- Email: [email protected]
The countries' point of view
The countries' point of view Hermann G. Schatzmayr Several important factors in the supply of quality vaccines to developin9 countries are explained. These include central purchasing, establishment of a National control authority and local vaccine production. Keywords: Vaccine supply; developing countries; quality control; technology transfer
The role of countries in the process of obtaining vaccines of good quality can be presented in different ways. We discuss in this paper some points based on experience gained in developing countries in the last decades. On the subject of vaccine production, the vast majority of developing countries are importers and have to obtain the products abroad in order to immunize their children. Production of biologicals, however, is already well established in some not fully industrialized countries and it seems possible 1o expand the list of producers very quickly, especially in Asia. The most important aspects to be implemented in the developing areas, as basic approaches for better quality of vaccines, are: • Centralization of the purchase of vaccines, both imported and locally produced. Excluding the vaccines purchased by private doctors or the public, for individual use, a mechanism has to be organized at a central level in the country, to import or buy from local producers all biologicals necessary for the immunization of the population. This system allows an overview of all batches available in the country and avoids the use of low quality products purchased in small batches by regional authorities and, very often, used without previous control. • Establishment of a National Authority to control the quality of each batch of vaccine. A National Authority, competent for vaccine control, represents a basic approach 1o the quality of the products available in thc country. The National Authority should act as an independent organization, although collaboration with the producers is an important aspect of control. The control of the vaccines, in countries with limited laboratory capabilities, may be established stepwise, from sterility tests to potency evaluations and may demand a few years until a dependable and experienced staff'is ready to carry out their duties. The cost/benefit relationship of the establishment of such a group, however, is highly favourable and inter-
Fundaq&o Oswaldo Cruz, Rio de Janeiro, Brazil. 0264~410X/92/1309,54-01 ',i~ 1992 Butterworth-Heinemann Ltd
954
Vaccine, Vol. 10, Issue 13, 1992
national efforts should be made to support this goal. A network of laboratories in one country for vaccine control should be avoided. Maintenance of quality of the vaccine controller is also an important point to be evaluated. The control authority should be supported through national and multinational agreements to maintain a high standard of quality; training courses, conferences and exchange of experts dedicated to biologicals control, should be encouraged. The mutual collaboration of control authorities at a regional level has been shown to be very effective. An example is the annual course on measles vaccine control, carried out in Latin America, with international support, which assures a high standard for the measles vaccines used in the region. Other aspects such as legislation, biosafety and bioethics should also be supported and European manufacturers and controllers may play an important role in these matters. Implementation of local production of vaccines, by technology transfer to governmental and private institutions, in order to reduce the costs of importation and improve technological development of existing institutions. Technology transfer for vaccine production seems to be the long-lasting way to improve and keep the high quality of vaccines in the world. Indeed, technology transfer includes a close interaction of the institutions involved and the establishment of a strict control of quality along the process. Experience shows that technology transfer is not an easy task. Lack of stability of the institutions in developing countries seems to be the most difficult point to overcome. Difficulties in infrastructure and delays due to lack of decision by the local authorities are also problems which very often block good projects for years, until they are no longer feasible. We understand, however, that European producers, both private and governmental, are able to participate in this transfer of technology which would expand both market and business opportunities.
The role of countries in the process of obtaining vaccines of good quality can be presented in different ways. We discuss in this paper some points based on experience gained in developing countries in the last decades. On the subject of vaccine production, the vast majority of developing countries are importers and have to obtain the products abroad in order to immunize their children. Production of biologicals, however, is already well established in some not fully industrialized countries and it seems possible 1o expand the list of producers very quickly, especially in Asia. The most important aspects to be implemented in the developing areas, as basic approaches for better quality of vaccines, are: • Centralization of the purchase of vaccines, both imported and locally produced. Excluding the vaccines purchased by private doctors or the public, for individual use, a mechanism has to be organized at a central level in the country, to import or buy from local producers all biologicals necessary for the immunization of the population. This system allows an overview of all batches available in the country and avoids the use of low quality products purchased in small batches by regional authorities and, very often, used without previous control. • Establishment of a National Authority to control the quality of each batch of vaccine. A National Authority, competent for vaccine control, represents a basic approach 1o the quality of the products available in thc country. The National Authority should act as an independent organization, although collaboration with the producers is an important aspect of control. The control of the vaccines, in countries with limited laboratory capabilities, may be established stepwise, from sterility tests to potency evaluations and may demand a few years until a dependable and experienced staff'is ready to carry out their duties. The cost/benefit relationship of the establishment of such a group, however, is highly favourable and inter-
Fundaq&o Oswaldo Cruz, Rio de Janeiro, Brazil. 0264~410X/92/1309,54-01 ',i~ 1992 Butterworth-Heinemann Ltd
954
Vaccine, Vol. 10, Issue 13, 1992
national efforts should be made to support this goal. A network of laboratories in one country for vaccine control should be avoided. Maintenance of quality of the vaccine controller is also an important point to be evaluated. The control authority should be supported through national and multinational agreements to maintain a high standard of quality; training courses, conferences and exchange of experts dedicated to biologicals control, should be encouraged. The mutual collaboration of control authorities at a regional level has been shown to be very effective. An example is the annual course on measles vaccine control, carried out in Latin America, with international support, which assures a high standard for the measles vaccines used in the region. Other aspects such as legislation, biosafety and bioethics should also be supported and European manufacturers and controllers may play an important role in these matters. Implementation of local production of vaccines, by technology transfer to governmental and private institutions, in order to reduce the costs of importation and improve technological development of existing institutions. Technology transfer for vaccine production seems to be the long-lasting way to improve and keep the high quality of vaccines in the world. Indeed, technology transfer includes a close interaction of the institutions involved and the establishment of a strict control of quality along the process. Experience shows that technology transfer is not an easy task. Lack of stability of the institutions in developing countries seems to be the most difficult point to overcome. Difficulties in infrastructure and delays due to lack of decision by the local authorities are also problems which very often block good projects for years, until they are no longer feasible. We understand, however, that European producers, both private and governmental, are able to participate in this transfer of technology which would expand both market and business opportunities.