Réseau Pharmaceutique Œcuménique (EPN)

• News
• Fake Drugs
• Access to Medicines—PEPFAR and Generics
• Use of Medicines—Antibiotic Resistance
• Essential Drugs Monitor, No. 33
• HIV/AIDS
• Malaria
• Resources
• Indian NGO Website
• Drug and Therapeutic Committees - Training of Trainers
• Managing Drug Supply for Primary Health Care - Training Course
• Global Fund Procurement Policy

NEWS

Fake Drugs

According to WHO, up to 25% of medicines consumed in the developing world are counterfeit or substandard, but fake drugs are a lucrative market and the developed world also has problems. The US Food and Drug Administration (FDA) has released a report on counterfeit medicines in the US. It calls for more secure packaging, distribution, and tracking measures, stronger legislation and penalties, and better information gathering and sharing on the issue. The practice of buying cheap drugs over the internet is increasing the problem.
http://www.fda.gov/oc/initiatives/counterfeit/

In India, the government will consider a new bill to combat the problem of counterfeit drugs, based on recommendations from the Mashelkar Committee. The bill recommends the death penalty for those who threaten lives or cause serious harm through the manufacture or sale of counterfeit drugs, with a minimum sentence of 10 years in prison. The Committee also recommends the creation of a central drug administration to control licensing of all drugs.
http://cdsco.nic.in/html/Interim%20Report.htm

In China, the Shanghai Municipal Food and Drug Administration (SMFDA) has reached a memorandum of understanding (MoU) with Pfizer Inc, to more effectively detect and deter the presence of counterfeit drugs in Shanghai and its surrounding region. Pfizer will also help train government investigators.
http://www.china.org.cn/english/Life/96393.htm

Access to Medicines—PEPFAR and Generics
After implying that the WHO prequalification is not sufficient to guarantee quality and bioequivalence of fixed-dose combination anti-retrovirals, the US PEPFAR fund for HIV/AIDS treatment is now offering a way to allow recipients to procure generic drugs. A parallel US FDA approval process is to be set up to allow generic producers to apply for registration. However, this process, which may not be in place before September, will still take several months to complete and is estimated to cost US$100,000–US$500,000 in legal fees. It seems that it will still be very difficult for PEPFAR beneficiaries to procure generic FDCs.
http://lists.essential.org/pipermail/ip-health/2004-April/006336.html

Use of Medicines—Antibiotic Resistance
The Global Threat of Antibiotic Resistance seminar at the Dag Hammarskjöld Foundation, Uppsala, Sweden, provided a venue for the first steps towards creating a new worldwide movement to preserve effective antibiotic treatment for present and future generations. Over 50 percent of prescriptions for antibiotics are believed to be unnecessary and drug-resistant strains of bacteria are a very real and growing threat to global public health.
http://www.dhf.uu.se/abiotic_press_release.html

Essential Drugs Monitor, No. 33
News in this issue includes: a manual on starting and maintaining drug and therapeutics committees; a database on rational use of medicines, showing where surveys and interventions have been conducted; a special supplement on medicine prices, including the WHO/HAI medicine price database; a study tour in Moldova; and a report on “The quality of antimalarials: A study in selected African countries”.
http://www.who.int/medicines/library/monitor/33/mon33.shtml

HIV/AIDS

The South African government has announced AIDS treatment roll-out in 27 pilot sites in four of the nine provinces (1^st April 2004). The treatment programme has been promised since August 2003 and finally appears to be getting underway, despite bureaucratic objections and delays.
http://www.accessmed-msf.org/upload/PressClips/264200495092/lancet%20sa.pdf
http://allafrica.com/stories/200405210476.html

The Indian government has also launched a free AIDS treatment programme, but initially at only seven clinics and with very limited supplies of drugs. There are concerns that some AIDS sufferers may try to migrate towards clinics that they believe have supplies of drugs if there are any delays in rolling out the programme.
www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2004/04/02/MNGTO5VM9H1.DTL

Uganda has begun distributing free antiretroviral drugs to HIV-positive people, after an announcement by Minister of Health Jim Muhwezi. An estimated 100,000 of the 1.2 million HIV-positive Ugandans are in need of antiretroviral treatment, but as of December 2003 only 17,000 people had access to the drugs. Government price negotiations and generic versions of antiretroviral drugs have helped reduce the treatment costs from $1,500 per person per month, to $30 per person per month. Drugs are scheduled to be delivered to hospitals in June, as well as to selected private clinics, police, army and research centres. Funding from the GFATM and PEPFAR will help pay for the free drugs, with priority distribution to low-income people.
http://www.kaisernetwork.org/daily_reports/rep_hiv_recent_rep.cfm?dr_cat=1&show=yes&dr_DateTime=15-Jun-04#24202

AIDS drugs are now available in Kenya for Ksh500 ($6) per month, according to the head of the National Aids Control Programme (Nascop), Dr Kennedy Chebet.
The drugs are available in 17 health institutions – 12 government and five mission hospitals – spread across the country and selected on assessment of the percentage of the HIV/AIDS burden they carry.
The East African, Monday, June 14, 2004: http://www.nationmedia.com/eastafrican/current/Regional/Regional140620043.html

