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Drugs are not enough


8-9/2005
 

Drugs are not enough

Distorting the debate, HIV/AIDS has drawn international attention to drug prices. While excessive drug prices do prevent treatment, financial affordability does not, in itself, guarantee that needy people will be helped. The general public’s acceptance of health services is essential, and so is accessibility. The government must serve its function as steward of public welfare. Civil society also has a useful role to play.


[ By Alexander Schulze ]

Public debate on poor people’s access to treatment revolves around the availability of affordable drugs. This argument was triggered by the rapid spread of HIV/AIDS. The pandemic is causing great individual suffering by millions of people with enormous social and economic repercussions. Social problems are seldom discussed without the question of responsibility being raised. Accordingly, the research-based pharmaceutical industry has been targeted as the relevant actor.

Indeed, only few pharmaceutical companies responded proactively to the HIV/AIDS-crisis. Most did not consider it their responsibility to provide cheap drugs for the disadvantaged. One reason was that effective generic drugs had been available for decades for most tropical diseases such as malaria and tuberculosis. Second, the pharmaceutical companies’ markets are mainly in rich countries, where prosperous customers, whose illnesses frequently result from affluent life styles, require other drugs than those needed in the poorest countries.

That situation has changed, however, because of the spread of HIV/AIDS on the one hand and the development of resistances to common malaria and TB drugs on the other. The precarious situation of many poor people gave rise to public pressure. NGOs and the media compelled the pharmaceutical industry to respond to the new challenges, be it by way of drug donations, differential pricing for rich and poor countries, or non-prosecution of patent infringements in least developed countries. The increase in the number of corresponding industry initiatives is proof of growing problem awareness (DFID 2005). There is even new momentum in the research on diseases previously neglected. Among those to contribute to this trend are private actors such as the Bill and Melinda Gates Foundation, public-private partnerships and non-profit research institutes of the pharmaceutical industry (IFPMA 2004).

Nevertheless, there is still controversy. Patent issues are one example. International NGOs want pharmaceutical companies to relinquish their patents, so that drugs can be made widely available. Research-based firms, however, insist on off-setting their high expenses through patent protection. They therefore favour setting up differential pricing systems, such as Novartis does with the malaria drug Coartem, or granting licences to selected manufacturers of generics. Both practices make sure that drug prices do not collapse in advanced nations.


Limited reach

These issues deserve debate. However, it should be clear that drug prices are not the only factor that determines access to medical treatment. They are perhaps not even the main factor. The fight to eliminate leprosy provides a telling example. Since 1995, an effective combination therapy has been available free of charge for all patients throughout the world. Japanese foundations guaranteed free drug provision until 2000, and the manufacturer Novartis has been doing so since. Nonetheless, the number of patients treated did not iniatially increase as was hoped. Only after extensive awareness raising campaigns and the integration of leprosy treatment into general health services were many previously “undetected” cases reported. It was impossible to contain leprosy on a global scale until these people were treated (WHO 2005: 118-123, Grewal et al. 1998).

It was necessary to raise awareness to break down the stigma associated with leprosy, which prevented sufferers from seeking diagnosis and treatment in the first place. Even the prospect of free treatment did not encourage many of the affected to visit the specialist clinics, because they did not want to be ostracised as “lepers”. It was therefore essential to spread the message that leprosy can be cured and does not result in deformity if treated early on. It also had to be made common knowledge that there is no longer any risk of infection once treatment has started.

Moreover, the integration of leprosy treatment into general health care services made facilities available closer to patients. As a result, transport (and similar) costs dropped. The integration strategy was successful as local personnel can now diagnose and treat leprosy with simple resources. It has become possible to eliminate the public health problem of leprosy in the foreseeable future.

This example demonstrates that the availability of effective drugs is not enough to provide people with treatment. This over-arching goal must be pursued on a case-by-case basis. In the case of leprosy, the issue was to destigmatise the disease and to integrate leprosy therapy into the general health care system. In the case of HIV/AIDS, the situation is quite different. Of course, there is also a stigma attached to this pandemic. However, we are dealing with a chronic infection for which there is currently no cure. Patients require treatment for life, and this treatment is much more complicated than the one for leprosy. Consequently, it will not be possible to provide treatment free of charge for an ever decreasing number of patients until the eventual elimination of the disease, as is being done in the case of leprosy.


Access issues

Given the complexity of the access problem, it makes sense, at an operational level, to pursue comprehensive approaches, which allow for specific contexts. One must consider, first, features of the illness in question and, second, socio-economic conditions in the region where it is prevalent. Our diagram distinguishes five basic elements which affect access to treatment (Penchansky, 1981): affordability, availability, quality of care, acceptability and accessibility.

The five elements entail a variety of potentially decisive factors. For example, affordability depends not only on the drug price, but also on consultation, transport or opportunity costs such as loss of wages. However, many people cannot even afford cheap generic drugs, which account for 302 of the 319 compounds listed on the WHO Essential Drug List, unless they are protected by insurance, a welfare state programme, or a social network. In the agricultural hinterland of many developing countries, most farmers are at best able to afford generic drugs, which are cheap only in global terms, after the harvest season. For this reason, the topic of micro-insurance will probably gain more attention in the general development debate. It is likely to acquire a status similar to that of micro-credit.

The availability of effective treatment, however, depends not only on drugs, but also on accessability of health facilities, pharmacies and suchlike. Medically competent staff are not of much help if they do not act in a patient-focussed way, deterring sick people from attending health facilities (WHO 2000: 23ff).

