In October 2014 a new Lancet Commission on Essential Medicines Policies was established with the goals of:
- Re-confirming the ongoing relevance, and the crucial need of comprehensive essential medicines policies to achieve broader global health and sustainable development goals, especially universal health coverage
- Formulating recommendations for global essential medicine policies for the next two decades
The work of the Commission will result in a report in The Lancet planned for November 2015, to commemorate the 30th anniversary of the 1985 Nairobi Conference on the Rational Use of Drugs.
Lancet has recognised that ‘Access to essential medicines globally is a highly charged political issue that is often about trade, policies, and protest.’ [1]
These issues are not new to HAIAP members. HAI activities in support of the essential medicines concept have been documented in detail in publications such as HAI-Europe’s 25th anniversary publication Pills Politics Practice and HAIAP’s Fast Flexible and Furious, 2006, and in our regular HAIAP News. Here we just touch some stepping stones along the journey from the focus of the essential medicines concept on the medicines that were
‘of the utmost importance to satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford’
to the challenges of using the TRIPS flexibilities o maintain access to essential medicines.
The Essential Drugs (Medicines) Concept
‘While drugs alone are not sufficient to provide adequate health care, they do play an important role in protecting, maintaining and restoring the health of people … It is clear that for optimal use of limited financial resources the available drugs must be restricted to those proven to be therapeutically effective, to have acceptable safety and to satisfy the health needs of the population. The selected drugs are here called ‘essential’ drugs, indicating they are of the utmost importance and are basic, indispensable and necessary for the health needs of the population.’ WHO 1977
Essential Medicines and Primary Health Care
Background
Until the 1960s, the medicines that were used to treat health problems were mainly from plants; or were salts like potassium iodide, potassium bromide, potassium citrate. People living in the main towns in developing countries (mostly colonies of European powers), who consulted western doctors, were prescribed those sorts of medicines. Aspirin had been synthesised in 1897 so there was an effective drug to relieve pain that was not an opium derivative.
There were limited antibiotics to treat infections and few new drugs to treat many other common conditions. People living in rural areas in the colonies relied mostly on their traditional medicines.
Soon after the Second World War things had begun to change. Sulphonamides and penicillins were developed. Barbiturates were produced and used as sedatives; and drugs to treat a wide range of problems including cardiovascular problems, epilepsy and allergies were developed and made available.
The 1960s witnessed enormous developments in the production of modern drugs. Newly independent countries became rapidly expanding markets for transnational drug companies or for local traders who imported medicines from other countries.
Some countries had legislation to control the import and distribution of pharmaceuticals, but the range and scope of products increased faster than the understanding of potential dangers and ahead of expanded legislation. In any case, the means to implement existing legislation was mostly not well developed. During the next 20 years, a huge number of potent substances became available in non-regulated markets for anyone who could afford to pay for them. Untrained drug sellers gained status almost equal to doctors. The new medicines prescribed by health professionals and sold by drug sellers were often seen as magic cure-alls but unfortunately there were dangers and side-effects with many of the new products.
The wealthier people in the less developed countries spent a lot on self-medication through over-the-counter purchase of uncontrolled substances for real and imagined problems including modern life-style problems. At the same time, poorer people in urban areas, and most people in rural and remote areas had no access to even the most essential medicines.
During the 1960s and 1970s several countries or regions of countries had initiated successful programs to deliver a basic but comprehensive program of primary care health services, including access to a limited range of essential medicines, to cover poor rural populations. Among them were Tanzania, Mozambique, Papua New Guinea and in the Asia Pacific region, areas of Bangladesh and the Jamkhed area of India. The concepts behind the initiatives were recognised by the World Health Organization (WHO) and UNICEF.
Dr Halfdan Mahler
Dr Halfdan Mahler from Denmark, had joined the WHO in 1951 as a senior officer for the National Tuberculosis Programme in India. After a range of appointments, in 1970, he was made Assistant Director-General of the WHO. In 1973, he was elected as the third Director-General and he was re-elected for two successive five-year terms in 1978 and 1983 respectively. His leadership was extremely significant in the development of the essential medicines concept.
