[e-drug] The role of Universities in access to medicines

[e-drug@healthnet.org]

E-DRUG: The role of Universities in access to medicines
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[crossposted with thanks from DRUGINFO; WB]

Hi all

Stavudine probably provides the best example of how generic competition,
aided by a decision by the patent-holder (Yale) not to exercise that patent
in developing countries, brought down prices and led to widespread adoption
of this ARV as part of the first-line regimen, sometimes as part of a
fixed-dose combination. The text of the Philadelphia consensus statement is
included below. 

For more details see Chokshi DA (2006) Improving Access to Medicines in Poor
Countries: The Role of Universities. PLoS Med 3(6): e136 DOI:
10.1371/journal.pmed.0030136 - accessible in full at
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/
journal.pmed.0030136

regards
Andy
~~~

http://www.bmj.com/cgi/content/full/333/7578/1090-b 
Universities' drug discoveries must aid poor countries, student group says 
Janice Hopkins Tanne 
1 New York 

Universities should change the way they license research developments so as
to make new drugs, vaccines, and diagnostic tests available to people in
poor countries, says Universities Allied for Essential Medicines, a
coalition of students at universities across North America. 

The group's "Philadelphia consensus" says that universities should promote
equal access to the results of their research, conduct research on neglected
diseases, and measure their research success by its effect on human welfare.


"Universities are key developers of drugs, vaccines, and diagnostics. They
can leverage their intellectual property [rights] on these innovations to
ensure low-cost access in the developing world," the consensus statement
says. Universities might grant rights to manufacturers of generic drugs to
make and export their innovations to poor countries or give price reductions
or non-patenting agreements in low and middle income countries. 

Expanding access in poor countries won't hurt drug companies' profits, the
statement adds. It says, "Because patients in developing countries aren't
currently able to afford the drugs they so desperately need, they do not
factor into pharmaceutical company revenue or university royalties." 

Attempts to improve access to drugs for people in poor countries by relaxing
intellectual property rights have failed, says an Oxfam report on the Doha
declaration (BMJ 2006;333:1036). The declaration said that intellectual
property rules should not prevent countries from protecting public health. 

The coalition submitted its consensus statement to the World Health
Organization's intergovernmental working group on intellectual property and
health last week. The WHO group is charged with drawing up a global strategy
and plan of action aimed at, among other things, securing "an enhanced and
sustainable basis for needs-driven developing countries." It is to submit
this strategy and plan of action to the 61st World Health Assembly in May
2008. 

David Chokshi, a medical student at the University of Pennsylvania and
spokesman for the coalition, said that the goal of the consensus statement
was to make sure that the WHO's global strategy and plan of action
emphasised the role of universities. The coalition has chapters at more than
35 universities in the United States and Canada, and its members include
undergraduate and graduate students in medicine, law, nursing, and public
health. 

The Philadelphia consensus has been endorsed by leaders in science,
medicine, law, public policy, and public health and by many organisations. 

----------------------------------------------------------------------------
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The Philadelphia consensus statement and a list of signatories is at
http://consensus.essentialmedicine.org. 

PHILADELPHIA CONSENSUS STATEMENT
On University Policies for Health-Related Innovations

According to the World Health Organization, about ten million people-most of
them in developing countries-die needlessly every year because they do not
have access to existing medicines and vaccines. Countless others suffer from
neglected tropical diseases, such as sleeping sickness, lymphatic
filariasis, and blinding trachoma. Because these neglected diseases
predominantly affect the poor, they attract very little research and
development funding, which leads directly to a paucity of safe and effective
treatment options.

We believe that access to medical care and treatment is a basic human
right.1 Lack of access to medical treatment in developing countries stems
from several factors, including high prices for medicines, underfunded
health care systems, and a global biomedical research agenda poorly matched
to the health needs of the world's destitute sick. Comprehensive solutions
are thus needed to increase both access to existing medicines and research
on neglected diseases. 

We believe that universities have an opportunity and a responsibility to
take part in those solutions. University scientists are major contributors
in the drug development pipeline. At the same time, universities are
dedicated to the creation and dissemination of knowledge in the public
interest. Global public health is a vital component of the public interest.
Therefore, universities best realize their objectives when they promote
innovation and access to health-related technologies.

To this end, we, the signatories of this Statement, urge universities to
adopt the following recommendations.

As owners of intellectual property, universities have the ability to promote
widespread availability of their technologies in the developing world. When
university-owned intellectual property is necessary for the development of a
health-related end product-including but not limited to drugs, vaccines,
diagnostics, monitoring tools, know-how and technical expertise-universities
