[Pharm-policy] RE: [Ip-health] TACD statement on Access to Medicines in Developi
ng Countries
Kasper, Toby
TobyK@GMHC.org
Thu, 20 Jan 2000 13:27:01 -0500
Hi Jamie,
A few comments on the TACD draft. I'm not sure if your call for comments
was intended to start a discussion about this on the email lists - if so,
feel free to forward this; otherwise, use as you will privately.
First, a quick update: you really don't want to be calling for NIH to make
the license for FddA (aka lodenosine) available. Grammatically it's an
issue because it's not an FDA-approved drug, so it is not "highly profitable
and high price," but far more importantly, US Bioscience, which was
developing it, recently stopped all clinical trials of it after a death
occurred in a trial, meaning that for all intents and purposes, the chances
of it coming to market in the near future are nil. I'm not positive about
this, but I think that I recall once hearing that abacavir, a potent
nucleoside analog reverse transcriptase inhibitor, was developed with some
NIH money, so (if you can confirm my shaky memory) it might make a good
substitution.
Second, a couple of additional things that might be relevant to ask for,
regarding TRIPS and the WTO:
* An extension of both the non-violation clause (Article 64.2) and the
transition phase (especially Article 65.2 but also Article 66.1) of TRIPS.
The former was included in the "Annex: Possible Decisions at Seattle on
Implementation" (i.e., items for which there was some significant support
but no consensus) of the draft Declaration that was never voted on in
Seattle, whereas the latter is something developing countries were pushing
for in Seattle but which the US wouldn't give in on (see, for example, the
OAU statement of 2 December 1999). Both of these extensions will provide
developing countries with the time they need to ensure that their national
laws are both TRIPS-compliant and sufficiently flexible to maximize their
ability to ensure access to medicine, without the looming threat of trade
sanctions and WTO actions (and without a vast dedication of resources needed
to fend them off). I think that you have the documents mentioned and so the
exact language that has been proposed; let me know if you'd like me to
circulate it. An alternative to formal support of an extension of either of
these would be a commitment not to pursue Dispute Settlement cases against
developing and least developed countries until the Ministerial can be
reconvened to discuss the proposals for extension. This is especially
relevant in light of the utter failure of developed countries to
operationalize the provisions of TRIPS that call for technical support for
implementation - which might have allowed developing countries to bring
their national laws into TRIPS-compliance - and technology transfer
(particularly Articles 67, and 7 and 66.2 , respectively);
* A genuine commitment to put into practice the technology transfer
provisions of TRIPS, particularly Articles 7 and 66.2. Precious little
concrete action has followed from the promises developed countries committed
to in the drafting of TRIPS, and until these provisions are operationalized,
developing countries are severely hampered in their abilities to genuinely
develop indigenous capacity to research and produce medicine relevant to
local need. Worse still, the US has sought to limit the ability of
developing countries to impose technology transfer requirements on companies
that seek to invest in their markets by amending the TRIMS (Trade-Related
Investment Measures) Agreement to specifically prohibit such requirements
(see the WTO document WT/GC/W/115). You've probably seen it, but if not, I
recommend Carlos Correa's excellent paper, "Review of the TRIPS Agreement:
Fostering the Transfer of Technology to Developing Countries," which goes
into much greater depth on the subject of technology transfer.
Take care,
Toby
-----Original Message-----
From: James Love [SMTP:love@cptech.org]
Sent: Friday, January 14, 2000 2:21 PM
To: IP-Health list; pharm-policy
Subject: [Ip-health] TACD statement on Access to Medicines in
Developing Countries
This is a first draft of a TACD statement on Access to
Medicines in Developing Countries. Suggestions are
welcome. TACD will be meeting in Washington, DC on
Feb 10, 2000. (See http://www.tacd.org for background
on TACD).
Jamie Love <love@cptech.org>
version 1.0
Pharmaceuticals
1. Access to Medicines in developing countries.
a. Developing countries are facing a crisis in access to
essential medicines.
Large disparities in incomes have contributed to a crisis in
terms of access to essential medicines in developing countries.
Consider the following:
- 1.3 billion people in the world live on less than US$1 per
day 20% of the world's population consumes 80% of the
world's resources
- Every 3 seconds a child dies of diseases of poverty
- 17 million deaths per year are due to infectious disease
- Currently 33 million people live with HIV, 7-8 million with
active TB
- More than 90% of all death and suffering from infectious
diseases occurs in the developing world
- 20% of the world's population uses 80% of the world-wide
production of medicines
- 0.2% of pharmaceutical research is devoted to acute
respiratory infections, TB, diarrhoea, while 18% of deaths
are attributable to these diseases.
b. Trade disputes involving health care are common.
