The policy of Essential Drugs is, simply, an expansion of the political criteria developed above: to improve the evaluation process of the available drugs to identify those that exhibit with adequate technical evidence, clear advantages over similar compounds, so that society may, in this area of health care, use its resources in the most efficient way. The three basic criteria are, in logical order: Effectiveness, Safety and Cost/Benefit.
Two arguments usually arise when facing essential drugs:
1) First, it is said that the concept of essential drugs is an adequate policy for poor countries, but irrelevant in rich countries. A misconception has led supporters of this theory to consider that essential drugs are simply the cheapest. However, the essential drugs are selected for being the best, not for being less costly. Why are they then usually amongst the least expensive?
The price of drugs has little to do with the manufacturing cost and more with the marketing strategies of the manufacturer. A key factor in this strategy is the novelty of the product: each new product has great expectations, based on which a high price can be fixed. Paradoxically, that in- creases the expectations and the price that consumers (or, rather, the prescribers) are prepared to pay (or to have others pay) for the product. This price is maintained at a high level under the proprietary rights of the patent that, over a number of years, grants the absolute monopoly to the manufacturing company. When the patent rights end, new suppliers come to the market with prices closer to the real cost of the compound, but the original product has already «positioned itself» in the market and usually maintaing its original price level.
It is almost inevitable that expectations on the drug's effectiveness should fall over time, following a more or less typical curve. If the above is «almost» an inevitable fact, the evidence of the decline in safety is definite: every drug is launched based on the results of clinical trials, but always with some form of restriction. During these trials, a number of side effects may become apparent, and the probability of their appearance becomes statistically higher when their use is extended to the general population. Side effects with lower statistical probability begin to appear when the use of a drug has been made available to the entire population. For these reasons, a new drug is almost never ranked as an essential drug, since the real scope of either its effectiveness or safety has not yet been consistently proven. Essential drugs, therefore, are products which have been in the market for several years, during which time their proprietary rights usually have expired and their prices have reached an equilibrium level within the market.
It is common knowledge, for example, that use of third generation cephalosporins in Japan is more widespread than in other countries. Someone may believe that this would reflect a better use of this pharmaceutical resource since budgetary restrictions are not as strong. We all know, however, that such a situation, far from being optimal, is totally inconvenient and irrational, not only for each individual patient (who is quickly left without therapeutic alternatives in reserve), but for the entire society and humankind, that advances hopelessly towards bacterial resistance. Comparative evaluations conducted by various institutions on a regular basis show that some new products, with prices three (or more) times higher than the more traditional ones, offer practically no therapeutic advantage. So it becomes evident that the policy of essential drugs is not only valid for poor countries but also for those with greater resources. Rationality is not only for the poor.
2) The second controversial aspect refers to the presumed interference of the «prescriber's autonomy». Once again, we enter the realm of the role of the State. The State, which has meticulously supervised a prescriber's suitability before allowing him to go into practice, has every power to regulate such practice in the light of public health care requirements. Based on conspicuously technical evaluations, the State promotes the use of the best drugs, especially (but not exclusively) when such use occurs within public or National Health Service systems. In fact, a policy for essential drugs is nothing but an extension of the selective exercise carried out by the State, on behalf of the rights a community has to useful and safe products, to identify drugs which deserve marketing approval. The principle of convenience tends to be up for consideration in an increasing number of countries, especially as the pharmaceutical industry becomes more prolific, more complex and uses products which are increasingly powerful, and consequently more hazardous. We are, therefore, talking about State powers, which are above the winds of change of liberalization or intervention.
If we were to evaluate the specific exercise of the State authority in the selection of drugs, we would have to say that the least developed countries (where the selection of essential drugs is more firmly enforced) show a more uniform and a more effective defence of the social interests. Rich countries, shielded behind a supposedly unrestricted budget, are adopting an irrational use of drugs, which may have serious financial and health consequences.
A double line of thought can be traced in the richer countries: on the one hand, the incentive to the convenience evaluation policy to accept new drugs (most probably led by Norway); on the other hand, the lists of drugs selected by the National Health Service, as is the case of Great Britain5.
5 Within the developing world, this policy has nearly always been on the agenda. Note that, in Clinton's failed attempt to reform the Social Security system, a selection criterion for medicines was almost non-existent.