Elevating Healthcare ethics & innovation in Kenya’s pharma industry

The Kenya Association of Pharmaceutical Industry (KAPI), is a membership-based organization that represents research-based manufacturers and distributors of pharmaceuticals in Kenya. Established in the mid-1960s, KAPI was formed to address the need for a unified effort to bring about positive change in the pharmaceutical industry in Kenya.

Over the years, KAPI has grown to become a strong community that advocates for ethical and fair business practices in the pharmaceutical industry. However, after resolving the issues it was initially formed to tackle, KAPI went into hibernation mode. It was not until 2003 that the association was re-established, and it has been going strong ever since.

To ensure it discharges its mandate effectively, KAPI has put in place an elaborate leadership structure that is comprised of an Executive Committee, a committee on communications and public relations, and one on research and regulation. Holding the fort and steering the KAPI ship is Dr. Winnie Ng’ang’a. In a position as Chair, she provides strategic planning and direction to the association.  vast experience in the pharmaceutical industry, specifically in regulations and decision-making. Assisting her in this great task KAPI Vice Chairman Mr. Vinod Guptan (who also serves as the CEO of MedSource). HealthCare Middle East and Africa magazine recently interviewed both of them about the association.

The two note that since its resurgence, KAPI has become a powerful voice for the pharmaceutical industry in Kenya. With a growing membership of 34-member biopharmaceutical companies, they are proud that KAPI is actively working towards creating a business environment that is ethical, fair, and free of counterfeits.

Fighting counterfeits head-on

Despite their best efforts, counterfeit pharmaceutical products continue to pose a significant challenge to the Kenya Pharmaceutical Industry, according to Dr. Ng’ang’a. The influx of unregulated pharmaceutical products in the market has opened up avenues for counterfeit products which not only threaten patient safety but also undermine the credibility of the pharmaceutical industry.

Dr. Ng’ang’a emphasizes the importance of stakeholder engagement in combatting counterfeit trade, noting that KAPI has established partnerships and relationships both locally and internationally. One such partnership is with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), with whom KAPI has developed training, policy frameworks, and a code of ethics to align stakeholders toward the same goal of combatting counterfeits.

Locally, KAPI also works closely with the Pharmacy and Poisons Board, the Global Self-Care Federation, and a regional self-regulation body that promotes self-regulation of over-the-counter medicines dispensation. By collaborating with these stakeholders, KAPI aims to ensure that all players in the pharmaceutical industry are working together towards a common goal of promoting safe and quality of medicine in Kenya.

Mr. Guptan further highlights KAPI’s collaborations with various local stakeholders to streamline processes, improve regulation, and combat counterfeit products. For instance, KAPI works closely with the Kenya Healthcare Federation, the Pharmacy and Poisons Board, the Anti-Counterfeit Association, Kenya Customs, Kenya Bureau of Standards (KEBS), Kenya Private Sector Alliance (KEPSA), and Kenya Revenue Authority (KRA) to achieve these goals.

KAPI’s collaborations with various stakeholders in the Kenyan market have proved instrumental in enhancing regulation and combating counterfeit products. One of the key strategies that KAPI employs is providing training to customs officers on product evaluation and counterfeit detection. By doing so, they help identify the prime zones of counterfeit manufacturing and the time zones when counterfeit products are brought into the country.

Furthermore, KAPI helps identify the types of products that are commonly traded as counterfeits in other markets, which helps improve the regulatory environment in the country. Capacity building, particularly in strengthening the regulation system, is a significant focus area for KAPI, and their efforts have resulted in a significant amount of activity, particularly in the prime zones of counterfeit manufacturing. Ultimately, these collaborations with various entities are aimed at strengthening the regulatory system in the country and promoting a better business environment.

Guptan acknowledges that identifying counterfeit products is a costly process, requiring random sampling, investigators, quality assurance pharmacists, and a well-equipped lab. Identifying fake from real is even becoming more difficult today as counterfeiters often make the packaging look even better than the original product and match that with copied batch numbers and barcodes. Based on visual impact alone, its almost impossible to differentiate genuine from copy, Gupta admits. To combat this, KAPI members have implemented innovative technologies such as barcodes, QR codes, 3D and 4D codes, and GS1. They have also introduced a new scratch and text system that allows consumers to text a number to verify the authenticity of the product.

Guptan’s analogy of buying a TV perfectly illustrates the seriousness of the issue KAPI is facing. “When you buy a faulty television, you may lose your money or be inconvenienced, but ultimately, it is not a matter of life and death. However, when it comes to counterfeit medicine, the stakes are much higher. Patients who take these drugs may suffer severe health consequences or even lose their lives,” he explains.

KAPI recognizes the importance of creating a regulatory environment that ensures fair and legal trade while protecting patients from counterfeit drugs. By working with regulators and policymakers, KAPI is helping to develop policies that promote the safety and efficacy of the medicines in the market. This will help patients trust that the medicine they are buying is genuine and safe, ultimately leading to a healthier population.

However, counterfeiters are constantly finding new ways to evade these measures—akin to the thieves always being way smarter than cops, which means KAPI members must continuously supplement their measures to stay ahead of the counterfeiters. As Mr. Guptan says, KAPI is exploring new methods, such as digitizing the entire supply chain, to combat counterfeiting. By creating a track and trace system that covers the entire journey of a product from the manufacturer to the end consumer, KAPI hopes to increase transparency and make it easier to identify and prevent the entry of counterfeit medicines into the Kenyan market.

When you buy a faulty television, you may lose your money or be inconvenienced, but ultimately, it is not a matter of life and death. However, when it comes to counterfeit medicine, the stakes are much higher.