The birth of the essential drugs concept
By the 1970s, it was recognised that causes of poor health in less developed countries such as inadequate or poor nutrition, poor housing and sanitary conditions and inadequate water needed to be addressed. However, it was realised at the same time that the right modern drugs were very important for health care.
In 1975, Dr Mahler, in his report to the World Health Assembly (WHA) [3] identified national pharmaceutical policies as a means of meeting health needs and economic priorities in developing countries. He also referred to experiences with carefully selected drug lists in Chile, Cuba, Mozambique, Papua New Guinea and Sri Lanka, which had led to improved access to drugs. This report was a major step in the campaign for access to essential medicines.
Before representatives of WHO Member States at the World Health Assembly, Dr Mahler insisted on the need to develop national pharmaceutical policies based on the affordability, quality and availability of drugs. National policies must cover all aspects from selection, procurement, quality assurance, legislation and regulatory control, to the use of drugs.
Primary Health Care and the first Model List of Essential Drugs
With Dr Mahler at the helm, the World Health Organisation began promoting the concept of essential drugs in 1975. The initiatives were supported by a World Bank Policy paper in 1975.
The Primary Health Care (PHC) approach was launched at Alma Ata (now the capital of Kazakhstan) in the former Soviet Union in 1978 and the place of Essential Drugs Programs was secured within the framework of PHC. Primary Health Care, as defined at Alma Ata, is
essential health care based on scientifically sound and socially acceptable methods and technology, made universally accessible to individuals, families and communities by their full participation.
This initiative took place in an era where the role of government in the provision of health, education and welfare services was taken for granted in most developed countries.
The emphasis in PHC is on the importance of preventive measures such as safe water supply, breast-feeding, immunisation against vaccine-preventable diseases and good nutrition associated with production of adequate good food but the need for appropriate curative care and access to essential medicines is recognised. The slogan ‘Health for all by the year 2000’ was launched.
The first model list of essential drugs
In support of the concept of Essential Drugs, a model list of essential drugs was prepared by an ‘Expert Committee’ in 1977 which included about 200 generic drugs and vaccines. Mrs Margarethe Helling Borda’s memories of the First Expert Committee meeting were recorded in the Essential Drugs Monitor.
All products were called by International Non-proprietary Names (INNs) (or generic names) rather than the brand names given by the companies producing them. Safety, affordability, need and efficacy (SANE) were the criteria for selection of drugs in the WHO Model List. Essential drugs were defined as ‘those that satisfy the health care needs of the majority of the population; they should be available at all times in adequate amounts and appropriate dosage forms’. Although the list has been revised and updated several times, the definition has remained unchanged. Countries were encouraged by the WHO to develop their own standard drugs lists, using the WHO list as a model.
The move by WHO in support of the essential medicines concept influenced many member states. Most WHO member states welcomed the new approach to medicines. But there was opposition – some medical associations argued that the concept of essential drugs was a threat to the freedom of prescribing, while the pharmaceutical industry – particularly the research-based industry, supported by some Western countries – argued that it would endanger the industry as well as jeopardize its future research efforts.
By 1979 the Alma-Ata Declaration had already generated criticisms and reactions worldwide. The goal ‘Health for All by 2000’ was not considered possible, implementation of PHC as formulated was far too expensive and the declaration did not have clear targets. As a result the Rockefeller Foundation sponsored the Health and Population Development Conference just a year after Alma-Ata. Selective Primary Health Care (SPHC) was introduced with the view that most lives could be saved by focussing on low-cost solutions that addressed very specific and common causes of death. The focuses would be Growth Monitoring, Oral rehydration for children’s diarrhoea, Breast-feeding and Immunisation – GOBI. This acronym later expanded and became GOBI-FFF after recognition of the need for food supplementation, female literacy and family planning.
Essential medicines received no attention. However it was becoming clear that access to essential medicines was being ruthlessly challenged by vested interests. In the early 1980s authors such as Charles Medawar, Diana Melrose, Mike Muller and Milton Silverman published works implicating pharmaceutical companies in the abuse of people’s health in developing countries. More authors followed with more accounts of continuing unethical activities by large pharmaceutical companies. A list of these books has been published by E-DRUG. [3] .
