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June 2004
Agenda for Members Meeting Wednesday 23rd June 2004
Come Patents, exit cheap anti-AIDS drugs
U.N. Agency Drops 2 Drugs for AIDS Care Worldwide
TAC comment on The New York Times' article [Above]
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Gendering
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ImpActAIDS 2004.
This is an official ImpActAIDS newsletter.
Agenda for Members Meeting Wednesday 23rd June 2004
Dear All
I hope everyone has got it in their diaries that the next meeing will be at Solas at 5.30 pm and I am also drawing everyone's attention to a couple of items on the agenda. Firstly, it was decided last month that we would spend a little time formulating a response to the gender debate which we started at the last ordinary meeting. It would probably help if people had the time to look at the VSO document 'gendering AIDS': I won't attach it as it will fill your mailbox, but you can download it from the VSO website: www.vso.org.uk
What I am attaching is the Chair's report presented at the AGM as people said they wanted to read that.
Now for the agenda: Jim has suggested that we try to change the way the agenda is organised, but there are a few essential items we have to include. Therefore what this is should not be taken as the final version. More a structure to start from.
See you on Wednesday.
CathySuggested AGENDA
1 Minutes and matters arising (if not covered by later agenda item)
2 Hosana's correspondence with Zimbabwe
3 Gendering AIDS: VSO document
4 Joint meeting VSO/ImpAcTAIDS in September
5 Officers Reports
6 AOB
7 Date of next meetingCome Patents, exit cheap anti-AIDS drugs
The new patent protection regime to be implemented in 2005 is all set to push India back in the field of manufacturing low-cost anti-retroviral drugs used in the treatment of HIV/AIDS.
Even globally, most of the costlier drugs, affordable only by the affluent, are ready to rule the roost with the entry of the new Patents regime.
A recent World Health Organisation report says, the Indian pharmaceuticals industry brought down the cost of AIDS treatment medicines from a whopping $10,000 to $140 per year.
But the new Patents regime threatens to undo all this, ushering in again a massive increase in the prices of anti-retroviral drugs.
The report further says: "Some of the new generic drugs will fall under patent protection from 2005 when the World Trade Organisation Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) takes effect in India."
The future HIV treatment scenario, according to WHO, presents a grim picture. "After this date, Indian generic manufacturers will have to wait until patents expire before they can begin production of new drugs or the country may face trade sanctions." To cut a long story short, it would not only mean a major setback for millions of AIDS patients all over the world, but also India, "as India in particular has emerged as a major manufacturer of affordable anti-retroviral drugs."
The WHO categorically said, several Indian drug companies, through manufacture of low cost generic drugs, have triggered a steep reduction in their prices globally, and "the price of anti-retrovirals has (therefore) dropped to one-thirtieth of its former level".
Source: The Statesman (India)
http://www.thestatesman.net/
date: 13 June 2004
author: Arun Anand in New DelhiU.N. Agency Drops 2 Drugs for AIDS Care Worldwide
The World Health Organization has pulled two generic antiretroviral drugs from its list of approved H.I.V. drugs that are most often used in poor countries, saying a routine check found the manufacturer had not proved that they were biologically equivalent to patented drugs.
It is the first time that W.H.O. has removed any H.I.V. drug from its list, Lembit Rago, an official of the Geneva-based agency, said yesterday
Dr. Rago said the problem was found during routine tests that the agency conducts among drugs it finds acceptable for procurement by United Nations agencies. But, he said, the problem was not expected to interfere with W.H.O.'s initiative to treat three million H.I.V.-infected people, mostly in Africa, by next year.
Cipla, an Indian company that has been in the forefront of getting generic drugs approved for use in poor countries, made the two generic drugs, lamivudine, which is also known as 3TC, and zidovudine, which is also known as AZT.
The action follows the Bush administration's recent announcement of a significant shift in its AIDS policy to allow the purchase of cheaper generic drugs for Africa and the Caribbean. Cipla said the situation was "on the mend" and that it expected its drugs to be put back on the list within a matter of weeks.
The problem was detected during an inspection of an independent laboratory that Cipla had hired to conduct bioequivalence studies among volunteers whose blood had been tested after they took the generic drugs. The tests were devised to determine whether the concentration of the generic drug in the blood was the same as in its patented counterpart. Dr. Rago did not provide the name of the company that did the testing.
A review found that the company's documents did not meet the standards known as good clinical and laboratory practice, Dr. Rago said in a telephone interview from Washington, where he was attending a meeting.
Despite the inspection's findings, the generic drugs may be bioequivalent to the patented drugs. But W.H.O. had to remove them because the documentation was lacking, Dr. Rago said.
Inspections have found similar problems with the bioequivalency of many drugs in countries in Europe and the United States, Dr. Rago said. He also said many developing countries do not require bioequivalency testing.
Cipla's chairman, Dr. Yusuf K. Hamied, said the problem was due to inadequate record keeping in the testing laboratory in Bombay. Dr. Hamied, reached by telephone in London, said that Cipla's lamivudine has been tested for bioequivalency in a laboratory in the United States and approved by the Food and Drug Administration and that he would submit that data to the health agency.
Dr. Hamied said the testing was done for the American drug agency because Cipla hopes to sell generic lamivudine when an American patent expires in 2006.
W.H.O. did not issue a news release about the problem after it was detected in May. Dr. Rago said such an announcement was not necessary because his agency had informed other United Nations agencies about the problem and had posted the delisting on its Web site, www.who.int
Source: New York Times
http://www.nytimes.com/
date: 16 June 2004
author: Lawrence K. Altman and Donald G. McNeil Jr.TAC comment on The New York Times' article
[Above] is a report from the New York Times. It suggests that the bio-equivalence documentation of CIPLA's zidovudine and lamivudine was not complete. Even though this report does not suggest that the drugs were sub-standard, or, not bio-equivalent, this lack of attention to detail undermines the use of generics.
More importantly, as people living with HIV who use these medicines we must know that they are bio-equivalent and safe. CIPLA (and its local subsidiary) have a public and legal duty to explain this situation.
The WHO must be commended from removing the drugs from its pre-qualifies list until the problems are cleared up. At the least, CIPLA must issue a clear, non-obfuscatory statement that cannot be misused by the brand name industry.
Source: Treatment Action Campaign, South Africa
http://www.tac.org.za/
date: 16 June 2004
author: Zackie Achmat, Chairperson, TAC