[Ip-health] Business Day: Government mulls plan to allow generic versions of HIV drug

Thiru Balasubramaniam thiru at keionline.org
Tue Nov 3 04:39:06 PST 2015


http://www.bdlive.co.za/national/health/2015/11/02/government-mulls-plan-to-allow-generic-versions-of-hiv-drug

National / Health

Government mulls plan to allow generic versions of HIV drug

BY AGENCY STAFF, NOVEMBER 02 2015, 15:06

Antiretrovirals should be used as early as possible, says WHO
MSF urges state to break patent on HIV drugs

GOVERNMENT is looking into a recommendation by medical charity Medecins
Sans Frontieres (MSF) to allow generic versions of HIV drug Lopinavir after
shortages resulted in interruptions to some treatments in the country.

A rise in patient numbers in April and capacity constraints at the European
plant of US Lopinavir supplier AbbVie led to reduced supplies of the drug
in SA, said Gavin Steel, the head of industry-wide procurement at the
Department of Health. The Chicago, Illinois-based company had since
resolved the issue, he said.

Availability of generic versions of the drug, which was used by about
160,000 people in SA, would help prevent patients needing treatment that
was "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 was also recommended for young children starting antiretroviral
therapy, Mr 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," Mr Shroufi said.

A solution to prevent shortages of drugs was to "override patents on
medicines of key importance", Mr Shroufi said.

Interruptions to treatment could cause patients to become resistant to the
medication, Mr 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, Mr Steel said.

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

SA had three times the required supply of Lopinavir, or 450,000 units,
available for November, Mr Steel said. According to AbbVie’s plan, SA would
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% of
adults between 15 and 49 years old, according to UNAIDS.

While the Department of Health "has heard the call" from Medecins Sans
Frontieres, the scarcity of supply had been addressed and the price quoted
by companies that could supply the generic was higher than what AbbVie
charged, Mr Steel said. The government was meeting weekly with AbbVie over
the supply of Lopinavir and would "continue to ensure that the
interventions have been sustained".

Undercut prices

AbbVie had "consistently undercut Lopinavir prices of generic suppliers",
which would maintain market dominance and discourage competitors, Medecins
Sans Frontieres said in a statement on Monday.

SA should consider a compulsory licensing or a licence that would force
AbbVie to allow generic companies to supply Lopinavir, regardless of the
patent, the organisation said.

The grounds for a compulsory licence "should be informed by a need to
improve access", Mr Steel said. If patient requirements were not met "all
reasonable avenues would need to be investigated", he said.

Compulsory licences "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," Medecins Sans Frontieres said.



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