This document discusses the issues around intellectual property rights (IPR) for pharmaceutical companies and access to HIV/AIDS drugs in developing countries. It provides details on: - The US pharmaceutical industry initially opposing relaxation of IPR under WTO rules to allow generic drugs in developing countries like South Africa facing health crises. - HIV/AIDS remaining a top global cause of death in 2008 despite decades of efforts, with most deaths in sub-Saharan Africa. - The high costs of antiretroviral drug cocktails that made treatment unaffordable for most in developing countries. - Pharmaceutical companies holding patents that limit competition from generic drugs and efforts by countries and organizations to expand access to affordable treatment

1. PHARMACEUTICAL
COMPANIES,INTELLECTUAL
PROPERTY,AND THE GLOBAL
AIDS EPIDEMIC
By
JAHNAB
BHASKAR RAKESH
RAHUL TOMY

2. The World Trade Organization (WTO) and
intellectual property rights (IPR)
• In August of 2003 after heavy lobbying from organizations such as
Doctors Without Borders ,the United States pharmaceutical industry
dropped its opposition to relaxation of the intellectual property rights
(IPR) provisions under World Trade Organization (WTO) regulations to
make generic, low-cost antiviral drugs available to developing
countries like South Africa facing epidemics or other health
emergencies.

3. The AIDS Epidemic and Potential Treatment of AIDS
• In 2008, two decades of fighting the AIDS epidemic and raising the
public awareness, HIV/AIDS still remained one of the leading causes
of death in the word, occupying the 6th position on the Wold Health
Organization (WHO) top 10 causes of death list. Since 1980, AIDS has
killed more than 25 million people. HIV is especially deadly because it
often remains dormant in an infected person for years without
showing symptoms and is transmitted to others often without the
knowledge of either person. HIV lead to AIDS when the virus attacks
the immune system and cripples it, making the person vulnerable to
diseases.

4. Potential Treatment
• There is no cure or vaccination for AIDS. Public health experts place a
high priority on prevention.
• Drugs help combat AIDS by prolonging the lives of those infected and
by slowing the spread of the disease. These drugs significantly reduce
deaths in developed countries, however the treatment is very
expensive.
• Manufacturers hold patents for drugs.
• Limits competitions from generic products.

5. Expenses of Antiretroviral Drugs (ARV)
• In 2000-2001 a year's supply of a "cocktail" of ARV drugs used to fight
AIDS cost between $10,000 and $12,000 in developed countries,
putting it beyond the reach of those in most developing countries.
• Dr. James , president of Doctors Without Borders
• "The poor have no consumer power, so the market has failed them.
I'm tired of the logic that says: 'he who can't pay dies.'"

6. AIDS in Southern and Western Africa.
• In sub-Saharan Africa, approximately 22.4 million people are living
with AIDS. Of the 2 million AIDS deaths globally in 2003,
approximately three-quarters or 1.6 million were in sub-Saharan
Africa.

7. HIV Transmission
• In Southern Africa most HIV transmission is from sexual activity rather
than transfusion or drug needles.
• There are now large numbers of single migrant male communities in
southern Africa. Many of them serve in the mining industry. Which
puts them at higher risk for AIDS transmission with easy access to
alcohol and commercial sex workers.

8. The toll AIDS takes in Southern Africa
• There is a great stigma attached to AIDS in southern Africa.
• In 1998 a South African AIDS activist declared on television that she
was HIV-positive and was stoned to death for shaming her
community.
• HIV/AIDS has slashed the life expectancy in South Africa from 66 to
50.

9. Large Pharmaceutical companies and the U.S.
government.
• The U.S. government resisted calls to relax intellectual property laws
that were thought to limit the provision of low-cost AIDS treatments,
South African president Thabo Mbeki himself had been accused of
engaging in "denial" as he had disputed established wisdom regarding
the source of and treatment for AIDS. Meanwhile, South Africans
continued to die from the disease, and the South African economy
also suffered direct and indirect costs from the disease's ravaging
effects.

10. Intellectual Property Rights
• Intellectual Property Rights (IPR) grant investors rights for original
creations.
• The goal of IPR protection is to stimulate creativity and innovation,
and to provide incentives and funding for R&D.
• IPR , such as patents, prevent people from using inventors' creations
without permission.

11. Drug Pricing in Developing Countries
• In 1997, South Africa passed a law to permit compulsory licensing of essential drugs.
• Pharmaceutical companies sued the South African government in an attempt to delay
implementation of the law.
• The Clinton administration lobbied the South African government to reverse its decision.
• In December of 1999, President Bill Clinton told members of the WTO that the U.S.
government would show flexibility and allow countries to obtain cheaper drugs during
health emergencies on a case-by-case basis.
• In the Summer of 2000, at the 13th International AIDS Conference in Durban, South
Africa a german pharm. company offered to make its AIDS drug, Viramune, available for
free.
• Many other companies made similar offers.
• In spring of 2001, three U.S. companies announced they would sell HIV drugs to
developing countries at cost.

