and equitable access to essential drugs
there are a number of factors, such as high cost, insufficient production,
and lack of research and development, which have ontributed to denying
equitable access to drugs to millions in the Third World, it is the international
trade regulations arising from globalisation that may prove to be the
biggest obstacle to such access. Ellen 't Hoen considers these impediments
to access and suggests some new global approaches to overcome them.
of the world's population lack access to essential drugs. In the most
impoverished parts of Africa and of Asia, more than half the population
do not have access to essential drugs.1 Many effective remedies are and
have for many years been out of reach to the people in developing countries.
Because of globalisation and new international trade rules, the situation
may even get worse in the near future, hence the need for new approaches
to protect and further the basic human right to access to health care.
of availability of essential drugs can have different causes, including
logistical supply and storage problems, substandard quality, irrational
selection of drugs, wasteful prescribing and use, insufficient production,
insufficient drug research and development (R&D) and prohibitive cost.
This paper will discuss access problems related to cost, insufficient
production, lack of R&D and consequences of global trade regulation.
Health Organisation (WHO) published the first Essential Drugs List (EDL)
in 1977. Essential drugs are 'those that satisfy the health needs of the
majority of the population; they should therefore be available at all
times in adequate amounts and in the appropriate dosage form'. The first
EDL contained 200 drugs. The EDL is revised every two years. The current
list contains 306 drugs. The inclusion criteria for the EDL are proven
safety and efficacy, well-understood therapeutic qualities and reasonable
price or cost. Most of the drugs on the EDL are generic products: only
around 15 are patented products.2 The essential-drugs concept has been
for many years a key strategy to help improve access to essential drugs
and contribute to improved health. Over 140 countries have adopted national
essential drug lists and access to essential drugs has increased. There
are, however, concerns that the gains will be lost because of the prohibitive
costs of new essential drugs, lack of research and development for tropical
diseases and the effects of new international trade agreements on drug
prices and local manufacturing capacity.
cost of medicines
of prohibitive cost, a number of essential drugs are already not included
in the EDL. All the AIDS drugs (except AZT for the prevention of mother-to-child
infection) and certain new antibiotics are not included even when infectious
diseases such as HIV and tuberculosis are responsible for a large proportion
of deaths occurring between the ages of 15 and 59 years in low- and middle-income
crisis shows an increasing gap in access to treatment between the developed
and developing world. Eighty-three percent of the HIV-infected people
in the world live in sub-Saharan Africa. The standard triple-therapy for
HIV infection costs around US$10,000 per year. The per capita expenditure
on drugs in the sub-Saharan region is approximately US$8.4 Treatment that
has considerably increased the life expectancy of people with HIV/AIDS
in industrialised countries is out of reach for almost all people with
HIV/AIDS in developing countries.
multidrug-resistant tuberculosis (MDRTB) in a developing country can range
in cost between $8,000 and $10,000. Most countries do not have the resources
to provide these treatments. The incidence of MDRTB will increase if the
disease is left untreated; more people will die even though effective
treatment exists and the disease will spread across borders.
of production of essential drugs
side of the supply problem is the discontinuation of essential drugs because
they are not commercially viable. This is the case with eflornithine (DFMO),
used in the treatment of human African trypanosomiasis, better known as
'sleeping sickness'. Sleeping sickness is caused by a parasite transmitted
by the tsetse fly and affects 30,000 people per year. In the advanced
stage, the parasite affects the central nervous system. If left untreated,
the disease will lead to death.
DFMO was developed
in the mid-1970s as an anti-cancer agent by Merell Dow. In 1985 the effectiveness
of DFMO in the treatment of sleeping sickness was established and development
took place under a successful public/private co-operation project between
WHO and Merell Dow during the 1980s. DFMO is the only treatment of proven
efficacy for advanced-stage sleeping sickness and is on the WHO EDL. Because
of lack of commercial opportunities, the company ceased production in
the early 1990s. Five years ago Hoechst Marion Roussel (HMR), which had
taken over Merell Dow, offered the technology, patent and commercial rights
of DFMO to WHO. WHO has since then been involved in negotiations to make
the product available again but to no avail.
lottery for people living with AIDS in Guatemala
Luis Angel Garcia Clinic in the San Juan de Dios hospital does not
have the resources to supply medicine to the 90 people living with
AIDS it cares for. The medicines bank of the clinic has anti-retroviral
medications for only four people. These four were selected through
a lottery. On 29 June 1999, in the waiting area of the clinic, 90
people living with AIDS gathered to see who would be the winners.
