The search for a vaccine to halt the Covid-19 pandemic is proceeding feverishly. Governments, industry and philanthropists are pouring funds into a multitude of vaccine development and manufacturing projects. Both conventional as well as less-explored technologies are being applied to develop a vaccine. At this intensity, a vaccine could be ready to take to market by mid-2021, some experts say.
But will the Covid-19 vaccine become freely available and be affordable? The global intellectual property system allocates the rights of the vaccine to the inventor or owner. These rights are granted for a limited period – 14 years for design rights, 20 years for patent rights in most places.
During this time, the owner has a monopoly over the product and can demand a price they seem fit. However, this provision has often been used by the inventors to limit access to essential goods to people who need them or to smaller companies that could manufacture the product at affordable prices.
An example is the legal fight by about 40 US pharmaceutical firms with the South African government that started in February 1998 to prevent the country from manufacturing low-cost generic antiretroviral medicines used to treat HIV. Even with millions of lives at stake, public health had taken a backseat to intellectual property. The fight continued till September 1999, until the United Nations intervened, and the lawsuit was dropped.
Will the coronavirus pandemic change these dynamics and calculations?
‘Compulsory licensing’
Looking at the current trends, we see two strong Intellectual Property dynamics being played out. On one hand, national governments are looking to use a practice called “compulsory licensing” whereby they can authorise a third-party to make, use, or sell the vaccine without the permission of the patent owner.
On March 18, for instance, Israel issued a compulsory licence to the Indian drugmaker Hetero to make the generic version of the drug Kaletra medicine, the patent for which is held by of AbbVie. Kaletra is an antiretroviral therapy medicine to treat HIV-1, and it is speculated that the drug might be useful in combating Covid-19.
Similarly, several countries have passed resolutions allowing their governments to authorise a third party to make, use, or sell healthcare products to tackle the coronavirus pandemic without the permission of the patent owner. Chile’s Lower House of Parliament and Ecuador’s National Assembly have passed resolutions relating to Covid-19 products; Canada has passed the Covid-19 Emergency Response Act; Germany has moved an Infectious Diseases Act and France has enacted an emergency law.
The World Health Organisation and the European Union are also exploring ways of buying Covid-19-related medicinal rights and establish a pool of patents that can be open accessed by anyone to help solve the crisis.
Prioritised access
On the other hand, despite uncertainty about the effectiveness of the vaccines in development, competition has started erupting over prioritised access to these vaccines. In May, French pharmaceutical firm Sanofi said that the first shipments of any vaccine it may develop will be for the United States because America made high-risk early investments in the development process .
While Gilead was applauded for giving free authorisation of their remdesivir medicine patents to three Indian generic drug manufacturers who have access to 127 countries, many experts noted that the access was not for profitable markets. As a result, even as these companies have made significant investments in manufacturing the drug, they will take much longer to recover their costs.
The German government, which is the main investor in the biotech company CureVac, said that US President Donald Trump’s administration has offered a deal for owning exclusive rights to its coronavirus vaccine. Furthermore, the Coalition for Epidemic Preparedness Innovation, which finances independent vaccine developers, and is based on the principles of equitable access to all, could not reach an agreement with the independent vaccine developers even by May on a fair and equitable price allocation system that would ensure the availability of vaccine at affordable prices.
The way out
Is there a way out? Is there a way to ensure easy and affordable access to the vaccine without trampling on the rights of the investor and the inventor?
Intellectual property owners of critical healthcare products could consider balancing their Intellectual Property Rights along with the public good. For example, the vaccine patent owners could be given transferable or roaming intellectual property rights. This means the company is awarded additional patent on a different product of their choice (for example, a new headache medicine) in exchange for voluntary licencing of any Covid-19 related drug or vaccine.
This would not impede the rights of a patent owner. Instead, would ensure easy availability at affordable prices in addition to keeping royalies flowing.
Another way could be to fast track approval whereby a company receives more rapid regulatory reviews for the product of its choice in exchange for providing the Covid-19 vaccine at reasonable rates. Advance purchase commitments by the government, provided through a guaranteed purchase, could also be an incentive.
Government’s role
In these options, the government would negotiate with the patent owner to provide licences to third parties at reasonable rates. Governments could take these initiatives for technology transfers based on what people in the field call “fair, reasonable, and non-discriminatory” terms.
Furthermore, promoting public pharmaceutical manufacturing facilities could also be an option. Vaccines developed at publicly funded research organisations would not only encourage innovation domestically but also effectively tackle affordability challenges.
A strong need for equitable and inclusive access to innovations for the research community is the need of the hour. The ability to import and export critical technologies will be the deciding factor. Intellectual property navigations should not slow down these processes.
Anjula Gurtoo is a professor at the Indian Institute of Science. Rahul Patil is a Research Associate, Centre for Society and Policy, Indian Institute of Science.
For this article, they acknowledge the discussions under the IPACST project