Health Action International



Number 121

HAI News reports on the developments in national and international campaigns
on health for all. This newsletter highlights activities of network contacts
involved in improving access to medicines, rational drug use and poverty eradication.

HAI news is produced by HAI Asia-Pacific Coordinating Office

Editors: Kiran Sagoo, K Bala & Passanna Gunasekera
Layout: Audrey Khoo. Web version: Sadara


 

Contents of this issue

Leading Article:   Healthcare - who cares? by K. Balasubramaniam
(also in PDF format and Word 6.0/95 format)
NetworkNews:    
  International   NGOs focus on Doha implementation
New English language section to Wemos website
NGO events at the 55th World Health Assembly
Roundup from the 55th World Health Assembly - by Alan Cassels
  Europe  

Netherlands: Dutch Health Inspectorate’s plan to stop monitoring pharmaceutical advertising and marketing practices criticized
France: Declaration for action to improve access

  Asia-Pacific  

Serendipitous move

JournalScan   More open procedure announced for the Model List
WHO unveils ARV quality list
Controlling rabies
Antimicrobial Resistance: A Global Response
Effectiveness of community health financing in meeting the cost of illness
Resources   Understanding factors that influence antibiotic use
WHO posts drug pricing information
'Codes in context: TNC regulation in an era of dialogues and partnerships' by Judith Richter
'Medical supplies and equipment for primary health care: a practical resource for procurement and management' by Manjit Kaur and Sarah Hall
'Connecting pre-marketing clinical research and medical practice: The case of cardiovascular drugs' by Nicolien Wieringa
Low income countries pay 70% of their TB bill
     
    Quotable quotes
    HAI calendar
    Contacts

The editors thank Qaseem Chowdhury, Lisa Hayes, Manjith Kaur, Judith Richter, Ellen Verheul and Nicolien Wieringa for their contributions to this issue.





International

 

NGOs focus on Doha implementation

In March, Médecins Sans Frontières (MSF), Consumer Project on Technology (CPT), Oxfam and Health Action International (HAI) co-organised a one-day conference on effective implementation of the Doha Declaration and public health technical assistance. Although the Declaration affirmed governments’ right to take necessary measures to ensure public health, the NGOs believed it gave an ambiguous map to all of the possibilities existing in the TRIPS agreement, including compulsory licensing and parallel importing. The meeting focused on the technical assistance to be provided by various stakeholders including the World Intellectual Property Organization (WIPO), the World Trade Organization (WTO), the UN Conference on Trade and Development (UNCTAD) and the World Health Organization (WHO). The speakers and the day’s discussion took stock of the progress already made and put forward recommendations to help countries benefit from the commitments made in the Doha Declaration.

A report about the meeting is now available from the HAI website at:
   http://www.haiweb.org/campaign/access/International_access.html

 

New English language section to Wemos website

Wemos has announced a new English language section to its website. To reach it, look for the language icon at the right hand corner of the homepage. Click here to go directly to this part of the site.

 

NGO events at the 55th World Health Assembly

People’s Health Movement

On the invitation of the World Health Organization, the Peoples Health Movement presented the People’s Charter for Health in a technical briefing session organized by the WHO-Civil Society Initiative. The briefing on the Charter was one of six technical briefings at the World Health Assembly 13-18 May 2002.

This technical briefing on the Peoples Health Charter was chaired by Dr. Manuel Dayrit, the Secretary of Health of Philippines. Senior officials of WHO, which included Dr.Gro Harlem Bruntland, Director-General of WHO and Dr. David Nabarro, Executive Director, Office of the Director-General, attended the session. Dr. Brundtland welcomed the group and presented WHO’s key concerns and her interest in Civil Society partnerships.The background of the PHA mobilization and key elements and concern of the Charter were presented. Post PHM concerns and initiatives from Latin America, Africa and Europe were also shared.

The briefing session put forward five key messages to WHO, and highlighted 14 specific action points, as listed in the box below:

Call the World Health Organisation

Be a strong advocate for poverty eradication, eg:

  • Greater equality (in WTO/WB/IMF)
  • Debt cancellation (in WB/IMF)
  • Fairer trade (in WTO/TRIPS)
  • Poverty and Health Commission (WHO & PHM)

Promote comprehensive approaches, eg:

  • Avoid vertical wholly technological initiatives (eg. GAVI)
  • Ensure greater intersectorality (like THAI-BMN)
  • Involve community and people's organisations in 'evidence and action'

Strengthen public sector for health

  • No evidence that privatisation leads to equity
  • Prevent agenda setting by corporate interests (be like Tobacco Free Initiative not Roll Back Malaria)

Involve people's organisations in WHO work, eg:

  • At national levels (WRs)
  • At regional levels (WHO Regional Offices)
  • At WHO level (beyond Civil Society Initiative) and WHA

Promote more participatory, relevant transparent policy processes and planning, eg:

  • From 'DOTS' to 'Community Oriented TB Services (COTS)'
  • From micronutrients to 'food'

Source: Technical Briefing by PHM at WHA, May 2002

Throughout the week, the PHM lobby team was active in various activities. At the NGO Forum for Health session titled ‘Partnership for Action in Health’, the People’s Charter for Health was presented as an alternative approach to health. Health for All and Comprehensive Primary Health Care were upheld as the fundamental principles which should guide international health policy. Concern was raised on the ability of WHO to respond to the forces of globalisation, in terms of analyzing the health impact of global economic change and in terms of the role of WHO in relation to other global institutions such as WTO, the World Bank and International Monetary Fund. Issues were also raised on the need for caution in classifying not for profit NGOs and civic society in the same group as ‘for profit – private sector’ in public-private initiatives.

