There are three groups (or centres of concern) which strive for normalisation in various dimensions of the drug market. First comes the State, with its obligation to protect the health of citizens. The mechanisms it employs are: the pharmaceutical register; quality control and evaluation of drugs; monitoring good manufacturing practices; and negotiation of prices. The impacts of these instruments can vary according to the specific norms established, e.g. good manufacturing practices cost money to establish and sustain, and the private investments involved are generally higher if the good manufacturing practices are international rather than national or regional5. For this reason, norms of very high level would tend to be an obstacle for smaller, domestically financed companies. Second are the innovative pharmaceutical firms. They want control of market access (for products, firms and distributors), and a certain freedom to set product prices. The instruments used for these purposes have impacts at two levels. With regard to access as such, the rights obtained through intellectual property are of critical significance, although other aspects of the marketing of products also play a major role (advertising laws are a prime example).
5 It would appear that in some cases the outlays simply to reach the standards of national GMP are excessively high; in Indonesia, for example, 40 per cent of local firms say that they cannot afford the necessary investments. In such a situation, the relevant firms should be closed by the authorities.
In the areas of production and trade there are, besides what is established in patent law, important factors which include the regulations that influence foreign direct investment and tariff policy. These matters fall within the sphere of government and not directly that of corporations. Yet it is here that the strength of international normalisation makes itself felt. The innovative pharmaceutical firms, through the presentation of views to their own governments (the outstanding case is that of PhRMA and the US), with the aim that they will be taken as the official position in international negotiations, and to emerging countries governments so that they might modify their domestic rules and practices, have managed to turn the instruments of production and trade into their very own assets.
For the third group we must again consider the State, but this time in its obligations to look after the economic well-being of the country along with the health of the citizens. The relevant instruments are normally those which help to improve the relationship between cost and quality, and those which encourage local production (the two aims do not always go hand in hand). The most common examples, besides those which pertain to generics and to customs policy, are public purchase and fiscal policy (in relation to firms).
From this sketch of the factors driving normalisation, a few conclusions can be drawn which shed light on recent events and on likely developments. First, the drug market necessarily requires normalisation: what really counts is, who are the organised groups that influence the process? Second, a norm can, according to its content, favour evolution of one kind of market or another. The convergence of norms among countries whose morbidity/mortality profiles diverge considerably, brings with it the prospect of a growing dichotomy in some of those countries, between market structure and health needs. Third, some caution is required when it comes to describing exactly what structure of market will be shaped as a result of adopting particular norms. The prevailing terminology («free», «unprotected», «global») often disguises rather than clarifies the processes at work. Only an empirical analysis can indicate the real directions in which normalisation is leading: the aim of the following subsections is to provide such an assessment.