E-drug: MSF Statement at the EC DG Trade Health Issues group
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On June 26 DG Trade held the third health issues group meeting with
civil society. One of the agenda items was access to medicines.
Around 28 NGOs - which included around ten trade associations and
representatives from pharmaceutical companies - were present.
Representatives of the following sections of the Commission were
present: trade, development and health and consumer protection.
On Access to Medicines other presentations were made by Bas van
der Heide from Health Action International (www.haiweb.org) and
David Earnshaw from the European Federation of Pharmaceutical
Manufacturers (www.efpia.org). Their was no statement from the
Commission. The Commission will post all contributions on the
website.
Next meeting on Access to medicines is on July 11th. For registration
and details on the Health Issues group see the European Commission's
Web site: http://europa.eu.int/comm/trade/2000_round/fmig.htm
should you wish to participate in the next meeting please contact the
European Public Health Alliance genon@epha.org and or Health Action
International bas@hai.antenna.nl - who coordinate the NGO input in
these meetings.
Ellen F.M. 't Hoen LL.M.
Drug Policy Consultant
PO Box 15605
1001 NC Amsterdam
The Netherlands
e-mail: ethoen@compuserve.com
tel: + 31 20 6201743
fax: + 31 20 6201581
Mobile: + 31 6 55735472
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Statement from M�decins Sans Fronti�res, Campaign for Access to
Essential Medicines at the Health Issues Group DG TRADE Brussels,
26 June 2000
by Ellen 't Hoen
Co-ordinator Globalisation Project MSF Campaign for Access to
Essential Medicines.
Introduction
One-third of the world's population lacks access to essential drugs. In
the most impoverished parts of Africa and of Asia that number is more
than 50%. Many effective medicines remain out of reach to people in
developing and Eastern and Central European countries. Long-time
killers such as tuberculosis (TB) and malaria continue to claim millions
of lives in the developing world. Very few people in this region have
access to medicines that are the standard in industrialised countries.
The access to medicines crisis paints a picture of 2 opposite worlds in
an increasing globalised economy: access, even excess in the western
industrialised world and no access to essential and other key
medicines in the developing world.
The global HIV/AIDS - crisis has provided us with a magnifying glass
under which the inequity in access to treatment became painfully
clear. As one minister of health pointed out at the World Health
Assembly held in May: "With AIDS the disease is in the South and the
treatment in the North."
But the access crisis is not limited to HIV/AIDS. In the absence of
effective medicines that are affordable and simple to use, respiratory
infections, malaria and tuberculosis remain the principal causes of
morbidity and mortality in Africa, Asia and Latin America.
Many factors contribute to the problem of limited access to essential
and key medicines. Unavailability can be caused by logistical supply
and storage problems, substandard drug quality, irrational selection of
drugs, wasteful prescribing and use, inadequate production,
insufficient drug research and development (R&D) and prohibitive
prices and lack of affordable generic drugs.
In the context of this hearing I would like to highlight the following
aspects and make recommendation for action by the European
Commission.
1) Prohibitive drug prices put essential medicines out of reach of
people in developing countries.
High drug prices are caused by patent monopolies. Irrational mark up
policies contribute to higher prices so may inappropriate taxing
systems and the dismantelement or lack of pricing policies.
We just completed a pricing survey in East Africa which compares
prices of a basket of 13 important drugs. The study compared the
prices of five anti-retroviral products in in Tanzania as in Norway.
Three of the five were more expensive in Tanzania than in Norway.
The other prices were similar. The pricing survey of Health Action
International showed that total price for the a basket of 13 important
drugs in Canada was 277 US$ In Tanzania 409 US$. In Canada an
unskilled worker would have to work 8 days to buy the basket. An
unskilled worker in Tanzania has to work 215 days to pay for this
basket.
Drug prices in general have little relation to the actual production cost.
The best illustration of this is the dramatic drop in price when a drug
comes off patent and when a comparison between patented drugs
prices with generic prices is possible. Fluconazole is an essential
medicine for the treatment and prophylaxis of cryptococcal meningitis.
Pfizer holds the patents for the product and charges 12 US$ to 27
US$ per capsule where it has a monopoly. The product is available in
generic form in India and Thailand for around .30$ per capsule.
