E-drug: MSF proposals for the 54th World Health Assembly
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Dear e-druggers,
please find below the text of recommendations for WHO from the MSF
Access to Essential Medicines Campaign at the 54th World Health
Assembly. This text is also available in English and French (with
charts) on our website (www.accessmed-msf.org) as a downloadable Word
file.
Suerie Moon
Editor
Access to Essential Medicines Campaign
M�decins Sans Fronti�res (MSF)
rue du Lac 12
CP 6090
1207 Geneva
Switzerland
tel: +41 (22) 849 84 01
fax: +41 (22) 849 84 04
access-com@geneva.msf.org
www.accessmed.msf.org
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ACCESS TO ESSENTIAL MEDICINES:
CAN THE WORLD HEALTH ORGANIZATION DO MORE?
M�decins Sans Fronti�res Briefing for the 54th World Health Assembly
Introduction
M�decins Sans Fronti�res (MSF) has been campaigning since 1999 to
improve access to essential medicines. For years, we have had to
watch our patients die for lack of effective, affordable drugs. MSF
is encouraged to see that in the last year the World Health
Organization (WHO) has made significant progress towards addressing
this crisis. WHO has begun discussions to reform the process of
updating the Model List of Essential Drugs (EDL), created a database
of information on drug prices with other UN agencies, and become more
involved in trade issues that impact health.
However, as the world's leading health agency, and armed with the
clear mandate of recent WHA resolutions, WHO can and should do much
more. In particular, MSF calls on WHO to advocate more vocally for
public health concerns at the World Trade Organization (WTO) and its
TRIPS Council(1); to defend more staunchly the rights of Member States
to incorporate measures in their legislation that protect access to
medicines, (such as compulsory licensing, parallel imports, and
measures to accelerate the introduction of generics (2)); and to
develop a clearer vision on global equity pricing(3) for essential
medicines. In addition, Member States should support ongoing WHO
efforts to expand the EDL to include therapeutically essential drugs
previously excluded because of high cost.
Stronger role for WHO needed at WTO and TRIPS Council
The adoption of the Revised Drug Strategy Resolution by the WHA in
1999 (WHA52.19) marked a major turning point in WHO's work on access
to medicines. Member States explicitly expanded WHO's mandate to
include monitoring and analysing the public health implications of
trade agreements (specifically TRIPS), and supporting Member States in
addressing concerns about the effects of these agreements on access to
medicines.
But has WHO done enough? As noted in its report on the Revised Drug
Strategy (A54/17), "after a two-year process, WTO's TRIPS Council
accorded WHO observer status on an ad hoc basis." While "observer
status" signifies some progress, WHO should not merely play the role
of observer, but rather, should actively advocate for public health
when it is affected by trade policies. WHO should increase its
capacity, which is currently insufficient, to support Member States in
implementing TRIPS with the highest protection for public health, by
helping countries make full use of the flexibility in the Agreement.
The upcoming TRIPS Council meeting in June will provide WHO a good
opportunity to promote a public health perspective on issues currently
under debate. MSF urges WHO to back strategies that ensure that
protection of health takes precedence over protection of intellectual
property rights. (For specific recommendations, see p.4)
Wanted: equity pricing
Over the past year, global equity pricing policies that would mean
lower prices for essential medicines in developing countries have
gained momentum and support from all sectors, including industrialised
and developing countries, drugmakers, and civil society. Recently,
WHO and WTO jointly hosted a meeting in Norway to discuss differential
pricing, but achieved few concrete results. Many questions remain
unanswered about WHO's vision on differential pricing, and how a
differential pricing system can contribute to making drugs truly
affordable: Will it include all developing countries? Will it include
generic manufacturers, or only the proprietary drug industry? Will it
rely on individual negotiations with drugmakers or set up a
transparent, global system?