The birth of HAI
Following the World Health Assembly in May 1981, Health Action International (HAI) was founded at a meeting in Geneva after the baby food activists had successfully lobbied for a code of conduct at the Assembly. At this meeting Civil Society Organizations (CSO) from 26 countries came together and established this network of world specialists in medicines policy, to counteract the increasing influence of the pharmaceutical industry on public health and to represent the interests of consumers in healthcare policy debates. The network was later established across all continents as HAI-Africa, HAI Asia Pacific and HAI Latin America. It is worth revisiting the HAI publication Pills Politics Practice – 25 years of promoting people-centred medicines policy 1981-2006 to appreciate the birth and life of HAI.
In 1982 Dr Zafrullah Chowdhury, one of HAI’s founding members, experienced first hand the battles that would need to be fought in order to gain essential medicines for the people of Bangladesh.
By developing Bangladesh’s National Drug Policy in 1982 he challenged the might of the international pharmaceutical industry by establishing a just and affordable health strategy based in part on the local manufacture of a relatively small number of essential generic drugs.
His book The Politics of Essential Drugs – The Making of a Successful Health Strategy: Lessons from Bangladesh, published by Zed Press, London, in 1995, tells the story of this initiative, including its achievements and limitations. He sets it in a global context, discusses the pressures mobilized (both now and at the time) by the pharmaceutical corporations and others to reverse the new strategy, and reflects on the relevance of Bangladesh’s experience for other countries.
The 1985 Nairobi Conference
Despite strong resistance from the pharmaceutical industry, WHO convened, in 1985, the Conference of Experts on the Rational Use of Drugs – the so-called Nairobi Conference – which brought together specialists from different disciplines and perspectives, including industry, consumer groups, donors, academics and national policy-makers. The conference agreed on important issues relating mainly to drug information, drug regulatory programs and prescribing practices. The Nairobi conference reached a consensus over the need to develop national medicines policies as the basis for of promoting rational use of drugs.
In November 2014 Dr Mira Shiva wrote in a message to HAIAP colleagues:
‘I cannot believe 30 years have passed since the WHO’s International Conference of Experts on Rational Use of Drugs in Nairobi 1985. For the first time Consumer activists involved with Rational Use of Drugs had been invited. I recall Dr Zafrullah, Dr Andrew Herxheimer , Charles Medawar, Diana Melrose and I were there. The Nairobi meeting was immediately followed by a meeting in Chennai of drug activists the from the Asian region called “Drugging of Asia”. It was co-organized by IOCU-ACHAN, VHAI (where I was coordinator) and Low Cost Drugs and Rational Therapeutics. Dr Bala and Dr Prem John were there. We had been infiltrated by a ‘plant’ from the drug industry as the High Dose Estrogen Progesterone campaign was on and we had a PIL (Public Interest Litigation) in the Supreme Court’
That conference gave an impetus to the Revised Drug Strategy that would be adopted by the World Health Assembly in 1986. The overall goal of the strategy was to rationalise drug use in cooperation with the health professions, academia, the pharmaceutical industry, NGOs, and the public and to expand access to good quality affordable essential medicines. The scope of the strategy was extended to cover, for example, access to newer drugs for HIV and other life threatening conditions, control of counterfeit products and inclusion of traditional medicines.
Meanwhile, the struggle to implement PHC and essential medicines programs continued.
The Bamako Initiative
The cost of implementing PHC and providing essential medicines was becoming a major concern. In 1984, James Grant, then Director of UNICEF, at a meeting in Bamako in Mali, launched the idea of payment for medicines as a way to help finance Primary Health Care. The idea became known as the Bamako Initiative and was presented to WHO in 1987. Implementation was attempted in some countries, particularly in Africa. However, there were many concerns. For example, as described by Kanji (1989) [4], ‘administration of user fees requires management skills and time that might not be available; medicines might be provided only to those who are prepared to pay for them; and the revenue generated from the sales of medicines may be insufficient to have much impact on supporting the cost of more medicines or the PHC program in general. There could be preference for providing more expensive medicines and rational use of medicines could be less of a priority.’
