In October 2020, South Africa and India bid to waive the rules of the World Trade Organisation (WTO)’s agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The agreement plays a central role in utilising intellectual property (IP) for production and facilitating trade in knowledge and creativity as well as resolving trade disputes over IP. TRIPS does not seem to be working well for developing countries concerning pharmaceuticals, where little investment in scientific research and development (R&D) has created a scenario where developing countries have to rely on IP from advanced economies to produce medicines.
The two countries attempt for waivers on utilisation of IP, came on the backdrop of the COVID-19 pandemic which revealed dire need for developing, more so African countries to produce their own drugs and pharmaceutical products. As it currently stands, about 80% of the continents’ medical & pharmaceutical products are imported. Shortages of medications and lack of products such as vaccines in most African countries during the pandemic, brought into question the sustainability of highly depending on life saving pharmaceutical imports and revealed a gap for which the pharmaceutical industry in Africa can take up.
Zambia, like several other developing African countries is not able to produce most medications to supply its population and is largely dependent on medical imports from India. Several reasons exist as to why the manufacturing of pharmaceutical products poses a challenge. The first is that the pharmaceutical sector in many economies especially the high-developed economies, is a highly regulated sector shadowed in red-tape and results in expensive rights to manufacture the patented pharmaceuticals.
Because most developing countries do not have the capacity to invest in research and development (R&D), they therefore cannot innovate and produce lifesaving medication as shown in the recent case of the COVID – 19 pandemic, and prior during the HIV/AIDS pandemic. Investment into state-of-the-art laboratory, research facilities and research personnel in Zambia’s health sector has lagged and affected the level of patented innovations.
According to the Patents and Companies Registration Agency (PACRA) 2020 annual report, only 27 patent applications were lodged in 2020, out of which 9 were ultimately granted. According to the Global Innovative Index by the World Intellectual Property Organisation (WIPO), Zambia was amongst the worst performers in innovation and ranked 122 out of 131 countries in terms of innovation. The low levels of R&D therefore inhibit any level of collaboration with the pharmaceutical industry, whose role is to scale up and commercialize pharmaceutical products.
Another major challenge for manufacturing growth in the sector is that excise duty is charged on raw materials and products of the pharmaceutical sector. Whilst there are no import duties on final pharmaceutical products that are imported into Zambia, disincentivising local manufacturing. Therefore, trading and distribution become easier for Zambia pharmaceutical companies as they would rather import and distribute rather than manufacture locally. Government policies need to be revised to enhance production of medication locally.
Moreover, the lack of pharmaceutical product intellectual property registration in developing countries which increases production costs drastically and the concurrent huge capital, entails that in developing countries with small populations such as Zambia, recouping the investment from the domestic market alone may take time. A country like India, which has a huge population, has taken advantage of this large market to establish a big pharmaceutical industry, whilst also having strong export markets in several developing nations.
Despite the outlined hindrances that stand in the way of Zambia increasing its production of pharmaceutical products, urgent need arises for a shift from being entirely dependent on the import of pharmaceutical products from other countries. While the anticipation that TRIPS might be waived is still but a longshot, Zambia could pursue developing patents for pharmaceutical products locally using R&D into indigenous medicines and remedies.
In a 2018 publication for the WIPO titled Documenting Traditional Medical Knowledge, Dr Ryan Abbott highlighted how traditional medicines already comprise of a multibillion-dollar, international industry. Furthermore, the publication showed how the biomedical sector is increasingly investigating the potential of genetic resources and traditional knowledge. Zambia needs to seriously embark on researching on traditional medical cures and develop a patent system for indigenous knowledge systems (IKS).
Once commercialised, the marketing challenges can be remedied by successfully pursuing trade exports in the African Continental Free Trade (AfCFTA). Successful national implementation of the AfCFTA can serve a bridge between the longstanding problem that Zambia and several other African nations have faced when it comes to having a fragmented individual market for pharmaceutical products.
Developing a strong pharmaceutical industry in Zambia will require the Government to invest in pharmaceutical R&D facilities and partner with private sector players in ensuring that IKS are utilised. Global shocks in the past 20 years have shown that supply chains become disrupted and critical goods like medication cannot afford to be in short supply. The commencement of the AfCFTA has already opened a large market for Zambia to utilise in terms of pharmaceuticals exports, but this can only be done if investment in modern laboratory infrastructure and personnel to conduct research of international standards are propelled.
