In the healthcare sector, recombinant DNA products, vaccines, monoclonals and targetted drug delivery in several facets are already available from developed countries. Some of these are now produced in a handful of developing countries. Presently, more than 40 recombinant DNA products and 15 potent vaccines, including recombinant ones effective against infectious and communicable diseases, a large number monoclonal antibodies to treat certain cancers, rheumatoid arthritis and cardiovascular conditions are available globally.
More than 700 new biotech drugs are under different stages of development the world over. There is yet no freely available published literature on the protected products that are patented in developed countries. There is also little interest in the developing countries on information about how many new products are under development. Such information needs to be continuously generated and extensively studied by industries in the developing countries in order to narrow down product selection, taking into consideration local strengths, capabilities and strategic advantages where applicable. Gene therapy, cell therapy, organ transplantations, effective immunomodulators at molecular level, genomics, proteomics and bioinformatics are at a developmental stage the world over, including in the developed countries. Opportunities could be created in developing countries for conducting research in some selected areas only by taking advantage of the local skills where available and by creating alliance with technology and resourcerich developed countries/industries. Diplomatic skills and long-term planning are necessary for creating such alliances. In agriculture, transgenic plants are are emerging at a fast speed the world over.
The spectra include transgenic crop plants that are resistant to pests, herbicides, various microbial diseases, abiotic stresses like salt tolerance, drought or excess water tolerance, etc. Some nutritional quality improvement programmes are also under development. Several disease-resistant transgenic forest plants are under experimentation. Some plants have been made to bear fruits that are used as vaccines against infectious diseases. All these developments in modern biotechnology are in the hands of a few international companies, although the application of these technologies would require the use of germplasms and local cultivators that are largely in the possession of developing countries. Therefore, alliances would be created among the technology possessors and the germplasm holders for creating a win-win situation among all the participating partners. Forest development through biotechnology is another area of relevance. The selection and development of trees resistant to abiotic and biotic stresses, the choice of microbes for creating healthy plants, the choice of recipes for the upgradation of degraded lands are some of the thrust areas that could be pursued.
Other biotech products used for the management of environment include transgenic microbes for cleaning of oil spills and toxic organic wastes, etc. Transgenic plants for accumulating toxic heavy metals from contaminated soils or water bodies are under development in certain developed countries. Applications of these technologies could be extended in developing countries. In the industrial sector, transgenic microbes for the production of enzymes used for treating textiles, leather, paper, etc. are also under development.
Several food-processing enzymes are in use, which are produced by recombinant DNA technologies. In these areas also, the need for collaboration from developing countries is enormous, although technological capabilities are yet not adequate in them. All these products and technologies are required for adding value to the primary regenerating raw materials.
CREATION OF INFRASTRUCTURE FOR SPECIALIZED SKILLS
In developing countries, companies would require acquiring skills in molecular biology and cloning of microorganisms, including bacteria, fungi, yeast and certain mammalian cell lines. Skill in fermentation, biochemical engineering, biochemistry, microbiology and molecular immunology would also be necessary. For medical products, expertise in conducting clinical trials, regulatory approval procedure and documentation would also be needed.
The developing countries could take advantage of research results in certain areas, such as conducting research with human embryos or foetal or adult human stem cells by creating conditions that are application worthy, as these materials are available in plenty. In agriculture, besides expertise in molecular biology and cloning capabilities, hands-on experience in conducting contained greenhouse and field trial experiments, especially when dealing with genetically engineered organisms, would also be advantageous. Environmental risk assessment and risk management capabilities have to be at the national level and companies should have capabilities to generate information in accordance with a country's regulations.
Transboundary movement of GMOs would also require the creation of strong infrastructure and knowledge about handling such products safely. Besides, food safety assessment capabilities would also have to be developed for crops, for which, appropriate upgraded laboratories with animal houses should be in place. In plants, for more experimentation is expected to upgrade the core competence besides improving the level of confidence, this will bring down the application time of economically beneficial food crops as well as forest plants that are empowered to withstand more unfavourable condition.
The IPR issues would assume tremendous significance and the IPR laws of countries should at least have to be consistent with the provisions of WTO. In fact, public-friendly IPR laws within the provision of would be more useful to the needs of developing countries.
SEEKING ALLIANCE FOR TECHNOLOGIES
Industries in developing countries would enormously depend upon access to technologies. External environment can have significant influence on in-country development of modern technologies in developing countries, which are resource-poor and multi-focused in developmental efforts. Modern technology development is a collective endeavour of skillful people in different disciplines. Individuals alone, howsoever skillful they may be, cannot achieve this. While industries in developing countries would be conducting some in-house R&D and may also be involved in sponsored research in public institutions by co-financing public institutions with governments, they would primarily be dependant upon acquisition of value-added technologies from a relatively small number of foreign companies.
Such technology providing companies would also be the relatively small players in the international context. Products from modern biotechnology being highly skill-based and also being extremely science-intensive, those who possess such technologies would not be ready to part with them, unless they are small companies or there are other compelling reasons. Powerful companies would usually be ready only to offer value-added products and services at exorbitantly high prices till competitors emerge in the scene and make the availability, driven by market competition.
