Laws, Politics, and Access to Essential Medicines in Developing Countries

-Heinz Klug

standardized, corporate-inspired, intellectual property regime

-example of the HIV/AIDS pandemic to demonstrate how the
stability of this new
regime came under pressure, both locally and globally
-while the global HIV/AIDS pandemic and the social movements
that
emerged in response to government inaction have effectively
challenged the TRIPS
regime, this complex contestation has reached an unsustainable
stalemate in which
development aid, corporate, and non-governmental philanthropy
is simultaneously
providing increased availability to drugs while precluding a more
lasting solution
to the crisis of access to essential medicines in developing
countries
-Life-saving pharmaceuticals represent a symbolic paradox; they
are, at the
same time, a mark of extraordinary scientific progress and a
demonstration of an
abysmal lack of social solidarity at the beginning of the twenty-
first century
-Run by coporations
-many debates, arguments; variety of patients
-Essential medicines represent a direct challenge to the existing
pharmaceutical
regime.
-1970s: WHO adopted policy of securing essential drugs, and
developing nat'l drug policy: usually included generic, off-market
drugs
+1999, first year WHO included a patented, pharmeceutical
on list (HIV treatment)
-In developing countries, the ability of governments to effectively
combat
the pandemic remains captive to an ongoing struggle over
intellectual property
rights in the global economy
-A tention between social struggle to have treatment and
property rights/econ freedom has arisen.
-Struggle to get anti-rhetral viris treatment
-South Africa has has to struggle in order to have the ability to
produce ARV drugs, as copyright/patent prevented it
-TRIPS - trade related inellectual property rights
-agreement on
TRIPS was signed at Marakesh in April 1994
-Historically, there was not even a general notion of intellectual
property;
instead, there was a clear distinction drawn between patent
rights, considered
industrial property, and other forms of intellectual property, such
as copyright
and trademarks
-before, medicine was treaded as a global, public good, often
relaxed patents.
-Pharmaceuticals pushed for greater protection
-Pfizer, which worked with the Pharmaceutical
Manufacturers Association to lobby Congress
-USTR (trade representative) agreed to “expend the considerable
diplomatic effort needed to put intellectual property on the GATT
Uruguay Round agenda.. Then Pzizer and IBM pushed for more
Intellectual property protection
-3 ammendments to legislation in congress (79, 84, and 88) gave
more power to USTR to take action against IP violations
+pressured countries around world to enforce
-Canada had had a much more liberal stance with regards to
pharmeceuticals: they let cheap generic in, lowering prices.
-This was an issue as for NAFTA as the US didn't want there to be
a special regime for pharmeceuticals
- Pharmaceutical Review in 1991, which concluded that
competitive patent protection
was needed to attract new investment and to encourage research
and
development.
+Furthermore, they supported proposals for 1991 Uruguay
rounds that would internationalize patent protection
-Canada provides not full patent protection, but patent protection
for applications filed in Canada on or after October 1, 1989
+Not exactly what US wants, it HAS kept prices down.
-Although intellectual property rights (IPRs) were raised for the
first time in
the context of international trade negotiations at the 1982
ministerial meeting of
the GATT, it would take until 1986 before IPRs would be a formal
part of the
Uruguay Round agenda.
-The Uruguay Round was the 8th round of multilateral trade
negotiations (MTN) conducted within the framework of the General
Agreement on Tariffs and Trade (GATT), spanning from 1986-1994 and
embracing 110 countries as “contracting parties”. The Round
transformed the GATT into the World Trade Organization.
-The Uruguay Round Agreement on Agriculture, administered by the
WTO, brings agricultural trade more fully under the GATT. It provides
for converting quantitative restrictions to tariffs and for a phased
reduction of tariffs. The agreement also imposes rules and disciplines
on agricultural export subsidies, domestic subsidies, and sanitary and
phytosanitary (SPS) measures.
-TRADE REGIME:System of tariff and non-tariff barriers and export
incentive schemes aimed at strengthening the competitiveness of local
producers.
-Whereas under GATT, each country could lower tarriffs in specific
areas of the economy, under the WTO, it would be accross the board
tarriff control
- The IP provisions of trips were put into the WTO, and pharmeceuticals
got equal patent protection
-Trips + The Agreement on Trade Related Aspects of Intellectual
Property Rights (TRIPS)
-Even though it seems that the trade isssues on IP have been
settled, the issue of medicine for aids, malaria, ect. has
prompted gov'ts activists ect to press for change.
-Debate really heighted in 1996, two years later, when anti-rhetral
virus drugs were introduced but which needed to be taken for life.
- S. AFrica introduced legislation that would make paralell
importation and generic brands, though pharmeceuticals of S.
Afrique and multinationals opposed along with embassador
from US, noting it violated obligations under TRIPS
-USTR put S.A. on watch-list, congress passed legislation to cut
aid until S.A. takes out provision
-A parallel import is a non-counterfeit product imported from another
country without the permission of the intellectual property owner.
Parallel imports are often referred to as grey product, and are
implicated in issues of international trade, and intellectual property.
-In 2000, US said it wouldn't revoke or reform any part of the TRIPS
with respect to aids treatment to AFRIQUE
-Big issue over ARV treatment to nursing mothers. Gov't of SA said the
prices of the medecine were artificially high
-19.6 percent of the population are HIV positive: is means treatment would go
beyond nat'l health budget
-In a compulsory license, a government forces the holder of a
patent, copyright, or other exclusive right to grant use to the state or
others. Usually, the holder does receive some royalties, either set by
law or determined through some form of arbitration.
+compulsory license would not be enough to reduce costs
-some pharmeceuticals have donated to SA's poor, though its not
enough: shit should be available on the public market
-After Seattle, 2001 Doha meeting initiated separate regulations on
public health and TRIPS
+agreed that the TRIPS agreement “does not and should not prevent
Members from taking measures to protect public health
-• Ironically, it was the anthrax scare that prompted US to
insist upon
compulsory lincensing
-Thus US capitulated to needs of developing world
--in 2001, Doha did not go very far in ensuring medicine to those most
in need. Did not resolve this issue: merely recongnizes right to use
compulsory licensing domestically, said nothing of using it
internationally

