Role of patent waivers and compulsory licensing in aiding access to COVID-19 vaccines
The world as we now know has undergone drastic changes as a result of the COVID-19 pandemic, which took the world by storm and disrupted the important facets of our economy and everyday lives. With infections spreading and the death toll rising by the day, there is the need to ensure speedy access to COVID-19 vaccines.
Despite being the “saviours of public health”, pharmaceutical companies are still commercial entities that depend on Intellectual Property (IP) to recoup their investment on Research and Development (R&D) carried out. Indeed, IP has always been the backbone of the pharmaceutical industry, and this is made obvious in several years. Firstly, the new drugs that are created are protected as patents. When the drug is ready for circulation to the public, the manufacturer then gives it a name, e.g AstraZeneca, which is then protected as a trademark. These Intellectual Property Rights (IPRs) allow the manufacturers have exclusivity over the use of their IP for a number of years. Thus, where a manufacturer fails to leverage on these IPRs, it will be unable make profit out of its creations.
However, sometimes the patents that grant exclusivity may have to be mitigated, especially when the patents under consideration may hold the key to nations escaping this pandemic.
As the law of demand and supply states, the higher the price of goods, the lower the demand. Thus, by enforcing their monopolistic rights, the pharmaceuticals would exclude others from producing generic replicas of their medicine and consequently making the price of these medicines unaffordable for most developing and low-income nations.
For instance, South Africa has ordered only 1.5 million doses of the AstraZeneca COVID-19 vaccines despite the population of approximately 58 million but will pay more than double of what the European Union (EU) is paying per dose. The EU however justifies its position by stating it is entitled to a lower price because they invested in the vaccine’s development, disregarding the fact that the AstraZeneca vaccine’s clinical trial was carried out on South Africans in 2020.
It is argued that occurrences like this may keep happening if we continue to hold on strongly to the capitalist structure that IP seeks to uphold in crucial times like this. There must be a deviation from the orthodoxy towards the prioritisation of public health to flatten the curve.
In this article, we explore the possibility of exploiting patent waivers in the Trade Related aspect on Intellectual Property (TRIPS) Agreement and compulsory licensing in facilitating access to the vaccines.
The purpose of the TRIPS agreement
By the late 20th century, technology and innovation had begun to advance, and this meant that devices, which could reproduce creations at a relatively low cost were being produced. Industries that were heavily reliant on IP protection for generation of their revenue were seeing their works being pirated by companies in other jurisdictions and being sold at lower prices, consequently pushing the original products out of the market in the infringer’s country.
These and other factors led to the introduction of the TRIPS Agreement, which is a multilateral agreement aimed at reducing distortions and impediments to international trade, whilst taking into account the need to promote effective protection of IPRs and ensuring that they do not themselves become a barrier to international trade.
At the signing of the TRIPS Agreement, any nation that wanted to take part in the World Trade Organization (WTO) was obliged to amend its IP legislation to meet the guidelines set out in the agreement, thus creating a uniform international standard of protection for IPRs. This set out a standard system for IP, which was able to protect works across borders.
However, it was noted that the TRIPS Agreement had some shortcomings especially in the promotion of access to medicines and it would appear that the lacuna the TRIPS Agreement initially left was filled during the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration).
The Doha Declaration was adopted by the WTO Ministerial Conference of 2001 in Doha and it reaffirmed flexibility of TRIPS member states in circumventing patent rights for better access to essential medicines
The combined reading of the TRIPS Agreement and Doha Declaration sheds light on two main mechanisms which can be used in emergencies to facilitate access to medicines. They are patent waivers and compulsory licensing of patents.
Compulsory licensing of medicines
Compulsory licensing means the non-voluntary acquisition of a patent from the owner combined with the payment of remuneration based on its economic value.
The concept of compulsory licences has been recognised by our local legislation as well as international treaties. Some relevant provisions include the following:
a) Section 15 and 20 of Part 1 to the 1st Schedule of the Nigerian Patent and Designs Act enjoins the Minister of Industry, Trade and Investment to grant compulsory licences for reasons, which include the following:
i. For the maintenance of supplies and services essential to the life of the community;
ii. For securing a sufficiency of supplies and services essential to the well-being of the community;
iii. Generally for ensuring that the whole resources of the community are available for use, and are used, in a manner best calculated to serve the interest of the community.
b) Article 31 of the TRIPS Agreement provides that a patent can be used by the government, or third parties authorised by the government, without the authorisation of the right holder.
c) Article 5(2) of the Paris Convention confers upon each contracting state party to the convention, the right to grant compulsory licences to prevent abuses which might result from the exercise of exclusive rights conferred by the patent.
d) Paragraph 5(b) of the Doha Declaration similarly states that each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.
