Shot of Hope: Equal access a hurdle after race to coronavirus vaccine

The second of a two-part series examines challenges linked to IPR and monopoly once Covid-19 vaccine is created

Even if a vaccine is created and manufactured within the expected timeframe, it may not mean an end to Covid-induced misery for all. Equal access to the vaccine could be a major challenge, according to experts. Experience during the Swine Flu pandemic shows how.       

When in 2009 the World Health Organization (WHO) declared the Swine Flu influenza a pandemic, big pharmaceutical firms invested huge sums in research and developed a vaccine, which they then patented. The resultant monopoly over its formulation led to the highest bidders – developed nations such as the US, Canada, and Australia – placing large orders and stockpiling the product. Low and middle-income nations faced huge shortages.

This sparked a row around equitable access to vaccines and how intellectual property regime (IPR) may have resulted in such disparity. Indonesia, for instance, had earlier refused to share H5N1 virus strains with the world, citing unfairness of sharing resources only to have a developed country monopolise a vaccine.

Efforts to produce a legal framework to bridge this gap have only started to gain traction now. The European Union (EU) took charge at the WHO’s Health Assembly in May to introduce provisions regarding voluntary pooling of patents, and the ‘Access to Covid-19 Tools Accelerator’ through which countries can share technical knowhow and resources.

“The idea behind these is that the knowhow can be owned collectively and then further licensed to all states so they can produce vaccines,” says Kashish Aneja, a lawyer working with O’Neill Institute for National and Global Health Law in Washington.

While this was supported by some, countries such as the US chose to “disassociate” themselves from certain parts of the resolution which reference the Doha Declaration. According to Doha Declaration, governments could overrule intellectual property in case of a public emergency. The US also steered clear of contributing to an $8-billion fund to ensure equal access to vaccines for the world.

This development is worrisome for other countries since the US, with a large number of ongoing projects, has a high chance of creating a vaccine. According to international law, any vaccine which is created becomes the property of the sovereign, who has the right to leverage its distribution. Australia, for instance, prohibited exports of Swine Flu vaccines in 2009.  

The same vaccine could have been manufactured in India and other developing countries by applying a provision known as voluntary licensing. However, experts say pharma giants remained sceptical of IPR regimes in developing nations, fearing violations. “The inability of developing countries to negotiate a licensing fee, lack of better returns, and political concerns could all have played a role here,” says Aditi Verma Thakur, partner at IndusLaw.

“However, businesses now realise that if they license a vaccine to a firm here and some other firm violates their patent rights, they can enforce their rights in an easier manner,” adds Aditya Gupta, attorney of law at IRA law.

Currently, Indian biotech firms such as Panacea, Serum Institute and Bharat Biotech are playing a key role in trying to ensure availability of vaccines by collaborating with firms abroad. Serum Institute along with AstraZeneca has ensured supply of vaccines to India and other low-income countries.

International biotech companies, however, still have a reason to be wary as India is prone to compulsory licensing — a mechanism through which governments can manufacture a patented drug without the permission of the patent holder and sell it at an affordable price. This often puts it under pressure from countries such as the US, which claim exploitation of their firms and threaten sanctions against those countries which feature on their ‘301 List’.

Meanwhile, companies are being careful with their strategy as they’re nervous about public backlash. Gilead Sciences asked the USFDA to rescind the orphan drug status for its drug Remdesivir, which is being touted as a potential Covid-19 cure, after outcry from public, since the tag comes with many years of market exclusivity. AbbVie noted that it won’t enforce patent rights for its drug Kaletra, another candidate for a Covid-19 cure. French firm Sanofi altered its stance after initially announcing that the US had the “right to the largest pre-order” of the vaccine, after outrage from the public as well as the French government.

Despite efforts, a framework which makes it obligatory – not just a choice – for countries to share resources is still missing. Even though some legal instruments mention an individual’s right to health, it still remains a right which is considered responsibility of a nation to enforce in its own land, without making it an obligation for the international community. During the Swine Flu pandemic, developed nations did not resort to donating vaccines until they realised that a single dose of vaccine would be enough to cover their citizens and what they had was much more than they needed. 

Since pharma giants had monopolies over prevention and their primary incentive was wealth, not public good, it was reason enough for them to supply to those who paid the most, point out analysts. 

The IPR framework has always been caught in a research-versus-public benefit debate. The jury’s still out on whether Covid-19 will be able to change the regime.
 

THEN
 

• During the Swine flu pandemic, developed nations such as the US, Canada and Australia pre-booked large quantities of the vaccine 

• Low- and middle-income countries fell short

• Australia prohibit manufacturers from exporting the vaccine until its own needs were met 

• Canada refused to donate vaccines citing shortages of its own 

NOW 

• Indian biotech firms such as Panacea, Serum Institute, and Bharat Biotech are collaborating with international institutions to ensure availability

• Gilead Sciences rescinded its 'orphan drug' status for remdesivir after public backlash

• Sanofi altered its stance after saying that the US had the “right to the largest pre-order” of its vaccine 

• The WHO has touted the ACT programme to allow sharing technical know-how and Covid-related resources

Series concluded