Abstract Book Vol. 2 [International Conference on AIDS (14th: 2002: Barcelona, Spain)]

XIV International AIDS Conference

Abstracts ThPeG8395-ThPeG8398 681

Description: Recognising that HIV/AIDS is characterized by stigma, unfair discrimination, ostracism and abuses of a range of other human rights and that there
is plenty of evidence to support a view that disclosure of one's status can lead to
ones demise, the paper will discuss options available to ensure the protection
of confidentiality for people living with HIV/AIDS. The pros and cons will be discussed. Reference will be made to case studies and the author's experience at
the ALP.
Lessons learned: The paper will attempt to demonstrate how law has failed to
protect the right to confidentiality for poor people living with HIV/AIDS in SA.
Recommendations: Finally, this paper will argue that continued education
around all issues HIV related including human rights of PWAs, as opposed to
recourse to the courts is the only mechanism of ensuring confidentiality for PWAs.
Presenting author: Teboho Motebele, c/o CALS, Private Bag 3, Wits, 2050,
South Africa, Tel.: [phone], Fax: [phone], E-mail: motebelet@law.
wits.ac.za
ThPeG8395 Using competition law to increase access to
treatment for HIV/AIDS
J.M. Berger. AIDS Law Project, Witswatersrands, South Africa
Issues: The legal debate about access to treatment for HIV/AIDS has largely
centered on international trade law and the impact of the TRIPS agreement on
domestic patent regimes. In spite of this, a significant part of the regulatory flexibility afforded by Article 31 of TRIPS-dealing with compulsory licensing and arguably offering the greatest potential for increasing access-is dependant upon
whether a particular practice is determined to be anti-competitive. This raises the
difficult question of what constitutes an anti-competitive practice in the field of
patent law, given that patents-by their very nature-serve to exclude competition
from the market place.
Description: In terms of Article 31, competition law can be used to increase access in two significant respects. First, the requirement that the use of a compulsory license be "predominantly" for the supply of the domestic market is waived
when the license is issued to remedy an anti-competitive practice. Second, the
extent of compensation to be paid following the issue of a license is in part determined by the need to correct anti-competitive practices. By exploring the relationship between patent and competition law, which includes a comparative analysis
of competition law in the European Union, South Africa and the USA, this paper
examines how competition law may be used to attain the full benefit of regulatory
flexibility introduced by the anti-competitive provisions of TRIPS.
Lessons learned: Understanding the relationship between patent and competition law serves as the basis for the recognition that competition law has the
potential to increase the available legal tools for ensuring sustainable access to
essential treatments.
Recommendations: Although a relatively unexplored area of the law, competition
law needs to be harnessed if the flexibility afforded by TRIPS is to be exploited to
its full.
Presenting author: Jonathan Berger, AIDS Law Project, Private Bag 3, Wits,
2050, South Africa, Tel.: [phone], Fax: [phone], E-mail: jonathan.
berger@ utoronto.ca
ThPeG8396I Balancing of private rights and public obligations:
The import of socio-economic constitutional rights
for compulsory licensing in South Africa
T.J.B. Bollyky. Fulbright Scholar at AIDS Law Project, AIDS Law Project, Centre
for Applied Legal Studies, University of Witswatersrand, Johannesburg 2050,
South Africa
Issue: Patent monopolies on antiretroviral drugs have made them unaffordable
to many South Africans. The consequences have been devastating. An option for
ensuring affordable access to drugs is compulsory licensing.
Description: Governments grant compulsory licenses for manufacture of lower
cost, generic versions of patented drugs without the permission of the patent
holder. This approach tests the delicate balance of the private rights of inventors
and the public welfare obligations of governments. The role of the private sector
is to supply health care providers and to invest in improving treatment options.
Patents play a critical part in creating the incentives that enable and drive that
mission. The public sector has a fundamental responsibility to pursue effective
health care for its constituents. When treatment ceases to be affordable to those
who desperately need it, these private rights and public obligations must be reconciled. Much analysis has been devoted to the role of international trade regime
and intellectual property (IP) agreements in this regard. This approach balances
IP rights and public priorities in a vacuum. Little consideration has been given
to the substantial role constitutional socio-economic rights - i.e., the obligation to
progressively realize access to health care services within available resources -
can play in arriving at a South African solution to this balance.
Lessons learned: The South African Constitution does not guarantee access to

health care. This Constitution is unusual, however, in that it commits all branches
of government to join together with their constituents in crawling towards the universal provision of this most fundamental of human needs.
Recommendations: Consideration of compulsory licensing should occur within
the framework created by socio-economic rights for balancing private rights and
public obligations and addressing South Africa's unique economic, political and
epidemiological needs.

