Contents of this issue

When Industry Ignores Need:

The international campaign to get essential medicines to those who need them

By Lisa Hayes & Bas van der Heide*

Building on last issue’s cover story on HIV/AIDS: Improving Access to Essential Drugs, this article focuses on HAI’s activities in the International Campaign on Access to Essential Medicines.

Today 33.5 million people are living with HIV/AIDS. [i] HIV/AIDS has become the leading cause of death in sub-Saharan Africa. The health epidemic invading Africa has such repercussions for the political and economic future of the continent that it was recently the focus of a United Nations Security Council debate, the first time a health catastrophe has had this dubious honour. It has turned 11 million children into orphans  (90% of them in Africa) and has dramatically affected other parts of the world as well. For example, the number of people in the Newly Independent States living with HIV/AIDS has doubled just within the last two years. And today more than six million Asians are infected with the virus too.[ii]

At the same time, improving access to medical treatment for those living with HIV/AIDS in poorer countries has remained a low priority for the developed world. As WHO Director-General Dr Gro Harlem Brundtland recently stated“"Treatment in developed countries has led to a dramatic fall in deaths due to AIDS. But in Africa many people have no access to palliative medicines, let alone antiretroviral therapies or drugs for treating opportunistic infections. Squarely put: the drugs are in the North and the disease is in the South. This kind of inequity cannot continue."[iii]

Of course, gaining access to medicines is only one crucial part of a complex equation resulting in the provision of quality primary health care. Other elements such as providing skilled health care workers, developing and maintaining an infrastructure to deliver health care services and sustaining the political will to make it a priority remain essential. However, those that argue that access is a non-issue simply because some countries lack well-developed health care systems, oversimplify the issue.

HAI’s commitment to access

Promoting people’s right to obtain needed medicines has been an integral part of HAI’s work since its creation almost twenty years ago. HAI and its partners agree that increasing access to essential medicines doesn’t mean destroying the current patent protection system. Instead, they believe that patents should be protected, but not at an unacceptable human cost.

The current HIV/AIDS pandemic is the latest, tragic example being highlighted by HAI to show how people in developing countries still cannot obtain the treatments they need. HIV/AIDS is a potent example of the access issue because many of the drugs developed to treat it are quite new and therefore still under patent. The price of many HIV/AIDS drugs shows how treatments can quickly become unaffordable when no generic alternatives are available.[iv] Aside from HIV/AIDS, diseases including tuberculosis, malaria and a range of life-threatening tropical diseases claim millions of lives each year in poor countries because people and governments cannot afford the needed medicines or they don’t exist. Because there is no profitable market for many of these drugs, pharmaceutical companies have no incentive to develop medicines to treat the diseases that disproportionally affect poor countries. "Multinational pharmaceutical companies neglected the diseases of the tropics,"   wrote Isabel Hilton in The Guardian  earlier this year, "not because the science is impossible but because there is, in the cold economies of the drug companies, no market. There is, of course, a market in the sense that there is a need: millions of people die from preventable or curable diseases every week. But there is no market in the sense that, unlike Viagra, medicines for leishmaniasis are needed by poor people in poor countries." [v]

Campaign successes and future goals

Last November, HAI, Médecins Sans Frontières (MSF) and Consumer Project on Technology (CPT) co-organised the international conference: Increasing Access to Essential Drugs in a Globalised Economy: Working towards solutions. The two-day meeting held in Amsterdam brought together more than 350 participants from 50 developed and developing countries to discuss hurdles to access and ways to improve the situation. In her speech to the conference, the Dutch Minister of Development Cooperation strongly promoted existing legal means to lower drug prices and called on powerful groups such as the United States and the European Union to stop intimidating national governments attempting to use them. She said "We cannot accept the kind of bilateral dealings in which one country puts pressure on another to enforce certain laws, or refrains from enforcing them."[vi]

The conference organisers released a joint statement on access to medicines aimed at the trade ministers who would be meeting the following week at the 3^rd World Trad Organization (WTO) Ministerial meeting in Seattle, US. In it, they pointed out that political action, not just market forces, was necessary to correct the health and resource imbalances facing developing countries. They asked national governments to develop ways to ensure adequate funding for research and development of neglected diseases. They also called for the WTO Member States to create a Standing Working Group on Access to Medicines. The group would consider the impact that trade policies have on people in developing and least developed countries and provide a public health framework for the interpretation of key features of the WTO agreements.

While disagreement ultimately caused the overall Seattle negotiations to fail, an important victory for access was achieved. Pressure building from months of high-profile campaigning by US-based AIDS activists and other NGOs contributed to the announcement by US President Clinton on World AIDS Day that the US would revise its intellectual property policy so that developing countries could better respond to public health crises.  In his announcement Clinton said "Intellectual property protections are very important in a modern economy, but when HIV and AIDS epidemics are involved, and like serious health-care crises, the United States will henceforth implement its health care and trade policies in a manner that ensure that people in the poorest countries won’t have to go without medicine they so desperately need."[vii]

That statement signalled a reversal in US policy which only months earlier had been calling on countries to adopt stronger patent protections than even the TRIPs agreement called for. The new policy suggests the US government would no longer exert bilateral pressure on other countries without having its trade representative first take advice from the health department. This could result in the easing of challenges to two legal means to increase access: compulsory licensing (forcing a drug manufacturer to allow a local drug company to produce its drug after receiving compensation) and parallel importing (shopping for and importing a drug from the country with the lowest price).

