Halla Thorsteinsdóttir

Top ten biotechnologies for improving health in developing countries.

Most research into genomics and other related biotechnologies is concerned with the priorities of industrialized nations, and yet a limited number of projects have shown that these technologies could help improve health in developing countries. To encourage the successful application of biotechnology to global health, we carried out a study in which we asked an international group of eminent scientists with expertise in global health issues to identify the top ten biotechnologies for improving health in developing countries. The results offer concrete guidance to those in a position to influence the direction of research and development, and challenge common assumptions about the relevance and affordability of biotechnology for developing countries.

Regenerative Medicine and the Developing World

This is the first study to systematically identify and prioritize which applications of regenerative medicine are the most promising for improving health in developing countries.

Cultivating regenerative medicine innovation in China

AIM While China has become a significant contributor and prolific publisher in regenerative medicine, its role in the field is not well understood. We analyze how capacity in regenerative medicine was built in China to identify some of its main strengths and challenges. MATERIALS & METHODS This case study of regenerative medicine in China is primarily based on interviews with experts in China, including researchers, policy makers, clinicians, representatives of firms and regulators. RESULTS Our analysis shows that diverse groups are active in this field in China. Leading research groups are contributing extensively to international peer-reviewed journals. Strong governmental support and recruitment of highly trained Chinese scientists from abroad has made it possible for China to rapidly build up capacity in regenerative medicine. However, some hospitals in China are offering stem cell therapies with limited scientific evidence supporting their efficacy/safety, and international skepticism of medical research in China presents a challenge to the development of the field. CONCLUSION China has been able to catapult itself into the forefront of regenerative medicine but needs to address current regulatory challenges in order to secure its position in this emerging field.

South-South entrepreneurial collaboration in health biotech

A survey of entrepreneurial collaborations among health biotech firms in developing countries reveals a surprisingly high level of collaboration but a lack of emphasis on new or improved health biotech products and processes.

Priority setting for orphan drugs: An international comparison

OBJECTIVES To describe the process of priority setting for two orphan drugs - Cerezyme and Fabrazyme - in Canada, Australia and Israel, in order to understand and improve the process based on stakeholder perspectives. METHODS We conducted qualitative case studies of how three independent drug advisory committees made decisions relating to the funding of Cerezyme and Fabrazyme. Interviews were conducted with 22 informants, including committee members, patient groups and industry representatives. RESULTS (1) DESCRIPTION: Orphan drugs reimbursement recommendations by expert panels were based on clinical evidence, cost and cost-effectiveness analysis. (2) EVALUATION: Committee members expressed an overall preference for the current drug review process used by their own committee, but were concerned with the fairness of the process particularly for orphan drugs. Other informants suggested the inclusion of other relevant values (e.g. lack of alternative treatments) in order to improve the priority setting process. Some patient groups suggested the use of an alternative funding mechanism for orphan drugs. CONCLUSIONS Priority setting for drugs is not solely a technical process (involving cost-effective analysis, evidence-based medicine, etc.). Understanding the process by which reimbursement decisions are made for orphan drugs may help improve the system for future orphan drugs.

Introduction: promoting global health through biotechnology.

term ‘health biotechnology’ evokes images of research-intensive universities such as Stanford University and the Massachusetts Institute of Technology (MIT), as well as initial public offerings on NASDAQ. Ty pically, we don’t think about biotechnology in connection with health solutions for poor people in developing countries. Still, as has been demonstrated in a technology foresight exercise, biotechnology can potentially be applied to a wide spectrum of health problems all over the world 1 .S uccessful research and development in health biotechnology is taking place in several countries that typically are classified as lower income countries or developing countries. With a view to understanding these successes and reproducing them more widely in the developing world, we have undertaken a detailed study of health biotechnology development in seven countries. This supplement reports the results of a 3-year study of health biotechnology innovation systems in Brazil, China, Cuba, Egypt, India, South Africa and South Korea. When compared with industrially advanced nations, the seven countries in this study are each at a different stage of economic development, but they can generally be considered ‘innovating developing countries’ (IDCs) 2 . Our objective was to identify and analyze the conditions encouraging successful development of health biotechnologies in developing countries. Ultimately, we want to identify lessons on how these countries have been able to build up capacity in health biotechnology. These lessons can potentially be put to use in other developing countries that so far have not succeeded in promoting biotechnology development, but may also be of relevance to industrially advanced nations. This

Off the beaten path

Biotech is no longer the exclusive domain of Western economies. A group of experts from around the world discuss emerging trends and opportunities for biotech in territories outside the United States and Europe.

Genomics--a global public good?

In October, 2002, scientists published the sequence of the parasites responsible for most of the world’s human malaria, Plasmodium falciparum and P yoelii, as well as the mosquito that carries it, Anopheles gambiae. (1-3) The knowledge of these genomes and of the human genome, will lead to new drug and vaccine targets against malaria. But how fully will new genomics knowledge be used to the benefit of developing countries?

Genomics knowledge and equity: a global public goods perspective of the patent system

Genomics, the comprehensive examination of an organisms entire set of genes and their interactions, will have a major impact on the way disease is diagnosed, prevented and treated in the new millennium. Despite the tremendous potential it holds for improving global health, genomics challenges policy-makers to ensure that its benefits are harnessed equitably across populations and nations. The classification of genomics as a global public good and the inequity encountered in the development and application of genomics knowledge are outlined in this paper, We examine the effect of the current patent system on the distribution of costs and benefits relating to genomics knowledge between countries of different economic strength. The global public goods concept provides a normative economic rationale for the modification of certain aspects of the current patent system and for the creation of complementary mechanisms to respond to the health needs of low-income and middle-income countries.

Biotechnology patenting takes off in developing countries

We investigated the levels and patterns of biotechnology patenting in several developing countries by examining patents registered in the US Patent and Trademark Office (USPTO) database. The results showed, firstly, that developing countries have increased their biotechnology patenting during the period with the leading countries demonstrating inventive strengths in this field. Secondly, whereas in some countries national patenting ownership was high in others it was relatively low, which may limit the ability of the countries to harness their inventions. Thirdly, the research sector has been particularly active in patenting, especially in countries with relatively strong track records in developing biotechnology products, but industrial patenting is still limited in most of the countries studied. Finally, several of the countries we examined have a strong focus on health biotechnology compared to other types of biotechnology in their patenting rates. It remains to be seen if the increased patenting will foster biotechnology innovation.