A differential pricing system will not be enough to achieve the goal
of equity pricing. Differential pricng will only be effective if it
is part of a more comprehensive system that includes generic
competition, global/regional procurement and distribution, local
production through voluntary licensing and technology transfer, and
donor support. In short, medicines will not be made affordable
through one single strategy. Rather, a combination of
mutually-supportive measures is required. (See chart below.) WHO
should also support countries in procuring affordable medicines by
identifying quality producers through a pre-qualification process,
where appropriate.
Generic competition is one of the key factors in bringing prices down
on a sustainable basis. The dramatic fall in prices of AIDS drugs,
from over $10,000 per patient/year for triple therapy to as low as
$347 in one year, provides strong evidence of the need and efficacy of
competitive pressure:
Next steps for the Essential Drugs List (EDL)
The EDL is one of the most important public health tools, promoting
access to needed medicines and their rational selection and use. WHO
has reported that various changes to the process of updating the EDL
are under consideration, including "application review procedures and
reporting to be standardized and made transparent; selection of
essential drugs to be closely linked to WHO treatment guidelines;
decisions on inclusion to be based on evidence rather than consensus;
evaluation of safety and efficacy to be separated from cost
considerations; continual rather than two-yearly updates; and
electronic publication in all major languages." MSF welcomes these
suggestions as necessary and effective measures for ensuring that the
EDL is primarily a medical tool, and particularly welcomes the fact
that expensive drugs will no longer be excluded from the list solely
because of price.
The expansion of the EDL should go hand-in-hand with measures to
ensure that these medicines become affordable and available. WHO
should support policies that reduce the prices of essential medicines
that are currently too expensive for developing countries.
Recommendations for WHO
To advocate more vocally for public health concerns at the WTO and
TRIPS Council, WHO should:
1. Develop a strategy to monitor the potentially negative impacts of
TRIPS on public health.
2. Advocate for extending TRIPS implementation deadlines for
developing countries until the Agreement's impact on health can be
thoroughly evaluated.
3. Articulate the public health benefits of policies that accelerate
the introduction of generics, including both Bolar provisions and
limits on anti-competitive levels of data exclusivity.
4. Report on the failure of TRIPS to stimulate research and
development (R&D) of drugs for diseases that primarily affect
developing countries. Propose alternative methods for stimulating
such R&D and ensuring equitable access to its end products.
5. Provide Member States with model laws and regulations on compulsory
licensing and other legal measures to improve access to expensive
medications.
6. Analyse the public health benefits of allowing the export of drugs
produced under compulsory license, so that this measure can benefit
developing countries both with and without production capacity.
To promote equity pricing, WHO should:
7. Actively pursue a global policy of equity pricing for essential
medicines through a mix of mutually-supportive strategies, including
generic competition, differential pricing of branded drugs, global
procurement and distribution, and local production.
8. Support countries in procuring affordable medicines by identifying
quality producers through a pre-qualification process, where
appropriate.
To maximise the value of the Essential Drugs List, WHO should:
9. Strengthen the WHO Model List of Essential Drugs with a list of
therapeutically essential medicines that are not yet included because
of price, then support measures to reduce the prices of these
medicines.
10. Expand its work on a database of prices for medicines, and
particularly, add information on their patent status to enable Member
States to identify affordable quality sources of essential drugs.
NOTES:
1. The body that is responsible for monitoring the operation of the
Agreement on Trade Related Aspects of Intellectual Property Rights
(TRIPS), and in particular, how WTO members comply with their
obligations under it.
2. Also known as Bolar provisions.
3. MSF will use the term "equity pricing" to describe pricing policies
that ensure that, from the point of view of the community and the
individual, the price of a drug is fair, equitable and affordable,
even for a poor population and/or the health system that serves them.
Equity pricing is based on the principle that the poor should pay less
for, and have access to products such as essential medicines. The
terms "differential pricing," "preferential pricing" and "tiered
pricing" are also often used to describe lower prices for low-income
populations, but they do not necessarily result in affordability or
equitable access to a product. Rather, they are commercial terms for
pricing practices aimed at maximising the income of the seller. While
differential, preferential or tiered pricing may lead to equitable
access to medicines, they do not necessarily mean that even the lowest
prices charged will be affordable.
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