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Intellectual Property and Access to AIDS Drugs

Pharmaceutical companies agree that developing nations facing a national health emergency have the right under World Trade Organization rules to manufacture and import generic versions of AIDS drugs. In many countries, such a waiver is unnecessary. AIDS medicines are not under patent in most African countries, so governments there are free to import or manufacture generic versions. A number of pharmaceutical companies also are offering AIDS medicines to developing nations at greatly reduced costs or, in some instances, for free.

Social, political and economic conditions are the real hurdles to drug access and quality care in impoverished nations. "[T]he extreme dearth of international aid finance, rather than patents, is most to blame for the lack of antiretroviral treatment in Africa," Professor Amir Attaran of Harvard's Kennedy School of Government and attorney Lee Gillespie-White of the DC-based International Intellectual Property Institute concluded in a study published in the Journal of the American Medical Association (JAMA) in October 2001.

Nevertheless, some observers continue to argue that patents are driving up prices and keeping needed drugs out of Africa and the rest of the developing world. In fact, empirical data show patents are not a barrier to drug access.

JAMA Study by Attaran and Gillespie-White

Patents on AIDS medicines form only a very small obstacle to treatment in Africa, the Attaran and Gillespie-White study concluded, because very few antiretrovirals are covered by patents in Africa.

For the study, Professor Attaran and attorney Gillespie-White surveyed the patent status of 15 A RVs in 53 African countries between October 2000 and March 2001. Their hypothesis was that if that patent protection were really the barrier to treatment, one could expect to find that most medicines are under patent in most African nations. With the exception of South Africa, the survey found the opposite was true.

  • In 25 percent of the 53 African countries surveyed, no ARVs are covered by patents.
  • In the rest, an average of only four of the 15 ARVs are under patent; in 26 African nations, patents cover 4 or less.
  • There was not a single country where all ARVs were under patent.
  • Other than South Africa, no country has more than 8 ARVs under patent.

Across the continent, a total of 172 ARV patents existed, less than a quarter of the 759 potential patents that could exist, given the number of drugs (15) and countries involved (53).

Where there is no patent on an AIDS drug, there are no legal barriers to using generic versions of AIDS drugs or manufacturing generic versions locally. Nevertheless, there is almost no treatment of AIDS patients with ARVs in these African nations.

Survey of Patients on Other Infectious Disease Medicines

Similarly, a PhRMA survey of its member companies shows low levels of patent protection for drugs for other infectious diseases (as of August 1, 2001). The medicines surveyed are used to treat opportunistic infections (OI) associated with HIV/AIDS; tuberculosis; malaria; trypanosomiasis (sleeping sickness); and diarrheal diseases.

  • OI Treatments: 27 drugs available.
    - In two out of three countries surveyed, no OI treatments are under patent
    - There's not one country where all OI drugs are under patent

  • Tuberculosis (TB): 11 drugs available.
    - In 94 percent of the countries surveyed, no TB drugs are under patent
    - There's not one country where all TB drugs are under patent

  • Malaria: 13 drugs available.
    - In 94 percent of the countries surveyed, no malaria drugs are under patent
    - There's not one country where all malaria drugs are under patent

  • Trypanosomiasis: four drugs available.
    - None of the trypanosomiasis drugs are under patent

  • Diarrheal Diseases: three drugs available.
    - None of the diarrheal treatments are under patent

    Final Analysis

    Weakening international patent rules would not help AIDS victims. Erosion of the patent system will only lead to lessened innovation of the new drugs needed to treat diseases. Criticisms of drug patents deflect attention from the real barriers to health care‹poverty, inadequate infrastructure, flawed health systems, cultural barriers and lack of political will.

    01/07/2003


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