Fact Checker: Pharmacists right to oppose new regulator

Kenyan pharmacists have come out to oppose the proposed creation of a super-regulator to police drugs and food substances in the country in the latest row between the State and stakeholders in the private sector.

Under the Kenya Pharmaceutical Society of Kenya, drug traders and distributors have accused the Government of rushing to create the Kenya Food and Drug Agency without carrying out adequate assessment or stakeholder engagement.

“We already have a drugs regulator, the Pharmacy and Poisons Board (PPB),” explained Dr Louis Somoni Machogu, President of the Pharmacists’ Society of Kenya. “It’s scope and remit have not yet been updated to align with the Health Act, and this needs to happen.”

PSK argues there is thus no need to create a new regulator for food as well as drugs as a means of achieving universal health care. In this respect the pharmaceutical lobby is correct.

Part of the mandate of the PPB under the Pharmacy and Poisons Act, 2012 include registering and deregistering pharmacists, maintaining a register of approved practitioners and premises as well as regulating the manufacture and sale of medical substances in Kenya.

The Kenya Plant Health Inspectorate Service, carries out a complementary function for the agricultural sector with a mandate that includes registering, licensing and inspecting seed sellers, testing and certifying of plant materials as well as farm inputs such as imported fertiliser and agro chemicals.

This means both the agricultural sector and health sector have dedicated regulators charged with policing the standards of food and medicines used in the country. However, despite efforts to have the regulators operate autonomous of government interventiontheir function has been handicapped by state bureaucracy.

For instance, despite being recorgnised as a semi-autonomous State agency five years ago, the National Quality Control Laboratory of the PPB still lacks adequate budgetary support to carry out its mandate.

“Previous experience has shown that when budgetary allocations are channelled through the ministry of health a number of items requested for procurement as per the approved budget and procurement plan remain as pending bills as a result of lack of compliance with the allocated budget lines,” stated PPB director Hezekiah Chepkwony in a recent report.

“The Laboratory requires budgetary support to be channelled directly to its account to continue performing its core functions,” he said. While cases of counterfeit food and drug substances in the country remain high, enforcement of already existing mechanisms would be more effective than creating duplicating agencies.