Throughout the week, contacts were made with individuals and organizations, and a symbolic gathering of participants was held in the centre of Geneva. A seven member team met Dr. Peter Piot, Executive Director UNAIDS and some of his colleagues to understand the concerns and initiatives of UNAIDS and share concerns and suggestions of movement on the HIV/AIDS problem in their own countries and regions.

WHO’s Medicines Strategy

NGO STATEMENT MADE AT THE 55th WORLD HEALTH ASSEMBLY

I am speaking on behalf of Consumers International, Health Action International, Medecins sans Frontieres, Oxfam, and Save the Children Fund, U.K.

Thank you for this opportunity to address the Committee.

During her speech to the Assembly the Director General stated that the WHO has come a long way in making essential medicines accessible to a much larger number than we could have envisaged even only three years ago. We praise the progress so far and agree with her that there is much more to do.

We believe that access to basic healthcare is a fundamental human right and that unhindered access to essential medicines is an important component of this right. We are pleased to see that WHO has led a number of important developments recently in improving global access to medicines, particularly in the provision of drug price information data, the pre-qualification process for medicines, and the recent revision to WHO’s model list of essential medicines. This revised process promises to be more independent, transparent, evidence-based and more useable for member states. We are particularly pleased that the high cost of drugs is no longer a barrier for inclusion in the Essential Medicines List.

In the 109th Session of the WHO Executive Board in January this year we heard many board members praise the Doha declaration which states unequivocally that the agreement "can and should be implemented in a manner supportive of WTO members’ right to protect public health and, in particular to promote access to medicines for all".

In this light, we believe that the WHO should remain fully engaged in health and access to medicines issues, as these issues are too important to be left to the World Trade Organization and the World Intellectual Property Organization who do not have health as a central part of their mandate. WHO should therefore step up and take a leadership role by providing technical assistance to member states on how to put health first when implementing intellectual property legislation.

A particular opportunity to assert WHO leadership is at the TRIPS Council in June when the Council discusses the export issue related to compulsory licensing. WHO should support the developing countries’ call for exceptions to allow export of essential medicines produced under compulsory licensing to other countries, which may not have production capacity themselves.

We were pleased to see that 10 antiretroviral drugs were added to the core essential medicines list, however drug prices, particularly antiretrovirals, are still too high. Again we urge WHO to help countries bring down prices by stimulating competition (through compulsory licensing or parallel imports) or working towards unrestricted systematic differential pricing policies.

In March we were heartened to see WHO release its first list of pre-qualified AIDS drugs including patented and generic medicines. Of part of this standard-setting role, we urge the WHO to expand its pre-qualification work to drugs for malaria, tuberculosis and other major infectious diseases and urge Member States to increase financial support for these efforts and to make use of the information.

We are particularly concerned with the trend towards so-called partnerships with commercial entities which may jeopardise WHO’s independence. We urge WHO to analyse the health and social outcomes and sustainability of these initiatives in an open and transparent manner. Further, the status of WHO’s guidelines to address potential conflict-of-interest issues associated with interactions with the private sector is unclear, as is the progress made in WHO’s work in addressing conflict-of-interest in general. We urge WHO to accelerate these efforts and to actively involve civil society in the process.

Thank you Mr. Chairmain for this opportunity to address the Committee on these important issues.

Poverty reduction strategies and health: actors and rôles

WHO and Save the Children, United Kingdom, in collaboration with Medact and Wemos organised a seminar to discuss ways to strengthen the integration of health in Poverty Reduction Strategies. The session was chaired by Ms. Malayah Harper, Senior Adviser Health Systems, Department for International Development, United Kingdom.

Four speakers, representing the government, international and national NGOs, donors and WHO’s perspective put forward their views. Among issues raised were the relevance and consistency of suggested strategies in Poverty Reduction Strategy Papers (PRSP) and the lack of transparency and monitoring mechanisms. A number of contradictions also existed at the global level that needs to be resolved. First, the PRSP approach aims to put ownership in the hands of developing countries and promotes a comprehensive approach to development policy. The new global initiatives (GAHF, GAVI, etc.) on the other hand, are tightly controlled by donors and are selective in their approach, dealing with a limited number of diseases.

The impact of economic policies on health is also neglected in PRSPs. For example, no attention is paid to the impact of trade policies at household level. There is an urgent need for more analysis and for donors to be more consistent and coherent in their policies. In this light, the recent disestablishment of the Health and Development department of WHO, with the implication of less staff and effort devoted to work on poverty and health, is worrying. WHO’s new strategic unit needs to be equipped with solid knowledge on health in poverty reduction.

