Business Daily (Nairobi)
Steve Mbogo
1 May 2008
analysis
The Pharmacy and Poisons Board is losing the war against counterfeit medicine on sale in Kenya - thanks to the lack of a law against fakes and proxy wars between manufacturers and importers.
Kenyans are believed to be spending about Sh4 billion each year on fake medicine, exposing them to health complications arising from taking drugs that are not effective against the illnesses they purport to cure.
There are now fears that the war against counterfeits is about to be lost as illegal traders search for new avenues for quick riches following the substantial success of global efforts against narcotics.
This, analysts say, has seen drug traffickers turn to human medicine and increase the availability of counterfeit drugs in countries such as Nigeria where six in every 10 doses are likely to be fake. In Kenya, the counterfeit ratio is three in every 10 in a sector that has sales of Sh14 billion annually.
Industry players blame a lax PPB for the deteriorating situation, saying it has been caught up in the turf wars between pharmaceutical manufacturers, importers of generic drugs and retailers.
Manufacturers fear that the situation could tend towards Nigeria's unless the policing role is enhanced. In the meantime, they have taken measures to ensure that counterfeits cannot be traced to them just in case.
"This is some kind of insurance because the incidents of counterfeits are becoming too many," says Dr William Mwatu, the medical and regulatory affairs director at GSK.
As criminals shift preference to human medicines, Africa is an easy target because of the weak policing environment. Kenya in particular is targeted because of the bigger drug market.
According to GSK, the multinational pharmaceutical company with a local manufacturing presence, total annual sales for Uganda or Tanzania equal a month of Kenya's sales.
Kenya is currently the largest producer of pharmaceutical products in the Common Market for Eastern and Southern Africa (COMESA) region, supplying about 50 per cent of the market.
Out of the region's estimated 50 recognised pharmaceutical manufacturers, approximately 30 are based in Kenya.
At the centre of the counterfeit merchants is a proxy war between local drug manufacturers and the parallel drug importers, in which the PPB finds itself in the middle. Parallel drug importers are generally traders licensed by the government to import and register medicines which are under patent and are already registered in Kenya, and which originate from anywhere approved by the Board. Ideally, such medicine should be cheaper than what is available in the country to ensure as many Kenyans as possible benefit.
In September 2006, the board, together with the industry partners developed guidelines for parallel importation of medicines in Kenya.
Manufacturers accuse the board of failure to implement the guidelines, leaving the public at the mercy of importers of counterfeit medicines.
The pharmaceutical companies say they are not opposed to parallel imports but would like to see the rules enforced. The guidelines require that imported medicine should have the same formulation, quality and proprietary name as those already registered in Kenya.
A parallel importer should also register the drugs with the board and be liable in the event of a recall or adverse incident, which must be reported to the board. The importer should provide the price at which the parallel imported medicine will be sold in Kenya and the drug's shelf-life.
The medicine should also be labelled with words "Parallel Imported Medicine" or the abbreviation "PIM" (plus name and address of the Parallel Importer) on each distributed pack.
Importers of parallel medicine, on the other hand, accuse local medicine manufacturers of usurping the board's role in order to protect their business.
"Negative campaigns by multinationals have eroded public confidence in affordable parallel imported medicines as they have been associated with counterfeits," said Dr Kamamia wa Murichu, the chairman of the Kenya Pharmaceuticals Distributors Association.
Provisional data indicates that the licensed 42 parallel drug importers in Kenya control about 40 per cent of the Sh14 billion industry in sales. Their share could get higher if the Kenya Medical Suppliers Agency (Kemsa) decided to buy generic drugs. Kemsa has an annual purchasing budget of Sh3 billion although only Sh2 billion is used on medicine with the rest going to medical equipment and related expenses.
Pharmaceutical manufacturers say parallel importers capacity is limited to importing and distributing and would not be adequate like in the case of a recall.
Local manufacturers also say because of poor monitoring, the price benefit accrued from parallel imports is not being passed on to patients. It has also been difficult to ascertain whether the medicines come from factories that meet minimum pharmaceutical manufacturing standards.
KPDA, a membership body for parallel importers, accuses the regulatory bodies of big pushed by big pharmacies to introduce unrealistic guidelines on parallel importation with a view to killing the trade.
The association says the requirement for instance for drug registration would push up drug prices and eliminate the benefits of parallel importation. It takes up to four years to register a drug in Kenya.
The association says since parallel importation started in Kenya, prices of some medicines have gone down by as much as 50 per cent.
The case for parallel imports lies in the high cost of drugs in the country compared to other developing countries. For instance a dose of Azthromycin capsules used to treat genital ulcers costs Sh829 in Kenya and the equivalent of Sh246 in India, Sh563 in Brazil and Sh386 in Spain.
One dose of Cefriaxione used for treating meningitis costs Sh7,757 in Kenya, Sh4,921 in Brazil and Sh3.850 in Spain. When parallel importation was introduced in Brazil for instance, the prices of the equivalent branded products dropped by 82 per cent.
On quality, KPDA says standards of production are set by pharmaceutical companies. "The quality of drugs does not change from country to country. Whether in Spain, Pakistan, India or Brazil, quality is still the same."
In January, the WHO's International Medical Products Anti-Counterfeiting Taskforce warned that failure to treat counterfeiting medical products as a serious crime was exposing populations to health risks.
"Sanctions are sometimes much lighter than those applicable to counterfeiters of products that have no implications for health, such as T-shirts," the taskforce said, calling for harsher deterrents.
In Kenya, the draft Counterfeit Bill is yet to be legislated while the Pharmacy and Poisons Act, cap 244 is lenient on counterfeits. Those convicted of counterfeiting for instance are liable to a fine of only Sh5,000.
The Industrial Property Act does not have specific provisions for control of illegal trade and counterfeits. The inspectorate department PPB also lacks capacity to man the points of entry.
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