1. Industry meeting with Nicholas Crisp on 27 February 2012
Feedback on
Industry meeting with Nicholas Crisp on 27 February 2012
Jaco van Biljon
23 March 2012

2. South Africa Health Products Regulatory Authority (SAHPRA) - Background
Still government policy to implement a new HA
Fundamental changes are required
Full implementation can take up to 5 years
Many grey areas to be covered
E.g. Act 101/1965 and Act 72/2008 refer to devices - no intention to regulate them yet
Act 72/2008 was signed by the president – never promulgated
Part of backlog project was to conceptualize a new Regulator, as a separate juristic person with the structure:
What kind of juristic person required ?
Minister of Health
CEO
Advisory Committee

3. Public Entities Public Finance Management Act (PFMA)
Provides for several options within governmental departments
However, no provision for such an entity in the Department of Health
Public entities
Autonomous
Report to Treasury
Must have a governing body
Act 72/2008 makes no provision for a governing body !
Unions are not in favour of parastatals

4. Act 72/2008
Went back to cabinet
SAHPRA was endorsed as public entity
SAHPRA name was approved – contradicts the removal of definition of “health product”
Without a governing board
With a CEO and Advisory Committee
Amendments :
e.g. removed the definition of a “health product”
Transitional provisions were strengthened
Not circulated for public comment – for reason : no substantive change
Still awaiting the parliamentary approval process

5. ….. 5 year implementation period though !
Feedback
….. 5 year implementation period though !
Backlog crisis was acknowledged
Assurance that the new HA will bring relief
No corruption, abuse and interpretation issues
New HA cannot be implemented until the Act is amended
New HA will take care of
CAMS
Food
Devices
Cosmetics
Disinfectants
African traditional medicines

6. New project team Project lead : Charles Dalton & Nicholas Crisp
Legal ( 2 persons to draft amendments and write new regulations)
IT ( 2 persons looking at the IT challenges in Civitas, e.g. own servers, implement EDMS, convert CTD to eCTD)
Finance (2 persons working on fees structure)
Industry interface person : Allison Vienings
Tasked to -
Determine specific capacities required to manage the various sectors
Extend the organogram
Write the job descriptions of each position (40 is already done, need more !)
Develop HR necessities
Conditions of service for employees
Infra structure development
Existing regulations and changes converted into new regulations and replace current references to Registrar, Council, etc. with new terminology
Close the gaps and write unambiguous regulations covering all sectors
Write new regulations for devices inline with global standards and nomenclature

7. Conclusions
New HA cannot function independently as long as they are situated in the Civitas building
Infrastructure proposal to be completed soonest
Budget available to the project team will last until June/July 2012
Challenging task to complete the infrastructure proposal in only 6 months
Amended Act 72/2008 must complete the approval process and be promulgated
Transition from MCC to new HA will need careful planning
The current backlog will not be immediately relieved with implementation of the new HA
Additional personnel for the new HA needs to be recruited and trained
Industry proposals for
Abbreviated review process for NCEs
“Blue print’ dossier for generics
will receive no consideration prior to implementation of the new HA

8. ….we will need to trust the system ….