The process is currently dominated by the Ministry of Finance, with limited civil society involvement. Ministers of Health do not have a strong role. WHO is needed to provide technical support to governments and civil society, for example on understanding the links between health and economic policies, including trade. Clear suggestions for an agenda for the WHO country offices, include:

  • providing technical support in health sector analysis, developing pro-poor goals and indicators, and costing of interventions
  • advocating for health and build bridges between ministries of health and other sectors, international organisations, civil society
  • providing long-term support, building on positive experiences
  • having a leading role in donor coordination, including accommodating the new global initiatives to country needs

What should WHO do? The global efforts to politicise health and put it on the development agenda still need to feed through to the country level. WHO should use its convening power and bring together key actors for health at the national level. People working at country level need be better equipped, for example, to engage with Ministries of Finance. WHO could help countries to deal with complex realities, in which for example PRSPs and global initiatives are developed at the same time. How to link them up? It is clear that both horizontal and vertical programmes are needed in health systems. Furthermore, WHO can assist in decisions about investments in health and in health systems and monitoring progress in achieving the Millennium Development Goals. A core business for WHO is to support countries to access international funds, which is time-consuming. A lot of work is needed in terms of preparing guidelines for country work on PRSPs, essential drugs, trade and health.

Instead of having a separate poverty department which risks being sidelined, WHO aims to mainstream this work and facilitate institutional ways of working on poverty reduction.

"The richest 1 percent of the world's people received as much income as the poorest 57 percent..."


Roundup from the 55th World Health Assembly - by Alan Cassels

All four regions of the HAI network participated in the 55th Assembly held in Geneva last May. As part of the Consumers International delegation, the team focused on three priority issues: WHO’s medicines strategy; access to essential medicines; and public-private initiatives.

Background

The last WHO Executive Board meeting in January 2002 was dominated by a lively discussion on the essential drugs strategy and resulted in the preparation of a consensual text which was adopted (resolution EB109.R17).

The key parts of this resolution were recommendations to the World Health Assembly to:

  • Strengthen the Expert Committee on the use of essential drugs
  • Consider the impact of trade agreements on access to medicines
  • Advocate for promotion of differential pricing for essential medicines and
  • Continue work developing methodologies for gathering data on drug prices.

HAI and other public health advocacy groups at the meeting were able to draw upon the international agreements accepted at the WTO Ministerial Conference in Doha November 2001. The most relevant document from that meeting, the Doha Declaration, carries a powerful public health message that places public health firmly before the interests of the multinational pharmaceutical manufacturers. On the essential drugs list (EDL) issue, HAI was concerned that a concerted effort would be made to weaken and change the finalised EDL revision process. The resulting process and the revised list (which included 10 antiretrovirals) turned out to be quite acceptable from a public health standpoint. Since WHO’s medicines policy was the team’s top agenda item for this WHA, it used this opportunity to continue to make the case for improving access to essential medicines.

In preparation for the WHA, HAI, in conjunction with Médecins Sans Frontières (MSF), Voluntary Services Overseas (VSO), Save the Children UK and Oxfam issued a briefing paper entitled “Drug Policy at the 55th World Health Assembly: Ensuring Accessibility of Essential Medicines”. HAI Europe published this briefing paper in English, French and Spanish for use at the meeting. It was sent to all HAI regional distribution lists, announced on various electronic list servs and sent to media contacts. During the Assembly, it was used to lobby country delegations taking part in the meeting and handed out freely to the press.

Dr. Gilbert Buckle from Ghana delivered the team’s statement on the “WHO Medicine’s Strategy” on behalf of HAI/CI/Oxfam/MSF/Save the Children UK. In it, he urged WHO to take a stronger leadership role in helping member states increase and sustain access to needed drugs. (See also WHO Medicine’s Strategy, above.)

WHO’s Medicines Policy: Improving and sustaining access to essential medicines

During her speech to the Assembly the Director General stated that WHO has come a long way in making essential medicines accessible to a “much larger number than we could have envisaged even only three years ago.” Doha is probably the single most important event that has made this happen. The spirit of Doha is found in the main resolution on the access issue (WHA A55.14) which spells out in clear terms its intent to be “supportive of the rights of countries to protect public health and, in particular, to promote access to medicines for all.”

The main resolution of interest on access (WHA A55.14) was largely uncontested. It appears that the US’s interest in amending it was squashed from the outset by Brazil’s threat to meet any proposal from the US with strong counter amendments. This resulted in an agreement not to propose any changes to the medicines resolution and it was eventually passed as written without last-minute changes. Some amendments concerning pricing, generics and trade issues appeared in the resolutions on the sustainable development summit and on WHO’s millennium development goals but these were not controversial.

The positions of most countries on the medicines strategy came as no surprise, given that much of what was said was presented in earlier debates, in particular on the Global Fund and on HIV/AIDS. The essential medicines debate saw, in all, 26 countries and two non-governmental organisations (CI/HAI and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA)) speak on the issue.

As usual, the strongest positions could be sorted along the lines of developed versus developing countries—with the developing countries being most vocal in defending pro-public health positions. Brazil, South Africa, Thailand, Columbia and India presented the strongest statements, and in general praised the WHO’s involvement in expanding access to anti-retroviral therapy (ARV) and urging the WHO to defend public health in WTO agreements. The USA, Japan, Spain (representing the EU) Canada, Australia and the IFPMA emphasised the need for strong patent protection and otherwise had a number of contrary opinions concerning access, as described below.

