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The innovation of medicines: addressing medical needs worldwide

There is growing global concern about the low productivity of the pharmaceutical and biotechnology industry. Research and development (R&D) is expensive, and there are many regulations for introducing new medicines. How does this innovation process work and what are the implications for developing countries?

The Organization for Economic Cooperation and Development (OECD) initiated a project to investigate the innovation process in the pharmaceutical and biotechnology industry among its 30 member countries. Tufts University’s Center for the Study of Drug Development (Tufts CSDD), USA, was asked to review a sample of current innovation projects among OECD countries. The aim was to deliver better convergence between health care priorities and innovation and identify the tools necessary for appropriate decision making by governments, industry and academics.

As a follow-on project, Tufts CSDD studied innovation projects in non-OECD countries, many of which are developing countries. Although the innovation process is fundamentally the same in both regions, and regardless of the disease being researched, the circumstances in non-OECD countries create additional problems. These include:

• a lack of capacity to manufacture new medicines and a lack of laboratories for research
• a lack of capital, both investment and intellectual (core expertise and specialised training)
• competing public health priorities, due to the huge number of unmet medical needs
• complicating factors, such as political instability, environmental crises and poverty.

Their preliminary findings were:

• The five diseases with the highest mortality rates in non-OECD countries were HIV and AIDS, diarrhoeal diseases, malaria, childhood cluster diseases (such as measles and polio) and tropical diseases (such as Chagas’ disease and leishmaniasis). All these mortality rates were higher than in OECD countries.
• In non-OECD countries, there were three times more programmes addressing HIV and AIDS than for the other four disease groupings put together.
• The major organisational approach was public-private partnerships (51 percent). The majority of these focus on drug development (41 percent), but also global health, regulation and quality assurance, drug and health service delivery and drug access and distribution.

Efforts to improve the efficiency of innovation in OECD countries focus on strengthening education and training, modernising clinical trials methods and increasing meaningful communication between regulatory agencies and industry. In contrast, the main focus in non-OECD countries is targeting the work of new R&D institutes and laboratories, and effectively distributing limited resources to severely under-resourced health services.
With this in mind, innovation projects in non-OECD countries must:

• Focus on greater sustainability by making better use of domestic raw materials such as indigenous medicinal plants, and increasing the manufacturing capacity for bulk and finished products
• Achieve a more balanced distribution of projects among all diseases with disproportionately high public health impacts.

Christopher-Paul Milne and Brian Young

Further Information
Tufts Center for the Study of Drug Development, Tufts University, 192 South Street, Suite 550, Boston, MA 02111 , USA

Email christopher.milne@tufts.edu or brian.young@tufts.edu

‘Towards medicines for the future: improving efficiency in the innovation process’ Discussion paper commissioned by Organization for Economic Cooperation and Development, by J.M Reichert and C.P Milne, March 2006 (published report anticipated in 2007)

‘The innovation of medicines: Addressing unmet medical needs worldwide’, research project commissioned by the Pharmaceutical Researchers & Manufacturers of America, by C-P. Milne and B.Young (ongoing project as outlined in this id21 viewpoint)

World Health Organization (WHO) Global Burden of Disease (GBD) 2002 Revised Estimates

January 2007

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