WHO has removed two antiretroviral products from the WHO List of prequalified products: Lamivudine 150mg blister pack of 10 tablets from Cipla Ltd, Kurkumbh, India, and Lamivudine 150mg plus Zidovudine 300mg blister pack of 10 tablets from Cipla Ltd, Vikhroli, India. The quality is not in question, but prequalification bioequivalence data originally accepted from Cipla have since been invalidated as the laboratory that carried out the testing has been assessed as not complying with Good Clinical Practices and Good Laboratory Practices. Cipla can resubmit new bioequivalence data.
http://www.who.int/mediacentre/statements/2004/statement_aidsprequal/en/

The international courier DHL announced on May 5th that it is to provide non-profit courier services to deliver antiretrovirals from Merck & Co in the Netherlands. Drugs will be delivered to treatment centres and distribution centres in Africa at a no-profit cost that will reflect the costs of shipping.
http://www.aidsmap.com/news/newsdisplay2.asp?newsId=2696

A new consortium, CUMVIVIUM (“live together in friendship”), has been formed from representatives of the Holy See, generic pharmaceutical companies, the International Federation of Catholic Pharmacies, and academics. CUMVIVIUM's goals are to facilitate access of affordable medicine and to remove all barriers that delay or prevent consumer healthcare, leveraging the international network of 128,000 Catholic health institutions.
http://www.essentialdrugs.org/edrug/archive/200405/msg00007.php

The Global Fund to Fight AIDS, Tuberculosis, and Malaria has stopped funding to three HIV/AIDS programmes in Ukraine. Nine months after approving grants worth $25 million over 2 years, only $740 000 has been spent and there has been no increase in the number of people receiving treatment. Funds will be diverted to another, as yet unnamed organization.
http://www.thelancet.com/journal/vol363/iss9408/full/llan.363.9408.news.28758.1

Drug users in Russia are being harassed by both the police and the government, worsening the HIV/AIDS crisis. Users are denied access to HIV/AIDS medication, methadone treatment to help them get rid of their drug habit is banned, and the fear of police arrest often keeps them away from clean needle exchange programmes, increasing the likelihood of infection and transmission.
http://www.aidsmap.com/news/newsdisplay2.asp?newsId=2679

Malaria

MSF has called for a more rapid and broader uptake of artemisin compound–based treatments (ACT) for malaria. ACTs have been available in Asia for ten years and are relatively new to Africa, but are proving very effective, with improved recovery times. However, action must also be taken now to avoid a global shortage of products.
http://www.accessmed-msf.org/prod/publications.asp?scntid=22420041138132&contenttype=PARA&

RESOURCES

Indian NGO Website
Community Development Medicinal Unit, West Bengal, India, an NGO engaged in the procurement and distribution of low cost essential medicines and medical supplies, has launched a website to provide range of information on essential drugs and rational therapeutics, including counterfeit medicine reports.
http://www.cdmubengal.org

Drug and Therapeutic Committees - Training of Trainers
Regional Training Course on Drug and Therapeutics Committees and Training of Trainers
August 29 to September 11, 2004
The Faculty of Medicine, Makerere University in Kampala, Uganda.

The course is organized by the Makerere University Faculty of Medicine, Uganda Ministry of Health, and Rational Pharmaceutical Management Plus (R P M Plus) Program of Management Sciences for Health (MSH) in collaboration with the WHO Department of Essential Drugs and Medicines Policy (WHO/EDM) and INRUD-Uganda. The course is supported by the U.S. Agency for International Development (USAID).
The course is designed for physicians, pharmacists, and health officials in hospitals, ministries of health, universities or private organizations, and those interested in improving formulary management and promoting rational use of drugs through drug and therapeutics committees (DTCs) and are in a position to provide training and technical assistance to other DTCs are invited to apply.
Applications and fees (2,200 USD, including accommodation and meals) are due no later than July 25, 2004 and there is a limit of 35 participants, so apply early. Please visit http://erc.msh.org/dtc, or email Dr. Paul Waako at pwaako@med.mak.ac.ug with copies to: Dr. Jasper Ogwal-Okeng at jogwal@utlonline.co.ug, Dr. Mohan P. Joshi at mjoshi@msh.org, and Sarah Paige at spaige@msh.org.

Managing Drug Supply for Primary Health Care - Training Course
Managing Drug Supply for Primary Health Care
October 18 - October 29, 2004
Amsterdam, The Netherlands

The course is organised by the World Health Organisation (WHO), International Dispensary Association (IDA), Le réseau Médicament et Développement (ReMeD), and Management Sciences for Health (MSH).
It aims to:

• Expose participants to modern management techniques of drug supply systems and to teach how to apply those in their own specific situation.
• Provide practical tools to decision-makers in essential drugs programs to improve their level of performance.
• Exchange views and experiences between senior decision-makers.

Applications and fees (3,500 EUR, including accommodation and meals) are due no later than August 15, 2004. Please visit http://www.ida.nl/en-us/content.aspx?cid=155 or email Ms Line Kreft at lkreft@ida.nl.

Global Fund Procurement Policy
The Global Fund has released the "Guide to Global Fund's Policies on Procurement and Supply Management". The guide is intended to clarify the policies to recipients of funds and their advisers. It will be followed by an accompanying document that will assist recipients and local funding agents to implement these guidelines. The document does not replace any existing guidelines, and should be used in conjunction with existing ones from WHO, MSH, etc.
http://www.theglobalfund.org/pdf/procurement_supply_management_policies.pdf