On Friday, wealthy countries reportedly blocked India and South Africa-led efforts at the World Trade Organisation, seeking a temporary waiver of Trade Related Intellectual Property Rights obligations to ensure equitable access to Covid-19 drugs, vaccines and medical products. The proposal, which has the support of developing nations, the World Health Organisation and several NGOs in public health like Medecins sans Frontieres, will now go before the WTO general council early next month.

“If rich countries prefer profits to life, they will kill it by tying it down in technicalities,” news agency Reuters quoted a delegate who had supported the motion to waive the intellectual property rights on the drugs and vaccines as saying.

Scroll.in spoke to KM Gopakumar, an expert on the global intellectual property regime, on the significance of the proposal, especially as a few rich nations hoard more than half of the expected vaccine supply.

Can you explain the need for exemptions from intellectual property protection and how this will translate into more equitable access to Covid-19 medical products for developing countries like ours?

The joint waiver proposal from India, South Africa, Kenya, Eswatini, Mozambique and Pakistan, if adopted, will give the freedom to WTO member states to suspend the protection and the enforcement of certain types of intellectual property rights with regards copyrights, industrial design, patent and trade secrets for the prevention, containment or treatment of Covid-19.

The primary objective of the waiver proposal is to facilitate availability of Covid-19 medical products, such as personal protection equipment, diagnostics, vaccines, medicines and other medical devices like ventilators, at an affordable price through scaling up of production through multiple manufacturers.

IP protection legally prevents other parties from manufacturing or use of the IP-protected products/technologies without the permission of the owner of the IP. This legal prohibition eliminates competition in the market and leads to inadequate supply and high prices of medical products.

An effective response to Covid-19 requires a huge supply of these medical products at an affordable price. The suspension of the protection and enforcement of the above mentioned forms of IP would enable countries to allow manufactures and innovators to freely use/produce the IP-protected technology/ product and create competition and affordability in the Covid-19 medical products market. The availability of Covid-19 medical products would enable the governments to take measures including public provisioning to ensure equitable access.

KM Gopakumar, expert on global intellectual property rights.

WHO’s efforts with COVAX, its global initiative, is meant to ensure that every country gets fair and equitable access to evential Covid-19 vaccines. Two vaccine candidates have published very promising interim late-stage trial results: Moderna and Pfizer.

Only Moderna is part of the COVAX portfolio. But even Moderna has signed multiple bilateral purchase agreements with many rich countries. In fact, several countries that are part of COVAX are also signing bilateral agreements with vaccine manufacturers. How will this work?

Will the vaccine manufacturer first meet bilateral purchase agreement obligations or the understanding with COVAX? I ask this because in the initial phase of manufacturing, demand is obviously going to overwhelm supply.

Though there is encouraging news about the vaccine efficacy there is a big question mark about the timely availability of these vaccines in the developing countries.

Rich countries are stockpiling vaccines and not ready to facilitate technology transfer to scale up production. This quest for profiteering would push the people in developing countries to the edge. An Oxfam release shows 13% of the world population living in the developed countries cornered 51% of the vaccines. While low income countries have not made any bilateral deals and are depending on COVAX facilities to cover 20% of their population by the end of 2021, countries like Canada bought vaccines to vaccinate their population five times over.

It is very clear that the originator companies alone cannot meet the demand and there is an urgent need to transfer the technologies to scale up the production.

Towards this purpose, countries should shed their commercial interest and treat the vaccines as a global public good. Though heads of UN and WHO termed the Covid-19 vaccine as a global public good along with some heads of state like France, South Korea, China, there is little [effort] to translate the idea into action.

The most practical way to ensure availability of enough vaccines to meet the demand is through scaling up production. The IP protection acts as a legal barrier to technology transfer and thus prevents dissemination of technology. Public funding is leading the Covid-19 vaccine research and development and therefore there is no real justification for IP protection for Covid-19 vaccines.

Moderna has said it will not enforce patents on its vaccine for the duration of the pandemic. Is this an unusual declaration from a pharma company? And does it mean that India can manufacture low-cost versions of Moderna’s vaccine?

The Moderna statement reads:

“We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our Covid-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for Covid-19 vaccines to others for the post-pandemic period”.

As per the statement, Modern is committed not to enforce the patent during the pandemic. This is a conditional commitment only during the pandemic. No vaccine manufacturer would come forward to use the patent only for a short duration without a clarity on the implications of the patent enforcement. Further, apart from patent access, the know-how is very critical to expedite the production of vaccines by another manufacturer. Generally speaking, know-how is often protected as trade secrets and the statement is silent on access to the know-how.