Recent developments of compulsory licensing in the COVID-19 era
The use of compulsory licences to combat a health crisis is not novel. It was used during the HIV/AIDs epidemic in the early 2000s where compulsory licensing was gotten to import generic anti-retroviral medicine by low-income nations such as Ghana and South Africa.
For governments to invoke the compulsory licensing provision of the TRIPS Agreement for COVID purposes, they must first domesticate those provisions or have allowances in their local laws.
Consequently, following WHO’s declaration of the coronavirus as a global public health emergency, some countries have issued compulsory licences and are amending existing laws to accommodate the issuance of compulsory licences in response to the ongoing pandemic.
For instance, in early 2020, the legislative arm in Canada, Chile and Ecuador began to lay the groundwork for the issuance of compulsory licences. Canada in response to the pandemic amended their Patent Act to allow for a faster process in issuing compulsory licences by granting the licences first and negotiating remuneration later.
Chile has similarly passed a resolution granting the use of compulsory licences for the prevention and treatment of COVID-19. To be precise, the resolution declares that the coronavirus pandemic suffices as a national emergency to invoke compulsory licensing of COVID-19 related inventions. In the same light, the National Assembly in Ecuador has passed a resolution requiring the Ecuadorian President and Minister of Health to provide free or subsidised access to these COVID-19 medicines through compulsory licensing.
Additionally, on March 18, 2020, Israel issued compulsory patent licences for the importation of lopinavir/ritonavir, which is a patented HIV medicine and one of the approved testing drugs by WHO, for the treatment of its coronavirus patients.
Despite all these preparations, no country has invoked compulsory licensing in relation to vaccines yet. Additionally, Africa appears to lag behind in this trend of passing resolutions in support of compulsory licensing of COVID-19 vaccines.
Concept of Patent Waivers
A patent waiver as the name implies means the removal of all rights accrued to an invention, which normally would have granted the inventor monopoly over it.
Pursuant to Article 27 of the TRIPS Agreement, members may exclude from patentability, the commercial exploitation of inventions, which are necessary to protect public order or morality, including protecting human life or health. They may also exclude from patentability, diagnostic, therapeutic and surgical methods for the treatment of humans.
Patent waivers are also not novel as they were used during the polio epidemic. However, in this instance, the manufacturer of the vaccine voluntarily waived off his patent right and when asked in an interview who owned the patent, he responded by saying “there is no patent, could you patent the sun?” This waiver enabled Israel to manufacture polio vaccines locally and aided them in the eradication of polio in their country.
Recent developments of patent waivers in the COVID-19 era
In the later parts of 2020, South Africa and India proposed at the WTO, the temporary suspension of patent grants regarding COVID-19 technologies. This was however rejected at the first instance by majority of developed countries, the United States and United Kingdom inclusive.
Recently, the United States under the presidency of Joe Biden has expressed its acceptance of the patent waiver and this was commended by the WTO, during the general council meeting where the issue of IP and access to essential COVID-19 medicines and medical equipment was addressed. The Director General of the WTO, Dr. Ngozi Okonjo-Iweala condemned vaccine nationalism and opined that all other nations should follow the United States’ stance, as the situation where richer countries get access to vaccines and poorer nations are left behind should be avoided at all costs.
The United Kingdom has nonetheless stood their ground in the opposition of patent waivers. They opine that patent waivers are not the solution to curbing the pandemic situation as licensing is a more viable tool.
This article, which examines the role of patent waivers and compulsory licensing in facilitating access to COVID-19 vaccines flows from the theme of a webinar held on June 25, 2021. At the event, the National Institute for Pharmaceutical Research and Development (NIPRD) and the law firm of AELEX held a joint colloquium where they explored how, as one of the methods that can be used to curb the spread of the coronavirus and improve access to vaccination globally, holders of patents to the COVID-19 vaccine can waive their rights or license the patents they hold in such vaccines.
At the event, the Director General of NIPRD, Dr. Obi Adigwe, and the Head of AELEX’s Intellectual Property Practice, Mr. Davidson Oturu, who are the authors of this article, hosted academics, health experts, and intellectual property lawyers who shared their opinions on COVID-19 response in Nigeria and other African countries.
Notable personalities including the Honourable Minister of Technology, Dr. Ogbonnaya Onu and the Honourable Minister of State for Health, Senator Olorunnimbe Mamora, praised NIPRD and AELEX for the timely discourse, which could accelerate access to COVID-19 vaccines and improve access to health for the Nigerian public.
In the second part of this article, we will explore the pros and cons of the two proposed mechanisms and propose recommendations on how the COVID-19 vaccines can be more accessible, especially by low-income nations.
• Oturu is a Partner and the head of the Intellectual Property Practice at AELEX, while Dr. Adigwe is the Director General of the National Institute for Pharmaceutical Research and Development.