At the level of acceptability, treatment provision heavily depends on how households perceive illnesses, health care providers and drugs. In Tanzania, it is not unusual for children with a serious form of malaria, of which convulsions are a symptom, to be taken to traditional healers rather than to public hospitals. Their parents, after all, believe they are suffering from spirit obsession rather than from an infectious disease. These children only reach hospitals late when tradtional treatment does not take effect. If the children die in hospital, however, that reinforces the public health system’s negative image and scares away other patients.

Moreover, health institutions are often too far away. In the time of high transmission risk in Tanzania, for example, 79 per cent of the malaria cases investigated occur precisely when many rural families temporarily move to remote areas where they cultivate land far from their villages. This was revealed in studies carried out as part of the ACCESS project, which the Novartis Foundation is undertaking in cooperation with the Swiss Tropical Institute and a scientific organisation in Tanzania.

As the diagram also shows, the various dimensions are interdependent. Whether services are culturally acceptable, for instance, depends on how they are made available. If patients do not adhere to treatment, on the other hand, there is the risk of setbacks as well as an increased likelihood of resistance development. To counteract these phenomena, treatment must be easily understood and simply carried out. Moreover, access to treatment is determined not only by micro-factors within the home or the local health system, but also by macro-determinants. Health policy, research and development cooperation can all make a difference.

Poverty and vulnerability, in their various dimensions, also interact with the other factors. All summed up, access must be improved in other senses than only the quality and affordability of drugs. It is important that patients demand treatment, comply with advice and are satisfied with the results.


Practical consequences

Based on the factors listed above, it is possible to draw up a frame of reference, which allows us to thoroughly analyse specific access problems and to put together an appropriate package of measures. A number of key questions helps to provide a better understanding.
First, typical access obstacles should be analysed:
– Are effective and affordable drugs available?
– How relevant are the quality, accessibilty and cultural acceptability of the treatment providers in question?
– Is information available on similar access problems, and has it been analysed? Is new research necessary?
– Are the obstacles at an international, national or local level?

The following questions arise with regard to planning and implementing access-oriented interventions:
– At which levels is action necessary?
– Which actors should be involved, and what expertise should they have?
– Which obstacles can actually be overcome, given the background of existing cooperation and the current financial environment?
– How can the services necessary in resource-poor countries be provided on a nation-wide basis and in a competent manner, but at the same time cost-effectively and for the long term?
– Are the interventions chosen appropriate in cultural, social and technical terms and have they been institutionally embedded?

Monitoring and evaluation should be guided by the following questions:
– How efficient and cost-effective are the interventions implemented in terms of reducing the obstacles identified?
– Which obstacles prove to be significant?
– Are findings analysed continuously and are results made available?
The ACCESS project has adopted this frame of reference and carried out interventions on two levels to improve access to malaria treatment. First, there is an extensive awareness raising programme explaining the illness with the goal of encouraging treatment acceptability in tune with the national guidelines. Second, ACCESS aims to improve the quality malaria treatment in public services and pharmacies. Both aspects are evaluated regularly.


Sustainable cooperation

Cooperation between Novartis, the WHO and the relevant national health ministries was and is critical for the fight against leprosy. Novartis is supplying and shipping the requisite drugs in the necessary quantities, whereas WHO organises the distribution to the countries affected. Without leadership from the national health ministry, however, it is impossible to integrate leprosy services or to raise awareness properly.

The complexity of the access issue calls for constructive and sustainable cooperation. So does the need for context-specific approaches. Whenever pharmaceutical companies donate drugs or grant favourable terms, they depend on the relevant national health ministries, international health organisations (WHO, UNICEF), and bilateral donors and NGOs working together to remove non-price obstacles to treatment.

Health ministries in particular must act responsibly, draft appropriate strategies and implement them at an institutional level. The state must serve a steward function, as is also evident in the emerging debate on the right to health (Leisinger 2005). State actors must register drugs, develop treatment guidelines and provide training for staff. Patients and health care providers must be involved in the areas of acceptability, quality and accessibility for services to build ownerhsip and sustainability. In this context, NGOs and bilateral donors can be of help because, unlike the pharmaceutical industry, they understand the socio-cultural environment.




Alexander Schulze
is a project manager with the Novartis Foundation for Sustainable Development. He is in charge of issues related to health service funding and access.
alexander.schulze@novartis.com
http://www.novartisfoundation.com




References:
ACCESS-Programme: http://www.novartisfoundation.com/en/projects/access_health/malaria/index.htm
Department for International Development (DFID) 2005: Increasing people’s access to essential medicines in developing countries: a framework for good practice in the pharmaceutical industry. London.
Grewal, Penny et al. 1998: Social marketing to eliminate leprosy in Sri Lanka. In: Social Marketing Quarterly 4, p. 27-31.
International Federation of Pharmaceutical Manufacturers Associations (IFPMA) 2004: Building healthier societies through partnership.
Leisinger, Klaus M. 2005: The Right to Health – A duty for whom? In: UN Global Compact Quarterly. April.
Penchansky R. / J.W. Thomas 1981: The concept of access: Definition and relationship to consumer satisfaction. In: Medical Care. 19 (2).
WHO 2000: The World Health Report 2000 – Health systems: improving performance. Geneva.
WHO 2005: Weekly Epidemiological Record. No. 13, 80.