Mr. Vinod Guptan – Vice Chairperson, KAPI

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Making sustainability a priority

Sustainability is a priority for KAPI, and the association has taken measures to ensure its operations are environmentally friendly. KAPI collaborates with the Global Safe Care Federation to test the environment for pharmaceutical waste management and educates the community on managing pharmaceutical waste to protect the environment. KAPI has also developed guiding documents that bring together key stakeholders and launched the UHC report to emphasize the importance of public-private partnerships (PPP) in ensuring sustainability efforts are successful. To this end, KAPI remains committed to continuing its sustainability efforts and making a positive impact on the environment.

While environmental sustainability is a crucial aspect of KAPI’s mission, the association also faces sustainability concerns related to member companies leaving the market. According to Mr. Guptan, the number of KAPI members has decreased over time, with some companies being taken over, splitting into smaller entities, or simply leaving the market. To address this issue, KAPI is trying to bring back former members who have split off into independent companies.

One such company that has left the Kenyan market is GSK, but they have left behind a positive legacy by introducing Haleon, which is now part of the company. However, Sanofi is also considering exiting the market, which could have significant implications. Nevertheless, KAPI has received representation from a member company that imports similar products and offers similar services, indicating that even if some companies leave, there will still be member companies aligned with the association’s objectives, Mr. Guptan reveals.

KAPI’s sustainability is based on membership fees and a well-structured funding system for ad hoc projects. However, if member companies continue to leave the market, it could affect the association’s funding and ability to carry out its mission effectively. Therefore, KAPI is working to maintain a strong membership base and engage in partnerships and collaborations to ensure its sustainability and ability to combat counterfeit products in the Kenyan market.

Encouraging pharma industry growth locally through PPPs

KAPI is actively engaged in public-private partnerships (PPP) to encourage the growth of the pharmaceutical industry in Kenya. Through PPPs, KAPI is looking to partner with the government to strengthen regulation initiatives, fund projects, share resources, and transfer technology. Mr. Guptan reflects that the PPP “idea was initially proposed by the Kibaki government and is now seeing progress under the current leadership.” By incentivizing local manufacturers to revive or establish their manufacturing units in Kenya, KAPI hopes to create a more conducive environment for businesses and provide employment opportunities in the country. This would also make Kenya a hub and a trendsetter in the pharmaceutical industry in East Africa and sub-Saharan Africa, he adds.

One of the major benefits of revamping local manufacturing units is that it would lead to the production of good quality products at a lower cost. Transportation costs can be expensive and time-consuming, and manufacturing products locally can reduce these costs, making it easier for Kenya to provide pharmaceutical products to other sub-Saharan African markets. KAPI’s efforts towards incentivizing local manufacturing not only contribute to the development of the healthcare industry in Kenya but also the region as a whole.

Overall, KAPI recognizes the need for a better-structured playing field for entities to manufacture locally in Kenya, which can potentially benefit the country’s economy and its people. Through its partnerships with the government and other stakeholders, KAPI is committed to promoting sustainable growth in the pharmaceutical industry in Kenya and beyond.

Sentient about the needs of the community

As part of its corporate social responsibility (CSR) duties, KAPI collaborates with regulators, stakeholders, and its members to create sustainable solutions that benefit the country and its people.

While KAPI itself does not deal in products, its members have launched numerous products, including COVID vaccines such as AstraZeneca and Pfizer. KAPI members are also involved in the import and distribution of vaccines and antimalarials into the country, which plays a significant role in the healthcare sector. One example of a sustainable project that KAPI members were involved in is the Affordable Medicines Facility-malaria (AMFM) project aimed at eradicating malaria in Africa.

The association’s dedication to CSR is further demonstrated through its engagement in various activities that benefit the country and its systems. KAPI members have donated instruments and equipment to national quality control labs, including Kenyatta and MTRH. Such donations help improve the capacity of these labs, which ultimately leads to better quality control of pharmaceutical products in the country.

Future plans

KAPI has identified several investment opportunities to further its mission of promoting fair and legal trade while improving the quality of healthcare in Kenya. One of the immediate plans is to buy its own office space, which has been in consideration for several years. This investment will provide stability and a permanent base for KAPI’s operations while also potentially saving costs in the long run.

Furthermore, KAPI is exploring opportunities to invest in training pharmacists and pharm techs to improve their business management skills, as this is an area where they typically lack expertise. As qualified practitioners, these individuals often lack business management skills, which is why KAPI is seeking to bridge that gap through continuous medical education and financial training.

To support these efforts, KAPI is also investing in strengthening its Secretariat by hiring more human resources. This will ensure that the association has a capable team in place to manage its activities efficiently and effectively.

In addition to investing in its own operations, KAPI is also looking to expand its reach by supporting other markets in Sub-Saharan Africa. The association is in the process of forming the Uganda Pharmaceutical Association and is also exploring partnerships with Ethiopia, Burundi, and Rwanda where it believes there is a need for strong trade associations that can represent the pharmaceutical industry in these countries, and it is currently helping to formulate constitutions and governance structures for these new associations.

KAPI is confident that it can help establish these new associations quickly, as many of its members, such as AstraZeneca, Sanofi, Roche, Eli Lilly, GSK, and Pfizer, are already present in these countries and can quickly join the new associations. The association believes that the process of forming these associations is relatively simple, provided there is willingness and blessings from country heads.

Expanding into new markets is a significant step for KAPI, as it will help create a sustainable market for the pharmaceutical industry across Africa. The association’s board is keen on bringing together member organizations from other African countries to strengthen the industry and create a fair business environment. KAPI’s success in Kenya can be replicated in other countries, and with the collaboration of key stakeholders, it is hopeful that the pharmaceutical industry in Africa will experience tremendous growth.

This feature appeared in the June 2022 issue of Healthcare Middle East & Africa. You can read this and the entire magazine HERE