WHO and the private sector

The area in which HAI saw the least amount of progress at the 55th WHA was on the issue of public-private initiatives (PPIs). The debate about WHO's growing collaboration with the private sector was a topic for discussion for a workshop with Judith Richter (consultant on the politics of health). She participated in an NGO Forum for Health Symposium 14 May 2002 with the presentation “’Partnerships’ between UN agencies and the commercial sector?: Some critical questions.”

PPIs have been and continue to be a primary focus for HAI during the WHA and the EB as voluntary ‘partnerships’ continue to grow in prominence. This is especially apparent in light of two major initiatives involving the private sector (GAVI and GAIN).

The GAIN Initiative (Global Alliance for Improved Nutrition) was recently launched and consists of collaborations with groups such as Nestle and Heinz, companies that continue to violate the WHO Guidelines on marketing of breast milk substitutes. The Director General and her staff continue to stress the term 'partnership' and other than a few NGOs, groups working with HAI and the breastfeeding advocates, few others seem to be questioning the fundamentals of this ‘new’ way of doing business. There is growing concern about WHO's increasing dependence on the private sector and the strong possibilities for conflict of interest which accompany that dependence.

About the team

The HAI lobby team at the 55th Assembly came from the four regions and many countries. The group helped shape HAI’s official lobbying points before the start of the Assembly, and cooperated in the drafting of its statement and press items. Group members attended briefing sessions on priority issues, brought out country concerns and ensured that country delegates were aware of the joint access briefing paper. The team was a very involved and motivated group that cooperated efficiently. The HAI Europe office would like to thank all of the team members for taking part in this important event and contributing to its success.

(This article was written by Alan Cassels, the WHA team’s communications director.)

 


Europe

 

Netherlands: Dutch Health Inspectorate’s plan to stop monitoring pharmaceutical advertising and marketing practices criticized


At a time when the pharmaceutical industry has never been more powerful and wealthy, HAI Europe strongly criticized the Dutch Inspector General's decision to close its sector that monitors illegal and unethical marketing practices within the drug industry.

"We are extremely concerned about the consequences of this decision," said Margaret Ewen, Co-director of HAI Europe and an expert on drug promotion. "Time and again this sector has had the courage to challenge drug companies' unethical marketing practices aimed at both health professionals and consumers."

HAI Europe believes the need for the sector is growing, not shrinking. In such countries as the United States, the need for monitoring the drug industry is clear. This year alone the US Food and Drug Administration has already sent out 20 warning letters to drug companies about their marketing practices.

The fact that the Inspector General believes that pharmaceutical marketing poses little threat to the public's health is alarming, says HAI Europe. Unethical and inappropriate marketing of medicines means that health professionals and sometimes consumers receive biased information about a drug. Research shows this can lead to irrational prescribing and use. National health budgets can also be strained when heavily marketed drugs are over-prescribed.

During the past few years, HAI Europe's members and other public health advocates have applauded the Inspectorate's groundbreaking work to bring a number of important test cases about direct-to-consumer advertising to court, despite strong pressure from the industry. The Dutch government has shown commitment to enforce the current European Union's ban on direct-to-consumer advertising. This appears to have been a principal reason to pursue these cases. Although recent cases have been decided in favour of the industry, the sector's work is crucial to keep any kind of balance in the system.

HAI-Europe believes the Inspector General's proposal to dismantle the pharmaceutical monitoring sector could also have serious consequences for other EU countries. While the Netherlands has been a leader in enforcing laws against inappropriate marketing of medicines in recent years, this decision will send a message to other Ministries of Health that governments no longer need to make this area a priority. The network believes that the sector's shutdown will also suggest that the industry can monitor itself. "However, evidence shows that self-regulation simply does not work," said Ewen.

 

France: Declaration for action to improve access


Participants at a meeting held at the invitation of the French Ministry of Foreign Affairs and with the support of UNAIDS and WHO ended a year-long consultative process on access issues involving 155 experts from 27 countries and 57 national and international organizations. The result is the declaration: Framework for action to improve access in developing countries. The group ReMeD which coordinated the year-long process now hopes to circulate the declaration to all international and national partners working on HIV/AIDS so that they can promote its endorsement by appropriate fora, governments and interested organizations.

To read and sign the declaration, visit: http://www.remed.org/declaration.



Asia-Pacific

 

Serendipitous move

HAI was founded at the International NGO Seminar on Pharmaceuticals, organized by Consumers International (formerly known as International Organization of Consumer Union IOCU), Buko-Pharma and Social Audit, in Geneva, 27 – 29 May 1981.

The following recommendations were adopted by the seminar:

  • There should be a coordinating framework for the groups committed to social action on pharmaceuticals.There would be no legal structure, with the basic functioning unit being the individual groups that belong to this network. The name for the network shall be Health Action International.
  • The network shall have a clearing-house. The IOCU Regional office for Asia & Pacific (IOCU ROAP) agreed to serve as the clearinghouse for HAI. The clearing- house should not attempt to collect everything but should develop a network of information resource centres working in the area of pharmaceuticals.
  • The network shall have a newsletter. This will be prepared by the clearing-house at IOCU ROAP, and it would act as a simple and cheap means of information sharing within the network.

HAI, an informal global network, consists of NGOs and individuals from around the globe as network partners.

The need for an informal network to bring together all HAI partners in Asia – Pacific was first thought of during an Asian Workshop entitled “Pharmaceuticals and the Poor” in December, 1985.

