Significant progress is being made in particular in China
While pharmaceutical R&D is still heavily concentrated in high-income countries, there is a trend of such activities moving into middle-income countries. For example, between 2005 and 2010, the R&D spend by Pharmaceutical Research and Manufacturers of America (PhRMA) members increased by 455% in Asia-Pacific (excluding Japan), 112% in Latin America, 303% in India, a new report conducted by consultant Charles River Associates (CRA) has found.
The majority of pharmaceutical R&D sites of international firms are located in the US and Europe. Of the middle-income countries, China is leading the list with 12 R&D centres. India (3), Brazil (1) and Russia (1) also host R&D centres of international pharmaceutical companies.
These are some of the findings of the report, Policies That Encourage Innovation in Middle-Income Countries, which was released this week at the 26th Assembly of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) in Geneva, Switzerland. It examined growing biopharmaceutical innovation in Brazil, China, Colombia, India, Malaysia, Russia, South Africa and South Korea.
There has been a significant increase in the number of clinical trials in China (undertaken to a significant extent through the development of contract research organisations) and South Korea, but in South Africa and Russia the number is significant but appears to be declining or steady, the report has found. In terms of the types of trial, only China, South Korea and India have a significant proportion (over 10%) of Phase I trials.
China and Brazil have seen increased investment in early stage research, supported by an increase in publications by researchers and more patent applications. For example, in 2009, eight of the middle-income countries submitted 1,339 PCT pharmaceutical patent applications.
Tailoring medicines for the local markets in middle-income countries is common
Tailoring medicines for the local markets in middle-income countries is common, with a significant number of products developed in India and China, and there are a significant number of innovative products in Phases II and III. Although there have been a few commercialised novel medicines developed in South Korea, China and India, there are no international blockbuster drugs from middle-income countries.
In spite of this, the report says participating in a range of innovative activities will bring a number of extra benefits in the long term:
‘In recent years, the number of countries where biopharmaceutical innovation takes place has increased, and this trend is expected to continue,’ said Eduardo Pisani, IFPMA Director General. ‘Middle-income countries are becoming increasingly important for innovative activities ranging from early-stage research to clinical development. We commissioned this report because it is crucial for governments and industry to have a clearer understanding of what stimulates and drives innovation in these countries.’
The primary factors for success are consistent long-term policy and legal frameworks, the study says, which should be coupled with effective coordination of national industrial and health policies, encouragement of collaborations between stakeholders, and adequate intellectual property protection.