E-DRUG: CPT Senate Statement on Africa AIDS crisis
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[copied from Pharm-Policy; WB]
This is the CPT statement submitted for today's Senate hearing on the
Africa AIDS crisis. Jamie
http://www.cptech.org/ip/health/aids/frist-feb24-2000.html
Consumer Project on Technology
P.O. Box 19367, Washington, DC 200036
202.387.8030; fax 202.234.5176
http://www.cptech.org
February 24, 2000
Senate Committee on Foreign Relations
Subcommittee on African Affairs
Washington, DC
Dear Senators Frist and Feingold,
Please include this statement as part of the record of the
hearing on AIDS and Africa. Our comments will focus on the
following topics:
- What is US trade policy as it relates to access to
medicines?
- What are the concerns of public health groups with regard to
US trade policy?
I. US Trade policy and access to medicines.
For decades, the US government has advanced the interests of
large pharmaceutical companies in its trade policy. The
pharmaceutical sector is considered a major export industry, and
US government trade policy has been focused almost entirely upon
the commercial interests of companies like Merck, Bristol-Myers
Squibb, Pfizer and other members of trade associations like the
Pharmaceutical Research and Manufacturers Association (PhRMA) and
the International Federation of Pharmaceutical Manufacturers
Associations (IFPMA).
Among the features of US policy, as expressed in countless
bilateral negotiations and multilateral fora, are the following:
1. The US government has pushed to end the exemptions
for medicines in national patent laws.
2. The US government has pushed for a minimum term of
20 years in patent laws.
3. The US government has put pressure on governments
to create patent extensions for pharmaceuticals.
4. The US has pushed for a broader scope of
patenting, on issues such as patenting of doses and
treatment regimes for medicines, formulations of
medicines, patents on second uses of medicines, and
patents on biotechnology.
5. The US government has been an aggressive opponent
of the use of compulsory licensing of patents on
medicines by developing countries.
6. The US government has objected when other
countries have proposed US "Bolar" style patent
exceptions for testing of bioequivalence of generic
products.
7. The US government has opposed efforts by
developing countries to require the use of the generic
name of a product on pharmaceutical packaging, claiming
this violates company trademark rights.
8. The US government has opposed the efforts by
developing countries to require generic prescribing, or
generic substitution laws, as a violation of company
trademark rights.
9. The US government has opposed efforts by many
countries to impose price controls on pharmaceuticals.
10. The US government has objected to efforts by many
countries to use US style "managed care" formularies to
obtain better prices on drugs.
11. The US government is seeking extensive non-patent
regulatory barriers to entry for generic drugs, such as
regulatory exclusive marketing rights for products not
protected by patent.
12. The US government is asking countries to provide
10 years of commercial exclusivity for data used in
regulatory reviews of the safety and efficacy of
pharmaceuticals as a barrier to entry for generic
versions -- even though the US laws only provide five
years of data exclusivity.
13. US trade officials oppose laws that would permit
parallel imports of pharmaceutical drugs, thereby
denying countries the ability to get the best world
price on branded pharmaceutical products.
14. The US government has rejected proposals by public
health groups to permit the World Health Organization
to use US government rights in taxpayer funded health
care patents, to expand access to medicines in
developing countries.
15. The US government has opposed proposals that the
World Health Organization advise developing countries
on intellectual property policies, as they relate to
access to HIV/AIDS drugs.
I could add to the list or simply refer persons to the
National Trade Estimates (NTE) reports of the United States Trade
Representative (USTR), other US government trade publications and
CPT's extensive reports on trade disputes involving
pharmaceutical drugs. These can all be found on the web here:
http://www.cptech.org/ip/health.
While US trade officials sometimes claim they are merely
protecting the legitimate interests of investors in intellectual
property, the US positions are often perceived outside the US as
extreme, hypocritical, unfair or protectionist, and increasingly
are criticized by the public health community for the negative
impact on access to medicines.
II. Public Health concerns regarding US trade policy.
The rising concern over the global AIDS crisis has
highlighted the need to change US trade policy. With more than
22 million persons currently infected with HIV/AIDS in Africa,
and millions more in developing countries outside of Africa, it
is clear that the costs of treatment would be astronomical, if
there ever was a serious effort to do so. A typical HIV/AIDS
cocktail in the US costs more than $10,000 per year, for the
drugs alone. At just $10,000 per year, it would cost more than
$222 billion per year to provide drugs to the current population
of African persons living with HIV/AIDS, and for significant
portions of the population, this would not be effective without
other investments in health care infrastructure. But even if
one has far more modest treatment goals -- the prices of drugs
are important -- as illustrated, for example, by the lack of
access to fluconazole, an important, high priced, but cheap to
produce, antifungal medicine.
This committee will hear from many informed persons who can
describe the nature of the HIV/AIDS crisis in Africa and other
developing countries. We will simply note the obvious, which is
that this is an overwhelming tragedy that challenges all of
humanity to fashion a response equal to the human suffering.