Following on a recommendation of this workshop, Mr Anwar Fazal, Director of the International Organization of Consumers Unions Regional office for Asia and Pacific (1975-1991) and Dr Prem Chandran John, Co-coordinator of the Asian Community Health Action Network (ACHAN) convened a planning meeting in Penang, Malayisa in March 1986 to set up an Asian Drug Campaign.

The following five NGOs were invited to the planning meeting:

  • Gonshasthraya Kendra (GK) Bangladesh
  • All India Drug Action Network (AIDAN) India
  • Health Action Information Network (HAIN) Philippines
  • Gamasaviya, Sri Lanka and
  • Drug Study Group (DSG) Thailand

This meeting founded Action for Rational Drugs in Asia (ARDA) network, which would function as the Asian arm of the HAI network. IOCU ROAP and ACHAN were identified as the coordinators for this network, with the coordinating centre being based in Penang, Malaysia hosted by IOCU ROAP. A Consultative Committee was elected to function as an advisory body to ARDA.

The objectives of the ARDA network were to campaign for:

  • Adoption by governments in the region of National Drug Policies based on the concept of Essential Drugs
  • Increasing prescriber and consumer awareness on concept of Essential Drugs
  • Initiating changes to undergraduate medical / pharmacy curriculum in order to introduce concepts of essential drugs and rational drug use.

The meeting recommended that ARDA Review and Planning Meetings be held biannually to review the work done and plan for the future. The first ARDA Review and Planning Meeting was hosted by the Drug Study Group in Bangkok April 1987. One of the recommendations at this meeting was that ARDA should plan for a Peoples Health Assembly (PHA) to bring Primary Health Care back into international focus and make Health for All a reality. GK volunteered to host the Assembly. ARDA and GK kept this collective dream alive. In collaboration with six NGOs, ARDA set up a PHA secretariat in Penang in October 1998 and GK hosted a very successful Peoples Health Assembly in December 2000.

One of the major achievements of ARDA has been the forging of a new level of partnership among our network partners, academicians, media and health ministry officials in the Asia-Pacific regions. These partnerships were established during the following meetings:

  1. International Consultation on Rational Drug Use in Undergraduate Medical and Pharmacy Education, August 13-18 1988. Manilla, Philippines. Senior medical & pharmacy educators from about 15 countries joined ARDA partners. They set up an informal network called Educators for Rational Drug Use (ERDU). The main objective was to develop and introduce curricular changes in undergraduate medical and pharmacy education designed to promote rational and economic use of drugs.
  2. International workshop on Consumer Health & Drug Information & Education, August 12-16, 1990 in Penang, Malaysia. Media representatives from about 15 countries in the region participated. The participants agreed that at country levels, network partners, academicians and media personnel will join together to provide health & drug information in the mass media to consumers.
  3. ARDA organized an Asia-Pacific workshop on Pharmaceuticals for Health Ministry officials in Colombo, Sri Lanka in June 1992. The governments of Australia, Bangladesh, Brunei Darussalam, Fiji, Lao PDR, Malaysia, Marshall Islands, Myanmar, Nepal, Philippines, Sri Lanka, Thailand, Vietnam and West Samoa sent senior drug regulatory officials. One of the recommendations was that an electronic bulletin be set up to enable drug regulatory officials in the region to share drugs information.
    This recommendation was reiterated again at the Asia-Pacific Regional Consultation on sharing of drug information in Penang, Malaysia on 14-16 April 1997 organized by ARDA in collaboration with WHO . Based on the mandate, the National Poison Centre in Universiti Sains, Malaysia (USM), Penang in collaboration with ARDA set up an electronic bulletin board. This electronic bulletin board is now regulated by the WHO Collaborating Centre for Drug Information in USM, Penang.

Other achievements include the following:

  1. ARDA network partners in several countries of the region are regularly invited by Health ministries to meetings to discuss health & drug policies. They also sit in several committees.
  2. Several harmful drugs have been withdrawn from the market in countries of the region.
  3. Several countries have developed national drug policies and lists of essential drugs.
  4. Daily newspapers in English & the respective national languages in many countries of the region give wide coverage and report on national network partners’ activities and those of the ARDA network.
  5. An external evaluation of ARDA was carried out in 1995. The evaluation was positive about the need for ARDA, its role in Asia-Pacific and the achievements of the objectives it had set for itself in relation to the time, monetary and human resources available. ARDA was advised to expand membership, work with more network partners and go beyond pharmaceuticals into other issues related to health.
    During the last few years there have been informal discussions among some network partners & the ARDA Consultative Committee on restructuring HAI.
    In 2001, ARDA Consultative Committee decided to relocate ARDA out of CI ROAP and set it up as an independent NGO with its own legal entity.