The next years
The List of Books on Pills shows publications that appeared during the following 10 years that provide a picture of the essential medicines journey and the challenges faced by those attempting to implement essential medicines programs. A comprehensive picture is provided in Drugs Policy in Developing Countries by Najmi Kanji, Anita Hardon, Jan Willem Harnmeijer, Masuma Mamdani, and Gill Walt (Zed Press 1992). Reviewer David Stevenson describes how
‘the authors, with practical experience in developing countries, give an account of the development of and changes in the policies of WHO, UNICEF and other agencies, and of the actions of drug manufacturing companies and of the governments of individual countries, in relation to the supply of medicines. In many developing countries one can see expensive and inappropriate medicines on sale to the public while health units do not have enough basic supplies to treat common illnesses. Parents may be persuaded to spend scarce money on ineffective proprietary “tonics” when it they would be better to buy good food for their undernourished children. Dye-containing pills have been advertised to cure nearly every ill – one can see the poisons leaving the body with the coloured urine which results!’
Conference on National Medicines Policies, Sydney 1995
The 1995 conference led by WHO in Sydney, Australia, was a major landmark. It brought together 300 people from almost 50 countries and focused on four key themes of national medicines policies: equity of access to medicines, rational use, the quality of medicines, and the role of the pharmaceutical industry. That conference produced a number of general recommendations along with specific recommendations relating to the four themes of the conference. The proceedings of the conference were reported in a supplement to Australian Prescriber (Aust Prescr 1997;20 Suppl 1).
Many HAI and HAIAP members and partners participated and took the opportunity to plan further activities.
The conference provided a great impetus for policy work in the region. As an outcome of a networking meeting at the conference Dr Bala initiated the planning for the HAIAP sponsored first regional consultation of pharmaceutical sector and consumer groups for 14 Pacific Island Nations in Nadi, Fiji, in1996. We believe it was that initiative that put the Pacific Island Nations on the map. Since 1996 WHO has convened very fruitful regional consultations among Pacific Island Nations’ pharmaceutical sector leaders almost every year, resulting in the sort of regional cooperation that might be just a dream in other regions. The Sydney conference also led to educational interventions in rational drug use and ethical promotion, and underpinned discussions on rational drug use that continued at the International Conference on Improving Use of Medicines held in Thailand in 1997.
It was 17 years after the 1995 conference that 233 delegates from 46 countries participated in the follow-up Asia Pacific Conference on National Medicines Policies in Sydney, Australia on 26–29 May 2012. It provided the opportunity to share achievements and challenges. The impetus for this conference was the recognition that while many countries in the Asia Pacific region reported having a national medicines policy, progress on the implementation of these policies had been inconsistent. In addition, it was re-affirmed that robust and effective national medicines policies are an important tool in achieving the objectives of universal access to needed medicines and their rational use. It was also recognised that a policy, no matter how carefully formulated, has no value if it is not implemented. Therefore, a detailed strategic plan is needed to link with National Medicinal Policy and include short- medium- and long-term strategies for policy implementation.
The Conference Report was published by Australian Prescriber.
In keeping with the conference theme of promoting and supporting further implementation of national medicines policies, there is particular emphasis in this report on identifying the key barriers and key enablers to policy implementation, steps to address these barriers and enablers, and how to monitor progress. An important outcome of this conference was continuing commitment to further implement national medicines policies within the Asia Pacific region. There is enthusiasm for ongoing discussion between countries and the development of regional collaborations, groups and networks to support this important policy work.
Current challenges
Arguably the most challenging battles continue to be associated with Intellectual Property Rights.
TRIPS
For 10 years after introduction of the Essential Drugs Concepts and recommendation for use of generic drugs the pharmaceutical industry negotiated quietly behind the scenes and came up with TRIPS – Trade Related Aspects of Intellectual Property Rights.
WHO and others were advocating for ‘essential drugs’, and that movement was seen as a possible threat to multinational pharmaceutical company sales.
TRIPS (Trade Related Aspects of Intellectual Property Rights) (WTO 1995) aimed at
- ‘Harmonisation’ by 2005 – all countries to join the World Trade Organisation (WTO) except for Least Developed Countries who could wait until 2016
- 20 year patent would apply for all new products in WTO member countries
- ‘Reducing impediments to trade’
- ‘Promoting technological innovation and transfer to the mutual advantage of producers’
PreTRIPS, 50 countries did not respect pharmaceutical patents at all.
