Nigeria-bound HIV/AIDS Drugs Seized
What: On November 12, 2008, Dutch authorities seized a shipment of Indian-made abacavir—an antiretroviral drug for HIV/AIDS treatment—bound for Nigeria. The abacavir tablets were found to violate patent rules and were declared counterfeit; however it’s been disputed whether
the drugs were actually counterfeit. The Financial Times reported that “dozens” of HIV patients were placed at risk as a result of the seizure.
Who: GlaxoSmithKline; Aurobindo Pharma Ltd.; UNITAID
When: November 12, 2008
Where: Transported from India; destined for Nigeria; seized in the Netherlands
How: Reports indicate that the drugs were paid for by international governments supporting UNITAID—including several nations in the European Union—and were to be distributed via the
William J. Clinton Foundation, which was established by former U.S. President Bill Clinton. The drugs were shipped through the Schipol airport in Amsterdam by UNITAID.
According to Mint of The Wall Street Journal, 49 kilograms of abacavir, an FDA-accepted generic substitute for Ziagen, was confiscated on November 12, 2008 at the Schipol Airport in Amsterdam, as it moved from India to HIV/AIDS patients in Nigeria. It was seized on the grounds that it contained counterfeit materials and infringed on intellectual property rights (IPRs). GlaxoSmithKline owns the patent for abacavir. The seized drugs were manufactured by Aurbindo Pharma Ltd. in India.
UNITAID publicly stated that the confiscated drugs were not counterfeit, and encouraged their immediate release so that they could reach their intended recipients. The seized medication was to provide treatment for 166 patients for three months, according to a UNITAID senior adviser. As of March 6, 2009, the drugs had not been released to their intended recipients.
UNITAID is purchase arm of the World Health Organization (WHO), through which the Clinton Foundation purchased the abacavir tablets.
The abacavir seizure highlights a grey area between EU legislation and World Trade Organization (WTO) involving patent rules on medications. As described by the London Financial Times, “A 2003 European Council regulation requires the seizure and destruction of counterfeits or goods violating intellectual property rights from third countries, even if they were only being shipped via the EU.”
In February 2009, the EU was accused by developing countries of using intellectual property laws to seize generic drugs, putting lives at risk in developing nations where cheaper medicines are often sought. Mint described the case as a “sensitive issue between rich and poor countries—access to affordable medicines—and has been cited by developing countries as an example of rising protectionism in the economic crisis.”
Mint reported that the abacavir seizure was the sixth seizure of an Indian drug manufacturer’s exports in transit in Europe destined for other markets.
In January 2009, Brazilian officials said they would file a complaint against the WTO over a seizure of generic high blood pressure medication made in India: “The Brazilian government feels that the decision by Dutch authorities to detain the basic material critical for the public health of a developing country [is] a serious step backward on the question of universal access to drugs.”
On March 4, 2009, UNITAID released the following statement: “The tablets are not counterfeit nor does this shipment infringe other form of intellectual property to our knowledge. They are medicines used in second-line treatment of HIV/AIDS manufactured by Indian company Aurobindo. These medicines have been prequalified by the World Health Organization and have received tentative approval by the United States Food and Drug Administration.”
On March 13, 2009, the WHO released a statement on the seizure saying, “Recent events related to the handling of medicines in transit and the potential consequences for the supply of medicines in developing countries are of major concern to the organization. Ensuring that the interests of trade and health are appropriately managed also means that the flow of legitimate medicines, including generic medicines, is not impeded.”
On March 16, 2009, Nigerian newspaper, The Punch, reported that stakeholders, including those affiliated with the Network of Persons Living with HIV/AIDS, expressed concern about the seizure. The chairman of the Lagos state branch of the Network said that releasing the drugs might trigger scarcity and resistance to antiretroviral drugs in Nigeria.
“Brazil to object to Dutch seizure of generic drug,” Reuters. January 23, 2009.
“India, Brazil raise EU drug seizures issue at
WTO,” Mint, Wall Street Journal. February 4, 2009.
“UNITAID statement on Dutch confiscation of medicines shipment,” UNITAID. March 4, 2009.
“Dutch seizure of HIV drugs highlights patent friction,” London Financial Times. March 5, 2009.
“UN agency protests Dutch seizure of Indian HIV drugs,” Mint, The Wall Street Journal. March 6, 2009.
“Alarm Escalates Over Delayed Generic Drug Shipments As Action Sought,” Intellectual Property Watch. March 6, 2009.
“Access to Medicines,” WHO statement. March 13, 2009.
“Stakeholders express concern about seized HIV drugs,” The Punch. March 16, 2009.