Presenting author: Thomas Bollyky, AIDS Law Project, Centre for Applied Legal Studies, University of Witswatersrand, Johannesburg 2050, South Africa, Tel.:
[phone], Fax: [phone], E-mail: [email protected]
ThPeG8397 Estimating HIV drug development costs from
publicly disclosed data
B. Huff. Gay Men's Health Crisis (GMHC), Gay Men's Health Crisis (GMHC), 119
West 24th St., New York, NY, United States
Background: Published estimates for the cost of bringing a new pharmaceutical
agent to market range from $70 million to $700 million. Higher estimates have relied on unaudited industry surveys while lower estimates tend to ignore significant
investment costs. These figures are often quoted in competing arguments about
the feasibility of offering antiretroviral therapy in developing nations.
Methods: This study examined publicly disclosed research and development
(R&D) costs as reported in US government filings from two pharmaceutical companies specializing in HIV drug development. The companies are similar as to
capitalization and year of organization. Research and development expenses
were charted from inception until May of 2001 and were correlated with development milestones of key drug candidates.
Results: Two U.S. drug companies, Trimeris, Inc. and Triangle Pharmaceuticals,
Inc. were selected for analysis. The companies were comparable on the basis of
year of establishment, geographic location and initial capitalization. Both companies initiated public stock sales after meeting significant early milestones for their
most promising drug candidates. Both companies entered into distribution agreements with major pharmaceutical partners as Phase III trials were begun. The
initiation of later phase trials contributed to the greatest increases in cash expenditures. With at least two years remaining before market approval of any product
could be expected, Trimeris had spent over $200 million and Triangle over $250
million on R&D.
Conclusions: Audited financial statements allow an examination of R&D expenditures by companies with dedicated HIV drug programs giving an unusual degree of transparency into the costs of preclinical and clinical drug development.
Based on trends in R&D spending by these two companies, an estimate for the
total cost of bringing a single HIV drug to market can be plausibly set at a figure
approaching $300 million.
Presenting author: Bob Huff, Gay Men's Health Crisis (GMHC), 119 West 24th
St., New York, NY, United States, Tel.: [phone], Fax: [phone],
E-mail: [email protected]
ThPeG8398 Your money or your life: the high cost of
pharmaceutical treatments in Canada
D.L. Bond', L. Binder2, G. Hillson3, T. di Pede2, B. Mills4. ICanadian Treatment
Action Council, 12-149 Langside St., Winnipeg, Manitoba, Canada; 2Canadian
Treatment Action Council, Toronto, Canada; 3Canadian Treatment Action
Council, Vancouver, Canada; 4Canadian Treatment Action Council, Edmonton,
Canada
Issues: The current drug pricing protection system in Canada, the Patented
Medicine Prices Review Board (PMPRB) is limited by a number of regulations,
policies, and procedures that render it unable to counterbalance the effects of
extended patent protection. High drug prices put a strain on public and private
insurance plans, resulting in denial of access to medications for people living with
HIV/AIDS.
Description: The PMPRB was created to ensure drug prices are not excessive
and to collect relevant pricing information from pharmaceutical companies. Following NAFTA, pharmaceutical companies promised price restraint as a component of 20 year patent protection. The PMPRB sets the maximum introductory
price for new patented drugs and monitors further increases, but is restricted in
that it can only assess drugs after they have received patents and cannot look
at the price of generics. To evaluate excessive pricing, the PMPRB can only consider a 'basket' of seven industrialized countries, including the U.S (unrestricted
aside from what the market will bear), which are not necessarily comparable to
the Canadian situation.
Lessons learned: The burden on the health care system increases though individual drugs prices rise moderately. Drug price protection systems should not be
based on pricing of other nations. With differences such as health care systems,
population, political and social structures, each country must develop an independent, relevant system of price protection. Pharmaceutical companies should be
required to justify prices based on relevant data.
Recommendations: Changes are required to the Canadian PatentAct and Regulations and the mandate, policies and practices of the PMPRB to ensure that
drug prices in Canada are not excessive and are not restricting access to drugs
for people living with HIV/AIDS by being outside the reasonable range of budgets
for public and private reimbursement plans.
Presenting author: Daryn Bond, 12-149 Langside St., Winnipeg, Manitoba,

Canada, Tel.: [phone], Fax: [phone], E-mail: dlbond@mts.
net