Since 1997, South Africa has been attempting to implement
legislation to provide fast track mechanisms for compulsory
licensing and parallel importing of essential medicines. South
Africa is engulfed in a tragic health care crisis, with an
estimated 20 percent of its young adults testing positive for
HIV/AIDS. During the past three years, the US government, the
European Commission, and officials from the United Kingdom,
Germany and France have pressured South Africa to modify or
repeal sections of its Medicines Act that would facilitate fast
track compulsory licensing and parallel importing of essential
medicines. There have been similar pressures on Thailand, a
country with 1 million HIV/AIDS patients, and many other poor
countries. The Dominican Republic, which faces a growing
HIV/AIDS problem and an under funded public health effort, is
currently being pressured over proposed fast tract compulsory
licensing legislation. India is being pressured over proposals
for fast tract compulsory licensing. The Philippines, Mexico,
Thailand, South Africa, Indonesia and other countries have been
pressured over proposals to promote the use of generic names in
prescriptions and package labeling. There are also trade
disputes over price controls, early working of patents, research
exemptions, scope of patents, the timing of adherence to new WTO
rules regarding intellectual property, the period of exclusivity
for health registration data and many other issues.
c. Public Health Considerations should be paramount in trade
policies as they relate to access to medicines.
The US and EU governments should review trade policies to ensure
that developing countries do not face trade related barriers for
access to essential medicines and other medical technologies.
This is consistent with the World Health Assembly's endorsement
EB103/4, which called upon member countries:
(1) to reaffirm their commitment of developing,
implementing and monitoring national drug policies and to
taking all necessary concrete measures in order to ensure
equitable access to essential drugs;
(2) to ensure that public health interests are
paramount in pharmaceutical and health policies; and
(3) to explore and review their options under
relevant international agreements, including trade
agreements, to safeguard access to essential drugs;
On December 1, 1999, the United State government announced a new
initiative to incorporate public health considerations into trade
policy, and to modify its trade policy in order to ensure broader
access to medicines for HIV/AIDS and other illnesses. The EU and
its member countries should do the same.
d. R&D on neglected diseases.
Today there is very little research and development on diseases
such as malaria, chagas disease and other illnesses that
primarily impact the poor. The US, the EU and other developed
countries should enter into an agreement to support far higher
levels of R&D on these diseases. Moreover, these R&D efforts
should be designed with access in mind, and address issues such
as reasonable pricing and the allocation of intellectual property
rights.
e. Access to publicly supported R&D
Public health groups have called upon the US and the EU and its
member countries to enter into agreements with the World Health
Organization (WHO) to give the WHO licenses to use taxpayer
funded health care inventions in developing countries. This
would involve more than licenses to orphan patents (diseases
without commercial markets). For example, the US government
could issue licenses for patents on such highly profitable and
high priced AIDS drugs as ddI, d4T, ddI, 3TC, Norvir and fDDa,
and provide the WHO with licenses to use data from Taxol clinical
trials.
f. WTO Working Group on Access to Medicines
Public Health Groups have called upon the World Trade
Organization to create a working group on access to medicines.
This working group would work within the WTO to consider the
impact of trade policies on people in developing and
least developed countries, and will provide a public health
framework for the interpretation of key features of WTO
agreements, and evaluate and propose changes in the WTO rules
that would expand access to medicines. TACD supports this
proposal.
g. Production for Export under compulsory license
The EU and the USA should send communications to the WTO
acknowledging the need to interpret the WTO TRIPS agreement in a
way that will permit countries to authorize production for export
to countries have issued compulsory licenses for life saving
drugs. Most countries in the world do not have sophisticated
domestic pharmaceutical industries, and it will be essential for
the world trading system to permit exports and imports of drugs
that are sold in markets with compulsory licenses.
h. No TRIPS plus pressures
The US and EU governments should stop putting pressures on
developing countries to adopt TRIPS plus levels of intellectual
property protection for medicines. A proposal to prevent the US
government from requiring TRIPS plus for medicines in Africa has
been passed by the US Senate.
i. Private actions limit access to essential medicines
A number of larger US and European pharmaceutical companies are
currently suing in the South African courts to hold up
implementation of the South African Medicines Act provisions on
fast track compulsory licensing. In Kenya, Medecins Sans
Frontieres (MSF) is being threatened with legal action by Pfzier
if MSF imports to Kenya inexpensive copies of fluconazole, a drug
used to treat HIV/AIDS related cryptococal meningitis, and
Bristol-Myers Squibb is fighting a Thailand proposal for a
compulsory license to ddI, a US government funded HIV/AIDS drug.
AIDS activists are asking governments to take administrative
action to pressure large pharmaceutical companies who are
currently blocking access to inexpensive medicines in countries
that face public health care emergencies. For example, the US
and EU governments could decide to withhold contracts or
cooperative research agreements from companies to block access to
essential medicines in country's with health care emergencies.
Countries that regulate prices for pharmaceutical reimbursements
could also impose penalties on firms that impede access to
essential medicines.
--
--
James Love
http://www.cptech.org
mailto:love@cptech.org
voice 1.202.387.8030
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