Govt bows to pressure, waives directive on inspection of imported medicines temporarily

The government has bowed to pressure and lifted a directive subjecting pharmaceutical products, especially medicines, to double regulation under the Pre-Export Verification of Conformity to Standards (PVoC), however, temporary.

Industry, Trade and Cooperatives Cabinet Secretary, Peter Munya on Saturday issued a three-month waiver order exempting medicines from the requirements of PVoC as the health sector in the country had started to feel the burden of this policy that saw stock-out of essential medicines.

In the directive, Munya, however, said within the next 90 days, the relevant agencies and other actors should be able to streamline the import and conformity assessment procedures.

“The Cabinet Secretary Ministry of Industry Trade and Corporative has given a three months waiver from the requirements of Pre-Export Verification of Conformity (PVOC) for imports of medicines,” a brief statement released by the Kenya Bureau of Standards (KEBS) reads in part.

By Thursday this week, health facilities and pharmacies across the country had reported major stock-outs of medicines, the worst hit being insulin, a drug administered to diabetes patients. Available statistics show that between 1.3 million and 2 million Kenyans live with the disease associated with lifestyle.

The World Health Organisation (WHO) findings show that currently in Kenya the annual prevalence rate of diabetes is 3.3 percent and projected to rise to 4.4 percent in 2035 if lifestyle consumption trends remain the way they are.

KEBS Corporate Communications office confirmed to People Daily the move to issue a waiver from PVoC for medicines but did not explain much how the move was arrived at.

“That is the correct position,” Zeyana Mohamed, Kebs acting Corporate Communications Manager said.

However, while welcoming the waiver, pharmacists have criticised the government for giving timelines, and say, the decision should have been more solid and direct, if there could have been “serious stakeholder engagements.”

Meraky Healthcare Limited Head of Commercial and Operations, Dr. Wairimu Mbogo said the impact of the waiver must be well understood by the experts and a decision made to mirror the situation post the 90-day reprieve.

“It’s good that they have given a waiver to resolve the crisis, but that should have involved all the stakeholders. Timelines are actually not important at this stage,” she added.

 The pharmacists have been arguing that this directive introduced sometimes early in the year, is unnecessary for medicines since they are not like any other commercial commodities, but lifesaving health products.

Kenya Pharmaceutical Distributors Association (KPDA) chairman, Kamamia wa Murichu who welcomes the waiver, had warned last Thursday that as the tug of war between pharmacists and government continues, the situation is likely to worsen in the next few days that would also affect also affect other essential medicines. He listed these drugs as anti-cancer medicines; blood products and HIV and AIDS medicines.

“Some key brands of insulin are already out of stock in hospitals many chemists in the country. Insulin is a life-saving drug; without it, there is fear we may lose many Kenyans who live with diabetes because they need it on a daily basis,” Wa Murichu told People Daily.

Already there is a reported shortage of blood products in the country, which Aga Khan University Hospital’s paediatric oncologist, Prof. William Macharia described as acute that needs to be addressed urgently.

“This means that importation of these commodities starts immediately,” Wa Murichu said after receiving information that PVoC on medicines has been waived.

Other pharmacists however, are demanding that the waiver should be specific. “It would be prudent to get the list of codes this move applies to, or is it for everything with a Pharmacy and Poisons Board (PPB) permit?” one pharmacist who declined to be named said.

Wa Murichu dismissed a recent directive by Health Cabinet Secretary, Sicily Kariuki asking pharmaceutical companies to provide documented statistical evidence for the impact of the controversial Pre-Export Verification of Conformity (PVoC) on the supply of medicines to Kenya.

“The problem we have in this country is that the Ministry of Health is run by people who are not technical and have little knowledge of the issue at hand. CS Kariuki has demonstrated that she does not understand this issue.

The evidence she is asking for is already on her table as we speak,” he added.

In July this year, the pharmacists were shocked that KEBS, against the advice of PPB had introduced PVoC for medicines.

And those who reacted to this move told People Daily then that; “this will mark the end of access to affordable medicines for whatever condition. Kenya is the only country asking for this. This affects other conditions, including HIV.”

This move they argued; would increase the cost of medicines; inability to access specialised medicines as the manufacturer will find it uneconomical to go through the PVOC process. “Which is very useless for medicines.”

Sometime this year, patients who use colostomy bags took to online platforms such as Facebook to protest the shortage of the bags.

Scientifically, colostomies - and resulting colostomy bags - are used to help patients who have problems with their colons. And by diverting waste away, the colostomy bag can allow irritated or inflamed areas of the colon to heal.

The shortage, a pharmaceutical importer said, was as a result of the introduction of PVOC on medical devices by KEBS. “KEBS have unrealistic requirements for the PVOC that make many manufacturers shun this market,” he further argued.

Pharmacists have been insisting that whilst the PVOC is a good idea to ensure quality, it does not on the other hand; work for specialised products like healthcare products since KEBS is clueless on the quality standards of these products.

The pharmacists are still demanding audience with President Uhuru Kenyatta to explain properly what the PVoC means to the country’s health sector especially for his Universal Healthcare Coverage (UHC) programme.

Kenya adopted PVoC in 2005, but a recently expanded guideline by KEBS has been criticised heavily by the pharmacists who are arguing that it does not support the government’s ease of doing business policy.

The government on its part, it is arguing that PVoC will assure Kenyan consumers of the safety and quality of the imported goods they buy, and to protect local manufacturers from unfair competition.

Medicines make up to 80 percent of pharmaceutical imports in the country, but in the ensuing impasse, the importers have ceased to import pharmaceutical products until the matter is resolved.

Faced with limited options on the way forward, the pharmacists had threatened to increase the cost of medicines by 40 to 60 percent, to bear the new charges of inspection imposed on them.