KAPI:

Established in the mid-1960s, the Kenya Association of Pharmaceutical Industries (KAPI) remains committed to its mission of working towards promoting an ethical, innovative, and responsible healthcare industry

By BENJAMIN OPUKO

The Kenya Association of Pharmaceutical Industry (KAPI) is a leading voice in the pharmaceutical industry in Kenya. Established in the mid-1960s, KAPI was formed 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 a Board of Directors with executing committees catering for the different areas of focus such as Trade Regulation and Policy, Compliance and Governance, Communications and Public relations, Medical Device and IVD and Pharmacovigilance and Medical Affairs committees. Holding the fort and steering the KAPI ship is Dr. Winnie Ng'ang'a, a Regulatory Affairs Director and Government

Affairs Lead at GSK. In her position as KAPI Chair, Dr. Ng'ang'a brings with her a wealth of experience in the pharmaceutical industry, particularly in the areas of regulations, thoughtleadership, strategic partnerships, and corporate governance making her a valuable asset to the association. Assisting her in this great task is KAPI Vice Chairperson Mr. Vinod Guptan, who also serves as the CEO of MedSource. In an exclusive interview with HealthCare Middle East and Africa magazine, both leaders provide insight into the association's operations and how KAPI is actively working towards creating a progressive healthcare industry that caters for the patient as the primary focus. The two note that since its resurgence, KAPI has become a powerful voice for the pharmaceutical industry in Kenya.

The fight against counterfeit pharmaceuticals has long been a priority for the Kenya Association of Pharmaceutical Industry (KAPI), a membership-based organization representing research-based manufacturers and distributors of pharmaceuticals in Kenya. With a growing membership of 34-member biopharmaceutical companies, KAPI has been actively working towards creating a business environment that is ethical, fair, and free of counterfeits.

"To minimize the counterfeits, we are also working with international associations such as IFPMA to create more awareness in the markets and bring more support in terms of developing guidelines," explains Dr. Winnie Ng'ang'a.

But it's not just counterfeits that KAPI is tackling. As Dr. Ng'ang'a notes, "Other than counterfeits, we also experience the challenge of unregulated imports." However, the association remains undeterred. Unfazed, she mentions that the association is "working with the Pharmacy and Poisons Board to streamline the imports through guidelines that are secure and that will ensure the importation of safe and quality medicine."

The fight against counterfeit drugs and unregulated imports requires a collective effort from all stakeholders in the pharmaceutical industry. As Dr. Ng'ang'a emphasizes, KAPI recognizes the importance of stakeholder engagement in this battle and has established partnerships and relationships both locally and internationally to combat this challenge.

KAPI has embarked on different strategies to combat unregulated imports and counterfeits. One of the key strategies that KAPI employs is providing training to customs officers on product evaluation and counterfeit detection.

As Mr. Guptan explains, the process of identifying counterfeits requires a range of experts, including random samplers, investigators, quality assurance pharmacists, and a well-equipped lab. With counterfeiters improving the packaging and copying batch numbers and barcodes, distinguishing real from fake is becoming increasingly challenging.

"Based on visual impact alone, it's almost impossible to differentiate genuine from copy," admits Mr. Guptan. However, to combat this challenge, Guptan cites that “KAPI members have implemented innovative technologies such as barcodes, QR codes, 3D and 4D codes, and GS1 barcodes. They have also introduced a new scratch and text system that allows consumers to text a number to verify the authenticity of the product.”

The issue of counterfeit medicines is a significant challenge for consumers of medicines worldwide. These fake drugs pose serious risks to patients, which makes them a matter of life and death. Mr. Guptan's analogy of buying a faulty TV perfectly illustrates the gravity of the issue that consumers may face as a result of purchasing counterfeit medicines.

“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. 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.

Despite the efforts of industry players and regulators, counterfeiters are constantly finding new ways to evade these measures, which presents a significant challenge to the industry. As Mr. Guptan explains, the situation is akin to “thieves always being way smarter than cops”

To combat this challenge, KAPI members must continuously supplement their measures to stay ahead of the counterfeiters. To this end “KAPI is exploring new methods to combat counterfeiting, such as digitizing the entire supply chain,” states Mr. Guptan. 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.

The benefits of a digitized supply chain go beyond counterfeit prevention. It also increases efficiency, reduces waste, and provides greater visibility into the supply chain, which is crucial for regulatory compliance. With the digitized supply chain, KAPI hopes to create a secure, transparent, and efficient supply chain that benefits both patients and the industry.

However, the implementation of a digitized supply chain is not without its challenges. It requires significant investment in technology and infrastructure, as well as training and education for stakeholders. KAPI acknowledges these challenges but believes that the benefits far outweigh the costs.

Additionally, KAPI is passionate about ethical practice within the healthcare industry and as such has partnered with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), an association which Dr. Ng'ang'a cites as an example of one of the strategic partnerships that has led to successful initiatives across East Africa.

