I’m in Riyadh, Saudi Arabia where I just spoke at the first Saudi Quality Forum (sponsored by King Saud University). I also had the opportunity to meet with the leadership of the Saudi Food and Drug Authority (SFDA) -- which is also the national reimbursement agency. (And no product gets licensed without first concluding price negotiations.)
And you thought FDA swings a big stick.
My suggestion to their executives is that they form an Office of Policy and Planning – and that one of the first items on the agenda be chairing a regular meeting of industry (both innovator and generic) and academia to address issues of common interest including API and excipient quality, biosimilars (specifically the issues of biosimilarity and interchangeability), 21st century pharmacovigilance, generic interchangability, and other issues that fill the Arabian regulatory gulf -- like re-registration.
The SFDA aspires to be not only the gold standard for the region, but also a world-class regulatory agency. But to do so they must recognize their responsibility to be both regulator and colleague to industry and an innovation enabler. Sound familiar?
My favorite sound-bite from the conference came courtesy of the SFDA’s Mohammed Dahhas (Executive Director of Inspection and Law Enforcement, Drug Sector): On the issue of quality by design, “Quality is the magic key.”
My favorite new concept came from Accenture’s Pierre Anhoury, who introduced the conference attendees to notion of “value vigilance” – a new way to view post-approval value-based reimbursement via pharmacovigilance, quality of life, therapeutic benefit, and pharmaco-economic impact. Maybe we should call it Phase 4.1.
(Have a look at Anhoury’s new white paper on the topic, Approval is Nothing: Why Pharmaceutical Companies Need a Value Management Operating Model.)
Wouldn’t it be NICE to bury the QALY in the sands of Saudi?
