Jelena Madir had an impressive career trajectory as a banking and finance lawyer. As the General Counsel at Gavi – a vaccine alliance which aims to boost access to immunisation in developing countries – she tells In-House Perspective about how the pandemic transformed her role and her determination to end vaccine inequity.

When Jelena Madir joined Gavi in November 2019, she had no idea that the onset of the biggest pandemic in living history was just around the corner.

Madir came from a financial background, having practised as a finance and capital markets lawyer in the US before working both in-house and in private practice in her native Croatia and in Germany, and later joining the European Bank of Reconstruction Development (EBRD) in London in 2009.

She spent nearly 11 years there, working across debt and equity transactions, restructurings and workouts, and providing financial, corporate governance and policy advice to governments across the EBRD’s jurisdictions. After establishing the bank’s capital markets compliance function, she went on to spearhead its Fintech regulatory practice, advising both governments and the bank’s senior management on blockchain-based smart contracts and digitisation policies.

When she was approached by a head-hunter in 2019, she says initially she didn’t see the correlation between her background as a finance lawyer and the opportunity at Gavi – a vaccine alliance which aims to boost access to immunisation in developing countries.

However, it soon became apparent that her experience of working alongside multilateral stakeholders on a broad range of projects across heavily regulated industries made her extremely well placed to lead Gavi’s legal team. ‘Both the EBRD and Gavi are international organisations with a very strong sense of mission,’ says Madir. ‘Gavi had also been looking at expanding its private sector initiatives and engagement and I had spent three years building EBRD’s fintech regulatory practice area and led several projects on blockchain.’

Madir says the variety inherent in the role made it a compelling proposition. ‘What attracted me to this role is the intellectual challenge of being responsible for a wide variety of legal issues, from more routine aspects of the job – such as employment, insurance and procurement matters – all the way to contracts with pharmaceutical companies, other international organisations, governments and private sector partners,’ she says. ‘It was also obviously an opportunity to be part of the organisation’s strategic leadership team.’

Dramatic changes

When she took up the GC reins in November 2019, she had a modest team of four. Increasingly her department was tasked with more novel projects, such as drafting capital markets documentation related to the issuance of vaccine bonds and working with logistics, telecom and medical drone delivery companies to deploy mobile health technology and vaccines to remote areas.

However, after the onset of Covid-19 in early 2020, Madir says the direction of the team’s work changed dramatically. While pharmaceutical companies were scrambling to develop life-saving vaccines, Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO) were grappling with how to accelerate the development, production and mass rollout of Covid-19 vaccines. ‘We were tasked with answering the question of how we can make sure that Covid-19 vaccines – when they become available – are distributed in a fair and equitable manner so that we avoid a situation where they are available only to a handful of high-income countries that have struck bilateral deals with the manufacturer,’ she says.  

By late April, they had found the answer and launched COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT)-Accelerator, which aims to give the world’s poorest nations access to vaccines and related medication and medical equipment.

Madir says COVAX was ‘a whole new ball game’ and increased the demands on her team exponentially. ‘When we started to conceptualise COVAX in 2020 the issue was that we didn’t have the requisite skillset in the legal team for this type of project, which is very different from Gavi’s business-as-usual work,’ she says. ‘It involves securing vaccines not only for the poorest countries that are funded by donations, but also for a large number of self-financing countries in the upper-middle income and high-income brackets.’

Many of the middle- and high-income countries are longstanding donors to Gavi and some are even represented on its board. However, the new relationships brokered through COVAX required considerable negotiation. ‘That required a significant shift in the mindset of colleagues who were used to working with a much smaller set of donor governments,’ says Madir. ‘Quickly they had to become much more alert to the risks involved in working with a much wider pool of sovereign countries.’

The scale of COVAX as a project has been immense, spanning agreements with more than 150 governments, guarantees with numerous countries and commercial banks and advance purchase agreements with a number of pharmaceutical companies. Tasked with both growing and upskilling her team simultaneously, over the course of the past 18 months Madir has hired seven new lawyers on a consultancy basis to work specifically on COVAX matters, mainly working remotely out of Paris and London. Her core team has also increased to five to cope with the increasing workload, bringing the team’s total headcount to 12.

Although it has represented a significant amount of work, she believes the COVAX model could act as a blueprint for states to resolve future global crises. ‘COVAX represents a unique and innovative model,’ she says. ‘It tries to cater to both high-income and upper middle-income countries, which are required to pay for their vaccine doses and then you have a group of 92 low-income and lower middle-income countries that are donor-funded.’

Innovation to beat inequality

The pandemic has exposed the dearth of vaccine production and distribution capabilities in many developing nations, not to mention the myriad of logistical and infrastructure challenges facing many rural populations when trying to access vaccines. For this reason, Gavi created a dose-sharing mechanism to allow countries to donate surplus doses and also a humanitarian buffer to guarantee that even the most vulnerable and remote population can gain access to the vaccine.

Of course, vaccines, like any drug, carry risks of side-effects, and vaccine manufacturers have raised concerns over whether they will be indemnified for any losses incurred in connection with claims related to unexpected side-effects. Therefore, Madir is also excited about another of Gavi’s innovations, its no-fault compensation mechanism – the first-ever compensation programme to cover the 92 low- and middle-income countries eligible to benefit from vaccines supplied through COVAX. The compensation will be funded via donor contributions by applying a small levy on each dose.

