Next week, the 4th African Regulatory Conference in Senegal will bring together pharma and regulatory representatives to address the problem of increasing access to medicines across the continent.
One of the major setbacks is that there is limited regulatory capacity in many countries which leads to inefficiencies, delays in registration and an increased danger of counterfeits entering the market, but increased pharma investment in the region could help improve the system, according to Dakshina Reddy, DRA Head of Southern Africa at Novartis.
“The first step to investment is the technology transfer process,” he told in-Pharmatechnologist.com. “If you can then start building up technology then you will get the other building blocks in place, of which the regulatory standards and capacities are a key part, so in a way the tech transfer is the early entry point for the pharmaceutical industry.”
Reddy is also a member of the Africa Regulatory Network (ARN), a sub-group of industry-led body the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which advocates technology transfer as a means to increasing local manufacturing, drawing up regulatory guidance and improving access to medicine.
Political instability and IP
The group also adheres to the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property Rights of the World Health Organization (WHO) which looks “to promote transfer of technology and production of health products in developing countries through identification of best practices, and investment and capacity building provided by developed and developing countries where appropriate.”
Most Big Pharma firms, including Novartis, are yet to have invested in manufacturing capacity on the continent being put off by political instability and IP issues, but technology transfer is a “stepping stone to begin to have a better base,” Dakshina said, in what is a huge emerging market.
One example cited was Eli Lilly, which transferred technology for two tuberculosis drugs, capreomycin and cycloserine, to several manufacturers including Aspen in South Africa in order to global rise in multidrug-resistant tuberculosis cases in the late 1990s and early 2000s.
Gilead out-licensed its tech last year to bring the hepatitis C drug Sovaldi to the majority of African countries at a cut price, but the firm transferred its technology to Indian drugmakers, rather than supporting local manufacture.