Suleiman Mbatiah
NAIROBI, Jul 30 2010 (IPS) – A major pharmaceutical company in Kenya alleges that special trade measures to make medicines available in poor countries create loopholes for counterfeit medicines to enter the market a claim that health rights advocates refute.
Parallel importation of medicines creates loopholes for counterfeiters to bring counterfeit medicines into Kenya, alleged GlaxoSmithKline medical and regulatory affairs director in Kenya, Dr. William Mwatu, in an interview with IPS.
Mwatu said that unscrupulous profiteers use the legalisation of parallel importation of generic drugs to import counterfeits.
Kenya s Industrial Property Act of 2001 allows parallel importation under Section 58 (2). Parallel importation involves the legitimate importation of non-pirated goods without the permission of the rights holder. It is allowed under the World Trade Organisation s (WTO) Doha Declaration of 2001.
The main objective is to provide citizens in poor countries that cannot manufacture their own drugs with access to medicines that are of good quality, safety and efficacy while being affordable.
But Mwatu argued that, provisions and existing guidelines on parallel importation offer counterfeiters channels to bring in counterfeits under the guise of generics to the Kenyan market .
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In response, Health Action International (HAI) Africa pointed out that parallel importation has nothing to do with counterfeiting. Counterfeiting is willful, commercial-scale trademark infringement.
HAI Africa is part of a global independent network working to promote access to essential medicines.
Parallel importation is one of the flexibilities allowed in the WTO s Trade- Related Intellectual Property Rights (TRIPs) agreement which gives the Kenyan government the opportunity to shop around the world for the best price for a medicine in other countries where the medicine has already been marketed, explained Christa Cepuch, HAI-Africa programme director.
Once a medicine is on the market in a country, its patent holders rights are what is known as exhausted , which means they cannot be enforced again and again in other markets, Cepuch told IPS.
GSK regional head John Musunga told IPS earlier this year that Kenyans exposure to fake medicines cause health complications while reducing the profit margins of patent holders.
He also blamed parallel importation as leading to the importation of counterfeits rather than legitimate drugs .
Mwatu explained to IPS that parallel importation should be regulated to ensure that there is no space for counterfeiters to take advantage of. His company is not opposed to parallel importation but wants to see rules fully enforced.
In September 2006 the Pharmacy and Poisons Board, together with the pharmaceutical industry, developed guidelines for the parallel importation of medicines into Kenya.
Under the guidelines, a parallel-imported medicine must have the same formulation, meet the same quality standards and have the same proprietary name as the medicine already available and registered in Kenya, according to Mwatu.
He added that parallel importers should register drugs with the Pharmacy and Poisons Board and bear the liability, in the event of any. The importer should at the same time provide the price at which the parallel imported medicine will be sold in Kenya and the drug s shelf-life.
The guidelines should be operationalised. We want to know who imports what and where. Transparency is all we need, Mwatu added.
Pharmaceutical companies argue that policymakers were lenient with counterfeiters in the Industrial Property Act as it contains no specific provisions for the control of illegal trade and counterfeits and does not address the lack in numbers and competence of personnel at points of entry.
Cepuch said in response that parallel importation is clearly governed under Kenya s Industrial Property Act of 2001 and its objectives are obvious and rooted in public health. Parallel importation is used solely to advance public health interests, as opposed to commercial interests, Cepuch added.
According to HAI Africa, medicines that are parallel imported are not exempt from the regulatory processes of the Pharmacy and Poisons Board and as such, any medicine which is parallel imported will be scrutinised and regulated to ensure it meets quality, safety and efficacy standards set out by the regulatory authority.