Feedback on Industry meeting with Nicholas Crisp on 27 February 2012

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 ? 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. 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 ….