The standardisation accomplished in recent years in the International Pharmaceutical Industry, signifies a major leap ahead for the innovative pharmaceutical firms along the road which they have spent years building and improving. The fact that the norms are consecrated precisely at that point in time when emerging countries are undergoing epoch-making changes in their approaches to development, means that there is an urgent need to examine the steps these countries can and should follow. Such steps encompass actions at national level and efforts aimed at reinforcing the interchange of information and experiences. The sketch which follows in no way lays claim to originality regarding the methods suggested - but it does underline that the context in which the measures are to be undertaken is new. Three broad headings may be signalled:
(i) Regarding Products; critical aspects are:
• organisation of national committees for register and evaluation of pharmaceuticals, and for the exchange of working methods, guides and staff among them;
• likewise with regard to good manufacturing practices;
• exchanges of experience/information regarding the application of new standards and the space which thereby remains for the design of policies (whether national or wider in scope) in this area:
- data banks on technology and production systems sources;
- the functioning of public purchasing systems.
(ii) Regarding skill formation and information; key elements are:
• diffusion of information to doctors and pharmacists on choice of drugs and prescription handling;
• detailed examination of the lessons to be learned from countries where standards have been operating for some time (for example, in the management of cost containment policies, the use of incentives to R&D);
• choice of key investments to promote skill formation and R&D.
(iii) Regarding the organisation of pressure groups. It should never be overlooked that changes of context in the International Pharmaceutical Industry are the outcome of political struggles which demand good organisation. Whether the mechanisms used are the «industry clubs» of ASEAN, the sectoral councils that frequently function in multilateral negotiations in Latin America, or through groups such as ALIFAR, it is vital to seek a joint vision, establish what that implies in terms of political/institutional context, and invest in the necessary entities and logistics to consolidate the steps. If this does not happen the pharmaceutical industry in emerging countries runs the risk in the future of being the «standardised object», instead of being the prime actor in the setting of standards.