The prize: a year's supply of life-saving anti-retroviral medications.
'It was the most depressing lottery I have ever seen', commented
Richard Stein, Director of the Associacion Agua Buena in San Jose,
Costa Rica. 5
Today the only
existing DFMO vials are in the Medecins Sans Frontieres (MSF) drugstore
in Kampala and will expire by the end of July 1999. HMR offered the remaining
200 kg bulk product for free but is no longer able to put the product
in vials. WHO and MSF have offered to pay for this and are presently looking
for a company that can put the product in vials. For the long term, there
are no sustainable solutions yet for the production of DFMO.6
of essential research and development
present systems for research and development of new drugs, there is a
lack of commitment to product development in the public interest. Research
and development for diseases found in developing countries is insufficient
and has since the 1970s practically come to a halt. Between 1975 and 1997,
out of 1,223 new chemical entities, only 13 (1%) are for the treatment
of tropical diseases. Only four of these are the result of R&D activities
of the pharmaceutical industry.7
investments focus R&D on products that may be attractive from a commercial
point of view but which add little to therapeutic innovation. In the period
1981-1998, an assessment of 1,779 new drugs in France showed that only
seven could be considered a real therapeutic breakthrough. In total, 1,043
were drugs that fell into the category 'nothing new' and were mostly 'me-too'
products. A 'me-too' product is an imitation - a slightly modified molecule
- of a successful product of a competitor brought out to secure a share
of a particular segment of the market. It hardly ever provides significant
new therapeutic possibilities.8
The lack of
essential R&D by drug companies poses the question: should the industrial
agenda be set by the industry alone? The present situation calls for an
international approach to essential medical research and development to
ensure that the vast amount of financial resources used for new drug development
will lead to the production of products that address real health needs.
trade regulation and access to drugs
and international regulation of trade is becoming increasingly important
for the health field. There are legitimate concerns about the effects
of the World Trade Organisation (WTO) Agreement on Trade-Related Aspects
of Intellectual Property (TRIPS) on access to drugs. TRIPS is the most
important international agreement on the protection of patents, copyright
and trademarks. TRIPS obliges WTO member states to provide a minimum term
of patent protection of 20 years. Industrialised countries should have
implemented the TRIPS Agreement by 1996, and developing countries by the
beginning of this year. Least developed countries have to apply the provisions
of the agreement by 2006.
the effect of the TRIPS Agreement on access to drugs include the following:
* Increased patent protection will lead to higher drug prices, while the
number of patented drugs of importance from a public-health point of view
will increase in the coming years.
* The access gap between developed and developing countries will increase.
A key question is whether developing countries should have to wait for
20 years before they can have access to innovations.
* Enforcement of the WTO regulations will have an effect on local manufacturing
capacity and remove a source of generic innovative quality drugs on which
the poorer countries depend.
* There is no reason to believe that the TRIPS Agreement will encourage
technology transfer and R&D in developing countries; neither are there
incentives or provisions to ensure that increased revenues will go towards
the development of essential medical technologies.
* Industrialised countries will pressure developing countries to implement
patent legislation that provides a higher standard of protection for the
patent holder than under the minimum requirements of the TRIPS Agreement.
trade and WHO
about globalisation and the effect of international trade agreements on
access to drugs were raised at the World Health Assembly (WHA) for the
first time in 1996 in a resolution on the Revised Drug Strategy (RDS).
The WHA is the gathering of member states of WHO and the governing body
of WHO. It meets once a year.
Drug Strategy was formulated in 1985 and adopted by the WHA in 1986 (WHA39.27).
The RDS is a comprehensive policy to ensure equitable access to essential
drugs of acceptable quality and to promote the rational use of drugs.
It promotes the development of national drug policies and addresses all
stakeholders. The WHO member states have reaffirmed their commitment to
the RDS in a series of WHA resolutions and have made additions to the
RDS to enable WHO to address current pharmaceutical issues.
In 1996 the
WHA adopted a resolution on the RDS in which it requested the WHO's Director-General
'to report on the impact of the work of the World Trade Organisation (WTO)
with respect to national drug policies and essential drugs and make recommendations
for collaboration between the WTO and WHO.'
were again on the agenda of the WHA in 1998. A draft resolution on the
RDS proposed by the representative of Zimbabwe led to heated debate. The
US fiercely opposed the resolution and claimed that WHO had no role to
play in trade issues. The proposed resolution was not adopted and the
issue was referred back to the WHO Executive Board. A major stumbling
block was the proposed wording: 'urges Member States to ensure that public
health interests rather than commercial interest have 'primacy' in pharmaceutical
and health policies and to review their options under the TRIPS to safeguard
access to essential drugs'.
