VZCZCXRO8860
PP RUEHBZ RUEHDU RUEHJO RUEHMR RUEHRN
DE RUEHLS #0040/01 0101503
ZNR UUUUU ZZH
P 101503Z JAN 08
FM AMEMBASSY LUSAKA
TO RUEHC/SECSTATE WASHDC PRIORITY 5307
RUCPDOC/DEPT OF COMMERCE WASHDC
INFO RUCNSAD/SOUTHERN AF DEVELOPMENT COMMUNITY COLLECTIVE
RUEAUSA/DEPT OF HHS WASHINGTON DC
RUEHPH/CDC ATLANTA GA

UNCLAS SECTION 01 OF 03 LUSAKA 000040 
 
SIPDIS 
 
DEPARTMENT FOR AF/S, S/GAC, AND EB/CBA (DWINSTEAD) 
COMMERCE FOR 4510/ITA/IEP/ANESA/OA 
DEPARTMENT PASS TO USPTO 
 
SENSITIVE 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: ECON ETRD KIPR BEXP KHIV EAID ZA
SUBJECT: PHARMACEUTICAL INTELLECTUAL PROPERTY RIGHTS (ZAMBIA) 
 
REF:  LUSAKA 211 
 
¶1. (SBU) Summary.  Although counterfeit medicines are prevalent on 
the local market, the GRZ has not determined the extent of the 
problem and its implications on the economy and public health. 
Zambian regulatory institutions lack resources to carry out their 
mandate, and this shortcoming might contribute to some corrupt 
activities in GRZ drug procurement.  The counterfeit medicines pose 
health risks to consumers and have resulted in numerous alleged 
deaths.  This cable also outlines other problems in the general 
enforcement of intellectual property rights in Zambia.  End 
Summary. 
 
---------------------------- 
Scale of the problem unclear 
---------------------------- 
 
¶2. (SBU) A Pharmaceutical Society of Zambia official advised Embassy 
Commercial Assistant that there is an influx of counterfeit 
pharmaceutical products in Zambia, but that the scale of the problem 
is not clear.  This was corroborated by Pharmaceutical Regulatory 
Authority (PRA) Director General, Esnat Mwape, who explained that 
the PRA has confiscated counterfeit medicines and issued public 
warnings.  Embassy contacts opine that the most prevalent 
counterfeit pharmaceutical products are over the counter 
painkillers, such as Panadol (a registered brand that contains 
paracetamol), and prescription antibiotics, such as ampicillin and 
tetracycline. 
 
¶3. (SBU) The GRZ established the Pharmaceutical Regulatory Authority 
in 2006 to oversee public and private health care providers as well 
as pharmaceutical suppliers.  The PRA is responsible for registering 
pharmaceutical dealers, inspecting medical facilities, and providing 
pharmaceutical testing services.  The PRA has procured two minilab 
test kits, to perform basic tests on imported pharmaceuticals, and 
has installed one at the National Institute for Scientific and 
Industrial Research to support inspections at Lusaka International 
Airport.  It intends to install the other at the high-volume 
Chirundu land border with Zimbabwe.  The minilab kits require 
significant support from the National Drug Quality Control 
Laboratory to process and analyze specimens and generally are unable 
to identify counterfeit medicines.  The PRA lacks financial, 
technical, and human resources to enforce its mandate.  According to 
embassy information, the PRA currently employs four inspectors. 
 
¶4. (U) To date, the PRA inspectors have directed their attention to 
reputable pharmacies in more affluent commercial districts.  They 
have neglected the lesser known, yet perhaps more popular, 
pharmaceutical outlets in the bustling shopping areas frequented by 
low-income consumers.  These outlets, which stock their shelves with 
the cheapest available products, are perhaps the most likely 
distribution points for counterfeit medicines.  A December 4, 2007, 
article in a state-owned daily newspaper, the Times of Zambia, 
appealed to the PRA to conduct regular unannounced inspections of 
these outlets, adding that "it is a common sight nowadays to see 
drugs, especially antibiotics, displayed next to soaps, lotions, 
batteries, and confectionaries in dust strewn, sun streaked shops in 
the market or [at] bus stations." 
 
¶5. (SBU) In a previous meeting with the Ambassador and Embassy 
HIV/AIDS relief program administrators, Health Minister Brian 
Chituwo acknowledged the problem of counterfeit medicines and the 
lack of GRZ resources.  Chituwo requested USG support to establish a 
pharmaceutical quality laboratory to ensure drug safety and 
efficacy.  Embassy representatives responded that the AIDS relief 
program funding could only be applied to HIV/AIDS projects, but 
communicated the request to Embassy PolEcon section. 
 
------------------------------- 
Problem may point to corruption 
------------------------------- 
 
¶6. (SBU) There are no reports of intellectual property violations 
concerning medicines procured through the World Health Organization 
or donor funded programs such as the President's Emergency Plan for 
AIDS Relief (PEPFAR).  A manager of a USAID project in Zambia told 
Embassy Commercial Assistant that counterfeit antiretroviral drugs 
(ARVs) have not been a problem in Zambia in recent years.  One 
embassy contact suggested that the availability of free ARVs through 
PEPFAR has dramatically diminished the market for fake products. 
 
¶7. (SBU) Conversely, in numerous instances medicines procured 
through GRZ resources or directly by individuals/retailers have been 
found to be counterfeit.  For example, an anti-malaria treatment 
drug, Fansidar, that the Ministry of Health supplied to Zambia's 
 
LUSAKA 00000040  002 OF 003 
 
 
third largest hospital, Kitwe General Hospital, was found to contain 
chalk.  In response, the hospital stopped using the product, but did 
not investigate the matter further.  Caroline Yeta, PRA Director of 
Inspections, confirmed other cases of counterfeit over the counter 
anti-malaria medicines, such as fake Co-Arinate, which she said 
originates in China. 
 
