Feedback on

1
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 ?

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
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 .