Through this collaboration, KAPI has developed training, policy frameworks, code of ethics and most recently delivered a First in Africa Multisectoral Health Consensus framework that focuses on ethical conduct and integrity in healthcare providers, this was launched with 17 other partners within the healthcare industry. The Launch of the Kenya Consensus framework for ethical collaboration was a remarkable achievement that brought diverse health stakeholders together to strengthen ethical conduct and together to save lives and strengthen our health systems in Kenya. The result is that patients will trust the healthcare system more and experience better holistic care. With this consensus commitment, we expect that Kenyans will receive the right treatment at the right time and for the right reason with the best therapeutic outcome.

"By partnering with organizations such as IFPMA, GSCF (Global Self Care Federation) we are able to create more awareness in the markets and bring more support in terms of developing internationally acceptable standards and guidelines," says Dr. Ng'ang'a. She goes on to stress that KAPI's relationships with key stakeholders enable it to leverage knowledge and resources for the greater good of the industry.

As Mr. Guptan highlights, KAPI's partnerships with key stakeholders such as the Kenya Healthcare Federation, Pharmacy and Poisons Board, Anti-Counterfeit Association, KEPSA, PSK, and others, have been crucial in ensuring the association's success in these areas. With a united effort and shared goals, KAPI and its partners are working towards a more sustainable and ethical future for the pharmaceutical industry in Kenya and beyond.

Capacity building is a crucial area of focus for KAPI, particularly in strengthening the regulation system, according to KAPI Vice Chairperson, Mr. Guptan. The association's collaborations with various entities are aimed at promoting a better business environment while simultaneously strengthening the regulatory system in the country.

In today's world, sustainability has become a top priority for organizations across all industries. And KAPI, the Kenya Association of Pharmaceutical Industry, is no exception. KAPI has been leading the way in leveraging technology to achieve sustainability goals in the pharmaceutical industry. Dr. Ng'ang'a's insight into KAPI's adoption of digital technology for sustainability is impressive. The Association is well aware that leveraging technology is a key factor in ensuring sustainability. Digitalization also brings more transparency to the landscape, which benefits all parties involved Dr. Ng’ang’a states that “There has been a positive move by the government with the creation of online platforms for transacting from regulation, registrations, importing and exporting of pharmaceutical products.” she adds that “This is a positive move and KAPI commends the Pharmacy and Poisons Board for setting for pace for the rest of the East Africa markets in digitalizing their systems.”

“Digital Health is the future and we have to be ready to hit the ground running by working with the authorities to ensure that the proper legislations and regulations are in place and that all the appropriate policies are enforced to support this area of growth.

Hopes to make good use of data driven valuebased supply chain.

KAPI's dedication to sustainability is not just a trend but a conscious effort to make a positive impact on the environment. According to Dr. Ng'ang'a, "KAPI is committed to taking a leadership role in environmental sustainability and ensuring that its member companies do the same." This commitment to environmental protection is evident in KAPI's partnership with the Global Safe Care Federation, which is focused on developing a more environmentally friendly approach to pharmaceutical waste management.

KAPI's dedication to sustainability has not gone unnoticed. The Association has been recognized for its efforts, including the development of guiding documents that bring together key stakeholders. Dr. Ng'ang'a shares that KAPI's UHC report, launched in 2021, emphasizes the crucial role that entrepreneurs play in forming publicprivate partnerships to ensure sustainability efforts are successful. She adds, "We are proud to be at the forefront of sustainability efforts in our industry, and we hope to inspire others to follow our lead. The innovative biopharmaceutical industry’s holistic approaches focus on three key strategies.

These include collaborating across sectors to strengthen healthcare systems and respond to local needs, working to support national strategic priorities, and increasing access to quality healthcare and treatment. Dr. Ng’ang’a reiterates, “With our mission to discover, develop, manufacture, and distribute valuable medicines that enable people to live longer, healthier, and more productive lives, the innovative biopharmaceutical industry is a key actor in Kenya’s healthcare landscape.”

As part of its sustainability efforts, Dr. Ng’ang’a explains that “KAPI is working with Global Self Care Federation (GSCF) to Charter for Environmentally Sustainable Self-Care, with key focus on Plastics and Packaging, Pharmaceutical Waste disposal in the environment and CO2 footprint. “

Looking to the future, KAPI remains committed to continuing its efforts towards sustainability and making a positive impact on the environment. As Dr. Ng'ang'a notes, "We believe that our industry has a responsibility to protect the environment, and we are committed to doing our part. Through our partnerships, education initiatives, and continued dedication to sustainability, we aim to make a real difference in the world."

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. The government’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.

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.

KAPI through the leadership of Dr. Ng’ang’a has seen the association build Corporate governance structures that ensure that it has longevity in its operations. KAPI is currently revising its constitution to make it fit for the future.

KAPI is seeking to work more with the county governments to address emerging issues in healthcare as well as seek solutions in healthcare financing for the benefit of the patients and to increase access to their ever-growing portfolio from the innovator member companies.

KAPI is also looking to expand its reach by supporting other markets in Sub-Saharan Africa. The association is in the process of supporting the other East and West African markets to create strong trade association 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.

Expanding into new markets is a significant step for KAPI member companies, 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