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

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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
WHO Drug Information Vol 20, No. 1, 2006Regulatory Action and NewsNew requirements forprescribing informationUnited States of America — The Food and DrugAdministration (FDA) is issuing final regulationsamending the content and format of prescribinginformation for human drug and biological products.The final rule revises the current regulationsto require that the prescribing information of newand recently approved products includes highlightsof the prescribing information and a table ofcontents for the full prescribing information.Requirements on the Content and Format ofLabelling for Human Prescription Drug andBiological Products, come into effect on 30 June2006.The goal is to provide more informative andaccessible prescribing information, resulting in abetter risk communication and management tool.These revisions will make it easier for healthcareprofessionals to access, read, and use prescribinginformation, and will enhance the safe andeffective use of prescription drug products.Reference: FDA News, P06-08. 18 January 2006. http://www.fda.gov/cder/regulatory/physLabel/default.htmPaediatric hepatitis A vaccineapproval extendedUnited States of America — The Food and DrugAdministration (FDA) has approved an applicationto allow use of the paediatric/adolescent formulationof hepatitis A vaccine, inactivated (Havrix ® )for persons 1—18 years of age. Previously,paediatric use of hepatitis A vaccine was approvedfor use in persons aged 2—18 years.The formulation, dosage, and schedule for Havrixhave not been changed. Each 0.5-mL dose ofpaediatric/adolescent the vaccine contains 720enzyme-linked immunosorbent assay units offormalin-inactivated hepatitis A viral antigenadsorbed onto aluminium hydroxide. The formulationcontains 0.5% 2–phenoxyethanol as apreservative.The primary vaccination schedule is unchangedand consists of 2 doses, administered on a 0, 6—12–month schedule. Hepatitis A vaccine iscontraindicated in persons with known hypersensitivityto any component of the vaccine.References1. Notice to Readers: FDA Approval of Havrix (HepatitisA Vaccine, Inactivated) for Persons Aged 1-18. MMWR:posted on line 12/22/20052. CDC. Prevention of hepatitis A through active orpassive immunization: recommendations of the AdvisoryCommittee on Immunization Practices (ACIP). Morbidityand Mortality Weekly Report, No. 48, (RR-12) 1999.Electronic individual case safetyreports: testing has begunUnited Kingdom — The Medicines andHealthcare Products Regulatory Agency (MHRA)is preparing the introduction of mandatoryelectronic transmission of an individual casesafety report (ICSR) between marketing authorizationholders (MAHs) and the MHRA.All MAHs will be required to successfully testelectronic transmission with the MHRA prior toswitching from paper to electronic reporting.Testing will be conducted within a dedicatedtesting environment at the MHRA. Paper reportingof real reports in fulfilment of reporting obligationsshould continue in parallel during the testingperiod. Once testing has been completed to thesatisfaction of the MHRA and the MAH, paperreporting can stop and electronic reporting of realreports can begin. It is not intended to have atransition period of parallel paper and electronicreporting of real reports.If an MAH has already successfully testedelectronic reporting with the EMEA Eudra-Vigilance system or intends to submit reports viathe EMEA EVWEB tool, then it is envisaged that atruncated testing process can be followed.Registering requests should be sent toICSRTesting@mhra.gsi.gov.uk26
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