P B Jayakumar / Mumbai October 16, 2009,
Business Standard (India)
Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief (Pepfar).
Out of the 100 approvals by the US drug regulator Food and Drug Administration (FDA) so far, close to 95 per cent are for Indian companies.
Aurobindo leads the list with 34 approvals, followed by Cipla and US-based Mylan Laboratories' Indian arm Matrix Laboratories with about 15 approvals each. Companies such as Strides, Emcure and Hetero also would supply about 5-15 drugs each under the programme.
The Pepfar programme, started in 2003, aimed at the prevention, treatment, and care of people infected with HIV/AIDS worldwide.
On October 6, the FDA approved the 100th anti-retroviral drug under the Pepfar programme.
"It is a service to the society and we are happy to be the leader in supplying anti-retrovirals, at one-third of the prices of original drugs under the programme," said K Nityananda Reddy, managing director of Hyderabad-based Aurobindo.
The service to society makes business sense, too, for the drug companies. Pepfar is the largest commitment ever by any nation for an international health initiative dedicated to a single disease and is focused on 15 of the hardest-hit countries in Africa, Asia, and the Caribbean.
These countries are Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam and Zambia. In May 2007, then US President George W Bush reauthorised the programme by increasing procurement of generic drugs and offered another $30 billion, in addition to the initial $15 billion commitment made in 2003.
“On average, we have earned $20 million to $25 million (Rs 92 crore to Rs 115 crore) annually in the last few years from Pepfar supplies. I anticipate a slight plus or minus revenue to this figure in the coming years from this programme,” said Amar Lulla, joint managing director of Mumbai-based Cipla, another major supplier.
As on September 30, 2008, the most recent figure available, Pepfar supported life-saving antiretroviral treatment for more than 2.1 million living with HIV/AIDS. In 2008, it provided nearly $1.6 billion in support of treatment programmes, including antiretroviral drugs and services.
“There is no separate data on the spend for drug procurement under the programme. Companies involved in the programme do not reveal their revenues separately. Supplies are staggered and procurement takes months or quarters later from the date the orders are placed,” said Ranjit Kapadia, vice president, institutional research with HDFC Securities.
"It is estimated that FDA’s actions are allowing Pepfar to spend $150 million (Rs 690 crore) more each year on patient access to care,” US FDA Commissioner Margaret A. Hamburg said in a statement.
The approval process for drugs is rapid. Even patent-protected drugs are procured for supply with a tentative approval in the countries covered under the programme.
The goal of the programme is to support treatment of at least 3 million people, prevention of 12 million new infections, and providing care for more than 12 million HIV-infected and affected people by 2013. In addition, Pepfar will support training for at least 140,000 health care workers in HIV/AIDS prevention, treatment, and care.
Showing posts with label pepfar. Show all posts
Showing posts with label pepfar. Show all posts
Wednesday, November 11, 2009
Wednesday, January 28, 2009
Why Dybul Was Sacked: New Details Emerge
Why Dybul Was Sacked: New Details Emerge
Jodi Jacobson on January 28, 2009 - 3:52pm
RH Reality Check
A furor has arisen among some right-wing conservatives and some AIDS treatment advocates regarding the departure of Mark Dybul as the US Global AIDS Coordinator. And because the right-wing sees two basic causal factors in every problem (taxes and sex), it has now become the cause celebre to fault reproductive health and prevention advocates for causing Dybul's dismissal.
Dybul not only did not advance, he set back efforts to prevent HIV infection, especially among women and youth---the groups most at risk in the AIDS epidemic---so it would be hard to say we're sad to see him go.
But for those still mourning Mark's empty chair, consider this:
Last week--after the new Administration had made plain that it was putting a halt to development of new regulations and new guidance until it could review both law and policy--Dybul was found on the Hill lobbying for a more restrictive interpretation of the PEPFAR conscience clause than currently exists, with the intention of placating the Catholic Church.
In the first phase of PEPFAR, a conscience clause existed that was in itself onerous enough. This first clause was written by conservatives to allow groups receiving PEPFAR funds to refuse to provide certain kinds of services. So, for example, Catholic Relief Services (CRS) or the United States Conference of Catholic Bishops (USCCB)--which rejects family planning, condoms for HIV prevention, GLBT people and....well many other things in the real world--could receive PEPFAR funding for prevention of sexual transmission but refuse to provide condoms.
The clause was, however, interpreted by saner heads still remaining somewhere in the Bush Administration apparatus to require some sort of referral on the part of these groups.
An example: Let's say that CRS or the Bishops were trying to prevent new infections within HIV-discordant couples (one spouse is positive, the other is not...they are married...we are not even talkin' unmarried people) under the original conscience clause.
Their answer would be: don't have sex. (Seriously...I was at a conference in Abuja, Nigeria where it was suggeted by PEPFAR-funded faith based groups that these couples, rather than using condoms, simply "find other means of expressing marital love than through physical affection....for the rest of their lives.")
Public health professionals within USAID recognized that increasingly it is women whose husbands are not down with this no-sex strategy who are getting infected all across Africa. So guidance was written to require groups "protected" by the conscience clause to offer referrals if they could not provide services. Under this interpretation, a group such as CRS would have to ensure that they were partnered with, or linked to, or could refer to an organization or program that would in fact counsel those discordant couples who desired to actually have sex on how to use condoms correctly and consistently, and actually provide condoms to them.
This "liberal interpretation" of the use of your taxpayer dollars irked the Catholic Church and many like-minded evangelical groups. So they fought for--and with Mark Dybul's help won--an even more restrictive policy in the PEPFAR reauthorization last year, guaranteeing for example that they need not even provide care to those people they did not like.
