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It could allow the generic manufacture or import of Kadcyla without the permission of Roche, subject to affordable compensation for the company.
The government has been considering allowing the generic manufacture of a number of patented drugs to give India's 1.2 billion people access to affordable medicines, putting it at odds with Western pharmaceutical companies.
For example, generic manufacture of efavirenz API has fallen from US$1,100 to US$130/kg over this period.
These include differential pricing (charging more in high-income countries) and voluntary licensing (allowing third-party generic manufacture).
These price estimates are based on the previous experience with production of ARVs for HIV treatment, which assumes market competition through generic manufacture.
The current reductions in the cost of anti-retroviral therapy (Eg. due to generic manufacture) may enable high levels of anti-retroviral use to be achieved in many Asian countries.
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This innovative work offers a broader intelligence picture and is contributing to the identification of newly discovered falsified antimalarial medicines, including WHO-prequalified generic manufactured products.
The authors found that the number of AE reports processed by generic manufactures was much lower than expected based on market share and the number of events attributable to specific generic enoxaparin products was approximately ninefold lower than expected [ 26].
As a "Least Developed Country", Rwanda in 2008 became the first country to take advantage of the World Trade Organization WTOO) amendment to the TRIPS (Trade Related aspects of Intellectual Property) Agreement [ 19], when it awarded a tender to the Canadian generic manufacturer Apotex to manufacture the triple combination AIDS drug "Apo Triavir" on its behalf.
"In appropriate circumstances, pharmaceutical patent holders should award voluntary licenses to generic manufacturers who agree to manufacture and supply medicines to poor, developing countries," the group wrote.
Data exclusivity is a period when a patent holder may withhold test data from generic manufacturers thereby constraining the ability to manufacture it (although this may be voluntary for developing countries) [ 127, 128].
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