"These statements are a real, much needed step forward,"  said Zafar Mirza, coordinator of HAI’s team in Seattle. "However, they need to be followed with actions."  Daniel Berman, coordinator of MSF’s Access to Essential Medicines campaign added "On a daily basis, our doctors in developing countries witness people dying from the lack of access to affordable lifesaving medicines. Although the US policy change is an important first step, it is important that health concerns become more broadly integrated into the WTO rules."

Following strong lobbying by Member States and NGOs, WHO has also publicly expressed its clear commitment to increase access to essential medicines. In Seattle, Michael Scholtz, WHO’s Executive Director of the Drug and Health Technologies Division, spoke out in favour of tools including compulsory licensing to make essential drugs available to the world’s poor.[x] The organisation’s standpoint is based on the mandate given to it by a resolution passed at the 1999 World Health Assembly. The resolution calls on the WHO to provide advice to member states so they can assess the public health consequences of international trade agreements and find ways to reduce any negative consequences caused by them.[xi]

WHO has also emphasised the importance of working with industry to find long-term, sustainable solutions to this global problem. One popular industry response is to offer highly publicised drug donations for specific diseases. However, Brundtland, like HAI and MSF, has dismissed industry donation initiatives as “short-term solutions”[xii]  and has echoed both groups’ call for differential drug pricing by country saying, “The end-point of international consensus should be that the poor would not have to pay the same price for life-saving drugs as those who are better off.”[xiii]

Access work in the regions

Asia and the Pacific

HAI Asia’s coordinator, Dr. Bala presented a paper, “Consumers and the WTO/TRIPs Agreement” at the International Convention on WTO/TRIPs on Access to Drugs held in Pakistan in July 1999. (The paper is available on the web at http://www.consumersinternational.org/roap).  HAI partners, Dr Zafar Mirza from the Network, Pakistan and Prof. Kris Weerasuriya, from the University of Colombo, Sri Lanka also participated in the Convention.  Dr Zafar presented a paper on the TRIPs Agreement and its implication on drug prices, and Prof. Kris presented a country paper on Sri Lanka.  Dr Bala also attended the Regional Consultation on WTO Multilateral Trade Agreements and their implications on Health-TRIPs organised by the WHO Regional Office for South East Asia held in Bangkok in August 1999. Bala also spoke on the “Impact of WTO/TRIPs Agreement on the Access to Essential Drugs for People Living with HIV/AIDS” at the 5^th International Conference on AIDS in Asia-Pacific held in Kuala Lumpur, Malaysia in October 1999. (The full text of this presentation can be found at http://www.consumersinternational.org/trade/index.html under the section on original research.)

In India, an international brainstorming workshop on WTO Agreements and People’s Concerns was held in New Delhi on 30^th October and 1^st November. This workshop was organised by the Centre for Study of Global Trade System and Development. The workshop noted that international trade agreements have contributed to the widening of the socio‑economic and technological gap between developed and developing countries. To put forward an alternative framework, the participants drafted A Delhi Declaration and Statement of People’s Concerns and WTO issues. (Copies of the documents can be obtained from the Centre for Study of Global Trade System and Development, A‑388, Sarita Vihar, New Delhi 110 044, India. E-mail: , Tel. and Fax: + (91–11) 694 7403.)

In Thailand, the Foundation for Consumers has campaigned for a compulsory license to be issued for the manufacture of didanosine (ddI), an HIV drug. They have also worked with the Alliance of NGOs on AIDS in Thailand to call for a shortening in the length of safety monitoring programmes for drugs used in the treatment of HIV/AIDS so that people would have access to the drugs more quickly.

The Asian Community Health Action Network (ACHAN) has organised training workshops on globalisation and its effects on health in the Philippines, India, Sri Lanka and Nepal. The meetings’ purpose was to discuss the current role of NGOs and their strategies and strengthen their advocacy skills.

Africa

HAI Africa formed a working group on trade and access to essential medicines in March 1999 to facilitate the flow of key information and documents about trade issues to partners in Africa.  The working group developed a strategy for working on these issues at the national level which included the following elements: 

(1)   identify the basic barriers to access in a country and current medicines priorities and level of access;

(2)   identify government officials, academics, media persons and NGOs working on trade issues in the country and develop links and share information;

(3)   hold meetings that include a cross-section of actors that are or should become more involved in examining the public health aspects of trade agreements in order to share information, expertise and build relationships; and

(4)   formulate action plans and follow up with activities, including increasing public awareness and building effective coalitions to address these issues.

This strategy was first used in Kenya, where HAI Africa organised two meetings in 1999.  The first meeting (see HAI News, October 1999), attended by 23 people from government, industry, NGOs, legal experts and the media, formulated an action plan.  The second meeting, attended by 31 people, extended participation to trade officials and resulted in a submission to parliament on the need to revise the pending Industrial Property Act (see related article in this issue under Network News).