12. The Global Fund
• In April 2001 UN Secretary General, Kofi Annan proposed creation of
a global fund to combat AIDS. Noting that pharmaceutical companies
were beginning to accept that "generic medication can be produced
where it can save lives."
• Pressure Mounts
• June 2002, 2 weeks before the 14th International AIDS Conference in
Barcelona, the WTO council responsible for intellectual property
extended until 2016.

13. Drug prices have fallen...
• $1200/person/yr in developing countries
• *Estimated prices needed to fall as low as $30-40 /person/yr to reach the poorest
recipients.
Trade-Related Aspects of Intellectual Property Rights (TRIPS)
• TRIPS attempted to bring conformity among different nations' protection of IPR.
• TRIPS covered five basic areas
• 1. Basic Principles
• 2. How to provide adequate protection.
• 3. Enforcement.
• 4. Dispute settlement.
• 5. Special transitional arrangement

14. Joint Efforts to Combat AIDS
• Companies agreed to invest further in research & development of
new HIV-related medicines adapted to resource-limited settings

15. Questions

16. 1) Do pharmaceutical companies have a responsibility to distribute drugs
for free or at low cost in developing countries? What are the main
arguments for and against such an approach?
• Pharmaceutical companies are not always required to distribute drugs
for free or at a low cost in developing countries unless they are facing
epidemics or a health emergency.
• The treatment, R&D costs of developing the drug are so high that
giving them away for free or at low cost would essentially hurt the
manufacturer of the drug not allowing them enough money to
continue to produce it.
• With AIDS specifically, there is no known cure and all the drug would
be doing is slowing down someone’s death, maybe even allowing
them to potentially live longer, causing them to perhaps continue to
spread the disease.

17. • Some of the drug-free programs stated that they want to test what
the drug has on survival. However, some are worried about
corruption and diversion of the sample of drugs if it is free because
they may not get to the necessary people and perhaps they may try
to sell the drugs to people within the country to make money off of
them.
• If they are sold at low no-profit prices the company still has some
control over who is purchasing them as well as they are able to
recover some of their costs back as opposed to giving the drugs for
free where they will never receive anything for them.

18. 2) What are the principal arguments of pharmaceutical companies that
oppose making exceptions to IPR laws for developing countries? What are
the arguments by NGOs and others for relaxing IPR laws?
• They would lose contributions from sales of a drug faced with a
knockoff in a specific county. They feared a domino effect,
compulsory licensing spreading across developing countries and
sharply hurting profits in several markets. Also, prices in developed
countries may sink because of a gray market in generics or because of
pressure to cap prices as information on the significant price
differential between countries becomes widely available and
developed-country consumers start an outrage to receive the same
low prices

19. 3) What impact would you expect South Africa’s decision to levy duties on
drug imports from Western nations to have on the international
distribution of drugs to South Africa?
• There seems to be a clear relationship between tariffs and the access
to necessary medicines. By increasing a tariff by 1% reduces the
access to medicine and denies millions of people access to essential
medicine just because of tariffs. These taxes are usually imposed to
protect local manufacturers from imports and competition so by
South Africa doing this will probably stop some companies from even
trying to send drugs to the country. “They frustrate the competition,
reduce innovation, raise prices of goods to domestic consumers, and
provide no real long-term benefit to the nation”

20. 4) In June 2002, the WTO extended the transition period during which least-developed countries.
(LDCs) had to provide patent protection for pharmaceuticals. In your opinion, was this an appropriate
change in policy or a dangerous precedent? What could be some of the negative ramifications of this
resolution? What about the effects for other industries?
• I think overall this was a good decision, I feel that in today’s society money
and profit is taking precedent over people’s health. The LDCs need to have
a fair chance at survival and without having the technology and funding as
many other countries have it makes it nearly impossible for them ever to
get ahead. I think the focus needs to be on people’s health more so than
patents and profits. Some of the negative effects would be with some
many generics now being allowed to be produced it will take away sales
and imports from the bigger pharmaceutical companies that are currently
holding on to that patent. Even though the drug prices have decreased,
they are still not low enough for everyone. They estimated that the price
needs to fall to about $30 to $40 per person per year for the drugs to
actually reach the poorest parts of the countries, which are usually the
most affected.

21. 5) Given the initiatives announced by global development and aid organizations and
among pharmaceutical companies themselves, was it necessary to relax IPR rules in
order to ensure that adequate supplies of AIDS medications would be available for
distribution in the developing world?
• Soln:
• IPRs grant investors rights for original creations and to protect creativity
and innovation.
• It prevents people from using inventors’ creations without permission.
• The pharmaceutical companies view the relaxation of the IPR rules as a
negative impact on their company which is completely understandable
• However, there needs to be some type of line drawn when it comes to
company’s profiting and a person’s health (life or death).
• SO I think that it was somewhat necessary to relax some of the IPR rules.

22. 6) What role do MNCs have in providing funding or other assistance to
international organizations such as the Global Fund, UN, and WHO?
• By providing funding or other assistance to international
organizations they are allowing donations to help support the
development of new drugs and generics which will allow the LDCs to
access these at much cheaper rates.
• If everyone continues to help and make sacrifices the AIDS epidemic
can hopefully one day be under control.

23. THANK YOU