(2004; 98 pages)
2.5 The national level
In most developing and transitional economies, medicines represent the second largest government health expenditure after personnel costs. Getting the best health care value for such expenditure is vital. Consumer use of medicines is affected by government policies on provision of essential medicines through public health channels and by the regulation of the supply and promotion of medicines by the private sector.
Implementing essential medicines policies
Today more than 150 countries have an essential medicines list. In 1999, 71 countries reported to WHO that the list guides drug procurement in the public sector (WHO, 2000). However, drug supply in the private sector is generally neither regulated nor guided by the essential medicines policy. This is a problem, as studies show people rely heavily on private and informal sources of medicines. The Philippine market, for example, includes more than 14,000 medicines. Many of these drugs are not essential, expensive, unsafe and ineffective. Most of them can be bought over-the-counter even if they are registered as prescription-only products. It is impossible for rational drug use programmes to inform consumers about all 14,000 medicines on the market.
Essential medicines policies tend to emphasize drug procurement and supply, and appropriate prescribing by health workers. Promotion of rational drug use by consumers is not a priority in many countries.
Reductions in spending in the public sector make it difficult for governments to provide quality health care and the essential medicines that people need. It also becomes more difficult to control the way in which drugs are used. The current focus on private/public partnerships makes it much harder for governments (or international agencies) to promote policies which may not be consistent with the interests of major players in the private sector or with ‘free market’ philosophies. Social solidarity and support to the public sector are less of a priority and the solutions to lack of access are increasingly sought in terms of stimulating the private sector and partnership with the industry rather than in strengthening basic services and reallocation of resources.
In some countries, particularly in Latin America, the increasing importance of the private sector has been accompanied by reduced government regulatory control of pharmaceuticals. However, as WHO has pointed out, as the role of the private sector increases stronger not weaker central, i.e. government regulatory control, is required.
The private sector includes private pharmacies and drug sellers, private not-for-profit NGOs (for example, the Church is a major provider in many African countries) and the informal or illegal sector (many drugs exchange hands through market stalls or are sold again after being prescribed by a health worker). The private sector is harder to regulate/control and influence than the public sector. Improving drug use and implementing the essential drugs concept in the informal and illegal sectors is very hard.
Drug promotion creates demand for medicines in various ways. Firstly, it defines illness conditions that need treatment. It also promotes the idea that medicines are the best remedy as opposed to non-drug alternatives. Lastly, it tends to emphasize a medicine’s efficacy while minimizing possible health risks.
Companies spend vast amounts of money (an estimated one-third of sales revenues) on marketing. This is often more than double the amount spent on research and development (Mintzes, 1998). Campaigns to promote the rational use of medicines have much less money to spend. In the absence of effective regulation of drug promotion, community interventions to promote rational drug use will have limited impact.
Drug promotion to consumers is becoming an increasingly important component of drug companies’ marketing strategies (Mintzes, 1998). In the past, most consumer advertisements promoted over-the-counter medicines. More recently, companies have started promoting prescription drugs to consumers. Direct-to-consumer advertising (DTCA) for prescription drugs is allowed in the United States and New Zealand. It is now under consideration by regulatory authorities elsewhere. The pharmaceutical industry has devised ways to create consumer demand for prescription products even where DTCA for prescription medicines remains illegal (Mintzes, 2002).
WHO’s Ethical Criteria for Medicinal Drug Promotion (WHO, 1988), adopted at the 1988 World Health Assembly, call for promotion of prescription and over-the-counter drugs to contain reliable claims without misleading or unverifiable statements. The Criteria also state that promotion should not contain omissions that could lead to health risks. They emphasize that promotion should not be disguised as educational or scientific activities. Ten years later, WHO reported that the Criteria have only been adopted to a ‘modest’ degree in national drug policies. Criteria for drug promotion are only mentioned in 17 of 42 national medicines policies studied and their implementation remains weak (WHO, 1998). A separate study done in Australia, for example, analysed 140 advertisements to the public and found that only 29% provided warnings or cautions about possible health risks (Watson, 1995).
Financing and reimbursement
One of the big differences between consumers in industrialized countries and most of those living in developing countries is the payment mechanisms for drugs. In industrialized countries, the cost of prescribed medicines tends to be covered by social security or private insurance schemes. At the national level, insurance companies’ reimbursement policies play an important part in shaping medicine use. In some countries, such as the Netherlands and the United Kingdom, the government decides which medicines will be reimbursed, so ensuring equitable access to essential drugs. In the United Kingdom, the National Institute for Clinical Excellence (NICE) is charged with determining which new drugs should be available in the National Health Service. In developing countries, medicines are sometimes available in public health services. To obtain them, people must often pay a user fee, a cost that is sometimes proportional to the amount of medicine received. However, access to medicines in the public sector is limited. The majority of medicine purchases occur in the private sector in most countries. Drug costs are an important factor in consumers’ decisions on how to treat illness episodes, as we have seen.
Consumer advocacy can influence drug use at the national level of health care. Advocacy initiatives include monitoring implementation of essential medicines policies, informing health workers and consumers about the rational use of medicines, and highlighting unethical drug promotion practices. However, many developing countries, particularly in sub-Saharan Africa and the Western Pacific region do not have consumer organizations. Those that do exist may not be powerful enough to influence policy. Patient organizations tend to focus on the medicine needs of specific patient populations. At times they push governments to allow new drugs on the market and lobby for these drugs to be reimbursed. In such campaigns patient groups are often the allies of pharmaceutical manufacturers.
The media can play a key role in raising awareness on problems with drugs, publicizing serious health hazards related to drugs, when these are brought to their attention. Also, unethical promotion is an issue that journalists tend to pick up. Media attention can have a positive effect on consumer drug use, but can also sensationalize the discovery and potential efficacy of new untried and often unregistered drugs. The media are frequently used by the pharmaceutical industry to covertly promote products in the guise of what has come to be known as “advertorials”. Moreover, the pharmaceutical industry is often a significant advertiser and broadcasting companies, newspapers and journals may be hesitant to publish information perceived by the industry to be negative.
Pharmaceutical companies attempt to interest mass media journalists in their medicines. For example, one study reported that even though journalists tend to be sceptical about information from industry sources, in practice they often use industry materials for articles on medicines (van Trigt, 1995). The researcher found that drug manufacturer, GlaxoSmithKline, informed Dutch journalists about its new anti-migraine drug sumatriptan (Immigran) at a scientific meeting before the product was officially registered. The announcement led to a series of newspaper and magazine articles that reported on the “new drug against migraine, not yet available in the Netherlands” and stated that the “new anti-migraine drug is effective”. This media coverage led to a discussion in the Dutch Parliament on ‘clandestine advertising’. The same debate has taken place in the United Kingdom, with an incontinence campaign initiated by the company Pharmacia and Upjohn as the focus. Television advertisements used in the campaign encouraged women with bladder control problems to see their doctors although DTCA is illegal. In an interesting twist, some of these ‘disease awareness’/ DTCA campaigns are strongly supported by patient groups. This may be linked to the fact that patient groups (both national and international) are increasingly and sometimes solely funded by the pharmaceutical industry (Herxheimer, 2003).
Public education on medicines for consumers
Few countries have effective public education programmes. Often the programmes are limited in coverage and content, for example, there may be educational programmes on malaria treatment, but not on other diseases. School curricula are often put forward as an ideal medium for public education on medicines, but only a few countries have such curricula.