These meetings have produced a coalition of NGOs to continue campaigning and raising NGO and government awareness about trade and medicines issues.  In Africa, numerous NGOs have built up expertise and campaigning experience on TRIPs because of their work on biodiversity.  These NGOs understand and welcome the addition of public health perspectives to their campaigning and HAI partners have benefited from their experience.  One of the biggest problems is the lack of information and expertise in African governments concerning trade and public health issues. HAI Africa partners are working in cooperation with local chapters of MSF and ActionAid and national NGOs that have been working over time on trade issues in the region.

Networking from these initial meetings resulted in the addition of a presentation on access to essential medicines to a regional training workshop agenda for journalists writing on trade issues.  A press conference was arranged that was the catalyst for coverage in the international press.  Articles also appeared in the local press and interviews were given to the BBC and national radio stations.  Two of the members of the Kenya coalition attended the WTO ministerial in Seattle.

Using this basic strategy, the Uganda Consumers’ Protection Association, with support from HAI Africa and MSF, will hold a two-day meeting in Kampala in February.  A similar meeting is being planned by HAI partners in Malawi. HAI Africa expects to organise campaigning in more countries in 2000.

Europe

Now that the international conference on access has taken place, the HAI Europe office is working to advance access on the European agenda. HAI contacts in Europe are now planning to raise awareness about access issues and European trade policy at a seminar to be held in Brussels on April 18th. Physicians for Social Responsibility, MSF, Wemos, the European Public Health Alliance and others will work with HAI to brief EU Parliamentarians, public interest health NGOs and journalists on the EU’s current policy on patents and its effects on access to essential drugs in developing countries. Follow-up meetings are also planned.

(The information summarised in this section has been provided by the regional coordinators.)

The campaign’s next steps

HAI and its partners are closely monitoring the work of the TRIPs Council which oversees the implementation of the Agreement’s policies. This year the Council is required to review the Agreement (and will probably due so at its meeting 21-22 March in Geneva.) What this review will entail is still unclear. The Council must also decide how to handle some countries’ request to extend the date by which they must conform to the TRIPs agreement’s policies. All countries (with some exceptions) were bound to be in compliance by the start of this year. HAI will work with its partners MSF and CPT in monitoring and reporting on the activities of this important meeting.

The access issue will next be highlighted in May at the 2000 World Health Assembly in Geneva. Here, a HAI lobby team comprised of contacts from every region of the network will talk with delegates and raise awareness about access and related issues. HAI and its partners will also meet with other NGOs working on this issue to see where the organisations can support each other’s initiatives.

The US government has made a number of high level announcements that it will make changes in US trade policy, as it relates to access to drugs. These high level announcements have been welcomed by the NGO community.  However, it is also the case that US policy has changed very little on the ground in most developing countries.  CPT Director Jamie Love says, "For example, the US government is putting huge amounts of pressure on the Dominican Republic, to prevent that country from adopting a compulsory licensing law, and pressure on The Philippines to prevent that country from enacting laws that will promote generic substitution, to mention only a few cases. At the World Health Assembly Executive Board, the US government asked to eliminate references to intellectual property rights in a resolution on HIV/AIDS, and opposed WHO advocacy on intellectual property issues."

Partner groups in the US and EU are now working to pressure these governments to adopt policies which would enhance access. On February 12, 2000, the Trans Atlantic Consumer Dialogue (TACD) sent a number of important resolutions on intellectual property and pharmaceuticals to the US and EU governments, asking for further changes in US and EU policies on access to medicines in developing countries.  "Prior to the meeting”, says Love, “the EU government had prepared a statement opposing these resolutions that could have been, and maybe was, written by the IFPMA."

The campaign on access has made some gains but will remain an integral part of HAI’s work for the coming years. HAI contacts interested in joining the campaign are encouraged to contact their regional office for more information. Additional details about HAI’s work on trade and access and new developments can be found on HAI’s website: http://www.haiweb.org.

Lisa Hayes is Publications & Information Officer for HAI Europe. Bas van der Heide is HAI’s Regional Coordinator for Europe.