The 1999 WHA
adopted a revised resolution that strengthens the mandate of WHO in international
trade affairs and asks WHO to study the effects of international trade
regulation on health and to assist countries in implementing trade regulation
while addressing public health needs and priorities.9
On the surface
of it, the resolution may seem rather innocuous but it may have far-reaching
consequences. Following the adoption of the resolution, Gro Harlem Brundtland,
Director-General of WHO, said, 'When trade agreements affect health, WHO
must be involved from the beginning. We need to analyse and monitor how
new international agreements can support public health'. The spokesperson
for the South African minister of health said: '... health now
has a role in all international trade and finance
Agreement sets out minimum requirements. It also provides options to incorporate
provisions in national patent laws to ensure and increase access to drugs.
The RDS resolution gives WHO the mandate to assist countries in developing
or adjusting patent legislation in order to increase access to drugs and
protect public health. Examples of such options are parallel imports of
patented drugs and compulsory licensing.10
imports are cross-border trade in a product without the permission of
the manufacturer. It takes place when there are price differences for
the same product in different markets. For example, the price of Glaxo
Wellcome's AZT from international parallel importers varies from $124,95
to $53.50 per 250mg/40 cap. pack.11 A pricing study carried out by Health
Action International in 1995 shows the following prices for Smithkline
Beecham's Amoxicillan Amoxil: $8 in Pakistan, $14 in Canada, $16 in Italy,
$22 in New Zealand, $29 in the Philippines, $34 in Malaysia, $36 in the
USA, $40 in Indonesia and $60 in Germany.12 Malaysia could enjoy considerable
savings if it buys Amoxil in Pakistan.
is the global version of shopping around for the best value. It is permitted
under the TRIPS Agreements. Countries can decide whether they want to
restrict parallel imports for certain products. Many European countries
have significant parallel trade. Clearly it is not in the interest of
developing countries at this point to restrict parallel imports of pharmaceuticals.
licensing refer to when a legal authority, for example a court or a government,
grants a licence without permission from the patent holder. This may be
done on various grounds of general interest, including public health.
The patent holder receives an adequate remuneration. Compulsory licensing
is a legal option that is consistent with the TRIPS (Article 31). In many
countries compulsory licensing is part of the patent law. The French law,
for example, authorises compulsory licensing when patented drugs 'are
only made available to the public in insufficient quantities or quality
or at abnormally high prices'.
over compulsory licensing
of compulsory licensing for public health reasons warn of its harmful
effects on R&D for new medicines. According to an industry spokesperson,
compulsory licensing presents barriers to innovative treatments needed
by patients around the world.13 Harvey Bale, director of the International
Federation of Pharmaceutical Manufacturers Associations (IFPMA), wrote
to the e-mail list 'Treatment Access Forum': '... if anyone wants to kill
incentives for further research into a targeted disease area (e.g., AIDS),
then one of the quickest ways to do this is to institute a compulsory
licensing regime for drugs that treat that disease.'
has been under pressure from the US to repeal its draft medicines law
because it contains provisions for compulsory licensing and parallel import.
Through these provisions South Africa aims at increasing access to essential
drugs. South Africa has endorsed the TRIPS accord and the medicines law
is TRIPS-compliant. If South Africa ever issues a compulsory licence,
the US government could challenge the action before the WTO. This would
be a fairer course of events than bilateral pressures and trade sanctions.
The US foreign policy has led to a global campaign in which AIDS activists
from Africa, Asia and the USA join forces to oppose the US government's
policies. As a result the question of trade policies and access to life-saving
medicines is high on the political agenda in the US.14
and parallel imports are no panacea and will not be useful at all, or
not be useful in many situations or at a particular moment. Still these
options need to be maintained and protected. Many countries are under
tremendous pressure to remove provisions for compulsory licensing and
parallel import from their legislation or to not incorporate them in new
patent laws. WHO and the World Intellectual Property Organisation (WIPO)
should play a strong role in providing technical assistance and advocating
and protecting provisions in trade agreements that can be used to increase
access to essential drugs. Dr Michael Scholtz, executive director, pharmaceuticals
and medical technology at WHO, spoke the following encouraging words on
access to essential drugs in March 1999: 'It is our mandate given by the
WHA to assist Member States to implement TRIPS in consideration of public
health concerns. This includes provisions for compulsory licensing as
outlined in the agreement.'15
to drugs and commercial interests
greater access to drugs at lower prices affect commercial interests in
such a way that the future of drug development is at stake? To answer
this question, the following points need to be taken into consideration:
* In 2002 Africa will account for 1.3% of the entire world pharmaceutical
market. South-East Asia and China will account for 5%.16 These markets
are relatively unimportant from a commercial point of view. It is hard
to see how providing drugs - that were previously not purchased
- at lower cost can harm the commercial interests of the pharmaceutical
* The research and development costs for new drugs are high. However,
consistent and reliable figures on the cost of developing a new drug are
hard to come by. Estimates vary from $1.6 million - 4 million (NIH National
Cancer Institute estimates from 1988), $2.3 million (US government tax
credit office '94)17 to an estimate of $ 500 million by the IFPMA.18 The
truth is that information about the costs of developing a new drug is
shrouded in secrecy. Still, important policy decisions are made based
on unreliable data.
