Predictions by global health experts that future outbreaks of COVID-19 are likely, once suppression measures, like social distancing, are lifted, have made, even more urgent, the push to develop a vaccine, which will curb current transmissions and prevent future occurrences. As of April 2020, 70 COVID-19 vaccines were under development, with 14 in the US alone. The estimated timeline for an effective COVID-19 vaccine, from inception, is 12-18 months, which experts have noted to be unusually optimistic, given that an effective Ebola virus vaccine was approved three years after the initial outbreak.
The global watch for an effective vaccine is perhaps equally matched by the desire for an equitable distribution plan. This concern is based off of past experiences where countries, like Australia, Canada and the US used their wealth advantage to secure large advance orders of medical resources from manufactures, making it difficult for less wealthy countries to receive life-saving resources in quantities needed. And reports, like the Trump administration’s attempt to buy CureVac, a German firm developing a COVID-19 vaccine, have aggravated this concern.
Several initiatives for free patent-sharing have arisen out of the desire to forestall monopolies: the World Health Organization (WHO) endorsed a proposal by the Costa Rican government for a patent pool into which countries, companies and universities can deposit their Intellectual Property and grant reasonable access- the COVID-19 Technology Access Framework to provide “rapidly executable non-exclusive royalty-free licenses … in a bid to facilitate rapid global access”, and the presidents of Italy, France, Germany and Norway, led the charge to raise Euro 7.5Bn. to be donated to global health organizations to ensure that all countries in the world receive what they need to initially fight the pandemic.
African nations have not been left behind in the unified quest for people’s vaccine. An open letter calling on all governments and necessary stakeholders in pharmaceuticals and research to pledge their intellectual property was signed by over 140 world leaders including the presidents of Senegal, Ghana and South Africa, Macky Sall, Nana Addo Dankwa Akufo-Addo, and Cyril Ramaphosa, respectively. Ramaphosa, who is also chair of the African Union said, “Billions of people today await a vaccine that is our best hope of ending this pandemic…As the countries of Africa, we are resolute that the COVID-19 vaccine must be patent-free, rapidly made and distributed, and free for all. All the science must be shared between governments. Nobody should be pushed to the back of the vaccine queue because of where they live or what they earn.”
Prior to this new call, international patent-sharing provisions exist. Although, typically the manufacturer of a product has complete authority over the manufacture, distribution, sale and price of its products, Article 31 of TRIPS provides for compulsory licenses which allows persons, including government and third parties authorized by the government, to use the subject matter of the patent without the authorization of the patent holder. This license among other requirements specifies that the patent holder must be paid adequate remuneration, which takes into account the economic value of the authorization.
A compulsory license granted by a government or court can be issued in a case where a patentee refuses to grant a voluntary license when requested to do so on reasonable commercial terms.
Another scenario in which compulsory licenses can be issued is in the cases of national emergencies, and with relation to public health concerns, it allows the holders of the license to produce generic versions of the medication to satisfy domestic needs. It also requires that the use of the license by any member state must be for the domestic market. However, this was not beneficial to developing nations without manufacturing capacity in pharmaceuticals. Thus, subsequently, Article 31, which included a provision that the manufacture of drugs must be for the domestic market was amended to favour countries without manufacturing capacity in pharmaceuticals.
The Doha Declaration on TRIPS and Public Health addressed specifically the licensing of drugs for serious diseases for developing countries without manufacturing capacity. This allows countries unable to produce the medicines to obtain cheaper copies produced under compulsory license elsewhere.
In all instances where a compulsory license is issued, the patentee is paid an amount determined by the country issuing the license. In cases of national emergency, including urgent public health need, countries are allowed to issue compulsory licenses. Under the TRIPS agreement, the patentee, does not need to be approached first for a reasonable commercial terms and conditions. But he must be notified as soon as is reasonably practicable.
All sub-Saharan African countries have national laws permitting compulsory licensing, including Nigeria. For instance, between 2001 and 2005, Cameroon, Eritrea, Ghana, Guinea, Mozambique, South Africa, Rwanda, Swaziland, Zambia and Zimbabwe all issued compulsory licenses for drugs to tackle the HIV/AIDS pandemic, paying between 2% – 5% royalty rate to the patent holders.
The main difference between the current established means of international IP cooperation and what is currently being proposed is that the patents be free, meaning countries who are able to use the patent will not be required to pay for it, unlike under a voluntary or compulsory licensing structure. This would mean that the patent owner would lose the ability to set its price. Given that a huge part of the argument for this unprecedented move in international IP cooperation is access to required medicines to treat the virus regardless of wealth, this could be a primary reason why African countries are vying for the patents to be made free, as under the compulsory or voluntary licensing African countries will still have to pay a specified amount per the rules of TRIPS, Berne Convention or contract between themselves and the patent owner. CEPI (Coalition for Epidemic Preparedness Innovations) estimates that developing up to three vaccines in the stated 12–18 months would require an investment of at least US$2 billion to cover the cost of the clinical trials, excluding the cost of manufacture and delivery. Even severely discounted, this and the estimated price of $10 per dose of a finished vaccine, would pose a challenge for many African nations.
Traditionally, new drugs and vaccines would go to the world’s wealthiest countries, but the exact order of the countries could depend on who produces the vaccine first especially if developed in either the US or China.
Trump’s Operation Warp Speed has a mandate to develop a vaccine for the American people as soon as possible. The Trump Administration has also announced its payment of 1.2 billion$ to AstraZeneca, a drugmaker to work on a vaccine that would be ready by January, 2021.
On the other hand, China, who has at least 4 trials at home, has vowed to spend 2billion to help developing nations in the fight against COVID 19. China has also signed a WHO resolution that advocates that any vaccine discovered be treated as a “global, public good” and distributed fairly and affordably.
In either case, hedging one’s bets seems to be the safest course for African nations. While Nigeria assents to a patent free drug, it is also advisable to keep looking inwards to see what homegrown remedies like those found in Madagascar will be beneficial to suit the needs of the populace. Most nations and multinational vying for a patent free regime are bringing their own expertise to bear in the fight against COVID 19. They are conducting national trials and tests and the desire for a patent free regime is based off of the recognition that the pandemic is not restricted to borders and an outbreak in one country can throw the world off its course again.
Earlier, the Minister had stated that three potential treatments have been identified and are going through the phases, while these are cures and not innoculators, they may serve to ensure that Nigeria is out of the rat race for those requiring an immediate cure, in the event of a second wave. Hopefully this serves a portent for the country’s investment into local research and health institutions.