By Mercy King’ori
The novel Coronavirus has spread from China to other countries in the world. The virus which was first detected in December 2019 in the Wuhan region in China is not sparing even developing countries. There is no known cure for the disease, however, pharmaceutical companies are working to help develop a cure. There are only numerous clinical trials of drugs being done with the hope that a cure will be found. Currently, the response to the outbreak in many countries has been to stop flights to and from badly affected areas. At a medical level, the response has been to manage the symptoms of the disease for those infected. Additionally, countries are establishing centres within existing health facilities to deal with any suspected cases. Of particular interest in this pandemic are developing nations whose medical systems are known to be strained. Most African nations categorised as developing are improving their capacity to detect and cope with it. While this is noteworthy, the writer cannot help but wonder whether the same progress will be made in the event a cure is discovered. How accessible will the drugs be to developing nations to deal with a pandemic?
The concerns emanate from the fact that most medicines and the processes of creating them are most likely to be protected under the intellectual property rights (IPR) regime. Historically, developing nations have had challenges with access to medicine due to the restrictive nature of IPR in the pharmaceutical industry. This post explores how the patent system negatively affects access to medicines in developing countries. Also to demonstrate how this may still play out in the event a cure for Covid19 is discovered. Pursuant to this, the blogger explores existing approaches that seek to aid access to medicine to developing nations and if they can be useful presently. As a working assumption, the blogger proceeds on the presumption that any drug developed will be patented. Additionally, it acknowledges the existence of pledges such as the “Open COVID Pledge” which requires groups committed to implementing it adopt the Open COVID License. The Pledge aims to freely avail any intellectual property necessary to end the pandemic.The post concludes that there is overwhelming evidence that the patent system may negatively affect access to Coronavirus drugs in developing nations upon discovery. However, the Doha Declaration provides a reference point on how it can facilitate access to medicines due to a public health crisis.
Patents and medicines
As mentioned earlier, medicines; the products and processes are usually protected by IPR. They are patentable under several international agreements including the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). A patent grants the owner exclusive rights to an invention. An invention may be a product or a process that provides a new way of doing something or solution to a technical problem. Patents in the pharmaceutical industry are often seen as a reward mechanism for the amount of research and development as well as the huge financial implications of developing a drug. They grant the patent owner the exclusive rights to produce, use, offer for sale, sell or import the medicines. The exclusive rights are often granted for a period of upto 20 years. After expiry of the patent, the technical information falls to the public domain and can be freely used by anyone without such use being considered to be infringing. Patent owners use this temporary exclusive period to recoup the investment made in drug development usually through pricing. Therefore, it is common to find the price of a drug being high during the life of their patent. This phenomenon of charging high prices for inventions in the medicine field is so prevalent to the extent that there have been calls for the high costs of research and development to be de-linked from drug prices. A call that has been termed as a “dead end” as it may encourage free riders.
Challenges of pharmaceutical patents to developing countries
The relationship between pharmaceutical patents and access to medicines in developing countries has not been rosy at all. The patent system has proven to be exclusionary of developing countries despite the existence of public health needs of certain patented medicines. A good example of this exclusionary aspect is the South African HIV epidemic. South Africa has a high number of people living with HIV hence dependent on antiretroviral drugs (ARVs). The ARVs are categorised into 1st line, 2nd line and 3rd line. Most people do not benefit from 1st and 2nd line ARVs due to drug resistance and side effects thus need 3rd line. However, the former is still under patent making the drugs very expensive and not accessible in public health facilities. A campaign launched in South Africa dubbed “Fix the Patent Laws” explains how the expensive nature of third-line drugs are not highly recommended due to certain factors including the high prices using the story of a man who is infected with the virus.
The problem is further exacerbated by pharmaceutical companies that file patent applications in developing countries upon drug discovery. Patents are territorial in nature. Therefore, a patent filed in a developed country has no effect in a developing country unless the owner files in the latter. This has given rise to the practice of filing patent applications in developing countries by patent owners particularly in the pharmaceutical industry. This bars any form of generic manufacturing of the drug. Therefore, generating a monopoly over pharmaceutical markets. Generic industry heavily contributes to affordable medicines hence more access. This practice has seen a developing country such as India which is a huge contributor of generic medicines reject patent applications from international drug manufacturers such as Norvatis and Gilead. The two companies manufacture cancer and Hepatitis C drugs respectively. Allowing patent applications for certain medicines especially those needed due to public health concerns delays the entry of affordable generic drugs into the market.