Consequently, under the prevailing circumstances, strong in-house capabilities would have to be created not only to develop novel products but also to acquire skills to absorb the procured high-class technologies, so that further developments could be initiated for remaining competitive in the times ahead. Between the events of setting up production infrastructure and commercialization of biotech products, there is an event called marketing.
Biotech product marketing is a more complex issue than marketing of the commodities, including a pharmaceutical formulation. The intermediate players who affect actual sales, like doctors for pharma products, pathologists for diagnostic products or vocal public and farmers for agricultural products, need to be effectively informed. A strong line of active communicators needs to be developed and kept vibrant in place with a team of specially trained personnel in order to obtain success in sales. Biotech products introduced in the market by a group of generalists are anticipated to be aborted sooner than surmised from the market, if specialists do not continuously support them.
FACTORS GOVERN SUCCESS FOR PROMOTING ALLIANCE
Biotechnology industry is characterized by fierce competition. Only those countries would be able to take advantage that have created adequate infrastructure and have put concerted efforts to develop biotechnology through multi-disciplinary alliance. The success would include a well-defined product portfolio, early entry into market, acquisition of technical skills for process development and capability for rapid commercialization, emphasizing on application-oriented R&D, concentrating on off-patent drugs and teaming up with transnational corporations.
Strong alliance can be forged only between strong partners. Strength comes from skills and complimentary competence. Countries with abundant genetic resources are considered to be with gifted advantage. With leadership and determination, skills can be acquired.
Cuba is a glaring example of acquired skills in biotechnology. The need is to have a long term strategy. In the Indian context, about forty companies are presently involved in marketing of biotech products. Most of them have alliance with transnational corporations for product marketing.
Indian Institute of Science (IISc), Bangalore started a landmark experiment of providing space to companies so as to forge strong basic as well as application-oriented research within the premises of IISc. It was perhaps assumed that the complementing basic research capabilities would emanate from IISc and the companies at the space licensed by IISc would carry out the developmental R&D. This conceptually sound endeavour kicked-off well with Monasanto Inc. taking the lead followed by Cadila Pharmaceuticals and Lupin, but the myopic views of the institute and the researchers to obtain a lion's share of the grants from such collaboration along with equally stronger short- sightedness of the licensee companies to invest less in R&D, did not result in any great success. The antagonists to the concept added fuel to fire by viewing such a concept as commercializing institutes of learning into corporate cultures for profits and surpluses. The concept is getting weaker, day by day. There is a need to revisit the concept and to make changes in the policies at the national level that will enable the birth of economy - uplifting industrial endeavour from such befitting conceptions. In developing countries alliances would not come about without a push from the top.
Governments must push alliances as a necessity. They should not view these as obstacles to progress. Alliances happen among mature partners with complementing capabilities.
ALLIANCE: BENEFIT FOR DEVELOPED COUNTRIES
Alliance can be forged only among able partners. Ability arises either from the possession of complementing technological skills or from complementing synergies of supply -consumption needs. Some developing countries have a large pool of low-cost skilled manpower. They also have large potential markets. R&D cost for developing is usually much lower in developing nations. Cost of clinical trials for pharmaceuticals is substantially lower in developing countries. There are advantages of access to large germplasms, genetic materials, cheap agricultural raw materials and low-cost infrastructure.
Biotech research in future years would depend upon access to exotic genetic materials. The provisions of the Convention on Biological Diversity promote access to genetic materials through mutually agreed terms between the recipient and the supplier countries. As developing countries have greater access to such materials, alliances can also be forged between industries of developed countries and governments of developing countries for mutual benefits within the provisions of law and accepted cultural practices. Alliance in this area is expected to be gradually evolving.
Developing countries and industries therein would be benefited from alliance with industries in developed country in various ways. While there would be an opportunity to have access to modern biotech products, they would also learn the intricacies of handling such products, which are often fragile and require careful handling under cold chain conditions when they are pharmaceuticals.
These properties of bio-pharmaceuticals necessitate acquaintance in product documentation, registration and approval procedure. Such products also require specialized marketing networks, where documentation and supply cannot follow the usual routes of non-biotech pharmaceuticals. Qualified people need to handle such products, even for marketing. Use of such products also requires the setting up of sophisticated regulatory laboratories that could assess the quality of such products. In transgenic foods, agriculture capacities to identify such substances also assume importance as the products are new and the governments need to assure the public about their safety for which both identification and assessment of safety infrastructure needs to be upgraded.
Alliances between private parties in these areas for product marketing would require up-gradation of the regulatory infrastructure of a country that overseas safety as well as efficacy. Internationally reputed companies that possess biotech products seek to invest and team up with those countries and companies where they are assured of protected use of their products, ensured about adequate returns and encouraged by the government to invest.
However, an ideal environment does not exist. Consequently, within the prevailing environment, investment decisions are to be taken. Generally, developing countries form large potential markets that are growing fast as well. Besides, certain countries have surplus skilled manpower; adequate R&D infrastructure and government policies are supportive to collaborations.
Teaming up, therefore, brings additional bonus points. As biotechnology is highly science-based and heavily skill-intensive, several products and services could be created in small laboratories and could be in the possession of public or private funded institutions. Such products and services are protected through IPR and are often not available in the ready-to-use form.
- (The author is president, Biotechnology, Cadila Pharmaceuticals Limited, Ahmedabad)