Story behind the ARV drug shortage

Ajith* is living with HIV and his doctors tried out many drug combinations but none of them were effective. But finally about eight days ago one combination seemed to work. But now he hears of a shortage of drugs and wonders whether he will be able to battle the virus inside of him. He fears for his life.

“We know of at least three people struggling without drugs,” said Lanka Plus President Princey Mangalika who herself is living with HIV and is on treatment. Lanka Plus is an NGO working for the welfare of those living with HIV.

The Sunday Times understands that of the more than 800 men, women and children diagnosed with HIV/AIDS since 1987 some 125 are being administered drugs called Anti-Retrovirals (ARVs) which keeps their virus load under control.

The three-drug combination that has to be taken throughout an affected person’s life has to follow a rigid regimen with the drugs having to be taken every 12 hours.

Arguments and counter-arguments have come to the fore, with some doctors saying there is an ARV shortage due to “poor planning” and others say it is not so.

The National HIV/AIDS Prevention Project (NHAPP) said the “stock delays” were due to a World Bank directive requesting that the procurement system be changed while the World Bank countered this allegation by saying that earlier Sri Lanka had payed “much higher prices than the regional average”.

National STD/AIDS Control Programme (NSACP) Director Dr. Nimal Edirisinghe said there was a shortage of ARVs and two drugs were not available.

“However” he stressed “no patient has suffered except for one at the Infectious Diseases Hospital who was to start treatment. We requested the NHAPP to set up under the World Bank to procure our requirements in December, but we came to know the order was only placed in March. There has been lethargy in procurement. The manufacture is to be completed at the end of April and stocks shipped in the first week of May to arrive in the latter part of May or early June,” said Dr. Edirisinghe who had also been Acting Director of the NHAPP from July 11-December 31, 2006.

The Sunday Times learns that the NSACP gives the ARV requirements of the state-sector to the NHAPP, which in turn orders the stocks. This is because initially free medication from the state to people living with HIV was negotiated under the World Bank Project.

“The immediate cause of the delay of the drugs is because we followed a World Bank directive to get the drugs through the Clinton Foundation,” says NHAPP Director Prof. Colvin Goonaratne, who had earlier been the State Pharmaceuticals Corporation Chairman for seven years.

He said the out of stock situation was not due to the negligence or delay on the part of the NHAPP. From information available, The Sunday Times understands that the World Bank Mission Team had proposed during their last review mission in September 2007 that NHAPP should procure the ARV drugs from the Clinton Foundation sources because Sri Lanka’s purchase prices were the highest in Southeast Asia.

However, sources who spoke on condition of anonymity said the World Bank did not give any comparative data to substantiate its claim nor did it give any contact details for the Clinton Foundation.

It was the NSACP Director who finally undertook to obtain the details and the information that the Clinton Foundation agents were the CHAI Consortium. The details were given on January 3 and the NHAPP sent an e-mail on January 8, to the World Bank asking for a “no objection” note in writing to purchase ARVs via the CHAI Consortium, because up to that time there had been only verbal instructions.

“On January 21 after a delay of 13 days, the World Bank gave the ‘no objection’ and on January 23 it was relayed to CHAI Consortium. On January 25, a request for prices was made from CHAI Consortium and the procedure to be followed in making the purchases,” the source said, giving the details as follows.

The technical queries made by CHAI Consortium from NHAPP by e-mail on January 29, were submitted to the relevant technical people for advice and matters clarified directly with the agent.

On February 6, NHAPP received three quotations for the supply of ARV drugs from CHAI Consortium which were forwarded to the NSACP for technical advice, the observations being given on February 15. Then NHAPP made a determination on February 17 to purchase the drugs from CIPLA of India. On February 20, this was conveyed to CHAI Consortium and on February 27, CHAI had informed via email that CIPLA had been told to go ahead.

CHAI Consortium had requested consignee details from NHAPP on March 3, which had been sent on March 4 by e-mail. Then on March 10, CHAI Consortium had informed NHAPP that production would be completed only on April 30. Another source said that earlier, the NHAPP was getting the ARVs through Citihealth, the only Colombo-based organization importing ARVs to the country and ironically it too was ordering from CIPLA.

“The stock delay is due to the World Bank’s insistence that NHAPP purchase through the Clinton Foundation on alleged cost-benefit of which we have no actual data/figures and the Clinton Foundation agent CHAI Consortium’s convoluted purchasing procedures including manufacture delays,” another highly placed source alleged.

NSACP Director Dr. Edirisinghe said in the meantime as a precautionary measure emergency supplies were being sought from Chennai with funding being secured from the 8th International Congress on AIDS in Asia and the Pacific (ICAAP) which was held in Colombo last year.

“We will get the stocks couriered,” he said. Adds NHAPP Director Prof. Goonaratne: “We have now asked SPC to import these ARV drugs directly from STC India and got a ‘no objection’ from the World Bank for local purchase of ARV drugs from Citihealth.”

A recent assessment carried out by UNAIDS as part of the costing of the National Strategic Plan for HIV/AIDS, indicated that Sri Lanka is paying much higher prices for ARVs than the regional average. Given this assessment, the Bank recommended to the Project team in September last year, to make arrangements with the Clinton Foundation to purchase ARVs at a lower cost.
The Clinton Foundation negotiates reduced prices for HIV/AIDS drugs and diagnostic equipment on behalf of the government.

Demand for ARVs will be increasing over time, and thus the Bank felt sustainability issues were an important consideration. The Bank received a request for clearance for the procurement of ARVs for this year, through the Clinton Foundation, on January 8. The Bank gave its clearance on the January 20.

It is unfortunate that the procurement process was initiated without sufficient stock in hand, particularly since it was clear it would involve different procedures. Even more unfortunate, was the fact that the provider (CIPLA) had unexpectedly run out of stock when it received the purchase order. We are very concerned about the hardship this has entailed on people living with HIV.