-Yet some countries did not have the capacity to produce

under compulsory licence or did not have access to generics:
so problem remains

-as of 2003, coiuntries were required to prove they had a

national emergency/could not access medecine.
+ Problematic because many countries had too much
pride to do that, did not want to scare investors, tourism,
ect.
+ Canada delivered ARV treatment to Rwanda

-The Doha Development Round or Doha Development Agenda

(DDA) is the current trade-negotiation round of the World Trade
Organization (WTO) which commenced in November 2001. Its objective
is to lower trade barriers around the world, which allows countries to
increase trade globally. As of 2008, talks have stalled over a divide on
major issues, such as agriculture, industrial tariffs and non-tariff
barriers, services, and trade remedies.

-ARV is being provided by many philanthropic organizations, however

these groups often insist upon buying the authentic, not generic. The
big issue is over whether or not this is sustainable, given that ARV
must be taken for life.

-Much of the distribution of ARV too poor is thtough NGO or gov’t

initiatives, though the source, that is, the production, is often
disrupted, causing many people to have to go off it for a bit, causing
resistnence, illness, ect.

-Prices PRICES prices, are a huge barrier because people/gov’ts,/NGOs

still spend beaucoup bucks. More competition would be better. India,
as of 2005, was restricted from making generics w/o a license.

-WHO formed in 1948, headquartered in Geneva.

-WHO’s mission butts up with the EU, US, Japan stance that
copyright/patent must be respected, trade regulations enforced. WHO
claims that medecine ought to be a public good. So does author

-Human rights groups, gov’ts, some generic producers have been

pressing WTO to change

-Instead of relying on thin strands of legal flexibility,

NGOs, international organizations, countries, and governments
attempting
to address the global HIV/AIDS pandemic were encouraged to look to
the
building of this new, multifaceted, and complex solidarity to assert a
human
rights–based interpretation of the international trade and intellectual
property
regime—one which places public health ahead of property claims.

-Suing Nelson Mandela to prevent his government from implementing

a WHOinspired
essential medicines program was symbolically the kiss of death for the
pharmaceutical corporations

-encourage as many pharmaceutical producers as possible would

ensure lower prices