Drug Deal

[Guest guest]

http://www.alternet.org/story/22081/

 

This is being posted to show how politics determine health more than

any other aspect. Politics determine what kind of food we eat and what

nutrition it may contain if any. The same for water. Politics determine what

type of health care system is used. Politics determine what type of health care

is available to us and if we have choices or not. Politics determine all aspects

of health insurance. Politics

determine what kind of health information is disseminated to the

public and who it benefits. Politics determine what types of toxins we

are exposed to in our lives. Politics determine what the monetary

costs involved in all of the above. When politicians rig the game

to benefit special interests, health suffers. Almost all of the

aspects of health and health care are rigged or are in the process of

being rigged against the population. Politics is the single biggest

determinant in what will be the resultant level of health and lifespan

of a population. This article is not being posted to promote the

taking of pharmacuetical drugs.

 

 

 

 

Drug Deal

 

By Kelly Hearn, AlterNet. Posted May 25, 2005.

 

If Congress ratifies Bush's controversial CAFTA bill, pharmaceutical

companies will be in for a windfall -- and the casualties will be poor

AIDS patients.

 

For Luis Lopez, a 42-year-old single dad in Guatemala, globalization

has nada to do with economics or democracy. On the contrary, for

Lopez, it's about something much more basic: los anti-marcas (against

brands), los genericos -- the cheap, generic medications that poor

AIDS patients like him need to stay alive.

 

More than 78,000 Guatemalans are currently living with HIV/AIDS ,

according to Doctors Without Borders (also called Medecins Sans

Frontieres, or MSF). Approximately 13,500 of them are in urgent need

of antiretroviral (ARV) treatment; only 3,600 were receiving it as of

December 2004. If, in coming weeks, Congress ratifies the bill

President Bush signed last year -- the Dominican Republic-Central

American Free Trade Agreement (DR-CAFTA) -- many of these patients

could wind up literally dying for cheap drugs.

 

According to groups such as Oxfam and MSF, CAFTA's intellectual

property protections will give monopoly-like status to high-priced,

brand-name drugs in poor markets; potentially killing off generics in

El Salvador, Nicaragua, Guatemala, Costa Rica, Honduras and the

Dominican Republic, and preventing millions of AIDS patients from

being able to afford the meds they need.

 

" People here are very worried about laws that will amplify patents and

the testing time for drugs, " Lopez said via telephone from Guatemala City.

 

Here's a look at some public health ramifications of CAFTA's

intellectual property provisions -- a rarely acknowledged set of

dangers that illustrates how pharma-friendly U.S. trade negotiators

use back-door legalisms to stamp out generic medications.

 

Umm, That's My Data

 

To understand CAFTA's most controversial aspect, consider " data

exclusivity. " As it stands, the World Trade Organization's TRIPS

agreement (Trade Related Aspects of Intellectual Property), gives poor

countries the right to break drug patents in health emergencies. The

U.S. signed on to that deal, as well as a subsequent agreement called

the Doha Declaration, which further clarified the public health

aspects of intellectual property and reaffirmed poor countries' rights

to essential medicines.

 

But critics claim that CAFTA, through the " data exclusivity "

provision, dilutes those rights by erecting barriers around

pharmaceutical test data to delay the registration of generic drugs in

poor markets.

 

To encourage the use of generic medicines, U.S. law states that

generic drug-makers need not conduct their own trials; instead, they

can rely on safety and efficacy data gathered by brand-name companies

and placed on file with the FDA. To compensate the brand-names for

their costly work, Congress restricted generic manufacturers' access

to that key data -- they won't be able to use it for the next five

years. CAFTA takes that even further, extending the prohibition window

to " at least five years " of exclusivity for the brand-name companies.

This detail could translate to long delays in bringing life-saving

generics to the market.

 

There's more: public health experts worry that data exclusivity could

ban generics from poor markets where even the brand-name originator

drugs aren't sold -- shutting down all drug access until the

prohibition window runs out.

 

CAFTA does agree to let generic companies conduct their own test data

in order to enter a market. But this position could stink of

hypocrisy. Multinational drug companies -- which justify high drug

prices by citing massive R & D cost for new drugs -- know that generic

companies in poor countries likely can't afford such costly trials.

Plus, it would be an ethical breach to subject patients in Costa Rica

or Guatemala to drug studies that have already been conducted

elsewhere in the world.

 

Without the power to compulsory license the test data (just as they

can compulsory license brand-name drugs through TRIPS), poor nations

have their hands tied through an indirect but restrictive patent law

nuance.

 

NDRAs: Enforce It For Us

 

Health experts also claim that CAFTA transfers abusive powers to

national drug regulatory agencies (or NDRAs) in signatory countries.

In the U.S., a brand-name drug company can stop a generic from being

produced if the generic will infringe on an existing patent. CAFTA

tweaks that burden of proof; local NDRAs in countries like Guatemala

are prohibited from approving a patent unless the agency first proves

that no other patent is being infringed upon.

 

The upshot is that the provision will essentially ban generics

whenever a patent is in force. And by passing the responsibility of

patent enforcement on to NDRAs (which know nothing about such a job)

in countries like Guatemala or Costa Rica, the process is kept in

bureaucratic darkness, as opposed to a drug company suing for patent

infringement through the courts.

