Interesting panel discussion at end of Stream A – Emerging Markets at Day Two at the World Vaccine Congress including:
âº Dr G S Reddy, Chief General Manager, Manufacturing, Indian Immunologicals
âº Prof Jorge Kalil, Director & Chairman of the Board, Instituto Butantan
âº Dr Uwe Peukert, Chief Medical Adviser, NewVac
The local player panel included vaccine experts working in Russia, India and Brazil. Each country has its unique challenges, but all of the panelists have found a way to work within these environments.
In Russia, Dr. Peukert says that it is not about the high level point of view – the devil is in the details and you really have to pay attention to the details. You need to have a local person who is well versed in an ever-changing regulatory environment to navigate. But there is significant opportunity. The Russian government has announced that they will move from importing 80% of drugs to 50% by 2020. In Russia, the government wants to be part of innovation. It is more important to be a part of an interesting new piece of medical science than to bring in a "me-too" drug. Also, you cannot start a clinical trial with a formulation that can be adapted in later trial phases. You need to have the final formulation at the start of the trials. If you change it, you need to begin again. Another barrier is that there is a minimum requirement that Russian patients are included in clinical trials in order for a vaccine to be approved in that country.
In Brazil, Dr. Kalil explained that most vaccines are low cost and the investment by public institutions for vaccines is relatively low. Every time a new vaccine is available, you need to go to the government and convince them that it is a good opportunity to build a local manufacturing facility in order to keep vaccine costs low.
Dr. Redy says that in India, the opportunity is with the private market. The government expects to pay very low prices for the public market and only provides vaccines against six diseases. All other vaccines are in private market. Even in the private market, pricing can't be too high. Dr. Redy says that there are Indian manufacturers who are ready to build new facilities and use tech transfer to manufacture existing vaccines.
In summary, emerging markets are critical and growing in importance both because of the market size and the manufacturing and clinical trial capabilities they now offer. There has been a lot of progress but challenges remain.