i   UN Press briefing given by Carol Bellamy, UNICEF Executive Director, September 20, 1999.
(http://www.un.org/News/briefings/docs/1999/19990920.bellamy.html) 
ii Gro Harlem Brundtland, Towards a strategic agenda for the WHO Secretariat, Statement by the Director-General to the Executive Board at its 105^th session,  EB105/2 p. 6 
iii Brundtland EB statement, p. 7 
iv Patent situation of HIV/AIDS related drugs in 80 countries, Geneva, January 2000 UNAIDS/WHO
http://www.unaids.org/publications/documents/health/access/patsit.html, p. 2. 
v Isabel Hilton “A bitter pill for the world’s poor: Drug companies do care for the suffering-if they have some cash”, Guardian & BBC, 5 January 2000. 
vi Press release “Dutch minister backs new strategy to increase access to drugs in poor countries” HAI/MSF/CPT, 26 November 1999. 
vii Remarks by President Bill Clinton at luncheon honouring ministers attending the meetings of the World Trade Organization, Four Seasons Hotel, Seattle, 1 December 1999, see (http://www.usia.gov/topical/econ/wto99/pp1201j.htm) 
viii Press release: Major U.S. Policy change opens door for poor countries to produce affordable drugs, HAI, MSF, CPT, 2 December 1999; Sustainable developments 34:1;3, 1 December 1999.  (http://www.haiweb.org/campaign/novseminar/seattle_press_2dec.html) 
ix Gro Harlem Brundtland, Statement to the 105^th EB (EB105/2, p.8) 
x Press release: Lifesaving drugs for killer prices, HAI, 1 December 1999. (http://www.haiweb.org/campaign/novseminar/seattle_press_1dec.html) 
xi 52^nd World Health Assembly resolution on the Revised Drug Strategy (WHA52.19) 24  May 1999, see http://www.who.int/wha-1998/WHA99/PDF99/e_reso.pdf 
xiiBrundtland EB statement, p. 7 
xiii Brundtland EB statement, p. 8 
xiv  K Bala and Kiran Sagoo,  Patents & Prices: a draft discussion document, HAI/CI for the International Conference on Increasing Access to Essential Drugs in a Globalised Economy: Working towards solutions, 25-26 November 1999. 

News

International

HAI speaks out on sponsorship

HAI urged the World Health Organization (WHO) to protect its status as a truly independent advocate for human rights and health for all in its response to the draft text of the WHO Guidelines on Interaction with Commercial Enterprises. The network questioned whether or not WHO’s increasingly close collaboration with the private sector was actually a major step forward towards health for all. In the letter, Bas van der Heide, coordinator of HAI Europe, wrote “WHO must be able to demonstrate that the poor directly benefit from this collaboration. Private sector initiatives rarely benefit the poor as much as they benefit specific diseases or health problems encountered by a section of the population, or of course, an industry itself.”

HAI also pointed out that the guidelines in their current form do not give adequate guidance for any serious evaluation of the activities of potential and current commercial partners. The letter set out a number of fundamental questions for WHO to address before moving forward in structuring its relationship with commercial enterprises.

HAI raised the issue of conflict of interest again at the January meeting of the WHO Executive Board. To read the full text of HAI’s comments (and other organisations) on the guidelines and at the Board meeting, see http://www.haiweb.org/news/news.html or contact the HAI Europe office.

ANY NEWS?

Do share with us your activities/campaigns on rational drug use and access to essential medicines.  Please write to: The Editor, HAI News, PO Box 1045, 10830 Penang, Malaysia.  Fax No: (60-4) 228 6506; Email: ardaroap@tm.net.my

United Kingdom

Consumer group creates independent information source for patients

The editors of Consumer Association’s Drug and Therapeutics Bulletin (DTB), have decided to create an information bulletin just for patients. Since it was founded in 1962, DTB has been used by doctors and pharmacists for up‑to‑date information about best practices in medical care, and over the years DTB has earned a reputation for providing authoritative, practical guidance for working clinicians. CA now wants to fill the patient's information gap by reinterpreting the information it gives to doctors and pharmacists in DTB in a bulletin for health care consumers, a doctor‑ or pharmacist‑supplied leaflet that is accurate, concise, easy to read and timely.

The bulletin will contain one topic per leaflet, such as ‘help with losing weight’ and ‘antibiotic resistance.’ It will give background information for the newly diagnosed patient and advice and recommendations that match the ‘parent’ DTB bulletin. Pilots of the new bulletin are being tested with patients and health professionals and regular editions should start appearing shortly. DTB hopes local health authorities will purchase the bulletin and make it available free from doctors’ surgeries and community pharmacists. An electronic version should follow by the end of the year.

For more information, contact Philip Taylor at UK's Consumer’s Association: Drug and Therapeutics Bulletin, 2 Marylebone Road, London NW1 4DF, tel: (+44‑20) 7830 7608, fax: (+44‑20) 7830 7664, and e‑mail: taylorp@which.co.uk

Germany

Export drugs of questionable quality

German pharmaceutical companies are a major supplier of drugs for many developing countries.  For this reason, BUKO Pharma-Kampagne recently published a report, Poor Choices for Poor Countries, which examines the marketing of German drugs in Third World countries.  The report looked at the drugs’ therapeutic usefulness and its result do not stand up to the good image German medicines now enjoy.  A review on the report is available in this issue under Resources.

Contributed by Lisa Hayes, Press & Publications Officer, HAI-Europe.

Asia-Pacific

Australia

National Medicines Policy

A National Medicines Policy was launched in December. The policy objectives are: timely access to affordable medicines, medicines should meet appropriate standards of quality, safety and efficacy, quality use of medicines, and maintenance of a responsible and viable medicines industry.  Peter Mansfield gives a short write-up on the evolution to this policy.

1950        The Pharmaceutical Benefits Scheme commenced.  This consisted of a limited list of 139 life saving or diseases-preventing drugs made available for prescription free of charge.  It now consists over 500 drugs subject to co-payment.