Now it appears that the groups in question, concerned that the Obama Administration and the Democratic Congress would more flexibly interpret the new and more restrictive conscience clause, went into action, again with Dybul as their personal savior (speaking rhetorically).
Several legislators knowledgable about the clause and its adverse impacts had indicated their willingness to soften it in forthcoming legislative action, with the "insidious" purpose of ensuring that all people have access to the services, information, and tools they need to prevent the next new HIV infection.
The thought of this was again too much for CRS, USCCB, and apparently for Mark Dybul, who in the last few weeks was reportedly working on guidance that would have made the conscience clause even more restrictive than the law (as he has done with the abstinence-until-marriage provision, the prostitution pledge and every other element of PEPFAR criticized by experts across the globe).
To help his friends, not only did Dybul begin drafting more restrictive guidance, underscoring that groups would no longer need to refer to nor partner with other programs to ensure individuals got everything they needed to protect themselves, but he went to Congress several times this month to make a case for this!
Without permission from the White House!
(Was he on the ballot in November? I can't remember. Or is he just answering to a higher power?)
Dybul, who may have gotten a little full of himself up there at OGAC with all that money at his disposal, seems to have been free-lancing in trying to head off efforts in the new Congress to moderate the public health and human rights abuses inherent in a conscience clause that actually denies people at risk evidence-based information.
Secretary Clinton knew exactly what she was doing and why it needed to be done.
Dybul defenders?
_______________
More on Dybul
Jodi Jacobson on January 28, 2009 - 3:52pm
RH Reality Check
A furor has arisen among some right-wing conservatives and some AIDS treatment advocates regarding the departure of Mark Dybul as the US Global AIDS Coordinator. And because the right-wing sees two basic causal factors in every problem (taxes and sex), it has now become the cause celebre to fault reproductive health and prevention advocates for causing Dybul's dismissal.
Dybul not only did not advance, he set back efforts to prevent HIV infection, especially among women and youth---the groups most at risk in the AIDS epidemic---so it would be hard to say we're sad to see him go.
But for those still mourning Mark's empty chair, consider this:
Last week--after the new Administration had made plain that it was putting a halt to development of new regulations and new guidance until it could review both law and policy--Dybul was found on the Hill lobbying for a more restrictive interpretation of the PEPFAR conscience clause than currently exists, with the intention of placating the Catholic Church.
In the first phase of PEPFAR, a conscience clause existed that was in itself onerous enough. This first clause was written by conservatives to allow groups receiving PEPFAR funds to refuse to provide certain kinds of services. So, for example, Catholic Relief Services (CRS) or the United States Conference of Catholic Bishops (USCCB)--which rejects family planning, condoms for HIV prevention, GLBT people and....well many other things in the real world--could receive PEPFAR funding for prevention of sexual transmission but refuse to provide condoms.
The clause was, however, interpreted by saner heads still remaining somewhere in the Bush Administration apparatus to require some sort of referral on the part of these groups.
An example: Let's say that CRS or the Bishops were trying to prevent new infections within HIV-discordant couples (one spouse is positive, the other is not...they are married...we are not even talkin' unmarried people) under the original conscience clause.
Their answer would be: don't have sex. (Seriously...I was at a conference in Abuja, Nigeria where it was suggeted by PEPFAR-funded faith based groups that these couples, rather than using condoms, simply "find other means of expressing marital love than through physical affection....for the rest of their lives.")
Public health professionals within USAID recognized that increasingly it is women whose husbands are not down with this no-sex strategy who are getting infected all across Africa. So guidance was written to require groups "protected" by the conscience clause to offer referrals if they could not provide services. Under this interpretation, a group such as CRS would have to ensure that they were partnered with, or linked to, or could refer to an organization or program that would in fact counsel those discordant couples who desired to actually have sex on how to use condoms correctly and consistently, and actually provide condoms to them.
This "liberal interpretation" of the use of your taxpayer dollars irked the Catholic Church and many like-minded evangelical groups. So they fought for--and with Mark Dybul's help won--an even more restrictive policy in the PEPFAR reauthorization last year, guaranteeing for example that they need not even provide care to those people they did not like.
Now it appears that the groups in question, concerned that the Obama Administration and the Democratic Congress would more flexibly interpret the new and more restrictive conscience clause, went into action, again with Dybul as their personal savior (speaking rhetorically).
Several legislators knowledgable about the clause and its adverse impacts had indicated their willingness to soften it in forthcoming legislative action, with the "insidious" purpose of ensuring that all people have access to the services, information, and tools they need to prevent the next new HIV infection.
The thought of this was again too much for CRS, USCCB, and apparently for Mark Dybul, who in the last few weeks was reportedly working on guidance that would have made the conscience clause even more restrictive than the law (as he has done with the abstinence-until-marriage provision, the prostitution pledge and every other element of PEPFAR criticized by experts across the globe).
To help his friends, not only did Dybul begin drafting more restrictive guidance, underscoring that groups would no longer need to refer to nor partner with other programs to ensure individuals got everything they needed to protect themselves, but he went to Congress several times this month to make a case for this!
Without permission from the White House!
(Was he on the ballot in November? I can't remember. Or is he just answering to a higher power?)
Dybul, who may have gotten a little full of himself up there at OGAC with all that money at his disposal, seems to have been free-lancing in trying to head off efforts in the new Congress to moderate the public health and human rights abuses inherent in a conscience clause that actually denies people at risk evidence-based information.
Secretary Clinton knew exactly what she was doing and why it needed to be done.
Dybul defenders?
_______________
More on Dybul
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