1. IPASA presentation to Portfolio Committee on Health 31 October 2014 Abeda Williams

2.  Introduction to IPASA  General comments on Bill 6  Key concerns on Bill 6 ‐ Structure and Governance ‐ Systems and Processes ‐ Resources ‐ Transitioning measures ‐ Enabling Regulations  Additions for consideration  Summary AGENDA 1

3.  Pharmaceutical Industry Trade association (Innovative Pharmaceutical Association of South Africa)  Role and Goals ‐ patient-focused healthcare system with universal access to quality care; ‐ Environment conducive to investment, continued development and sustainability of the pharmaceutical industry; ‐ Respect for and protection of intellectual property rights; ‐ Ethical conduct and practices; and ‐ Adherence to the Code of Marketing Practice. IPASA 2

4. 3 IPASA member companies (25)

5. General comments on Bill 6/Act 72 IPASA supports:  basic principles of Act 72 and Bill 6  establishment of SAHPRA Noted:  Several comments previously made by industry have been included in Bill 6 Presentation will focus on key concerns and general points for consideration 4

6. Structure and Governance 1.Accountability (S.2 (b) and (c) & 2A to I)  Organs of State like SAHPRA should report to Parliament on performance and MoH for oversight 2.Roles and responsibility of Board (section entitled “Functions of the Board” required)  Need to be defined e.g. responsible for technical or advisory oversight of committee 3. Expanded scope of SAHPRA (S.2 (b)  Inclusion of foodstuffs, devices etc., need clear functional responsibilities for each type of product 4. Advisor / technical committee ((S.4 (c))  Mandate needs to be defined 5

7. Processes and systems  Systems and processes need to be improved to allow SAHPRA to be efficient  Systems, processes need to be reviewed and changed ‐ Implementation of Risk Based Assessment ‐ Expand s(2)(b)(2) – must (not “may”) liaising with other Regulatory authorities and institutions to streamline processes ‐ Quality screening of all submissions and rejection of inferior submissions ‐ Separation of product reviews to benefit from specialised skills i.e. generics, new chemical entities, devices, etc 6

8. Resources  Regulatory Science Institute is welcomed but it will take a few years before adequately skilled people are available to SAHPRA, hence  Short Term ‐ Need to expedite clearing of the backlog by: o building capacity of existing staff o improving processes o Risk based assessments  Long Term ‐ Resource SAHPRA with competent and dedicated staff 7

9. Transitional measures Expanded scope (S. 2B(3)) (devices, foodstuffs)  Medicines currently under review by MCC – ‐ clarity needed on how process will be managed as well as transition into new structure  Diverse products to be “registered” ‐ Products need: o different regulatory pathways o defined call up process -Grandfathering for SAHPRA to manage process in accordance to its resources ‐ Question: how will products “on the market” that are not registered be managed?  Resourcing and Contingency plans Avoid transferring the backlog and creating additional backlogs 8

10. Enabling Regulations  Parallel process of consultation with industry prior to enactment of regulations and implementation of guidelines is required for effective implementation of the amended Medicines and Related Substances Act  Provisions made for enabling regulations to address concerns raised  Regulations defining timeframes and fee for services (S.35)  Regulations relating to governance, process,  Regulations relating to Functions of Authority 9

11. Additional comments  Overview of legislation is needed to avoid any conflicts / overlaps to allow structures to execute duties within an appropriate legal framework ‐ e.g. Foodstuffs Act, Hazardous Substances Act, National Health Act, etc.)  IPASA comments included Sections that needs clarity and minor technical changes e.g. ‐ Section 14 (a) (b) ‐ Section 22 (h) Note: distribution chain differs depending on whether it is a medicine, medical device or IVD) 10

12.  IPASA support Act 72 and the Bill of 2008 and Bill 6 of 2014  Request that Parliament Portfolio Committee on Health takes into consideration comments and proposal  A process of consultation with industry is needed to facilitate a seamless transition into the new SAPHRA structure and new process  It is critical to have a comprehensive business plan to guide the transition into the new structure. Summary 11

13. Contact: CEO of IPASA - Dr Konji Sebati Tel: (011) 781 3256