1958        A Therapeutic Substances Act was passed and a National Biological Standards Laboratory (NBSL) was established.  By 1989, this had evolved to a comprehensive Therapeutic Goods Act overseen by a centralised Therapeutic Goods Administration in Canberra.

1987        Patent life extensions from 16 to 20 years were  permitted, as were price correction payments for companies performing local research and development

1992        The Pharmaceutical Health and Rational Use of Medicines (PHARM) working party became the PHARM committee and the Australian Pharmaceutical Advisory Council (APAC) was  established

1995        A National Medicinal Drug Policy was established

1999     Australia’s National Medicines Policy was launched 

Malaysia

National Drugs List launched

Consumers and their representatives were delighted that the Ministry of Health and the National Committee on Essential Drugs have finalised the National Drugs List.  The list which was launched in January, consists of generic and brand names of 615 drugs, with their prices.  The list has been extended for use both in the public and private sector.  The list was hailed as a milestone as it empowers consumers by giving them the right of choice about the medication they need.

The list was developed by the Ministry of Health together with the Malaysian Pharmaceutical Society, the Federation of Private Medical Practitioners, the Malaysian Medical Association, the Pharmaceutical Association of Malaysia, the Malaysian Organisation of Pharmaceutical Industries, the National University of Malaysia and the Science University of Malaysia.

The National Poison Centre at the Science University, assisted in the formulation of the list by providing drug information.  The centre has a webpage for information on essential drugs in Malaysia.  Information can be accessed at http://prn.usm.my/edl/essentia.html

Latin America

Bolivia

Conference on WTO & Health

AIS/HAI Bolivia will be organising a 5^th National Conference on March 22 & 23 which will examine the impact of multilateral trade agreements under the WTO on consumer rights.  The themes that will be discussed are: access to medicines, health, food security, the Codex Alimentarius, the International Code on Marketing of Breastmilk Substitutes, environmental protection and consumers’ rights.

The conference will bring together a broad range of stakeholders which include international experts, policy makers, civil society representatives, NGOs, academics, professional associations, UN bodies, worker’s union and industry.

The conference is being supported by NOVIB, WEMOS, Consumers International Regional Office for Latin America, WHO Regional Office for the Americas/Pan American Sanitary Bureau (PAHO), Medicus Mundi, Misereor  (Germany), Medical College of La Paz, International Baby Food Action Network- Latin America (IBFAN) and HAI-Latin America.

For more information , please contact: AIS/HAI Bolivia, Casilla 568, Av.abel Ituralde 1178, Miraflores, La Paz, Bolivia, Email: aisbolol@ceibo.entelnet.bo

Bolivian Essential Drug Programme: Efficiency and openness requested

AIS/HAI Bolivia in a letter to the Bolivian Health Ministry, has expressed concern on the management of the Bolivian Essential Drug Programme (PNMEBOL).  Specific areas of failures and the negative consequences that millions of Bolivians would experience were identified.  Also requested was closer co-operation between PNMEBOL, it’s executives and consumer associations.  Currently, co-ordination initiatives taken by consumer associations, such as the AIS-CODEDCO Bolivia Initiative, has not had adequate support from  the PNMEBOL, despite the fact that this initiative reaches out to a wide population through daily radio programmes, newsletters, seminars and talks.

HAI Bolivia has on numerous occasions requested the Bolivian Health Authorities to include consumer associations, patients organisations and representatives of civil society in the programme’s Board of Directors, to ensure coordination, more transparency and openness in the programme.

Administrative failures in the PNMEBOL was brought to light when it was announced in the local media that the Netherlands government had temporarily frozen financial support due to poor planning and mismanagement. Financial support was renewed in January 2000 after a reformulated proposal was submitted.

AIS-CODEDCO Bolivia will be closely observing the developments of the programme to ensure that the marginalised sections of the population benefit from the programme.

News on Bolivia contributed by Oscar Lanza, AIS Bolivia Coordinator.

Africa

Kenya

Lawmakers told legislation would harm access to essential medicines

A coalition of Kenyan NGOs criticised the pending Industrial Property Bill (IPB) for not adequately addressing public health considerations in its submission before the Kenyan parliamentary committee reviewing the bill in October.

The coalition represented the views and conclusions of 31 participants in an October roundtable meeting convened by HAI Africa in Nairobi to look at the implications of World Trade Organisation (WTO) agreements and Kenya’s proposed IPB on public health and access to essential medicines.  (See HAI News October 1999)

The bill is meant to bring Kenya into compliance with the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement, which requires patents on products and processes for 20 years.

According to roundtable participants, the IPB demonstrates the problems that WTO members from developing countries are having meeting WTO deadlines for being fully compliant with WTO rules. Kenya was given until 1 January 2000 to enact legislation necessary to meet its WTO membership obligations.

Kenya’s current law grants patents for seven years. The extension of patent protection for products and processes to 20 years will keep medicines prices extremely high and unaffordable for too long.  And, according to Kenyan experts at the roundtable meeting, in some cases, drug companies could keep needed drugs under patent longer than 20 years.

According to the coalition, the proposed bill contradicts the Kenyan national drug policy, which states that ‘patent laws applicable to pharmaceutical products will be reviewed and revised to balance the need to support the development of local production, the need to respect international property rights and the need to protect consumers from excessively high pharmaceutical prices. Research and development will be encouraged to support local production.’

