Q: What is your experience in managing Intellectual Property protection?
A.Lyubchenko – This is probably the toughest part. India is best. They have added protection laws in 2005 which launched the pharmaceutical industry in India. They also have Intellectual Property laws, which is good. Russia does not have such a such law; and I do not believe Brazil does either. Russia and China are taking steps. We try not to provide any additional information and only provide it to those who need it.



Q: How is Budget Management and Negotiation facilitated in BRIC Countries:
J. Zimmerman – Have a local attorney in that country, who is someone you can trust, negotiate for you.

L. Koelle – For negotiations, having someone local is the only way to do it right. There are other things to consider to include in the budget. For example, the sponsor is expected to pay for some things In Brazil, that is not written out, but understood by the ethics committee. Another example and “hot topic” is providing at no cost, the study drug post-trial. All these things need to be included in the budget and local people have that knowledge.
It’s the additional costs, especially in oncology trials, that the sponsor needs to be aware of.

Q: Are sponsors walking away from Brazil and using Brazil as a last resort?

L. Koelle – We had a huge increase in clinical research in Brazil for the past 5 years, and I think we are reaching a plateau. As people understand what is going on, the new regulations are not making sponsors leave, it’s a matter of them becoming comfortable with them and understanding the risks involved, and then they bring their trials to Brazil.