Articles 30/31 of the TRIPS Agreement spell out flexibilities that allow compulsory licensing to manufacture without permission of ‘rightful owner’ in a national emergency so that it is possible to access medicines that are still under patent at reduced costs.
Other articles cover more flexibilities eg public health need and public use.
However, to use these flexibilities, governments have to adapt their own national laws.
The TRIPS flexibilities allow countries to rightfully determine how they will access cheaper versions of newer medicines.
The Doha Declaration
The 4th WTO Ministerial Conference in Doha (Oct 2001) provided a clear political statement that public health concerns must override commercial interests – ‘a road map to key flexibilities in TRIPS’
- countries are free to determine what is a national emergency
- governments can override patents without negotiations with companies and without threat of retribution, where patent medicines are beyond the reach of people who need them
- countries can make own rules about parallel imports
- procedure for issuing a compulsory license becomes easier and faster
- least developed countries granted 10 year extension – TRIPS compliance at earliest by 2016 instead of 2006
In HAIAP we have been kept aware of the activities undertaken by our members to maintain the rights of countries to access to essential medicines in the face of enormous pressure from pharmaceutical companies such as Novartis in India, also reported here. Companies often try to confuse governments with misinformation – causing doubt about their legal rights to use the TRIPS flexibilities.
It is clear that there is need for our activities to continue.
Free Trade Agreements
Other threats to access to affordable medicines can come in the form of Free Trade Agreements (FTAs)
FTAs are negotiated in secret and agreements made can over-ride legislation. For example, even if legislation underpins the use of compulsory licenses to access generic copies of a medicine, the agreement can say that the country is obliged to import a particular branded version at higher cost.
Vigilance is crucial to expose and counter potential agreements that can have a negative impact on public health and access to medicines.
HAIAP has a very important role in advocacy associated with IP issues and with FTAs
Why is advocacy needed?
- To support peoples’ rights – solidarity
- To counter misinformation about what is possible / legal
- To clear up legal uncertainty of rights under TRIPS
- To counter efforts to weaken provisions of the Doha agreement – advocacy for delegates at regional meetings, ‘ministerials’
- To counter pressure on countries from vested interests eg MNCs and US government
- To address poor coordination between ministries or lack of awareness of implications of actions eg participation in ‘trade agreements’
- ‘chill factor’ – to support governments who are scared to use their rights because of perceived threats
- To counter myths
The Lancet Commission’s tasks are seen as
- Synthesising lessons learned from the first 30 years of essential medicines policies’ development and implementation
- Developing an agenda for the next 20 years of institutional, regional, national and global policies on essential medicines and other health technologies
- Raising global awareness of the relevance of essential medicine policies in achieving global health and sustainable development goals, with special attention paid to universal health coverage
- Defining the current needs of operational research that contributes to increasing the effectiveness and efficiency of essential medicines policies and programmes
Conclusions
During the last 30 years HAIAP members have stood against the might and wealth of people in power and have worked unselfishly for peoples’ health and justice. HAIAP members also recognise that to achieve equity in access to essential medicines it is necessary to work with governments to strengthen components of essential medicines systems by development and implementation of comprehensive national medicines policies. We feel that the Lancet Commission could beneficially call on the expertise that is available within networks such HAI and HAIAP given these networks’ 30 year history of championing the cause of access to essential medicines and rational use of drugs. The experience of individuals in these networks would be extremely valuable for appraisal of issues and agenda development.
More details about the Commission have been provided by the Boston University Centre for Global Health.
[1] www.thelancet.com Vol 384 November 8, 2014
[2] Report to the 28th World Health Assembly, Official Records of the World Health Organization, No. 226, Annex 13, pp. 96–110. Geneva: World Health Organization, 1975.
[3]E-DRUG – the international list serve on essential medicines discussion group – has developed a list of ‘Activist’ books that had been written and published to increase awareness of the issues that challenge access to essential medicines. They have called it a list of Books on Pills. The list here is in order of date of publication and will download to your desktop if you click here
[4]Kanji, N. (1989). Charging for drugs in Africa: UNICEF’s Bamako Initiative. Oxford Health Policy and Planning, 4, 110-120.