The benefits of conducting clinical trials in the BRIC nations far outweigh the challenges that have traditionally discouraged multinational drugmakers.
That is the key message from a report by Thomson Reuters on doing business in Brazil, Russia, India and China. It notes, however, that there are many issues unique to the BRIC markets that can delay trials and drive costs upwards, citing local needs, regulatory hoops and quality issues.
In Brazil, for example, the analysis concludes that the “rapidly changing clinical landscape and complexity and lengthiness of approval and import processes” have been cited as the biggest drawbacks. It adds that “the multiple reviews required for placebo trials and the associated timelines and cost have also discouraged global sponsors”.
Thomson Reuters goes on to state that regulations in Russia and India “are being enacted faster than foreign pharmaceutical companies can keep up” with, while the upheaval of the healthcare system and “tumultuous landscape” in Russia are seen as additional barriers.
China is the only BRIC country that has experienced an increase in the number of clinical trials initiated each year, but foreign companies “continue to face challenges that limit their cost savings in the drug development process”.
Despite these issues, the report argues that the benefits of performing trials in BRIC countries are numerous. “A pool of almost three billion patients in research-rich centres across major cities leads to fast recruitment and cost-effective trials”, it states, adding that increased spending on healthcare and R&D has “fostered a growing number of educated and trained health professionals as well as investigational-medicine product manufacturers and central laboratories”.