* Although the cost of R&D is high, so are the profits and returns
of the pharmaceutical industry. The pharmaceutical industry is one of
the most profitable in the world. In 1997 total sales increased by 11.5%
and accounted for $112.1 billion.19 The CEO of a UK-based drug company
received a pay package in 199920 that amounted to more than the public
spending on health in some least developed countries.
* Much of the real innovation is a result of extensive government efforts
and public funding. This is true for many of the anti-AIDS drugs such
as AZT, DDI and D4t.21
* Effective patent protection is a prerequisite for a successful, innovative
pharmaceutical industry. Patents are used to restrict access to innovations
in order to create economic incentives for R&D. But restrictions to
access must be reasonable and not create a situation where large sections
of a population are denied effective therapies.
for the future
more equitable access to essential drugs in a globalised economy, new
approaches are needed. Clearly, implementation of national drug policies
to increase the rational supply, quality and use of medicines remains
a basic instrument in public health policy. But national policies will
be increasingly influenced by international agreements and the international
approaches are therefore needed:
* International trade agreements should be humanised and should be subject
to health impact assessments. The protection of public health should have
primacy over commercial interests. Future review of the TRIPS Agreement
should seek to bring about an exceptional status for essential health
care products. WHO's input into understanding and implementing TRIPS should
be sought and its involvement in trade disputes with a health angle should
* Unilateral pressure on countries to adopt trade, patent or health legislation
that is not in the public interest and is not legally required should
* Public health policy should include strategies to ensure the development
of essential medical technology. Public policy should aim at shifting
the focus of commercial R&D to addressing real health needs and encourage
R&D for tropical diseases. National orphan drug policies should take
the needs in developing countries into account.
* Alternative methods of world-wide sharing of R&D costs should be
* The international community should take the responsibility to ensure
the production of essential medicines where the market fails to do so.
* Reliable cost data on the development of new drugs should be made public.
* Industrialised countries should develop policies to make government
invented drugs available to poor countries. WHO should spearhead a project
on developing an international agenda for essential medical research and
assess the impact of the WTO agreements on health, including access to
* WHO in cooperation with other UN agencies should consult with the academic
medical community, consumer groups, and a wide range of industry groups
to determine where compulsory licensing of medical technologies is needed
to overcome market failures.22
To take these recommendations further, a strong, broad-based global advocacy
movement for greater access to essential medicines, that includes WHO,
demand compulsory licensing of AIDS drug
governments debate proposals at international fora to promote equitable
access to essential medicines, the lives of the diseased come under
increasing threat with each passing moment in which they are unable
to obtain such access.
sheer urgency of the matter, especially in a country like Thailand
where an estimated one million people are infected with HIV, was
poignantly highlighted in December last year when about 100 protesters
set up camp outside the Thai Health Ministry calling on the government
to break a US firm's monopoly of the AIDS drug didanosine.
to a Reuters report by Sutin Wannabovorn ('Thais protest US firm's
AIDS drug monopoly'), the protesters demanded that the government
issue a compulsory licence to allow cheap local production of the
drug, which is produced and marketed by the US pharmaceutical giant,
with zidovudine (AZT), didanosine, also known as ddI, makes up an
anti-retroviral drug cocktail prescribed for HIV-infected Thais
to prolong their lives. While Thailand's Government Pharmaceutical
Organisation (GPO) began producing AZT in 1995 at about a fourth
the price of the imported version, campaigners say the drug-cocktail
treatment is still out of the reach of the vast majority of those
infected because of the high price of ddI.
