How patents influence access to vaccines and what we could do

In pursuit of long lives well lived, the development of new vaccines plays a critical role in fighting infectious diseases and tackling the challenges of public health and global bio- ethics. The issue of patents and ownership rights has been part of the international discourse because of grave inequalities in vaccine availability and access across different countries.

Data from Oxfam International reveals that, as of May 2021, people in the G-7 countries were 77 times more likely of have been vaccinated than those living in the world’s poorest nations. Around 28% of the 1.77 billion doses of covid vaccine administered across the globe by May 2021 were provided in the G-7 nations. The share of low-income countries was an abysmal 0.3% of total vaccinations.

Public goods often lead to what is known as the ‘free rider’ problem, where people who benefit from public goods do not pay or underpay for using them. This leaves little incentive for producers to innovate and produce that good. Supporters of patent rights believe that patents deliver economic growth by preventing infringement of intellectual property and making inventions profitable. Also, pharma companies are business entities aiming for profit and hence cannot be expected to act in a completely altruistic manner. Yet, they have a strong incentive to innovate and enhance production, as the need for both is so evident in healthcare. Also, the ethical principles of non-maleficence and justice are violated if developed countries deprive other countries of access to vaccines. The fundamental rights of life and liberty are basic human rights and should take precedence over ownership and property rights, especially in times of a health emergency.

In many cases, funding for vaccine development is provided by governments, which is often overlooked in the granting of patents but should oblige patent holders to serve broad public ends that include global vaccine distribution in case of a crisis.

In the wake of covid, several companies came together for ‘The Open Covid Pledge’, which hands out “non-exclusive and royalty-free” licences for covid products and provides an open framework under which patent holders can voluntarily pledge not to assert the exclusivity of their rights to manufacture, use, sell, reproduce and import these products. However, this is not a long-term solution.

Unesco’s International Bioethics Committee and its World Commission on the Ethics of Scientific Knowledge and Technology advocate universal access to healthcare through international coordination based on the imperatives of equality, justice and solidarity. They support Covax, which is an initiative led by the World Health Organization, Gavi the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations.

There are several mechanisms regulating patents and ownership rights. In order to prevent patent right abuses, compulsory licensing has been introduced by the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights agreement. However, as the rules for this are restricted to territorial jurisdictions, it may not help enhance global access to vaccines and drugs very much. Many countries have their own domestic laws for compulsory licensing, but major economies like the US and China lack such a statute.

The Indian government has played a major role in promoting vaccine development domestically. For example, the Indian Council of Medical Research provided funding for covid vaccine development, as it is important for the state to fund research and innovation for public health purposes.

In the last 15 years, vaccine development has largely been the pursuit of small manufacturers, while multinational corporations have seen their programmes stagnate. For example, Pune-based Serum Institute of India developed a vaccine for meningitis for use in Africa, with help from the Bill & Melinda Gates Foundation and Path, a non-profit group that works for health equity. It helps when governments commit to purchase vaccines from manufacturers in advance, thereby directing research resources at clearly targeted goals and appropriate projects.

Direct government funding is crucial in the case of public health emergencies. A recent example is Operation Warp Speed in the US, which led to the rapid development and roll-out of covid vaccines—by assuring pharma companies decent profits.

Monopoly pricing, however, remains a risk. To counter the effects of it, vaccines could be bought at an international level (say by the United Nations or World Bank) for developing countries at a single price and then payments could be collected from these countries depending on their income levels. Patent pools can also improve vaccine access by coordinating the actions of complementary patent holders, while reference pricing may be used by governments to reduce the prices of branded as well as generic drugs and vaccines.

Most countries have domestic patent laws that deal with the regulation of intellectual property rights. But there are also other laws, like India’s Competition Act of 2002, which can be used to examine whether the high price or inadequate availability of a drug is the result of anti-competitive practices or ‘abuse of a dominant position’.

Another form of incentive can be a cash reward offered by the government for the development of any new vaccine that is made accessible to the public at minimal or zero cost.

It is true that patents may constrict vaccine availability in developing countries, but transfers of technology and public funding by advanced countries can address the problem of vaccine inadequacy to a large extent without requiring patent waivers.

Domestic patent laws and international conventions must aim to foster innovation, but at the same time, they should not have the effect of reducing vaccine accessibility in instances of dire need, as experienced during the covid pandemic. These two should not be looked upon as separate government policies, but must act in a complementary manner, with the balance shifting in accordance with the state of public health in the country.

Ruma Bhargava & Megha Bhargava are, respectively, lead, healthcare, Centre for the Fourth Industrial Revolution, World Economic Forum, India; and joint commissioner IT, ministry of finance, Government of India