.

Examples include border closures, travel, airport entries, customs and import-export rules and transportation.

For example, in Mexico, a lack of coordination between the Mexican and USgovernments resulted in the closure of manufacturing facilities, which affected health product supplies.

The extent of the lack of coordination differed across countries:

• For example, in the Mexican legal system only ‘links’ the country to International Health Regulations regarding epidemiological vigilance and reporting. However, the country is not legally bound. As such, there was a ‘complete absence of international legal harmonisation and coordination’.
• By contrast, the Dutch or French governments effectively collaborated with the EU to acquire the right to medical device and vaccine supplies.
• The EU also adopted a series of measures, for instance on public tenders, to smooth rules around the procurement of health supplies and built a research platform, VACCELERATE.EU aimed at accelarating cooperation and research around the fight against the virus and its variants. The EMA itself has issued guıdance on the management of clinical trıals during the Covid-19 pandemic (Version 4 04/02/2021) to faciltate clinical trial projects. The Agency has put in place rapid review procedures related to Covid-19, which aimed at delivering assessments of applications from sponsors in the shortest possible timeframes while ensuring robust scientific opinions.
• However, the EU embargo on the exportation of the AstraZeneca vaccines adversely affected many countries, including Australia.

Which national laws worked under the stress of the pandemic?

Therapeutic goods regulation

Many countries, including Australia and some EU Member States, were able to review or simply enforce their already existing laws regarding the registration and regulation of therapeutic goods to fast track necessary products, including the launching and priority approval of clinical trials, diagnostic tests and vaccines.

Contract law was flexible to allow contracts between governments and hospitals and the private sector pharmaceutical and medical device companies for the supply of therapeutic goods, including vaccines and intensive care supplies.

A number of countries acknowledged that there was room for more work to encourage vaccination, including in relation to civil liability and compensation, such as universal insurance schemes.

The intellectual property system allowed the industry to quickly respond to the pandemic due to the years of investment in scientific research prior to the pandemic. Dependable IP enabled firms to understand and select complementary technologies to invest in and then piece together all the necessary components or to understand where different components were needed to be sourced from or developed. For example, developing an mRNA vaccine requires mRNA stabilisation technology for which there are separate and diverse IP holdings and ownership. Obtaining the rights to mRNA stabilisation was available to mRNA vaccine developers through various sources and could be obtained under negotiable terms. Concurrently, firms assembled and developed the many processes and components that were needed to be combined.

For some countries, the legislation governing the private healthcare system was effective, while for others, the legislation was not. For example, the legal requirement for all persons to have full healthcare insurance in the Netherlands did not ‘present serious problems’, despite the general lack of medical resources and capacity.

Most countries reviewed or accelerated their health care system and reimbursement to allow for e-health, including telemedicine and electronic prescribing, with aims such as:^[1]

• Using telemedicine to assist intensive care against Covid-19;
• Deliver new devices and tools for faster, cheaper and easier diagnosis;
• Use telemedicine and Al to diagnose and monitor patients safely and to reduce the burden on health systems;
• Protecting health care workers through new technologies; and
• Supporting and fostering the uptake of innovative tools and technologies by small companies.

There was a lack of consensus on whether constitutional emergency powers worked under the stress of the pandemic.

Constitutional powers were described as ‘anachronistic, weak and impractical’ for confronting the pandemic in some countries. By contrast, it was also argued that it was a lack of leadership, and efficacy by governments rather than a lack of regulation. These contrasting arguments were particularly prevalent for the Mexican Political Constitution and Laws such as the General Health Law and Medical Supplies Regulations. A lack of transparency and consistency has also been reproached on other governments.

Data protection

While General Data Protection Regulation (GDPR) and national legislations have helped legally secure and structure projects aimed at fighting against the pandemic through the development of new devices or drugs, or the setting up of new research data bases, some national data protection agencies have been able to accelerate their processes. For instance, in France,  a priority procedure was set up by the French Data Protection authority (the CNIL) to issue clincial trial authorisations. However, ad hoc projects have possibly been hindered by a lack of clear positioningor sufficiently harmonised guidelines, letting project leaders take the risk of unstable data protection.

