[Ip-health] IHT: A WHO report finds system fails the poor

Mon May 22 03:20:39 2006

A WHO report finds system fails the poor
By Elisabeth Rosenthal International Herald Tribune

SUNDAY, MAY 21, 2006

World Health Organization delegates meeting in Geneva this week will be
discussing a new report that will dramatically increase pressure on
pharmaceutical companies, governments and even on the organization itself
to do far more to develop and provide medicines for the world's poor
countries.

Commissioned by the WHO General Assembly in 2003 and released quietly last
month, the expert panel report offers a stinging condemnation of the
current patent-based global system for new drug development, marketing and
pricing.

The current system of "research and development has not yet produced the
results hoped for, or even expected, for the people of developing
countries," the report of the Commission on Intellectual Property Rights,
Innovation and Public Health says. While in richer nations the system
"broadly works to provide the health care required by their inhabitants,
this is far from being the case in developing countries."

The pharmaceutical industry and many developed countries insist that the
current system of granting lucrative patents for new drugs is crucial for
encouraging and financing the invention of much-needed medicines, which are
almost always produced in the private sector.

But the commission, led by former President Ruth Dreifuss of Switzerland,
said that this path to innovation was inadequate, because people in the
developing world often cannot afford to pay for high-priced new drugs, and
because they sometimes need treatments that offer little profit for drug
companies.

Governments should therefore develop and finance an alternate system for
drug development and distribution in the developing world, the report
concluded. More controversially, it suggested that drug companies should
not seek patents in poor countries.

The report marks the first time the organization has positioned itself to
become so directly involved in this contentious issue, which drug companies
and global health charities have argued over increasingly in recent years.

"This is a very strong call for governments and the WHO to take leadership
in an area where it has not shown a lot of leadership before," said Ellen
't Hoen, director of advocacy at the M=E9decins Sans Fronti=E8res Campaign =
for
Access to Essential Medicines. "It is the first time the WHO has dealt
comprehensively with the link between access to medicines and intellectual
property rights."

Delegates meeting at the World Health Assembly in Geneva this week will
take up the report Thursday or Friday, said Daniella Bagozzi, a spokeswoman
for the organization in Geneva, although she said it was too early to know
if its recommendations would be adopted. "In the past, research and
development of medicines wasn't seen as a primary part of access, but this
report says we should be working on both," she said.

"If the member states say this is part of WHO's mandate, then we'll take it
on," Bagozzi said.

The issue gained particular urgency a decade ago, with the advent of new
lifesaving AIDS drugs costing $10,000 a year, far too expensive for
residents of African nations being decimated by the condition.

But it is much broader than that.

Last week, for example, the U.S. Food and Drug Administration recommended
approval of the first vaccine to prevent cervical cancer, the leading cause
of death from cancer among women in poor countries, which harbor 80 percent
of the world's cases. In the developed world, routine tests usually detect
the disease in its treatable, precancerous stages.

With that announcement, Merck, the manufacturer, announced the price: $500
for the series of three shots - making it unaffordable where it is needed
most.

In the past, such cost problems have been partly remedied by a number of
mechanisms: Manufacturers cut deals with poorer countries, one at a time,
for discounted rates. Manufacturers of generic drugs in countries like
India invoke special provisions of trade law to produce low-cost versions
of patented drugs - although drug companies condemn and sometimes block the
practice. And foundations and international projects, like the Gates
Foundation and the Global Fund to Fight AIDS, Tuberculosis and Malaria,
have managed to purchase and distribute costly drugs in pilot projects.

But these initiatives fall far short of meeting the global need, treating
only a small fraction of poor patients. Although the Clinton Foundation
purchases drugs for children with AIDS in central China, for example, it
provides hundreds of treatment courses - not the thousands that are needed.
That means that where an older brother might get the lifesaving drugs, his
younger siblings would have to suffer the disease.

"The response till now has been, we have private-public partnerships and
then there is Bill Gates," said 't Hoen of M=E9decins Sans Fronti=E8res. "W=
hat
the report says is that this should not be just a matter of charity - it is
a global responsibility and that political action is needed."

Some of the loopholes that have allowed cheaper generic drugs into the
developing world have been closing in recent years.

A thriving generic-drug industry in India has helped bring the cost of the
standard three-drug treatment for HIV, the virus that causes AIDS, down to
about $150 a year. That was possible because for many years India did not
have pharmaceutical patents, and poor countries invoked World Trade
Organization exceptions allowing them to bypass patent laws and import such
generics in the event of a national emergency.

But since January of last year, India has begun enforcing medicine patents
to be fully compliant with WTO rules. Pharmaceutical manufacturers are now
applying for patents for newer AIDS drugs in India, which makes generic
production impossible. Newer AIDS drugs that many patients require are
unavailable or prohibitively expensive in the developing world.

The WHO report concludes, "Governments have the major responsibility to
mobilize funds and promote new financing and incentive mechanisms to meet
our shared goals."

Brazil and Kenya, two countries with serious HIV problems, have proposed
that the organization's General Assembly use the report as the basis for
creating some sort of global program for developing essential drugs. Both
countries have come under fire from drug manufacturers and the nations
where they are based for violating patents, and have even been threatened
with trade sanctions.

But many health advocates worry that the organization will not heed the
recommendations in the report that it solicited on intellectual property,
noting that the topic was not accorded prime position on the World Health
Assembly agenda this week.

Dreifuss, who heads the committee that produced the report, has not been
invited to address the meeting, for example, although she has spoken at
seminars organized by outside groups.