Enforcing Doha

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In 2001, the World Trade Organization (WTO) approved the Doha Declaration, to address the conflict between corporate patents and the urgent need for access to medicines in the developing world.  The Declaration recognizes that intellectual property rights cannot trump “WTO members’ right to protect public health and, in particular, to promote access to medicines for all,” and gives nations the ability to determine when a health emergency requires placing human lives above corporate profits.

In one striking example, African trypanosomiasis, otherwise known as sleeping sickness, kills approximately 50,000 persons – primarily in rural sub-Saharan Africa – each year.  Until 1990, the only second-stage treatment, malarsoprol, was so toxic that the arsenic-containing drug itself killed nearly 8% of those who took it.

Enter eflornithine, a drug patented and produced by Avantis-Sanofi that is marketed in developed countries as a treatment for unsightly facial hair, but that also, in combination with nifurtimox, provides a highly effective treatment for second-stage West African trypanosomiasis (T.b. gambiense), and the related but less lethal American trypanosomiasis (T. cruzi), also known as Chagas Disease.

Availability of eflornithine remains limited and dependent upon Avantis-Sanofi, which stopped production completely during the period 1995-2001 due to lack of profitability.  Since 2001, due primarily to public relations concerns, Avantis-Sonofi has produced limited quantities in partnership with the WHO and Doctors Without Borders and in 2009 forged a new agreement with the Drugs for Neglected Diseases Initiative (DNDi) to donate eflornithine to reduce the burden of trypanosomiasis.

Nevertheless, production of an urgently needed drug remains subject to the corporate interests of a single for-profit company.

As long as brand pharmaceutical companies, rather than local governments and nonprofits, in cooperation with generic manufacturers, control production of urgently needed drugs, we will never be able to ensure that all global citizens have access to safe, effective primary health care.  The world community, including the United States and the EU, should immediately and fully implement the Doha Declaration, and simultaneously work to remove other obstacles to the prevention, treatment and eradication of neglected tropical diseases.

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5 Responses to “Enforcing Doha”

  1. chatcher Says:

    I think this is an excellent post, highlighting a critical issue in health care in developing countries. We experienced something similar this year in Burkina Faso, when they began seeing cases of serogroup X meningococcal meningitis, for which there is no existing vaccine. All we could do was hope the vaccines against the other serogroups provided some level of cross-protection. Even for diseases for which a vaccine or treatment is available, skyrocketing costs are prohibitive of governments implementing them without donor contribuitions. I agree that the global health care community has a responsibility to ensure that pharmaceuticals are produced with public health – and not profit – in mind.

  2. sbfhopkins Says:

    Thank you for raising a very important issue. I agree that the interests of a single company should not trump the public health. It is clear that we need a better system in place to ensure that disadvantaged populations can have access to the medications they need. However, I am curious as to how we structure a system that does not remove the incentive for companies to develop medications to treat neglected tropical diseases and disadvantaged populations. It is a challenge as it is to get pharma companies to develop and manufacture treatments in these areas as it is but if we remove all ability for them to make a profit I am concerned that there will be no incentive. Although I would like to see companies making strategic decisions based solely on altruistic motives, the reality is that for-profit companies must make a profit to be responsive to their boards and their investors. How do you recommend that we continue to address this unmet need in developing countries (and often in the US) for low-cost pharmaceuticals without pushing for-profit companies out of the business of developing these products and into the more lucerative business of me too drugs and wrinkle creams and hair loss?

    • hopkinsblogger Says:

      @ sbfhopkins:

      Thank you for sharing your perspective. While I understand your point regarding the need for innovation in pharmaceutical treatments, I believe that whether there are patent protections or not will have little effect on whether pharmaceutical companies conduct more research aimed specifically at the treatment of neglected tropical diseases. This is because persons afflicted with neglected tropical diseases are overwhelmingly developing world residents of low SES who would not have the resources to pay for brand medicines in any event, so there is little profit motivation to conduct research – patent protected or not.

      My understanding is that most medicines currently used to treat neglected tropical diseases were originally researched for another purpose. For example eflornithine was originally developed by Aventis-Sanofi as a possible treatment for cancer. Similarly, ivermectin, used to treat onchocerciasis, is marketed by Merck in the United States primarily as Heartgard for dogs.

      My post was not aimed at promoting additional research on neglected tropical diseases, which I think is also an excellent topic warranting attention, but on steps we can take to ensure that, when an effective treatment for a disease is discovered, persons in urgent need of the treatment have access to it.

      I think that your argument is much more salient in the context of diseases such as HIV that affect both the developed and the developing world, and for which pharmaceutical companies conduct research specifically aimed at developing treatments for these diseases. Personally, I still do not accept the argument that providing access to generics in the developing world to prevent the spread of HIV is going to hinder research – after all, generic HIV drugs are currently being produced in Brazil and India and this has not, to my knowledge, halted research on additional treatments in the US. I know that there are differences of opinion on this point, however, and, if you are interested, the US and EU member states made arguments similar to yours in opposing the adoption of Doha.

      Thanks very much for responding!

  3. sbfhopkins Says:

    I wasn’t quite finished when I accidentally hit “submit” and now I can’t figure out how to edit… that last part should read “hair loss products.” Sorry for the typos and the poor format in my comment!

    I just wanted to reiterate that I agree entirely with the premise that we need to provide low-cost medications to people who need them. I am just wondering whether we need to admit that for-profit companies will not fulfill this critical unmet need and therefore, we must put more pressure on governments and the non-profit sector to work to fill this public health role. Or perhaps there is another way that we can align the industry’s incentives better so that they are eager to work to meet this public health need.

    I would be very interested in hearing any other creative solutions that folks might have in response to this very difficult ethical question.

  4. itan2 Says:

    Thank you for posting this; this is one impediment in working towards providing better health care in the developing countries. This problem ranges from total lack of supply because pharmaceutical companies stopped the production; to the use of inferior older generation drugs with established adverse effects in the developing countries (eg HIV medication – stavudine; medications for chronic hepatitis). More pressing problem is making drugs available; at an affordable cost. Patents is here to stay to allow pharmaceutical companies to continue to invest in R&D. The Doha Declaration; though in place for the last 10 years; has not been invoked often enough to ease the medication shortage problem in the developing countries. The government; together with WTO, and NGOs may apply more pressure on the the pharmaceuticals to address this. To make it truly effective, the world should come together to endorse the Doha Declaration.

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