Certainly the Subcommittee will hear how complex are the
problems in dealing with HIV/AIDS in Africa. There are many
aspects of the problem -- poor medical infrastructure, limited
budgets, lack of education, ineffective prevention efforts,
discrimination and bias, employment practices, the need to change
sexual behavior, the failure of African countries to allocate
greater funding to health care, the crushing burden of debt on
African countries, the paucity of foreign aid, the high prices of
drugs, the rules for the protection of intellectual property and
bilateral trade pressures to protect the pharmaceutical industry.
There are many issues that must be addressed to save lives
and limit suffering in Africa. There are no silver bullets, no
single solutions -- simply a large list of things that must be
done. There should be no controversy that this list will include
changes in US trade policy, and addressing intellectual property
rules. And, while compulsory licensing and other measures will
change private R&D incentives, it is worth noting that Africa
only accounts for about 1.3 percent of the worldwide
pharmaceutical market, and that much R&D on HIV/AIDS related
medicines is funded by the US government.
Defenders of current US trade policy sometimes say that the
price of drugs isn't the "the issue," pointing the many other
problems. But as is often said, when someone says it isn't about
the money, it is often about the money, and only a fool would
suggest the price of drugs is not important to people in Africa
who are infected with HIV/AIDS.
Responding to increasing international and domestic
criticism of US trade policies on pharmaceutical drugs, President
Clinton announced on December 1, 1999, that he was removing South
Africa from the USTR Watch list on intellectual property, and
that US trade policy would be changed to facilitate access to
medicines. That review is just beginning, and has produced very
few results so far.
The WTO TRIPS agreement as a norm for Africa
The World Trade Organization Agreement on Trade Related
Aspects on Intellectual Property, known as the TRIPS agreement,
is the most important international agreement on intellectual
property rights. The TRIPS accord is extensive and
comprehensive, covering patents, trademarks, copyright, trade
secrets, undisclosed health registration data and other items.
Under the TRIPS, all WTO member countries will have to extend 20
years of patent protection to pharmaceuticals. The TRIPS accord
places restrictions on government use or compulsory licensing of
patents, and provides countless other protections for the owners
of intellectual property.
However, the US government does not accept the WTO rules as
appropriate for African countries. It seeks much higher levels
of protection --- so called "TRIPS plus" levels of protection.
US policy on this is itself a seeming violation of the WTO rules.
Article 1 of the TRIPS says:
Members . . . shall not be obliged to, implement in
their law more extensive protection than is required by
this Agreement. . . . Members shall be free to
determine the appropriate method of implementing the
provisions of this Agreement within their own legal
system and practice.
The public health community is split on the degree to which
the WTO TRIPS agreement should be modified to address public
health concerns. There is, for example, much controversy over
whether or not poor countries should be required to have 20 year
patents on pharmaceutical drugs. However, there is much less
disagreement on the issue of TRIPS plus obligations. Given the
huge suffering in Africa today, a policy of requiring TRIPS plus
-- more than the WTO rules for medicines -- is morally repugnant.
A February 10-12, 2000 meeting of the Trans Atlantic
Consumer Dialogue (TACD) produced a set of recommendations on
health care and intellectual property that provide a useful
overview of public health community views on these disputes. I
have attached the TACD resolutions to this letter. We ask the
members of this Subcommittee to formally ask the US government to
provide a written response to the TACD recommendations.
From these recommendations, I would highlight several issues
that are a priority to public health groups.
1. The US and EU governments should not require TRIPS plus
levels of intellectual property protection on medicines.
This is an issue addressed in the Senate version of the
African Trade Bill.
2. The US government should support the call to create a
working group on access to medicines within the WTO. This
would provide an important and needed forum to discuss a
number of important trade related aspects of the access to
medicines problem.
3. The US government should permit the World Health
Organization, UNAIDS or other international bodies to use US
government funded patents in developing countries. It is
shocking and ethically indefensible to withhold use of US
government funded medical inventions in developing
countries.
4. The US government should provide the WTO with a
communication supporting an interpretation of Article 30 of
the TRIPS that would permit patent exceptions for production
of medicines for export.
I will elaborate briefly on item 4, concerning patent exceptions
and exports of medicines. Under the WTO rules, governments can
issue a compulsory license to a patent, but in most cases, the
use must be limited to domestic consumption. The practical
effect of this is that only a handful of developing countries
will have a large enough domestic industry to manufacture their
own products. Moreover, it is inefficient if not absurd to think
of more than 100 different manufacturing facilities for each
essential medicine that might be a subject of compulsory
licensing.
If one was serious about providing treatments for HIV/AIDS
medicines in developing countries, one would focus attention on
those issues that would lead to the cheapest and highest quality
production of medicines. This would involve:
a. Fast-track compulsory licensing (as has been proposed in
South Africa and the Dominican Republic).
b. Coordinated global procurement, to take advantage of
economies of scale, joint bargaining power and the best
international production facilities, and
c. An agreement by the WTO that patent exceptions for
production of medicine for export would be a reasonable use
of TRIPS Article 30.
Finally, thanks to Senators Frist and Feingold for addressing
this important issue.
Sincerely,
James Love
Director
Consumer Project on Technology
202.387.8030, fax 202.234.5176
love@cptech.org, http://www.cptech.org
James Love, Consumer Project on Technology
P.O. Box 19367 | http://www.cptech.org
Washington, DC 20036 | love@cptech.org
Voice 202/387-8030 | Fax 202/234-5176