The Effects of Generic Competition
Sample AIDS triple-combination: lowest world prices per patient per year
(stavudine (d4T) lamivudine (3TC) nevirapine)Click on image for full size
Southern Sudan: A "refugee-like" situation?
Over the last two years, the MSF Access to Essential Medicines Campaign has moved beyond debate to achieve a number of successes that are of real benefit to patients. Production has been restarted or secured for several drugs to treat sleeping sickness. Prices for AIDS drugs have fallen dramatically. Landmark legislation has been passed or affirmed in Kenya and South Africa, making access to certain medicines more likely for some of the world's poorest. Yet, for many people suffering from diseases common in developing countries, accessible treatment options are still out of reach or do not exist.
Production of sleeping
sickness drugs secured
A key accomplishment has been the secured production of medicines for sleeping sickness, a painful disease that threatens 60 million people in sub-Saharan Africa. Just two years ago, production of four out of the five drugs needed to treat the disease had either been abandoned or was on the verge of being stopped. Today, because of public pressure, producers Aventis and Bayer will donate enough of the drugs to the World Health Organization (WHO) to meet global needs for the next five years and have committed to looking for long-term solutions. MSF will support this project by assessing needs and storing and distributing the medicines.
The two companies will also donate funds to support the WHO's programs for disease control and research. There is still much to be done. Donors, governments, and NGOs must all find new resources to commit to the struggle, and well-planned operational research is still needed to develop simplified treatment protocols. But getting the drugs back into production was a vital first step - it brought hope to a situation that appeared desperately gloomy just a year ago.
Patients with multi-drug resistant tuberculosis lie in an isolated ward in Prison Colony ##16 in Novokuznets, Siberia. Patients are still treated with drugs discovered 40 years ago.
AIDS drug price cuts bring
treatment closer to reality
The quest for affordable AIDS drugs in developing countries - and the debate about treatment versus prevention - has dominated the global agenda over the last year.
At the international AIDS conference in Durban, South Africa, in summer 2000, MSF's assertion that the price of triple-combination antiretroviral therapy could fall to as low as US$200 per patient per year was met with widespread disbelief. Today, that price is within reach (see graph).
Various Indian generic manufacturers have offered triple-combinations for as low as $250-$350. The prices offered by proprietary companies also fell dramatically, from $10,000 a year ago to $700-$1,000 in August 2001.
These lower drug prices have led to greater drug access for people with AIDS in Uganda, Senegal, and Cote d'Ivoire, and have also allowed Botswana and Nigeria to launch large-scale AIDS treatment programs. But, although generic competition has forced prices down, only a fraction of all people needing life-extending therapy are receiving it. Now national governments need to focus their energies on getting treatment to more people. There is still an urgent need for the international community to help subsidize developing country efforts.
Prices have fallen not only for AIDS drugs, but also for malaria treatments. The recent agreement announced between the World Health Organization and Novartis for a price reduction on Coartem®, a new antimalarial combination treatment, is a step in the right direction. It is important now to extend these types of price cuts to new antibiotics, vaccines, and diagnostic tests.
Medicines are not Barbie dolls or CDs,
but a matter of life and death
Yet competition and voluntary price cuts from companies are not a reliable foundation on which to build access to medicines. To solidify and extend the gains of the past two years, real policy changes are necessary. Here, too, progress has been made.
In the area of trade and patent protection, there is growing recognition that the TRIPS Agreement (the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights) should be interpreted to ensure that it protects public health. Medicines are not Barbie dolls or CDs. They are a matter of life and death for millions of people; therefore, patent protection needs to be flexible. Patents, a cornerstone of intellectual property law, should benefit not only the innovator, but also those who need access to the innovation.
The TRIPS Agreement sets out minimum standards for patent protection all WTO members must abide by. It also includes rules to counter the negative effects of patent protection. The critical factor is determining the balance between these two elements on a practical level.
TRIPS already contains safeguards that can and should be used to promote access to medicines. These can be understood through a few examples. Azithromycin is an antibiotic used to treat respiratory and sexually transmitted infections, among the most highly prevalent diseases in developing countries.