The first Planning Meeting of the Advisory Group of ARDA/HAIAP was held in Colombo, Sri Lanka 18-20, February 2002. The ARDA Consultative Committee nominated the following seven to the Advisory Group. Dr Prem John and Dr Anwar Fazal, the two conveners of the Planning Meeting in Penang, March 1986 which founded ARDA and who have been associated very closely with ARDA; representatives of the five NGOs which participated in the same planning meeting in March 1986 which founded ARDA. They were:

  • Dr Zafrullah Chowdhurry - Gonoshasthaya Kendra – Bangladesh
  • Dr Mira Shiva - All India Drug Action Network
  • Dr Joel Fernando - Gamasaviya - Sri Lanka
  • Dr Edelina de La Paz - Health Action Information Network – Philippines
  • Dr Niyada Angsulee - Drug Study Group - Thailand

The meeting discussed mechanisms for setting up a democratic governing structure, membership structure, policy making and fundraising. The meeting also identified issues of priority for the network, which included impact of globalization on health and drug policies, monitoring marketing practices of the pharmaceutical industry, undertaking campaigns on rational drug use, developing relevant tools, research in the area of poverty, traditional medicine and strengthening and expansion of the network. The coordinating centre will build on its earlier work in the area of implementing national drug policies, increasing prescriber’s awareness and consumer education on rational drug use.

The Planning Meeting arrived at the following conclusions:

  • In line with the other three co-coordinating centres, the office in Asia-Pacific should be registered under the name of HAI Asia – Pacific to provide uniformity in the name of all the four coordinating offices.
  • Set up an Interim Management Board (IMB).The IMB will be the policy making body and provide support to the HAIAP office until a Governing Council is elected at the First Review and Planning Meeting of HAIAP.

HAI-AP will continue the on going work on campaigning for rational and economic use of drugs and take up new issues in the area of poverty & health and traditional medicines.

 


HAI CALENDAR

Pharmacovigilance & The Study of Adverse Drug Reactions Training Course
Canberra, Australia
4-15 November 2002

Contact :
WHO-UMC at TGA Training Course
Adverse Drug Reactions Unit
P O Box 100
Woden ACT 2606, Australia
T: +61 2 6232 8292
F: +61 2 6232 8180/ + 61 2 62328392
E: adrac@health.gov.au

Promoting Rational Drug Use In The Community
Rose Garden Hotel, Bangkok, Thailand
3-16 November 2002

Contact :
Ms Trudie Gerrits/Ms Annelies Dijkstra
Oudezijds Achterburgwal 185
1012 DK Amsterdam
The Netherlands
T: +31 20 5252670
F: +31 20 5253010
E: prduc@pscw.uva.nl




 

 

More open procedure announced for the Model List

In April, WHO convened an expert committee to draft its 12th model list of essential drugs. Directly before the meeting, it held an “open day” to present its new procedure for determining which drugs will be placed on the model list. The process includes reviewing evidence and carrying out a pharmaco-economic review of the proposed drug. The drugs are also compared with existing essential drugs and must be shown to have comparative advantage. The process now aims to be more transparent than in the past. Representatives from civil society and other stakeholders can comment on the proposed drugs and some comments are now available on the WHO Essential Drugs and other Medicines website: http://www.who.int/medicines). More drugs should be added shortly. The complete set of expert papers can be reviewed at: http://www.who.int/medicines/organization/par/edl/expertcomm.shtml. The current model list is also available on the EDM site.

 

WHO unveils ARV quality list


After much anticipation, WHO has released quality data on generic and other antiretrovirals and related medicines used to treat HIV. In total, eleven ARVs and five drugs used to treat opportunistic infections have been deemed to meet WHO’s recommended standards of quality and good manufacturing practices. WHO has called the list a new effort that could make treatment services more accessible in poor countries. “The project demonstrates the vital contributions research-based and generic companies can make to innovation, quality and access to life-saving medicines,” said WHO’s Director-General, Gro Harlem Brundtland.

The pilot project is seen as part of the UN-wide strategy to increase access to essential medicines. The process has been co-ordinated by WHO but calls on the expertise within UNICEF, UNAIDS and is supported by the UN Population Fund and the World Bank. (The complete list of drugs can be found by clicking here.)

This list is just the first step in a process that will keep adding drugs and suppliers that meet the standards. More than 100 products are still under review. The release of the list has caused controversy among the pharmaceutical industry as it lends legitimacy to generics without regard for patent rights. Products on the list are approved for purchase by UN agencies. “We did not look at patent status’ in evaluating the drug list” said Jonathan Quick, director of WHO’s Essential Drugs and other Medicines Unit “Patents are a national issue. If the drug was legal and registered in the country producing it, that was the entry ticket.”

 

Controlling rabies

Compared with AIDS, tuberculosis, and malaria, rabies receives relatively little coverage. Rabies is an incurable disease that continues to kill about 35000 people every year. Rabies retains the dubious distinction of being the infectious disease with the highest case-fatality ratio. Mammalian hosts of the rabies virus occur on every continent except Antarctica, but rabid dogs still pose the greatest hazard to human beings. Rupprecht and colleagues note that rabies can be controlled in vector animals through parenteral immunization or the distribution of vaccine-laden baits for free-living species. Tools exist to make a significant impact on this fatal disease.

Source: The Lancet (click here for the article).

Antimicrobial Resistance: A Global Response

The ability of microorganisms to become resistant to the major therapies used against them has long been recognized and is becoming increasingly apparent. Increasing antimicrobial resistance (AMR) presents a major threat to public health because it reduces the effectiveness of antimicrobial treatment, leading to increased morbidity, mortality, and health care expenditure. For example, the mortality rate in outbreaks involving resistant strains of Salmonella spp. was found to be 3.4%, whereas it was only 0.2% in those involving sensitive strains. In 1995 the cost of containing an outbreak of infection caused by methicillin-resistant S.aureus in a district general hospital in the United Kingdom was estimated to exceed US$560 000, while the annual health care cost associated with the treatment of resistant infections in the USA was estimated at over US$4 billion, an amount recently revised to more than US$7 billion. AMR is the cause of professional, governmental, and public concern and has been classified as a national security risk in the USA.