 

This provision, known as " linkage " (drug registration linked to patent

protection processes), " essentially makes drug regulation agencies

become a mechanism for private interests of patent holders, " says

Brook Baker, a law professor at Northeastern University. In other

words, drug companies won't have to take patent complaints to court

themselves, but, under CAFTA, can sit back and let drug agencies in

countries like Costa Rica or Guatemala do it for them.

 

Bush's Political Baby

 

Another way CAFTA helps Big Pharma is by mandating two types of patent

extensions based on delays in the patent examination and drug approval

processes. In short, helping stretch out standard 20-year patent terms

embedded in TRIPS.

 

As if that weren't enough, some Congressional critics recently argued

against CAFTA's IP provisions on domestic grounds. According to a

recent letter by three U.S. representatives, CAFTA could mean higher

drug prices in the U.S. when Washington eventually harmonizes CAFTA's

heightened patent protections with domestic law.

 

And what about the Bush administration, which has made CAFTA its

current political baby?

 

The Office of the U.S. Trade Representative did not respond to

interview requests. But officials spin CAFTA critics as nearsighted

protectionists. Speaking at the Heritage Foundation on May 16, U.S.

Deputy Secretary of State Robert Zoellick toed the administration's

parroted line that CAFTA will spur economic growth and strengthen

democratic reforms throughout the Central America. " Improved

protection for intellectual property will encourage new creative

industries and access to life-saving medicines, as we have already

seen in other FTA partners, from Jordan to Singapore, " Zoellick said.

 

Downward Spiral

 

But recent events in Guatemala -- the country that has already taken a

first step toward implementing CAFTA -- seem to prove differently.

 

In two Guatemala City hospitals, and health centers in Coatepeque and

Puerto Barrios, MSF administers antiretroviral medicines to 1,100

patients. Because these meds haven't been patented there, MSF is able

to treat more patients -- it dispenses drugs that are 75-99 percent

cheaper than the brand-name drugs bought by the Guatemalan government.

Example: MSF pays $216 per person per year for the generic version of

AZT+3TC, a part of triple combination ARV therapy. Guatemala's social

security system, which buys brand-name, shells out $4,818 per person

per year for the same combination.

 

In March came a frightening bellwether of CAFTA's trends.

 

The Guatemalan Congress, under U.S. pressure, passed a hugely

controversial law that paved the way for CAFTA, in part by offering a

" data exclusivity " provision. With the help of a civil group known as

Grupo Solidaridad Positiva, Luis Lopez and his fellow AIDS sufferers

helped organize massive demonstrations. But it may be too late to stop

the law and its impact.

 

" If current data exclusivity provisions [in the new Guatemalan law]

had been in effect prior to 2001, generic ARVs would not have been

marketed in Guatemala and MSF would not have been able to access

generics, " according to MSF testimony. " This would have limited our

ability to expand access to treatment and demonstrate the feasibility

of delivering ARV treatment. In order for the Guatemalan government to

expand access to ARV treatment for all those in need, it will need to

retain the right to procure affordable generic AIDS medicines. "

 

If CAFTA passes, the ramifications will obviously extend beyond

Guatemala. In Costa Rica, the deal's constrictions on generic

production will cause government spending on pharmaceuticals to go

from 8 to 45 percent of the national health budget. Citing a study by

the Costa Rican drug industry, the watchdog group Public Citizen

claims that CAFTA could cause drug prices to shoot up 800 percent

across the board. And the Congressional letter referenced above notes

that Costa Rica faces AIDS drug costs so steep that if it is forced to

forego generic drugs, available funds will cover only 18 percent of

the AIDS patients who are being treated today.

 

Private Industry vs. Public Health

 

While politicians spin their versions of CAFTA's merits, pain runs

deep for people working on the ground.

 

" We are disgusted [that the] government finds it more important to

protect the commercial interests of private industry rather than

public health, " said Rachel Cohen, advocacy liaison for MSF's Access

to Essential Medicines Campaign. " It is unacceptable that health is so

subordinate to trade and economic industry. We are fighting for lives

of patients, and we do not accept that health is traded away like any

other commodity. "

 

The Pharmaceutical Research and Manufacturers Association, the drug

industry's 800-pound lobbying gorilla, declined to be interviewed for

this story. But brand-name drug companies often note that poor markets

already get deep discounts. Furthermore, certain high prices are

necessary -- even in poor markets -- to pay for the massively

expensive production of AIDS drugs. But public health experts point

out that many brand-name AIDS drugs already on the market either

aren't available or aren't sold for profit in the developing world.

What's more, better manufacturing and economies of scale make it

possible for companies to produce extra quantities of expensive

medications at low costs.

 

The struggle to balance IP protections with public health was summed

up last year in testimony before the International Trade Commission

(ITC). Joy Spenser of the Consumer Project on Technology, a respected

think tank, asked members of the commission to watch a video entitled

Dying for Drugs. The video, she said, depicts the sufferings of a

child dying of AIDS whose parents could not afford fluconazole -- a

Pfizer product that costs pennies to make but is priced at $27 per

pill in Honduras.

 

" Watch this film with your children, " Spenser said, " and then explain

why the U.S. needs the IP provisions on medicines in the CAFTA. "

 

Kelly Hearn is a former UPI staff writer who lives in Washington DC

and Latin America. His work has appeared in several U.S. publications

and websites including the Christian Science Monitor, American

Prospect and High Country News.