How new trade deal will limit Kenyans' access to affordable drugs

Kenya is facing a potential setback in access to affordable medicines as new clauses in the proposed Comprehensive Economic Partnership Agreement (CEPA) introduce five extra years of data exclusivity for multinational drug makers.

Experts warn that this could delay the entry of cheaper generic medicines, raise treatment costs and slow the growth of local pharmaceutical manufacturing, which currently accounts for just 30 per cent of the country’s supply.

The briefing in Nairobi was called to explain why Parliament placed reservations on two clauses of the agreement.

Officials said the pause was necessary to prevent trade provisions from undermining patient safety, hospital standards and the country’s ability to supply its own essential medicines.

Dr Wairimu Mbogo, president of the Pharmaceutical Society of Kenya (PSK), said the agreement, if implemented without reservations, would compromise local manufacturing.

“If manufacturers are denied access to data for registration, they cannot produce generics. This will lock out local factories, raise the cost of treatment and make key medicines harder to reach,” she said.

She explained that Kenya currently imports about 70 per cent of its medicines and that the country’s goal is to increase local production to at least 50 per cent in the coming years.

She also emphasised the role of pharmacists in improving patient care. “We train more than 500 pharmacists every year, yet nearly 40 per cent are unemployed or underemployed. Hospitals and pharmacies have often relied on less qualified staff because they were cheaper. This is no longer acceptable. We need to use our trained professionals to guarantee safe, effective care,” Dr Wairimu said.

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According to Dr Wairimu, the issue is not just about economics but about constitutional rights. “Article 43(1)(a) guarantees every Kenyan the highest attainable standard of health. That includes safe medicines and proper pharmaceutical care. If we compromise this under a trade deal, we are failing the public,” she said.

She added that pharmacies and hospitals must comply with professional oversight rules to prevent medication errors, particularly for patients with diabetes, hypertension and cancer.

Dr Dominic Karanja, a senior lecturer and PSK member, said the proposed clauses go beyond what the global Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement requires.

“This proposal introduces a TRIPS-plus provision that delays generics even after patents expire. It does not serve the public interest,” he said. He explained that TRIPS allows generic manufacturers to prepare medicines once patents near expiry, but the CEPA clauses would block this for five additional years, slowing access to affordable drugs.

He also criticised the attempt to classify medicine regulations as non-tariff barriers. “These controls are not barriers. They are essential safeguards that ensure quality, stop counterfeits and protect patients,” Dr Karanja said. He warned that treating medicines as ordinary trade commodities would be a grave mistake, exposing Kenyans to poor quality and unsafe drugs.

Dr Wairimu and Dr Karanja urged government negotiators to maintain the reservations in CEPA. “We are not protecting business interests. We are protecting public health,” Dr Wairimu said. Dr Karanja added, “This is about the lives of Kenyans. We cannot trade safety and access for speed or profit. Any agreement that compromises patient care is unacceptable.”

The society urged that keeping the reservations would support local manufacturing, secure jobs for qualified pharmacists and safeguard access to safe, affordable medicines across the country.