The rate of development of AMR is accelerated by the use and misuse of antimicrobials. The factors responsible include over-the-counter availability of antimicrobials without professional controls, the use of drugs of low potency and effectiveness as a result of poor manufacture or counterfeiting, and the availability of drugs from roadside stalls and hawkers who have little or no knowledge of dosage regimens, indications or contraindications. Containment of AMR thus requires a range of strategies. AMR is a global problem. Globalization increases the vulnerability of countries to imported diseases, and infectious diseases travel faster and further than ever before. During the 1990s, for example, a resistant Pneumococcus sp. first identified in Spain was rapidly found in Argentina, Brazil, Chile, China (Province of Taiwan),Columbia, Malaysia, Mexico, the Philippines, Republic of Korea, South Africa, Thailand, USA, and Uruguay. No country acting on its own can adequately protect the health of its population against AMR. International collective action is essential, yet responsibility for health remains predominantly national. Consequently, there is a potentially significant disparity between the problems and solutions associated with AMR and the institutions and mechanisms available to deal with them.

The global nature of AMR calls for a global response. The following key activities should be undertaken by international bodies in order to encourage and promote international collective action.

Raising the profile and priority of AMR in countries. In order to secure international cooperation it is necessary to obtain national recognition of the problem that AMR presents, the interdependence of countries, and the impact and responsibility that each country has in relation to global health. This is a prerequisite for effective global collective action.

Establishment and maintenance of global AMR surveillance data to which countries contribute and have access. An important first step is the specification and coordination of international standards in laboratory susceptibility testing techniques.

Promoting standardization of research methods, coordinating research activities and disseminating information. International agencies could act as repositories for information from countries on current research projects and on the implementation and evaluation of strategies for tackling AMR.

Source: Bulletin of the World Health Organization 2002, 80 (2), pg 126 – 133

 

Effectiveness of community health financing in meeting the cost of illness

One of the world ’s most urgent problems is financing and providing health care for the 1.3 billion poor people who live in low-and middle-income countries. Many poor people lack access to effective and affordable drugs and to surgery and other interventions, largely because of weaknesses in the financing and delivery of health care. Although 93% of the global burden of disease falls on 84%of the world’s poor, only 11% of global health spending (US$2800 billion) occurs in low-and middle-income countries. For years, many low-and middle-income countries have tried to leapfrog the developmental process needed to expand risk protection to universal coverage. The preferred mechanism for this has been to design and implement traditional public
financing instruments, such as general revenues and social insurance. Few have succeeded in this approach .Estimates of the expenditure gap to achieving universal access to health
services at low income levels through such public financing mechanisms range from US$25 –50 billion to over US$100 billion. In this context, community financing, notwithstanding its shortcomings, is often the only viable option for providing some financial protection and access to basic health services for the poor.

Role of communities
Discouraged by the inability of governments to reach rural populations and people engaged in the informal sector, communities have increasingly been mobilizing themselves to secure financial protection against the cost of illness for excluded population groups. A range of health financing instruments has emerged over the past decade, including microinsurance, community health funds, mutual health organizations, rural health insurance, revolving drugs funds, and community involvement in user-fee management. Their common feature is the active involvement of the community in revenue collection, pooling, resource allocation and, frequently, service provision. There has been an increasing awareness of the links between social capital, i.e. community, network, institutional and societal links and a range of development outcomes.

Source : Health care financing for rural and low-income populations : the role of communities in resource mobilization and risk sharing – http://www.cmhealth.org/wg 3.htm.



"Policy not charity will determine whether new technologies become a tool for human development everywhere."

"Development is about expanding the choices people have to lead lives that they value."

"Technology is created is response to market pressures not the needs of poor people who have little purchasing power."

Source: Human Development Report 2001


 

Understanding factors that influence antibiotic use

While antibiotics play a major role in fighting diseases with a bacterial origin, their overuse has led to a steady increase in drug resistance. A new review authored by Aryanti Radyowijati and Hilbrand Haak has gathered information from scientific studies on the factors that influence the use of these drugs by health providers, dispensers and community members in developing countries. It suggests that the factors involve a complex mixture of medical, psychosocial, cultural, economic and political factors. In its conclusion, the report calls for concerted action against the problem by governments, public and private institutions and medical leaders in order to change the way antibiotics are used.

The report can be downloaded from: http://www.childhealthresearch.org/doc/AMR_vol4.pdf or http://dcc2.bumc.bu.edu/richardl/ih820/Resource_materials/amr_vol4.pdf

 

WHO posts drug pricing information

WHO’s Essential Drugs and Medicines Department has published a summary of drug price information services designed to show readers what WHO is doing to improve drug price information. The summary includes international price information services. You can download the information from: http://www.who.int/medicines/organization/par/ipc/drugpriceinfo.shtml

 

'Codes in context: TNC regulation in an era of dialogues and partnerships'
By Judith Richter
Corner House Briefing no. 26

As corporations have expanded beyond their national borders, it has become harder for individual countries to protect public interests through national regulation alone.