Furthermore, the bill would harm the effectiveness of the essential drug list, efforts to liberalise domestic markets and implementation of health sector reform policies.

The bill does not provide for compulsory licensing, parallel importing, early working of patents or other strategies that can help to increase access to drugs and reduce prices. The NGOs pointed out to parliamentarians that all of these strategies, when adopted into domestic legislation are compliant with WTO obligations.  All of these provisions would benefit Kenyans. The fact that they are missing shows that the proposed bill favours foreign interests over Kenyan citizens’ health needs.

The coalition pointed out that adoption of the IPB in 1999 would contradict Kenya's own WTO position on TRIPs, which called for a review of TRIPs and extensions to allow developing countries more time to enact TRIPs-compliant legislation that adequately reflects their domestic needs, particularly in the area of public health and safeguarding access to affordable essential medicines. Kenya’s position on TRIPs was adopted as the Africa position going into the WTO ministerial conference in Seattle in November 1999.

They also noted that the proposed bill fails to reflect the World Health Organization’s (WHO) Revised Drug Strategy, which Kenya supported when it was passed at the World Health Assembly in May1999, which calls on WHO member states to ‘take all necessary concrete measures in order to ensure equitable access to essential drugs, to ensure that public health policies are paramount in pharmaceutical and health policies and to explore and review their options under relevant international agreements, including trade agreements, to safeguard access to essential drugs.’ These steps were echoed in the statement of Organisation of African Unity Ministers of Health made in Cairo in October 1999.

The NGO coalition recommended that the IPB be shelved until after the WTO ministerial conference and not passed until significant amendments could be made so that the bill would adequately protect public health and ensure access to affordable essential drugs. Revisions to the bill should be formulated in consultation with all key stakeholders, including consumers and the Ministry of Health.

Cameroon

First radio campaign to promote generics

The Network for Rational Use of Drugs (NETRUD) and the Cameroon Consumers Union (UCOCAM) have carried out the first-ever radio campaign to increase the prescription and consumption of essential generic medicines in urban areas.

Although generics are widely available, they are used less than 48 percent of the time.   According to NETRUD’s co-ordinator, Thierry Dzukou, low use is due to bad information about generics circulating among consumers and health care professionals.

In December 1998, NETRUD and UCOCAM brought together Ministry of Health officials, health professionals, consumer representatives and media to discuss how to develop a media campaign to increase the use of generic drugs.  In February 1999, NETRUD and UCOCAM linked up with the Uganda Media Women’s Association (UMWA), which has experience and expertise in formulating radio messages about rational drug use. (See side panel)

Based on UMWA’s advice, NETRUD and UCOCAM developed a radio campaign focused on families that earn less than US$50 per month.  These families make up 65 percent of the urban population in Cameroon.  Radio messages in both French and English were developed by a women’s group and radio producers working with Lucie Kidi, a pharmacist.   These 35-second messages were then pretested on the project’s working group and a focus group of 40 women and revised as recommended.  Beginning in September and for five weeks, two French and two English messages were aired twice daily at prime times on the national radio, which has the largest audience.  According to the National Essential Medicines Procurement Centre, orders for generics rose 20 per cent between September and December 1999.

The Ministry of Public Health was very pleased with the campaign and the apparent effect on generic drug orders.  NETRUD was very proud of its first-ever media campaign.  NETRUD would like to conduct a study on the knowledge, attitudes and practices of a representative group of consumers after the campaign and compare it with prescription and consumption information prior to September.  At the same time, it would be useful to have a study of generics dispensation by pharmacists.  If possible, it would be beneficial to conduct these studies on a larger, national scale.

Other partners in the radio campaign included the Ministry of Public Health, National Essential Medicines Procurement Centre, Mirabelle Action (a rural women’s NGO) and the Cameroon Radio-Television Office.

Readers can find out more tips for radio campaigning in "Using the airwaves” in "The Health Exchange," Feb 99, published by the International Health Exchange or in "Working Effectively with Media," in "Moving in from the Margin" (HAI 1999), which is available in print from HAI Europe (no charge for single copies) and soon to be available on the HAI website.

Contributed by Beryl Leach, HAI Africa Co-ordinator.

Journal Scan

Research findings

Pediatric use of drugs in the EU

The European Network for Drug Investigation in Children carried out a survey to determine the extent of use of unlicensed and off label drugs in hospitals in the United Kingdom, Sweden, Germany, Italy and the Netherlands.

Of 2262 drug prescription given to 624 children, 872 (38.5%) were off label and 164 (15.8%) were unlicensed. About two-thirds of the patients – 421 (67%) received an unlicensed or off label drug prescription.

The use of unlicensed and off label drugs was greatest in Bergamo, Italy and Rotterdam, the Netherlands. The network urges the European Union, departments of health, politicians and the European Medicine Evaluation Agency to take a more proactive role in getting drugs tested on children. (British Medical Journal, UK, Jan 8, 2000)

Direct-to-consumer prescription drug advertising

Researchers from the University of California’s Davis and Los Angeles campuses surveyed 329 consumers about direct-to-consumer (DTC) prescription drug advertising.