Patent is not the only barrier for the non-originator production of vaccines. The current regulatory system insists that the non-originator producer has to obtain the know-how from the originator for a speedy marketing authorisation. Otherwise the non-originator vaccine manufacturer has to undergo all the regulatory requirements of the originator. This is time- and resource-consuming activity and delays the competition. This can be quickly addressed by the regulatory authorities by making available the know-how. The India-South Africa waiver proposal can empower the regulatory authority to do so.

People walk by the Pfizer world headquarters in New York on November 9, 2020. Photo: Kena Betancur/AFP

What is the most glaring example, in recent history, of inequitable access to medicines because of prohibitive patents that resulted in (preventable) deaths?

The most glaring case of patent-engineered access crisis is in the context of HIV/AIDS.

Though efficacious medicines for opportunistic infections as well as antiretroviral drugs medicines were available in the developed world, they could not be accessed in developing countries primarily due to the exorbitant prices. Antiretroviral prices in 1999 were approximately between $10,000-12,000 per person per year. Neither governments nor people in the developing countries could afford such a price and it resulted in thousands of avoidable deaths

In 2001 it was the Indian generic drugs company Cipla that showed the world that these medicines can be produced and sold at $350 per person per year. The lack of product patent protection in India at that time allowed more Indian companies to enter into the market and reduced the price drastically to $168 by 2005.

However, the introduction of product patent to pharmaceuticals in 2005 incapacitated Indian companies to repeat the magic when it came to treatment of Hepatitis C. The patent protection on Sofosbuvir allowed American biopharmaceutical company Gilead to impose voluntary licence on the generic manufacturers. (Voluntary licence is the permission granted by the owner of IP to another individual or entity to use the IP. It contains conditions including geographical areas under which such use can take place)

Though compared to the price of Gilead ($84,000) the price of Sofosbuvir in India is low (Rs 36,000 to Rs 61,452 for 12 weeks) but it is unaffordable to the majority of the people. The price in Egypt is $72 for 12 weeks, where there is no patent protection.

What are the 2001 Doha Declaration on TRIPS Agreement and Public Health, or TRIPS flexibilities adopted at the WTO? And why are the TRIPS flexibilities not enough today for countries seeking access to Covid 19 medicines and vaccines?

The Doha Declaration on TRIPS Agreement and Public Health was adopted during the peak of the HIV/AIDS crisis, especially in Africa, where thousands of people were dying due to lack of access to antiretrovirals. Patent protection prevented many countries who were facing the HIV/AIDS crisis to procure affordable medicines including antiretrovirals from countries like India, where there was no product patent protection for pharmaceuticals. The Doha Declaration reiterated that WTO member states can use various flexibilities in the TRIPS Agreement including a compulsory license to ensure access to medicines at an affordable price.

Compulsory license is a permission granted by the government to a third party to produce the patented products or use the patented technology without the permission of the patent holder. Since the adoption of the Doha Declaration there have been more than 45 instances of using compulsory license to facilitate access to medicines.

However, the flexibilities mentioned in the Doha Declaration are primarily applicable in the context of patented medicines and may not be workable in the context of other forms of IP such as trade secrets, copyrights etc.

The range of medical products required for Covid-19 are vast such as personal protective equipment, diagnostics, vaccines, medicines and other medical devices like ventilators. These medical products are protected through various forms of IP protection and some forms of IP protection become critical for the replication of each medical product.

For instance, vaccines are protected through patents and trade secrets. A compulsory license alone is not enough to facilitate the non-originator production of the vaccine. Similarly, copying of software codes may be required for the replication of a contact tracing app or to transform a diagnostic platform to use for Covid-19 context. Indian Copyrights Act allows the reverse engineering of codes to achieve interoperability but not to develop a competing product. Similarly, there is a lack of clarity with regard to the scope of flexibility in relation to trade secrets. Here, waiver of the TRIPS obligations will give the required freedom to WTO member states.

Similarly, compulsory licence is an effective tool to overcome the patent barriers in relation to a specific product or technology. In the context of Covid-19 there are no such specific products existing at this moment therefore companies and individuals are to be encouraged to develop such products using even existing IP protected technology/products.

If there is uncertainty with regard to the freedom of operation due to IP protection, it would prevent the research and development actors from using those technologies and substances to develop Covid-19 medical products. This chilling effect of IP could be addressed effectively through adoption of the waiver proposal.

It is also worthwhile to note that both the private sector and developed country governments pressured developing countries against the use of TRIPS flexibilities, especially when they used compulsory license to facilitate access to medicines other than HIV/AIDS.

For instance, the US-India Joint Business council submission to United States Special Trade Representative Special 301 report states that the Indian officials gave a private assurance not to grant a compulsory licence further. Countries subjected to such pressures include Thailand, Colombia etc. Such pressures, especially political pressure, creates a chilling effect on the use of TRIPS, especially compulsory license. Adoption of the waiver proposal would bring the required legal clarity and it can be used as a shield against such illegal pressures.