Reuters report states that ddI costs about 49 baht ($1.25) per tablet
in Thailand, putting the monthly cost of the two-drug cocktail at
about 8,000 baht ($205) in a country where the minimum monthly wage
stands at 5,400 baht ($138). Activists say Bristol-Myers has offered
to cut ddI's price, but not to the extent local production would
eventually allow. While compulsory licensing would allow local production
on payment of a royalty, developing countries are wary of taking
this step for fear of trade retaliation by the US to protect the
interests of drug companies.
'DdI is the hope for those with HIV, but I don't think Thailand
will dare take the radical action in colliding head-on with the
United States because of the fear of trade retaliation,' said Saree
Aongsomwang of the Foundation for Consumers.
pressure groups, including the 1999 Nobel Peace Prize-winning aid
group Medecins Sans Frontieres (Doctors Without Borders), have been
urging Thailand to make a stand on the issue.
say Bangkok should be emboldened after US President Bill Clinton
pledged on World AIDS Day on 1 December last year, a change in US
trade policy to support greater worldwide access to life-saving
in the absence of measures to drastically lower the price of the
drug, the lives of poor patients hang by the thinnest of threads.
Paisal Tanhood, chairman of the HIV Infection Network, which has
more than 20,000 members: 'Only 5% of about one million people with
HIV have access to ddI because it's so expensive, so cutting the
price a bit is not a good solution for underprivileged people.'
is one of the 'underprivileged.' While his wife is using ddI for
free under a trial programme at a government hospital, the 34-year-old,
who was diagnosed HIV-positive eight years ago, is himself unable
to afford the drug.
to address trade and pharmaceuticals. Press release WHA/13. Geneva, Switzerland:
WHO 22 May 1999.
2 Scholtz M, Executive Director, Health Technology & Pharmaceuticals.
Presentation at the Meeting on Compulsory Licensing of Essential Medicines.
Geneva, 26 March 1999.
3 The World Health Report 1999. Making a Difference. Geneva, Switzerland:
4 Velasquez G, Madrid Y, Quick JD. Health reform and drug
financing. Selected topics. Health Economics and Drugs No.6. WHO Action
Programme on Essential Drugs. Geneva, Switzerland: WHO 1998.
5 Information provided by Richard Stern, Director of the Asociacion
Agua Buena in San Jose, Costa Rica by e-mail, 19 July 1999.
6 Pecoul B. Sleeping Sickness, After three years of negotiations.
Medicines Dossier. Paris, France: Medecins Sans Frontiéres 1999.
7 Pecoul B, Chirac P, Trouiller P, Pinel J. Access to Essential
Drugs in Poor Countries. A Lost Battle? JAMA. 1999; 281:361- 367.
8 Enrichir sa panoplie therapeutique. Bilan de l' annee 1998. La
revue Prescrire. 191;43:55. Janvier 1999.
9 Revised Drug Strategy. WHA52.19. 24 May 1999.
10 WHO has published key information for countries that are reviewing
their patent legislation: Globalization and Access to Drugs. Perspectives
on the WTO/TRIPS Agreement. Health Economics and Drugs DAP series No.
7 Revised. Geneva, Switzerland: World Health Organization 1999.
11 Pricing information from Informedica presented by James Love
at the Technical Briefing at the 52nd WHA, Geneva, May 1999.
12 Balasubramaniam K. Dr. retail drug prices in the Asia-Pacific
region. HAI News Number 86, December 1995.
13 Statement released by the IFPMA on the occasion of a meeting
on ‘Compulsory Licensing and Access to Essential Drugs', 26 March 1999.
14 Campaign over drug licensing to grow. Financial Times 29 March
15 For additional information about intellectual property rights
and health, visit: http://www.cptech.org/ip/health/
17 Love J. Call for more reliable costs data on clinical trials.
Marketletter, 13 January 1997.
18 The Question of Patents. The key to medical progress and industrial
development. '98 edition. Geneva, Switzerland. IFPMA: 1998.
19 IMS American Business Watch. May 1999.
20 Finch J. Record 93m package for boss of drugs firm. The Guardian
25 March 1999.
21 Mitsuya H, M.D., Weinhold K, Yarchoan R, M.D., Bolognesi D, Broder
S, M.D. Credit government scientists with developing anti-AIDS drugs.
Letter to the editor. New York Times, 29 September 1989.
22 This is in line with the 'Recommendations of the Trans Atlantic
Consumer Dialogue (TACD) http://tacd.org/meeting1/dialoguehtml#pharmaceuticals.
't Hoen is Coordinator, Globalisation Project of Medecins Sans Frontieres'
Access to Essential Medicines Campaign.
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