¶8. (SBU) Medical Stores Limited (MSL), a relatively well-managed 
government warehouse/distributor located in Lusaka, is responsible 
for supplying medical products to public hospitals and health 
centers on behalf of the Ministry of Health.  MSL undertakes random 
(spot-check) qualitative tests on some of its medicines at its 
warehouse before distributing the products.  Many districts and 
hospitals do their own procurement, however, and the products are 
purchased and delivered without MSL oversight.  One mission 
development officer speculated that it is at this point that 
counterfeit medicines most likely sneak into the GRZ system. 
 
¶9. (SBU) The lack of GRZ resources to regulate the pharmaceutical 
industry creates opportunities for corrupt activities in GRZ drug 
procurement.  In February 2007, a Lusaka Magistrate found a former 
Ministry of Health Permanent Secretary, Kashiwa Bulaya, guilty of 
corruption in a case involving a government contract to purchase 
HIV/AIDS medication (Ref A).  The prosecution revealed that Bulaya 
was not concerned about the efficacy of the product (an untested 
natural herb remedy) and had awarded a contract for personal gain. 
In its draft national anti-corruption strategy, the GRZ is proposing 
a new Procurement Act, which has the potential of reducing the 
incidences of counterfeit medicines in GRZ facilities. 
 
--------------------------------------- 
Markets exporting counterfeit medicines 
--------------------------------------- 
 
¶10. (SBU) According to a local expert, most counterfeit medicines in 
Zambia originate in India and China.  He speculated that legitimate 
Zambian pharmaceutical companies manufacture a relatively small 
amount of the counterfeit non-prescription products.  Although it 
would be relatively easy to trace these medicines from the retailer 
to the manufacturer, inspectors have not yet done so.  Because of 
their size and reputation, these companies are seldom inspected by 
the PRA. 
 
¶11. (SBU) The expert opined that the imported products enter Zambia 
through the Mwami land border post with Malawi because of its lax 
customs enforcement.  Importers and vendors are primarily Indians 
who own shops on both sides of the border.  He expressed his view 
that organized crime syndicates bring in counterfeit goods, 
including some pharmaceutical products, through Lusaka International 
Airport with the collusion of airport employees, customs officers, 
and senior GRZ officials. 
 
--------------------------------------- 
Health dangers of counterfeit medicines 
--------------------------------------- 
 
¶12. (U) Chipupu Kandeke of the Church Health Association of Zambia 
(CHAZ) warned that some counterfeit medicines have dangerous 
ingredients, which could be fatal if consumed in large quantities. 
He also noted that pharmaceutical products with low active 
ingredient content, such as ampicillin and tetracycline, can cause 
resistant strains to emerge. 
 
¶13. (U) In mid-2007, a private television station reported that 
twelve girls in Petauke District, Eastern Province, died after 
taking anti-malaria tablets at a public health center.  Subsequent 
laboratory tests, according to the same report, revealed that the 
anti-malaria tablets were counterfeit.  To Post's knowledge, the GRZ 
has not issued a statement on the deaths, or explained the presence 
of the allegedly counterfeit pharmaceuticals at the public health 
center.  GRZ authorities also have not made any public announcements 
about planned preventative measures that they will implement to 
avoid future incidences. 
 
---------------------- 
Broader IPR Challenges 
---------------------- 
 
¶14. (U) A number of factors impede the general enforcement of 
intellectual property right in Zambia, including: 
 
--slow litigation (IPR cases are adjudicated by High Courts, which 
meet less frequently than subordinate courts and are overburdened 
with cases); 
 
 
LUSAKA 00000040  003 OF 003 
 
 
--law enforcement regulations that prohibit police officers below 
the rank of Inspector from conducting searches, making arrests, and 
confiscating pirated material; 
 
--lack of coordination of national policy and regulations 
(currently, the Ministry of Information is responsible for piracy 
and copyright issues, the Ministry of Commerce, Trade, and Industry 
is responsible for patents and standards, and the Ministry of Health 
is responsible for pharmaceutical registration); and 
 
--inadequate, non-TRIPS-compliant legislation (as a member of the 
Least Developed Countries, Zambia is not required to have 
TRIPS-compliant patent legislation in place until 2016). 
 
-------- 
Comment 
-------- 
 
¶15. (SBU) The continued presence of counterfeit medicines suggests 
that the situation has not improved in recent years, despite the 
creation of the PRA.  In its 2008 Activity Plan, the PRA included 
counterfeit medicine detection training for its staff, which will 
also consist of guidance for carrying out "door-to-door" inspections 
of retail outlets.  Although this should enhance its ability to 
combat IPR violations and/or counterfeit products, the PRA will 
still be in dire need of additional resources.  To date, the PRA has 
hired only four inspectors and has yet to recruit laboratory 
personnel. 
 
¶16. (U) The media also has a role to play in sensitizing the public 
to the dangers of counterfeit products.  Even with ample media 
coverage, however, it will continue to be difficult for consumers to 
distinguish between genuine and counterfeit medicines.  Regrettably, 
the Zambian public--particularly the majority who live below the 
poverty line--will continue to be drawn to the cheapest products 
available and to less-reputable retail outlets, despite the 
prevalence of counterfeit medicines at these locales, because of a 
perceived lack of affordable alternatives. 
 
KOPLOVSKY