Nature：把生物技术从实验室带到病人床边（含原文）

Financial considerations

When it comes to finance, what is really meant is affordability and commercialization. New medicines developed as a result of advances in biotechnology must be affordable to people in developing countries (see page 176), and new drugs should be commercially viable in low-resource settings.

The commercialization of products for developing countries might entail financial risk. And entrepreneurs must take into account the limited funds available for production and the small profit margins in these regions. One way to boost commercialization is to manufacture drugs locally, making these drugs more affordable.

Increased affordability, in turn, results in access to larger markets and more opportunities for industry to balance profit and social benefit. An example of successful commercialization is India's first domestically produced and marketed recombinant vaccine against hepatitis B. The innovative manufacturing processes used by Shantha Biotechnics, in Hyderabad, made this vaccine affordable to the Indian population11. Another example is the vaccine against human rabies produced by Indian Immunologicals, also based in Hyderabad. The company developed a distribution network of refrigerated vehicles and franchise clinics to ensure that the vaccine reaches rural villages11.

Another crucial challenge for industry in the developing world is the weakness or absence of regulatory systems, which stifles innovation and patent registration and undermines the public's trust. Furthermore, our interviewees acknowledged that respect for intellectual property will be crucial if countries are to join the 'development ladder' (see page 174). But they emphasized that addressing global health crises will require ingenuity in devising commercialization strategies and guarding intellectual property.

A. NATH/AP

Engaging the local community is crucial to the success of new ideas.

For many interviewees, the issue of affordability was underpinned by considerations of fairness. Interviewees saw clear roles and responsibilities for providing affordable technologies to the poor on the part of the private sector, the government and international organizations. These involve differential pricing (supplying products to different markets at different prices) and single-buyer markets (for example, governments or the World Health Organization), subsidies for vaccines and drugs, building up infrastructure and providing health care. The moral imperative to make products affordable is especially strong when considering those who participate in successful clinical trials but cannot afford to continue treatment when the trial ends. Overall, the main challenge in terms of finances is to balance affordability with incentives to innovate.

Politics and policy

The final area that affects the development and uptake of health-related biotechnology is politics: political will and the domestic policy environment. Our interviewees stressed that governments should include biotechnology in policies aimed at broadening national development and that these policies should span the sectors of medicine, health, development and trade.

Governments have the potential to fund the development and manufacture of drugs and to supply the single-buyer markets that make drugs affordable. Our interviewees called for governments in the developing world to follow the example of countries such as Brazil, China, Cuba, India, Rwanda, South Africa and Thailand, which have reaped the benefits of policies giving priority to science and technology. For example, the world's first vaccine against infection with Neisseria meningitidis serogroup B, which causes meningitis12, was produced in Cuba. Antigens manufactured in Cuba are also distributed to other developing countries: for example, for the hepatitis B vaccine produced at South Africa's Biovac Institute in Wadeville.

Corruption, competing political priorities, inadequate public infrastructure for health care and anti-biotechnology lobbies can all block funding and access to new health products. Affordable hepatitis B vaccines, for example, fail to reach South Africans who need them, partly because public-health programmes are not politically expedient. Strong political champions, however, can forge progress. This has been shown by the New Partnership for Africa's Development, which has increased the visibility of science and innovation to African heads of state and has acknowledged the link between economic transformation and innovation in science and technology.

A model for the future

Several of those interviewed for our study stressed the importance of a broad approach to health-related biotechnology issues. For example, Adi Paterson, Group Executive of the South African government's Department of Science and Technology, urged all investigators to consider ethical factors in their analysis: "When a model is science-centric, it loses its ability to actually reflect early on the ethical question."

As a result of our interviews, we have assembled a model that can be used to assess the potential success of particular health-related biotechnologies with respect to bottlenecks, regional variations and changes over time. (see graphic, above). In addition to the more obvious issues relating to science and finance, our model highlights that other issues — ethical, social, cultural and political — need to be addressed when seeking to improve health in the developing world.

It provides a framework for taking health-related biotechnology from the lab to the village. It offers a guide to structuring product and market readiness and to identifying factors that could impede the development of new products, such as vaccines, nutritionally enhanced foods, chemical and genetic strategies to control vectors, and diagnostics.

Using the model to assign priorities should streamline the development and adoption of emerging technologies. The model could, for example, be applied to the 2007 report Freedom to Innovate: Biotechnology in Africa's Development by the African Union and the New Partnership for Africa's Development, specifically to the 20-year comprehensive approach to fostering health-related biotechnology in the region. In this context, the model could provide a blueprint for commercializing African health products.

We asked our study participants only about health-related biotechnology, so we cannot claim that the model applies to other types of technology, although it might resonate with some. We also acknowledge that the limited number of Latin American participants could diminish the scope of the model's application in that region, so the model might not apply in all developing-world contexts. However, key themes recurred in different regions, supporting the general relevance of the model. Some components of the model might seem simple and self-evident to experts, but this only affirms the validity of our empirically generated model.

Backed by the voices of experts in the developing world, the model enables the complex issue of biotechnology development to be systematically tackled, through examining the forces that affect health-related biotechnology in developing countries. The millions of deaths from preventable diseases every year demand clarity in interpreting and addressing these factors.