In Kenya, azithromycin is patented by the pharmaceutical company Pfizer and marketed under the trade name Zithromax®. The Kenyan trade price per 250mg capsule of Zithromax® was US$2.02 in October 2001. In India, where pharmaceutical products are not covered by patents, many generic manufacturers market azithromycin. Because of this competition, the Indian retail price for Pfizer's Zithromax® is much lower than Kenya's trade price: US$0.84 in March 2001 - 2.4 times cheaper.
The TRIPS Agreement allows for parallel imports, enabling countries to obtain patented medicines at the lowest price available on the world market. If Kenya were to use this mechanism to import India's cheaper Zithromax®, more than twice as many people could be treated on the same budget.
However, despite the existence of safeguards, many developing countries are pressured into not implementing them. This is why MSF is calling for not only clarification of some of the articles in TRIPS, but also a clear affirmation by WTO members that nothing in TRIPS can stand in the way of public health.
The passage of a pro-public health Industrial Property Bill in Kenya and the capitulation of 39 drug companies in their widely publicized lawsuit against the South African government in April 2001 were signs of hope for other developing countries wanting to make use of such safeguards (see following page for more on the South Africa case).
Prevention versus treatment:
the false dichotomy
Until recently, treatment for AIDS was not considered cost effective. Today, political leaders from both developing and donor countries, as well as key leaders at the United Nations, are speaking of the inextricable relationship between prevention and treatment. MSF firmly believes that treatment is fundamental to stemming the spread of the AIDS epidemic.
MSF's experience with AIDS programs shows that medical interventions, such as providing antiretrovirals to treat AIDS patients directly or to prevent mother-to-child transmission of the disease, cause the dynamics in communities to change. When we have something to offer people who are infected with HIV, they begin to seek out voluntary counseling and testing - and this drives more effective prevention efforts.
As of October 2001, we are offering antiretroviral treatment to patients in Malawi, South Africa, Guatemala, Cameroon, Thailand, and Cambodia, with similar programs planned for several other countries as well. Antiretrovirals are used to prevent mother-to-child transmission of HIV in Malawi, South Africa, Ukraine, Uganda, El Salvador, and Kenya. It is important to show that these types of treatment programs can work for people living in developing countries. Effective medicines cannot be reserved only for the rich.
Report reveals empty pipeline
When medicines are more affordable and accessible, when countries can make use of existing safeguards in international law, treatment will still only be possible if effective drugs exist. Unfortunately, research and development (R&D) for new drugs for many diseases has come to a standstill. In September 2001, MSF sought to stimulate debate and action in this area with the publication of a report, "Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases."
The report is the result of two years' work by the Drugs for Neglected Diseases Working Group, a group of independent experts from developed and developing countries convened by MSF in 1999 to study the R&D problem.
"Fatal Imbalance" revealed that the pipeline for drugs for the diseases of the poor - the "neglected" and "most neglected" diseases that primarily affect people in developing countries - is nearly empty. Out of the 11 respondents to a survey of the world's top 20 pharmaceutical companies, eight spent nothing for R&D for drugs to treat sleeping sickness, leishmaniasis, or Chagas disease, all diseases that exclusively touch people in poor countries.
None of the 11 companies has brought a product to market for these three diseases in the last five years, and only two have done so for malaria. The report also showed how government inaction and changing public research priorities are compounding this crisis.
To respond to this crisis, MSF has made several recommendations: among them, that a well-defined and needs-driven research agenda be established at a global level; that governments become directly and proactively involved in the search for solutions; that increased and long-term funding be secured for R&D into neglected diseases; and that a new not-for-profit enterprise be explored as one way to address the shortage of R&D for the most neglected diseases.
The political environment for the discussion of access to medicines has begun to change, with the issue now a part of the international health agenda. Practical successes have brought clear hope to some patients. Yet, after two years of intense campaigning, it is clear that much work remains to be done to translate these successes into lasting solutions.
For the full text of "Fatal Imbalance," as well as additional information on all the topics mentioned here, go to
www.accessmed-msf.org or www.msf.org.