WHO Drug Information Vol. 20, No. 1, 2006 - World Health ...

WHO Drug Information Vol 20, No. 1, 2006Access to Medicinesto reproduce patented medicines, without compulsorylicensing. This is already the case of medicinessuch as second-line HIV treatments.Global efforts, such as WHO’s 3 by 5 Strategymay have helped to put more people on treatment,but it has also increased the need — asresistance inevitably develops — for a switch tosecond-line or third-line treatments. The genericcompetition that resulted in the price plunge forfirst-line antiretrovirals (ARV) does not yet existfor the second-line medicines. Current prices ofthe typical second-line treatments can be 6 to 12times higher than those of the older first-linemedicines. Governments and internationalorganizations will have to develop alternativestrategies to ensure the future sustainability ofARV treatment, particularly in low-income countries.Compulsory licensing to permit imports (andlocal production) of generic second-line ARVs isan obvious option to introduce market competitionand reduce prices.Third, the seemingly imminent avian flu pandemicdemonstrates that it is neither easy nor possibleto predict the future need for medicines, or thequantities in which they may be required. In theevent of another public health emergency orpandemic, countries will want to ensure theirability to obtain the necessary treatments insufficient quantities, at affordable prices. Theglobal debate about access to oseltamivir and theability of countries to fill national stockpiles haveraised questions about the need to ensuremultiple suppliers to guarantee availability andaffordability.The amendment proposing this solution isexpected to come into force 1 December 2007.WTO Members have set this deadline to have theamendment ratified by the required two-thirds ofthe membership. It would appear that this systemwill be the permanent solution to the Paragraph 6problem. WTO Members have been congratu-lated for their unprecedented decision to amendthe TRIPS Agreement, which demonstrates theirwillingness and flexibility to take concrete steps toimprove intellectual property rules to ensure theprimacy of health.References1. World Health Organization. Implementation of theWTO General Council Decision on Paragraph 6 of theDoha Declaration on the TRIPS Agreement and PublicHealth (2004). Health Economics and Drugs. EDMSeries No. 16.2. Médicins Sans Frontières. Untangling the web ofprice reductions: A pricing guide for the purchase ofARVs for developing countries. (2005) http://www.accessmed-msf.org/index.asp3. Sources and prices of selected medicines anddiagnostics for people living with HIV/AIDS at: http://www.who.int/medicines/4. World Health Organization. Implementation of theWTO General Council Decision on Paragraph 6 of theDoha Declaration on the TRIPS Agreement and PublicHealth, at: http://www.who.int/medicines/5. World Health Organization. Statement on the TRIPSAmendment for the WTO Ministerial Conference inHong Kong, 13–18 December 2005 at: http://www.who.int/medicines/areas/policy/WHO_Statement_Hong_Kong.pdf6. Will the TRIPS Amendment on compulsory licensingwork? Bridges Monthly Review, 10(1): 22 (2006) at:http://www.ictsd.org7. World Health Organization. Determining the patentstaus of essential medicines in developing countries.(2004). Health Economics and Drugs. EDM Series No.178. World Health Organization. Remuneration guidelinesfor non-voluntary use of a patent on medical technologies.(2005). Health Economics and Drugs. EDM SeriesNo. 1825