[Ip-health] CPTech comments on the APC/AMC approaches

[James Love]

http://www.cptech.org/blogs/drugdevelopment/2006/07/cptech-comments-
on-apcamc-approaches.html

The debates over the various version of the Advanced Purchase
Commitment (APC)/Advanced Marketing Commitments (AMC) proposals have
a fairly long history (since the late 90s). Most of the people in the
debate are sincerely motivated to address extremely important gaps in
R&D for persons living in poverty in developing countries. There
were, particularly in the beginning, ideological aspects of the
debate, as some proponents of the APC/AMC approaches presented the
issue in such as way as to understate the importance of public sector
directed medical research and overstate the efficiency and benefits
of the patent system -- which they claimed, "worked fine" so long as
people had sufficient purchasing power, which the APC/AMC sought to
remedy. (Views emphasized by the IFPMA, for example). This led to a
backlash against the proposals by persons who saw other flaws in the
patent system, or wanted to defend the importance of "push" funding
by governments and PPPs, and to call attention to the potential
"crowding out" problems if massive funding went into APC/AMC proposals.

There have also been a host of practical issues raised about the
proposals, including the specifications of the qualifying products,
rewards for follow-on R&D, and many other issues.

CPTech has viewed the APC/AMC proposals as having the most appeal in
the context of vaccines or other products where it is particularly
useful to tie the incentive to innovate to practical plans to insure
that patients actually have access to and benefit from the new
products.   Our concerns about the APC/AMC proposals are several,
including those about the crowding out of other R&D funding
possibilities, but more importantly, we question whether or not the
fundamental approach of structuring commitments to buy products that
meet particular standards is the best approach.

Like the proponents of the APC/AMC proposals, we are convinced that
some significant public funding should be devoted to so called "pull"
mechanisms, that reward successful drug developers. In terms of the
R&D incentive aspects of the proposals, we would reduce the
complexity of the AMC proposal by replacing the purchase commitments
with large prize fund like rewards that were tied to positive health
care outcomes. We proposed such systems in 2002, in the context of a
broader separation of the markets for innovation and products.
Others, particularly Aidan Hollis, have elaborated on how this might
be done in the context of neglected diseases.

The APC/AMC proposals essentially link together the R&D incentives
with the delivery of products to patients. We would prefer if these
were not tied together, and rather that developers would be rewarded
regardless of who markets, sells or delivers products. We (as others)
would also prefer that rewards be tied more generally to health
outcomes, rather than specific product standards, so that drug
developers would have more flexible targets -- the more general, the
better, in our view. Perhaps this could be also tied to the voluntary
licensing of patents to a patent pool that faciliated generic
competition for products.

That said, we do appreciate and agree with the point made by APC/AMC
proponents that it is important to fund also the systems that deliver
products to patients. We would not link this so closely in practice
to the R&D issue, however.

Jamie

Here are a few links for some background documents on the G8
discussions on Advanced Marketing Commitments


Proponents and explainers of the AMC proposals

http://www.dfid.gov.uk/consultations/amc-report-tremonti.pdf
Advanced Market Commitments for vaccines, A new tool in the fight
against disease and poverty, Report to the G8 Finance Ministers,
Giulio Tremonti, Minister of the Economy and Finance, Italy, December
2, 2005

http://www.dfid.gov.uk/pubs/files/amc-consultation-report.pdf
Advance Market Commitments, Results Of UK Consultation, February 2006

http://www.cgdev.org/section/initiatives/_active/vaccinedevelopment/
overview
Making Markets for Vaccines (one of many of the CGDev papers on this)

http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=4762
Advanced Market Commitment (AMC) Proposal an Important Step in Right
Direction to Develop & Provide Access to New Vaccines, IFPMA, Geneva,
Switzerland, 4/24/2006

Critics of AMC approach

http://www.slate.com/id/2133355/?nav=fo
Run-AMC: The latest idea in vaccine funding won't cure AIDS and malaria.
By David Dobbs, Dec. 29, 2005, which makes refers to:

http://www.economics.ox.ac.uk/members/andrew.farlow/CIPIH1May2005.pdf
Concerns Regarding the Center for Global Development Report, "Making
Markets for Vaccines," Submission to the CIPIH, 29 April 2005.
Andrew, W.K. Farlow, Donald, W. Light, Richard, T, Mahoney, Roy Widdus.

--
Posted by James Packard Love to Drug Development (with access) at
7/10/2006 12:02:00 PM

---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

"If everyone thinks the same: No one thinks."  Bill Walton