However, instead of international legislation, industry self-regulation or co-regulation is often seen as the best way to set global rules. This briefing paper challenges the effectiveness of such voluntary approaches.

Using the case study of the baby food industry, it raises crucial questions about efforts to make multinationals publicly accountable at a time when dialogues and partnerships are often considered the best way to interact with them.

Copies of the briefing paper can be obtained in various formats by sending an e-mail message to The Corner House at: cornerhouse@gn.apc.org

 

'Medical supplies and equipment for primary health care: a practical resource for procurement and management'
By Manjit Kaur and Sarah Hall (2001)
Published by ECHO International Health Services, Ltd

Drugs, medical supplies and equipment have a significant impact on the quality of patient care and account for a high proportion of health care costs. Health services need to make the right choices about what to buy in order to meet priority health needs and avoid wasting limited resources.

Many organizations have produced useful information about essential drugs, but less information is available about essential medical supplies and equipment. Despite the fact that there is a much wider range of different brands and items to choose from, selecting supplies and equipment is often given little attention. This can result in procurement of items that are inappropriate because they are technically unsuitable, incompatible with existing equipment, because spare parts and consumables are not available, or because staff have not been trained to use them.

To address this situation, ECHO has produced this guide to medical supplies and equipment for primary health care. The manual is intended to be a practical resource for those responsible for procurement and management of medical supplies and equipment at primary health care level. It includes guiding principles for selecting supplies and equipment, provides guidelines for ordering and procurement, storage and stock control, and care and maintenance, and considers safe disposal of medical waste. The manual also discusses the use of standard lists as a tool for encouraging good procurement practice and includes model lists of medical supplies and equipment and essential drugs required for primary health care activities in health facilities and in the community as well as for basic laboratory facilities.

Although the manual is mainly intended for primary health care level, it will also be a useful resource for those responsible at national and district levels for health planning and management, training, and managing medical stores.

The publication is available from the ECHO website at: http://www.echohealth.org.uk. A single, free copy is available to organizations in the South. Additional copies or copies for international organizations cost £7.50 (plus postage) and can be obtained from ECHO International Health Services, Ullswater Crescent, Coulsdon, Surrey, CR5 2HR, United Kingdom or by contacting e-mail: cs@echohealth.org.uk.

 

'Connecting pre-marketing clinical research and medical practice: The case of cardiovascular drugs'
By Nicolien Wieringa
Doctoral thesis published by the University of Groningen

Before new drugs are approved for marketing and doctors can prescribe them to patients, their efficacy and safety are carefully studied. An important part of this process is the clinical trials that test the new drug against a placebo or other drugs. Clinical trials are conducted in different types of populations. However, the exclusion of elderly and female patients, patients from ethnic minorities and those with other illnesses or using other medications is often justified by the need for homogenous trial populations. This reduces the applicability of trial results to medical practice, where large variations between patients exist. This gap poses a problem to doctors, pharmacists and patients who want the right drug to be prescribed, delivered and used by the right patient at the right time and in the right dosage. Other actors involved in health care are affected by this problem too, the government, health care insurers and pharmaceutical companies.

The gap between clinical research and medical practice, in particular regarding new drugs, is the central theme of this thesis. Today there are few empirical studies focusing on the differences between populations in clinical trials and in daily practice using new drugs. This study was designed to investigate the nature and size of the demographic and disease-related differences between patients in pre-marketing research and medical practice. Cardiovascular drugs were chosen because they are widely used, by both younger and older patients, of whom the latter often present with co-morbidity and co-medication. The study also investigates the gap between clinical research and medical practice from the perspective of medical practitioners.

A number of changes regarding drug regulation are suggested to improve the connection between pre-marketing clinical research and medical research. These changes refer to the standards applied to drug regulation and the organization of that process. The thesis argues that issues which are relevant to medical practice, in particular variability in drug responses and demonstration of clinical effectiveness, should become core issues in drug regulation.

Copies of the thesis can be obtained by contacting the author: e-mail: nwieringa@cvz.nl or by writing to her at: N. Wieringa, Hoendiepskade 14, 9718 BE Groningen, The Netherlands.

 

Low income countries pay 70% of their TB bill

A strategy that can cure up to 90% of all tuberculosis cases, and thus is the best chance for controlling the global TB epidemic , is reaching only 27% of the world’s TB patients.

Public health officials estimate that $ 1 billion a year will be needed to treat patients and control the TB epidemic in 22 countries that now account for 80% of the world’s TB burden. Surprisingly, WHO found that the governments of these 22 low-income nations are already paying 70% of the cost of TB treatment and control.

The goals set for TB are that by 2005, 70% of the all active infectious TB cases will be diagnosed and 85% will be successfully treated. This requires a regular supply of drugs, equipped labs and trained health professionals, while all of this is expensive, even the poorest countries are financing the bulk of TB costs themselves.

Even so, this still leaves a gap of $ 300 million a year: about 30 cents a year for each person in the industrialized world. This shortfall has slowed the rate of expanding diagnosing and treatment services. According to the new WHO report, at the current rate, TB targets set for 2005 will not be reached until 2013.

Source: Press release WHO/21 22 March 2002

Information available from WHO Report 2002: Global Tuberculosis Control http://www.who.int/gtb/publications/globreo02/index.html

 


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