The Coronavirus (COVID-19) Pandemic
The reality of the HIV epidemic and related challenges of access to medicine bring to question whether the situation would be any different if Covid-19 drug(s) are developed and patented. Based on this experience is it likely that the same reality may play during the current pandemic, disadvantaging people with limited or no capacity to purchase the drugs.
Doha Declaration on the TRIPS Agreement and Public Health (the Declaration)
The Doha Declaration was adopted by the WTO Ministerial Conference of 2001. The Declaration sought to assure members of the flexibility of TRIPS with regards to legally circumventing patent rights to ensure access to medicines due to public health reasons. It acknowledges that while TRIPS contains stringent provisions for protection of the pharmaceutical industry, it is also flexible enough to protect public health. It recognises the role of IP protection for the development of new medicines while recognising its effect on drug prices and eventual accessibility. Two aspects of the Declaration make it a preferred approach for developing countries when faced with the challenge of accessibility due to existing patent rights.
1.The right to grant compulsory licenses
Compulsory licensing occurs when a government permits manufacturing of a patented product or performance of a patented process without authorisation from the patent owner. This form of licensing allows manufacturing for local use and not importation. This form of licenses came into existence when TRIPS became effective in 1995 but were later interpreted for the pharmaceutical industry through the Doha Declaration.
However, misunderstanding of this provision has led to many developing countries not using it. WHO highlights these misconceptions in stages. First, the misconception that there has to be a national emergency for compulsory licensing to be granted. To the contrary, the Declaration states that a country is at liberty to determine what amounts to a national emergency. Secondly, that the patent owner has relinquished their rights. This is not the case. In fact, under a compulsory license, a patent owner is entitled to compensation. The amount payable is to be determined at the national level and the patent owner has the right to appeal the amount.
In Kenya, compulsory licences of this kind are provided for under the Industrial Property Act. The Act defines them as “compulsory licences for non-working and similar reasons”. The Act provides that “a person may apply to the Tribunal for a licence to exploit the patented invention on grounds that a market for a patented invention is not being supplied on reasonable terms”. The Act provides conditions under which a compulsory licence may or may not be granted by the Tribunal.
2. Permitting parallel importation
Parallel importation is “ the importation and resale of genuine products from a distributor who legally obtained it from a manufacturer at a low price instead of buying directly from the manufacturer”. The “products are placed on the market in a country with the approval of the intellectual property rights (IPRs) owner and they are imported to another country without the authorization of the IPRs owner”. It allows a country to import the patented medicines from a region where they are being sold at a cheaper price into a region where the same drug is being sold at a higher price.
Challenges to implementing these flexibilities
One of the major challenges of implementing the TRIPS flexibilities has been lack of knowledge and political pressure from developed countries. According to WHO, most procurement departments in developing nations are not aware of these flexibilities hence cannot utilise them. Similarly, developing nations are under political pressure to implement stronger patent protection. This can be seen from the uncoordinated and usually unsuccessful war against counterfeits. Therefore, this has kept many developing countries at bay to manufacture even generics. It therefore ceases to be a legislative barrier since the laws allow flexibilities. It becomes a matter of practically using the provisions.
The novel Coronavirus is not only affecting developed countries, developing countries also are bearing the brunt. This epidemic provides a chance to explore how the patent system has historically disadvantaged developing nations and how a cure for the virus, if patented, may not pose an access injustice. However, all is not lost for developing nations as the Doha Declaration provides relief for parties to the TRIPS Agreement. The TRIPS Agreement provides flexibilities as explained in the Doha Declaration for developing nations to use patented medicines to resolve a public health crisis. However, there still remains implementation problems of the Declaration due to lack of awareness and political pressure which must be navigated before the flexibilities are enjoyed.