Patent Environment To Complicate Further

BMI View : While generic competition has resulted in falling prices for antiretrovirals, developing countries continue to be challenged by patents that threaten to overwhelm their ability to purchase the newer and more costly antiretrovirals. As countries look to find ways to gain access to affordable medicines, multinational drugmakers may be faced with governments in emerging markets increasingly using TRIPS flexibilities, including pre-grant patent examination, third party oppositions and compulsory licences. This would further complicate the patent environment outside the developed states and hinder company return on research and development investment.

Highlighting the positive effects of generic competition on the prices of therapeutics for the treatment of HIV, according to a report published by the Medecins Sans Frontiers (MSF), the price of first- and second-line antiretrovirals (ARVs) to treat HIV are falling because of increased competition among generic producers.

  • The 'best possible' price of the World Health Organization (WHO) recommended one-pill-a-day first-line combination (TDF/3TC/EFV) of has fallen 68% in the last seven years (from USD426 to USD136 per person per year (ppy)), with some countries able to achieve even lower prices in large volume orders.

  • As new generic competitors have emerged, the prices of a key medicine (atazanavir/ritonavir) used in second-line treatment fell by 9.3% over the last year, with the most affordable second-line combination now priced at USD243 per year.

Still Too Pricy

Generic Competition = Falling Prices
The Evolution In Price Of Different First-Line ARV Regimens (USD per patient per year)

BMI View : While generic competition has resulted in falling prices for antiretrovirals, developing countries continue to be challenged by patents that threaten to overwhelm their ability to purchase the newer and more costly antiretrovirals. As countries look to find ways to gain access to affordable medicines, multinational drugmakers may be faced with governments in emerging markets increasingly using TRIPS flexibilities, including pre-grant patent examination, third party oppositions and compulsory licences. This would further complicate the patent environment outside the developed states and hinder company return on research and development investment.

Highlighting the positive effects of generic competition on the prices of therapeutics for the treatment of HIV, according to a report published by the Medecins Sans Frontiers (MSF), the price of first- and second-line antiretrovirals (ARVs) to treat HIV are falling because of increased competition among generic producers.

Generic Competition = Falling Prices
The Evolution In Price Of Different First-Line ARV Regimens (USD per patient per year)
  • The 'best possible' price of the World Health Organization (WHO) recommended one-pill-a-day first-line combination (TDF/3TC/EFV) of has fallen 68% in the last seven years (from USD426 to USD136 per person per year (ppy)), with some countries able to achieve even lower prices in large volume orders.

  • As new generic competitors have emerged, the prices of a key medicine (atazanavir/ritonavir) used in second-line treatment fell by 9.3% over the last year, with the most affordable second-line combination now priced at USD243 per year.

Still Too Pricy

While the cost of first- and most second-line regimens have fallen over the last 12 months and over a longer 7-year period, second-line regimens are still more than double the cost of first-line treatment, with some countries paying more than 12 times more than the lowest known price. As an example, Middle-income countries - especially those in Latin America - continue to pay high prices for lopinavir/ritonavir for use in second-line regimens, with Argentina (USD2,570 ppy) and Mexico (USD2,511 ppy) paying over 12 times more for LPV/r than South Africa (USD204 ppy).

A Wide Variation In Prices
2013: Price Per Patient Per Year Of LPV/R As A Component Of A Second-Line ARV Regimen (USD per patient per year)

Additionally, newer patent protected HIV medicines, such as integrase inhibitors, are much more expensive. The best possible price of a possible salvage regimen for people who have failed second-line treatment is USD2,006 per year in the poorest countries - nearly 15 times the price of first-line treatment and six times the price of second-line treatment. Middle-income countries pay even more. For raltegravir (which is the active ingredient in Merck's Isentress) - Argentina pays USD8,986 ppy, Peru USD5,463 ppy, Thailand USD4,676 ppy and South Africa USD617 ppy.

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Related sectors of this article: Pharmaceuticals & Healthcare
Geography: Global, Latin America, Argentina, Brazil, Canada, Chile, Mexico, Peru, United States
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