[e-drug] Advanced Purchase Contracts and Other Ideas

["Spring Gombe" <spring@haiweb.org>]

E-DRUG: Advanced Purchase Contracts and Other Ideas
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regards

Ms. Spring Gombe
Policy Analyst
HAI Europe
Jacob van Lennepkade 334T
1053 NJ Amsterdam 
The Netherlands
Phone  +31 20 6833684
Fax +31 20 6855002
e-mail: spring@haiweb.org
 
-----Original Message-----
From: CIPIH [mailto:cipih-participant@who.int] 
Sent: 29 November 2004 15:29
To: Commission on Intellectual Property Rights, Innovation and Public
Health
Subject: Re: [cipih] Advanced Purchase Contracts and Other Ideas
 
Commission on Intellectual Property Rights, Innovation and Public Health
Open Discussion Forum 
********************* 
This posting was submitted by: "Kevin Outterson" 
Tax credits are widely used in the US for orphan diseases.  Criticisms
include the industry practice of slicing the proposed market for a drug
quite thinly to qualify for orphan status (in the US, less than 200,000
patients), and then expanding the drug to many other conditions after
the orphan tax credit is received.  The language in the US tax code
permits the credit to be paid for drugs which are not really orphans in
the traditional sense.
 
Fast track is also the current US FDA practice for innovative, priority
medicines.  The FDA has also promised fast track service for WHO PQ
drugs which desire procurement under PEPFAR.
 
Transferable patent extensions are a very controversial and
under-studied idea.  Why offer a multi-billion dollar jackpot to a
cholesterol drug for R&D on neglected diseases?  This would mask the
prize (pull) incentive by running it through the patent & reimbursement
systems.  A more transparent and accountable system would reward such
R&D directly, and there are several major proposals afloat to do exactly
that.  
 
Kevin Outterson
 
Associate Professor of Law
West Virginia University
304 293 8282
kevin.outterson@mail.wvu.edu
LL.M. (Cantab.)
J.D. (Northwestern)
SSRN Author Page:  ssrn.com/author=340746
 

>>> cipih-participant@who.int 11/29/2004 5:53:26 AM >>>
Commission on Intellectual Property Rights, Innovation and Public Health
Open Discussion Forum
*********************
This posting was submitted by: "Charles Clift" <cliftc@who.int>
Dear Participants

The London Independent (see below)reports today that GSK, in a letter to
Tony Blair, has suggested various other ideas to stimulate R&D on
diseases mainly affecting developing countries. Do we have any views on
these i.e. tax credits, fast track regulatory approval or "transferable
exclusivity?    

Regards

Charles Clift
Secretary
CIPIH

Glaxo tells Blair to press G8 for patents reform
By Stephen Foley
29 November 2004
GlaxoSmithkline, the UK's largest pharmaceuticals company, has written
to Tony Blair to demand new tax credits and patent concessions to
encourage the development of medicines for the world's poorest
countries.

The company is also urging the Prime Minister ! to use Britain's
presidency of the G8 group of industrialised nations to strengthen
global agreements on intellectual property rights.

The Government has said it will put the healthcare problems of Africa
among its priorities for the G8 presidency, which begins in January. But
GSK's letter highlights the difficulties of getting compromises in this
area, and sets the scene for another showdown with non-governmental
organisations such as Oxfam.

GSK, which produces some of the leading HIV treatments, proposes a
system of "transferable exclusivity" for patents, where the development
of a drug for a developing world disease is rewarded by an extension of
patent protection for a developed world medicine.

This would, in effect, mean Western governments paying more for their
most commonly used drugs to help subsidise medicines in poorer
countries.

Jean-Pierre Garnier, GSK's chief executive, said the international
community must find ways to incentivise t! he pharmaceuticals industry
to produce life-saving medicines for tropi cal diseases where companies
would not otherwise invest. GSK's letter also suggests the G8 adopt tax
credits for developing world disease research and a fast-track approval
process for tropical disease medicines.

Michael Bailey, senior policy adviser at Oxfam, said the G8 must not bow
to industry pressure on the rigid enforcement of patent rights.

Meanwhile, GSK is poised to drop work on its drug Avandia as a possible
treatment for psoriasis, the skin complaint.

Separately, a BBC programme this week will accuse GSK of backing drugs
trials in the US in which underpriviliged children were forced to test
Aids treatments against their will.

---
A posting from the Commission on Intellectually Property Rights,
Innovation and Public Health e-Forum 

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--- 
A posting from the Commission on Intellectually Property Rights,
Innovation and Public Health e-Forum 


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********************* 

The CIPIH e-Forum contains submissions from parties outside the World
Health Organization. 
The views expressed in these submissions are solely the responsibility
of the authors 
and do not necessarily represent the views of the World Health
Organization.