should: 

PROMOTE EQUAL ACCESS TO UNIVERSITY RESEARCH

1. Require the inclusion of licensing terms in exclusive technology transfer
agreements that ensure low-cost access to health-related innovations in the
developing world. 

The Equitable Access License (EAL)2 is one example of a model license
promoting access to university intellectual property in which all qualified
entities3 are permitted to supply the product to public and private sector
markets in low- and middle-income (LMI) countries.4

2. Develop a transparent, case-by-case global access strategy to ensure
access to health-related technologies where licensing provisions like the
EAL will not serve the access objectives defined above. 

For example, biologicals (e.g., complex macromolecules and vaccines) and
healthcare devices (e.g., diagnostic tests) are subject to different
scientific and technical constraints than synthetic small molecules and may
require different methods to ensure access. Components of a global access
strategy could include (a) forgoing the university's share of royalties to
incentivize the licensee to facilitate access by offering discounts in
developing countries; (b) actively seeking a third-party organization to
participate in research, development, and distribution to facilitate access
in developing countries; and (c) incorporating licensing provisions, such as
non-patenting requirements, that guarantee access to data and materials
necessary to promote generic production or adaptations for developing
countries.

Neglected diseases are those for which treatment options are inadequate or
do not exist and for which drug- market potential is insufficient to attract
a private-sector response. In order to advance the development of therapies
for neglected diseases (ND), universities should:

PROMOTE RESEARCH AND DEVELOPMENT FOR NEGLECTED DISEASES

1. Adopt policies promoting in-house ND research. 

Universities should (a) adopt a classification system defining and
prioritizing neglected diseases5; (b) support existing researchers engaged
in ND work; (c) recruit talented ND researchers by establishing proper
incentives and marketing their ND research programs; and (d) formalize
annual review practices aimed at identifying new or currently shelved
technologies with promising potential for application to ND end product
development.

2. Engage with nontraditional partners to create new opportunities for ND
drug development. 

Universities should actively seek out nontraditional partners (e.g.,
public-private partnerships, grantmaking organizations, nonprofits, and
developing-world companies or research institutions) to facilitate
development of technologies applicable to neglected diseases. Example
interactions include: patent donation, dual-market licensing, and
straightforward exclusive/non-exclusive licensing. In order to access novel
funding sources for neglected diseases, universities should remove any
barriers, such as intellectual property restrictions, to accepting research
grants from nontraditional funders.

3. Carve out an ND research exemption for any patents held or licenses
executed. 

Licensing terms should allow other non-profit institutions to conduct
research for neglected diseases using the university's patented innovation.6
Similarly, for any out-licensed technologies, universities should retain the
right to non-exclusively license use of its intellectual property for
neglected disease research and for distribution of any resulting products in
developing countries.

Given their avowed commitment to the public good, universities should
measure success in technology transfer by impact on global human welfare
rather than simply by financial return. The positive social impact from
university innovations-particularly in poor countries-would go largely
unnoticed if technology transfer were to be measured in dollars alone. In
order to develop transparent criteria measuring access to health
technologies and innovation in neglected-disease research, universities
should:

MEASURE RESEARCH SUCCESS ACCORDING TO IMPACT ON HUMAN WELFARE

1. Collect and make public statistics on university intellectual property
practices related to global health access. 

To further elucidate how university patenting and licensing strategies
affect access to the end products of academic research in developing
countries, each university should disclose all healthcare-related end
products in which it holds any intellectual property. Data should also be
published on patents applied for or granted in all low- and middle-income
countries. Conversely, universities should make known the number of
licensing agreements that include access-minded provisions7 as well as
details of nontraditional partnerships for ND research and development.

2. Collaborate with other universities and consortia to develop more robust
technology transfer metrics that better gauge access to public health goods
and innovation in neglected-disease research.

References
1. See Article 25, Universal Declaration of Human Rights,
http://www.un.org/Overview/rights.html.
2. See http://www.essentialmedicine.org/EAL.pdf.
3. Qualified entities include, but are not limited to, public or private
generic manufacturers registered in the country of production. 4. We use the
categories of low- and middle-income countries as defined by the World Bank
at http://www.worldbank.org/data/countryclass/classgroups.htm.
5. For example, the United States Orphan Drug Act could provide a legal
basis for defining a set of neglected diseases. 6. See
http://www.essentialmedicine.org/EAL.pdf.
7. Access-minded provisions include, but are not limited to: (1)
facilitation of generic competition, (2) mandatory sublicensing clauses for
LMI markets, (3) specific access milestones, and (4) agreements that reduce
royalty payments from the licensee to the university in exchange for fair
pricing in LMI markets on the part of the licensee.