Multi-drug resistant TB, currently costs between $US 8,000 and US$
13,000 to treat, is a death sentence for the vast majority of people
suffering from it. HIV/AIDS treatments that are the standard in
industrialised countries are out of reach of people living with HIV/AIDS
in the developing world.
2) Lack of research and development of new drugs for diseases
prevalent in developing countries.
Of the 1,233 new chemical entities that were developed between
1975 and 1997 only 13 were for the treatment of tropical diseases.
Five were a result of veterinary research, two developed by the US
army, three were a result of R&D efforts of pharmaceutical companies
of which two are re-formulation of old drugs. The market fails when it
comes to R&D for diseases of the poor. The vaccine for tuberculosis
was developed in 1923 The last novel treatment for TB was
developed over 30 years ago and is loosing its effectiveness. There is
a need for new effective and simple treatments for TB but there is
almost no investment in this area.
3) Lack of production and lack of sustainable production.
We call these the "abandoned drugs". Unsecured production leads to
a situation where the disease is knows, the treatment is known, the
patients are suffering and the doctor stands empty-handed. Examples
include DFMO or eflornithine for sleeping sickness.
We now also see the phenomenon of the opposite "newly embraced
drug" An example is pentamidine a re-formulation of an essential drug
for the treatment of sleeping sickness (lomidine) which was affordable
and available until its usefulness in the treatment of opportunistic
infections related to AIDS was established. The price went up and the
drug now is hardly available on the market in Africa for its original
indications. The response to this crisis is drug donations.
4) Inappropriate selection, procurement, distribution and quality
problems. This is often a result of lack of an effective national drug
policy (NDP) or failure to implement and enforce the NDP.
5) The effects of the Agreement on Trade Related Aspects of
Intellectual Property Rights (TRIPS).
There are concerns that the implementation of TRIPS will lead to
further drug price increases and will have harmful effects on
developing countries' capacity to produce affordable, generic versions
of life-saving drugs. It is unlikely that the TRIPS agreement will
encourage adequate research and development in developing countries
for diseases such as malaria and TB. Developing countries are under
pressure from industrialised countries and industry to implement
patent legislation that goes beyond the obligations of the TRIPS
agreement. This is called "TRIPS plus" protection. Implementation of
TRIPS can lead to a further widening of the access gap, if safeguards
are not put in place and employed.
Towards proposals for change
We cannot rely on market forces to address the access crisis. In
formulating policies we need to draw lessons from the past. In Europe
the TB epidemic was not effectively addressed until strong
government action was taken. Access to vaccines is rooted in the
believe that these are public goods and should be made accessible to
all, which was achieved my significant price differentiation where the
rich countries paid the higher prices. To address the imbalance in
access to medicines globally, political leadership and commitment is
needed.
Donations and announcements of price reductions are not sustainable
solutions. Proposals that are presented as public private partnerships
too often lack a strong public component and are misused as PR
responses to legitimate criticism rather than contributing to
sustainable solutions. Certain drug donation proposals expect
governments to hand over decisions about health policy to the
pharmaceutical industry. This is unacceptable. This is presently the
case with the Pfizer drug donation offer of fluconazole to South
Africa. Low price offers and donations of medicines should only be
supported if they are done in the framework of the normal existing
supply and health care systems.
Medicines can not be treated as mere commodities. Often access to
medicines is a question of life or death. Yet in international trade they
are regulated very much the same way as any other consumer good.
What is needed is political commitment and international leadership to
achieve he following:
1. lower drug prices to a level that make them affordable for people in
poor countries;
2. essential R&D driven by health priorities and need rather than by
profit motives;
3. intellectual property protection that balances the rights of
innovators and the public that needs access to the innovations.
We ask the European Commission the following:
-Continue and strengthen the support for the development of national
drug policies that regulate all aspects of appropriate medicines supply
and rational use of medicines within a health policy framework. NDP
could include provisions for price controls, drug regulation, selection
and supply, rational use, control of unethical advertising, consumer
education, appropriate tax levels and pharmacy mark ups, quality
control etc.
- Encourage voluntary licensing and technology transfer with the aim
to increase production in developing countries of affordable essential
and other key medicines. Licensing agreements can include provisions
to prevent back-flow of low priced medicines to the industrialised
world.
