South Africa Asked to Allow Generics for AbbVie HIV Drug

  • Medecins Sans Frontieres says Lopinavir supply needs backup
  • South Africa says shortages of HIV drug have been addressed

South Africa’s government is looking into a recommendation by medical charity Medecins Sans Frontieres to allow generic versions of HIV drug Lopinavir after shortages resulted in interruptions to some treatments in the country with the highest number of infections by the virus.

A rise in patient numbers in April and capacity constraints at the European plant of U.S. Lopinavir supplier AbbVie Inc. led to reduced supplies of the drug in South Africa, according to Gavin Steel, the head of industrywide procurement at the Department of Health. The Chicago, Illinois-based company has since resolved the issue, he said.

Availability of generic versions of the drug, which is used by about 160,000 people in South Africa, would help prevent patients needing treatment that is “much more limited, expensive and harder to obtain,” Amir Shroufi, a medical co-ordinator for Medecins Sans Frontieres, said by e-mail on Friday. Lopinavir is also recommended for young children starting anti-retroviral therapy, Shroufi said.

“This issue exposes very clearly the importance of drug company patents in effectively blocking people from getting their essential medicines from other sources,” Shroufi said. A solution to prevent shortages of drugs is to “override patents on medicines of key importance,” Shroufi said.

Interruptions to treatment can cause patients to become resistant to the medication, Shroufi said. Lopinavir is already used by sufferers who have become immune to standard treatment of the virus.

The supply of Lopinavir had improved by mid-July after three additional AbbVie manufacturing sites were approved and by October there were no back orders, Steel said.

AbbVie has developed a supply plan that both meets monthly demand in South Africa and any unexpected extra demand, spokesman Ahmed Negm said in an e-mailed response to questions. The patent that covers the medication’s compound expires in December 2016, he said.

South Africa has three times the required supply of Lopinavir, or 450,000 units, available for November, Steel said. According to AbbVie’s plan, South Africa will receive 1.1 million units of Lopinavir in the next quarter, he said. There were 6.8 million people living with HIV in the country in 2014, or 19 percent of adults between 15 and 49 years old, according to UN Aids.

While the Department of Health “has heard the call” from MSF, the scarcity of supply has been addressed and the price quoted by companies that could supply the generic is higher than what AbbVie charges, Steel said. The government is meeting weekly with AbbVie over the supply of Lopinavir and will “continue to ensure that the interventions have been sustained.”

Undercut Prices

AbbVie has “consistently undercut Lopinavir prices of generic suppliers,” which would maintain market dominance and discourage competitors, MSF, or Doctors Without Borders, said in a statement on Monday. South Africa must consider a compulsory licensing, or a license that would force AbbVie to allow generic companies to supply Lopinavir, regardless of the patent, the organization said.

The grounds for a compulsory license “should be informed by a need to improve access,” Steel said. If patient requirements aren’t met “all reasonable avenues would need to be investigated,” he said.

Compulsory licenses “have a proven record in other developing countries of ensuring access to medicines and supply security for people living with HIV and other life-threatening diseases,” MSF said.

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