The researchers found that approximately 50 per cent of those who participated in the survey thought DTC advertisements had to be submitted to the Food and Drug Administration (FDA) for prior approval; 43 per cent thought that only ‘completely safe’ prescription drugs could be advertised directly to consumers; 21 per cent believed that only ‘extremely effective’ drugs could be advertised to consumers; and 22 per cent believed that the advertising of prescription drugs with serious adverse effects had been banned.

In fact, no regulations have ever been written that specifically address the issue of advertising prescription drugs to the public.

The results are disturbing. The large amounts of money being pumped into TV commercials and print ads to promote drugs to the lay public are having their intended effect: namely, to mislead consumers and thereby create a broader demand for such drugs.

DTC ad spending, $600 million in 1996, is projected to reach $7.5 billion in 2005 – a 12-fold increase in less than 10 years. Consumers will wind up paying the cost of these ads either directly through higher prescription prices at the pharmacy counter or indirectly in the form of ever increasing costs for health insurance or managed care premiums.

(Worst Pills, Best Pills, US, Jan 2000)

Orphan drug finds home

Human African trypanosomiasis or sleeping sickness rarely makes the headlines in the international press but according to health authorities in the Democratic Republic of the Congo (formerly Zaire), the number of deaths due to human trypanosomiasis at least equals the number of deaths due to AIDS in two provinces of the largest central African country. It is estimated that 55 million people in 36 African countries south of Sahara are exposed to the risk of contracting the disease.

Hoechst Marion Roussel and WHO have signed a License Agreement, which allows WHO in collaboration with other partners to arrange for the production and distribution of the life-saving drug, eflornithine, to treat human African trypanosomiasis.

Technology transfer from Hoechst Marion Roussel will take place once WHO has found a new partner in the private sector, capable of producing eflornithine. In the meantime, MSF and WHO have been in contact with the international donor community to finance the purchase of adequate drug supplies. Since the vast majority of people with sleeping sickness will not be able to afford to pay for the drug, international financing will be needed. Securing procurement funds in advance will facilitate the search for a producer.

The drug should be administered intravenously in four equal doses every six hours for 14 days in a hospital setting. The current cost of treatment per patient is US$700. Eleven of the 16 countries that regularly report cases of sleeping sickness have per capita Gross National Product about US$1000. In many of the affected countries, the total annual health budget is less than US$10 per person. The worst affected countries are Angola, Democratic Republic of the Congo, Sudan and Uganda. In many villages prevalence of sleeping sickness is over 50 per cent, thus making it usually the first cause of mortality. (WHO Press Release WHO/74, 6 Dec 99)

Generic drugs: safe & effective

US Food and Drug Administration (FDA) Commissioner, Jane Henney reassures patients and physicians that ‘if the FDA declares a generic drug to be therapeutically equivalent to an innovator drug, the two products will provide the same intended clinical effect’.

In a recent FDA survey, three measures of therapeutic equivalence were compared between innovator products and their generic equivalents. The difference for the area under the curve (AUC) from time O to time t was +/-3.47%, while the AUC from time O to infinity was +/-3.25%. For the highest drug concentration (C max) attained in blood, the difference was +/-4.29%. These differences are not significant.

The FDA conducted the study to address questions that have been raised about the ethics, safety and effectiveness of generic drugs being substituted for brandname products. (SCRIP No. 2500, UK, 1 Dec & 22/24 1999)

Drug Promotion

BMS website breaches UK code

Bristol Myers Squibb has breached the UK code of practice for advertising a prescription-only medicine to the public, because its website for healthcare professionals could be accessed by the public, who were exposed to promotional claims. The Prescription Medicines Code of Practice Authority (PMCPA) panel considered claims made in these pages, such as d4T being a ‘foundation of anti-HIV therapy’, was a breach of the code, which does not allow advertising of a prescription-only medicine to the public. (SCRIP No. 2508, UK, Jan 26, 2000)

Settling FTC charges

The Bayer Corporation will launch a $1 million consumer education campaign to settle Federal Trade Commission (FTC) charges that it made unsubstantiated claims in a series of aspirin ads, in violation of a previous FTC order.

The offending Bayer ads claimed that a regular aspirin regimen is appropriate for the prevention of heart attacks and strokes in the general adult population. The FTC alleged that since some adults are less likely to benefit from a daily aspirin regime, and some may suffer adverse health effects from taking aspirin on a daily basis, the ad claims were unsubstantiated.

The consumer education campaign features a brochure, "Aspirin Regimen therapy – Is It Right For You?" that Bayer will distribute free. Full-page print ads featured in the February through May editions of major magazines will promote a toll-free number for consumers to use to obtain the brochure, and more than half a million copies will be distributed through doctors’ offices.

