Novartis' attack against the Indian law is hardly exceptional. Large pharmaceutical companies and Northern nations are increasing their attacks, intended to reduce access to generic drugs in developing countries. Even the WHO is involved, explains pharmacist Sophie-Marie Scouflaire.
What do the attacks against generics involve?
Several strategies are being pursued to slow the production and sale of generic drugs.
Some countries have set up a mechanism to protect clinical trial data to slow the registration of generics. Manufacturers of generic drugs refer to this data regularly to obtain marketing authorization. When a data protection mechanism exists, manufacturers of generic versions no longer have access to them and cannot obtain marketing authorization during the protection period.
Bilateral and regional sales agreements are another technique. The United States has entered into such agreements with certain developing countries, like Morocco, requiring them to extend patents beyond the 20 years required by the WTO’s TRIPS agreements.
Other countries are subjected to intense pressure when they try to modify their intellectual property laws to reflect the flexibility that the TRIPS agreements provide. In 2001, in Kenya, civil society groups and local political leaders had to mobilize to promote passage of a law that would provide for the full flexibility provided by the TRIPS agreements. And last year, those same elected officials and organizations helped prevent legislators from adopting an amendment that would have abolished all the safeguards passed three years earlier. The pressure from the large pharmaceutical companies is on-going.
Even so, hasn’t Thailand just authorized the manufacture of a generic version of Kaletra, which is still under patent?
Thailand is one of the first countries to develop the local production of generic antiretroviral drugs to promote treatment of AIDS patients. On January 26, the Thai Ministry of Health issued a compulsory license authorizing its local industry to disregard the current patent on Kaletra in order to produce a generic version of the drug. This decision is key to making this second-line antiretroviral available at an affordable price.
However, as Thailand is an export-oriented country whose goods are intended primarily for the U.S. market, we are very concerned that the government will face reprisals in the form of trade sanctions. Even more surprising and troubling, Margaret Chan, the new director of the World Health Organization, has criticized Thailand’s decision. Rather than taking the position of the large pharmaceutical companies, she should be defending those countries moving to promote access to medications, as authorized by international agreements.
Several years ago, Thailand wanted to manufacture a generic version of Didanosine, a patented antiretroviral. Under pressure, the local industry ultimately produced powdered Didanosine, which is not patented but is considerably less practical to administer.
Returning to the issue of the Novartis lawsuit, what are the likely impacts of repealing Article 3 of the Indian patent law for a medical organization like MSF?
If Article 3 is repealed, we could end up in the same situation we faced six years ago, when we began treating AIDS patients in our projects. Generics didn’t yet exist then. The large pharmaceutical companies were not registering their ARVs in all countries because the market was not promising. In addition, companies’ prices varied based on certain conditions (including the country’s level of development and the prevalence of AIDS), which made it impossible for us to centralize our purchasing. It was a real headache, but when generics came on the scene, the problem was solved, as they were distributed at the same price in all the countries where we work.