Which national laws impeded or slowed down the pandemic response?

Many countries reported imperfections with their public health legislation, including:

• A lack of clarity on the extent of government powers. In the Netherlands, there was a lack of clarity on the disruption of legal competences between national and regional authorities. Additionally, the General Health Law in Mexico gave ‘general and unspecific’ powers to health authorities.
• Many countries had a lack of clarity of when vaccines could be mandated by employers without government orders or on the way health protection protocols should be implemented with changing instructions being issued on a frequent basis.

There were several reported issues with PPE and vaccines logistics management:

• Poor organisation and upscaling of testing and distribution of vaccines, as well as purchasing and distributing medical supplies.
• Legislation on data protection may have slowed down innovative projects in some countries (for instance in France, the dispute around Microsoft hosting data that had been processed by the French health data hub, whose aim is to foster innovation in the health domain).
• A lack of transparency on supply agreements, terms, prices and relevant data with the public, resulting in anti-vaccination attitudes. In Turkey, only 63 per cent of the population has been vaccinated as there was no regulation that made vaccines compulsory.

Despite the incredible collaboration, we have already started to see calls for policies that could hinder collaboration in the future (increased government march-in rights, restrictive pricing terms in government contracts, etc). This is an area that we will need to watch closely moving forward.

Concrete improvements and forward-looking recommendations for legal policy reform.

We recommend changes to health regulatory frameworks, including:

• Better regulation of public health laws during emergencies;
• Improved interaction between the roles of federal and local governments during health emergencies;
• Simplifying long and complex approval processes for therapeutic goods including tests, treatments and vaccines while maintaining important regulatory protections;
• Incentivising the use of digital health, telemedicine and electronic clinical files;
• Ensuring public health legislation equips all levels of government with a toolbox and criteria on how to deal with medical supply and capacity shortages;
• Reviewing the issue of informed consent to vaccination during a pandemic – individuals should be protected from that pressure but may have to accept quarantine as an alternative; and
• Foster the possible reuse of health personal data for research and innovation purposes and promote open data.

There were several recommendations for legal policy reform at an international scale, including:

• The creation of a legal and regulatory framework for international and national executive actions during pandemics. This framework would provide a clear and harmonised international approach to several subject areas, including the distribution of medical supplies, support for innovation efforts, expedited regulatory approval pathways, vaccine injury compensation and civil liability due to an adverse event arising from the use of medicines and medical devices required during an emergency.

Should there ultimately be an international pandemic treaty? What should it cover? Is it even realistic?

There should be an additional treaty or the review of existing treaties.

Covid-19 has shown that no single government can handle the pandemic alone.

International treaties should cover:

• Harmonisation of laws regulating therapeutic goods to enable fast track registration;
• Faster scientific reporting of the outbreaks of pandemics without fear or political interference, enabling the proper investigation of the causes of pandemics and laws which respond to prevent those causes from re-occurring (eg, international regulation of known causes, such as bat to human contact and international regulation of handling biohazardous substances);
• Creating a new global system of surveillance and cooperation between countries’ research needs;
• Harmonisation of border controls, travel, airport entries, customs and import-export rules and transportation. For example, the establishment of an international protocol for advanced communication of border closures and current vaccination status being electronically linked to passports;
• Resource allocation including an international fund for underdeveloped or developing countries;
• How to manage the risk of spreading the disease – including travel restrictions, general rules and conditions for introducing lockdowns;
• Establishment of a pandemic authority in each country (acting on scientific evidence), regulating the constant communication between countries and strengthening the transfer of knowledge – and potentially reviewing the role of the World Health Organization; and
• Dealing with infection across borders, including cruise ships and other vessels which were left stranded.

While it would be ideal to include in an international treaty a protocol regarding the supply of therapeutic goods, including tests, ventilators, vaccines and raw materials, unfortunately, we believe that would not be achievable as countries prioritise the protection of their own population in the case of an emergency.

In summary, much has been learnt from the Covid-19 pandemic. The world’s response to the crisis fell tragically short. There is so much more that can be done.