The Food and Drug Administration recognises an aspirin regimen is effective in reducing the risk of stroke or heart attacks in certain groups of people – such as those who have had a previous ischemic (or clotting) stroke, and those who have suffered a previous heart attack or who have angina. However, regular aspirin use can, itself, cause health problems such as an increased risk of gastrointestinal bleeding and prolonged bleeding time. (Corporate Crime Reporter, USA, Jan 17, 2000)

Trade & Pharmaceuticals

France to oppose parallel importing

The French government says it intends to issue a decree soon implementing a streamlined procedure for the approval of parallel imports, after the EC Commission told it to change its rules or risk being taken to court. France still subjects parallel imports to a full marketing authorisation procedure, whereas EC rules require a rapid and simplified procedure intended solely to ascertain that the parallel import is identical to the corresponding product already marketed in France.

The Commission sent the agency a "reasoned opinion". In this it states that France is infringing Article 28 of the Treaty of Rome on the free movement of goods. After receiving the "reasoned opinion", France has two months to come forward with a satisfactory reply, otherwise the Commission can take the matter to the European Court of Justice. (SCRIP No. 2506, UK, Jan 19, 2000)

Return of price control in Brazil?

The Brazilian health minister, Jose Serra, has made it clear that he is considering bringing back price controls on pharmaceutical products. According to Mr Serra, since prices were liberalised in 1992, pharmaceutical company profits have grown faster than in all other industry sectors. The minister is waiting for the results of a number of investigations into pricing and alleged ‘abusive’ increases and he has stated that if price control is recommended then it will be reintroduced. (SCRIP No. 2507, UK, Jan 21, 2000)

Resources

This is the third study of German drugs marketed in the Third World by German drug companies.  Previous studies were done in 1988 and 1992.

The present survey evaluated over 2000 drugs sold in 30 developing countries.  The authors attempted to answer the following questions:

·        Does the range of German drugs cater to the essential health needs of the people?

·        Do the drugs meet the important basic criteria for rational drugs?

Drug information on German products in national drug compendia from developing countries was analysed and evaluated according to clearly defined criteria.  Pharmaceuticals were evaluated as rational if their efficacy is clinically proven, and if their therapeutic benefit outweighs the risks.

The study revealed that only 20 per cent of the drugs evaluated was found to be essential according to the criteria proposed by WHO; 42 per cent of the drugs did not cater to the health needs of the people and was judged irrational.

The German pharmaceutical industry as one of the largest exporter of drugs to the Third World should change their marketing practices; withdraw ineffective and harmful drugs and concentrate on safe and effective essential drugs.

This book should be read by all those interested in the promotion of rational and economic use of drugs particularly in developing countries where about 30-60 per cent of the limited health budget goes on purchasing drugs.  Those interested will include NGO health activists, health ministry officials, international agencies and donors to pharmaceutical programme.

Copies available from: BUKO Pharma-Kampagne, August-Bebel-Str. 62, 33602 Bielefeld, Germany.

·        Kerala State Drug Formulary, number 1 (April 1999), published by Government of Kerala, Thiruvananthapuram, Rs. 100.00, 601 pp.

Kerala, one of the Indian States in the southern end of the subcontinent, is well-known among health development workers throughout the world as a State which, inspite of low per capita GNP, has a record of achieving very good health indices – low infant mortality, high life expectancy and almost 100 per cent literacy.  The State has recorded another achievement; it has published a Kerala State Drug Formulary (KSDF).

The first 445 pages contain traditional formulary notes on the drugs commonly used in practice by doctors at various levels in both  public and private sectors.  The information include: indications, contra-indications, precautions, side effects, available dosage forms, dose, drug interactions and cost.  The second part (100 pages) contains:

·        Therapeutic guidelines for managing some of the common clinical conditions seen in peripheral hospitals.

·        Formulary notes on immunisation.

·        Therapeutic guidelines for managing clinical conditions seen in secondary and tertiary hospitals including the management of medical emergencies.

Part three lists those drugs that should be in stock at all times in three levels of government hospitals – dispensary, primary health centre and ‘Taluk’ hospitals with estimated quantities of each of the drugs for the three institutions.

Appendices include:

·        Dental practitioners’ formulary;

·        National Essential Drug List with pregnancy risk category of each of the 279 listed drugs;

·        List of drugs banned in India.

The KSDF fills in a long felt need by prescribers both in the public and private sectors who have no access to objective information on drugs, manage-ment of common illnesses and immunisation.

A recurring problem in all developing countries is the shortage of essential drugs in public health institutions in the periphery; health professionals in these institutions have no training or experience in stock control and inventory forecasting.  Part three which gives estimates of essential drugs for the different institutions, is a unique addition to this book.  This will be helpful to officers in charge of these institutions to make realistic estimates of the stocks needed and get them from their respective central medical stores.  It will also be a useful guide to doctors in the private sector, particularly those in rural areas, who dispense their own prescriptions to have adequate stocks all the time.  In Asia, almost all doctors in the private sector dispense their own medicines.

This formulary is targetted to prescribers in Kerala.  But going through this excellent book, it can safely be said that prescribers in the other Indian states, as well as those in other Asian countries, will find the Kerala State Drug Formulary a useful companion to rational and economic prescribing.

Available from: Kerala State Drug Formulary Committee, College of Pharmaceutical Sciences, Medical College, Thiruvanan-thapuram 695 011, Kerala, India.