CAPE TOWN — QdotPharma, the only South African-owned clinical research organisation able to do "first in man" drug studies, has closed its doors, citing delays in project approvals by the Medicines Control Council (MCC).
The closure has not only cost 80 highly skilled people their jobs, but will affect an industry already battling negative perceptions of SA as a destination for clinical drug development.
The delays at the MCC, which also hamper the capacity of pharmaceutical manufacturers to register new medicines for sale in SA, highlight the challenge the government faces in achieving its ambition of building a local pharmaceutical industry, as spelled out in its New Growth Path.
Clinical trials, which test the safety and efficacy of new medicines and vaccines, must be approved by the MCC before patients are enrolled.
In a globalised industry, where regulatory authorities such as the US Food and Drug Administration and the European Medicines Regulatory Agency review clinical trial applications within four weeks, delays at the MCC of even a few months can spell the end of a potential project, said QdotPharma owner Michelle Middle.
"There was a time when it seemed the MCC was getting its act together, but in the past 12 months it has been absolutely horrifying," she said. "They are not reliable, and unfortunately the message does go out to overseas companies. They are not willing to send work to SA because they know the chances are good there will be delays."
US-based Quintiles, which also operates in SA, agreed that the country’s image as a preferred destination for clinical trial research had taken a knock.
"Up until now we’ve been able to say (to drug makers) that there are improvements, albeit marginal, or at worst things have not regressed too much," Michael Klein, vice-president for sub-Saharan Africa, said yesterday.
"It becomes really difficult to toe that line when they can read that some company has closed down because of the performance of the MCC.
"Where you have places like India doing all they can to attract work, it’s easy to see how SA could become uncompetitive."
It typically took between four and six months to approve trials, Mr Klein said.
Victor Strugo, MD of clinical research organisation Triclinium, said the MCC’s turnaround time was erratic and uncertain.
"It’s really a Russian roulette as to whether an application gets processed or gathers dust," he said. "We would have more than double the business if they were more reliable."
SA had a strict regulatory system and patients lost out when clinical trials were cancelled, as they provided free access to drugs that might not otherwise be available to them, Mr Strugo said.
QdotPharma closed earlier this month after MCC delays led to two companies cancelling contracts worth R9m, Dr Middle said.
Registrar Mandisa Hela conceded MCC timelines for approving clinical trials "were not as quick as they should be", but suggested other factors may have contributed to QdotPharma’s fall.
The MCC had shortened its turnaround time from 16 to eight weeks for trial applications. "I’m the first to admit it’s not ideal, and we still have problems with post-approval amendments and protocol amendments," she said.
She blamed MCC resource constraints for the delays, saying the government planned to improve its regulatory capacity by replacing the council with the South African Health Products Regulatory Authority.
BusinessDay
http://www.businessday.co.za/articles/Content.aspx?id=174618