- Support for the proposal to set up an international pharmaceutical
prices database as it was formulated by the WHA, to increase price
transparency in the global market place
- Actively encourage generic competition in the pharmaceutical
market. This includes active support for "Bolar" provisions to
encourage speedy introduction of generic products after a patent term
has expired. Avoid restrictive and anti-competitive interpretations of
country obligations under Article 39 of TRIPS. Article 39 is intended to
prevent 'unfair commercial use' of health registration data. MSF wants
the Commission to support a narrow definition of 'unfair commercial
use'. In the absence of data exclusivity, generic drugs or drugs
produced under a compulsory license can be introduced onto the
market on the basis of simple bioequivalence tests, without having to
replicate time consuming and expensive clinical trials that are used to
establish the efficacy and safety of the products.
A recent UNAIDS study shows the following effects of generic
competition in Bazil for AIDS medication between 1996 - 2000:
Lamivudine price per tablet came down from 2.90 $ to 0.83$
Zalcitabine (ddC) from 1.55$ to 0.08$
Didanisine (ddI) 1.85$ to 0.51$
Zidovudine (AZT) from $0.56 to 0.18$
- The European Commission should join the World Bank and the WHO
in encouraging developing countries to make full use of safeguards
that are possible under the TRIPS Agreement such as compulsory
licensing and parallel import as part of a comprehensive strategy to
increase access, instead of opposing this as has been the case so far.
- The Commission should engage in strategies to ensure that
developing countries that are in the process of developing or
amending IP laws receive the right kind of support and technical
assistance to do so. The absence of a strong public health voice in
TRIPS implementation has been detrimental. WHO involvement in this
should be encouraged and not hampered.
- We would like to see a clear commitment from the European
Commission that it will not seek bilateral higher levels of IP protection
than were multilaterally agreed upon.
- Allow for longer transitional periods for TRIPS implementation by
developing countries. This will for example be necessary for the
countries party to the Bangui agreement.
- The Commission should support the proposal for a working group on
access to medicines at the WTO as outlined in the Amsterdam
Statement.
- Trade issues with a health component that are discussed in the
Committee article 113 should also be sent to the health ministers of
the EU.
- We ask the Commission to support proposals to stimulate R&D for
neglected diseases. MSF advocates the development of an
international essential medical research agenda coupled with proposals
for funding. This could include reinvestment obligations, public
funding and maintenance of the IP rights to ensure that medicines that
are a result or partly a result of public funding of R&D can be made
available at low cost in developing countries.
- We support the call for greater transparency of pharmaceutical
economics as put forward by the Trans Atlantic Consumer Dialogue
and Health Action International. Solid data on R&D cost for example
will facilitate the discussions on how to share the global
pharmaceutical cost burden.
- Strategies for change should not only target and involve Big Pharma.
The generic industry can and has to play a major role, so do not for
profit suppliers.
- Proposals and strategies should not be limited to addressing the
HIV/AIDS crisis. Other priority areas are TB, Sleeping sickness,
malaria, leichmaniasis and many infectious diseases for which
expensive anti-biotics are needed.
- Proposals and strategies should not be limited to the least developed
countries. Countries with a certain infrastructure level may be priority
countries to focus on. For example Thailand has the infrastructure and
the medical profession to provide AIDS care that compares to the
standard in the West. The single most important barrier is price. I
would like to stress the need for an inter-sector approach. Obviously
there are many aspects to the access crisis that go beyond the scope
of DG Trade.
In case there is any doubt. MSF is not against patents and not against
patent legislation. True innovation deserves to be protected and to be
awarded. We advocate a balanced IP regulation that takes into
account the specific needs and priorities of developing countries and
that follows the principles that are outlined in the TRIPS: patents
should benefit the innovator and those who need access to the
innovation. Should it not be possible to achieve this balance under the
present international agreements it will be necessary in the TRIPS
review process to strengthen the public interest further by providing
explicit exceptions for key health care technologies.
We would like to propose a subgroup to this meeting to explore some
of the practical proposals made. We invite multinational drug
companies, the generic manufacturers, representatives from all
relevant sectors of the European Commission and health and
development NGOs to take part in a working group to explore
proposals for lowering of drug prices including voluntary licensing of
key medicines and strategies to encourage research and development
for neglected diseases.
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