Although Madir points out that vaccine indemnities aren’t unusual, they’re particularly important given the expedited timeframe for the rollout and in the context of the ongoing efforts globally to incentivise uptake of Covid-19 vaccines. ‘In the past, governments have also provided indemnity to pharma companies that make vaccines against the likes of smallpox and influenza – so it’s not that new,’ she says. ‘But in the case of Covid-19 vaccines, manufacturers believe that because the use of their vaccine is for the benefit of society, they should not be held financially accountable for any consequences of vaccine reaction. Then the question becomes who will pay compensation if a vaccine causes unexpected adverse effects? And what about the countries that are unable to provide satisfactory indemnification to manufacturers?’

Madir says this scheme is a win-win for both manufacturers and vaccine recipients. It also has the added bonus of speeding up resolution of any legal disputes, she says. ‘It offers to manufacturers that additional assurance that individuals that suffer unfortunate side-effects from Covid-19 vaccines administered through COVAX will not sue them and they will not go after the manufacturers. Instead, they’ll go through this no-fault compensation scheme, which means they don’t have to prove fault. It’s much faster. They don’t have to go through lengthy court proceedings, and they will get compensated that way.’

These innovations haven’t gone unnoticed in the wider legal community. Gavi was ranked top by the Financial Times for strategic and risk advice in its most recent survey of in-house legal teams. Madir and her team earned praise for their ability ‘to manage risks, which were critical to securing the participation of countries receiving the vaccines — and from the vaccine makers’.

Vaccinating the world

Although COVAX has dominated much of Madir’s recent work, she and her team have contributed to other innovative ventures that have furthered Gavi’s goals of increasing access to immunisation in developing countries. Her team played a crucial role in brokering a financing agreement in August with GlaxoSmithKline and MedAccess to guarantee continued production of the antigen for the WHO’s RTS,S/AS01E malaria vaccine following successful pilot immunisation programmes in Ghana, Kenya and Malawi.

Gavi, alongside the Global Fund to Fight AIDS, Tuberculosis and Malaria and global health agency Unitaid, had already committed nearly US$70m to fund the pilot programmes. The financing agreement then paved the way for the WHO’s announcement in October that it would be rolling out the new malaria vaccine across sub-Saharan Africa. This marked a major milestone for the eradication of the disease in Africa, which still accounts for around 94 per cent of all malaria cases and deaths worldwide.

In June, G7 leaders pledged to donate one billion doses of vaccines to developing countries, but as many countries face new waves and variants of Covid-19, Gavi’s work is far from over. In September, President Biden convened a virtual Global COVID-19 Summit which called on world leaders to step up their efforts to boost vaccination manufacturing and distribution capabilities and bring an end to the pandemic.

Madir says vaccine nationalism continues to be the single biggest challenge facing Gavi and its partners. ‘The UN Economic and Social Council has actually taken the stand that Covid vaccines are for the global public good,’ she says. ‘They say that they should not be treated as marketplace commodities available only to those countries and people who can afford to pay the asking price. At the same time, we are seeing some wealthy countries purchasing enough doses to vaccinate their entire population multiple times.’

Without global and coordinated efforts, she says they run the very real risk of vaccines being prioritised for individuals ‘based on the ability to pay and other grounds, including nationality and country of residence, rather than based on the principles of equity’.

Madir is passionate that vaccines should be available to all, regardless of where they live or their socio-economic background. ‘Manufacturers across the board have been making decisions not to prioritise and supply to COVAX, which means they’re not prioritising supply to the majority of the world’s population,’ she says. ‘What we are trying to push for is that countries should insist that manufacturers are transparent in relation to their order timelines, so we know that COVAX isn't being bumped. I think that’s what the Summit tried to tease out. We really need to change this and we need to prioritise COVAX and be transparent.’

Madir also says that the process of ‘slot swapping’ – by which high-income countries can reallocate some of their existing vaccine orders with manufacturers and give earlier slots to COVAX – will be a game-changer for bridging the vaccine divide worldwide. ‘If countries are ahead of COVAX in the queue and they don’t need the doses, we are asking that they step back and let COVAX take their place and those donations,’ she says.

Madir highlights that while Gavi appreciates the critical role that nations can play, what’s needed is for them to be faster and donate larger and more predictable volumes. She says that currently they’re sharing relatively low volumes at short notice, and also with shorter-than-ideal expiry dates. ‘That makes it a huge logistical lift to allocate and deliver those to countries that are able to absorb them,’ explains Madir. ‘This also has an impact on my team because it requires contractual adjustments.’

It has been a whirlwind two years for Madir, not least with the added challenge of leading a team remotely for most of this period. She still hasn’t met most of her new recruits in person and is keen to get back to the office and have in-person interactions with colleagues. In the meantime, she is enjoying seeing that her team continues to make an impact. ‘As an in-house lawyer, you can become closely involved in the organisation by supporting a whole range of its activities and really see how the legal input contributes to meeting those business objectives and protecting your organisation’s assets and interests,’ she says.

‘It also goes without saying that being at a global vaccine alliance in the middle of the pandemic and grappling with so many novel and innovative questions has been fascinating – what an opportunity,’ she adds. ‘Secondly, just being a GC in general and having that exposure to such a breadth of legal issues is what I love about my job.’